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The Ultimate Guide to Qualitative Research - Part 1: The Basics

• Introduction and overview
• What is qualitative research?
• What is qualitative data?
• Examples of qualitative data
• Qualitative vs. quantitative research
• Mixed methods
• Qualitative research preparation
• Theoretical perspective
• Theoretical framework
• Literature reviews

Research question

• Conceptual framework
• Conceptual vs. theoretical framework

Data collection

• Qualitative research methods
• Focus groups
• Observational research

What is a case study?

Applications for case study research, what is a good case study, process of case study design, benefits and limitations of case studies.

• Ethnographical research
• Ethical considerations
• Confidentiality and privacy
• Power dynamics
• Reflexivity

Case studies

Case studies are essential to qualitative research , offering a lens through which researchers can investigate complex phenomena within their real-life contexts. This chapter explores the concept, purpose, applications, examples, and types of case studies and provides guidance on how to conduct case study research effectively.

Whereas quantitative methods look at phenomena at scale, case study research looks at a concept or phenomenon in considerable detail. While analyzing a single case can help understand one perspective regarding the object of research inquiry, analyzing multiple cases can help obtain a more holistic sense of the topic or issue. Let's provide a basic definition of a case study, then explore its characteristics and role in the qualitative research process.

Definition of a case study

A case study in qualitative research is a strategy of inquiry that involves an in-depth investigation of a phenomenon within its real-world context. It provides researchers with the opportunity to acquire an in-depth understanding of intricate details that might not be as apparent or accessible through other methods of research. The specific case or cases being studied can be a single person, group, or organization – demarcating what constitutes a relevant case worth studying depends on the researcher and their research question .

Among qualitative research methods , a case study relies on multiple sources of evidence, such as documents, artifacts, interviews , or observations , to present a complete and nuanced understanding of the phenomenon under investigation. The objective is to illuminate the readers' understanding of the phenomenon beyond its abstract statistical or theoretical explanations.

Characteristics of case studies

Case studies typically possess a number of distinct characteristics that set them apart from other research methods. These characteristics include a focus on holistic description and explanation, flexibility in the design and data collection methods, reliance on multiple sources of evidence, and emphasis on the context in which the phenomenon occurs.

Furthermore, case studies can often involve a longitudinal examination of the case, meaning they study the case over a period of time. These characteristics allow case studies to yield comprehensive, in-depth, and richly contextualized insights about the phenomenon of interest.

The role of case studies in research

Case studies hold a unique position in the broader landscape of research methods aimed at theory development. They are instrumental when the primary research interest is to gain an intensive, detailed understanding of a phenomenon in its real-life context.

In addition, case studies can serve different purposes within research - they can be used for exploratory, descriptive, or explanatory purposes, depending on the research question and objectives. This flexibility and depth make case studies a valuable tool in the toolkit of qualitative researchers.

Remember, a well-conducted case study can offer a rich, insightful contribution to both academic and practical knowledge through theory development or theory verification, thus enhancing our understanding of complex phenomena in their real-world contexts.

What is the purpose of a case study?

Case study research aims for a more comprehensive understanding of phenomena, requiring various research methods to gather information for qualitative analysis . Ultimately, a case study can allow the researcher to gain insight into a particular object of inquiry and develop a theoretical framework relevant to the research inquiry.

Why use case studies in qualitative research?

Using case studies as a research strategy depends mainly on the nature of the research question and the researcher's access to the data.

Conducting case study research provides a level of detail and contextual richness that other research methods might not offer. They are beneficial when there's a need to understand complex social phenomena within their natural contexts.

The explanatory, exploratory, and descriptive roles of case studies

Case studies can take on various roles depending on the research objectives. They can be exploratory when the research aims to discover new phenomena or define new research questions; they are descriptive when the objective is to depict a phenomenon within its context in a detailed manner; and they can be explanatory if the goal is to understand specific relationships within the studied context. Thus, the versatility of case studies allows researchers to approach their topic from different angles, offering multiple ways to uncover and interpret the data .

The impact of case studies on knowledge development

Case studies play a significant role in knowledge development across various disciplines. Analysis of cases provides an avenue for researchers to explore phenomena within their context based on the collected data.

This can result in the production of rich, practical insights that can be instrumental in both theory-building and practice. Case studies allow researchers to delve into the intricacies and complexities of real-life situations, uncovering insights that might otherwise remain hidden.

Types of case studies

In qualitative research , a case study is not a one-size-fits-all approach. Depending on the nature of the research question and the specific objectives of the study, researchers might choose to use different types of case studies. These types differ in their focus, methodology, and the level of detail they provide about the phenomenon under investigation.

Understanding these types is crucial for selecting the most appropriate approach for your research project and effectively achieving your research goals. Let's briefly look at the main types of case studies.

Exploratory case studies

Exploratory case studies are typically conducted to develop a theory or framework around an understudied phenomenon. They can also serve as a precursor to a larger-scale research project. Exploratory case studies are useful when a researcher wants to identify the key issues or questions which can spur more extensive study or be used to develop propositions for further research. These case studies are characterized by flexibility, allowing researchers to explore various aspects of a phenomenon as they emerge, which can also form the foundation for subsequent studies.

Descriptive case studies

Descriptive case studies aim to provide a complete and accurate representation of a phenomenon or event within its context. These case studies are often based on an established theoretical framework, which guides how data is collected and analyzed. The researcher is concerned with describing the phenomenon in detail, as it occurs naturally, without trying to influence or manipulate it.

Explanatory case studies

Explanatory case studies are focused on explanation - they seek to clarify how or why certain phenomena occur. Often used in complex, real-life situations, they can be particularly valuable in clarifying causal relationships among concepts and understanding the interplay between different factors within a specific context.

Intrinsic, instrumental, and collective case studies

These three categories of case studies focus on the nature and purpose of the study. An intrinsic case study is conducted when a researcher has an inherent interest in the case itself. Instrumental case studies are employed when the case is used to provide insight into a particular issue or phenomenon. A collective case study, on the other hand, involves studying multiple cases simultaneously to investigate some general phenomena.

Each type of case study serves a different purpose and has its own strengths and challenges. The selection of the type should be guided by the research question and objectives, as well as the context and constraints of the research.

The flexibility, depth, and contextual richness offered by case studies make this approach an excellent research method for various fields of study. They enable researchers to investigate real-world phenomena within their specific contexts, capturing nuances that other research methods might miss. Across numerous fields, case studies provide valuable insights into complex issues.

Critical information systems research

Case studies provide a detailed understanding of the role and impact of information systems in different contexts. They offer a platform to explore how information systems are designed, implemented, and used and how they interact with various social, economic, and political factors. Case studies in this field often focus on examining the intricate relationship between technology, organizational processes, and user behavior, helping to uncover insights that can inform better system design and implementation.

Health research

Health research is another field where case studies are highly valuable. They offer a way to explore patient experiences, healthcare delivery processes, and the impact of various interventions in a real-world context.

Case studies can provide a deep understanding of a patient's journey, giving insights into the intricacies of disease progression, treatment effects, and the psychosocial aspects of health and illness.

Asthma research studies

Specifically within medical research, studies on asthma often employ case studies to explore the individual and environmental factors that influence asthma development, management, and outcomes. A case study can provide rich, detailed data about individual patients' experiences, from the triggers and symptoms they experience to the effectiveness of various management strategies. This can be crucial for developing patient-centered asthma care approaches.

Other fields

Apart from the fields mentioned, case studies are also extensively used in business and management research, education research, and political sciences, among many others. They provide an opportunity to delve into the intricacies of real-world situations, allowing for a comprehensive understanding of various phenomena.

Case studies, with their depth and contextual focus, offer unique insights across these varied fields. They allow researchers to illuminate the complexities of real-life situations, contributing to both theory and practice.

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Understanding the key elements of case study design is crucial for conducting rigorous and impactful case study research. A well-structured design guides the researcher through the process, ensuring that the study is methodologically sound and its findings are reliable and valid. The main elements of case study design include the research question , propositions, units of analysis, and the logic linking the data to the propositions.

The research question is the foundation of any research study. A good research question guides the direction of the study and informs the selection of the case, the methods of collecting data, and the analysis techniques. A well-formulated research question in case study research is typically clear, focused, and complex enough to merit further detailed examination of the relevant case(s).

Propositions

Propositions, though not necessary in every case study, provide a direction by stating what we might expect to find in the data collected. They guide how data is collected and analyzed by helping researchers focus on specific aspects of the case. They are particularly important in explanatory case studies, which seek to understand the relationships among concepts within the studied phenomenon.

Units of analysis

The unit of analysis refers to the case, or the main entity or entities that are being analyzed in the study. In case study research, the unit of analysis can be an individual, a group, an organization, a decision, an event, or even a time period. It's crucial to clearly define the unit of analysis, as it shapes the qualitative data analysis process by allowing the researcher to analyze a particular case and synthesize analysis across multiple case studies to draw conclusions.

Argumentation

This refers to the inferential model that allows researchers to draw conclusions from the data. The researcher needs to ensure that there is a clear link between the data, the propositions (if any), and the conclusions drawn. This argumentation is what enables the researcher to make valid and credible inferences about the phenomenon under study.

Understanding and carefully considering these elements in the design phase of a case study can significantly enhance the quality of the research. It can help ensure that the study is methodologically sound and its findings contribute meaningful insights about the case.

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Conducting a case study involves several steps, from defining the research question and selecting the case to collecting and analyzing data . This section outlines these key stages, providing a practical guide on how to conduct case study research.

Defining the research question

The first step in case study research is defining a clear, focused research question. This question should guide the entire research process, from case selection to analysis. It's crucial to ensure that the research question is suitable for a case study approach. Typically, such questions are exploratory or descriptive in nature and focus on understanding a phenomenon within its real-life context.

Selecting and defining the case

The selection of the case should be based on the research question and the objectives of the study. It involves choosing a unique example or a set of examples that provide rich, in-depth data about the phenomenon under investigation. After selecting the case, it's crucial to define it clearly, setting the boundaries of the case, including the time period and the specific context.

Previous research can help guide the case study design. When considering a case study, an example of a case could be taken from previous case study research and used to define cases in a new research inquiry. Considering recently published examples can help understand how to select and define cases effectively.

Developing a detailed case study protocol

A case study protocol outlines the procedures and general rules to be followed during the case study. This includes the data collection methods to be used, the sources of data, and the procedures for analysis. Having a detailed case study protocol ensures consistency and reliability in the study.

The protocol should also consider how to work with the people involved in the research context to grant the research team access to collecting data. As mentioned in previous sections of this guide, establishing rapport is an essential component of qualitative research as it shapes the overall potential for collecting and analyzing data.

Collecting data

Gathering data in case study research often involves multiple sources of evidence, including documents, archival records, interviews, observations, and physical artifacts. This allows for a comprehensive understanding of the case. The process for gathering data should be systematic and carefully documented to ensure the reliability and validity of the study.

Analyzing and interpreting data

The next step is analyzing the data. This involves organizing the data , categorizing it into themes or patterns , and interpreting these patterns to answer the research question. The analysis might also involve comparing the findings with prior research or theoretical propositions.

Writing the case study report

The final step is writing the case study report . This should provide a detailed description of the case, the data, the analysis process, and the findings. The report should be clear, organized, and carefully written to ensure that the reader can understand the case and the conclusions drawn from it.

Each of these steps is crucial in ensuring that the case study research is rigorous, reliable, and provides valuable insights about the case.

The type, depth, and quality of data in your study can significantly influence the validity and utility of the study. In case study research, data is usually collected from multiple sources to provide a comprehensive and nuanced understanding of the case. This section will outline the various methods of collecting data used in case study research and discuss considerations for ensuring the quality of the data.

Interviews are a common method of gathering data in case study research. They can provide rich, in-depth data about the perspectives, experiences, and interpretations of the individuals involved in the case. Interviews can be structured , semi-structured , or unstructured , depending on the research question and the degree of flexibility needed.

Observations

Observations involve the researcher observing the case in its natural setting, providing first-hand information about the case and its context. Observations can provide data that might not be revealed in interviews or documents, such as non-verbal cues or contextual information.

Documents and artifacts

Documents and archival records provide a valuable source of data in case study research. They can include reports, letters, memos, meeting minutes, email correspondence, and various public and private documents related to the case.

These records can provide historical context, corroborate evidence from other sources, and offer insights into the case that might not be apparent from interviews or observations.

Physical artifacts refer to any physical evidence related to the case, such as tools, products, or physical environments. These artifacts can provide tangible insights into the case, complementing the data gathered from other sources.

Ensuring the quality of data collection

Determining the quality of data in case study research requires careful planning and execution. It's crucial to ensure that the data is reliable, accurate, and relevant to the research question. This involves selecting appropriate methods of collecting data, properly training interviewers or observers, and systematically recording and storing the data. It also includes considering ethical issues related to collecting and handling data, such as obtaining informed consent and ensuring the privacy and confidentiality of the participants.

Data analysis

Analyzing case study research involves making sense of the rich, detailed data to answer the research question. This process can be challenging due to the volume and complexity of case study data. However, a systematic and rigorous approach to analysis can ensure that the findings are credible and meaningful. This section outlines the main steps and considerations in analyzing data in case study research.

Organizing the data

The first step in the analysis is organizing the data. This involves sorting the data into manageable sections, often according to the data source or the theme. This step can also involve transcribing interviews, digitizing physical artifacts, or organizing observational data.

Categorizing and coding the data

Once the data is organized, the next step is to categorize or code the data. This involves identifying common themes, patterns, or concepts in the data and assigning codes to relevant data segments. Coding can be done manually or with the help of software tools, and in either case, qualitative analysis software can greatly facilitate the entire coding process. Coding helps to reduce the data to a set of themes or categories that can be more easily analyzed.

Identifying patterns and themes

After coding the data, the researcher looks for patterns or themes in the coded data. This involves comparing and contrasting the codes and looking for relationships or patterns among them. The identified patterns and themes should help answer the research question.

Interpreting the data

Once patterns and themes have been identified, the next step is to interpret these findings. This involves explaining what the patterns or themes mean in the context of the research question and the case. This interpretation should be grounded in the data, but it can also involve drawing on theoretical concepts or prior research.

Verification of the data

The last step in the analysis is verification. This involves checking the accuracy and consistency of the analysis process and confirming that the findings are supported by the data. This can involve re-checking the original data, checking the consistency of codes, or seeking feedback from research participants or peers.

Like any research method , case study research has its strengths and limitations. Researchers must be aware of these, as they can influence the design, conduct, and interpretation of the study.

Understanding the strengths and limitations of case study research can also guide researchers in deciding whether this approach is suitable for their research question . This section outlines some of the key strengths and limitations of case study research.

Benefits include the following:

• Rich, detailed data: One of the main strengths of case study research is that it can generate rich, detailed data about the case. This can provide a deep understanding of the case and its context, which can be valuable in exploring complex phenomena.
• Flexibility: Case study research is flexible in terms of design , data collection , and analysis . A sufficient degree of flexibility allows the researcher to adapt the study according to the case and the emerging findings.
• Real-world context: Case study research involves studying the case in its real-world context, which can provide valuable insights into the interplay between the case and its context.
• Multiple sources of evidence: Case study research often involves collecting data from multiple sources , which can enhance the robustness and validity of the findings.

On the other hand, researchers should consider the following limitations:

• Generalizability: A common criticism of case study research is that its findings might not be generalizable to other cases due to the specificity and uniqueness of each case.
• Time and resource intensive: Case study research can be time and resource intensive due to the depth of the investigation and the amount of collected data.
• Complexity of analysis: The rich, detailed data generated in case study research can make analyzing the data challenging.
• Subjectivity: Given the nature of case study research, there may be a higher degree of subjectivity in interpreting the data , so researchers need to reflect on this and transparently convey to audiences how the research was conducted.

Being aware of these strengths and limitations can help researchers design and conduct case study research effectively and interpret and report the findings appropriately.

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How to Write a Case Study: Bookmarkable Guide & Template

Published: November 30, 2023

Earning the trust of prospective customers can be a struggle. Before you can even begin to expect to earn their business, you need to demonstrate your ability to deliver on what your product or service promises.

Sure, you could say that you're great at X or that you're way ahead of the competition when it comes to Y. But at the end of the day, what you really need to win new business is cold, hard proof.

One of the best ways to prove your worth is through a compelling case study. In fact, HubSpot’s 2020 State of Marketing report found that case studies are so compelling that they are the fifth most commonly used type of content used by marketers.

Below, I'll walk you through what a case study is, how to prepare for writing one, what you need to include in it, and how it can be an effective tactic. To jump to different areas of this post, click on the links below to automatically scroll.

Case Study Definition

Case study templates, how to write a case study.

• How to Format a Case Study

Business Case Study Examples

A case study is a specific challenge a business has faced, and the solution they've chosen to solve it. Case studies can vary greatly in length and focus on several details related to the initial challenge and applied solution, and can be presented in various forms like a video, white paper, blog post, etc.

In professional settings, it's common for a case study to tell the story of a successful business partnership between a vendor and a client. Perhaps the success you're highlighting is in the number of leads your client generated, customers closed, or revenue gained. Any one of these key performance indicators (KPIs) are examples of your company's services in action.

When done correctly, these examples of your work can chronicle the positive impact your business has on existing or previous customers and help you attract new clients.

Free Case Study Templates

Showcase your company's success using these three free case study templates.

• Data-Driven Case Study Template
• Product-Specific Case Study Template
• General Case Study Template

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Why write a case study? 

I know, you’re thinking “ Okay, but why do I need to write one of these? ” The truth is that while case studies are a huge undertaking, they are powerful marketing tools that allow you to demonstrate the value of your product to potential customers using real-world examples. Here are a few reasons why you should write case studies. 

1. Explain Complex Topics or Concepts

Case studies give you the space to break down complex concepts, ideas, and strategies and show how they can be applied in a practical way. You can use real-world examples, like an existing client, and use their story to create a compelling narrative that shows how your product solved their issue and how those strategies can be repeated to help other customers get similar successful results.  

2. Show Expertise

Case studies are a great way to demonstrate your knowledge and expertise on a given topic or industry. This is where you get the opportunity to show off your problem-solving skills and how you’ve generated successful outcomes for clients you’ve worked with. 

3. Build Trust and Credibility

In addition to showing off the attributes above, case studies are an excellent way to build credibility. They’re often filled with data and thoroughly researched, which shows readers you’ve done your homework. They can have confidence in the solutions you’ve presented because they’ve read through as you’ve explained the problem and outlined step-by-step what it took to solve it. All of these elements working together enable you to build trust with potential customers.

4. Create Social Proof

Using existing clients that have seen success working with your brand builds social proof . People are more likely to choose your brand if they know that others have found success working with you. Case studies do just that — putting your success on display for potential customers to see. 

All of these attributes work together to help you gain more clients. Plus you can even use quotes from customers featured in these studies and repurpose them in other marketing content. Now that you know more about the benefits of producing a case study, let’s check out how long these documents should be. 

How long should a case study be?

The length of a case study will vary depending on the complexity of the project or topic discussed. However, as a general guideline, case studies typically range from 500 to 1,500 words. 

Whatever length you choose, it should provide a clear understanding of the challenge, the solution you implemented, and the results achieved. This may be easier said than done, but it's important to strike a balance between providing enough detail to make the case study informative and concise enough to keep the reader's interest.

The primary goal here is to effectively communicate the key points and takeaways of the case study. It’s worth noting that this shouldn’t be a wall of text. Use headings, subheadings, bullet points, charts, and other graphics to break up the content and make it more scannable for readers. We’ve also seen brands incorporate video elements into case studies listed on their site for a more engaging experience. 

Ultimately, the length of your case study should be determined by the amount of information necessary to convey the story and its impact without becoming too long. Next, let’s look at some templates to take the guesswork out of creating one. 

To help you arm your prospects with information they can trust, we've put together a step-by-step guide on how to create effective case studies for your business with free case study templates for creating your own.

Tell us a little about yourself below to gain access today:

And to give you more options, we’ll highlight some useful templates that serve different needs. But remember, there are endless possibilities when it comes to demonstrating the work your business has done.

1. General Case Study Template

Do you have a specific product or service that you’re trying to sell, but not enough reviews or success stories? This Product Specific case study template will help.

This template relies less on metrics, and more on highlighting the customer’s experience and satisfaction. As you follow the template instructions, you’ll be prompted to speak more about the benefits of the specific product, rather than your team’s process for working with the customer.

4. Bold Social Media Business Case Study Template

You can find templates that represent different niches, industries, or strategies that your business has found success in — like a bold social media business case study template.

In this template, you can tell the story of how your social media marketing strategy has helped you or your client through collaboration or sale of your service. Customize it to reflect the different marketing channels used in your business and show off how well your business has been able to boost traffic, engagement, follows, and more.

5. Lead Generation Business Case Study Template

It’s important to note that not every case study has to be the product of a sale or customer story, sometimes they can be informative lessons that your own business has experienced. A great example of this is the Lead Generation Business case study template.

If you’re looking to share operational successes regarding how your team has improved processes or content, you should include the stories of different team members involved, how the solution was found, and how it has made a difference in the work your business does.

Now that we’ve discussed different templates and ideas for how to use them, let’s break down how to create your own case study with one.

• Get started with case study templates.
• Determine the case study's objective.
• Establish a case study medium.
• Find the right case study candidate.
• Contact your candidate for permission to write about them.
• Ensure you have all the resources you need to proceed once you get a response.
• Download a case study email template.
• Define the process you want to follow with the client.
• Ensure you're asking the right questions.
• Layout your case study format.
• Publish and promote your case study.

1. Get started with case study templates.

Telling your customer's story is a delicate process — you need to highlight their success while naturally incorporating your business into their story.

If you're just getting started with case studies, we recommend you download HubSpot's Case Study Templates we mentioned before to kickstart the process.

2. Determine the case study's objective.

All business case studies are designed to demonstrate the value of your services, but they can focus on several different client objectives.

Your first step when writing a case study is to determine the objective or goal of the subject you're featuring. In other words, what will the client have succeeded in doing by the end of the piece?

The client objective you focus on will depend on what you want to prove to your future customers as a result of publishing this case study.

Your case study can focus on one of the following client objectives:

• Complying with government regulation
• Lowering business costs
• Becoming profitable
• Generating more leads
• Closing on more customers
• Generating more revenue
• Expanding into a new market
• Becoming more sustainable or energy-efficient

3. Establish a case study medium.

Next, you'll determine the medium in which you'll create the case study. In other words, how will you tell this story?

Case studies don't have to be simple, written one-pagers. Using different media in your case study can allow you to promote your final piece on different channels. For example, while a written case study might just live on your website and get featured in a Facebook post, you can post an infographic case study on Pinterest and a video case study on your YouTube channel.

Here are some different case study mediums to consider:

Written Case Study

Consider writing this case study in the form of an ebook and converting it to a downloadable PDF. Then, gate the PDF behind a landing page and form for readers to fill out before downloading the piece, allowing this case study to generate leads for your business.

Video Case Study

Plan on meeting with the client and shooting an interview. Seeing the subject, in person, talk about the service you provided them can go a long way in the eyes of your potential customers.

Infographic Case Study

Use the long, vertical format of an infographic to tell your success story from top to bottom. As you progress down the infographic, emphasize major KPIs using bigger text and charts that show the successes your client has had since working with you.

Podcast Case Study

Podcasts are a platform for you to have a candid conversation with your client. This type of case study can sound more real and human to your audience — they'll know the partnership between you and your client was a genuine success.

4. Find the right case study candidate.

Writing about your previous projects requires more than picking a client and telling a story. You need permission, quotes, and a plan. To start, here are a few things to look for in potential candidates.

Product Knowledge

It helps to select a customer who's well-versed in the logistics of your product or service. That way, he or she can better speak to the value of what you offer in a way that makes sense for future customers.

Remarkable Results

Clients that have seen the best results are going to make the strongest case studies. If their own businesses have seen an exemplary ROI from your product or service, they're more likely to convey the enthusiasm that you want prospects to feel, too.

One part of this step is to choose clients who have experienced unexpected success from your product or service. When you've provided non-traditional customers — in industries that you don't usually work with, for example — with positive results, it can help to remove doubts from prospects.

Recognizable Names

While small companies can have powerful stories, bigger or more notable brands tend to lend credibility to your own. In fact, 89% of consumers say they'll buy from a brand they already recognize over a competitor, especially if they already follow them on social media.

Customers that came to you after working with a competitor help highlight your competitive advantage and might even sway decisions in your favor.

5. Contact your candidate for permission to write about them.

To get the case study candidate involved, you have to set the stage for clear and open communication. That means outlining expectations and a timeline right away — not having those is one of the biggest culprits in delayed case study creation.

Most importantly at this point, however, is getting your subject's approval. When first reaching out to your case study candidate, provide them with the case study's objective and format — both of which you will have come up with in the first two steps above.

To get this initial permission from your subject, put yourself in their shoes — what would they want out of this case study? Although you're writing this for your own company's benefit, your subject is far more interested in the benefit it has for them.

Benefits to Offer Your Case Study Candidate

Here are four potential benefits you can promise your case study candidate to gain their approval.

Brand Exposure

Explain to your subject to whom this case study will be exposed, and how this exposure can help increase their brand awareness both in and beyond their own industry. In the B2B sector, brand awareness can be hard to collect outside one's own market, making case studies particularly useful to a client looking to expand their name's reach.

Employee Exposure

Allow your subject to provide quotes with credits back to specific employees. When this is an option for them, their brand isn't the only thing expanding its reach — their employees can get their name out there, too. This presents your subject with networking and career development opportunities they might not have otherwise.

Product Discount

This is a more tangible incentive you can offer your case study candidate, especially if they're a current customer of yours. If they agree to be your subject, offer them a product discount — or a free trial of another product — as a thank-you for their help creating your case study.

Backlinks and Website Traffic

Here's a benefit that is sure to resonate with your subject's marketing team: If you publish your case study on your website, and your study links back to your subject's website — known as a "backlink" — this small gesture can give them website traffic from visitors who click through to your subject's website.

Additionally, a backlink from you increases your subject's page authority in the eyes of Google. This helps them rank more highly in search engine results and collect traffic from readers who are already looking for information about their industry.

6. Ensure you have all the resources you need to proceed once you get a response.

So you know what you’re going to offer your candidate, it’s time that you prepare the resources needed for if and when they agree to participate, like a case study release form and success story letter.

Let's break those two down.

Case Study Release Form

This document can vary, depending on factors like the size of your business, the nature of your work, and what you intend to do with the case studies once they are completed. That said, you should typically aim to include the following in the Case Study Release Form:

• A clear explanation of why you are creating this case study and how it will be used.
• A statement defining the information and potentially trademarked information you expect to include about the company — things like names, logos, job titles, and pictures.
• An explanation of what you expect from the participant, beyond the completion of the case study. For example, is this customer willing to act as a reference or share feedback, and do you have permission to pass contact information along for these purposes?
• A note about compensation.

Success Story Letter

As noted in the sample email, this document serves as an outline for the entire case study process. Other than a brief explanation of how the customer will benefit from case study participation, you'll want to be sure to define the following steps in the Success Story Letter.

7. Download a case study email template.

While you gathered your resources, your candidate has gotten time to read over the proposal. When your candidate approves of your case study, it's time to send them a release form.

A case study release form tells you what you'll need from your chosen subject, like permission to use any brand names and share the project information publicly. Kick-off this process with an email that runs through exactly what they can expect from you, as well as what you need from them. To give you an idea of what that might look like, check out this sample email:

8. Define the process you want to follow with the client.

Before you can begin the case study, you have to have a clear outline of the case study process with your client. An example of an effective outline would include the following information.

The Acceptance

First, you'll need to receive internal approval from the company's marketing team. Once approved, the Release Form should be signed and returned to you. It's also a good time to determine a timeline that meets the needs and capabilities of both teams.

The Questionnaire

To ensure that you have a productive interview — which is one of the best ways to collect information for the case study — you'll want to ask the participant to complete a questionnaire before this conversation. That will provide your team with the necessary foundation to organize the interview, and get the most out of it.

The Interview

Once the questionnaire is completed, someone on your team should reach out to the participant to schedule a 30- to 60-minute interview, which should include a series of custom questions related to the customer's experience with your product or service.

The Draft Review

After the case study is composed, you'll want to send a draft to the customer, allowing an opportunity to give you feedback and edits.

The Final Approval

Once any necessary edits are completed, send a revised copy of the case study to the customer for final approval.

Once the case study goes live — on your website or elsewhere — it's best to contact the customer with a link to the page where the case study lives. Don't be afraid to ask your participants to share these links with their own networks, as it not only demonstrates your ability to deliver positive results and impressive growth, as well.

9. Ensure you're asking the right questions.

Before you execute the questionnaire and actual interview, make sure you're setting yourself up for success. A strong case study results from being prepared to ask the right questions. What do those look like? Here are a few examples to get you started:

• What are your goals?
• What challenges were you experiencing before purchasing our product or service?
• What made our product or service stand out against our competitors?
• What did your decision-making process look like?
• How have you benefited from using our product or service? (Where applicable, always ask for data.)

Keep in mind that the questionnaire is designed to help you gain insights into what sort of strong, success-focused questions to ask during the actual interview. And once you get to that stage, we recommend that you follow the "Golden Rule of Interviewing." Sounds fancy, right? It's actually quite simple — ask open-ended questions.

If you're looking to craft a compelling story, "yes" or "no" answers won't provide the details you need. Focus on questions that invite elaboration, such as, "Can you describe ...?" or, "Tell me about ..."

In terms of the interview structure, we recommend categorizing the questions and flowing them into six specific sections that will mirror a successful case study format. Combined, they'll allow you to gather enough information to put together a rich, comprehensive study.

Open with the customer's business.

The goal of this section is to generate a better understanding of the company's current challenges and goals, and how they fit into the landscape of their industry. Sample questions might include:

• How long have you been in business?
• How many employees do you have?
• What are some of the objectives of your department at this time?

Cite a problem or pain point.

To tell a compelling story, you need context. That helps match the customer's need with your solution. Sample questions might include:

• What challenges and objectives led you to look for a solution?
• What might have happened if you did not identify a solution?
• Did you explore other solutions before this that did not work out? If so, what happened?

Discuss the decision process.

Exploring how the customer decided to work with you helps to guide potential customers through their own decision-making processes. Sample questions might include:

• How did you hear about our product or service?
• Who was involved in the selection process?
• What was most important to you when evaluating your options?

Explain how a solution was implemented.

The focus here should be placed on the customer's experience during the onboarding process. Sample questions might include:

• How long did it take to get up and running?
• Did that meet your expectations?
• Who was involved in the process?

Explain how the solution works.

The goal of this section is to better understand how the customer is using your product or service. Sample questions might include:

• Is there a particular aspect of the product or service that you rely on most?
• Who is using the product or service?

End with the results.

In this section, you want to uncover impressive measurable outcomes — the more numbers, the better. Sample questions might include:

• How is the product or service helping you save time and increase productivity?
• In what ways does that enhance your competitive advantage?
• How much have you increased metrics X, Y, and Z?

10. Lay out your case study format.

When it comes time to take all of the information you've collected and actually turn it into something, it's easy to feel overwhelmed. Where should you start? What should you include? What's the best way to structure it?

To help you get a handle on this step, it's important to first understand that there is no one-size-fits-all when it comes to the ways you can present a case study. They can be very visual, which you'll see in some of the examples we've included below, and can sometimes be communicated mostly through video or photos, with a bit of accompanying text.

Here are the sections we suggest, which we'll cover in more detail down below:

• Title: Keep it short. Develop a succinct but interesting project name you can give the work you did with your subject.
• Subtitle: Use this copy to briefly elaborate on the accomplishment. What was done? The case study itself will explain how you got there.
• Executive Summary : A 2-4 sentence summary of the entire story. You'll want to follow it with 2-3 bullet points that display metrics showcasing success.
• About the Subject: An introduction to the person or company you served, which can be pulled from a LinkedIn Business profile or client website.
• Challenges and Objectives: A 2-3 paragraph description of the customer's challenges, before using your product or service. This section should also include the goals or objectives the customer set out to achieve.
• How Product/Service Helped: A 2-3 paragraph section that describes how your product or service provided a solution to their problem.
• Results: A 2-3 paragraph testimonial that proves how your product or service specifically benefited the person or company and helped achieve its goals. Include numbers to quantify your contributions.
• Supporting Visuals or Quotes: Pick one or two powerful quotes that you would feature at the bottom of the sections above, as well as a visual that supports the story you are telling.
• Future Plans: Everyone likes an epilogue. Comment on what's ahead for your case study subject, whether or not those plans involve you.
• Call to Action (CTA): Not every case study needs a CTA, but putting a passive one at the end of your case study can encourage your readers to take an action on your website after learning about the work you've done.

When laying out your case study, focus on conveying the information you've gathered in the most clear and concise way possible. Make it easy to scan and comprehend, and be sure to provide an attractive call-to-action at the bottom — that should provide readers an opportunity to learn more about your product or service.

11. Publish and promote your case study.

Once you've completed your case study, it's time to publish and promote it. Some case study formats have pretty obvious promotional outlets — a video case study can go on YouTube, just as an infographic case study can go on Pinterest.

But there are still other ways to publish and promote your case study. Here are a couple of ideas:

Lead Gen in a Blog Post

As stated earlier in this article, written case studies make terrific lead-generators if you convert them into a downloadable format, like a PDF. To generate leads from your case study, consider writing a blog post that tells an abbreviated story of your client's success and asking readers to fill out a form with their name and email address if they'd like to read the rest in your PDF.

Then, promote this blog post on social media, through a Facebook post or a tweet.

Published as a Page on Your Website

As a growing business, you might need to display your case study out in the open to gain the trust of your target audience.

Rather than gating it behind a landing page, publish your case study to its own page on your website, and direct people here from your homepage with a "Case Studies" or "Testimonials" button along your homepage's top navigation bar.

Format for a Case Study

The traditional case study format includes the following parts: a title and subtitle, a client profile, a summary of the customer’s challenges and objectives, an account of how your solution helped, and a description of the results. You might also want to include supporting visuals and quotes, future plans, and calls-to-action.

Image Source

The title is one of the most important parts of your case study. It should draw readers in while succinctly describing the potential benefits of working with your company. To that end, your title should:

• State the name of your custome r. Right away, the reader must learn which company used your products and services. This is especially important if your customer has a recognizable brand. If you work with individuals and not companies, you may omit the name and go with professional titles: “A Marketer…”, “A CFO…”, and so forth.
• State which product your customer used . Even if you only offer one product or service, or if your company name is the same as your product name, you should still include the name of your solution. That way, readers who are not familiar with your business can become aware of what you sell.
• Allude to the results achieved . You don’t necessarily need to provide hard numbers, but the title needs to represent the benefits, quickly. That way, if a reader doesn’t stay to read, they can walk away with the most essential information: Your product works.

The example above, “Crunch Fitness Increases Leads and Signups With HubSpot,” achieves all three — without being wordy. Keeping your title short and sweet is also essential.

2. Subtitle

Your subtitle is another essential part of your case study — don’t skip it, even if you think you’ve done the work with the title. In this section, include a brief summary of the challenges your customer was facing before they began to use your products and services. Then, drive the point home by reiterating the benefits your customer experienced by working with you.

The above example reads:

“Crunch Fitness was franchising rapidly when COVID-19 forced fitness clubs around the world to close their doors. But the company stayed agile by using HubSpot to increase leads and free trial signups.”

We like that the case study team expressed the urgency of the problem — opening more locations in the midst of a pandemic — and placed the focus on the customer’s ability to stay agile.

3. Executive Summary

The executive summary should provide a snapshot of your customer, their challenges, and the benefits they enjoyed from working with you. Think it’s too much? Think again — the purpose of the case study is to emphasize, again and again, how well your product works.

The good news is that depending on your design, the executive summary can be mixed with the subtitle or with the “About the Company” section. Many times, this section doesn’t need an explicit “Executive Summary” subheading. You do need, however, to provide a convenient snapshot for readers to scan.

In the above example, ADP included information about its customer in a scannable bullet-point format, then provided two sections: “Business Challenge” and “How ADP Helped.” We love how simple and easy the format is to follow for those who are unfamiliar with ADP or its typical customer.

4. About the Company

Readers need to know and understand who your customer is. This is important for several reasons: It helps your reader potentially relate to your customer, it defines your ideal client profile (which is essential to deter poor-fit prospects who might have reached out without knowing they were a poor fit), and it gives your customer an indirect boon by subtly promoting their products and services.

Feel free to keep this section as simple as possible. You can simply copy and paste information from the company’s LinkedIn, use a quote directly from your customer, or take a more creative storytelling approach.

In the above example, HubSpot included one paragraph of description for Crunch Fitness and a few bullet points. Below, ADP tells the story of its customer using an engaging, personable technique that effectively draws readers in.

5. Challenges and Objectives

The challenges and objectives section of your case study is the place to lay out, in detail, the difficulties your customer faced prior to working with you — and what they hoped to achieve when they enlisted your help.

In this section, you can be as brief or as descriptive as you’d like, but remember: Stress the urgency of the situation. Don’t understate how much your customer needed your solution (but don’t exaggerate and lie, either). Provide contextual information as necessary. For instance, the pandemic and societal factors may have contributed to the urgency of the need.

Take the above example from design consultancy IDEO:

“Educational opportunities for adults have become difficult to access in the United States, just when they’re needed most. To counter this trend, IDEO helped the city of South Bend and the Drucker Institute launch Bendable, a community-powered platform that connects people with opportunities to learn with and from each other.”

We love how IDEO mentions the difficulties the United States faces at large, the efforts its customer is taking to address these issues, and the steps IDEO took to help.

6. How Product/Service Helped

This is where you get your product or service to shine. Cover the specific benefits that your customer enjoyed and the features they gleaned the most use out of. You can also go into detail about how you worked with and for your customer. Maybe you met several times before choosing the right solution, or you consulted with external agencies to create the best package for them.

Whatever the case may be, try to illustrate how easy and pain-free it is to work with the representatives at your company. After all, potential customers aren’t looking to just purchase a product. They’re looking for a dependable provider that will strive to exceed their expectations.

In the above example, IDEO describes how it partnered with research institutes and spoke with learners to create Bendable, a free educational platform. We love how it shows its proactivity and thoroughness. It makes potential customers feel that IDEO might do something similar for them.

The results are essential, and the best part is that you don’t need to write the entirety of the case study before sharing them. Like HubSpot, IDEO, and ADP, you can include the results right below the subtitle or executive summary. Use data and numbers to substantiate the success of your efforts, but if you don’t have numbers, you can provide quotes from your customers.

We can’t overstate the importance of the results. In fact, if you wanted to create a short case study, you could include your title, challenge, solution (how your product helped), and result.

8. Supporting Visuals or Quotes

Let your customer speak for themselves by including quotes from the representatives who directly interfaced with your company.

Visuals can also help, even if they’re stock images. On one side, they can help you convey your customer’s industry, and on the other, they can indirectly convey your successes. For instance, a picture of a happy professional — even if they’re not your customer — will communicate that your product can lead to a happy client.

In this example from IDEO, we see a man standing in a boat. IDEO’s customer is neither the man pictured nor the manufacturer of the boat, but rather Conservation International, an environmental organization. This imagery provides a visually pleasing pattern interrupt to the page, while still conveying what the case study is about.

9. Future Plans

This is optional, but including future plans can help you close on a more positive, personable note than if you were to simply include a quote or the results. In this space, you can show that your product will remain in your customer’s tech stack for years to come, or that your services will continue to be instrumental to your customer’s success.

Alternatively, if you work only on time-bound projects, you can allude to the positive impact your customer will continue to see, even after years of the end of the contract.

10. Call to Action (CTA)

Not every case study needs a CTA, but we’d still encourage it. Putting one at the end of your case study will encourage your readers to take an action on your website after learning about the work you've done.

It will also make it easier for them to reach out, if they’re ready to start immediately. You don’t want to lose business just because they have to scroll all the way back up to reach out to your team.

To help you visualize this case study outline, check out the case study template below, which can also be downloaded here .

You drove the results, made the connection, set the expectations, used the questionnaire to conduct a successful interview, and boiled down your findings into a compelling story. And after all of that, you're left with a little piece of sales enabling gold — a case study.

To show you what a well-executed final product looks like, have a look at some of these marketing case study examples.

1. "Shopify Uses HubSpot CRM to Transform High Volume Sales Organization," by HubSpot

What's interesting about this case study is the way it leads with the customer. This reflects a major HubSpot value, which is to always solve for the customer first. The copy leads with a brief description of why Shopify uses HubSpot and is accompanied by a short video and some basic statistics on the company.

Notice that this case study uses mixed media. Yes, there is a short video, but it's elaborated upon in the additional text on the page. So, while case studies can use one or the other, don't be afraid to combine written copy with visuals to emphasize the project's success.

2. "New England Journal of Medicine," by Corey McPherson Nash

When branding and design studio Corey McPherson Nash showcases its work, it makes sense for it to be visual — after all, that's what they do. So in building the case study for the studio's work on the New England Journal of Medicine's integrated advertising campaign — a project that included the goal of promoting the client's digital presence — Corey McPherson Nash showed its audience what it did, rather than purely telling it.

Notice that the case study does include some light written copy — which includes the major points we've suggested — but lets the visuals do the talking, allowing users to really absorb the studio's services.

3. "Designing the Future of Urban Farming," by IDEO

Here's a design company that knows how to lead with simplicity in its case studies. As soon as the visitor arrives at the page, he or she is greeted with a big, bold photo, and two very simple columns of text — "The Challenge" and "The Outcome."

Immediately, IDEO has communicated two of the case study's major pillars. And while that's great — the company created a solution for vertical farming startup INFARM's challenge — it doesn't stop there. As the user scrolls down, those pillars are elaborated upon with comprehensive (but not overwhelming) copy that outlines what that process looked like, replete with quotes and additional visuals.

4. "Secure Wi-Fi Wins Big for Tournament," by WatchGuard

Then, there are the cases when visuals can tell almost the entire story — when executed correctly. Network security provider WatchGuard can do that through this video, which tells the story of how its services enhanced the attendee and vendor experience at the Windmill Ultimate Frisbee tournament.

5. Rock and Roll Hall of Fame Boosts Social Media Engagement and Brand Awareness with HubSpot

In the case study above , HubSpot uses photos, videos, screenshots, and helpful stats to tell the story of how the Rock and Roll Hall of Fame used the bot, CRM, and social media tools to gain brand awareness.

6. Small Desk Plant Business Ups Sales by 30% With Trello

This case study from Trello is straightforward and easy to understand. It begins by explaining the background of the company that decided to use it, what its goals were, and how it planned to use Trello to help them.

It then goes on to discuss how the software was implemented and what tasks and teams benefited from it. Towards the end, it explains the sales results that came from implementing the software and includes quotes from decision-makers at the company that implemented it.

7. Facebook's Mercedes Benz Success Story

Facebook's Success Stories page hosts a number of well-designed and easy-to-understand case studies that visually and editorially get to the bottom line quickly.

Each study begins with key stats that draw the reader in. Then it's organized by highlighting a problem or goal in the introduction, the process the company took to reach its goals, and the results. Then, in the end, Facebook notes the tools used in the case study.

Showcasing Your Work

You work hard at what you do. Now, it's time to show it to the world — and, perhaps more important, to potential customers. Before you show off the projects that make you the proudest, we hope you follow these important steps that will help you effectively communicate that work and leave all parties feeling good about it.

Editor's Note: This blog post was originally published in February 2017 but was updated for comprehensiveness and freshness in July 2021.

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Organizing Your Social Sciences Research Assignments

• Annotated Bibliography
• Analyzing a Scholarly Journal Article
• Group Presentations
• Dealing with Nervousness
• Using Visual Aids
• Grading Someone Else's Paper
• Types of Structured Group Activities
• Group Project Survival Skills
• Leading a Class Discussion
• Multiple Book Review Essay
• Reviewing Collected Works
• Writing a Case Analysis Paper
• Writing a Case Study
• About Informed Consent
• Writing Field Notes
• Writing a Policy Memo
• Writing a Reflective Paper
• Writing a Research Proposal
• Generative AI and Writing
• Acknowledgments

A case study research paper examines a person, place, event, condition, phenomenon, or other type of subject of analysis in order to extrapolate  key themes and results that help predict future trends, illuminate previously hidden issues that can be applied to practice, and/or provide a means for understanding an important research problem with greater clarity. A case study research paper usually examines a single subject of analysis, but case study papers can also be designed as a comparative investigation that shows relationships between two or more subjects. The methods used to study a case can rest within a quantitative, qualitative, or mixed-method investigative paradigm.

Case Studies. Writing@CSU. Colorado State University; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010 ; “What is a Case Study?” In Swanborn, Peter G. Case Study Research: What, Why and How? London: SAGE, 2010.

How to Approach Writing a Case Study Research Paper

General information about how to choose a topic to investigate can be found under the " Choosing a Research Problem " tab in the Organizing Your Social Sciences Research Paper writing guide. Review this page because it may help you identify a subject of analysis that can be investigated using a case study design.

However, identifying a case to investigate involves more than choosing the research problem . A case study encompasses a problem contextualized around the application of in-depth analysis, interpretation, and discussion, often resulting in specific recommendations for action or for improving existing conditions. As Seawright and Gerring note, practical considerations such as time and access to information can influence case selection, but these issues should not be the sole factors used in describing the methodological justification for identifying a particular case to study. Given this, selecting a case includes considering the following:

• The case represents an unusual or atypical example of a research problem that requires more in-depth analysis? Cases often represent a topic that rests on the fringes of prior investigations because the case may provide new ways of understanding the research problem. For example, if the research problem is to identify strategies to improve policies that support girl's access to secondary education in predominantly Muslim nations, you could consider using Azerbaijan as a case study rather than selecting a more obvious nation in the Middle East. Doing so may reveal important new insights into recommending how governments in other predominantly Muslim nations can formulate policies that support improved access to education for girls.
• The case provides important insight or illuminate a previously hidden problem? In-depth analysis of a case can be based on the hypothesis that the case study will reveal trends or issues that have not been exposed in prior research or will reveal new and important implications for practice. For example, anecdotal evidence may suggest drug use among homeless veterans is related to their patterns of travel throughout the day. Assuming prior studies have not looked at individual travel choices as a way to study access to illicit drug use, a case study that observes a homeless veteran could reveal how issues of personal mobility choices facilitate regular access to illicit drugs. Note that it is important to conduct a thorough literature review to ensure that your assumption about the need to reveal new insights or previously hidden problems is valid and evidence-based.
• The case challenges and offers a counter-point to prevailing assumptions? Over time, research on any given topic can fall into a trap of developing assumptions based on outdated studies that are still applied to new or changing conditions or the idea that something should simply be accepted as "common sense," even though the issue has not been thoroughly tested in current practice. A case study analysis may offer an opportunity to gather evidence that challenges prevailing assumptions about a research problem and provide a new set of recommendations applied to practice that have not been tested previously. For example, perhaps there has been a long practice among scholars to apply a particular theory in explaining the relationship between two subjects of analysis. Your case could challenge this assumption by applying an innovative theoretical framework [perhaps borrowed from another discipline] to explore whether this approach offers new ways of understanding the research problem. Taking a contrarian stance is one of the most important ways that new knowledge and understanding develops from existing literature.
• The case provides an opportunity to pursue action leading to the resolution of a problem? Another way to think about choosing a case to study is to consider how the results from investigating a particular case may result in findings that reveal ways in which to resolve an existing or emerging problem. For example, studying the case of an unforeseen incident, such as a fatal accident at a railroad crossing, can reveal hidden issues that could be applied to preventative measures that contribute to reducing the chance of accidents in the future. In this example, a case study investigating the accident could lead to a better understanding of where to strategically locate additional signals at other railroad crossings so as to better warn drivers of an approaching train, particularly when visibility is hindered by heavy rain, fog, or at night.
• The case offers a new direction in future research? A case study can be used as a tool for an exploratory investigation that highlights the need for further research about the problem. A case can be used when there are few studies that help predict an outcome or that establish a clear understanding about how best to proceed in addressing a problem. For example, after conducting a thorough literature review [very important!], you discover that little research exists showing the ways in which women contribute to promoting water conservation in rural communities of east central Africa. A case study of how women contribute to saving water in a rural village of Uganda can lay the foundation for understanding the need for more thorough research that documents how women in their roles as cooks and family caregivers think about water as a valuable resource within their community. This example of a case study could also point to the need for scholars to build new theoretical frameworks around the topic [e.g., applying feminist theories of work and family to the issue of water conservation].

Eisenhardt, Kathleen M. “Building Theories from Case Study Research.” Academy of Management Review 14 (October 1989): 532-550; Emmel, Nick. Sampling and Choosing Cases in Qualitative Research: A Realist Approach . Thousand Oaks, CA: SAGE Publications, 2013; Gerring, John. “What Is a Case Study and What Is It Good for?” American Political Science Review 98 (May 2004): 341-354; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Seawright, Jason and John Gerring. "Case Selection Techniques in Case Study Research." Political Research Quarterly 61 (June 2008): 294-308.

Structure and Writing Style

The purpose of a paper in the social sciences designed around a case study is to thoroughly investigate a subject of analysis in order to reveal a new understanding about the research problem and, in so doing, contributing new knowledge to what is already known from previous studies. In applied social sciences disciplines [e.g., education, social work, public administration, etc.], case studies may also be used to reveal best practices, highlight key programs, or investigate interesting aspects of professional work.

In general, the structure of a case study research paper is not all that different from a standard college-level research paper. However, there are subtle differences you should be aware of. Here are the key elements to organizing and writing a case study research paper.

I.  Introduction

As with any research paper, your introduction should serve as a roadmap for your readers to ascertain the scope and purpose of your study . The introduction to a case study research paper, however, should not only describe the research problem and its significance, but you should also succinctly describe why the case is being used and how it relates to addressing the problem. The two elements should be linked. With this in mind, a good introduction answers these four questions:

• What is being studied? Describe the research problem and describe the subject of analysis [the case] you have chosen to address the problem. Explain how they are linked and what elements of the case will help to expand knowledge and understanding about the problem.
• Why is this topic important to investigate? Describe the significance of the research problem and state why a case study design and the subject of analysis that the paper is designed around is appropriate in addressing the problem.
• What did we know about this topic before I did this study? Provide background that helps lead the reader into the more in-depth literature review to follow. If applicable, summarize prior case study research applied to the research problem and why it fails to adequately address the problem. Describe why your case will be useful. If no prior case studies have been used to address the research problem, explain why you have selected this subject of analysis.
• How will this study advance new knowledge or new ways of understanding? Explain why your case study will be suitable in helping to expand knowledge and understanding about the research problem.

Each of these questions should be addressed in no more than a few paragraphs. Exceptions to this can be when you are addressing a complex research problem or subject of analysis that requires more in-depth background information.

II.  Literature Review

The literature review for a case study research paper is generally structured the same as it is for any college-level research paper. The difference, however, is that the literature review is focused on providing background information and  enabling historical interpretation of the subject of analysis in relation to the research problem the case is intended to address . This includes synthesizing studies that help to:

• Place relevant works in the context of their contribution to understanding the case study being investigated . This would involve summarizing studies that have used a similar subject of analysis to investigate the research problem. If there is literature using the same or a very similar case to study, you need to explain why duplicating past research is important [e.g., conditions have changed; prior studies were conducted long ago, etc.].
• Describe the relationship each work has to the others under consideration that informs the reader why this case is applicable . Your literature review should include a description of any works that support using the case to investigate the research problem and the underlying research questions.
• Identify new ways to interpret prior research using the case study . If applicable, review any research that has examined the research problem using a different research design. Explain how your use of a case study design may reveal new knowledge or a new perspective or that can redirect research in an important new direction.
• Resolve conflicts amongst seemingly contradictory previous studies . This refers to synthesizing any literature that points to unresolved issues of concern about the research problem and describing how the subject of analysis that forms the case study can help resolve these existing contradictions.
• Point the way in fulfilling a need for additional research . Your review should examine any literature that lays a foundation for understanding why your case study design and the subject of analysis around which you have designed your study may reveal a new way of approaching the research problem or offer a perspective that points to the need for additional research.
• Expose any gaps that exist in the literature that the case study could help to fill . Summarize any literature that not only shows how your subject of analysis contributes to understanding the research problem, but how your case contributes to a new way of understanding the problem that prior research has failed to do.
• Locate your own research within the context of existing literature [very important!] . Collectively, your literature review should always place your case study within the larger domain of prior research about the problem. The overarching purpose of reviewing pertinent literature in a case study paper is to demonstrate that you have thoroughly identified and synthesized prior studies in relation to explaining the relevance of the case in addressing the research problem.

III.  Method

In this section, you explain why you selected a particular case [i.e., subject of analysis] and the strategy you used to identify and ultimately decide that your case was appropriate in addressing the research problem. The way you describe the methods used varies depending on the type of subject of analysis that constitutes your case study.

If your subject of analysis is an incident or event . In the social and behavioral sciences, the event or incident that represents the case to be studied is usually bounded by time and place, with a clear beginning and end and with an identifiable location or position relative to its surroundings. The subject of analysis can be a rare or critical event or it can focus on a typical or regular event. The purpose of studying a rare event is to illuminate new ways of thinking about the broader research problem or to test a hypothesis. Critical incident case studies must describe the method by which you identified the event and explain the process by which you determined the validity of this case to inform broader perspectives about the research problem or to reveal new findings. However, the event does not have to be a rare or uniquely significant to support new thinking about the research problem or to challenge an existing hypothesis. For example, Walo, Bull, and Breen conducted a case study to identify and evaluate the direct and indirect economic benefits and costs of a local sports event in the City of Lismore, New South Wales, Australia. The purpose of their study was to provide new insights from measuring the impact of a typical local sports event that prior studies could not measure well because they focused on large "mega-events." Whether the event is rare or not, the methods section should include an explanation of the following characteristics of the event: a) when did it take place; b) what were the underlying circumstances leading to the event; and, c) what were the consequences of the event in relation to the research problem.

If your subject of analysis is a person. Explain why you selected this particular individual to be studied and describe what experiences they have had that provide an opportunity to advance new understandings about the research problem. Mention any background about this person which might help the reader understand the significance of their experiences that make them worthy of study. This includes describing the relationships this person has had with other people, institutions, and/or events that support using them as the subject for a case study research paper. It is particularly important to differentiate the person as the subject of analysis from others and to succinctly explain how the person relates to examining the research problem [e.g., why is one politician in a particular local election used to show an increase in voter turnout from any other candidate running in the election]. Note that these issues apply to a specific group of people used as a case study unit of analysis [e.g., a classroom of students].

If your subject of analysis is a place. In general, a case study that investigates a place suggests a subject of analysis that is unique or special in some way and that this uniqueness can be used to build new understanding or knowledge about the research problem. A case study of a place must not only describe its various attributes relevant to the research problem [e.g., physical, social, historical, cultural, economic, political], but you must state the method by which you determined that this place will illuminate new understandings about the research problem. It is also important to articulate why a particular place as the case for study is being used if similar places also exist [i.e., if you are studying patterns of homeless encampments of veterans in open spaces, explain why you are studying Echo Park in Los Angeles rather than Griffith Park?]. If applicable, describe what type of human activity involving this place makes it a good choice to study [e.g., prior research suggests Echo Park has more homeless veterans].

If your subject of analysis is a phenomenon. A phenomenon refers to a fact, occurrence, or circumstance that can be studied or observed but with the cause or explanation to be in question. In this sense, a phenomenon that forms your subject of analysis can encompass anything that can be observed or presumed to exist but is not fully understood. In the social and behavioral sciences, the case usually focuses on human interaction within a complex physical, social, economic, cultural, or political system. For example, the phenomenon could be the observation that many vehicles used by ISIS fighters are small trucks with English language advertisements on them. The research problem could be that ISIS fighters are difficult to combat because they are highly mobile. The research questions could be how and by what means are these vehicles used by ISIS being supplied to the militants and how might supply lines to these vehicles be cut off? How might knowing the suppliers of these trucks reveal larger networks of collaborators and financial support? A case study of a phenomenon most often encompasses an in-depth analysis of a cause and effect that is grounded in an interactive relationship between people and their environment in some way.

NOTE:   The choice of the case or set of cases to study cannot appear random. Evidence that supports the method by which you identified and chose your subject of analysis should clearly support investigation of the research problem and linked to key findings from your literature review. Be sure to cite any studies that helped you determine that the case you chose was appropriate for examining the problem.

IV.  Discussion

The main elements of your discussion section are generally the same as any research paper, but centered around interpreting and drawing conclusions about the key findings from your analysis of the case study. Note that a general social sciences research paper may contain a separate section to report findings. However, in a paper designed around a case study, it is common to combine a description of the results with the discussion about their implications. The objectives of your discussion section should include the following:

Reiterate the Research Problem/State the Major Findings Briefly reiterate the research problem you are investigating and explain why the subject of analysis around which you designed the case study were used. You should then describe the findings revealed from your study of the case using direct, declarative, and succinct proclamation of the study results. Highlight any findings that were unexpected or especially profound.

Explain the Meaning of the Findings and Why They are Important Systematically explain the meaning of your case study findings and why you believe they are important. Begin this part of the section by repeating what you consider to be your most important or surprising finding first, then systematically review each finding. Be sure to thoroughly extrapolate what your analysis of the case can tell the reader about situations or conditions beyond the actual case that was studied while, at the same time, being careful not to misconstrue or conflate a finding that undermines the external validity of your conclusions.

Relate the Findings to Similar Studies No study in the social sciences is so novel or possesses such a restricted focus that it has absolutely no relation to previously published research. The discussion section should relate your case study results to those found in other studies, particularly if questions raised from prior studies served as the motivation for choosing your subject of analysis. This is important because comparing and contrasting the findings of other studies helps support the overall importance of your results and it highlights how and in what ways your case study design and the subject of analysis differs from prior research about the topic.

Consider Alternative Explanations of the Findings Remember that the purpose of social science research is to discover and not to prove. When writing the discussion section, you should carefully consider all possible explanations revealed by the case study results, rather than just those that fit your hypothesis or prior assumptions and biases. Be alert to what the in-depth analysis of the case may reveal about the research problem, including offering a contrarian perspective to what scholars have stated in prior research if that is how the findings can be interpreted from your case.

Acknowledge the Study's Limitations You can state the study's limitations in the conclusion section of your paper but describing the limitations of your subject of analysis in the discussion section provides an opportunity to identify the limitations and explain why they are not significant. This part of the discussion section should also note any unanswered questions or issues your case study could not address. More detailed information about how to document any limitations to your research can be found here .

Suggest Areas for Further Research Although your case study may offer important insights about the research problem, there are likely additional questions related to the problem that remain unanswered or findings that unexpectedly revealed themselves as a result of your in-depth analysis of the case. Be sure that the recommendations for further research are linked to the research problem and that you explain why your recommendations are valid in other contexts and based on the original assumptions of your study.

V.  Conclusion

As with any research paper, you should summarize your conclusion in clear, simple language; emphasize how the findings from your case study differs from or supports prior research and why. Do not simply reiterate the discussion section. Provide a synthesis of key findings presented in the paper to show how these converge to address the research problem. If you haven't already done so in the discussion section, be sure to document the limitations of your case study and any need for further research.

The function of your paper's conclusion is to: 1) reiterate the main argument supported by the findings from your case study; 2) state clearly the context, background, and necessity of pursuing the research problem using a case study design in relation to an issue, controversy, or a gap found from reviewing the literature; and, 3) provide a place to persuasively and succinctly restate the significance of your research problem, given that the reader has now been presented with in-depth information about the topic.

Consider the following points to help ensure your conclusion is appropriate:

• If the argument or purpose of your paper is complex, you may need to summarize these points for your reader.
• If prior to your conclusion, you have not yet explained the significance of your findings or if you are proceeding inductively, use the conclusion of your paper to describe your main points and explain their significance.
• Move from a detailed to a general level of consideration of the case study's findings that returns the topic to the context provided by the introduction or within a new context that emerges from your case study findings.

Note that, depending on the discipline you are writing in or the preferences of your professor, the concluding paragraph may contain your final reflections on the evidence presented as it applies to practice or on the essay's central research problem. However, the nature of being introspective about the subject of analysis you have investigated will depend on whether you are explicitly asked to express your observations in this way.

Problems to Avoid

Overgeneralization One of the goals of a case study is to lay a foundation for understanding broader trends and issues applied to similar circumstances. However, be careful when drawing conclusions from your case study. They must be evidence-based and grounded in the results of the study; otherwise, it is merely speculation. Looking at a prior example, it would be incorrect to state that a factor in improving girls access to education in Azerbaijan and the policy implications this may have for improving access in other Muslim nations is due to girls access to social media if there is no documentary evidence from your case study to indicate this. There may be anecdotal evidence that retention rates were better for girls who were engaged with social media, but this observation would only point to the need for further research and would not be a definitive finding if this was not a part of your original research agenda.

Failure to Document Limitations No case is going to reveal all that needs to be understood about a research problem. Therefore, just as you have to clearly state the limitations of a general research study , you must describe the specific limitations inherent in the subject of analysis. For example, the case of studying how women conceptualize the need for water conservation in a village in Uganda could have limited application in other cultural contexts or in areas where fresh water from rivers or lakes is plentiful and, therefore, conservation is understood more in terms of managing access rather than preserving access to a scarce resource.

Failure to Extrapolate All Possible Implications Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings. If you do not, your reader may question the validity of your analysis, particularly if you failed to document an obvious outcome from your case study research. For example, in the case of studying the accident at the railroad crossing to evaluate where and what types of warning signals should be located, you failed to take into consideration speed limit signage as well as warning signals. When designing your case study, be sure you have thoroughly addressed all aspects of the problem and do not leave gaps in your analysis that leave the reader questioning the results.

Case Studies. Writing@CSU. Colorado State University; Gerring, John. Case Study Research: Principles and Practices . New York: Cambridge University Press, 2007; Merriam, Sharan B. Qualitative Research and Case Study Applications in Education . Rev. ed. San Francisco, CA: Jossey-Bass, 1998; Miller, Lisa L. “The Use of Case Studies in Law and Social Science Research.” Annual Review of Law and Social Science 14 (2018): TBD; Mills, Albert J., Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Putney, LeAnn Grogan. "Case Study." In Encyclopedia of Research Design , Neil J. Salkind, editor. (Thousand Oaks, CA: SAGE Publications, 2010), pp. 116-120; Simons, Helen. Case Study Research in Practice . London: SAGE Publications, 2009;  Kratochwill,  Thomas R. and Joel R. Levin, editors. Single-Case Research Design and Analysis: New Development for Psychology and Education .  Hilldsale, NJ: Lawrence Erlbaum Associates, 1992; Swanborn, Peter G. Case Study Research: What, Why and How? London : SAGE, 2010; Yin, Robert K. Case Study Research: Design and Methods . 6th edition. Los Angeles, CA, SAGE Publications, 2014; Walo, Maree, Adrian Bull, and Helen Breen. “Achieving Economic Benefits at Local Events: A Case Study of a Local Sports Event.” Festival Management and Event Tourism 4 (1996): 95-106.

Writing Tip

At Least Five Misconceptions about Case Study Research

Social science case studies are often perceived as limited in their ability to create new knowledge because they are not randomly selected and findings cannot be generalized to larger populations. Flyvbjerg examines five misunderstandings about case study research and systematically "corrects" each one. To quote, these are:

Misunderstanding 1 :  General, theoretical [context-independent] knowledge is more valuable than concrete, practical [context-dependent] knowledge. Misunderstanding 2 :  One cannot generalize on the basis of an individual case; therefore, the case study cannot contribute to scientific development. Misunderstanding 3 :  The case study is most useful for generating hypotheses; that is, in the first stage of a total research process, whereas other methods are more suitable for hypotheses testing and theory building. Misunderstanding 4 :  The case study contains a bias toward verification, that is, a tendency to confirm the researcher’s preconceived notions. Misunderstanding 5 :  It is often difficult to summarize and develop general propositions and theories on the basis of specific case studies [p. 221].

While writing your paper, think introspectively about how you addressed these misconceptions because to do so can help you strengthen the validity and reliability of your research by clarifying issues of case selection, the testing and challenging of existing assumptions, the interpretation of key findings, and the summation of case outcomes. Think of a case study research paper as a complete, in-depth narrative about the specific properties and key characteristics of your subject of analysis applied to the research problem.

Flyvbjerg, Bent. “Five Misunderstandings About Case-Study Research.” Qualitative Inquiry 12 (April 2006): 219-245.

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How to write a case study — examples, templates, and tools

It’s a marketer’s job to communicate the effectiveness of a product or service to potential and current customers to convince them to buy and keep business moving. One of the best methods for doing this is to share success stories that are relatable to prospects and customers based on their pain points, experiences, and overall needs.

That’s where case studies come in. Case studies are an essential part of a content marketing plan. These in-depth stories of customer experiences are some of the most effective at demonstrating the value of a product or service. Yet many marketers don’t use them, whether because of their regimented formats or the process of customer involvement and approval.

A case study is a powerful tool for showcasing your hard work and the success your customer achieved. But writing a great case study can be difficult if you’ve never done it before or if it’s been a while. This guide will show you how to write an effective case study and provide real-world examples and templates that will keep readers engaged and support your business.

In this article, you’ll learn:

What is a case study?

How to write a case study, case study templates, case study examples, case study tools.

A case study is the detailed story of a customer’s experience with a product or service that demonstrates their success and often includes measurable outcomes. Case studies are used in a range of fields and for various reasons, from business to academic research. They’re especially impactful in marketing as brands work to convince and convert consumers with relatable, real-world stories of actual customer experiences.

The best case studies tell the story of a customer’s success, including the steps they took, the results they achieved, and the support they received from a brand along the way. To write a great case study, you need to:

• Celebrate the customer and make them — not a product or service — the star of the story.
• Craft the story with specific audiences or target segments in mind so that the story of one customer will be viewed as relatable and actionable for another customer.
• Write copy that is easy to read and engaging so that readers will gain the insights and messages intended.
• Follow a standardized format that includes all of the essentials a potential customer would find interesting and useful.
• Support all of the claims for success made in the story with data in the forms of hard numbers and customer statements.

Case studies are a type of review but more in depth, aiming to show — rather than just tell — the positive experiences that customers have with a brand. Notably, 89% of consumers read reviews before deciding to buy, and 79% view case study content as part of their purchasing process. When it comes to B2B sales, 52% of buyers rank case studies as an important part of their evaluation process.

Telling a brand story through the experience of a tried-and-true customer matters. The story is relatable to potential new customers as they imagine themselves in the shoes of the company or individual featured in the case study. Showcasing previous customers can help new ones see themselves engaging with your brand in the ways that are most meaningful to them.

Besides sharing the perspective of another customer, case studies stand out from other content marketing forms because they are based on evidence. Whether pulling from client testimonials or data-driven results, case studies tend to have more impact on new business because the story contains information that is both objective (data) and subjective (customer experience) — and the brand doesn’t sound too self-promotional.

Case studies are unique in that there’s a fairly standardized format for telling a customer’s story. But that doesn’t mean there isn’t room for creativity. It’s all about making sure that teams are clear on the goals for the case study — along with strategies for supporting content and channels — and understanding how the story fits within the framework of the company’s overall marketing goals.

Here are the basic steps to writing a good case study.

1. Identify your goal

Start by defining exactly who your case study will be designed to help. Case studies are about specific instances where a company works with a customer to achieve a goal. Identify which customers are likely to have these goals, as well as other needs the story should cover to appeal to them.

The answer is often found in one of the buyer personas that have been constructed as part of your larger marketing strategy. This can include anything from new leads generated by the marketing team to long-term customers that are being pressed for cross-sell opportunities. In all of these cases, demonstrating value through a relatable customer success story can be part of the solution to conversion.

2. Choose your client or subject

Who you highlight matters. Case studies tie brands together that might otherwise not cross paths. A writer will want to ensure that the highlighted customer aligns with their own company’s brand identity and offerings. Look for a customer with positive name recognition who has had great success with a product or service and is willing to be an advocate.

The client should also match up with the identified target audience. Whichever company or individual is selected should be a reflection of other potential customers who can see themselves in similar circumstances, having the same problems and possible solutions.

Some of the most compelling case studies feature customers who:

• Switch from one product or service to another while naming competitors that missed the mark.
• Experience measurable results that are relatable to others in a specific industry.
• Represent well-known brands and recognizable names that are likely to compel action.
• Advocate for a product or service as a champion and are well-versed in its advantages.

Whoever or whatever customer is selected, marketers must ensure they have the permission of the company involved before getting started. Some brands have strict review and approval procedures for any official marketing or promotional materials that include their name. Acquiring those approvals in advance will prevent any miscommunication or wasted effort if there is an issue with their legal or compliance teams.

3. Conduct research and compile data

Substantiating the claims made in a case study — either by the marketing team or customers themselves — adds validity to the story. To do this, include data and feedback from the client that defines what success looks like. This can be anything from demonstrating return on investment (ROI) to a specific metric the customer was striving to improve. Case studies should prove how an outcome was achieved and show tangible results that indicate to the customer that your solution is the right one.

This step could also include customer interviews. Make sure that the people being interviewed are key stakeholders in the purchase decision or deployment and use of the product or service that is being highlighted. Content writers should work off a set list of questions prepared in advance. It can be helpful to share these with the interviewees beforehand so they have time to consider and craft their responses. One of the best interview tactics to keep in mind is to ask questions where yes and no are not natural answers. This way, your subject will provide more open-ended responses that produce more meaningful content.

4. Choose the right format

There are a number of different ways to format a case study. Depending on what you hope to achieve, one style will be better than another. However, there are some common elements to include, such as:

• An engaging headline
• A subject and customer introduction
• The unique challenge or challenges the customer faced
• The solution the customer used to solve the problem
• The results achieved
• Data and statistics to back up claims of success
• A strong call to action (CTA) to engage with the vendor

It’s also important to note that while case studies are traditionally written as stories, they don’t have to be in a written format. Some companies choose to get more creative with their case studies and produce multimedia content, depending on their audience and objectives. Case study formats can include traditional print stories, interactive web or social content, data-heavy infographics, professionally shot videos, podcasts, and more.

5. Write your case study

We’ll go into more detail later about how exactly to write a case study, including templates and examples. Generally speaking, though, there are a few things to keep in mind when writing your case study.

• Be clear and concise. Readers want to get to the point of the story quickly and easily, and they’ll be looking to see themselves reflected in the story right from the start.
• Provide a big picture. Always make sure to explain who the client is, their goals, and how they achieved success in a short introduction to engage the reader.
• Construct a clear narrative. Stick to the story from the perspective of the customer and what they needed to solve instead of just listing product features or benefits.
• Leverage graphics. Incorporating infographics, charts, and sidebars can be a more engaging and eye-catching way to share key statistics and data in readable ways.
• Offer the right amount of detail. Most case studies are one or two pages with clear sections that a reader can skim to find the information most important to them.
• Include data to support claims. Show real results — both facts and figures and customer quotes — to demonstrate credibility and prove the solution works.

6. Promote your story

Marketers have a number of options for distribution of a freshly minted case study. Many brands choose to publish case studies on their website and post them on social media. This can help support SEO and organic content strategies while also boosting company credibility and trust as visitors see that other businesses have used the product or service.

Marketers are always looking for quality content they can use for lead generation. Consider offering a case study as gated content behind a form on a landing page or as an offer in an email message. One great way to do this is to summarize the content and tease the full story available for download after the user takes an action.

Sales teams can also leverage case studies, so be sure they are aware that the assets exist once they’re published. Especially when it comes to larger B2B sales, companies often ask for examples of similar customer challenges that have been solved.

Now that you’ve learned a bit about case studies and what they should include, you may be wondering how to start creating great customer story content. Here are a couple of templates you can use to structure your case study.

Template 1 — Challenge-solution-result format

• Start with an engaging title. This should be fewer than 70 characters long for SEO best practices. One of the best ways to approach the title is to include the customer’s name and a hint at the challenge they overcame in the end.
• Create an introduction. Lead with an explanation as to who the customer is, the need they had, and the opportunity they found with a specific product or solution. Writers can also suggest the success the customer experienced with the solution they chose.
• Present the challenge. This should be several paragraphs long and explain the problem the customer faced and the issues they were trying to solve. Details should tie into the company’s products and services naturally. This section needs to be the most relatable to the reader so they can picture themselves in a similar situation.
• Share the solution. Explain which product or service offered was the ideal fit for the customer and why. Feel free to delve into their experience setting up, purchasing, and onboarding the solution.
• Explain the results. Demonstrate the impact of the solution they chose by backing up their positive experience with data. Fill in with customer quotes and tangible, measurable results that show the effect of their choice.
• Ask for action. Include a CTA at the end of the case study that invites readers to reach out for more information, try a demo, or learn more — to nurture them further in the marketing pipeline. What you ask of the reader should tie directly into the goals that were established for the case study in the first place.

Template 2 — Data-driven format

• Start with an engaging title. Be sure to include a statistic or data point in the first 70 characters. Again, it’s best to include the customer’s name as part of the title.
• Create an overview. Share the customer’s background and a short version of the challenge they faced. Present the reason a particular product or service was chosen, and feel free to include quotes from the customer about their selection process.
• Present data point 1. Isolate the first metric that the customer used to define success and explain how the product or solution helped to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 2. Isolate the second metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 3. Isolate the final metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Summarize the results. Reiterate the fact that the customer was able to achieve success thanks to a specific product or service. Include quotes and statements that reflect customer satisfaction and suggest they plan to continue using the solution.
• Ask for action. Include a CTA at the end of the case study that asks readers to reach out for more information, try a demo, or learn more — to further nurture them in the marketing pipeline. Again, remember that this is where marketers can look to convert their content into action with the customer.

While templates are helpful, seeing a case study in action can also be a great way to learn. Here are some examples of how Adobe customers have experienced success.

Juniper Networks

One example is the Adobe and Juniper Networks case study , which puts the reader in the customer’s shoes. The beginning of the story quickly orients the reader so that they know exactly who the article is about and what they were trying to achieve. Solutions are outlined in a way that shows Adobe Experience Manager is the best choice and a natural fit for the customer. Along the way, quotes from the client are incorporated to help add validity to the statements. The results in the case study are conveyed with clear evidence of scale and volume using tangible data.

The story of Lenovo’s journey with Adobe is one that spans years of planning, implementation, and rollout. The Lenovo case study does a great job of consolidating all of this into a relatable journey that other enterprise organizations can see themselves taking, despite the project size. This case study also features descriptive headers and compelling visual elements that engage the reader and strengthen the content.

Tata Consulting

When it comes to using data to show customer results, this case study does an excellent job of conveying details and numbers in an easy-to-digest manner. Bullet points at the start break up the content while also helping the reader understand exactly what the case study will be about. Tata Consulting used Adobe to deliver elevated, engaging content experiences for a large telecommunications client of its own — an objective that’s relatable for a lot of companies.

Case studies are a vital tool for any marketing team as they enable you to demonstrate the value of your company’s products and services to others. They help marketers do their job and add credibility to a brand trying to promote its solutions by using the experiences and stories of real customers.

When you’re ready to get started with a case study:

• Think about a few goals you’d like to accomplish with your content.
• Make a list of successful clients that would be strong candidates for a case study.
• Reach out to the client to get their approval and conduct an interview.
• Gather the data to present an engaging and effective customer story.

Adobe can help

There are several Adobe products that can help you craft compelling case studies. Adobe Experience Platform helps you collect data and deliver great customer experiences across every channel. Once you’ve created your case studies, Experience Platform will help you deliver the right information to the right customer at the right time for maximum impact.

To learn more, watch the Adobe Experience Platform story .

Keep in mind that the best case studies are backed by data. That’s where Adobe Real-Time Customer Data Platform and Adobe Analytics come into play. With Real-Time CDP, you can gather the data you need to build a great case study and target specific customers to deliver the content to the right audience at the perfect moment.

Watch the Real-Time CDP overview video to learn more.

Finally, Adobe Analytics turns real-time data into real-time insights. It helps your business collect and synthesize data from multiple platforms to make more informed decisions and create the best case study possible.

Request a demo to learn more about Adobe Analytics.

https://business.adobe.com/blog/perspectives/b2b-ecommerce-10-case-studies-inspire-you

https://business.adobe.com/blog/basics/business-case

https://business.adobe.com/blog/basics/what-is-real-time-analytics

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What Is a Case Study?

Weighing the pros and cons of this method of research

Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

• Pros and Cons

What Types of Case Studies Are Out There?

Where do you find data for a case study, how do i write a psychology case study.

A case study is an in-depth study of one person, group, or event. In a case study, nearly every aspect of the subject's life and history is analyzed to seek patterns and causes of behavior. Case studies can be used in many different fields, including psychology, medicine, education, anthropology, political science, and social work.

The point of a case study is to learn as much as possible about an individual or group so that the information can be generalized to many others. Unfortunately, case studies tend to be highly subjective, and it is sometimes difficult to generalize results to a larger population.

While case studies focus on a single individual or group, they follow a format similar to other types of psychology writing. If you are writing a case study, we got you—here are some rules of APA format to reference.  

At a Glance

A case study, or an in-depth study of a person, group, or event, can be a useful research tool when used wisely. In many cases, case studies are best used in situations where it would be difficult or impossible for you to conduct an experiment. They are helpful for looking at unique situations and allow researchers to gather a lot of˜ information about a specific individual or group of people. However, it's important to be cautious of any bias we draw from them as they are highly subjective.

What Are the Benefits and Limitations of Case Studies?

A case study can have its strengths and weaknesses. Researchers must consider these pros and cons before deciding if this type of study is appropriate for their needs.

One of the greatest advantages of a case study is that it allows researchers to investigate things that are often difficult or impossible to replicate in a lab. Some other benefits of a case study:

• Allows researchers to capture information on the 'how,' 'what,' and 'why,' of something that's implemented
• Gives researchers the chance to collect information on why one strategy might be chosen over another
• Permits researchers to develop hypotheses that can be explored in experimental research

On the other hand, a case study can have some drawbacks:

• It cannot necessarily be generalized to the larger population
• Cannot demonstrate cause and effect
• It may not be scientifically rigorous
• It can lead to bias

Researchers may choose to perform a case study if they want to explore a unique or recently discovered phenomenon. Through their insights, researchers develop additional ideas and study questions that might be explored in future studies.

It's important to remember that the insights from case studies cannot be used to determine cause-and-effect relationships between variables. However, case studies may be used to develop hypotheses that can then be addressed in experimental research.

Case Study Examples

There have been a number of notable case studies in the history of psychology. Much of  Freud's work and theories were developed through individual case studies. Some great examples of case studies in psychology include:

• Anna O : Anna O. was a pseudonym of a woman named Bertha Pappenheim, a patient of a physician named Josef Breuer. While she was never a patient of Freud's, Freud and Breuer discussed her case extensively. The woman was experiencing symptoms of a condition that was then known as hysteria and found that talking about her problems helped relieve her symptoms. Her case played an important part in the development of talk therapy as an approach to mental health treatment.
• Phineas Gage : Phineas Gage was a railroad employee who experienced a terrible accident in which an explosion sent a metal rod through his skull, damaging important portions of his brain. Gage recovered from his accident but was left with serious changes in both personality and behavior.
• Genie : Genie was a young girl subjected to horrific abuse and isolation. The case study of Genie allowed researchers to study whether language learning was possible, even after missing critical periods for language development. Her case also served as an example of how scientific research may interfere with treatment and lead to further abuse of vulnerable individuals.

Such cases demonstrate how case research can be used to study things that researchers could not replicate in experimental settings. In Genie's case, her horrific abuse denied her the opportunity to learn a language at critical points in her development.

This is clearly not something researchers could ethically replicate, but conducting a case study on Genie allowed researchers to study phenomena that are otherwise impossible to reproduce.

There are a few different types of case studies that psychologists and other researchers might use:

• Collective case studies : These involve studying a group of individuals. Researchers might study a group of people in a certain setting or look at an entire community. For example, psychologists might explore how access to resources in a community has affected the collective mental well-being of those who live there.
• Descriptive case studies : These involve starting with a descriptive theory. The subjects are then observed, and the information gathered is compared to the pre-existing theory.
• Explanatory case studies : These   are often used to do causal investigations. In other words, researchers are interested in looking at factors that may have caused certain things to occur.
• Exploratory case studies : These are sometimes used as a prelude to further, more in-depth research. This allows researchers to gather more information before developing their research questions and hypotheses .
• Instrumental case studies : These occur when the individual or group allows researchers to understand more than what is initially obvious to observers.
• Intrinsic case studies : This type of case study is when the researcher has a personal interest in the case. Jean Piaget's observations of his own children are good examples of how an intrinsic case study can contribute to the development of a psychological theory.

The three main case study types often used are intrinsic, instrumental, and collective. Intrinsic case studies are useful for learning about unique cases. Instrumental case studies help look at an individual to learn more about a broader issue. A collective case study can be useful for looking at several cases simultaneously.

The type of case study that psychology researchers use depends on the unique characteristics of the situation and the case itself.

There are a number of different sources and methods that researchers can use to gather information about an individual or group. Six major sources that have been identified by researchers are:

• Archival records : Census records, survey records, and name lists are examples of archival records.
• Direct observation : This strategy involves observing the subject, often in a natural setting . While an individual observer is sometimes used, it is more common to utilize a group of observers.
• Documents : Letters, newspaper articles, administrative records, etc., are the types of documents often used as sources.
• Interviews : Interviews are one of the most important methods for gathering information in case studies. An interview can involve structured survey questions or more open-ended questions.
• Participant observation : When the researcher serves as a participant in events and observes the actions and outcomes, it is called participant observation.
• Physical artifacts : Tools, objects, instruments, and other artifacts are often observed during a direct observation of the subject.

If you have been directed to write a case study for a psychology course, be sure to check with your instructor for any specific guidelines you need to follow. If you are writing your case study for a professional publication, check with the publisher for their specific guidelines for submitting a case study.

Here is a general outline of what should be included in a case study.

Section 1: A Case History

This section will have the following structure and content:

Background information : The first section of your paper will present your client's background. Include factors such as age, gender, work, health status, family mental health history, family and social relationships, drug and alcohol history, life difficulties, goals, and coping skills and weaknesses.

Description of the presenting problem : In the next section of your case study, you will describe the problem or symptoms that the client presented with.

Describe any physical, emotional, or sensory symptoms reported by the client. Thoughts, feelings, and perceptions related to the symptoms should also be noted. Any screening or diagnostic assessments that are used should also be described in detail and all scores reported.

Your diagnosis : Provide your diagnosis and give the appropriate Diagnostic and Statistical Manual code. Explain how you reached your diagnosis, how the client's symptoms fit the diagnostic criteria for the disorder(s), or any possible difficulties in reaching a diagnosis.

Section 2: Treatment Plan

This portion of the paper will address the chosen treatment for the condition. This might also include the theoretical basis for the chosen treatment or any other evidence that might exist to support why this approach was chosen.

• Cognitive behavioral approach : Explain how a cognitive behavioral therapist would approach treatment. Offer background information on cognitive behavioral therapy and describe the treatment sessions, client response, and outcome of this type of treatment. Make note of any difficulties or successes encountered by your client during treatment.
• Humanistic approach : Describe a humanistic approach that could be used to treat your client, such as client-centered therapy . Provide information on the type of treatment you chose, the client's reaction to the treatment, and the end result of this approach. Explain why the treatment was successful or unsuccessful.
• Psychoanalytic approach : Describe how a psychoanalytic therapist would view the client's problem. Provide some background on the psychoanalytic approach and cite relevant references. Explain how psychoanalytic therapy would be used to treat the client, how the client would respond to therapy, and the effectiveness of this treatment approach.
• Pharmacological approach : If treatment primarily involves the use of medications, explain which medications were used and why. Provide background on the effectiveness of these medications and how monotherapy may compare with an approach that combines medications with therapy or other treatments.

This section of a case study should also include information about the treatment goals, process, and outcomes.

When you are writing a case study, you should also include a section where you discuss the case study itself, including the strengths and limitiations of the study. You should note how the findings of your case study might support previous research. 

In your discussion section, you should also describe some of the implications of your case study. What ideas or findings might require further exploration? How might researchers go about exploring some of these questions in additional studies?

Need More Tips?

Here are a few additional pointers to keep in mind when formatting your case study:

• Never refer to the subject of your case study as "the client." Instead, use their name or a pseudonym.
• Read examples of case studies to gain an idea about the style and format.
• Remember to use APA format when citing references .

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach .  BMC Med Res Methodol . 2011;11:100.

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach . BMC Med Res Methodol . 2011 Jun 27;11:100. doi:10.1186/1471-2288-11-100

Gagnon, Yves-Chantal.  The Case Study as Research Method: A Practical Handbook . Canada, Chicago Review Press Incorporated DBA Independent Pub Group, 2010.

Yin, Robert K. Case Study Research and Applications: Design and Methods . United States, SAGE Publications, 2017.

By Kendra Cherry, MSEd Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

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Home » Case Study – Methods, Examples and Guide

Case Study – Methods, Examples and Guide

Table of Contents

A case study is a research method that involves an in-depth examination and analysis of a particular phenomenon or case, such as an individual, organization, community, event, or situation.

It is a qualitative research approach that aims to provide a detailed and comprehensive understanding of the case being studied. Case studies typically involve multiple sources of data, including interviews, observations, documents, and artifacts, which are analyzed using various techniques, such as content analysis, thematic analysis, and grounded theory. The findings of a case study are often used to develop theories, inform policy or practice, or generate new research questions.

Types of Case Study

Types and Methods of Case Study are as follows:

Single-Case Study

A single-case study is an in-depth analysis of a single case. This type of case study is useful when the researcher wants to understand a specific phenomenon in detail.

For Example , A researcher might conduct a single-case study on a particular individual to understand their experiences with a particular health condition or a specific organization to explore their management practices. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a single-case study are often used to generate new research questions, develop theories, or inform policy or practice.

Multiple-Case Study

A multiple-case study involves the analysis of several cases that are similar in nature. This type of case study is useful when the researcher wants to identify similarities and differences between the cases.

For Example, a researcher might conduct a multiple-case study on several companies to explore the factors that contribute to their success or failure. The researcher collects data from each case, compares and contrasts the findings, and uses various techniques to analyze the data, such as comparative analysis or pattern-matching. The findings of a multiple-case study can be used to develop theories, inform policy or practice, or generate new research questions.

Exploratory Case Study

An exploratory case study is used to explore a new or understudied phenomenon. This type of case study is useful when the researcher wants to generate hypotheses or theories about the phenomenon.

For Example, a researcher might conduct an exploratory case study on a new technology to understand its potential impact on society. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as grounded theory or content analysis. The findings of an exploratory case study can be used to generate new research questions, develop theories, or inform policy or practice.

Descriptive Case Study

A descriptive case study is used to describe a particular phenomenon in detail. This type of case study is useful when the researcher wants to provide a comprehensive account of the phenomenon.

For Example, a researcher might conduct a descriptive case study on a particular community to understand its social and economic characteristics. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a descriptive case study can be used to inform policy or practice or generate new research questions.

Instrumental Case Study

An instrumental case study is used to understand a particular phenomenon that is instrumental in achieving a particular goal. This type of case study is useful when the researcher wants to understand the role of the phenomenon in achieving the goal.

For Example, a researcher might conduct an instrumental case study on a particular policy to understand its impact on achieving a particular goal, such as reducing poverty. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of an instrumental case study can be used to inform policy or practice or generate new research questions.

Case Study Data Collection Methods

Here are some common data collection methods for case studies:

Interviews involve asking questions to individuals who have knowledge or experience relevant to the case study. Interviews can be structured (where the same questions are asked to all participants) or unstructured (where the interviewer follows up on the responses with further questions). Interviews can be conducted in person, over the phone, or through video conferencing.

Observations

Observations involve watching and recording the behavior and activities of individuals or groups relevant to the case study. Observations can be participant (where the researcher actively participates in the activities) or non-participant (where the researcher observes from a distance). Observations can be recorded using notes, audio or video recordings, or photographs.

Documents can be used as a source of information for case studies. Documents can include reports, memos, emails, letters, and other written materials related to the case study. Documents can be collected from the case study participants or from public sources.

Surveys involve asking a set of questions to a sample of individuals relevant to the case study. Surveys can be administered in person, over the phone, through mail or email, or online. Surveys can be used to gather information on attitudes, opinions, or behaviors related to the case study.

Artifacts are physical objects relevant to the case study. Artifacts can include tools, equipment, products, or other objects that provide insights into the case study phenomenon.

How to conduct Case Study Research

Conducting a case study research involves several steps that need to be followed to ensure the quality and rigor of the study. Here are the steps to conduct case study research:

• Define the research questions: The first step in conducting a case study research is to define the research questions. The research questions should be specific, measurable, and relevant to the case study phenomenon under investigation.
• Select the case: The next step is to select the case or cases to be studied. The case should be relevant to the research questions and should provide rich and diverse data that can be used to answer the research questions.
• Collect data: Data can be collected using various methods, such as interviews, observations, documents, surveys, and artifacts. The data collection method should be selected based on the research questions and the nature of the case study phenomenon.
• Analyze the data: The data collected from the case study should be analyzed using various techniques, such as content analysis, thematic analysis, or grounded theory. The analysis should be guided by the research questions and should aim to provide insights and conclusions relevant to the research questions.
• Draw conclusions: The conclusions drawn from the case study should be based on the data analysis and should be relevant to the research questions. The conclusions should be supported by evidence and should be clearly stated.
• Validate the findings: The findings of the case study should be validated by reviewing the data and the analysis with participants or other experts in the field. This helps to ensure the validity and reliability of the findings.
• Write the report: The final step is to write the report of the case study research. The report should provide a clear description of the case study phenomenon, the research questions, the data collection methods, the data analysis, the findings, and the conclusions. The report should be written in a clear and concise manner and should follow the guidelines for academic writing.

Examples of Case Study

Here are some examples of case study research:

• The Hawthorne Studies : Conducted between 1924 and 1932, the Hawthorne Studies were a series of case studies conducted by Elton Mayo and his colleagues to examine the impact of work environment on employee productivity. The studies were conducted at the Hawthorne Works plant of the Western Electric Company in Chicago and included interviews, observations, and experiments.
• The Stanford Prison Experiment: Conducted in 1971, the Stanford Prison Experiment was a case study conducted by Philip Zimbardo to examine the psychological effects of power and authority. The study involved simulating a prison environment and assigning participants to the role of guards or prisoners. The study was controversial due to the ethical issues it raised.
• The Challenger Disaster: The Challenger Disaster was a case study conducted to examine the causes of the Space Shuttle Challenger explosion in 1986. The study included interviews, observations, and analysis of data to identify the technical, organizational, and cultural factors that contributed to the disaster.
• The Enron Scandal: The Enron Scandal was a case study conducted to examine the causes of the Enron Corporation’s bankruptcy in 2001. The study included interviews, analysis of financial data, and review of documents to identify the accounting practices, corporate culture, and ethical issues that led to the company’s downfall.
• The Fukushima Nuclear Disaster : The Fukushima Nuclear Disaster was a case study conducted to examine the causes of the nuclear accident that occurred at the Fukushima Daiichi Nuclear Power Plant in Japan in 2011. The study included interviews, analysis of data, and review of documents to identify the technical, organizational, and cultural factors that contributed to the disaster.

Application of Case Study

Case studies have a wide range of applications across various fields and industries. Here are some examples:

Business and Management

Case studies are widely used in business and management to examine real-life situations and develop problem-solving skills. Case studies can help students and professionals to develop a deep understanding of business concepts, theories, and best practices.

Case studies are used in healthcare to examine patient care, treatment options, and outcomes. Case studies can help healthcare professionals to develop critical thinking skills, diagnose complex medical conditions, and develop effective treatment plans.

Case studies are used in education to examine teaching and learning practices. Case studies can help educators to develop effective teaching strategies, evaluate student progress, and identify areas for improvement.

Social Sciences

Case studies are widely used in social sciences to examine human behavior, social phenomena, and cultural practices. Case studies can help researchers to develop theories, test hypotheses, and gain insights into complex social issues.

Law and Ethics

Case studies are used in law and ethics to examine legal and ethical dilemmas. Case studies can help lawyers, policymakers, and ethical professionals to develop critical thinking skills, analyze complex cases, and make informed decisions.

Purpose of Case Study

The purpose of a case study is to provide a detailed analysis of a specific phenomenon, issue, or problem in its real-life context. A case study is a qualitative research method that involves the in-depth exploration and analysis of a particular case, which can be an individual, group, organization, event, or community.

The primary purpose of a case study is to generate a comprehensive and nuanced understanding of the case, including its history, context, and dynamics. Case studies can help researchers to identify and examine the underlying factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and detailed understanding of the case, which can inform future research, practice, or policy.

Case studies can also serve other purposes, including:

• Illustrating a theory or concept: Case studies can be used to illustrate and explain theoretical concepts and frameworks, providing concrete examples of how they can be applied in real-life situations.
• Developing hypotheses: Case studies can help to generate hypotheses about the causal relationships between different factors and outcomes, which can be tested through further research.
• Providing insight into complex issues: Case studies can provide insights into complex and multifaceted issues, which may be difficult to understand through other research methods.
• Informing practice or policy: Case studies can be used to inform practice or policy by identifying best practices, lessons learned, or areas for improvement.

Advantages of Case Study Research

There are several advantages of case study research, including:

• In-depth exploration: Case study research allows for a detailed exploration and analysis of a specific phenomenon, issue, or problem in its real-life context. This can provide a comprehensive understanding of the case and its dynamics, which may not be possible through other research methods.
• Rich data: Case study research can generate rich and detailed data, including qualitative data such as interviews, observations, and documents. This can provide a nuanced understanding of the case and its complexity.
• Holistic perspective: Case study research allows for a holistic perspective of the case, taking into account the various factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and comprehensive understanding of the case.
• Theory development: Case study research can help to develop and refine theories and concepts by providing empirical evidence and concrete examples of how they can be applied in real-life situations.
• Practical application: Case study research can inform practice or policy by identifying best practices, lessons learned, or areas for improvement.
• Contextualization: Case study research takes into account the specific context in which the case is situated, which can help to understand how the case is influenced by the social, cultural, and historical factors of its environment.

Limitations of Case Study Research

There are several limitations of case study research, including:

• Limited generalizability : Case studies are typically focused on a single case or a small number of cases, which limits the generalizability of the findings. The unique characteristics of the case may not be applicable to other contexts or populations, which may limit the external validity of the research.
• Biased sampling: Case studies may rely on purposive or convenience sampling, which can introduce bias into the sample selection process. This may limit the representativeness of the sample and the generalizability of the findings.
• Subjectivity: Case studies rely on the interpretation of the researcher, which can introduce subjectivity into the analysis. The researcher’s own biases, assumptions, and perspectives may influence the findings, which may limit the objectivity of the research.
• Limited control: Case studies are typically conducted in naturalistic settings, which limits the control that the researcher has over the environment and the variables being studied. This may limit the ability to establish causal relationships between variables.
• Time-consuming: Case studies can be time-consuming to conduct, as they typically involve a detailed exploration and analysis of a specific case. This may limit the feasibility of conducting multiple case studies or conducting case studies in a timely manner.
• Resource-intensive: Case studies may require significant resources, including time, funding, and expertise. This may limit the ability of researchers to conduct case studies in resource-constrained settings.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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• BUSINESS STUDIES GRADE 12 TERM 1 SBA TASK 2022

BUSINESS STUDIES GRADE 12 PROGRAMME OF ASSESSMENT

Terms of references for a case study and controlled test

• Teachers must provide learners with the topics on which the case study will be based for assessment.
• Learners to be given one week to collect resources on the topics
• The case study must be administered and completed within two hours under controlled conditions.
• Case studies are a very good way of keeping the subject up to date and relevant.
• Learners are presented with a real-life situation, a problem, or an incident related to the topic.
• Each formal assessment task must consist of only one assessment activity
• They should draw on their own experience or prior learning to interpret, analyse and solve a problem or set of problems and make suggestion/s and or recommendation/s to defend their arguments.
• Case studies may be taken from newspaper articles, magazine articles, video clips, or radio recordings and all sources must be acknowledged.

CONTROLLED TEST The control test must adhere to the following:

• It must be completed by all classes in the same grade on the same day.
• Where there is more than one teacher, an agreement must be reached on the scope as well as the date and time of the test.
• All learners write the same test under examination conditions.
• The duration of the controlled test must be one and half hours for 100 marks.
• The test must cover the different cognitive levels in examinations. See table on cognitive levels under Examinations in the following section.
• Include problem-solving questions.
• The test must cover a range of integrated topics, as determined by the annual teaching plan work schedule and the assessment plan.
• Questions must comply with year-end examination standards.

BUSINESS STUDIES CONSOLIDATION SCHEDULE

NAME OF LEARNER : ___________________________________ EXAMINATION NUMBER : ________________________________ NAME OF SCHOOL : ________________________________

ANNEXURE B DECLARATION BY LEARNER SCHOOL NAME : ___________________________________ NAME OF LEARNER : ___________________________________ TEACHER’S NAME : ___________________________________ I hereby declare that all SBA tasks contained in this portfolio are my original work and that if I have used any sources, I have acknowledged them. I will endeavour to keep my work original and not plagiarise other sources/people’s work. I agree that if it is determined by the relevant authorities that I have engaged in any fraudulent activities whatsoever about my SBA mark, I shall forfeit completely for this assessment (s) _________________________ ______________ CANDIDATE’S SIGNATURE            DATE ________________________ ______________ PARENT/ GUARDIAN                     DATE

As far as I know, the above statement by the candidate is true and I accept that the work offered is his/her name _________________________ ______________ TEACHER’S SIGNATURE                 DATE

ANNEXURE C EVIDENCE OF SCHOOL & DISTRICT MODERATION 

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ANNEXURE C EVIDENCE OF SCHOOL MODERATION GRADE 10-12

TERM 1 : Case Study DURATION : 2 Hours TOTAL : 50 Marks NB: This task should be completed under controlled conditions QUESTION 1 1.1 Read the case study below and answer the questions that follow:

1.1.1 Identify TWO Acts that Tumi Manufacturers complies with. Motivate your answer by quoting from the case study above. Use the table below as a GUIDE to answer QUESTION 1.1.1

(6) 1.1.2 Explain the purposes of the Acts identified in QUESTION 1.1.1 (4) 1.1.3 Identify the recruitment method used by TM to attract suitable candidates for the vacancy. Motivate your answer by quoting from the case study above. Use the table as a GUIDE to answer QUESTION 1.1.3

(3) 1.1.4 Discuss the positive impact of the recruitment method identified in QUESTION 1.1.3 (6) 1.1.5 Differentiate between the TWO components of job analysis. (6) 1.1.6 Advise TM on how can apply the following King Code principle for good corporate governance.

• Accountability (4)
• Transparency (4)

1.1.7 Identify the type of unethical business practices from the case study above. Motivate your answer by quoting from the case study above. Use the table below as a GUIDE to answer QUESTION 1.1.7

(3) 1.1.8 Explain how the unethical business practice identified in QUESTION 1.1.7 pose a challenge to TM as a business. (6) 1.1.9 Quote TWO ways in which TM applies the Delphi technique and Force Field analysis problem-solving techniques to solve complex business problems Use the table below as a GUIDE to answer QUESTION 1.1.8

(4) 1.1.10 Advised TM on other ways in which they can apply the TWO problem solving techniques mentioned in QUESTION 1.1.9 (4) TOTAL: [50]

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• CBSE Class 12

CBSE Class 12 Psychology Important Case Study Based Questions 2023: Read and Solve for Tomorrow's Exam

Psychology important case study questions for cbse class 12: practice important psychology case study-based questions for cbse class 12. these questions are important for the upcoming cbse class 12 psychology board exam 2023..

  CBSE Class 12 Psychology Exam 2023: Hello students! kudos to the efforts you put into tackling your 2023 board examinations. We understand that the last few weeks were tremendously tiring, both mentally and physically. Don’t worry, take a deep breath and relax as this is the final phase of your CBSE examination 2023. The class 12 Psychology exam is the last in the lane. Its paper code is 037. The exam is planned for 05th April 2023, that is, tomorrow. The exam will be for 3 hours scheduled between 10.30 AM to 01.30 PM. We believe you have already solved the sample question and previous year papers for Class 12 Psychology and must be aware of the exam pattern. If not, please refer to the links below.

• CBSE Class 12 Psychology Previous Year Question Papers: Download pdf
• CBSE Board Class 12 Psychology Sample Paper 2022-23 in PDF

CBSE Class 12 Psychology, Important Case Study-Based Questions:

Case 1: .

Read the following case study and answer the questions that follow: 

Sundar, a college-going 20-year-old male, has moved from his home town to live in a big city. He has continuous fear of insecurity and feels that enemy soldiers are following him. He gets very tense when he spots anyone in a uniform and feels that they are coming to catch him. This intense anxiety is interfering with his work and relationship, and his friends are extremely concerned as it does not make any sense to them. Sundar occasionally laughs abruptly and inappropriately and sometimes stops speaking mid-sentence, scanning off in the distance as though he sees or hears something. He expresses concern about the television and radio in the room potentially being monitored by the enemies. His beliefs are fixed and if they are challenged, his tone becomes hostile. 

Q1. Based on the symptoms being exhibited, identify the disorder. Explain the other symptoms that can be seen in this disorder.

Q2. Define delusion and inappropriate affect. Support it with the symptoms given in the above case study.

Read the case and answer the questions that follow. 

Alfred  Binet, in 1905,  was requested by the French government to devise a method by which students who experienced difficulty in school could be identified.  Binet and his colleague,  Theodore  Simon,  began developing questions that focused on areas not explicitly taught in schools those days, such as memory, and attention skills related to problem-solving.  Using these questions, Binet determined which were the ones that served as the best predictors of school success. 

Binet quickly realised that some children were able to answer more advanced questions than older children were generally able to answer and vice versa.  Based on this observation, Binet suggested the concept of mental age or a measure of intelligence based on the average abilities of children of a  certain age group.  This first intelligence test is referred to as the Binet-Simon  Scale. He insisted that intelligence is influenced by many factors, it changes over time,  and it can only be compared in children with similar backgrounds. 

Q1 . Identify the approach on which the Binet-Simon Intelligence Scale is based. Discuss its features.

Q2 . ‘Binet quickly realised that some children were able to answer more advanced questions than older children were generally able to answer and vice versa’. Why do individuals differ in intelligence? Using examples, give reasons for your answer.

Read the following case study and answer the questions that follow :

All the Indian settlers were contemptuously and without distinction dubbed “coolies” and forbidden to walk on footpaths or be out at night without permits. 

Mahatma Gandhi quickly discovered colour discrimination in South Africa and confronted the realisation that being Indian subjected him to it as well. At a particular train station, railway employees ordered him out of the carriage despite his possessing a first-class ticket. Then on the stagecoach for the next leg of his journey, the coachman, who was white, boxed his ears. A Johannesburg hotel also barred him from lodging there. Indians were commonly forbidden to own land in Natal, while ownership was more permissible for native-born people. 

In 1894, the Natal Bar Association tried to reject Gandhi on the basis of race. He was nearly lynched in 1897 upon returning from India while disembarking from a ship moored at Durban after he, his family, and 600 other Indians had been forcibly quarantined, allegedly due to medical fears that they carried plague germs. 

Q1. What is the difference between prejudice and discrimination ? On the

basis of the incidents in the above case study, identify a situation for each

which are examples of prejudice and discrimination.

Q2. What do you think could have been a source of these prejudices ? Explain

any two sources. 

Read the given case carefully and answer the questions that follow: 

Harish belonged to a family of four children, him being the eldest. Unlike any first born, he was not given the attention he should have had. His father worked as an accountant, while his mother stayed at home to look after the kids. He dropped out of school and could barely manage to get work for a little salary.

His relationship with his family played an important role in building his disposition. He felt a certain feeling of insecurity with his siblings, especially his brother Tarun, who was able to finish college because of parental support.

Due to the hopelessness Harish felt, he started engaging in drinking alcohol with his high school friends. Parental negligence caused emotional turmoil. He also had insomnia which he used as a reason for drinking every night.

Over time, Harish had to drink more to feel the effects of the alcohol. He got grouchy or shaky and had other symptoms when he was not able to drink or when he tried to quit.

In such a case, the school would be the ideal setting for early identification and intervention. In addition, his connection to school would be one of the most significant protective factors for substance abuse. His school implemented a variety of early intervention strategies which did not help him as he was irregular and soon left school. Some protective factors in school would be the ability to genuinely experience positive emotions through good communication.

(i)It has been found that certain family systems are likely to produce abnormal functioning in individual members.

In the light of the above statement, the factors underlying Harish's condition can be related to model.

(A) Humanistic

(B) Behavioural

(C) Socio-cultural 

(D) Psychodynamic

(ii) Over time, Harish needed to drink more before he could feel the effects of the alcohol. This means that he built a alcohol. towards the

(A) Withdrawal

(B) Tolerance

(C) Stress inoculation

(D) All of the above

(iii)He got grouchy or shaky and had other symptoms when he was not able to drink or when he tried to quit. This refers to

(A) Low willpower symptoms.

(B) Addiction symptoms

(C) Withdrawal symptoms

(D) Tolerance symptoms

(iv) Which of the following is not true about substance related and addictive disorders?

(A) Alcoholism unites millions of families through social interactions and get-togethers.

(B) Intoxicated drivers are responsible for many road accidents. 

(C) It also has serious effects on the children of persons with this disorder.

(D) Excessive drinking can seriously damage physical health.

Read the given case carefully and answer the questions that follow:

Monty was only 16 years when he dealt with mixed emotions for every couple of months. He shares that sometimes he felt like he was on top of the world and that nobody could stop him. He would be extremely confident. Once these feelings subsided, he would become depressed and lock himself in the room. He would neither open the door for anyone nor come out.

He shares, "My grades were dropping as I started to breathe rapidly and worry about almost everything under the sun. I felt nervous, restless and tense, with an increased heart rate. My family tried to help but I wasn't ready to accept." His father took him to the doctor, who diagnosed him. Teenage is a tough phase as teenagers face various emotional and psychological issues. How can one differentiate that from a disorder? Watch out when one is hopeless and feels helpless. Or, when one is not able to control the powerful emotions. It has to be confirmed by a medical practitioner.

During his sessions, Monty tries to clear many myths. He gives his perspective of what he experienced and the treatment challenges. "When I was going through it, I wish I had met someone with similar experiences so that I could have talked to her/him and understood why I was behaving the way I was. By talking openly, I hope to help someone to cope with it and believe that it is going to be fine one day."

Now, for the last five years Monty has been off medication and he is leading a regular life. Society is opening up to address mental health issues in a positive way, but it always helps to listen to someone who has been through it.

(i)Monty's symptoms are likely to be those of

(A) ADHD and anxiety disorder

(B) Bipolar disorder and generalised anxiety disorder 

(C) Generalised anxiety disorder and oppositional defiant disorder

(D) Schizophrenia

(ii) During his sessions, Monty tried to clear many myths. Which one of the following is a myth?

(A) Normality is the same as conformity to social norms.

(B) Adaptive behaviour is not simply maintenance and survival but also includes growth and fulfilment.

(C) People are hesitant to consult a doctor or a psychologist because they are ashamed of their problems.

(D) Genetic and biochemical factors are involved in causing mental disorders.

(iii) With an understanding of Monty's condition, which of the following is a likely symptom he may also be experiencing?

(A) Frequent washing of hands

(B) Assuming alternate personalities

(C) Persistent body related symptoms, which may or may not be related to any serious medical condition

(D) Prolonged, vague, unexplained and intense fears that are not attached to any particular object

(iv) Teenage is a tough phase as teenagers face various emotional and psychological issues. The disorder manifested in the early stage of development is classified as,

(A) Feeding and eating disorder

(B) Trauma and stressor related disorder

(C) Neurodevelopmental disorder

(D) Somatic symptom disorder

• CBSE Class 12 Psychology Syllabus 2022-23 .
• CBSE class 12 Psychology DELETED syllabus 2022-23.  
• NCERT Books for Class 12 Psychology - (All Chapters)
• NCERT Books for Class 12 Psychology (in Hindi) - (All Chapters)
• CBSE Class 12 Date Sheet 2023
• CBSE Topper Answer Sheet Class 12: Model Answer Paper Download PDF
• CBSE Class 12 Preparation Tips: TOP 10 Ways to Score High in CBSE Class 12th Board Exam

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• On what day CBSE Class 12 Psychology 2023 exam is? + As per the official schedule, the CBSE class 12 psychology exam will be conducted on 05th April 2023. It would a Wednesday.
• Is it important to solve case study questions for CBSE Class 12 Psychology exam? + Yes, as per the updates made by the CBSE Board in the past few years, the psychology paper now carries case study questions. It is of 4 marks with multiple subparts. Thus, students are advised to practice case-based questions to score fully in this section.
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Class 12 Maths Case Study Questions

Table of Contents

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Download the app to get CBSE Sample Papers 2023-24, NCERT Solutions (Revised), Most Important Questions, Previous Year Question Bank, Mock Tests, and Detailed Notes.

Class 12 Maths question paper will have 1-2 Case Study Questions. These questions will carry 5 MCQs and students will attempt any four of them. As all of these are only MCQs, it is easy to score good marks with a little practice. Class 12 Maths Case Study Questions are available on the myCBSEguide App and Student Dashboard .

Why Case Studies in CBSE Syllabus?

CBSE has introduced case study questions in the CBSE curriculum recently. The purpose was to make students ready to face real-life challenges with the knowledge acquired in their classrooms. It means, there was a need to connect theories with practicals. Whatsoever the students are learning, they must know how to apply it in their day-to-day life. That’s why CBSE is emphasizing case studies and competency-based education .

Case Study Questions in Maths

Let’s have a look over the class 12 Mathematics sample question paper issued by CBSE, New Delhi. Question numbers 17 and 18 are case study questions.

Focus on concepts

If you go through each MCQ there, you will find that the theme/case study is common but the questions are based on different concepts related to the theme. It means, that if you have done ample practice on the various concepts, you can solve all these MCQs in minutes.

Easy Questions with a Practical Approach

The difficulty level of the questions is average or say easy in some cases. On the other hand, you get four options to choose from. So, you get two levels of support to get full marks with very little effort.

Practice Questions Regularly

Most of the time we feel that it’s easy and neglect it. But in the end, we have to pay for this negligence. This may happen here too. Although it’s easy to score good marks on the case study questions if you don’t practice such questions, you may lose your marks. So, we suggest students should practice at least 30-40 such questions before writing the board exam.

12 Maths Case-Based Questions

We are giving you some examples of case study questions here. We have arranged hundreds of such questions chapter-wise on the myCBSEguide App. It is the complete guide for CBSE students. You can download the myCBSEguide App and get more case study questions there.

Case Study Question – 1

• A is a diagonal matrix
• A is a scalar matrix
• A is a zero matrix
• A is a square matrix
• If A and B are two matrices such that AB = B and BA = A, then B 2 is equal to

Case Study Question – 2

• 4(x 3  – 24x 2   + 144x)
• 4(x 3 – 34x 2   + 244x)
• x 3  – 24x 2   + 144x
• 4x 3  – 24x 2   + 144x
• Local maxima at x = c 1
• Local minima at x = c 1
• Neither maxima nor minima at x = c 1
• None of these

Case Study Questions Matrices -1

Answer Key:

Case Study Questions Matrices – 2

Read the case study carefully and answer any four out of the following questions: Once a mathematics teacher drew a triangle ABC on the blackboard. Now he asked Jose,” If I increase AB by 11 cm and decrease the side BC by 11 cm, then what type of triangle it would be?” Jose said, “It will become an equilateral triangle.”

Again teacher asked Suraj,” If I multiply the side AB by 4 then what will be the relation of this with side AC?” Suraj said it will be 10 cm more than the three times AC.

Find the sides of the triangle using the matrix method and  answer the following questions:

• (a) 3  ×  3

Case Study Questions Determinants – 01

DETERMINANTS:  A determinant is a square array of numbers (written within a pair of vertical lines) that represents a certain sum of products. We can solve a system of equations using determinants, but it becomes very tedious for large systems. We will only do 2 × 2 and 3 × 3 systems using determinants. Using the properties of determinants solve the problem given below and answer the questions that follow:

Three shopkeepers Ram Lal, Shyam Lal, and Ghansham are using polythene bags, handmade bags (prepared by prisoners), and newspaper envelopes as carrying bags. It is found that the shopkeepers Ram Lal, Shyam Lal, and Ghansham are using (20,30,40), (30,40,20), and (40,20,30) polythene bags, handmade bags, and newspapers envelopes respectively. The shopkeeper’s Ram Lal, Shyam Lal, and Ghansham spent ₹250, ₹270, and ₹200 on these carry bags respectively.

• (b) Shyam Lal
• (a) Ram Lal

Case Study Questions Determinants – 02

Case study questions application of derivatives.

• R(x) = -x 2  + 200x + 150000
• R(x) = x 2  – 200x – 140000
• R(x) = 200x 2  + x + 150000
• R(x) = -x 2  + 100 x + 100000
• R'(x) > 0
• R'(x) < 0
• R”(x) = 0
• (a) -x 2  + 200x + 150000
• (a) R'(x) = 0
• (c) 257, -63

Case Study Questions Vector Algebra

• tan−1⁡(5/12)
• tan−1⁡(12/3)
• (b) 130 m/s
• (a)  tan−1⁡(5/12)
• (b) 170 m/s

More Case Study Questions

These are only some samples. If you wish to get more case study questions for CBSE class 12 maths, install the myCBSEguide App. It has class 12 Maths chapter-wise case studies with solutions.

12 Maths Exam pattern

Question Paper Design of CBSE class 12 maths is as below. It clearly shows that 20% weightage will be given to HOTS questions. Whereas 55% of questions will be easy to solve.

• No. chapter-wise weightage. Care to be taken to cover all the chapters
• Suitable internal variations may be made for generating various templates keeping the overall weightage to different forms of questions and typology of questions the same.

Choice(s): There will be no overall choice in the question paper. However, 33% of internal choices will be given in all the sections

12 Maths Prescribed Books

• Mathematics Part I – Textbook for Class XII, NCERT Publication
• Mathematics Part II – Textbook for Class XII, NCERT Publication
• Mathematics Exemplar Problem for Class XII, Published by NCERT
• Mathematics Lab Manual class XII, published by NCERT

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CBSE Class 12 Maths Case Study Questions With Solutions

CBSE Class 12 Mathematics Case Study Questions are introduced this year in the updated CBSE Board Exam Pattern. According to that this year the candidates need to prepare for the case study problems along with the questions that are legacy of CBSE Board.

In Class XIIth Mathematics Case Study Questions there are problems based on Objective types of questions, Assertions and Reason, and cae based problems. These problems have the intention to examine the students' overall understanding of the subject. If you are preparing for the Maths board exam then this is the right place for you. 

Here, we have provided the complete set of CBSE class 12 maths case study questions With Solutions. These are developed by the subject matter expert. If you want to score good marks in the board papers then you should practice these Case based problems. It is absolutely free of cost. 

Download PDF CBSE Class 12 Maths Case Study From the Given links. It is in chapter wise format.

Class 12th Mathematics Important Formulas, MCQ, Case-Based, Assertion and Reason

Class 12th maths case study.

In class 12th Maths Case Study the questions are based on the real world scenarios. A passage filled with information or data is provided to the students. On the basis of that paragraph upto 5 questions are developed which should be answered by the students. To answer them they need to read the passage carefully and then pay attention to the given data to solve such questions.

These types of problems are generally known as case based questions which can be only solved by referring to the given paragraph.

Class 12 Maths Important Formulas

Knowing about the Maths Important Formulas is a crucial part of solving the Maths questions. Formulas help in solving the problems more efficiently and faster. Therefore the PDF file that we have provided here consists of all the basics and Important formulas of maths. It will help in revisions and solving the questions more accurately and easily.

Every chapter has its own topics and formulas so the PDF has been divided into chapter wise format. And if you access them from this place then you will be able to get all the formulas and other questions separately.

Class 12 Maths Assertion and Reason MCQs

Class 12th Maths Assertion and Reason MCQs PDF with Solutions are also given here. It is the most important part of Case Study Questions because scoring good marks in this section is not that much hard. If your basic concepts are clear. Because most of the time such types of questions are directly prepared by referring to the concepts.

Furthermore, the assertion and reason MCQs are solved by applying the distinct approaches. For instance, to answer these questions first candidates need to verify the Assertion (Statement) and then the reason if both are correct, then learners need to verify whether both statement and reason support each other or not.

There are a total of 5 sections in CBSE Class 12 Maths Questions Term 1. Section A contains 1 mark, Section B contains 2 marks, Section C contains 3 marks, Section D contains 4 marks and the last Section E contains 5 marks. A total of 5 questions are given in these sections.

No, In Term 1 exam there will be a total of 5 questions in each case study of class 12 maths, out of which 4 are compulsory to solve.

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Business Studies Class 12 Case Studies With Solutions

Here we have to provide Case Study Of Business Studies Class 12 CBSE PDF Download from BST Class 12 case studies with answers books prepared by the subject experts.

Case Study Of Business Studies Class 12 CBSE PDF

Business studies class 12 case studies with solutions, answers.

Part A & B: Principles and Functions of Management & Business Finance and Marketing

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Class 12 Maths: Case Study of Chapter 1 Relations and Functions PDF Download

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• Post published:
• Post category: 12 board / Class 12
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In Class 12 Boards there will be Case studies and Passage Based Questions will be asked, So practice these types of questions. Study Rate is always there to help you. Free PDF Download of CBSE Class 12 Mathematics Chapter 1 Relations and Functions Case Study and Passage Based Questions with Answers were Prepared Based on Latest Exam Pattern. Students can solve NCERT Class 12 Maths Relations and Functions  to know their preparation level.

Join our Telegram Channel, there you will get various e-books for CBSE 2024 Boards exams for Class 9th, 10th, 11th, and 12th.

In CBSE Class 12 Maths Paper, There will be a few questions based on case studies and passage-based as well. In that, a paragraph will be given, and then the MCQ questions based on it will be asked.

Relations and Functions Case Study Questions With answers

Here, we have provided case-based/passage-based questions for Class 12 Mathematics  Chapter 1 Relations and Functions

Case Study/Passage-Based Questions

Case Study 1:

A general election of the Lok Sabha is a gigantic exercise. About 911 million people were eligible to vote and voter turnout was about 67%, the highest ever.

Let I be the set of all citizens of India who were eligible to exercise their voting right in the general election held in 2019. A relation ‘R’ is defined on I as follows: R = {(𝑉1, 𝑉2) ∶ 𝑉1, 𝑉2 ∈ 𝐼 and both use their voting right in the general election – 2019}

• Two neighbors X and Y∈ I. X exercised his voting right while Y did not cast her vote in general election – 2019. Which of the following is true? a. (X,Y) ∈R b. (Y,X) ∈R c. (X,X) ∉R d. (X,Y) ∉R
• Mr.’𝑋’ and his wife ‘𝑊’both exercised their voting right in general election -2019, Which of the following is true? a. both (X,W) and (W,X) ∈ R b. (X,W) ∈ R but (W,X) ∉ R c. both (X,W) and (W,X) ∉ R d. (W,X) ∈ R but (X,W) ∉ R
• Three friends F1, F2, and F3 exercised their voting right in the general election 2019, then which of the following is true? a. (F1,F2 ) ∈R, (F2,F3) ∈ R and (F1,F3) ∈ R b. (F1,F2 ) ∈ R, (F2,F3) ∈ R and (F1,F3) ∉ R c. (F1,F2 ) ∈ R, (F2,F2) ∈R but (F3,F3) ∉ R d. (F1,F2 ) ∉ R, (F2,F3) ∉ R and (F1,F3) ∉ R
• The above-defined relation R is __ a. Symmetric and transitive but not reflexive b. Universal relation c. Equivalence relation d. Reflexive but not symmetric and transitive
• Mr. Shyam exercised his voting right in General Election – 2019, then Mr. Shyam is related to which of the following? a. All those eligible voters who cast their votes b. Family members of Mr.Shyam c. All citizens of India d. Eligible voters of India

Answer: 1. (d) (X,Y) ∉R 2. (a) both (X,W) and (W,X) ∈ R 3. (a) (F1,F2 ) ∈R, (F2,F3) ∈ R and (F1,F3) ∈ R 4. (c) Equivalence relation 5. (a) All those eligible voters who cast their votes

Case Study 2:

Sherlin and Danju are playing Ludo at home during Covid-19. While rolling the dice, Sherlin’s sister Raji observed and noted the possible outcomes of the throw every time belonging to set {1, 2, 3, 4, 5, 6}. Let A be the set of players while B be the set of all possible outcomes. A = {S, D}, B = {1, 2, 3, 4, 5, 6}

(i) Let R : B –> B be defined by R = {(x, y) : y is divisible by x} is (a) Reflexive and transitive but not symmetric (b) Reflexive and symmetric but not transitive (c) Not reflexive but symmetric and transitive (d) Equivalence

Answer: (a) Reflexive and transitive but not symmetric

(ii) Raji wants to know the number of functions from A to B. How many number of functions are possible? (a) 6 2 (b) 2 6 (c) 6! (d) 2 12

Answer: (a) 62

(iii) Let R be a relation on B defined by R = {(1, 2), (2, 2), (1, 3), (3, 4), (3, 1), (4, 3), (5, 5)}. Then R is (a) Symmetric (b) Reflexive (c) Transitive (d) None of these three

Answer: (d) None of these three

(iv) Raji wants to know the number of relations possible from A to B. How many numbers of relations are possible? (a) 6 2 (b) 2 6 (c) 6! (d) 2 12

Answer: (d) 212

(v) Let R : B –> B be defined by R = {(1, 1), (1, 2), (2, 2)(3, 3), (4, 4), (5, 5), (6, 6)}, then R is (a) Symmetric (b) Reflexive and Transitive (c) Transitive and symmetric (d) Equivalence

Answer: (b) Reflexive and Transitive

Hope the information shed above regarding Case Study and Passage Based Questions for Class 12 Maths Chapter 1 Relations and Functions with Answers Pdf free download has been useful to an extent. If you have any other queries of CBSE Class 12 Mathematics Relations and Functions Case Study and Passage Based Questions with Answers, feel free to comment below so that we can revert back to us at the earliest possible. By Team Study Rate

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Following the legalization of cannabis in Canada in 2018, people aged 65 + years reported a significant increase in cannabis consumption. Despite limited research with older adults regarding the therapeutic benefits of cannabis, there is increasing interest and use among this population, particularly for those who have chronic illnesses or are at end of life. Long-term Care (LTC) facilities are required to reflect on their care and policies related to the use of cannabis, and how to address residents’ cannabis use within what they consider to be their home.

Using an exploratory case study design, this study aimed to understand how one LTC facility in western Canada addressed the major policy shift related to medical and non-medical cannabis. The case study, conducted November 2021 to August 2022, included an environmental scan of existing policies and procedures related to cannabis use at the LTC facility, a quantitative survey of Healthcare Providers’ (HCP) knowledge, attitudes, and practices related to cannabis, and qualitative interviews with HCPs and administrators. Quantitative survey data were analyzed using descriptive statistics and content analysis was used to analyze the qualitative data.

A total of 71 HCPs completed the survey and 12 HCPs, including those who functioned as administrators, participated in the interview. The largest knowledge gaps were related to dosing and creating effective treatment plans for residents using cannabis. About half of HCPs reported providing care in the past month to a resident who was taking medical cannabis (54.9%) and a quarter (25.4%) to a resident that was taking non-medical cannabis. The majority of respondents (81.7%) reported that lack of knowledge, education or information about medical cannabis were barriers to medical cannabis use in LTC. From the qualitative data, we identified four key findings regarding HCPs’ attitudes, cannabis access and use, barriers to cannabis use, and non-medical cannabis use.

Conclusions

With the legalization of medical and non-medical cannabis in jurisdictions around the world, LTC facilities will be obligated to develop policies, procedures and healthcare services that are able to accommodate residents’ use of cannabis in a respectful and evidence-informed manner.

Peer Review reports

In October 2018, Canada became the second country to legalize non-medical cannabis [ 1 ]. Despite the increasing interest in cannabis among Canadians of all ages [ 2 ], the percentage of individuals over the age of 15 years reporting cannabis use a year following legalization remained relatively unchanged at 18% [3]. The only age group to report a significant increase in cannabis consumption was those aged 65 + years, with 7.6% reporting cannabis use in the past 3 months [ 3 ] in 2019 compared to 4% in 2018. This upward trend in cannabis use among Canadians 65 years or older was also observed in 2021 [ 4 ].

This increase may reflect a growing acceptance of cannabis among older populations who were previously dissuaded from taking cannabis due to its illegal status as well as limited accessibility through legal means. In addition, the rise in cannabis use among older adults may reflect a harm reduction approach, substituting cannabis for other recreational substances with substantial health risks, such as alcohol [ 5 ]. Moreover, the belief in the potential therapeutic benefits of cannabis [ 6 , 7 , 8 ], such as the management of pain and sleep issues, is becoming increasingly prevalent among older adults. There has been limited research, however, among older adults in Canada to understand this progressive trend in cannabis use and the influencing factors [ 9 ].

Canada has been a world leader in cannabis legalization, launching a federal medical cannabis program in 2001. Since this time, the medical cannabis program has undergone numerous revisions, including how authorization is obtained, what types of products are available, and where cannabis is purchased. Currently, Canadians can seek medical authorization from either a physician or a nurse practitioner, and access a variety of cannabis products, including dried flower, capsules, and oils, which are purchased online through a licensed producer (LP). Some individuals also apply for a personal or designated grow license to produce their own supply of dried cannabis. Outside of the medical authorization program, individuals can access non-medical cannabis through an authorized storefront. It is estimated that over 1 million Canadians are using cannabis for therapeutic purposes [4], with 247,548 individuals officially registered as of March 2022 [ 10 ]. Among the 479,400 individuals over the age of 65 who reported cannabis use in the third quarter of 2019, 52% utilized cannabis exclusively for medical reasons, and another 24% reported using cannabis for both recreational and medical purposes [ 3 ].

Despite the growing interest in cannabis as a therapeutic agent, there has been limited human research due to its illegal status in many countries, as well as the challenges posed by the complexity of the cannabis plant compared to single agent, pharmaceutical forms of cannabis (e.g., nabilone) [ 11 , 12 ]. Notwithstanding these challenges, there is emergent research on the potential role of cannabis-based medicines in the management of health conditions common among older adults, including osteoarthritis [ 13 ], sleep disorders [ 14 ], dementia [ 15 ], and Parkinson’s [ 16 , 17 ], which are also prevalent among individuals residing at long-term care (LTC) facilities. For example, several studies have found cannabis-based medicines to significantly reduce neuropsychiatric symptoms and improve quality of life among people living with Alzheimer’s Disease [ 18 , 19 , 20 ]. Cannabis may also play a significant role at end of life in not only alleviating physical symptoms, such as pain, nausea and vomiting, and appetite loss, but also addressing the emotional and existential issues that may arise [ 21 ]. It has also been proposed that cannabis may have a therapeutic role among rehabilitative populations who often reside in LTC settings, including those with spinal cord injuries [ 22 , 23 ] and traumatic brain injury [ 24 ]. The evidence base surrounding cannabis as a therapeutic agent, however, remains limited with few large randomized clinical trials conducted to date.

Cannabis is not a benign substance and may pose risk to older adults, especially those living with frailty or cognitive impairment. Given the known cognitive effects of tetrahydrocannabinol (THC), a cannabinoid found in many forms of cannabis, adults living in long-term and rehabilitative care settings may experience somnolence, confusion, and fatigue [ 25 ]. Cannabis high in THC may also negatively impact motor coordination and increase the risk of falls, especially among those with impaired balance and walking ability [ 25 ]. As research advances on cannabis, there has been growing awareness of its negative interactions with certain medications [ 26 ], which can pose a significant issue among older clients prone to polypharmacy. Lastly, numerous health conditions are contraindicated with cannabis use, including heart disease, and a personal or family history of psychosis, schizophrenia, or bipolar disorder [ 27 ].

Despite limited research with older adults regarding the therapeutic benefits of cannabis, there is increasing interest and use among this population, particularly for those who have chronic illnesses. As adults age, they are more likely to experience multimorbidity, and a significant number of older adults spend their last years of life residing in a LTC facility [ 28 , 29 ]. LTC facilities are, thus, placed in a unique position. While these facilities are considered medical institutions that provide evidence-informed supportive health care, they have also become home for individuals who are no longer able to reside safely in the community. Increasingly, these types of facilities are challenged to create home-like environments and offer residents the opportunity and autonomy to engage in potentially risky health behaviours [ 30 ]; behaviours that individuals in the community have the independence and legal right to choose, such as alcohol or tobacco consumption. With the legalization of non-medical cannabis and the growing interest in the potential of cannabis to manage challenging health conditions, it behooves LTC facilities to reflect on their care and policies related to the use of legal substances, such as cannabis, and how to address residents’ cannabis use within what they consider to be their home.

The overarching aim of this case study was to understand how one LTC facility, and its healthcare professionals (HCPs) and administrators, addressed the major policy shift in Canada related to medical and non-medical cannabis. Specific research questions included: (1) What are the experiences and perceptions of HCPs and administrators regarding the use of medical and non-medical cannabis at LTC settings?; (2) What are the perceived barriers/facilitators to medical and non-medical cannabis use at LTC facilities from the perspective of HCPs and administrators?; and (3) What are the educational needs, attitudes, and practices of HCPs at LTC facilities related to medical and non-medical cannabis?

Research design and setting

An exploratory case study design was utilized in this study. This type of case study is used to explore those situations in which the phenomenon being evaluated has no clear or single set of outcomes [ 31 ]. The case selected for this study was a large LTC facility in Western Canada. This 387-bed residential facility provides 24/7 care to a diverse population, including older adults with cognitive and physical disabilities, individuals recovering from stroke and traumatic brain injury, and those requiring end-of-life care. Individuals with these various conditions may reside in several units, including palliative care, rehabilitation, personal care home, and complex chronic care. The case study included an environmental scan of existing policies and procedures related to medical and non-medical cannabis use at the LTC facility, a quantitative survey of HCPs’ knowledge, attitudes, and practices related to medical and non-medical cannabis, and qualitative interviews with HCPs and administrators. The qualitative interviews were informed by qualitative descriptive methodology [ 32 ] and explored HCPs’ and administrators’ experiences, beliefs, perceptions regarding cannabis use in LTC, and the related barriers and facilitators.

Sample and recruitment

For the survey, a convenience sample was drawn from the entire population of accredited HCPs working in the selected facility. Eligibility criteria included being 18 + years, able to read/speak English, currently employed and providing care at the LTC facility, and able to provide informed written consent. Study participants were recruited through an emailed letter of invitation, posters placed in staff areas, and in-person presentations by a research assistant. From participants who took part in the survey, a subsample of HCPs, including administrators, who expressed interest in taking part in an interview was selected. The data collection period was from November 2021 and August 2022.

Data collection

For the environmental scan, facility administrators were approached via an emailed letter and asked to identify relevant policies and procedures related to cannabis use within their LTC facility. Policies relevant to both residents’ use of cannabis and HCPs’ practice related to medical and non-medical cannabis were requested. Provincial and federal cannabis policies were also collected.

The survey was modified from a questionnaire utilized in two national studies that examined Canadian physicians’ and nurse practitioners’ knowledge, attitudes, and perceptions of the associated barriers and facilitators related to medical cannabis use, as well as their preferences regarding medical cannabis education [ 33 , 34 ]. This survey has been found to be internally consistent, with Cronbach’s alphas of 0.70 to 0.92 reported across subscales [ 33 , 34 ]. Slight word changes were made to reflect the fact that individuals living in LTC facility are referred to as residents, not patients, and the name of the facility was used to orientate the questions towards HCPs’ attitudes and practices related to cannabis use within the LTC setting.

Survey items were added that assessed HCPs’ practices related to addressing residents’ and family members’ questions about cannabis, as well as requests for medical cannabis authorization and follow-up care. A demographic survey that assessed gender, age, professional designation, years in practice, area(s) of practice, and education related to medical cannabis was included. The survey was available in hard copy (Supplementary Material 1 ) as well as online through the software program, Qualtrics®.

An interview guide was developed by the research team, which included a facility administrator and HCP, and was informed by the literature and previous cannabis research conducted by members of the research team [ 35 ] (Supplementary Material 2 ). Due to the COVID-19 pandemic, all but one interview was conducted by the project coordinator (AAA) via Zoom, with one interview occurring over the phone. The interviews were 20–30 min in length and were digitally recorded and transcribed verbatim. Both the survey and interview were completed at times preferred by the respondents, including within and outside work time. No honoraria were provided for study participants.

Data analysis

The policies identified through the environmental scan were reviewed and summarized in table format, with similarities, contradictions and gaps identified.

Quantitative survey data was uploaded into the statistical program, SPSS® v.25. Descriptive statistics were used to summarize demographic information, knowledge about medical cannabis and related attitudes, perceived barriers and facilitators, practice experiences, and preferred educational approaches.

Perceived knowledge gap was calculated by computing the difference between perceived current and desired knowledge levels (i.e., “the level of knowledge you desire” about medical cannabis). Rather than using averages, the knowledge gap was calculated based on how much greater an individual’s desired knowledge level was compared to their current knowledge level [ 36 ]. Only response pairs (i.e., current and desired knowledge) were used, and responses where the desired level was lower than the current level were excluded. To further elucidate, the knowledge gap was calculated by having each respondent’s current knowledge level response subtracted from their desired knowledge level response.

Prior to the onset of qualitative data analysis, the accuracy of the transcripts was checked by listening to the digital recordings. Content analysis was used to analyze the qualitative data [ 37 ], with two team members (AAA and LGB) independently reading the transcripts and developing a preliminary coding scheme. Constant comparison of new and existing data ensured consistency, relevance, and comprehensiveness of emerging codes. Several strategies were applied to ensure rigour in the qualitative analysis. To increase credibility, a team member with expertise in qualitative inquiry (LGB) monitored the qualitative data and its analysis. Confirmability was addressed by using the participants’ own words throughout the process of data analysis, interpretation, and description. An audit trail was kept documenting the activities of the study, including data analysis decisions.

Environmental scan of cannabis-related policies

Administrators at the LTC facility provided the research team with the policies and procedures that addressed the management and use of medical and non-medical cannabis within the facility. The guiding policy adopted by the LTC facility was a generic policy applicable to all sites and facilities governed by a regional health authority. This policy, entitled “Patient Use of Medical Cannabis (Marijuana)” was issued in June 2020. The policy, which aimed to provide individuals with “reasonable access to medical cannabis”, outlined numerous issues that might arise with institutional cannabis use, including “ordering, labeling, packaging, storage, security, administration, documentation and monitoring requirements for the use of medical cannabis”. Key aspects of the policy are summarised in a table found in the Supplementary Material section (Supplementary Material 3 ).

Other relevant policies that were reviewed included the standards of practice issued by the provincial college of nurses and the college of physicians and surgeons [ 38 , 39 , 40 ], which provided direction to HCPs working in LTC about their scope of practice regarding medical and non-medical cannabis. The regional health authority’s smoke-free policy [ 41 ] also informed how inhaled forms of medical and non-medical cannabis were addressed, requiring residents to leave the facility grounds to smoke or vape cannabis. Lastly, the overarching federal Cannabis Act and Regulations provided guidance to both administrators and HCPs regarding the Canadian regulations specific to medical and non-medical cannabis [ 1 , 42 ]. Together, existing facility, regional, and national policies created a context in which cannabis was framed as neither a medicine nor a controlled substance, but something unique and complex that must be navigated by residents, family members and staff in LTC settings.

Quantitative survey

Demographic characteristics.

From the approximately 318 eligible HCPs employed at the LTC facility, a total of 71 participants consented and completed the survey, yielding a response rate of 22.3%. With regards to response rate by profession, pharmacists (50.0%) and social workers (42.9%) were best represented, followed by physicians (23.1%), nurses (21.0%), and PT/OT (11.4%).

Most respondents were women (71.8%), registered nurses (62.0%) and worked within the palliative care unit (76.1%) at the facility. The average age of the sample was 40.9 years and the largest proportion of the sample had worked in the LTC facility for 5 or less years. See Table  1 for additional details.

Knowledge about medical cannabis

HCPs reported being most knowledgeable about the therapeutic potential of cannabis (3.1/5.0), potential risks of medical cannabis (2.9/5.0), and the different ways to administer medical cannabis (2.9/5.0). They reported being least knowledgeable about the dosing of medical cannabis (2.0/5.0), how to create effective treatment plans related to medical cannabis (2.1/5.0), and the similarities and differences between different forms of cannabis products and prescription cannabinoid medications (2.2/5.0). The top three ranked knowledge gaps mirrored the items ranked lowest with regards to knowledge (see Table  2 ). Overall, there was high interest in gaining more medical cannabis knowledge, with all knowledge items scoring greater than 4 on desired knowledge level.

Practice experiences with medical cannabis

About half of HCPs reported providing care in the past month to a resident who was taking medical cannabis (54.9%) and a quarter (25.4%) to a resident that was taking non-medical cannabis. Over 60% had been approached by a resident and/or a family member to discuss the potential use of medical cannabis; however, few HCPs reported initiating these conversations. Moreover, when asked if they felt comfortable discussing medical cannabis, 32.4% of HCPs disagreed (data not shown). Less than 20% reported helping residents, either directly or indirectly, to use medical cannabis and a very small proportion (1.3–2.8%) reported assisting residents’ consumption of non-medical cannabis. With regards to authorizing the use of medical cannabis or prescribing cannabinoid medication, which in Canada can be done by either a physician or nurse practitioner, just over half of physicians reported supporting residents’ access to these types of treatment. See Table  3 for additional details.

Barriers to medical cannabis use in long-term care

Lack of knowledge, education or information about medical cannabis were reported to be barriers to medical cannabis use in LTC by most HCPs (81.7%). Moreover, the uncertain risks and benefits of medical cannabis and the lack of clinical guidelines were also perceived as barriers by 66.2% and 63.4% of HCPs, respectively. The complete list of barriers is presented in Table  4 .

Education about medical cannabis

Most of the HCPs agreed that additional education on medical cannabis would increase their comfort with discussing this treatment option with residents and family members (87.4%; data not shown). With regards to indirectly or directly administering medical cannabis to a resident, most HCPs for which this fell within their scope of practice also reported they would feel more comfortable if they had further education (59.2% and 56.4%, respectively; data not shown).

Over half of HCPs had not received any prior education related to medical cannabis (54.9%). Those that had, received it from conferences or workshops (65.6%), books or journal articles (43.8%) or through a colleague (37.5%). While almost half the sample (49.3%) reported receiving information from peer-reviewed sources, nearly a quarter received information about medical cannabis from a non-peer reviewed source or from a resident or family member. Some participants also received information from a cannabis industry source. Table  5 provides additional details.

The preferred sources of medical cannabis education were online learning programs (i.e., continuing education) (74.6%), monographs (66.2%), and topic-specific one-pagers (64.8%). See Fig.  1 for further details.

Percentage of respondents indicating prefered method of cannabis education*

Qualitative findings

A total of 12 HCPs were interviewed regarding their perceptions and experiences related to medical and non-medical cannabis in the LTC facility. This included 3 HCPs who were administrators, 6 nurses, 1 physician, 1 social worker and 1 pharmacist. Four main themes were identified.

Attitudes regarding medical cannabis: cautious support

There were mixed attitudes regarding the potential role of medical cannabis in general and in LTC populations. While some HCPs felt medical cannabis was a “good idea” for which there was beginning research regarding its health benefits, other HCPs believed additional high-quality evidence was needed prior to medical cannabis becoming a therapeutic option.

I think it’s [medical cannabis] the fair option, it helps some people, but it doesn’t help others. So, I think we need a bit more evidence and a bit more research and having it available sort of allows for that research to occur (Physician; PC07).

There appeared to be greater acceptance for medical cannabis use by individuals at end of life compared to those not considered immediately palliative (i.e., living with dementia, stroke, or traumatic brain injury), the latter of which comprise the majority of the people living in LTC settings. For individuals receiving palliative care, some HCPs perceived medical cannabis to be beneficial in managing pain, nausea, and anxiety, as well as reducing the use of other medications that may be problematic (e.g., opioids) due to their side effects. The potential value of medical cannabis in “adding quality of life and living” at the end of life was also mentioned.

I’m working on the palliative care unit right now. A lot of patients that I’ve seen use it [medical cannabis] for anxiety purposes, or for nausea… some people find beneficial. So, I’ve seen it – people find it helpful for those reasons, and then they have to take less of their other medications. So, if it’s worked well for them and that’s what they prefer to do, then I think it should be an option for people, especially if some people find it beneficial. (Registered nurse; PC03)

Within the context of LTC, several HCPs also spoke of the importance of respecting residents’ autonomy and previous experiences taking medical cannabis. The reality of a LTC facility being a resident’s “home” was particularly influential in HCPs’ support of medical cannabis being included as part of a holistic approach to care.

I guess because people live at [LTC facility’s name], that is their home and if they were at home in the community, they would be able to access it [medical cannabis]. (Registered nurse, PC02)

I think it’s a part of people’s lives. And I think if we’re allowing people to have certain things and keeping it as part of their treatment because if you look at a holistic view, preventing somebody from doing something that they’ve been doing for many years is not going to help them be accepting of other types of therapies. (Pharmacist, PC09)

Some HCPs also perceived medical cannabis as offering an alternative to medical treatments that were not consistently effective in managing challenging health conditions, such as dementia and agitation.

HCPs’ attitudes towards medical cannabis varied across different products and routes of administration. Given the existing smoke-free policy at the facility, HCPs were more supportive of edibles, oils, oral sprays or topical creams and lotions than any form of inhaled medical cannabis (i.e., smoking and vaping). They were concerned not only about lung health, environmental exposure, and maintaining a scent-free facility, but also about how to safely manage vulnerable residents travelling off the facility’s property to smoke or vape.

Medical cannabis access and use: concern, confusion, and limited conversations

According to HCPs interviewed, most residents using medical cannabis obtained their authorization prior to moving to LTC. Individuals who sought authorization after arriving at the facility struggled to have their requests acknowledged or addressed by the health care team. As one nurse shared:

I do remember I had a resident that did ask about it [medical cannabis]. And whenever it was kind of brought up, it didn’t seem to be acknowledged all the time. Or there were people who didn’t like the idea of having a resident on it. (Registered nurse; PC06)

Conversations about medical cannabis were perceived to be severely limited by the culture surrounding medical cannabis at the LTC facility. The lack of open discussion about medical cannabis was seen by some to create conflict and negatively impact the development of trust between residents, family members, and the health care team: “ Without that discussion, it does create conflict within the team and between the physician and family, and perhaps that could impact the trusting relationship” (Administrator; PA03). Further, several HCPs expressed the belief that conversations about non-pharmacological forms of medical cannabis could not be initiated by them due to policy issues; residents who expressed interest but did not have prior authorization were instead directed towards pharmaceutical forms of cannabis.

There have been residents who have asked about using cannabis. And as I said, you can’t initiate it, if they’re going to get it on their own, fair enough. That’s pretty much been the experience I’ve had with residents with just non-pharmaceutical medical cannabis . (Physician, PC07)

The only HCP-initiated conversations about medical cannabis mentioned were those occurring between pharmacists and residents, which focused on the potential side effects, benefits, and “red flags” to watch out for, such as allergic reactions.

HCPs shared that for those residents with authorization, they or a support person were responsible for ordering the medical cannabis product from an LP, which would then send the product to either the resident at the LTC facility or to their support person’s home. The cannabis product was then stored in a locked drawer in the resident’s room if they were self-administering or in a medication room if nursing staff were assisting with administration. According to one pharmacist, the pharmacy department was not permitted, due to existing federal regulations, to either directly order or dispense medical cannabis:

No, we don’t dispense any cannabis. It’s considered resident’s own. So, we don’t acquire it for them. They have to directly be the holders of it and have it provided to them directly. And I think that has more to do with the regulations within Canada, the resident has to have certain type of documentation in order to have medical cannabis. So, it’s directly to them, we’re not able to order it for them or anything like that on their behalf. (Pharmacist; PC09)

With regards to the type of medical cannabis products permitted in the facility, due to non-smoking policies and concerns about safety issues and the “smell”, combustible forms and inhaled routes of administration (i.e., joints, vaporizers, vape pens) were not allowed; instead, ingestible forms were mentioned most frequently by HCPs.

There was some confusion and concerns expressed regarding the storage and disposal of medical cannabis, which may have reflected changes in facility policies over time. Some HCPs expressed concerns about the storage of cannabis in residents’ rooms and the lack of “safeguards” to limit potential diversion and allow an accurate “count” of medical cannabis.

We have to go into our Pyxis machine to retrieve a key to open that drawer. So, by going by that you’re able to know who’s actually accessed the key, but once the key is out you have no idea how many people have used that key and accessed that drawer before it’s gone back. You have no way of knowing how much cannabis has been taken out [of the drawer] or used, because you know there’s no way to measure it. So that’s a huge problem, I find. (Registered nurse; PC01)

This nurse was particularly concerned about the potential risk of being accused of diversion:

I’m not worried about people abusing it, it’s more the worry of being accused. You know, like, if a resident says, ‘why is my cannabis running out already, I thought I had enough for a few more weeks?’ and we’re like, ‘I don’t know’, right? There’s the potential for that sort of thing to happen. (Registered nurse; PC01)

There was also a perception that there was a lack of direction from the facility regarding the appropriate disposal of medical cannabis. Most believed residents or family members were expected to remove any unused product once the resident was no longer at the facility. When such disposal was not possible, the policy was to destroy the cannabis product in a manner similar to narcotics or other controlled substances. However, variations in practice occurred with some HCPs described “throwing it in the trash” or using a medical waste disposal bin with or without a witness.

Barriers to medical cannabis use: safety, stigma and lack of knowledge

Numerous barriers to the use of medical cannabis by LTC residents were identified by HCPs. Foremost, the policies related to how cannabis products were ordered, accessed, stored, and administered were perceived to be complicated and created barriers to residents wanting to take medical cannabis, particularly those without family support. The inability of the LTC facility to order medical cannabis on behalf of a resident was perceived to be especially problematic, as described by one registered nurse:

I know when it became legal, there were a few residents who have inquired about it, but they didn’t have the family resources in place to be able to get it because I believe there’s some hoops that you have to go through to be able to have it medically prescribed in getting it on to the unit. And so, the ones who were interested in it didn’t have those supports in place, so they weren’t able to get it prescribed for them. (Registered nurse; PC05)

The lack of awareness and understanding of the regional policies related to medical cannabis by some of the clinical staff was also seen as being problematic. As one registered nurse shared:

My only concern is that there’s a lot of rules around being able to administer and how it’s [medical cannabis] administered, which can again make things a bit complicated. I would say that’s probably my biggest concern is just it’s hard to remember everything that you have to do when you’re trying to administer it or helping a resident. So, you don’t get involved. (Registered nurse; PC06)

Several HCPs attributed the lack of awareness about cannabis policy to the onset of the COVID-19 pandemic, which overshadowed all other health issues within their facility: “ Everybody’s been so focused on COVID for a year and a half that there hasn’t been really time to really think about or educate on other things. ” (Registered nurse; PC01).

HCPs suggested that more “straight forward” and tailored policies were needed that simplified how medical cannabis was managed. Having facility-specific policies would acknowledge the uniqueness of the LTC population, who may have cognitive impairment, limited social support, and complex healthcare plans. As one nurse shared: “ If it’s a dementia patient, they can’t really administer it on their own. So how do we follow the policy to help the patient take the cannabis? How would we know when they would want to take it PRN?” (Registered nurse; PC03). It was also recommended that the policy that prevented the facility from directly ordering and supplying medical cannabis required revision so that LTC residents were not reliant on family members to gain access. Lastly, several HCPs suggested that medical cannabis policies need to be well advertised and additional training developed for clinical staff to enhance their awareness and comfort level in providing appropriate and supportive care.

There needs to be a training session… staff have to read through them [cannabis policies] and get instructions about them, sort of like a self-learning activity. But that is not part of what we do when orienting. (Registered nurse; PC02)

Another perceived barrier frequently mentioned by HCPs was their lack of knowledge regarding the potential risks and benefits of medical cannabis. There was limited understanding about the effects of medical cannabis, how it may interact with other medications and health conditions, what side effects could arise, as well as basic information about starting dose, titration, and difference between THC and cannabidiol (CBD). Without such information, HCPs were perceived to be very hesitant about recommending or supporting medical cannabis as a treatment alternative for LTC residents:

There’s lots of unknown, that’s the problem. If there were more specifics about the recreational and the medical use of cannabis, then I think health care professionals would be more likely to want to provide it to the residents. But if not, then that’s kind of what’s hindering health care professionals to provide it. (Registered nurse; PC08)

There was also substantial discussion by HCPs regarding the “stigma” that they perceived to exist within the facility regarding medical cannabis. As described by one pharmacist: “ I think the understanding of cannabis, regardless of if it’s medical or anything, it’s still considered in many people’s minds as an illicit drug. It hasn’t shaken that. And I think there’s a lot of stereotypes around the type of people that use cannabis” (Pharmacist; PC09). The stigmatization of medical cannabis was perceived to be particularly pronounced among the medical staff, which led to what was described as a “hands-off approach” with regards to authorizing medical cannabis.

Almost all HCPs and administrators interviewed recommended that education programming and resources for HCPs be developed to address the lingering stigma associated with cannabis and the knowledge gaps that exist about medical cannabis and associated policies. Several participants recommended that education initiatives should first target physicians, who were responsible for authorizing medical cannabis in the facility. Physicians were perceived to need education on when and for whom medical cannabis would be appropriate, the latest evidence regarding efficacy and safety (i.e., drug interactions), and what their obligations and responsibilities were as the authorizing HCP. Participants also thought that all HCPs could benefit from additional training regarding medical cannabis, including the different types of cannabinoids and products, the process of titration, and dosing. Some of the nurses interviewed also expressed the need for education about the legal implications of medical cannabis and their role regarding provision and administration:

I think the legal implications of cannabis use, I think that would be a good focus for the nursing group – so that they understood what their obligations were, what they could be held accountable for, those kinds of things. (Administrator; PA02)

Finally, numerous HCPs spoke of the need for “safeguards” and clear policies and procedures to ensure that clinical staff were aware of what type of medical cannabis products residents were taking, what was the “right dose”, and the possibility of cannabis interacting with other medications. As shared by one pharmacist:

So that we know that this patient is on it because there are potential drug interactions with other things that patients are taking. So, we just have to be cautious and aware that patients are doing this. Because especially right now with studies, there haven’t been a lot of great studies on drug interactions. (Pharmacist; PC09)

Non-medical cannabis use: balancing autonomy and safety

HCPs were asked about their attitudes and experiences about residents’ use of non-medical cannabis in the facility. Two disparate points of view became apparent – those that perceived non-medical cannabis as a legal substance that should be available to LTC residents given the facility was their home and those that saw non-medical cannabis as a stigmatized substance that could lead to problematic use and disruptions in the care environment.

Because it is somebody’s home and so you’re trying to honour and match what their lifestyle and aspects of their life at home were and matching that here [LTC facility]. The bad is, while it is somebody’s home, it’s the next person’s home too, and so it’s trying to balance that, right? In an institutional setting, trying to make it as home-like as possible but, at the same time, you know, monitoring and matching for what everyone’s needs are. (Registered nurse; PA01)

Professionally, I think that it creates issues in terms of trying to police the use of recreational cannabis. In terms of smoking cigarette tobacco, that’s an issue in itself. We’re a non-smoking facility. So, adding cannabis to the mix creates issues…having staff perhaps exposed or other people exposed if people are using cannabis indoors or where they’re not supposed. Or if they want to access and use cannabis outside, who’s going to take them for that? Because that creates exposure too for staff or others who may have to escort them. (Registered nurse; PA03)

HCPs frequently mentioned the complexity of managing residents’ non-medical use of cannabis given the facility’s non-smoking policy that required residents to leave the facility grounds to use inhaled forms of cannabis. With staff unable to transport residents outside, concerns were raised regarding the safety of residents, particularly in the winter months, and who would be responsible for their transfer in and out of the facility as well as monitoring how much cannabis was consumed. In addition, residents’ access to non-medical cannabis was again dependent on having a support person that was able and willing to transport the product to the facility, posing a potential equity issue for some residents:

If someone’s wanting to go smoke outside, then mobility might be an issue. If they don’t have the right wheelchair or family to take them outside for that. If they have the access. Like, if they need family to go and buy it and bring it to them, that could be more of an access issue depending on their family support. (Registered nurse; PC03)

There was specific concern expressed for individuals in the rehabilitation units who may have pre-existing substance use issues. For these individuals, HCPs were concerned that allowing access to non-medical cannabis could add to an already complex care plan. In addition, with many vulnerable residents living at the facility, concerns were raised regarding them being “incredibly suggestible” to others encouraging their consumption of cannabis:

These people – they have an addiction. For sure they’re making choices, but those choices are influenced by physical withdrawal or influenced by stress; they’re influenced by lots of things. So, I would hate to put residents in a position where that was one other [non-medical cannabis] thing they had to contend with during the rehab stay. (Administrator, PA02)

The use of cannabis for therapeutic and recreational purposes is becoming more prevalent within older adult populations, both in the community as well as within healthcare institutions. There has also been growing interest in the possible role of medical cannabis for select chronic, rehabilitative, and palliative health conditions, frequently found among individuals residing within LTC settings. LTC facilities, thus, face the complex practice and policy implications associated with a substance that has been surrounded in controversy for close to a century. This case study is among the first to explore in one LTC facility in Western Canada how cannabis use is being addressed following the legalization of non-medical cannabis products, and what challenges exist. It provides an important snapshot of the complexities surrounding cannabis use in LTC and a foundation for future research.

Cannabis use in LTC settings: a clash of cultures

One challenge experienced by people residing in LTC facilities is the tension that exists between social and medical models of care that most facilities are founded on. Historically, LTC facilities have operated as what Goffman [ 43 ] termed “total institutions”, places where every aspect of a person’s life was controlled by others, paternalism dominated, and the medical needs of people were what drove care practices. Aspects of the total institution still exist, as noted in this case study, whereby cannabis use is in the control of the HCPs; it is dispensed during medication administration times rather than being freely available for use by the resident when they so desire as would be in a person’s home. In trying to create more home-like environments and meet the broad range of social and emotional needs of residents, resident-centred care practices and relational models of care have emerged [ 44 ]. Within this milieu, resident autonomy and choice are at the forefront and HCPs are there to assist, rather than take control of residents’ daily lives. In the most ideal settings, behaviours that are considered ‘risky’, like alcohol consumption, are treated as social experiences, not care tasks to be managed [ 45 ]. The tension arises, however, that despite the desire to be resident-centred, most LTC facilities are highly regulated by governments, putting limits to resident choice and, therefore, their autonomy [ 45 ]. While HCPs in our study acknowledged that residents should have the right to use medical or non-medical cannabis, the regional and institutional policies surrounding safety and the rights of other residents and staff to not be exposed to potentially risky behaviour underscored many of their views. LTC facilities would be wise to consider the principles of dignity of risk [ 46 ] with relation to cannabis consumption/use along the frail elderly population that reside in the home.

Cannabis policies and LTC: one size doesn’t fit all

The cannabis policies developed at the advent of legalization, without consideration of the unique populations and healthcare challenges that exist within LTC facilities, created numerous barriers to residents accessing and using cannabis, as well as for HCPs attempting to provide appropriate care. One of the most significant challenges experienced by LTC residents in our study was the inability to obtain a medical cannabis authorization from a physician working in the facility. Another significant challenge was the regional policy that medical cannabis could not be couriered directly to the LTC pharmacy; instead, the resident or their support persons were responsible for ordering and bringing cannabis products into the facility. Both challenges created enormous inequity in which residents that lacked the physical and cognitive ability to obtain authorization and order medical cannabis from an LP or were without a support person willing and able to obtain medical cannabis on their behalf, were unable to access medical cannabis. Given the nature of LTC populations, these policies led to only a few residents being able to access and use medical cannabis as part of their care.

Another policy that had substantial safety implications for residents wanting to use inhaled forms of cannabis was the regional and institutional no smoking policies that prevented both tobacco and cannabis products from being consumed within the centre as well as on the grounds. As a result, residents had to make their own way, or be accompanied by a support person, to walk approximately 300 m to the public sidewalk where they were allowed to smoke or vape cannabis. With the LTC facility located in a region where winter temperatures can reach − 35 Celsius and sidewalks are covered in snow and ice, this poses significant risk for residents who may be at heightened risk of falls and utilizing assisted walking devices. Similar safety implications of smoke-free policies have been identified in previous research [ 47 ].

Lastly, the policies surrounding the storage and self-administration of medical cannabis for those residents with the physical and emotional capacity (or with a support person willing to administer) may pose potential safety and liability risks and contribute to the concerns held by some HCPs about the use of cannabis in LTC. While residents’ autonomy must be respected, as well as their own expertise with regards to medical cannabis use, the value of standardized medication protocols to ensure the safety of residents as well as to inform care decisions must be acknowledged. The tension experienced in balancing LTC residents’ autonomy with health and safety concerns in the context of substance use has been cited in a recent scoping review [ 48 ] as well as prior research that has examined the use of tobacco in residential care settings [ 49 ].

The policy-related challenges identified by study participants suggest that consultations with LTC residents, families and HCPs are urgently needed to develop and refine cannabis policies that address the needs and reality of individuals living and receiving care in LTC. Future policy reviews must balance LTC residents’ autonomy with the safety issues associated with cannabis use (i.e., dignity of risk), particularly among older adults and those with cognitive and physical impairments. Approaching cannabis policies and procedures in LTC from a harm reduction perspective [ 50 ] with regards to supporting safer consumption of medical cannabis (e.g., route of administration, designated consumption areas) may also be important. Further, the unique context of LTC must also be acknowledged in that for many residents, a LTC facility is their home, and will continue to be so until the end of their lives. But the shared nature of a LTC setting requires that some boundaries be established to protect all residents, as well as those working within LTC. From a staff perspective, a review of policies related to the administration and documentation of cannabis use is needed to protect them from claims of diversion as well as other medicolegal challenges.

Cannabis knowledge gap and stigma in LTC

Across both the quantitative and qualitative data, the gap in knowledge regarding cannabis and the need for continuing education for HCPs working in LTC were readily apparent. When HCPs are unfamiliar about the various forms of medical cannabis, appropriate dosing and titration schedules, and routes of administration, they are hindered in their ability to engage in shared decision making with LTC residents as well as provide high-quality care [ 51 , 52 , 53 , 54 ]. Education is particularly needed that is tailored to the unique risks and benefits of medical cannabis use among LTC populations, including those living with physical and cognitive impairment. Older adults may be more sensitive to the side effects of cannabis due to changes in how medications and drugs are metabolised, and the predominance of polypharmacy among those residing in LTC may further complicate how individuals respond to cannabis [ 55 ]. Therefore, HCPs working in LTC must be aware of how cannabis use may impact individuals’ mobility, memory, and behaviour, as well as the potential for dependency, particularly among those who have experienced substance use issues in the past.

Beyond basic education regarding cannabis and its effects, HCPs must also become aware and informed about existing federal, regional, and institutional policies as well as professional practice standards regarding both medical and non-medical cannabis. The study findings highlighted the uncertainty many HCPs experienced regarding how medical and non-medical cannabis was to be accessed, authorized, administered, stored, and disposed within the LTC facility and what was within their professional scope of practice. Legal concerns about liability, workplace safety, and diversion were also raised.

It is important that future cannabis education programs targeting LTC settings also address the underlying stigma and stereotypes that still surround cannabis use [ 56 , 57 ], despite the existence of a medical cannabis program in Canada for over 20 years and the recent legalization of non-medical cannabis. Experiential training that promotes non-judgmental communication that avoids stigmatizing language (e.g., user, addict, marijuana) and considers both the risks and benefits of cannabis use, particularly within the context of end-of-life care, will help address the stigma that HCPs and LTC residents and families may hold towards cannabis.

With the legalization of cannabis in many regions around the world, it is imperative that undergraduate health professional training programs include information about both medical and non-medical cannabis. Currently, there is a knowledge gap among HCPs due to the lack of standardized curriculum for medical cannabis across nursing or medical schools [ 35 , 58 ]. Understanding such foundational knowledge such as the endocannabinoid system, the different forms and types of cannabis, and the potential health effects will enable physicians, nurses, pharmacists and other HCPs to engage in informed conversations with individuals and families both within and beyond LTC [ 33 ]. In addition, the development of continuing education programs focused on cannabis will ensure practicing HCPs have current knowledge about cannabis, including existing policies and programs relevant to medical and non-medical cannabis. For example, the Canadian Coalition for Seniors’ Mental Health created asynchronous e-learning modules to provide evidence-based knowledge for various clinicians [ 59 ].

Non-medical cannabis use in LTC: it’s legal but…

Despite non-medical cannabis being a legal substance for over three years in Canada at the time of the case study, the use of non-medical cannabis by LTC residents was considered controversial amongst the HCPs interviewed. Not only were HCPs limited in their ability to support the use of non-medical cannabis due to regional policies that prohibited non-medical cannabis consumption at any healthcare facility and surrounding grounds but concerns about potential safety risks and disruptions to the care environment made some HCPs hesitant about supporting residents’ use of non-medical cannabis.

Notwithstanding these challenges, at least a quarter of HCPs surveyed reported providing care to a LTC resident who used non-medical cannabis, which suggests that regulatory and policy changes are required to ensure there is equity across LTC residents who may express interest in non-medical cannabis, as well as to address the unique safety and care issues associated with recreational cannabis use in LTC populations. Similar to medical cannabis, LTC residents’ autonomy must be considered in future policy changes related to non-medical cannabis to facilitate care that is free from stigma and bias, respects residents’ rights to make informed decisions and to live with risk, and to create a home-like environment where residents can engage in activities that were an important part of their lives before entering LTC.

Lessons can be drawn from literature that has examined the use of other legal substances, such as alcohol and tobacco in LTC [ 48 , 60 ], and the need to develop person-centered care plans that ensure the safety of the individual, fellow residents, and the healthcare team.

Limitations

Like all case studies, the findings cannot be extrapolated to other LTC settings and populations. Given that this study was undertaken in Canada, which has a socialized healthcare system and legalized both medical and non-medical cannabis, the experiences and attitudes of HCPs who participated may be unique and limit the generalizability of the findings. However, there are lessons to be learned regarding the challenges that residents in LTC facilities face in using medical and non-medical cannabis, as well as the potential need for both education and policy reform to better support HCPs in providing appropriate, safe, and person-centred care of LTC residents. In addition, the collection of both quantitative and qualitative data allowed triangulation during the data analysis and helped improved the rigor of the findings [ 61 ]. Recruitment and data collection for this study also occurred during the height of the COVID-19 pandemic. Therefore, the response rate was lower than desired and there was limited diversity among study participants with regards health profession designation. However, the proportion of physicians, nurses, pharmacists, and other allied health professions reflected the overall staff composition of the LTC facility.

Implications for future research

Beyond the policy and practice implications discussed earlier, the study findings also point to the urgent need for research focused on cannabis use among populations commonly found within LTC settings. The lack of evidence regarding the potential health effects of cannabis in the management of diseases such as dementia, arthritis, Parkinson’s, traumatic brain injury, and multiple sclerosis led many of the HCPs interviewed to be hesitant about authorizing and supervising cannabis use for LTC residents living with these conditions. While there is a growing number of studies being undertaken focused on medical cannabis, many are limited by their sample size and study design. It is only through high-quality clinical trials that evaluate the efficacy and safety of medical cannabis that a change in practice will occur.

Future medical cannabis research must also be developed in a manner that is inclusive of older adults and those living in LTC. The exclusion of such populations from clinical research has been previously identified as problematic [ 62 ], resulting in research findings that lack generalizability and pose challenges in determining the applicability of research to older adults who may be living with numerous co-morbidities and using multiple medications. While the inclusion of older adults in medical cannabis clinical trials may be more methodologically and ethically challenging, it will lead to evidence that will inform both future policies and practices.

Lastly, our case study offers insight into the reality and challenges of cannabis use by residents of one LTC facility. Additional research across different jurisdictions is needed to explore how LTC settings are addressing cannabis use and to learn from their experiences. We encourage the continued use of mixed methods study designs to ensure the experiences and perspectives of residents, family members and HCPs are captured alongside administrative data related to medical and non-medical cannabis use.

With the legalization of medical and non-medical cannabis in jurisdictions around the world, LTC facilities will be obligated to develop policies, procedures and healthcare services that are able to accommodate residents’ use of cannabis in a respectful and evidence-informed manner. Balancing the safety concerns against the potential therapeutic value of cannabis, as well as considering residents’ autonomy and the home-like environment of LTC, will be important considerations in how cannabis use is addressed and regulated. Our case study highlights the lack of knowledge, inequities, and stigma that continue to surround cannabis in LTC. There is an urgent need for research that not only explores the potential risks and benefits of cannabis, but also informs the development of more nuanced and equitable policies and education resources that will support reasonable and informed access to medical and non-medical cannabis for older adults and others living in LTC.

Data availability

The datasets generated and analysed during the current study are not publicly available due to the small sample size drawn from one health care facility but are available from the corresponding author on reasonable request.

Abbreviations

Cannabidiol

Healthcare provider

Long–term care

Tetrahydrocannabinol

Licensed Producer

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Acknowledgements

The authors would like to thank the healthcare professionals that graciously took the time to share their thoughts about cannabis use in long-term care settings. In addition, Ms. Sina Barkman, Chief Human Resources Officer, Riverview Health Centre, helped the research team navigate the complexity of conducting research in long-term care settings during the COVID-19 pandemic.

Funding for this study was received from the Riverview Health Centre Foundation.

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“L.G.B, G.T, J.P and P.StJ. conceptualised the study. A.A.A. and D.S. engaged in recruitment and data collection activities. L.G.B. and A.A.A. analysed and interpreted the quantitative and qualitative data and developed a first draft of the manuscript, with assistance from G.T. All authors read and approved the final manuscript.”

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Ethical approval for the study was obtained from the University of Manitoba Research Ethics Board (R1-2021:011 (HS24693)) and was approved by the Riverview Health Centre Research Committee. Implied consent was received from participants who completed the survey and written informed consent was obtained from all participants who completed an interview. We confirm that all methods were performed in accordance with the relevant ethical guidelines and regulations, (i.e., Tri-Council Policy Statement).

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Balneaves, L.G., Alraja, A.A., Thompson, G. et al. Cannabis use in a Canadian long-term care facility: a case study. BMC Geriatr 24 , 467 (2024). https://doi.org/10.1186/s12877-024-05074-2

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(CNN) - A new study finds xylitol may be linked to heart attack and stroke.

The research was published Thursday in the “European Heart Journal.”

The study finds the common low-calorie sweetener may be linked to nearly twice the risk of heart attacks, stroke, and death in people who consume the highest levels of it.

Xylitol is used in many reduced-sugar foods and consumer products such as sugarless gum, breath mints, toothpaste, mouthwash, cough syrup, and chewable vitamins.

It’s a sugar alcohol, a carbohydrate found naturally in only tiny amounts in certain vegetables such as cauliflower, as well as berries.

The U.S. Food and Drug Administration recognizes sugar alcohols as “generally recognized as safe.”

Xylitol in commercial use is made from corncobs, birch trees or genetically engineered bacteria.

Last year, the same researchers found similar results for another low-calorie sweetener called erythritol.

That sweetener is used as a bulking sugar in Stevia, Monk Fruit and keto-reduced-sugar products.

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• Open access
• Published: 29 May 2024

Using 2% PVPI topical solution for serial intravitreous injections and ocular surface findings: a case control study

• José Henrique Casemiro 1 ,
• Ana Paula Miyagusko Taba Oguido 2 &
• Antonio Marcelo Barbante Casella 3  

International Journal of Retina and Vitreous volume  10 , Article number:  41 ( 2024 ) Cite this article

92 Accesses

Metrics details

The use of povidone-iodine for ocular surface asepsis is widespread for intravitreal injections. They became frequent procedures, leading to serial exposure of patients’ eyes to iodinated solutions. In this study, we investigate the changes in the ocular surface in patients submitted to repeated use of povidine for intravitreal injection of anti-VEGF asepsis, analyzing Ocular Surface Disease Index, non-invasive break up time, blinking quality, lipid layer, meniscus height and osmolarity.

This case-control study included 34 individuals (68 eyes), 14 males, 20 females aged 48 to 94. Inclusion criteria were individuals who received application of 2% povidone-iodine eyedrops for intravitreal injections treatment with the non-treated contralateral eye used as control. Ocular surface examinations were performed at a single occasion. A pre-intravitreal injection asepsis protocol with povidone-iodine was applied. All statistical analysis was performed using the STATA® 18.0 Software and a p-value = 0.05 was considered as the statistical significance value in all tests.

The median number of IVIs in treated eyes was 12 (range 6–20). The results in treated eyes compared with untreated eyes were respectively : median OSDI 16 (IQR 6–39) and 12.5 (IQR 8–39) ( p  = 0.380); mean NIBUT 10.30 (SD ± 2.62) and 10.78 (SD ± 2.92) ( s, p  = 0.476); median blinking quality 100 (IQR 100) and 100 (IQR 100 ) (%, p  = 0.188); median lipid layer 87 (IQR 77–90) and 86 (IQR 74–100) (nm, p  = 0.451); median meniscus height 0.22 (IQR 0.19-0,31) and 0.24 (IQR 0.20–0.27) (mm, p  = 0.862), median Meibomian gland atrophy 33 (IQR 24–45) and 31.5 (IQR 25–39) (%, p  = 0.524); and mean osmolarity 306.6 (SD ± 21.13) and 313.8 (SD ± 29) (mOsm, p  = 0.297). There was no statistically significant relationship between the repetitive use of 2% iodinated solution and signs or symptoms compatible with dry eye syndrome in this group of patients.

Conclusions

The findings suggest that 2% povidone iodine is a safe and efficacious agent for ocular surface antisepsis during intravitreal injections, not leading to substantial ocular surface modifications. This conclusion supports the continued use of povidone iodine in routine ophthalmic procedures without increased risk of inducing dry eye syndrome.

The use of povidone iodine (PVPI) for ocular surface asepsis is widespread, both for surgical procedures and intravitreal injections [ 1 , 2 , 3 , 4 , 5 ]. Surgeries for cataracts, glaucoma, and intravitreal injections have become common and frequent procedures in ophthalmology, leading to the serial exposure of patients’ eyes to iodine solutions [ 5 , 6 , 7 , 8 , 9 , 10 ]. These changes are directly associated with dry eye syndrome [ 11 , 12 ].

In particular, studies have demonstrated that intravitreal injections used to treat diabetic macular edema or age-related macular degeneration result in significant changes in the ocular surface, leading to dry eye syndrome and damage to homeostasis of the ocular surface [ 5 , 11 , 13 , 14 ].

Dry eye syndrome is a multifactorial disease of the ocular surface characterized by the loss of tear film homeostasis, hyperosmolarity, inflammation, damage and neurosensory abnormalities [ 11 , 15 , 16 , 17 , 18 ]. Its etiology is variable, ranging from nonspecific inflammation of the ocular surface to direct chemical or physical aggression, infections, and autoimmune diseases [ 11 , 12 , 15 , 19 ].

In addition to the most common symptoms, burning sensation, itching, speck, eye redness, excess tearing reflex, brightness sensitivity, and quality of vision loss are also frequent findings that affect efficiency at work and the quality of life of patients [ 11 , 12 , 15 , 19 , 20 ].

This study aimed to observe changes in the ocular surface and tear film due the serial use of 2% PVPI, the gold standard drug for asepsis of the ocular surface. As it is well known that pre-injection antisepsis of the ocular surface with PVPI has a toxic effect on the corneal epithelium, the aim is to identify changes in the tear film and ocular surface and avoid serious problem like dry eye syndrome [ 11 , 12 , 21 , 22 ].

A case-control study was conducted at the Ophthalmology and Psicology Clinic (APMTO MD) in Londrina, Paraná. The patients were recruited from the Retina and Vitreous Institute (AMBC MD) in Londrina, Paraná. The study included 34 individuals (68 eyes). 14 males, 20 females, aged 48 to 94 years. All participants signed the informed consent form, which allowed their participation in the study. Inclusion criteria were individuals who received application of 2% PVPI eyedrops for anti-VEGF IVIs treatment with the contralateral eye used as control, that had not been treated with any topical medication during the same period of applications and good comprehension of the Ocular Questionnaire Surface Disease Index (OSDI). Exclusion criteria were patients who could not understand the OSDI questionnaire; patients using antidepressant medicine, diuretics, sympathomimetics, eye drops for glaucoma, or eye lubricants; people with allergies to iodine; unfavorable clinical conditions to undergo the examination procedures for the study; inappropriate test quantity and quality; unsatisfactory images or unsatisfactory and inadequate data.

The study was approved by the Ethics and Research Committee Involving Human Beings of the State University of Londrina by N. 5.300.176.

The individuals underwent directed clinical and ophthalmological analysis, received explanations about the study, used their data, and signed consent forms. All clinical measures were performed using the IDRA equipment (SBSSISTEMI, Orbasano, Torino, Italy), at which time the OSDI questionnaire was also applied and tear osmolarity was collected using the I-PEN ® (I-MED PHARMA INC. Dollard-des-Ormeaux, QC, Canada). All examinations and administration of the questionnaire were performed by the same professional. No drops or medications that could cause changes in any subsequent measurements were used.

The variables analyzed were age, sex, date of the last PVPI application, number of PVPI applications, OSDI questionnaire, tear osmolarity, NBUT, tear film interferometry, tear meniscus height, percentage of meibomian gland loss, and blink quality. The sequence of procedures obeyed the following order: Explanation to the subject regarding the exams and questionnaire to which he would be submitted, guidance to the patient not to identify in any way the eye being treated and the eye not treated during data collection, nor during the questionnaire OSDI; patient positioning in the IDRA® equipment; capture of blinking quality video images; capture of tear film interferometry; capture of images to measure the height of the tear meniscus and immediate measurement; capture of tear film (NBUT); image capture for the percentage of meibomian gland loss by everting the lower eyelid with a cotton swab; positioning the patient outside the IDRA equipment; application of the I-PEN® electrode to capture tear osmolarity in the lower conjunctiva, first in the right eye, and subsequently in the left eye; application of the OSDI questionnaire.

All statistical analyses were performed using STATA® 18.0 Software and p-values ≤ 0.05 indicated statistical significance.

The Shapiro-Wilk test was used to verify data normality. Data that did not follow a normal distribution were analyzed using the Wilcoxon rank-sum test and were described as means and as medians and interquartile ranges. Data that showed normality were analyzed using the Student’s T test and presented as means and standard deviations. Descriptive, quantitative, and multivariate analyses compared treated (case) and untreated (control) eyes.

The average number of IVIs in treated eyes was 12 (range 6–20). The results in treated eyes compared with untreated eyes were respectively: median OSDI 16 (IQR 6–39) and 12.5 (IQR 8–39) ( p  = 0.380); mean NIBUT 10.30 (SD ± 2,62) and 10.78 (SD ± 2.92) ( s, p  = 0.476); median blinking quality 100 (IQR 100) and 100 (IQR 100 ) (%, p  = 0.188); median lipid layer 87 (IQR 77–90) and 86 (IQR 74–100) (nm, p  = 0.451); median meniscus height 0,22 (IQR 0.19–0.31) and 0.24 (IQR 0.20–0.27) (mm, p  = 0.862), median Meibomian gland athrophy 33 (IQR 24–45) and 31.5 (IQR 25–39) (%, p  = 0.524); and mean osmolarity 306.6 (SD ± 21.13) and 313.8 (SD ± 29) (mOsm, p  = 0.297).). The results revealed that the use of 2% PVPI did not affect the analyzed variables in a statistically significant way. All data is summarized on Table  1 .

These results are disposable on fig 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 and 9 as annexed.

Histogram showing the days of last application of IVIS ( intravitreal injections ) in treated eyes and the density showing the proportion of eyes in each period of time

Histogram showing the number of application ov IVIS ( intravitreal injections ) in treated eyes and the density showing the proportion of eyes in each amount of number of applications

Blue box plot showing score OSDI ( Ocular Surface Disease Index ) in treated eyes comparing with pink box plot showing score OSDI in fellow eyes

Blue box plot showing NIBUT ( non invasive break up time ) in seconds in treated eyes comparing with pink box plot showing NIBUT in seconds in fellow eyes

Blue box plot showing blink quality in treated eyes comparing with pink box plot showing blink quality in fellow eyes

Blue box plot showing lipid layer in treated eyes comparing with pink box plot showing lipid layer in fellow eyes

Blue box plot showing meniscus height in milimeters in treated eyes comparing with pink box plot showing meniscus height in milimeters in fellow eyes

Blue box plot showing Meibomian gland loss in treated eyes comparing with pink box plot showing Meibomian gland loss in fellow eyes

Blue box plot showing tear osmolarity in miliosmoles in treated eyes comparing with pink box plot showing osmolarity in miliosmoles in fellow eyes

Through multivariate analysis, we obtained some interesting outcomes as follows:

When controlling for NIBUT, meibomian gland atrophy, number of applications, and days of the last application according to treatment, sex was an important variable in explaining the variability in the OSDI score (coef = 15.63 | p-value = 0.003). On average, controlling for the abovementioned variables, being female contributed to an increase in the OSDI to 15.63 points.

After controlling for meniscus height and age according to treatment, tear osmolarity contributed significantly to variability in the lipid layer (coef = -0.266, p  = 0.004). In this sense, the addition of one unit in tear osmolarity led to a -0.266 drop in the lipid layer.

After controlling for meniscus height, OSDI, days since the last application, age, and sex according to the treatment, these factors contributed significantly to the variability in the lipid layer [(coef = 0.562 | p-value = 0.004) (coef = − 5.622 | p-value = 0.048)]. In this sense, the addition of one year of age led to a decrease of -0.562 on average. For the same treatment group, female sex led to a decrease of -5,622.

Age, lipid layer, meniscus height, sex according to treatment, age according to treatment, and sex were important factors for explaining the variability in tear osmolarity.

We noticed that a greater age correlated with lower tear osmolarity. However, being in the treated group reduced the decrease in tear osmolarity with advancing age.

Being female implied higher tear osmolarity. However, the increase in tear osmolarity was smaller in the treated group.

A greater height of the lipid layer and meniscus correlated with lower tear osmolarity.

The present study showed that the use of topical PVPI at 2% did not cause significant damage to the ocular surface when the findings of the ocular surface and tear film analyses were used.

Our results contradict some existing data indicating the toxicity of long-term iodine use on the ocular surface; we found two statistically relevant results that the application of iodine may improve the stability of the tear film in the elderly and women, since the eyes in older individuals and female patients that received iodine showed a smaller increase in tear osmolarity [ 4 , 14 , 23 , 24 ].

Moreover, the results of this study corroborated some hypotheses that the use of PVPI could be positive in some dry eye disease diagnostic features, such as the improvement of the tear film meniscus height and the decrease of the tear film osmolarity [ 25 , 26 ].

A localized anti-inflammatory surface effect of the anti-VEGF agent used in intravitreous injections should be considered and assessed in further studies [ 22 , 25 ].

The literature review also shows that there was an improvement in the tear function of some patients who used iodine in ocular asepsis [ 25 , 26 , 27 ], perhaps due to an antimicrobial action preventing the proliferation of bacterial flora that could produce harmful enzymes or cause meibomitis and blepharitis [ 25 , 26 , 28 ].

The cell regeneration mechanism might have satisfactorily recomposed the ocular surface or the tear homeostasis might have compensates for the damage caused by iodine in the cells in question; furthermore, these are just hypotheses.

We also determined that the risk factors for dry eye disease, age and female sex [ 10 , 16 , 29 , 30 ], were associated with the observed clinical data: greater ages lower the height of the tear meniscus, the greater the tear osmolarity, and the smaller the lipid layer of the tear film. The female sex was also associated with higher OSDI scores and fewer tear film lipid layers.

Regardless of the cause or consequence, the osmolarity and lipid layer of the tear film were inversely proportional.

Through multivariate analysis, we determined that the risk factors for dry eye syndrome, age, and female sex correlated with worse results in the tear meniscus measurement tests, OSDI questionnaire, and tear film interferometry, corroborating the literature implicating them as risk factors for dry eye disease [ 20 , 30 , 31 ].

Moreover, due to the sample size, false negatives, or simply because in practice, iodine in the amount and frequency used does not lead to histological damage that may reflect functional changes. The results did not discourage the use of iodine for ocular asepsis but also did not indicate its use for protocols with higher concentrations or more applications than those used in current protocols.

The strengths of the study are as follows: the same patient was the control and treated group, avoiding any environmental or medical bias. The number of injections administered was higher than that reported in other studies. No drops were used during the examination to avoid artificial changes to the tear film.

The limitations of this study were as follows: the study had a small sample size of 34 patients, resulting in 68 eyes being analyzed, which may have caused an analysis bias when using these data in the general population. We must remember that the analyzed population was from southern Brazil and had mostly descended from Italian, German, Spanish, and Portuguese immigrants; therefore, these data may only reflect the specific epidemiology of this population. The meibomian glands analyzed were located in the inferior tarsus.

The use of iodine on the ocular surface was not significantly associated with any of the evaluated parameters. There were no statistically significant correlations between the tests applied to the case eyes. The current study indicates that the application of 2% topical povidone-iodine (PVPI) does not inflict significant damage to the ocular surface, as evidenced by the analyses of the ocular surface and tear film. Notable strengths of this study include the use of the same patient as both the control and the treated subject, which minimizes potential biases from environmental or medical factors. Additionally, the absence of any artificial agents during the examination ensures that the tear film remains unaltered.

Contrary to previous concerns regarding the long-term toxicity of iodine on the ocular surface, our findings suggest potential benefits of iodine application in stabilizing the tear film, particularly in older individuals and female patients. This is supported by a smaller increase in tear osmolarity in these groups following iodine application. Furthermore, the study corroborates hypotheses that PVPI may positively affect certain Dry Eye Disease diagnostic features, such as improved tear film meniscus height and reduced tear film osmolarity.

Data availability

No datasets were generated or analysed during the current study.

Abbreviations

Povidine or polyvinylpyrrolidone-iodine

• Intravitreal injections

Vascular endothelial growth factor

Ocular Surface Disease Index

Non invasive break up time

Blink quality

Lipid layer

Standard deviation

Interquartile range

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Acknowledgements

APMO provided IDRA analysis, and was a contributor to design the study, revised, written and approved the manuscript. AMBC Applied intravitreal injections and provided patients for the study and was a contributor to design the study, revised, written and approved the manuscript.

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Postgraduate Program in Health Sciences, State University of Londrina, UEL, Londrina, Brazil

José Henrique Casemiro

Department of Health Sciences, Surgical Clinic, State University of Londrina, UEL, Londrina, Brazil

Ana Paula Miyagusko Taba Oguido

Londrina State University, Avenida Robert Koch, 60, Londrina, Paraná, 86038-440, Brazil

Antonio Marcelo Barbante Casella

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Contributions

JHC analyzed and interpreted patient data, reviewed the literature and was a major contributor to the acquisition of data, interviewed the patients, sponsored supplies, designed the study and written the manuscript. APMO provided IDRA analysis, and was a contributor to design the study, revised, written and approved the manuscript. AMBC Applied intravitreal injections and provided patients for the study and was a contributor to design the study, revised, written and approved the manuscript.

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Correspondence to Antonio Marcelo Barbante Casella .

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Casemiro, J.H., Oguido, A.P.M.T. & Casella, A.M.B. Using 2% PVPI topical solution for serial intravitreous injections and ocular surface findings: a case control study. Int J Retin Vitr 10 , 41 (2024). https://doi.org/10.1186/s40942-024-00557-1

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Introducing peanuts early reduces kids’ allergy risk: new study

They cracked the case.

Kids exposed to peanut products during infancy, as early as 4 months old, are less likely to be allergic to peanuts later in life, according to a UK study published Tuesday in the journal NEJM Evidence.

Researchers from King’s College London observed over 500 children to age 12. They found that kids who were fed peanuts as a paste or puree until they turned 5 were 71% less likely to develop a peanut allergy than children who avoided peanuts.

Another study yielded similar results but only examined children up to the age of 5, which “wasn’t clear that that was necessarily enough time to prove long-term tolerance,” Michelle F. Huffaker, one of the authors of the new research and the director of translational medicine at the University of California at San Francisco, told the Washington Post. 

Both studies were sponsored and co-funded by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases. 

The latest research found that 15.4% of kids who avoided peanuts developed an allergy by age 12, compared to just 4.4% of those who were exposed to peanuts. 

“Today’s findings should reinforce parents’ and caregivers’ confidence that feeding their young children peanut products beginning in infancy according to established guidelines can provide lasting protection from peanut allergy,” NIAID director Jeanne Marrazzo said in a statement.

“If widely implemented,” she added, “this safe, simple strategy could prevent tens of thousands of cases of peanut allergy among the 3.6 million children born in the United States each year.”

Gideon Lack, lead investigator and professor of pediatric allergy at King’s College London,  told CNN that he was not surprised by the findings. 

“Peanut allergy develops very early in most children between six and 12 months of life,” Lack said. “If you want to prevent a disease this needs to be done before the disease develops.”

“This biological phenomenon is based on an immunological principle known as oral tolerance induction,” he continued. “We have known for many decades that young mice or other experimental animals who are fed foods such as egg or milk or peanut cannot develop these allergies later.”

Though parents have been advised to give their infants peanuts, many still worry about exposing their kids to the legume, a recent study found.

Guidelines say peanut butter can be spread thinly, or mixed with breastmilk, formula or puree. Health officials warn that whole peanuts or chopped peanuts can cause choking hazards.

“There are a number of options, but plain old peanut butter mixed in warm water can work for a 4-month-old — it doesn’t need to be anything fancier than that,” study author Huffaker said.

• Open access
• Published: 01 June 2024

COVID-19 seroprevalence cohort survey among health care workers and their household members in Kinshasa, DR Congo, 2020–2022

• Joule Madinga   ORCID: orcid.org/0000-0003-2661-234X 1 ,
• Placide Mbala-Kingebeni   ORCID: orcid.org/0000-0003-1556-3570 2 ,
• Antoine Nkuba-Ndaye   ORCID: orcid.org/0000-0003-2850-7498 3 ,
• Leonel Baketana-Kinzonzi 3 ,
• Elysé Matungulu-Biyala   ORCID: orcid.org/0000-0002-4541-5723 3 ,
• Patrick Mutombo-Lupola 4 ,
• Caroline-Aurore Seghers   ORCID: orcid.org/0000-0002-3599-1719 5 ,
• Tom Smekens   ORCID: orcid.org/0000-0002-1340-4165 5 ,
• Kevin K. Ariën   ORCID: orcid.org/0000-0002-6344-3007 6 ,
• Wim Van Damme 5 ,
• Andreas Kalk 7 ,
• Martine Peeters 8 ,
• Steve Ahuka-Mundeke 9 ,
• Jean-Jacques Muyembe-Tamfum   ORCID: orcid.org/0000-0003-2933-818X 9 &
• Veerle Vanlerberghe   ORCID: orcid.org/0000-0002-6531-0793 10  

Journal of Health, Population and Nutrition volume  43 , Article number:  74 ( 2024 ) Cite this article

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Introduction

Serological surveys offer the most direct measurement to define the immunity status for numerous infectious diseases, such as COVID-19, and can provide valuable insights into understanding transmission patterns. This study describes seroprevalence changes over time in the context of the Democratic Republic of Congo, where COVID-19 case presentation was apparently largely oligo- or asymptomatic, and vaccination coverage remained extremely low.

A cohort of 635 health care workers (HCW) from 5 health zones of Kinshasa and 670 of their household members was interviewed and sampled in 6 rounds between July 2020 and January 2022. At each round, information on risk exposure and a blood sample were collected. Serology was defined as positive when binding antibodies against SARS-CoV-2 spike and nucleocapsid proteins were simultaneously present.

The SARS-CoV-2 antibody seroprevalence was high at baseline, 17.3% (95% CI 14.4–20.6) and 7.8% (95% CI 5.5–10.8) for HCW and household members, respectively, and fluctuated over time, between 9% and 62.1%. Seropositivity was heterogeneously distributed over the health zones ( p  < 0.001), ranging from 12.5% (95% CI 6.6–20.8) in N’djili to 33.7% (95% CI 24.6–43.8) in Bandalungwa at baseline for HCW. Seropositivity was associated with increasing rounds adjusted Odds Ratio (aOR) 1.75 (95% CI 1.66–1.85), with increasing age aOR 1.11 (95% CI 1.02–1.20), being a female aOR 1.35 (95% CI 1.10–1.66) and being a HCW aOR 2.38 (95% CI 1.80–3.14). There was no evidence that HCW brought the COVID-19 infection back home, with an aOR of 0.64 (95% CI 0.46–0.91) of seropositivity risk among household members in subsequent surveys. There was seroreversion and seroconversion over time, and HCW had a lower risk of seroreverting than household members (aOR 0.60 (95% CI 0.42–0.86)).

SARS-CoV-2 IgG antibody levels were high and dynamic over time in this African setting with low clinical case rates. The absence of association with health profession or general risk behaviors and with HCW positivity in subsequent rounds in HH members, shows the importance of the time-dependent, and not work-related, force of infection. Cohort seroprevalence estimates in a ‘new disease’ epidemic seem insufficient to guide policy makers for defining control strategies.

Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus and transmitted by respiratory droplets and aerosols [ 1 ]. Health care workers (HCWs) are among the high-risk groups for SARS-CoV-2 infection, as they are directly and/or indirectly exposed to COVID-19 patients in their working environment [ 2 ]. In sub-Saharan Africa (SSA), the COVID-19 pandemic was characterized by underreporting due to the limited testing capacity in many countries and by a large number of asymptomatic or mild symptomatic cases that are not seeking health care [ 3 ]. Hence, a significant number of patients who visit health facilities for other health problems and who could have a simultaneous asymptomatic COVID-19 infection were not tested, and they potentially exposed HCWs to the virus. On the other hand, this also holds for HCWs, who could have an asymptomatic infection and cause a risk of infection to colleagues and patients, including vulnerable individuals at high risk for severe COVID-19. Nosocomial transmission of SARS-CoV-2 accounted for 12–29% of cases in a study in China [ 4 ] and was associated with a higher mortality risk than community-acquired COVID-19 [ 5 ]. On the other hand, HCWs who acquire SARS-CoV-2 infection in health facilities bring the virus back to the communities through their close contact within households. Because of this potential role played by HCWs in the transmission of SARS-CoV-2 infection within health facilities and between health facilities and the community, it was of utmost importance to assess the importance of SARS-CoV-2 infection among HCW, comparing with community members being exposed to the general risk factors of an airborne infectious disease. Several publications are available for this target group in SSA [ 6 , 7 , 8 ], but most of them have a cross-sectional design, which gives information on the fraction of HCWs who tested positive at a given time during the epidemic but not on seroconversion or seroreversion over time. Studying changes in seroprevalence over time in two linked cohorts, health care workers and their household members, allows gaining insight in transmission dynamics between these two related groups of interest. Elsewhere in the first months after the start of the pandemic, as in Belgium, the seroprevalence of SARS-CoV-2 IgG among HCWs was 7.7% (95% CI: 4.8–12.1%) in April 2020 and 8.2% (95% CI: 5.7–11.6%) in September 2020 [ 9 ]. Within cohorts, seroreversion of IgG has been demonstrated, which was close to 40% over a 5-month period in a study in the USA [ 10 ]. The longevity of antibody persistence is described to be dependent on the severity of clinical signs and symptoms and has been demonstrated to be lower in asymptomatic infections [ 11 ], which are the majority of cases in SSA.

The first case of COVID-19 in the Democratic Republic of the Congo (DRC) was reported on March 10, 2020, in Kinshasa, the capital city of the country. On March 24, a state of emergency, including travel bans, was declared, and on April 6, a lockdown was installed in Gombe, which is an urban neighborhood containing the initial COVID-19 hotspot. By the end of 2021, the outbreak had spread all over the country, affecting 23 of 26 provinces and reaching a total of 79,273 confirmed cases [ 12 ], with a reported case fatality ratio of 1.5%. However, such an overall figure may hide a mortality risk of almost 50% when patients are hospitalized with severe or critical disease [ 13 ]. In November 2020, a sero-survey (Luminex assay) among the general population in Kinshasa showed a seroprevalence of 16.6% (95% CI 14.0-19.5) [ 14 ]. A study from eastern DRC in mid-2020 demonstrated a SARS-CoV-2 seroprevalence of 41.2% among HCWs in Panzi Hospital (EuroImmun IgG ELISA), with 22.3% of seropositive HCWs reporting symptoms congruent with COVID-19 illness [ 8 ].

In this study, we aimed to determine the prevalence of SARS-CoV-2 antibody levels, together with seroconversion/seroreversion dynamics among a cohort of HCWs and their household members in Kinshasa at several time points up to almost two years after the start of the pandemic. As a secondary objective, we evaluated the risk factors for seroprevalence and seroconversion/reversion in both groups and defined the temporal relation between a SARS-CoV-2 IgG positive health care worker and the seroconversion of their household members. In the discussion, we revisit the evidence generated in this study and the usefulness of seroprevalence studies for the definition of control program strategies [ 15 ].

Ethical statement

The current study was approved by the ethics committee of the University of Antwerp, Belgium (number B3002020000144) and the national DRC ethics committee (189/CNES/BN/PMMF/2020). Further approval was obtained from the Ministry of Health through the provincial health division as well as the heads of concerned health zones (HZ) and health facilities. Prior to inclusion, the purpose of the study was explained to each potential participant, and written informed consent was obtained.

The study was conducted in five health zones (HZs) of Kinshasa (Fig.  1 ), purposively chosen on the basis of the presence of COVID-19 treatment services in the main hospital of the HZ (N’djili, Lemba, Limete, Lingwala) and reports of COVID-19 cases in the first weeks of the pandemic (Bandalungwa). In the DRC, an HZ is the operational unit implementing primary health care strategies within the health system. HZs are divided into health areas covering a number of streets in urban areas. Each HZ comprises a central office, a general reference hospital, and at least one health center per health area. In 2020, the population of Kinshasa was estimated at 12,117,417 inhabitants by the National Health Information System and is distributed over 35 HZ. Kinshasa is a city that faces poverty, high population density, lack of an organized interurban transport network, and a low level of public hygiene standards. The city is also an important entry point through its international airport and port. In response to the COVID-19 epidemic, COVID-19 response teams were set up in each HZ of Kinshasa. They were responsible for the contact tracing of confirmed cases, investigations and detection of febrile/suspect cases in the community.

Geographical location of the five study health zones in Kinshasa, DRC, 2020–2022

Study design, population and data collection

This study was designed as a prospective cohort study (Fig.  2 ). The cohort of participants was interviewed and seroprevalence through SARS-CoV-2 IgG antibody levels assessed, at 6 time points, the first 4 at 6- to 8-week intervals and the last 2 at 4- and 8-month intervals. The study population consisted of HCWs from the different structures in the five selected health zones (HZs) and their household members (HH members). In each selected HZ, one hospital, two healthcare centers (with the highest frequency of consultations), and the COVID-19 response team of the HZ were included. In total HCWs were hence selected among 5 hospitals, 10 health care centers and 5 COVID-19 response teams. An HCW was defined as any category of staff working in a health establishment, whether or not they were in direct contact with patients and their objects. A household member was defined as a member of the health care worker’s household, which consists of groups of individuals who live together in the same house, share the same housekeeping arrangements and usually eat meals together. The sample size for our baseline survey in HCW and HHmembers was based on estimating an expected seroprevalence of 5% in the HCWs (estimated to be higher than the seroprevalence for HHmembers) with a precision of 2% (alpha error of 0.05) and a design effect of 1.4, leading to a minimum sample of 650 participants in both groups. For the cohort, for an expected difference of 1% seroconversion in HH members and 4% seroconversion in HCWs (both starting at an expected seroprevalence of 5%) in consequent surveys, to detect this with a power of 80% and 95% precision, 339 HCWs and 678 HH members were needed, and considering the 20% probability of loss to follow-up, the total study sample estimated was 650 HCWs and 975 household members. This sample size is also big enough to detect risk factors in each survey round with a presence of 50% and precision of 5%, using the same alpha error and power as stated above.

Within each facility, HCWs were randomly selected based on the payroll list stratified by department. A total of at least 118 HCW per HZ were selected as following: In the hospitals, at least 12 participants were randomly selected in each of 8 wards; in the health centers, at least 6 participants were selected in the consultations and 6 in the laboratory/reception/social service; in the COVID-19 response team, at least 10 participants were randomly selected. For the household members of the HCWs, a subsample was selected in order to reach the required sample size: 2 HCWs per ward in each health facility were randomly selected (ad random function Excel), and for those selected HCWs, all their household members were invited to come to the health infrastructure for the survey. The cohort of participants was followed up at 6 time points, the first 4 at 6- to 8-week intervals and the last 2 at 4- and 8-month intervals. At each survey or round, all participants answered the questionnaire, and a blood sample was taken and tested. The questionnaire for HCWs was adapted from the WHO surveillance protocol for SARS-CoV-2 infection among health workers [ 16 , 17 ] and for HH members from the WHO household transmission investigation protocol [ 18 ]. In addition to demographic and medical history characteristics, the questions were probing for work-related exposure in relation to COVID-19 patients and the concomitant risk factors for HCWs and for general COVID-19 transmission risk behavior for HH members. Participants’ reports on typical symptoms of COVID-19 infection and COVID-19 PCR testing over the month prior to the survey were also included in the survey.

The study period was from July 2020 to January 2022.

Epicurve of COVID-19 cases in DRC, reported by the Ministry of Health, with indication of the period of study surveys, 2020–2022

Laboratory analysis

Upon informed consent, a 6 ml whole blood sample was taken from each HCW and a finger prick sample (minimum 3 - max 6 whole blood spots (75 µl)) for HH members (minimal discomfort and higher acceptability for non-health professionals) by an experienced nurse or laboratory technician. The collected blood specimens and dried blood spots were stored in the health facility laboratory in temperature-controlled (4 °C) conditions before daily transportation to the reference ‘Institut National de Recherche Biomédicale’ (INRB) laboratory. Filter papers were stored as aliquots of serum samples after centrifugation in a -20 °C freezer until further analysis.

For analysis, blood spot filter papers were prepared by punching two discs of 4-mm diameter and eluted overnight in 160 µL of PBS-TBN (dilution 1:40, PBS-1% BSA-0.15% Tween, pH 7.4, Sigma‒Aldrich). Just before use in the immunoassay, the eluted samples were further diluted to a final plasma dilution of 1:200 in PBS-BN, similar to the serum samples. The presence of binding antibodies to SARS-CoV-2 was tested with a highly sensitive and specific in-house Luminex multiplex antibody-based assay used to simultaneously detect IgG antibodies to two viral antigens, i.e., recombinant Nucleocapsid (NP) and Spike (SP) proteins derived from SARS-CoV-2 (see detailed information in publications [ 14 , 19 ]). A sample was considered positive for immunoglobulin G (IgG) against SARS-CoV-2 if it reacted simultaneously with NP and SP proteins and negative if it reacted to only one protein or if the median immunofluorescence intensity was below the cutoff for both antigens.

Data analysis

A descriptive analysis of the demographic and exposure/risk factors for both the HCW and HH groups was performed stratified by seropositivity at baseline. Various composite indicators were made. The variable ‘Contact with patients in health facility’ was defined as [ 1 ] direct contact (professional groups who are in close contact with patients, namely, medical doctors, nurses and assistant nurses) [ 2 ], indirect contact (professional groups of laboratory and hygiene personnel) and [ 3 ] no or little contact (including professional groups of maintenance, administration, and community workers). The variable ‘Ward risk related to COVID-19’ was defined as ‘low’ if health personal was working in administration, pharmacy, radiology and cleaning services, as ‘medium’ in outpatient department, laboratory, or surgical wards, as ‘high’ in COVID wards, intensive care units and emergencies. The variable ‘Personal Infection control material availability’ is based on 9 questions about availability of water, soap, disinfectant, masks, gloves, face screens together with available training and knowledge on standard protection measures; ‘minimal’ was defined as answering positive on less than 4 questions, ‘good’ for 5–7 questions, and ‘very good’ for answering positive on 8 or 9 questions. The variable ‘Personal Protection practice’ ’ was based on 7 exposure questions to patient and/or their belongings and/or patient body fluids together with direct contact to COVID-patients (regrouped as: value of ‘basic’ if no use and exposure or not to COVID, and ‘good’ if PPE use with clear exposure to COVID). Probing for risk exposure to COVID-19 patients, a composite indicator ‘Exposure score to COVID-19 patients’ was made based on the presence of a COVID-19 ward in the hospital, being affected or not to such a ward, use of personal protection material, and realizing invasive procedures or not. A score of 4 or less was categorized as low exposure, and a score of 4 or more was categorized as high exposure to COVID-19. For HH members, ‘risk behavior’ was defined as having at least a score of 3 on the composite indicator, calculated by the addition of 6 risk behavioral variables: working/being outside the house for work/travel/studying, not washing hands, not wearing masks in the street, not wearing masks on public transport, participation in public gatherings, and not keeping a 1.5 m distance when outside the house. The variable ‘History of COVID-19 like symptoms in last month’ is based on the WHO case definition, namely, having had at least 3 of the COVID-19 symptoms (fever, cough, fatigue, headache, muscle pain, sore throat, runny nose, shortness of breath, vomiting/nausea, diarrhea and/or alteration of consciousness) in the last 4 weeks.

Subsequently, seroprevalence was calculated for the total sample and each group at each survey. Confidence intervals were obtained by the Clopper-Pearson procedure, and p  values were obtained by the chi-square test or an F test. A multilevel logistic regression model was used to estimate determinants for seroprevalence status, with random effects at the participant level. Only independent variables collected in both groups were tested (see Table  1 ). The R package lme4 was used [ 20 ].

To evaluate whether there was transmission from HCWs to their families, a subgroup analysis was performed, adding the variable ‘COVID seroprevalence result of HCWs in the previous round’ to the abovementioned multilevel logistic regression model. The inclusion criteria for this subgroup were being household members, who are themselves nonhealthcare workers, and for whom there was a result of sero-survey of the HCW (of this household) in the previous round.

To visualize the seroreversion and seroconversion patterns, an alluvial plot was constructed.

To evaluate the determinants of seroreversion, seroreversion was defined as ‘a participant’s current test result is negative, and their previous test result is positive (allowed to “jump over” previous rounds with no available test result)’. Every round where both the current and a previous test result were available and where the previous test result was positive is therefore an opportunity to have observed a seroreversion. The number of such rounds was considered the “population size” for that participant. The seroreversion rate, participants’ number of seroreversions, was modeled using Poisson regression, while including the log of “population size” as the offset.

NP and SP antibody levels follow an exponential distribution, and to analyze the ratio of change over time, a zero-inflated Poisson regression model was used. To account for the longitudinal nature of the data, we included random effects in the model for participant ID (but not for health zone and household, as the model was not converging). The R package GLMMadaptive was used to perform this analysis [ 21 ].

Data analysis was conducted using R software version 4.1.1.

Baseline participant characteristics and seroprevalence of SARS-CoV-2 infection

Baseline demographic, work profile and work-related COVID-exposure (for HCWs) and risk behavior (for HH members) characteristics in relation to SARS-CoV-2 seropositivity at baseline are shown in Table  1 (bivariate analysis). Of a total of 561 HCWs and 425 HH members, 320 (57.0%) and 233 (54.8%) were female, respectively. The ages of the HCW and HH participants ranged from 18 to 84 years with a median of 43 years (IQR = 34–50) and from 0 to 85 years with a median of 18 years (IQR = 11–28), respectively. More than half of the HCWs included (302/561) were working in a hospital, and 308 had direct contact with patients. Eighty (18.8%) of the HH members reported no or minimal protection against COVID-exposure, such as washing hands, wearing masks, and keeping a distance of 1.5 m. A total of 57 HCWs and 7 HH members reported symptoms similar to those of a COVID-19 infection during the month prior to the interview, but this was not significantly associated with seroprevalence. Overall, 97 HCW participants were positive (17.3%, 95% CI 14.4–20.6) at baseline, and the highest seroprevalence was found in the Bandalungwa health zone ( p  < 0.001). Seropositivity was lower for HH members, attaining 7.8% (95% CI 5.5–10.8) at baseline. Only 35 participants reported at baseline having been tested for acute COVID infection on the basis of a PCR test.

Patterns of SARS-CoV-2 seroprevalence over time

The seroprevalence pattern among HCWs and HH members over time had an increasing trend, reaching 62.1% and 31.2% in the last survey in health care workers and household members, respectively. Household members always had lower seroprevalence than health care workers, except in round 4, where seroprevalence was very similar in both groups (Fig.  3 ). Of the 902 participants in the last survey, 45 (5.0%) – 39 HCWs and 6 HH members – reported having received at least one COVID-19 vaccination.

COVID-19 seroprevalence in health care workers and their household members, Kinshasa, DRC, 2020–2022. Rounds: 1 = July/August 2020 ( n  = 996); 2 = September/October 2020 ( n  = 834); 3 = November/December 2020 ( n  = 828); 4 = December 2020/January 2021 ( n  = 787); 5 = April/June 2021 ( n  = 976); 6 = November 2021/January 2022 ( n  = 902)

Determinants of seropositivity and patterns of seroconversion and seroreversion

The multivariable analysis (Table  2 ) shows that seropositivity increased significantly with increasing rounds, increasing age, being a female (in comparison to male) and being a health care worker (in comparison to being a HH member).

In a subanalysis on the household members to evaluate whether transmission is suggestive of coming from health care workers toward other family members, it was observed that if a health care worker was positive in a previous round, household members were not more infected. It was even the opposite when controlling for the confounding factors (same as in Table  2 ), resulting in a crude OR of 0.87 (95% CI 0.64–1.19) and an adjusted OR of 0.64 (95% CI 0.46–0.91), n  = 563 participants, 1709 observations.

Over the entire study period, there were 372 participants, HCWs and HH members, who had six data and sample collections. Of them, five participants (1,3%), only HCWs, stayed positive from the start to the end, and 114 (30.6%) stayed negative over the entire period.

Sero-reversion was important and was observed from the second round onward (Fig.  4 ). In a subsample of participants (both HCWs and HH members), the association of seroreversion with demographic characteristics showed that health care workers were estimated to have a 40% lower seroreversion rate than household members. There was no evidence for an association with age or gender (Table  3 ). The low number of observations is because only 397 participants ever tested positive and had at least one test result in a subsequent round, meaning they had at least one opportunity to manifest a seroreversion.

COVID-19 Sero-conversion and sero-reversion in healthcare workers and their household members, Kinshasa, DRC, 2020–2022. Rounds: 1 = July/August 2020 ( n  = 996); 2 = September/October 2020 ( n  = 834); 3 = November/December 2020 ( n  = 828); 4 = December 2020/January 2021 ( n  = 787); 5 = April/June 2021 ( n  = 976); 6 = November 2021/January 2022 ( n  = 902)

Antibody levels over time

In the multiplex serological test used, both NP and SP antibodies were evaluated. A positive COVID-test result was based on being positive (above threshold) for both antibodies. Over time, we observed an increase in antibody levels among the positive samples (Fig.  5 ). With each round, the odds of having NP antibodies increased by 60%, odds ratio of 1.60 (95% CI 1.33–1.93), and the level of NP antibodies increased by 53%, rate ratio of 1.53 (95% CI 1.52–1.53). Likewise, the odds of having SP antibodies increased by 33%, odds ratio of 1.33 (95% CI 1.22–1.45), and their level increased by 72%, rate ratio of 1.72 (95% CI 1.72–1.72), with unexplained variance at the level of participants of 3.32 (5391 observations among 1306 participants) and 1.18 (5390 observations among 1306 participants), respectively. The global antibody count predicted by the model is marked in red.

Participants’ trend in COVID-19 NP and SP antibody levels, Kinshasa, DRC, 2020–2022. Rounds: 1 = July/August 2020 ( n  = 996); 2 = September/October 2020 ( n  = 834); 3 = November/December 2020 ( n  = 828); 4 = December 2020/January 2021 ( n  = 787); 5 = April/June 2021 ( n  = 976); 6 = November 2021/January 2022 ( n  = 902)

This study shows that in July/August 2020, 4 months after the first reported COVID-19 case in DRC, 17.3% of HCWs and 7.8% of their HH members in Kinshasa tested positive for the presence of SARS-CoV-2 antibodies, which increased to 62.1 and 31.2% by January 2022, respectively. The seroprevalence of the first survey found in our study lies within the range of what was reported in May and June 2020 among HCWs from Malawi [ 6 ] but is lower than that reported in HCWs from Bukavu, DRC, in July and August 2020 (41.2%) [ 8 ] and in Ibadan, Nigeria (45.1%) [ 7 ]. However, we have to be cautious when comparing seroprevalence results across different studies, as the figures can be influenced by the study design and the epidemiological context but also by the choice of the diagnostic tests, which tend to have differential sensitivity and specificity in the African setting [ 22 , 23 ]. The high seroprevalence in the first survey of our study was somehow surprising, given the low number of clinical COVID-19 cases (10,401 PCR positives) and deaths (267) by September 15th, 2020, in Kinshasa, DRC. This discordance between serology and confirmed cases was subsequently observed in other sero-surveys in Africa. At the same time, in Belgian HCWs, for example, the seroprevalence was approximately 8% in a setting with 98,600 PCR positives (mainly clinical cases) and 10,000 COVID-19-related deaths [ 24 ]. Underreporting of mild clinical cases is a plausible reason within the Kinshasa setting, but it would not explain the low number of hospitalized cases or deaths, unless another factor is interfering. Possible explanations evidenced to date are a high proportion of the young population often associated with asymptomatic infections and the reduced risk of severe COVID-19 in African patients with parasite coinfection, such as helminth infection [ 25 ]. After the high seroprevalence at baseline, there was a decrease and subsequently an increase in seroprevalence, coinciding with reported symptomatic cases, as can be observed in the epidemiological curve of COVID-19 in DRC. It should also be noted that in the first months after pandemic declaration, some containment measures were taken by the DRC government in the general population, and the provision of protective equipment was provided to HCWs, together with training on compliance with IPC measures.

All sociodemographic and professional categories were equally positive for COVID-19 antibodies, and there was also no association with self-reported exposure to known COVID-19 cases or with risk behavior. A few HCWs had taken a PCR COVID-19 test in the first months of the pandemic, but neither this nor the presence of typical COVID-19 symptoms was associated with seropositivity. The finding of a higher seropositivity in the Bandalungwa health zone for the HCWs cannot be explained by the routine epidemiological surveillance data, which did not detect a cluster in this zone. Spatial clusters were not reported in the serological survey conducted in the general population of Kinshasa after the first wave of the COVID-19 pandemic [ 14 ]. The increasing seroprevalence over time, together with the absence of association with work-related or general risk behaviors and with HCW positivity in subsequent rounds in HH members, shows the importance of the time-dependent force of infection in a context where control measures were poorly followed by the population.

The IgG seroreversion rate was high between the first and second surveys (September 2020, 6 months after the first detected case) and was similar to the cohort of mild and asymptomatic COVID-19 cases followed up in North Carolina, USA, with 75.6% seroreversion over 5 months [ 26 ], but higher than the 39.5% seroreversion rate over 5 months in Connecticut, USA, in a cohort of mixed symptomatic and asymptomatic cases [ 27 ]. In our cohort, only 5 HCWs remained positive over the entire study period, which is much lower than that observed in other studies [ 28 , 29 ], where the setting and proportion of symptomatic cases were different. Several factors may explain the seroreversion observed in our study. First, it has been shown that the magnitude of the immune response as well as the longevity of the antibodies are lower among asymptomatic infections [ 11 , 30 ], which was the case for almost the totality of infections described here. In addition, even though the Luminex assay we used detected IgG, which was reported to last longer than IgM [ 31 ], we considered as positive only samples with concomitant presence of anti-spike and anti-nucleocapsid antibodies. Hence, any drop of one of the two antibodies was considered a seroreversion. In the UK, it was observed in primary school children and staff that anti-nucleocapsid antibodies stayed positive longer than anti-spike antibodies [ 32 ]. The patterns of seroprevalence over time fluctuated, with a decrease in seroprevalence at the second and fourth visits. A similar downward trend has also been found in other studies [ 10 , 33 , 34 , 35 ]. These fluctuations have to be seen within the context of the COVID-19 epidemic in Kinshasa and the balance between seroreversion and seroconversion (Fig. 4). We showed that SARS-CoV-2 IgG antibody levels are dynamic over time in this African setting with low clinical case rates. This has implications for epidemiological studies; for example, if IgG levels fall below detection thresholds before they are measured, past infections may be underascertained, and spread of the virus could even be higher than observed in our study.

The WHO recently published a document [ 15 ]‘Toolkit for Integrated Serosurveillance of Communicable Diseases in the Americas’, where the potential uses of sero-surveys are discussed. On the basis of this document, we revisited the usefulness of sero-surveys within the COVID-19 pandemic in the setting of DRC, where relatively few clinical cases were described up to the end of 2021 and with a very low vaccination coverage of 21% in mid-2023 [ 12 ].

Potential uses of a sero-survey:

(1) – Estimate burden of disease. This was indeed one of the main objectives in the DRC study, as there was a very low availability of PCR testing for acute disease in the first months after the start of the pandemic, and there were very low numbers of symptomatic COVID-19 cases. The difficulty lies in the choice of a serological test. Within the first sero-survey round, different tests were used, and the congruence between test results was low, as described by Nkuba et al. [ 36 ]. In such conditions of a new disease, with uncertainty about case presentation and uncertainty about test interpretation, communication of findings to policy makers is hampered and does not aid the development of disease control strategies. During the subsequent rounds, using the same tests, interpretation of the trend was possible and gave, in addition to the reported COVID-19 cases, insight into the extent of transmission over time. It was evidenced that virus circulation was more important than based on clinical case reports.

(2) – Estimate the size of the population susceptible to disease and inherent risk for outbreaks and monitor changes in immunity over time due to exposure, infection, or interventions. At the start of the COVID-19 pandemic, it was not known that seroreversion would happen so quickly. We discovered seroreversion in the second survey in September 2020 but doubted these results, as the serological test was new and we had incongruent findings among the different tests used in the first survey [ 37 ]. This made us hesitant to report on seroreversion and hence the quick lowering of immunity, which is an important finding for policy makers, as it means that transmission is hardly lowered due to immunity after infection. We could follow up seroconversion and seroreversion in a setting with very low vaccination coverage up to the beginning of 2022.

(3) – Characterize patterns of pathogen transmission, monitor changes in pathogen transmission and investigate causes of the resurgence of diseases. We could indeed evaluate the link of transmission between HCWs and their households. Our main research hypothesis was that HCWs are bringing virus to their homes, and indeed, HCWs had higher seropositivity than HH members, but in the subanalysis, it was seen that household members did not have a higher risk of infection in the round after an HCW was positive. This result could only be obtained by the end of the study after several rounds, when there were enough observations. Hence, our initial hypothesis was rejected, but our results came too late to inform policy makers.

(4) – Identify high-risk groups. We could indeed identify risk groups, such as females, those who were older and those who were HCWs. However, these are not modifiable risk factors, and no intervention could be identified, except the priority of health care workers for vaccination campaigns, which was an obvious choice made in all countries affected by the pandemic. More important than identifying high risk for infection is determining who is at high risk of severe disease (and death). This has become clear quite early in the pandemic from clinical sites across the world: the elderly and those with comorbidities (especially diabetes, obesity, hypertension).

(5) – Determine the duration of immunity and detect the reintroduction or reemergence of diseases, monitor progress toward elimination goals and identify immunity gaps, establish theoretical herd immunity thresholds, and evaluate the impact of interventions. Due to the design of our study, sampling participants at fixed intervals, and the lack of availability of PCR tests, it was not possible to provide evidence on the duration of immunity. COVID-19 vaccines were hardly accepted in DRC, which started vaccinating on April 19th of 2021 [ 12 ], and with only 45 participants reporting being vaccinated between the fifth and sixth rounds, we could not evaluate the effect of interventions on the transmission force.

(6) – Summarizing evidence to provide a strong rationale and useful information that can be used to set priorities and guide policies and strategies for disease control and elimination. During the study, we were disappointed that it was not possible to have a direct impact on policy making. As it was a new disease and at time of the study no information on duration of antibodies was available, there was the doubt on the interpretation of serological results in general and of the sero-reversion in the second survey. This could have been important for policy, as this indicates the absence of increasing immunity or protection based on a natural infection. In subsequent surveys, we could follow up on the trend of transmission, which was higher than expected based on the reported cases, and the importance of seroreversion and seroconversion, but this did not provide much evidence for policy makers.

Although sero-surveys avoid the limitation of passive disease reporting systems, which can be unreliable due to underdiagnosis and undernotification, it turned out that the seroprevalence surveys were less useful than we had hoped for before the start of the study. This was due to the inherent characteristics of the disease and was not dependent on the design or rigor of the study. The evidence provided probably provides more information on what needs to be taken into account when performing sero-surveys in future outbreaks. The sero-survey was useful in the earliest days to realize that transmission of SARS-CoV-2 was very widespread, largely pauci- or asymptomatic. Afterwards, the information became less relevant, as infection and reinfection rates continued to be high, with seropositivity being a very poor predictor of protection against infection.

Epidemic dynamics result from an interaction between the spread of infection, built immunity, demographic migration and waning immunity [ 38 ]. Understanding this interaction is key, and serological surveys can provide information on this immunity landscape for many infectious diseases, yet this methodology remains underexploited and interpretation hampered in a situation of a new disease with an unclear serological profile and unclear clinical case presentation.

Data availability

No datasets were generated or analysed during the current study.

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Acknowledgements

We acknowledge the support of the DRC health authorities, health staff of the included health zones and surveyors’ team for the smooth realization of this study. We also acknowledge Chantal Lakis and Lisa Aketeng for the database cleaning and first exploratory analysis of the data.

The study was funded by Enabel (the Belgian Development agency), the German Ministry for Economic Cooperation and Development (BMZ) through GIZ (its Development agency), the framework agreement between the Institute of Tropical medicine and the Belgian Development Cooperation (FA4/CREDO) and ‘Institut de Recherche pour le Développement’ (IRD), France.

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Joule Madinga

Department of Epidemiology and Global Health, Institut National de Recherche Biomédicale & Faculty of Medicine, University of Kinshasa, Kinshasa, Democratic Republic of Congo

Placide Mbala-Kingebeni

Virology Unit, Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of Congo

Antoine Nkuba-Ndaye, Leonel Baketana-Kinzonzi & Elysé Matungulu-Biyala

Department of Epidemiology and Global Health, Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of Congo

Patrick Mutombo-Lupola

Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium

Caroline-Aurore Seghers, Tom Smekens & Wim Van Damme

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Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ), Bonn, Germany

Andreas Kalk

Unit Trans VIHMI, University of Montpellier, IRD/INSERM, Montpellier, France

Martine Peeters

Virology Unit, Institut National de Recherche Biomédicale & Faculty of Medicine, University of Kinshasa, Kinshasa, Democratic Republic of Congo

Steve Ahuka-Mundeke & Jean-Jacques Muyembe-Tamfum

Emerging Infectious Diseases Unit, Public Health Department, Institute of Tropical Medicine, Antwerp, Belgium

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Contributions

Conceptualization: Joule Madinga, Placide Mbala, Wim Van Damme, Andreas Kalk, Veerle Vanlerberghe, Jean-Jacques Muyembe

Data collection coordination: Caroline-Aurore Seghers, Joule Madinga, Patrick Mutombo Lupola

Laboratory analysis: Antoine-Jeremy Nkuba, Leonel Baketana, Elysé Matungulu, Kevin K. Ariën, Steve Ahuka, Martine Peeters,

Data analysis: Tom Smekens, Patrick Mutombo Lupola, Joule Madinga, Placide Mbala, Veerle Vanlerberghe

Interpretation of results: Joule Madinga, Placide Mbala, Wim Van Damme, Andreas Kalk, Veerle Vanlerberghe, Steve Ahuka, Martine Peeters

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Madinga, J., Mbala-Kingebeni, P., Nkuba-Ndaye, A. et al. COVID-19 seroprevalence cohort survey among health care workers and their household members in Kinshasa, DR Congo, 2020–2022. J Health Popul Nutr 43 , 74 (2024). https://doi.org/10.1186/s41043-024-00536-0

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Antegrade balloon dilatation of the duodenal papilla during laparoscopic cholecystectomy versus endoscopic retrograde cholangiography in patients with acute choledocholithiasis: a case control matched study

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• Simone Minder 1 ,
• Bianca Schnell 1 ,
• Gian Andrea Prevost 1 , 2 ,
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• Beat Schnüriger   ORCID: orcid.org/0000-0002-1672-2775 1  

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Introduction

In acute obstructive common bile duct (CBD) stones endoscopic retrograde cholangiography for CBD stone removal before cholecystectomy (ChE) (‘ERC-first’) is the gold standard of treatment. Intraoperative antegrade balloon dilatation of the duodenal papilla during ChE with flushing of CBD stones to the duodenum (‘ABD-during-ChE’) may be an alternative ‘one-stop-shop’ treatment option. However, a comparison of outcomes of the ‘ABD-during-ChE’ technique and the’ERC-first’ approach has never been performed.

Retrospective case control matched study of patients suffering from obstructive CBD stones (< 8 mm) without severe pancreatitis or cholangitis that underwent the traditional ‘ERC-first’ approach versus the ‘ABD-during-ChE’ technique. Primary endpoint was the overall Comprehensive Complication Index (CCI®) from diagnosis to complete CBD stone removal and performed ChE.

A total of 70 patients were included (35 patients each in the ‘ERC first’- and ‘ABD-during-ChE’-group). There were no statistical significant differences in terms of demographics and disease specific characteristics between the two study groups. However, there was a not significant difference towards an increased overall CCI® in the ‘ERC-first’ group versus the ‘ABD-during-ChE’ group (14.4 ± 15.4 versus 9.8 ± 11.1, p  = 0.225). Of note, six major complications (Clavien-Dindo classification ≥ IIIa) occurred in the ‘ERC-first’ group versus two in the ‘ABD-during-ChE’ group (17% versus 6%, p  = 0.136). In addition, significantly more interventions and a longer overall time from diagnosis to complete clearance of bile ducts and performed ChE was found, when comparing the ‘ERC-first’ group and the ‘ABD-during-ChE’ group (3.7 ± 0.8 versus 1.1 ± 0.4, p  < 0.001; 160.5 ± 228.6 days versus 12.0 ± 18.0 days, p  < 0.001).

In patients suffering from acute obstructive CBD stones smaller than 8 mm, compared to the ‘ERC-first’ approach, the ‘ABD-during-ChE’ technique resulted in significantly less interventions and reduced overall treatment time from diagnosis to complete clearance of bile ducts and performed ChE. This comes together with a strong trend of less intervention related complications in the ‘ABD-during-ChE’ group.

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Gallstone disease is one of the most prevalent and costly digestive diseases in developed countries. Around 10% of patients with gallbladder stones will be admitted with cholestasis resulting from obstructive common bile duct (CBD) stones [ 1 ]. Choledocholithiasis is widespread in the Western population: In Switzerland, 14,689 patients required surgery for cholelithiasis and its complications, and an estimated 20 million Americans suffer from gallbladder disease [ 2 , 3 ]. An estimated 5–20% of all patients undergoing cholecystectomy also have choledocholithiasis, making this disease a major impact on healthcare systems and the economic burden [ 4 , 5 ]. Standard treatment of CBD stones in combination with gallbladder stones is endoscopic retrograde cholangiography (ERC) with sphincterotomy and stone removal either before or after prophylactic laparoscopic cholecystectomy (ChE) in a two-step procedure (‘ERC-first’). Of note, stent placing may be required after ERC and sphincterotomy to ensure postinterventional patency of the bile ducts caused by bleeding, swelling of the sphincter region or left behind debris. Those stents have to be removed in a third intervention a few weeks after cholecystectomy.

ERC with sphincterotomy is associated with considerable short and long term morbidity [ 6 , 7 , 8 ]. The main complications are post-ERC-pancreatitis (2–5%), impaired sphincter of Oddi function with reflux of duodenal content to the bile ducts and a consecutive higher risk for cholangitis, stone recurrence and even a potential higher risk for cholangiocarcinoma [ 6 , 7 , 8 , 9 ].

Due to the above-mentioned disadvantages of ERC, surgical bile duct clearance during ChE over a transcystic antegrade approach has been proposed years ago [ 10 ]. This anterograde procedure has been described with similar CBD stone clearance rates, less morbidity and a better cost effectiveness compared to the ERC. However, despite being first described more than 20 years ago, providing a low rate of postoperative pancreatitis and a satisfying CBD stone clearance rate, this method has been practiced in specialized centers only [ 10 , 11 , 12 , 13 , 14 ]. Moreover, no comparison to the current gold standard ERC in the treatment of obstructive CBD stones has been published to date.

Recently, in a prospective observational pilot study, a detailed description of the antegrade approach to obstructive CBD stones during laparoscopic ChE has been published from our institution. It has been shown, that the antegrade balloon dilatation (‘ABD-during ChE’) technique is feasible and safe and may offer an alternative to the traditional ‘ERC-first’ approach in patients suffering from obstructive CBD stones of up to 8 mm in size [ 15 ]. Therefore, the aim of this study is to compare for the first time the overall morbidity of the traditional ‘ERC-first’ group to the ‘ABD-during-ChE’ group in a retrospective matched case control study. To assess morbidity, the Comprehensive Complication Index (CCI®) was used, in order to include grade and number of complications. Accordingly, the CCI ranges from 0 (uneventful course) to 100 (death) [ 16 ].We hypothesize that the overall morbidity, depicted as Comprehensive Complication Index (CCI®) over the entire treatment course from admission until complete CBD stone clearance and laparoscopic ChE will be significantly decreased in the new ‘ABD-during-ChE’ group compared to the traditional ‘ERC-first’ group [ 16 ].

Patient inclusion and exclusion criteria

This trial is a monocentric retrospective case control matched analysis of patients diagnosed with acute obstructive CBD stones at the Department of Visceral Surgery and Medicine at Bern University Hospital, University of Bern, Switzerland. The study population comprised of patients with an age ≥ 18 years admitted with obstructive CBD stones ≤ 8 mm and absent severe biliary pancreatitis or cholangitis that underwent either the traditional ‘ERC-first’ or the ‘ABD-during-ChE’ approach. All patients with previous surgical interventions to the CBD or evidence of intrahepatic biliary stones were excluded from analysis.

Choledocholithiasis was suspected in patients with right-sided upper abdominal pain, elevated cholestasis parameters and sonographically visualized cholecystolithiasis or visualized CBD stones on sonography or magnetic resonance cholangiography. The diagnosis of CBD stones was then confirmed either at intraoperative cholangiography (IOC) or ERC.

Severe pancreatitis was defined as pancreatitis with a persistent one-organ dysfunction (> 48 h). Severe cholangitis was defined as cholangitis not responding to initial medical treatment (antibiotics and supportive medication) or with at least one-organ dysfunction. Patients with mild to moderate pancreatitis or cholangitis were included. Mild to moderate pancreatitis was defined as more than threefold elevated serum lipase. Mild to moderate cholangitis was defined according to the Tokyo Guidelines 2018 [ 17 ]: The guidelines encompass systemic inflammation (fever, chills, or increased inflammatory markers), cholestasis (jaundice or abnormal liver function tests) and imaging (biliary dilation or evidence of stricture, stone, or stent). Diagnosis of cholangitis was confirmed in case all three parameters have been present.

Data collection

Data of patients that underwent the ‘ABD-during-ChE’ approach have been collected prospectively from 01/2021 to 04/2022 [ 15 ]. The demographics and disease characteristics of the ‘ERC-first’ group were retrospectively collected from the electronic patients’ records. These patients were treated from 01/2019 to 12/2020. Subsequently, the ‘ABD-during-ChE’ patients were matched 1:1 to the ‘ERC-first’ group using sex and age (± 5 years) as matching criteria.

Primary and secondary endpoints

Primary endpoint was the overall Comprehensive Complication Index CCI® [ 16 ]. Of note, the CCI® was calculated from all postinterventional complications occurring during the entire treatment period from diagnosis of CBD stone until complete stone clearance of the biliary tract and performed ChE. The severity of complications was assessed according to the Clavien-Dindo classification of surgical complications or the AGREE classification of adverse events in gastrointestinal endoscopy [ 18 , 19 ]. Secondary endpoints included the number of interventions, overall hospital length of stay, overall intensive care unit length of stay and the duration of overall treatment from diagnosis of CBD stones until complete stone clearance of the biliary tract and performed ChE. Overall hospital stay was defined as number of nights the patient was hospitalized, accumulated over all interventions.

Study procedure

Antegrade balloon dilatation (‘abd-during-che’) approach.

The ‘ABD-during-ChE’ technique has been described in detail previously [ 15 ]. Similarly to standard laparoscopic ChE, patients are placed in French- and reverse Trendelenburg position. Over an additional 3 or 5 mm 15 cm port, cholangiography by the insertion of the cholangiography catheter (5 French RX ERCP Cannula Tapered Tip, Boston Scientific, Marlborough, Massachusetts, USA) into the cystic duct is performed. In case of a positive cholangiogram for CBD stones or sludge, a guidewire (Jagwire High performance, 260 cm, 0.035-inch, straight tip, Boston Scientific, Marlborough, Massachusetts, USA) is placed via the cholangiography catheter and forwarded over the duodenal papilla into the duodenum. Over this guidewire, a biliary dilatation balloon (Hurricane™ RX, 6, 8 or 10 mm, 4 cm, Boston Scientific, Marlborough, Massachusetts, USA) is then inserted and advanced to the papillary level. The size of the balloon is adjusted to the size of the stone and was previously estimated comparing the diameter of the inserted 5 mm grasper under fluoroscopy. After checking the position of the balloon under fluoroscopy, sphincteroplasty is executed for two minutes with 10 atmospheres (atm) pressure. Afterwards, the guidewire as well as the biliary dilatation ballon is removed and the cholangiography catheter reinserted again. As a final step, the CBD is flushed with 20-40 ml of saline and the final result is controlled by cholangiography before ChE is finalized. If persisting stones were detected after flushing, stones are pushed to the duodenum by the gently inflated dilation balloon along the reinserted guidewire.

In case, CBD stone clearance could not be achieved by the above described ‘ABD-during-ChE’ technique, ChE was finalized and an ERC was subsequently performed at the same hospital stay.

Endoscopic retrograde cholangiography (‘ERC-first’) approach

ERC is a minimally invasive endoscopic procedure to diagnose and remove CBD stones. A flexible endoscope is inserted through the patient's mouth, down the esophagus, and into the stomach and duodenum. After visualization of the ampulla of Vater, a catheter (sphincterotome) is inserted through the endoscope and into the bile duct. For cholangiography, a contrast dye is injected into the CBD and fluoroscopy is used to identify the location and size of CBD stones. A guidewire is advanced through the cannula and into the CBD and a sphincterotomy is eventually performed. Over the guidewire, a balloon catheter is introduced above the level of the stone. The balloon is then carefully inflated and gently pulled back into the duodenum until CBD stone extraction has been achieved. Fluoroscopy is performed to confirm that all CBD stones have been removed. Dilatation of the papillary orifice may have to be performed in order to facilitate extraction of bigger stones. Sometimes, biliary stents have to be placed in order to maintain patency of the biliary tract. Finally, the cannula and endoscope are removed, and the patient is monitored as they recover from sedation.

Few days to weeks after the ERC, laparoscopic ChE is performed in a second intervention to remove the main source of gallstones in order to prevent from further biliary complications. In case a CBD stent is inserted at the initial ERC, an additional ERC (third intervention) for removal of the stent has to be performed after ChE.

Statistical analyses

Quantitative and qualitative variables are expressed as mean (standard deviation) or frequency (percentage). The matching process of the study groups by case control matching was performed by SPSS® version 25 (IBM, Armonk, New York, USA). Matching criteria included sex and age (± 5 years). Demographics, disease characteristics as well as primary and secondary endpoints were compared using Fisher exact test for categorical variables and the Mann–Whitney U test for continuous variables, as appropriate. P < 0.05 was considered statistically significant. Statistical analyses were performed using SPSS® version 25 (IBM, Armonk, New York, USA).

Figure  1 shows the study outline. The ‘ABD-during-ChE’ group consisted of 57 patients from the previous prospective observational pilot study [ 15 ]. These patients were 1:1 matched to the ‘ERC-first’ group. The ‘ERC-first’ group was recruited from a total of 978 patients who underwent an ERC between 01/2019 and 12/2021 at Bern University Hospital. After excluding patients that underwent ERC for other reasons than CBD stones, patients with a stone size of > 8 mm, patients with severe pancreatitis/cholangitis, and 199 patients who underwent cholecystectomy at another hospital, a total of 51 eligible ‘ERC-first’ patients remained for further analysis.

Study outline of the two study groups

After above-mentioned patient recruitment process, a total of 108 patients, who underwent treatment for CBD stones < 8 mm by the ‘ABD-during-ChE’ or the ‘ERC-first’ approach and absent severe pancreatitis or cholangitis were available for case control matching (Fig.  1 ). After case control matching a total of 70 patients (35 patients in the ‘ABD-during-ChE’ group and 35 patients in the ‘ERC-first’ group) were available for further analyses regarding primary and secondary endpoints.

Demographics

Demographics and disease specific data of the study populations are delignated in Table  1 . After matching, the ‘ABD-during-ChE’ group was similar to the ‘ERC-first’ group with regards to age, sex, body mass index, CRP level on admission, ASA classification and the Charlson-Comorbity index, respectively. Moreover, due to the inclusion/exclusion criteria, there were no severe pancreatitis or cholangitis or CBD stones > 8 mm in both groups.

However, there was a trend towards more mild to moderate pancreatitis and higher serum lipase levels on admission in the ‘ABD-during-ChE’ compared to the ‘ERC-first’ group (29% versus 11%, p  = 0.075; 992 U/L versus 548 U/L, p  = 0.093). In contrast, bilirubin levels tended to be higher in the ‘ERC-first’ compared to the ‘ABD-during-ChE’ group (72 mg/dL versus 39 mg/dL, p  = 0.091) (Table  1 ).

Primary endpoint

Table 2 summarizes overall CCI® of the two study groups. The ‘ABD-during-ChE’ group showed a lower overall CCI® compared to the ‘ERC-first’ group (‘ABD-during-ChE’ group 9.8 versus ‘ERC-first’ group 14.4, p  = 0.225), however this difference was not statistically significant.

A trend towards more major complications (Clavien-Dindo classification ≥ IIIa) were found for the ‘ERC-first’ versus the ‘ABD-during-ChE’ group (17% versus 6%, p  = 0.136). In the ‘ERC-first’ group 8 major complications occurred in 6 different patients including post-ERC cholangitis with need of ICU care ( n  = 1), post-ChE cholangitis with need of ICU care ( n  = 1), unplanned re-ERC after unsuccessful ERC ( n  = 3), unplanned ERC due to a CBD stent dysfunction ( n  = 1), and post-ChE fluid collection with transcutaneous drain insertion ( n  = 2). In contrast, in the ‘ABD-during-ChE’ group two patients suffered from two major complications. One patient underwent ERC due to increasing cholestasis after ChE and the other patient underwent unplanned negative gastroscopy during follow-up due to inconclusive upper gastrointestinal symptoms.

A total of 84 minor complications (Clavien-Dindo ≤ II) occurred in both study groups. In the ‘ABD-during-ChE’ group overall 36 minor complications occurred in 19 patients and in the ‘ERC-first’ group 48 minor complications occurred in 23 patients. With 37% of all patients ( n  = 26), constipation, defined as the need of laxative medication and without the need of gastric tube insertion, was in both study groups by far the most frequent minor complication.

Specific CCI® resulting from the ERCs or ChE are delineated and compared between the two study groups (Table  2 ). The CCI® resulting from the ERC specifically was significantly higher in the ‘ERC-first’ group compared to the ‘ABD-during-ChE’ group (‘ERC-first’ group 6.5 versus ‘ABD-during-ChE’ group 0.0, p  < 0.001). The most common ERC-related complications included postinterventional cholangitis in 7% ( n  = 5), post-ERC pancreatitis in 4% ( n  = 3) or postinterventional anemia in 4% ( n  = 3). In the ‘ABD-during-ChE’ group there was no occurrence of postoperative cholangitis or pancreatitis. During planned laparoscopic cholecystectomy, one patient in the ‘ABD-during-ChE’ group needed a conversion to an open cholecystectomy compared to 4 patients in the ‘ERC-first’ group (3% versus 11%, p  =  0.167 ).

The CCI® resulting from the ChE solely were similar between the two study groups (‘ERC-first’ group 9.4 versus ‘ABD-during-ChE’ group 9.5, p  = 0.690). The ChE related complications included postoperative paralytic ileus in 4% ( n  = 3), postoperative intraabdominal fluid collection in 3% ( n  = 2) or superficial surgical site infection in 1% ( n  = 1).

Secondary endpoints

In the ‘ABD-during-ChE’ group a mean number of 1.1 ± 0.4 interventions were needed until finalization of treatment, whereas in the ‘ERC-first’ group 3.7 ± 0.8 interventions were required ( p  < 0.001). Ultimately, the CCI® increased with increasing number of interventions (Fig.  2 ).

Correlation between the number of interventions during the entire treatment period and the Comprehensive Complication Index

The CBD stone clearance rate or successful antegrade balloon dilatation in the ‘ABD-during-ChE’ was 94% (33 of 35 patients). The two patients with unsuccessful ‘ABD-during-ChE’ approach were a 56-year old female patient that underwent ‘ABD-during-ChE’ due to acute choledocholithiasis with concomitant mild pancreatitis and a 39-year old male patient with acute choledocholithiasis. In both patients the intubation of the cystic duct with the cholangiography catheter or the guidewire intraoperatively was not achievable. Therefore these two patients underwent ERC at the first day after operative treatment with extraction of sludge from the CBD. Further follow-up of these two patients was uneventful.

Similarly, hospital length of stay as well as the overall time from diagnosis to complete clearance of bile ducts and performed ChE was significantly longer for the ‘ERC-first’ group versus the ‘ABD-during-ChE’ group (160.5 ± 228.6 days versus 12.0 ± 18.0 days, p  < 0.001) (Table  2 ). In contrast, due to the intraoperative clearance of bile ducts and balloon dilatation of the Sphincter of oddi at ChE, the duration of the ChE increased significantly in the ‘ABD-during-ChE’ group versus the ‘ERC-first’ group (110.7 ± 26.2 minutes versus 84.3 ± 29.6 minutes, p  < 0.001).

The current study shows that in patients suffering from obstructive CBD stones < 8 mm, the ‘ABD-during-ChE’ approach has a very high rate (94%) of CBD stone clearance in combination with a low total number of interventions. This stands in contrast with the ‘ERC-first’ approach, where all patients required at least two interventions to treat CBD stones including the prophylactic ChE. Moreover, treatment with the ‘ABD-during-ChE’ approach had a lower rate of clinically and outcome-relevant complications classified above Clavien-Dindo grade 3a, compared to the ‘ERC-first’ group. This indicates that ‘ABD-during-ChE’ should be considered as an efficient treatment alternative to ‘ERC-first’ in patients suffering from obstructive CBD stones < 8 mm. Especially in times of progressing shortage of hospitals’ personnel and infrastructural resources, the ‘ABD-during-ChE’ may be a valuable and lean alternative to the traditional two-step ‘ERC-first’ approach.

The disease of choledocholithiasis is common in western population. A total of 14′689 patients required ChE due to cholelithiasis and its complications in 2021 in Switzerland and estimated 20 million Americans suffering from gallbladder disease [ 2 , 3 ]. Estimating that 5% to 20% of all patients undergoing cholecystectomy have simultaneous choledocholithiasis [ 4 , 5 ], the disease has a very high impact on health care systems resulting in a significant economic burden. The ‘ABD-during-ChE’ technique offers a lean management for this group of patients with a significantly reduced total number of interventions and with it, according the current study, a significantly reduced treatment period by more than 5 months compared to the traditional ‘ERC-first’ approach. The five-month time from diagnosis to the end of treatment in the ‘ERC-first’ group is the result of a generous use of initial CBD stent insertion. It is common practice at our institution to achieve immediate biliary drainage by inserting a CBD stent in patients with acute obstructive CBD stones. This shortens the duration of the initial emergency ERC, which is favorable in terms of utilization of personnel resources and potentially reduces interventional morbidity. Secondary elective ERC for complete CBD clearance and stent removal is particularly advantageous in complex CBD stone situations. The rather high time from diagnosis to the end of treatment in the ‘ABD-during-ChE’ group is due to four outlying patients. These patients had a mean hospital length of stay of 5.8 days (± 1.7). The time from diagnosis to the end of treatment was prolonged as two patients received endoscopy due to persistent symptoms, one patient needed re-hospitalization due to cholangitis and one patient underwent CBD stent removal.

After elimination of non-clinically and outcome-relevant minor complications (Clavien-Dindo grades I and II), the morbidity of the ‘ABD-during-ChE’ was low with 6% major complications compared to 17% major complications in the ‘ERC-first’ group. This percentage was as low as reported in other studies investigating ‘ABD-during-ChE’ [ 11 , 13 , 14 ], where no major complications were described. Moreover, in the current study, ERC was comparable to other studies regarding major complications [ 20 , 21 ]. Noticeable is the high percentage of overall complications according to Clavien-Dindo in the current study. This may be explained by the meticulous documentation even of minor complications (e.g., constipation, anemia, or superficial surgical site infection). Whereas other studies assessed major complications only, the current trial used the CCI® as an instrument which integrates also minor complications.

The higher CCI® in the ‘ERC-first’ group may also be explained by the increased number of interventions compared to the ‘ABD-during-ChE’ group (Fig.  2 ). In the current study, the one-stop-shop-character of the ‘ABD-during-ChE’ approach proved to reduce the number of interventions by three. It is important to realize, that every intervention carries its own risk in terms of complications, which is why the indication for every intervention should be carefully examined. This includes both surgical and anesthesiological risks. Of note, according the literature, significant unplanned events are occurring in up to 23% of all patients undergoing ERC [ 22 , 23 ].

The surgical treatment of acute obstructive CBD stones during laparoscopic cholecystectomy is mentioned in the guidelines for endoscopic management of CBD stones of the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society of Gastrointestinal Endoscopy (ASGE) as well, but with weak recommendation as existing literature is of moderate quality [ 24 , 25 ]. The current study is the first that compares the ‘ABD-during-ChE’ to the ‘ERC-first’ approach, which is regarded the gold standard in the treatment of acute choledocholithiasis. The ‘ABD-during-ChE’ approach is one of several possible intraoperative approaches to the CBD (e.g. laparoscopic choledochotomy, transcystic choledochoscopy and removal of CBD stones with a Dormia basket). However, no comparative studies to the current ‘ABD-during-ChE’ approach exist. Often studies examined a combination of different intraoperative approaches on limited numbers of patients, making it difficult to draw any conclusions [ 26 , 27 , 28 ]. Moreover, surgical techniques requiring choledochotomy result in more postoperative morbidity due to its invasiveness [ 29 , 30 ]. In contrast, the ‘ABD-during-ChE’ approach provides a high CBD stone clearance rates, low morbidity and can be carried out with relatively little technical effort.

Even though the current study has clear limitations due to the retrospective design, the limited number of patients, a potential selection bias towards less complicated patients treated by ‘ABD-during-ChE’ and a limited follow-up, the use of stringent inclusion criteria and the case control matching have resulted in two comparable groups. Moreover, the size of differences in the number of interventions observed are partially related to the local clinical practice of liberal CBD stent placement at initial ERC (‘ERC-first’ group) and therefore, generalizability to other institutions is limited. Validation of these results in a randomized controlled setting is warranted in order to generalize indication and effectiveness for ‘ABD-during-ChE’ in acute choledocholithiasis and to strengthen evidence.

For treatment of acute obstructive CBD stones in uncomplicated patients with smaller CBD stones than 8 mm, the’ABD-during-ChE’ approach resulted in significantly less overall interventions and a trend towards less intervention related morbidity compared to the’ERC-first’ approach. Moreover, there is a great benefit regarding reduced overall time from diagnosis to finalization of treatment including CBD stone clearance and ChE. To generalize these results and to improve the scientific evidence, prospective randomized controlled trials are needed.

Abbreviations

• Antegrade balloon dilatation

Antegrade balloon dilatation during cholecystectomy

American Society of Gastrointestinal Endoscopy

Common bile duct

Comprehensive Complication Index

• Cholecystectomy

Endoscopic retrograde cholangiography

European Society of Gastrointestinal Endoscopy

Intraoperative cholangiography

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Severin Gloor, Simone Minder, Bianca Schnell, Gian Andrea Prevost, Reiner Wiest, Daniel Candinas & Beat Schnüriger

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The study was designed by SG and BS. SG, SM, BS, GAP and RW made data acquisition. SG, SM and BS wrote the manuscript and made statistical analysis. BS, GAP, RW, and DC revised the manuscript critically for important intellectual content. All authors read and approved the final manuscript. This article is based on the second author’s medical doctoral dissertation.

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Severin Gloor, Simone Minder, Bianca Schnell, Gian Andrea Prevost, Reiner Wiest, Daniel Candinas and Beat Schnüriger have no conflicts of interest or financial ties to disclose.

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This study was initiated after obtaining ethical approval from the Canton of Bern (KEK Nr. 2023–01251). General written informed consent was obtained from all subjects involved in the study.

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Gloor, S., Minder, S., Schnell, B. et al. Antegrade balloon dilatation of the duodenal papilla during laparoscopic cholecystectomy versus endoscopic retrograde cholangiography in patients with acute choledocholithiasis: a case control matched study. Surg Endosc (2024). https://doi.org/10.1007/s00464-024-10909-5

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DOI : https://doi.org/10.1007/s00464-024-10909-5

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