what is a case report form in research

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• Writing a case report...

Writing a case report in 10 steps

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• Peer review
• Victoria Stokes , foundation year 2 doctor, trauma and orthopaedics, Basildon Hospital ,
• Caroline Fertleman , paediatrics consultant, The Whittington Hospital NHS Trust
• victoria.stokes1{at}nhs.net

Victoria Stokes and Caroline Fertleman explain how to turn an interesting case or unusual presentation into an educational report

It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.

It usually falls to the junior to write up the case, so here are a few simple tips to get you started.

First steps

Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.

Getting consent

Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.

Information gathering

Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.

Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.

Coming up with a title

Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.

Background research

Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.

How your case is different

Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.

Finish by explaining why your case report adds to the medical literature and highlight any learning points.

Writing an abstract

The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.

Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!

Competing interests: We have read and understood BMJ’s policy on declaration of interests and declare that we have no competing interests.

Study Design 101: Case Report

• Case Report
• Case Control Study
• Cohort Study
• Randomized Controlled Trial
• Practice Guideline
• Systematic Review
• Meta-Analysis
• Helpful Formulas
• Finding Specific Study Types
• Case Reports

An article that describes and interprets an individual case, often written in the form of a detailed story. Case reports often describe:

• Unique cases that cannot be explained by known diseases or syndromes
• Cases that show an important variation of a disease or condition
• Cases that show unexpected events that may yield new or useful information
• Cases in which one patient has two or more unexpected diseases or disorders

Case reports are considered the lowest level of evidence, but they are also the first line of evidence, because they are where new issues and ideas emerge. This is why they form the base of our pyramid. A good case report will be clear about the importance of the observation being reported.

If multiple case reports show something similar, the next step might be a case-control study to determine if there is a relationship between the relevant variables.

• Can help in the identification of new trends or diseases
• Can help detect new drug side effects and potential uses (adverse or beneficial)
• Educational - a way of sharing lessons learned
• Identifies rare manifestations of a disease

Disadvantages

• Cases may not be generalizable
• Not based on systematic studies
• Causes or associations may have other explanations
• Can be seen as emphasizing the bizarre or focusing on misleading elements

Design pitfalls to look out for

The patient should be described in detail, allowing others to identify patients with similar characteristics.

Does the case report provide information about the patient's age, sex, ethnicity, race, employment status, social situation, medical history, diagnosis, prognosis, previous treatments, past and current diagnostic test results, medications, psychological tests, clinical and functional assessments, and current intervention?

Case reports should include carefully recorded, unbiased observations.

Does the case report include measurements and/or recorded observations of the case? Does it show a bias?

Case reports should explore and infer, not confirm, deduce, or prove. They cannot demonstrate causality or argue for the adoption of a new treatment approach.

Does the case report present a hypothesis that can be confirmed by another type of study?

Fictitious Example

A physician treated a young and otherwise healthy patient who came to her office reporting numbness all over her body. The physician could not determine any reason for this numbness and had never seen anything like it. After taking an extensive history the physician discovered that the patient had recently been to the beach for a vacation and had used a very new type of spray sunscreen. The patient had stored the sunscreen in her cooler at the beach because she liked the feel of the cool spray in the hot sun. The physician suspected that the spray sunscreen had undergone a chemical reaction from the coldness which caused the numbness. She also suspected that because this is a new type of sunscreen other physicians may soon be seeing patients with this numbness.

The physician wrote up a case report describing how the numbness presented, how and why she concluded it was the spray sunscreen, and how she treated the patient. Later, when other doctors began seeing patients with this numbness, they found this case report helpful as a starting point in treating their patients.

Real-life Examples

Hymes KB. Cheung T. Greene JB. Prose NS. Marcus A. Ballard H. William DC. Laubenstein LJ. (1981). Kaposi's sarcoma in homosexual men-a report of eight cases. Lancet. 2 (8247),598-600.

This case report was published by eight physicians in New York city who had unexpectedly seen eight male patients with Kaposi's sarcoma (KS). Prior to this, KS was very rare in the U.S. and occurred primarily in the lower extremities of older patients. These cases were decades younger, had generalized KS, and a much lower rate of survival. This was before the discovery of HIV or the use of the term AIDS and this case report was one of the first published items about AIDS patients.

Wu, E. B., & Sung, J. J. Y. (2003). Haemorrhagic-fever-like changes and normal chest radiograph in a doctor with SARS. Lancet, 361 (9368), 1520-1521.

This case report is written by the patient, a physician who contracted SARS, and his colleague who treated him, during the 2003 outbreak of SARS in Hong Kong. They describe how the disease progressed in Dr. Wu and based on Dr. Wu's case, advised that a chest CT showed hidden pneumonic changes and facilitate a rapid diagnosis.

Related Terms

Case Series

A report about a small group of similar cases.

Preplanned Case-Observation

A case in which symptoms are elicited to study disease mechanisms. (Ex. Having a patient sleep in a lab to do brain imaging for a sleep disorder).

Now test yourself!

1. Case studies are not considered evidence-based even though the authors have studied the case in great depth.

2. When are Case reports most useful?

When you encounter common cases and need more information When new symptoms or outcomes are unidentified When developing practice guidelines When the population being studied is very large

Evidence Pyramid - Navigation

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Basics of case report form designing in clinical research

Affiliations.

• 1 Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, India.
• 2 Clinical Research, USV Limited, Mumbai, India.
• PMID: 25276625
• PMCID: PMC4170533
• DOI: 10.4103/2229-3485.140555

Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

Keywords: Case report form; case report form design; completion guidelines; electronic case report form; standard templates.

Writing a Case Report

This page is intended for medical students, residents or others who do not have much experience with case reports, but are planning on writing one.  

What is a case report?  A medical case report, also known as a case study, is a detailed description of a clinical encounter with a patient.  The most important aspect of a case report, i.e. the reason you would go to the trouble of writing one, is that the case is sufficiently unique, rare or interesting such that other medical professionals will learn something from it.   

Case reports are commonly of the following categories :

- Rare diseases

- Unusual presentation of disease

- Unexpected events

- Unusual combination of diseases or conditions

- Difficult or inconclusive diagnosis

- Treatment or management challenges

- Personal impact

- Observations that shed new light on a disease or condition

- Anatomical variations

It is important that you recognize what is unique or interesting about your case, and this must be described clearly in the case report.

Case reports generally take the format of :

1. Background

2. Case presentation

3. Observations and investigation

4. Diagnosis

5. Treatment

7. Discussion

Does a case report require IRB approval?

Case reports typically discuss a single patient. If this is true for your case report, then it most likely does not require IRB approval because it not considered research.    If you have more than one patient, your study could qualify as a Case Series, which would require IRB review.  If you have questions, you chould check your local IRB's guidelines on reviewing case reports.

Are there other rules for writing a case report?

First, you will be collecting protected health information, thus HIPAA applies to case reports.   Spectrum Health has created a very helpful guidance document for case reports, which you can see here:   Case Report Guidance - Spectrum Health

While this guidance document was created by Spectrum Health, the rules and regulations outlined could apply to any case report.  This includes answering questions like: Do I need written HIPAA authorization to publish a case report?  When do I need IRB review of a case report?  What qualifies as a patient identifier?

How do I get started?

1. We STRONGLY encourage you to consult the CARE Guidelines, which provide guidance on writing case reports -  https://www.care-statement.org/

Specifically, the checklist -  https://www.care-statement.org/checklist  - which explains exactly the information you should collect and include in your case report.  

2. Identify a case.  If you are a medical student, you may not yet have the clinical expertise to determine if a specific case is worth writing up.  If so, you must seek the help of a clinician.  It is common for students to ask attendings or residents if they have any interesting cases that can be used for a case report. 

3. Select a journal or two to which you think you will submit the case report.   Journals often have specific requirements for publishing case reports, which could include a requirement for informed consent, a letter or statement from the IRB and other things.  Journals may also charge publication fees (see Is it free to publish? below)   

4. Obtain informed consent from the patient (see " Do I have to obtain informed consent from the patient? " below).  Journals may have their own informed consent form that they would like you to use, so please look for this when selecting a journal.

Once you've identified the case, selected an appropriate journal(s), and considered informed consent, you can collect the required information to write the case report.

How do I write a case report?

Once you identify a case and have learned what information to include in the case report, try to find a previously published case report.  Finding published case reports in a similar field will provide examples to guide you through the process of writing a case report.    

One journal you can consult is BMJ Case Reports .  MSU has an institutional fellowship with BMJ Case Reports which allows MSU faculty, staff and students to publish in this journal for free.  See this page for a link to the journal and more information on publishing-    https://lib.msu.edu/medicalwriting_publishing/

There are numerous other journals where you can find published case reports to help guide you in your writing. 

Do I have to obtain informed consent from the patient?

The CARE guidelines recommend obtaining informed consent from patients for all case reports.  Our recommendation is to obtain informed consent from the patient.  Although not technically required, especially if the case report does not include any identifying information, some journals require informed consent for all case reports before publishing.  The CARE guidelines recommend obtaining informed consent AND the patient's perspective on the treatment/outcome (if possible).  Please consider this as well.  

If required, it is recommended you obtain informed consent before the case report is written.

An example of a case report consent form can be found on the BMJ Case Reports website, which you can access via the MSU library page -  https://casereports.bmj.com/ .  Go to "Instructions for Authors" and then "Patient Consent" to find the consent form they use.  You can create a similar form to obtain consent from your patient.  If you have identified a journal already, please consult their requirements and determine if they have a specific consent form they would like you to use.

Seek feedback

Once you have written a draft of the case report, you should seek feedback on your writing, from experts in the field if possible, or from those who have written case reports before.   

Selecting a journal

Aside from BMJ Case Reports mentioned above, there are many, many journals out there who publish medical case reports.   Ask your mentor if they have a journal they would like to use.  If you need to select on your own, here are some strategies:

1. Do a PubMed search.  https://pubmed.ncbi.nlm.nih.gov/

   a. Do a search for a topic, disease or other feature of your case report 

   b. When the results appear, on the left side of the page is a limiter for "article type".  Case reports are an article type to which you can limit your search results.  If you don't see that option on the left, click "additional filters". 

   c. Review the case reports that come up and see what journals they are published in.

2. Use JANE -  https://jane.biosemantics.org/

3. Check with specialty societies.  Many specialty societies are affiliated with one or more journal, which can be reviewed for ones that match your needs

4. Search through individual publisher journal lists.  Elsevier publishes many different medical research journals, and they have a journal finder, much like JANE  ( https://journalfinder.elsevier.com/ ).  This is exclusive to Elsevier journals.  There are many other publishers of medical journals for review, including Springer, Dove Press, BMJ, BMC, Wiley, Sage, Nature and many others.

Is it free to publish ?

Be aware that it may not be free to publish your case report.  Many journals charge publication fees. Of note, many open access journals charge author fees of thousands of dollars.  Other journals have smaller page charges (i.e. $60 per page), and still others will publish for free, with an "open access option".  It is best practice to check the journal's Info for Authors section or Author Center to determine what the cost is to publish.  MSU-CHM does NOT have funds to support publication costs, so this is an important step if you do not want to pay out of pocket for publishing

*A more thorough discussion on finding a journal, publication costs, predatory journals and other publication-related issues can be found here:   https://research.chm.msu.edu/students-residents/finding-a-journal

Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D. 2013. The CARE guidelines: Consensus-based clinical case reporting guideline development.  Glob Adv Health Med . 2:38-43. doi:  10.7453/gahmj.2013.008

Riley DS, Barber MS, Kienle GS, AronsonJK, von Schoen-Angerer T, Tugwell P, Kiene H, Helfand M, Altman DG, Sox H, Werthmann PG, Moher D, Rison RA, Shamseer L, Koch CA, Sun GH, Hanaway P, Sudak NL, Kaszkin-Bettag M, Carpenter JE, Gagnier JJ. 2017.  CARE guidelines for case reports: explanation and elaboration document . J Clin Epidemiol . 89:218-234. doi: 10.1016/j.jclinepi.2017.04.026 

Guidelines to writing a clinical case report. 2017. Heart Views . 18:104-105. doi:  10.4103/1995-705X.217857

Ortega-Loubon C, Culquichicon C, Correa R. The importance of writing and publishing case reports during medical education. 2017. Cureus. 9:e1964. doi:  10.7759/cureus.1964

Writing and publishing a useful and interesting case report. 2019. BMJ Case Reports.  https://casereports.bmj.com/pages/wp-content/uploads/sites/69/2019/04/How-to-write-a-Case-Report-DIGITAL.pdf

Camm CF. Writing an excellent case report: EHJ Case Reports , Case of the Year 2019. 2020. European Heart Jounrnal. 41:1230-1231.  https://doi.org/10.1093/eurheartj/ehaa176  

*content developed by Mark Trottier, PhD

• Case Report Form: Types Uses & Template Examples

Case report forms are one of the most important data instruments used for clinical researches and medical examinations. When conducting clinical trials, the researcher needs to record even the smallest of observations as they happen. A case report form is designed for this purpose.

In a case report form, you can track the unique changes of each research subject as the clinical trial progresses. This article will discuss different case report forms and show you how to create this form from scratch using Formplus. 

What is a Case Report Form? 

A case report form is an essential tool for clinical research, although it has been extended for use in other areas of medicine. Primarily, it is a record of all symptoms, signs, diagnosis, treatment, follow-up, observations, changes, and other important information from each research subject during clinical trials. The data gathered via case report forms (CRFs) are analyzed to arrive at the research results and draw valid conclusions. 

It is one of the most effective ways to systematically collect and store all the information from research for use. For example, during clinical trials to test the efficacy of a drug, you need to collect data at every stage of the process to answer all your research questions. 

In a broader sense, a case study is a questionnaire used for collecting data from patients in the course of any medical procedure, including diagnoses and treatments. It provides valid information that makes up the patient’s medical history which can be used for medical research.

Importance of a Case Report Form  

• It provides valid information for hypothesis-testing during clinical research. 
• A case report form captures standardized clinical data at every stage of the research process. This data is analyzed to arrive at research outcomes.
• Case report forms play an essential part in medical research breakthroughs. By storing unique data from each research subject, case report forms create a large pool of verifiable medical research information. 
• It improves problem-based medical education. 
• Data from case report forms make up a large chunk of peer-reviewed journals in medical research. 
• Medical researchers leverage existing data from different case report forms to advance systematic investigations in specific fields and sub-fields.
• Data from case report forms have helped us develop treatments and vaccines for different diseases, viruses, and infections. 

Types of Case Report Form  

Paper case report form.

A paper case report form is the traditional method of collecting data during clinical trials. It is the use of paper questionnaires and paper-based systems to gather detailed information from research subjects as per the study protocol. This data is extracted, organized and analyzed to arrive at valid research outcomes. 

Advantages of Paper Case Report Forms

• It is relatively easier to create and implement paper case report forms. 
• It allows you to collect research data in remote areas without electricity supply and internet access. 

Disadvantages of Paper Case Report Forms

• Data loss due to theft and exposure to natural elements like fire outbreaks and floods. 
• It is difficult to organize and analyze large volumes of data. 
• When dealing with large volumes of information, it can be challenging to sort the data sets. 
• It is time-consuming and prone to errors. 

Electronic Case Report Form

An electronic case report form is an online questionnaire used for data collection in medical studies and clinical trials. This method of data collection in medical research was introduced in the late 1990s following the shortcomings of paper forms. Electronic case report forms support more accurate data collection and faster data processing. 

Advantages of Electronic Case Report Forms

• It allows for faster data collection; especially when you are dealing with large volumes of data. 
• It reduces data losses, errors and costs. 
• ECRFs allow you to share data remotely among different stakeholders in the research process. 
• It facilitates rapid data capture and data management. 
• Easy and transparent access to research data at all times. 

Disadvantage of Electronic Case Report Forms

• High costs depending on the complexity of the electronic case report form.

Case Report Form Template Examples  

• Case Report Form

Use this case report form from Formplus to collect specific data from patients as part of the standard medical research procedure. With this survey, you can gather all the important information you need from the patients at once, and then go ahead with a proper diagnosis.

•   Health Care Proxy Form

The Formplus health care proxy form serves as a legal document for individuals who want to empower others to make decisions for them when they are sick or unavailable. With this form, individuals can formally select their health care providers to act on their behalf when the need arises. You can also edit this proxy form to suit unique needs in the form builder.

• Medical Information Form

With the Formplus medical information form, patients can easily keep track of their health status by having all the information they need in one place. This form collects relevant information about the individual’s medical history, bio-data and doctor’s contact information in case of emergency. 

• Clinical Report Form

Are you conducting any type of clinical research? This form will help you to seamlessly gather and analyze all the data you need for your systematic investigation. While this is a template, you can always edit it to suit your needs using the different features in our drag-and-drop form builder.

•    Physical Examination Report Form

As you conduct physical examination of your patient, you can put all the information you gather in a Formplus physical examination form. This form allows you to collect data like the gender, weight, blood pressure and height of the patient. Our physical examination form makes it easy to document the patient’s health history. 

• Self Report Form

To make it easier for patients to check for symptoms and monitor their health, you can edit this self-report form and embed it on your hospital’s website for easy access. With this form, health officials and medical practitioners can keep track of and monitor the health status of their patients and employees if the need arises.

Why Use Formplus to Create a Case Report Form? 

A case report form can be administered as a paper form or an online form; that is, ECRF. Data collection platforms like Formplus allow you to create secure online CRFs with data validation and data export features. You can also generate reports from the data in the form analytics dashboard.

• Collect Data Anywhere : Formplus allows you to collect research data in locations with poor or no internet connection using offline forms. The information filled into the case report form is automatically updated on our servers or your preferred cloud storage system once internet access is restored. 
• Collect Data on Mobile Devices: You don’t need to have a laptop to record responses on your Formplus form. All Formplus forms are mobile-friendly and allow you to fill in responses from your smartphone. This allows you to record data on the go as you conduct clinical trials. 
• Analyze Data Easily : In the form analytics dashboard, you can access important insights about your data and data collection process. You can automatically generate custom visual reports for your form data using the reports summary tool available in Formplus. With just a few clicks, this tool instantly displays selected form fields and form data as custom graphs and charts.
• Add Multiple Form Fields : With more than 30 form fields, you can collect different types of information in your electronic case report form, seamlessly. You can add long text fields for open-ended questions and different types of scales and radio fields for closed-ended questions. 
• Export Data : Formplus allows you to export research data to other file formats including CSV, PDF and Google sheets. This makes it easier for you to collaborate with others and share data from your online case report form easily. 
• Teams and Collaboration: With teams and collaboration, you can easily keep all the members of your research team in sync as you work on forms, data, and responses. Formplus allows you to add important collaborators to your shared account so that everyone can have access to the clinical trials reports in real-time. 

How to Create Electronic Case Report Forms With Formplus

1. Create a free Formplus account on www.formpl.us . Then log into your new account to view your dashboard. 

2. Click on the “create new form” button to access the Formplus dashboard. 

3. In the Formplus dashboard, you can add multiple fields to the online case report form. Drag and drop the fields you want from the builder’s fields section into your form. 

4. Edit the form fields to include your question, options and other information. Here, you can also set the fields as required or read-only. 

5. Save all the changes you’ve made to access the form customization section. Use the different features and options to tweak the look and feel of your case report form. 

6. Copy the form link and share with respondents. 

Conclusion  

In this article, we have looked at different types and use-cases for case report forms. As a researcher, it is best to use electronic CRFs that reduce your risk of data losses and help you record information faster. 

When you sign up for a Formplus account, you can access different case report form templates to help your research. From medical information surveys to health care proxy forms, you are sure to find a template that suits your research purpose. In the form builder, you can edit these templates to align them with your research goals. 

Connect to Formplus, Get Started Now - It's Free!

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How to Prepare Case Report Forms

Planning how and what data to collect in an investigator initiated trial (IIT) is one of the most challenging tasks for researchers. On the one hand, there needs to be sufficient data collected to support and test the study’s hypotheses. On the other hand, the over-collection of data results in wasted resources. The case report form (CRF), which is used to collect patient data for analysis, therefore needs to be carefully designed with great attention to details.  This article will highlight some useful tips for you to keep in mind when designing your CRF.

Paper or Electronic Formats

There are two types of CRFs, the traditional paper form and the newer electronic format (eCRF). For small clinical studies and IITs, the paper CRF may be a suitable option because it can be easily implemented. It does not require upfront investment costs for the technology and training that is required for an eCRF. The drawback of paper CRFs, however, is that it is tedious to design and execute, as well as highly prone to errors in data entry and data transfer.  The use of eCRFs overcomes a lot of disadvantages just mentioned and is the preferred method globally for CRFs of large clinical trials. They are much less time-consuming and more friendly to use for the clinical investigators. Additionally, the use of eCRFs makes it easy to collect and harmonize data from multicentre studies. Moreover, the use of eCRFs also facilitates the approval process by regulatory bodies. The downside, of course, is there are costs associated with implementing an eCRF system. So, the choice between paper or electronic formats entirely depends on your preference and budget.

Design Tips

            A well-drafted CRF will ensure the integrity and quality of the data collected. In contrast, a poorly designed CRF form could prove costly for the study as it will lead to incomplete and inaccurate data collection—and in some cases not collecting essential data at all. We’ve summarized some of the essential tips to help you improve your CRF design:

• Avoid duplication of data and unwanted details
• Prevent page clutter by adding white spaces wherever possible
• Remove any potential ambiguity in language or data entry
• Provide clear instructions, questions, and prompts
• Use bold and italics to highlight instructions
• Provide adequate instructions as to when to skip questions or sections
• Ensure that the document is formatted the same throughout with proper font style and size
• Use visual cues such as box outlines to direct the place and format of data to be entered
• Use checkboxes instead of circling answers to avoid confusion
• Reduce the amount of free text response as these are hard to interpret
• For numeric entries, signify the number of decimal places and the units
• Ensure that date formatting and page numbers are consistent throughout the document
• Wherever possible, use pre-determined answers (yes/no, mild/moderate/severe)
• Avoid calculations on the CRF
• Ensure that the subject ID and CRF version appears on every page for keeping track of missing data

The example below on the left shows a poorly designed CRF. Notice how it does not include a version number in the footer or instructions on how to complete it. Furthermore, instead of using checkboxes with pre-determined answers, it uses free-text boxes that are hard to interpret and prone to errors. There are also no instructions on how to fill out the visit date or date of birth, so the date formats could vary between investigators. The example on the right shows a significantly better version of the CRF form.

There is often a lot of overlap in data requirements across clinical studies, so it’s a good idea to develop a standard CRF that can be customized as needed. Using the same standard structure will also reduce the amount of training required to fill out future CRFs. Some examples of CRF templates that can be reused across studies include demographics, medical history, physical examination, and adverse tracking list. Below you will find links to CRF templates that can help you get started:

• National Center for Complementary Integrative Health CRF templates ( https://www.nccih.nih.gov/grants/toolbox )
• University of Wisconsin-Madison CRF templates ( https://ictr.wisc.edu/clinical-research-toolkit-2/case-report-form-templates/ )

In addition to a CRF, you will also need to draft a CRF completion guideline. This document will provide step by step instructions to help investigators complete the CRF. The language should be clear and concise and easy to follow.

The objective of designing CRFs is to ensure accurate and complete data collection and ease-of-use for the investigators. Keep in mind that design is a process, and over time, after multiple iterations, your CRF will gradually improve and become more robust. As always, we recommend you ask your investigators for feedback on the CRF’s design and how to improve it. For more help on CRFs, IITs, and other clinical study-related topics, please contact Sengi.

• 1. Bellary S, Krishnankutty B, Latha MS. Basics of Case Report Form Designing in Clinical Research. Perspect Clin Res 2014;5:159-66.

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Clinical research tools: what is a crf (case report form), what is a crf in clinical trials.

In medical terms, CRF stands for case report form. A CRF is a document that is used to compile all protocol-related information for each participant in a clinical trial. This data can include everything from participants’ personal information to study visit results to treatment outcomes and side effects experienced. CRFs are integral for standardizing data collection and for sharing data across sites and between investigators and sponsors.

What is the purpose of a CRF in clinical research?

The primary purpose of the CRF is standardized data collection and recording, to ensure that complete information is collected for all participants in the same format. A CRF allows the investigators and sponsors to hold all important details about the participants in a clinical trial in one place, which is important for regulatory affairs as well as drawing conclusions from trial data.

The clinical trial sponsor/investigator is responsible for creating a study-specific CRF template that appropriately captures all data involved in or required by the study protocol. They will prepare CRF completion guidelines, and ensure that the staff at each study site is properly trained with respect to filling in this data. The sponsor/investigator is also responsible for managing, reviewing, and validating CRFs. Designing a good CRF is a complex and nuanced task, and has been called an art ; it requires significant planning, attention to detail, and consideration of the study protocol and various stakeholders.

What does a case report form consist of?

One CRF is created for each participant, and will contain all information that is collected and intended to be analyzed, as per the unique study protocol. Information that will not be analyzed should be excluded from the CRF. The CRF should be designed in such a way that data is entered consistently and completely for all participants; it will thus be fairly detailed in terms of how data should be entered. Although different studies will require different data fields in CRFs, parts of well-designed CRFs can often be used by sponsors across various trials. CRFs can vary in length, depending on the complexity and length of the trial.

A CRF form includes three major parts : a header, a safety module, and an efficacy module. The header specifies important identification details such as site, participant ID, and study numbers. The safety module covers principal safety analysis criteria outlined in the protocol, including fatalities, drop-outs, demographic data, medical histories, eligibility validation, adverse events, and physical examination records. The efficacy module concerns endpoints and additional tests that are used to assess treatment efficacy in the study protocol.

Before the site personnel transfers CRF data to the sponsor for reporting and analysis, it is often de-identified to keep the patient's identity anonymous. Each patient is assigned a study number, and certain personal information, attributes, or even the treatment group may be anonymized in order to avoid potential bias in the interpretation of results.

New developments in CRFs

There are challenges associated with manual data entry and standardization that commonly lead to issues with data integrity, completeness, and organization in paper-format CRFs if not properly controlled. In most clinical trials, a monitor is tasked with CRF data validation to check for errors and ensure accuracy and consistency of the data. This is a time-consuming task.

eCRF: Electronic case report forms

As technology and digitalization continue to revolutionize clinical research processes, many clinical researchers have switched from paper CRFs to electronic CRFs, or eCRFs. An eCRF contains the same data as a traditional CRF, but is filled out and stored electronically. This can help address manual data entry errors and streamline the data validation process. However, there is an ongoing debate over whether paper CRFs or eCRFs are better. Let's look at the main advantages and disadvantages of eCRFs relative to paper-format CRFs:

• Faster: Filling out an eCRF may be quicker and easier, especially as some aspects can be automated in specialized eCRF software solutions
• Reduced error: eCRFs can be created in such a way so as to minimize the possibility of data entry errors (field validation)
• Built-in validity checks: Built-in validation features in some eCRF solutions allows for rapid identification of missing data, inconsistencies, or unexpected values, which can facilitate data validation tasks and improve data quality

Disadvantages

Complexity of setup and installation: It will likely be necessary to utilize third-party software or design a program and/or workflow to manage the eCRFs. This will require an adjustment away from traditional methods and a learning curve for staff using the system. The system will need to be installed at all trial sites involved in a study as well as centrally for real-time data capabilities and organization.

Initial investment costs: In relation to the above point, there may be a one-off cost or monthly payment for the eCRF management software. Nonetheless, the costs are likely to be offset by the improved efficiency and data consistency.

Artificial intelligence and machine learning in CRFs

Artificial intelligence and machine learning are being leveraged to transform how CRFs are filled out in clinical trials. These technologies can be involved in automation techniques to enable batch data entry of critical patient information into eCRFs quickly and automatically.

Tips for designing error-proof CRFs

As mentioned, the CRF needs to be designed carefully in order to capture all essential data for the study and maximize data consistency and validity. Here are a few expert tips for designing high-quality case report forms:

• Be explicit: Provide instructions that are as detailed as possible to ensure data consistency
• Mark instructions clearly: Leverage italicized, bold, or otherwise stand-out format
• Work from the study protocol: Follow a hypothetical patient through the entire study process to ensure that all data expected from the protocol is provided for in the form
• Provide explicitly clear instructions regarding ‘skip patterns’ that are easily visible and logical to follow
• Include clearly defined and separate lines, fields, or boxes for each expected answer/entry.
• Reduce free text fields - include as much guidance as possible for data input. E.g.: Avoid: Date of birth: __________ Better: Date of birth: dd/mm/yyyy
• For paper CFRs, utilize multi-sheet NCR forms to ensure identical copies of the CRF
• Use consistent formatting (font, style, size) throughout the case report form - i.e., one style for instructions, another style for titles/headings, and another yet for example data
• In eCRF tools or electronic databases, activate built-in validity checks and flags for improperly entered/missing data

Conclusions

High-quality CRFs are key to successful clinical trial patient data management. Careful planning and design of the CRF template is important for optimizing data consistency, validity, and accuracy, which in turn facilitates data sharing and regulatory affairs, optimizes data organization, and streamlines analysis of study data and results. eCRFs are increasingly adopted in clinical trials as they can help reduce errors and minimize manual work while maximizing data consistency and its associated benefits.

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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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A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting. It is the main tool that Investigators use to collect information from clinical trial participants which is why there needs to be one completed CRF for each participant. 

The Sponsor-Investigator puts together the CRF Completion Guidelines and ensures that the site staff have received training before collecting, entering and reviewing data. 

All users are given a unique username and password to gain access to the CRF and the trial database. The Principal Investigator assigns permissions to each user which includes ‘data entry’ or ‘data view only’. Permission to access the data must be in accordance with the consent given by participants. 

The CRF should be completed soon after each participant's initial visit which ensures that information can be followed up on while the participant is easily accessible. 

All the data should be collected with users in mind and the requirements set out by regulatory agencies. The questions should be as clear and concise as possible to prevent any duplication. 

Relationship to Protocol 

The clinical trial protocol determines what kind of data should be collected - all the information found in the CRF should be specified by the protocol. Any data that will not be analyzed shouldn’t be included in the CRF. 

Elements of a CRF 

A Case Report Form consists of three main parts: a header, a safety-related module and an efficacy-related module. 

Header 

The header must contain key identification information including a study number, a site number and a participant ID number. 

Safety Modules 

Consists of the key safety analysis requirements found in the protocol which includes demographic information, adverse events, medical history, physical exam, deaths, drop-outs and eligibility confirmation. 

Efficacy Modules 

The protocol outlines the elements which are required in the efficacy modules. The elements of this module include the key efficacy endpoints of trial, additional tests to measure efficacy, how lesions will be measured and requited diagnostics. 

CRF Development Process 

The development of the CRF begins as soon as the development process begins. The responsibility of the design varies between Clinical Research Organizations, Clinical Research Associates, Data Managers, Research Nurses and Database Development. 

The only data collected for the CRF should be what is required by the protocol- nothing more, nothing less. An interdisciplinary review is needed for every CRF: 

• Each company has its own process for review. 
• Should include the relevant staff members involved in the conduct, analysis and reporting of the clinical trial. 

Properly and Poorly Designed CRFs 

An effective CRF allows for components to be reused across the clinical trial, saving time and money. 

A poorly designed CRF is one that is missing requested data or has unnecessary information meaning that it requires edits and modifications throughout the clinical trial. 

CRF Completion 

For a CRF to be completed, it needs to have: 

• Completed sections including headers with identifying items.
• Relevant modifications. 
• A record of adverse events and specific documentation for any serious adverse events. 

The data needs to be collected from the relevant source documentation (medical records) and entered into the CRFs by study personnel. Only designated members of the clinical trial staff are allowed to record or edit data in the CRFs. 

Important Tips for Completion 

• The CRF Completion Guidelines should be followed to ensure that each CRF is accurate and completed in a timely manner. 
• Make sure the appropriate protocol, Investigator, and participant identifying information is included in the header. 
• Ensure the data is entered in the correct data field (provide boxes or lines to make it clear where the answers should be entered). 
• Use the appropriate units of measurement. 
• Be consistent. 
• Double-check spelling and grammar. 
• Watch for transcription errors. 
• Use the comment section to expand on any answer (be as concise as possible). 
• Use consistent formats, font style and font sizes. 
• Visual cues (boxes) which indicate the place and the format of data to be recorded. 
• Use check boxes. 
• Separate columns with thick lines. 
• Use precoded answer sets (male/female, yes/no and mild/moderate/severe, etc) wherever possible. 

Electronic CRF (eCRF) 

• Ensures data integrity. 
• Provides an audit trail for data changes. 
• Ensures data preservation (automatic back-ups). 
• Essential identification information (protocol ID, site code and participant ID) will be generated from the first page to all other pages ensuring no duplication. 
• Linking data between 2 or more pages is easy. 
• There’s always the threat of losing valuable data due to software malfunction or if the eCRFs aren’t backed up successfully. 

Confidentiality and Security 

To protect confidential participant and clinical trial data, eCRFs must be stored on secure servers with restricted access, while paper CRFs must be stored in a secure location. Regular backups and archiving for future copies must be utilized. 

Freezing the Database 

Once the data has been finalized, it is necessary to lock the database which protects the integrity of the collected data and prevents any unauthorized edits from being made. 

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Perspectives from Researchers on Case Study Design

by Janet Salmons, PhD, Research Community Manager for SAGE Methodspace

Research design is the focus for the first quarter of 2023. Find a post about case study design , and read the unfolding series of posts here .

What is a “case study” research design?

Linda Bloomberg describes a case study as:

An in-depth exploration from multiple perspectives of the richness and complexity of a particular social unit, system, or phenomenon. Its primary purpose is to generate understanding and insights in order to gain knowledge and inform professional practice, policy development, and community or social action. Case study research is typically extensive; it draws on multiple methods of data collection and involves multiple data sources.

The researcher begins by identifying a specific case or set of cases to be studied. Each case is an entity that is described within certain parameters, such as a specific time frame, place, event, and process. Hence, the case becomes a  bounded system . Typically, case study researchers analyze the real-life cases that are currently in progress so that they can gather accurate information that is not lost by time.

This method culminates in the production of a detailed description of a setting and its participants, accompanied by an analysis of the data for themes, patterns, and issues. A case study is therefore both a process of inquiry about the case at hand and the product of that inquiry. (Bloomberg, 2018, p. 276)

Case studies use more than one form of data either within a research paradigm (multimodal ), or more than one form of data from different paradigms (mixed methods). As Bloomberg notes, the case study method is employed across disciplines, including education, health care, social work, history, sociology, management studies, and organizational studies. When you look at lists of most-read and most-cited articles you will find that this flexible approach is widely used and published. Here are some open-access articles about multimodal qualitative or mixed methods designs that include both qualitative and quantitative elements.

Qualitative Research with Case Studies

Brannen, J., & Nilsen, A. (2011). Comparative Biographies in Case-based Cross-national Research: Methodological Considerations. Sociology, 45(4), 603–618. https://doi.org/10.1177/0038038511406602

Abstract. This article examines some methodological issues relating to an embedded case study design adopted in a comparative cross-national study of working parents covering three levels of social context: the macro level; the workplace level; and the individual level. It addresses issues of generalizability, in particular the importance of criteria for the selection of cases in the research design and analysis phases. To illustrate the benefits of the design the article focuses on the level of individual biographies. Three exemplars of biographical trajectories and experiences are presented and discussed. It is argued that a multi-tiered design and a comparative biographical approach can add to the understanding of individual experience by placing it in context and thus yield knowledge that is of general sociological relevance by demonstrating the interrelatedness of agency and structure.

Ebneyamini, S., & Sadeghi Moghadam, M. R. (2018). Toward Developing a Framework for Conducting Case Study Research. International Journal of Qualitative Methods, 17(1). https://doi.org/10.1177/1609406918817954

Abstract. This article reviews the use of case study research for both practical and theoretical issues especially in management field with the emphasis on management of technology and innovation. Many researchers commented on the methodological issues of the case study research from their point of view thus, presenting a comprehensive framework was missing. We try representing a general framework with methodological and analytical perspective to design, develop, and conduct case study research. To test the coverage of our framework, we have analyzed articles in three major journals related to the management of technology and innovation to approve our framework. This study represents a general structure to guide, design, and fulfill a case study research with levels and steps necessary for researchers to use in their research.

Flyvbjerg, B. (2006). Five Misunderstandings About Case-Study Research. Qualitative Inquiry, 12(2), 219–245. https://doi.org/10.1177/1077800405284363

Abstract. This article examines five common misunderstandings about case-study research: (a) theoretical knowledge is more valuable than practical knowledge; (b) one cannot generalize from a single case, therefore, the single-case study cannot contribute to scientific development; (c) the case study is most useful for generating hypotheses, whereas other methods are more suitable for hypotheses testing and theory building; (d) the case study contains a bias toward verification; and (e) it is often difficult to summarize specific case studies. This article explains and corrects these misunderstandings one by one and concludes with the Kuhnian insight that a scientific discipline without a large number of thoroughly executed case studies is a discipline without systematic production of exemplars, and a discipline without exemplars is an ineffective one. Social science may be strengthened by the execution of a greater number of good case studies.

Morgan SJ, Pullon SRH, Macdonald LM, McKinlay EM, Gray BV. Case Study Observational Research: A Framework for Conducting Case Study Research Where Observation Data Are the Focus. Qualitative Health Research. 2017;27(7):1060-1068. doi:10.1177/1049732316649160

Abstract. Case study research is a comprehensive method that incorporates multiple sources of data to provide detailed accounts of complex research phenomena in real-life contexts. However, current models of case study research do not particularly distinguish the unique contribution observation data can make. Observation methods have the potential to reach beyond other methods that rely largely or solely on self-report. This article describes the distinctive characteristics of case study observational research, a modified form of Yin’s 2014 model of case study research the authors used in a study exploring interprofessional collaboration in primary care. In this approach, observation data are positioned as the central component of the research design. Case study observational research offers a promising approach for researchers in a wide range of health care settings seeking more complete understandings of complex topics, where contextual influences are of primary concern. Future research is needed to refine and evaluate the approach.

Rule, P., & John, V. M. (2015). A Necessary Dialogue: Theory in Case Study Research. International Journal of Qualitative Methods , 14 (4). https://doi.org/10.1177/1609406915611575

Abstract. This article is premised on the understanding that there are multiple dimensions of the case–theory relation and examines four of these: theory of the case, theory for the case, theory from the case, and a dialogical relation between theory and case. This fourth dimension is the article’s key contribution to theorizing case study. Dialogic engagement between theory and case study creates rich potential for mutual formation and generative tension. The article argues that the process of constructing and conducting the case is theory laden, while the outcomes of the study might also have theoretical implications. Case study research that is contextually sensitive and theoretically astute can contribute not only to the application and revision of existing theory but also to the development of new theory. The case thus provides a potentially generative nexus for the engagement of theory, context, and research.

Thomas, G. (2011). A Typology for the Case Study in Social Science Following a Review of Definition, Discourse, and Structure. Qualitative Inquiry, 17(6), 511–521. https://doi.org/10.1177/1077800411409884

Abstract. The author proposes a typology for the case study following a definition wherein various layers of classificatory principle are disaggregated. First, a clear distinction is drawn between two parts: (1) the subject of the study, which is the case itself, and (2) the object, which is the analytical frame or theory through which the subject is viewed and which the subject explicates. Beyond this distinction the case study is presented as classifiable by its purposes and the approaches adopted— principally with a distinction drawn between theory-centered and illustrative study. Beyond this, there are distinctions to be drawn among various operational structures that concern comparative versus noncomparative versions of the form and the ways that the study may employ time. The typology reveals that there are numerous valid permutations of these dimensions and many trajectories, therefore, open to the case inquirer.

VanWynsberghe, R., & Khan, S. (2007). Redefining Case Study. International Journal of Qualitative Methods , 6 (2), 80–94. https://doi.org/10.1177/160940690700600208

Abstract. In this paper the authors propose a more precise and encompassing definition of case study than is usually found. They support their definition by clarifying that case study is neither a method nor a methodology nor a research design as suggested by others. They use a case study prototype of their own design to propose common properties of case study and demonstrate how these properties support their definition. Next, they present several living myths about case study and refute them in relation to their definition. Finally, they discuss the interplay between the terms case study and unit of analysis to further delineate their definition of case study. The target audiences for this paper include case study researchers, research design and methods instructors, and graduate students interested in case study research.

Mixed Methods Research with Case Studies

Guetterman, T. C., & Fetters, M. D. (2018). Two Methodological Approaches to the Integration of Mixed Methods and Case Study Designs: A Systematic Review. American Behavioral Scientist, 62(7), 900–918. https://doi.org/10.1177/0002764218772641

Abstract. Case study has a tradition of collecting multiple forms of data—qualitative and quantitative—to gain a more complete understanding of the case. Case study integrates well with mixed methods, which seeks a more complete understanding through the integration of qualitative and quantitative research. We identify and characterize “mixed methods–case study designs” as mixed methods studies with a nested case study and “case study–mixed methods designs” as case studies with nested mixed methods. Based on a review of published research integrating mixed methods and case study designs, we describe key methodological features and discuss four exemplar interdisciplinary studies.

Luyt, R. (2012). A Framework for Mixing Methods in Quantitative Measurement Development, Validation, and Revision: A Case Study. Journal of Mixed Methods Research, 6(4), 294–316. https://doi.org/10.1177/1558689811427912

Abstract. A framework for quantitative measurement development, validation, and revision that incorporates both qualitative and quantitative methods is introduced. It extends and adapts Adcock and Collier’s work, and thus, facilitates understanding of quantitative measurement development, validation, and revision as an integrated and cyclical set of procedures best achieved through mixed methods research. It also offers a systematic guide concerning how these procedures may be undertaken through detailing key “stages,” “levels,” and practical “tasks.” A case study illustrates how qualitative and quantitative methods may be mixed through the use of the proposed framework in the cross-cultural content- and construct-related validation and subsequent revision of a quantitative measure. The contribution of this article to mixed methods research literature is briefly discussed.

Mason, W., Morris, K., Webb, C., Daniels, B., Featherstone, B., Bywaters, P., Mirza, N., Hooper, J., Brady, G., Bunting, L., & Scourfield, J. (2020). Toward Full Integration of Quantitative and Qualitative Methods in Case Study Research: Insights From Investigating Child Welfare Inequalities. Journal of Mixed Methods Research, 14(2), 164–183. https://doi.org/10.1177/1558689819857972

Abstract. Delineation of the full integration of quantitative and qualitative methods throughout all stages of multisite mixed methods case study projects remains a gap in the methodological literature. This article offers advances to the field of mixed methods by detailing the application and integration of mixed methods throughout all stages of one such project; a study of child welfare inequalities. By offering a critical discussion of site selection and the management of confirmatory, expansionary and discordant data, this article contributes to the limited body of mixed methods exemplars specific to this field. We propose that our mixed methods approach provided distinctive insights into a complex social problem, offering expanded understandings of the relationship between poverty, child abuse, and neglect.

Onghena, P., Maes, B., & Heyvaert, M. (2019). Mixed Methods Single Case Research: State of the Art and Future Directions. Journal of Mixed Methods Research, 13(4), 461–480. https://doi.org/10.1177/1558689818789530

Abstract. Mixed methods single case research (MMSCR) is research in which single case experimental and qualitative case study methodologies, and their accompanying sets of methods and techniques, are integrated to answer research questions that concern a single case. This article discusses the historical roots and the distinct nature of MMSCR, the kinds of knowledge MMSCR produces, its philosophical underpinnings, examples of MMSCR, and the trustworthiness and validity of MMSCR. Methodological challenges relate to the development of a critical appraisal tool for MMSCR, to the team work that is involved in designing and conducting MMSCR studies, and to the application of mixed methods research synthesis for multiple case studies and single case experiments.

Sharp, J. L., Mobley, C., Hammond, C., Withington, C., Drew, S., Stringfield, S., & Stipanovic, N. (2012). A Mixed Methods Sampling Methodology for a Multisite Case Study. Journal of Mixed Methods Research, 6(1), 34–54. https://doi.org/10.1177/1558689811417133

Abstract. The flexibility of mixed methods research strategies makes such approaches especially suitable for multisite case studies. Yet the utilization of mixed methods to select sites for these studies is rarely reported. The authors describe their pragmatic mixed methods approach to select a sample for their multisite mixed methods case study of a statewide education policy initiative in the United States. The authors designed a four-stage sequential mixed methods site selection strategy to select eight sites in order to capture the broader context of the research, as well as any contextual nuances that shape policy implementation. The authors anticipate that their experience would provide guidance to other mixed methods researchers seeking to maximize the rigor of their multisite case study sampling designs.

Bloomberg, L. (2018). Case study. In B. B. Frey (Ed.), The SAGE encyclopedia of educational research, measurement, and evaluation . https://doi.org/10.4135/9781506326139

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We need to think about research before we design and conduct it.

Julianne Cheek and Elise Øby, co-authors of the book Research Design: Why Thinking About Design Matters, discuss the first three chapters in these video interviews: Chapter 1 – Research Design: What You Need to Think About and Why

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Learn about connecting the unit of analysis with the qualitative methodology.

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Looking back at 2023, find all posts here! We explored stages of a research project, from concept to publication. In each quarter we focused on one part of the process. In this recap for the year you will find original guest posts, interviews, curated collections of open-access resources, recordings from webinars or roundtable discussions, and instructional resources.

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Designing Survey Research

Designing research with case study methods.

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Study Suggests Genetics as a Cause, Not Just a Risk, for Some Alzheimer’s

People with two copies of the gene variant APOE4 are almost certain to get Alzheimer’s, say researchers, who proposed a framework under which such patients could be diagnosed years before symptoms.

By Pam Belluck

Scientists are proposing a new way of understanding the genetics of Alzheimer’s that would mean that up to a fifth of patients would be considered to have a genetically caused form of the disease.

Currently, the vast majority of Alzheimer’s cases do not have a clearly identified cause. The new designation, proposed in a study published Monday, could broaden the scope of efforts to develop treatments, including gene therapy, and affect the design of clinical trials.

It could also mean that hundreds of thousands of people in the United States alone could, if they chose, receive a diagnosis of Alzheimer’s before developing any symptoms of cognitive decline, although there currently are no treatments for people at that stage.

The new classification would make this type of Alzheimer’s one of the most common genetic disorders in the world, medical experts said.

“This reconceptualization that we’re proposing affects not a small minority of people,” said Dr. Juan Fortea, an author of the study and the director of the Sant Pau Memory Unit in Barcelona, Spain. “Sometimes we say that we don’t know the cause of Alzheimer’s disease,” but, he said, this would mean that about 15 to 20 percent of cases “can be tracked back to a cause, and the cause is in the genes.”

The idea involves a gene variant called APOE4. Scientists have long known that inheriting one copy of the variant increases the risk of developing Alzheimer’s, and that people with two copies, inherited from each parent, have vastly increased risk.

The new study , published in the journal Nature Medicine, analyzed data from over 500 people with two copies of APOE4, a significantly larger pool than in previous studies. The researchers found that almost all of those patients developed the biological pathology of Alzheimer’s, and the authors say that two copies of APOE4 should now be considered a cause of Alzheimer’s — not simply a risk factor.

The patients also developed Alzheimer’s pathology relatively young, the study found. By age 55, over 95 percent had biological markers associated with the disease. By 65, almost all had abnormal levels of a protein called amyloid that forms plaques in the brain, a hallmark of Alzheimer’s. And many started developing symptoms of cognitive decline at age 65, younger than most people without the APOE4 variant.

“The critical thing is that these individuals are often symptomatic 10 years earlier than other forms of Alzheimer’s disease,” said Dr. Reisa Sperling, a neurologist at Mass General Brigham in Boston and an author of the study.

She added, “By the time they are picked up and clinically diagnosed, because they’re often younger, they have more pathology.”

People with two copies, known as APOE4 homozygotes, make up 2 to 3 percent of the general population, but are an estimated 15 to 20 percent of people with Alzheimer’s dementia, experts said. People with one copy make up about 15 to 25 percent of the general population, and about 50 percent of Alzheimer’s dementia patients.

The most common variant is called APOE3, which seems to have a neutral effect on Alzheimer’s risk. About 75 percent of the general population has one copy of APOE3, and more than half of the general population has two copies.

Alzheimer’s experts not involved in the study said classifying the two-copy condition as genetically determined Alzheimer’s could have significant implications, including encouraging drug development beyond the field’s recent major focus on treatments that target and reduce amyloid.

Dr. Samuel Gandy, an Alzheimer’s researcher at Mount Sinai in New York, who was not involved in the study, said that patients with two copies of APOE4 faced much higher safety risks from anti-amyloid drugs.

When the Food and Drug Administration approved the anti-amyloid drug Leqembi last year, it required a black-box warning on the label saying that the medication can cause “serious and life-threatening events” such as swelling and bleeding in the brain, especially for people with two copies of APOE4. Some treatment centers decided not to offer Leqembi, an intravenous infusion, to such patients.

Dr. Gandy and other experts said that classifying these patients as having a distinct genetic form of Alzheimer’s would galvanize interest in developing drugs that are safe and effective for them and add urgency to current efforts to prevent cognitive decline in people who do not yet have symptoms.

“Rather than say we have nothing for you, let’s look for a trial,” Dr. Gandy said, adding that such patients should be included in trials at younger ages, given how early their pathology starts.

Besides trying to develop drugs, some researchers are exploring gene editing to transform APOE4 into a variant called APOE2, which appears to protect against Alzheimer’s. Another gene-therapy approach being studied involves injecting APOE2 into patients’ brains.

The new study had some limitations, including a lack of diversity that might make the findings less generalizable. Most patients in the study had European ancestry. While two copies of APOE4 also greatly increase Alzheimer’s risk in other ethnicities, the risk levels differ, said Dr. Michael Greicius, a neurologist at Stanford University School of Medicine who was not involved in the research.

“One important argument against their interpretation is that the risk of Alzheimer’s disease in APOE4 homozygotes varies substantially across different genetic ancestries,” said Dr. Greicius, who cowrote a study that found that white people with two copies of APOE4 had 13 times the risk of white people with two copies of APOE3, while Black people with two copies of APOE4 had 6.5 times the risk of Black people with two copies of APOE3.

“This has critical implications when counseling patients about their ancestry-informed genetic risk for Alzheimer’s disease,” he said, “and it also speaks to some yet-to-be-discovered genetics and biology that presumably drive this massive difference in risk.”

Under the current genetic understanding of Alzheimer’s, less than 2 percent of cases are considered genetically caused. Some of those patients inherited a mutation in one of three genes and can develop symptoms as early as their 30s or 40s. Others are people with Down syndrome, who have three copies of a chromosome containing a protein that often leads to what is called Down syndrome-associated Alzheimer’s disease .

Dr. Sperling said the genetic alterations in those cases are believed to fuel buildup of amyloid, while APOE4 is believed to interfere with clearing amyloid buildup.

Under the researchers’ proposal, having one copy of APOE4 would continue to be considered a risk factor, not enough to cause Alzheimer’s, Dr. Fortea said. It is unusual for diseases to follow that genetic pattern, called “semidominance,” with two copies of a variant causing the disease, but one copy only increasing risk, experts said.

The new recommendation will prompt questions about whether people should get tested to determine if they have the APOE4 variant.

Dr. Greicius said that until there were treatments for people with two copies of APOE4 or trials of therapies to prevent them from developing dementia, “My recommendation is if you don’t have symptoms, you should definitely not figure out your APOE status.”

He added, “It will only cause grief at this point.”

Finding ways to help these patients cannot come soon enough, Dr. Sperling said, adding, “These individuals are desperate, they’ve seen it in both of their parents often and really need therapies.”

Pam Belluck is a health and science reporter, covering a range of subjects, including reproductive health, long Covid, brain science, neurological disorders, mental health and genetics. More about Pam Belluck

The Fight Against Alzheimer’s Disease

Alzheimer’s is the most common form of dementia, but much remains unknown about this daunting disease..

How is Alzheimer’s diagnosed? What causes Alzheimer’s? We answered some common questions .

A study suggests that genetics can be a cause of Alzheimer’s , not just a risk, raising the prospect of diagnosis years before symptoms appear.

Determining whether someone has Alzheimer’s usually requires an extended diagnostic process . But new criteria could lead to a diagnosis on the basis of a simple blood test .

The F.D.A. has given full approval to the Alzheimer’s drug Leqembi. Here is what to know about i t.

Alzheimer’s can make communicating difficult. We asked experts for tips on how to talk to someone with the disease .

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Q: What is Faculty Activity Reporting?

A: Faculty Activity Reporting is an enterprise-wide electronic system used to track faculty activities related to teaching, research, scholarship, service, and other areas and to populate annual reviews. It is housed within the Faculty Information System (FIS). Beyond the annual review, the data in My Activities will eventually be used to populate web pages, faculty profiles, and customizable templates for grant proposals and other applications. Ultimately, the information on faculty activities will be used to showcase faculty accomplishments to the world, and to facilitate collaboration, networking, and outreach.

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A: The FIS includes details related to your faculty appointment, such as rank and tenure status, as well as information about your scholarly activity. The FIS does not include information that would be found in the university's PeopleSoft HCM system, such as Social Security number, benefits, and payroll-related information. Personal information in the FIS is limited and includes date of birth (used to prevent duplicate records), demographic data, degrees, and contact information.

As noted above, the FIS is accessible only through a secure single sign-on portal that requires your CWRU credentials and DUO two-factor authentication. If you are connecting to the FIS from off campus, you must first log in to the university’s VPN.

Access to the FIS is restricted to CWRU faculty and administrative staff who are involved in business processes involving faculty information. Faculty will have access only to their own data. Department chairs and division chiefs will have access to activity data for their departments or divisions, and deans will have access to data for their school or college.

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A: Some sections, like Administration, Appointments, Citizenship, Degrees, and External, are locked and cannot be edited by a faculty member since these are managed by the dean’s offices. To request a change to the information in these sections, please contact your school’s dean’s office or Faculty Affairs office.

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Q: There are some activity sections that don’t apply to me or my discipline.

A: Since the FIS is an enterprise-wide system, the activity sections are universal across all of the schools, so there are some sections that might not apply to your school or discipline. You do not need to add information to these sections unless you choose to do so.

Q: How do I know what activity sections are required for me to complete?

A: Your annual review will note which activities are required.

Q: Should I enter activities that fall outside the dates of my annual review?

A: You can add historical activities to the My Activities sections if you wish. Historical activities will become relevant after CV generation is developed in the FIS.

Annual Review FAQ

Q: Why are the activities I entered in the Activity sections not appearing in my annual review?

A: The start and end dates for any activity entered in the Activity section must fall within the content period of your annual review. For example, if your annual review is for the calendar year 2021, the activities you entered must fall between January 1, 2021 and December 31, 2021.

Q: What happens if I start my annual review but want to return to it later? How can I get back to my annual review?

A: When you save each section, the data is stored but not submitted. No one will see it but you. You will not be able to edit your FAR after clicking the purple “Release for Review” button. The annual review is tied to your Network ID. Simply return to www.fis.case.edu , and you can reopen your annual review.

Q: Does the annual review save automatically?

A: Yes, the annual review saves responses automatically in each section. Your responses will not be submitted until you click Submit for Final Release.

Q: Can I preview my annual review before I submit?

A: The “Preview” button will create a PDF preview document at any time. (The preview is generated in a new browser window. Your browser's popup and/or ad blocker may prevent the preview window from opening. If you have problems generating a preview, see here.)

Q: What happens when I submit my annual review?

A: (1) You will receive an email confirmation that your annual review has been submitted successfully. (2) Your department chair or division chief will also receive an email informing him/her of your submission and will be guided to the FIS website to review your annual review and submit comments. (3) After the department chair or division chief submits comments, you will receive an email informing you of this and asking you to login to FIS to review the comments and submit your FAR for a final time.

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Money blog: 600 new skyscrapers 'on way' for London, report finds

A reader seeks help as her employer of 24 years is bringing in a new clock-in system to pay her by the minute. Read this and all the latest personal finance and consumer news in the Money blog - and share your own problem or dispute below.

Monday 13 May 2024 19:57, UK

• Gen Z would rather deliver parcels than work in restaurants, Michel Roux Jr claims
• 600 new skyscrapers on way for London, report finds
• Money Problem: My workplace is bringing in new clock-in system to pay us by the minute - is this allowed?
• Free childcare applications open for new age band

Essential reads

• How to make sure your car passes its MOT
• 'Loud budgeting': The money-saving trend that has nothing to do with giving up your daily coffee
• How to avoid a holiday data roaming charge (while still using the internet)
• Best of the Money blog - an archive

Ask a question or make a comment

Young homebuyers are being forced to gamble with their retirement prospects by taking on ultra-long mortgages, according to a former pensions minister.

Sir Steve Webb described data - supplied by the Financial Conduct Authority to the Bank of England - as "shocking".

It suggests that more than one million new mortgages have been issued over the past three years with end dates beyond the state pension age.

The ex-Liberal Democrat MP, who is now a partner at the consultancy firm LCP, voiced fears that borrowers could be forced to raid their pension savings to clear their mortgage in a worst-case scenario.

Sir Steve saw the potential for harm in any case, as longer-term mortgages deprive people of a period running up to retirement when they could be mortgage-free and boosting their pension.

What does the data say? 

• 42% of new mortgages in the fourth quarter of 2023 - or 91,394 - had terms going beyond the state pension age;
• In the final quarter of last year, people aged 30 to 39 accounted for 30,943 new mortgages lasting beyond state pension age;
• People aged 40 to 49 accounted for 32,305;
• Under-30s made up 3,676 of these mortgages;
• People aged 50 to 59 accounted for 18,854, and there were 661 who were over 70.

Mortgage rates have been rising since the end of 2021 when the Bank of England began action to tackle rising inflation.

Taking home loans with longer maturity dates tends to be more attractive when interest rates are high, as monthly repayments are lower.

You can read more on this story below...

Waitrose has become the only supermarket to receive a royal warrant from the King. 

The recognition means the company has regularly provided the royal household with products for at least five years. 

It also means it can use the King's coat of arms on packaging, as part of advertising or on any stationary it creates. 

Waitrose was first granted a royal warrant in 1928 for supplying King George V with groceries and cleaning materials.

"We are honoured and proud that His Majesty has granted us his warrant," James Bailey, executive director of Waitrose, said. 

"It means the world to all of us, and our farmers and suppliers. There couldn’t be a more powerful symbol of our commitment to service and quality, and our determination to have the highest environmental and animal welfare standards." 

Waitrose was previously granted a royal warrant by the late Queen in 2002 and the King when he was Prince of Wales in 2010.

The Queen has also granted her first royal warrants, picking seven companies, including luxury department store Fortnum & Mason and the florist that supplied her coronation flowers, Shane Connolly & Company. 

The royal nod could be bad news for customers, however, with a brand finance expert telling Sky News that having a royal warrant allows firms to charge a price premium.

David Haigh said his company's research estimated this to be "between 10% and 25%".

A royal warrant says a company or a product is luxurious, high quality and sustainable, he explained. 

He estimates the scheme is "worth billions to UK companies and… therefore it's a very high value to the UK economy".

"And one of the reasons for that is that a lot of foreign tourists and buyers have a preference for royal warrant holder products. We found that 100% of Chinese buyers would pay in excess of 10% for a royal warrant holder product."

Read more on the Queen's choices here :

Gordon Ramsay's restaurants tripled losses to £3.4m last year, as the chef warned businesses in the industry were facing a "challenging" climate. 

The chef's group spent millions opening five new restaurants in 2023, including a Lucky Cat in Manchester, a Bread Street Kitchen in Battersea Power Station and a Street Pizza in Edinburgh. 

Sales at his wide-ranging establishments rose, however, by 21% to £95.6m in the year to August, according to The Telegraph. 

"It's been a really hard-fought year, but at the same time an exciting year, and in tough times it amazes me how strong and vibrant our industry is," Ramsay told the news outlet. 

"It's challenging out there and businesses are battling to stay afloat, rising costs, rent and food costs, multiple strikes. It's a battle" 

He was optimistic, however, saying there hasn't been "so much passion and vibrancy" in the industry since he opened his first restaurant in 1998.

"We've still got something wonderful to celebrate, and I truly believe the industry has never been so exciting."

Once the UK's favourite alcoholic beverage, beer's popularity seems to be fading among the younger drinking generation... 

In fact, only 30% of people aged 18 to 24 ever drink it, according to a study commissioned by the Society of Independent Brewers. 

Instead, younger drinkers say they prefer drinking spirits, wine and cider. 

Pub visits appear to be suffering as well, with almost a quarter of the 2,000 people surveyed saying they have never visited their local. 

SIBA's 2024 Craft Beer Report paints a more positive picture for small and independent brewers, however, with more than 55% of beer consumers saying they now drink "local craft beer". 

It also found average beer production volumes among independent breweries has risen by 14% since last year - a return to pre-pandemic levels for the first time in 4 years. 

"Demand for local, independently brewed beer in the UK is strong, with independent brewers reporting production volumes up by 14%, meaning they have returned to 2019 volumes again," Andy Slee, SIBA's chief executive, said. 

But, he said, it's time for "cautious optimism" only, with the industry still plagued with a number of issues. 

"The short-term issue for small independent breweries isn't demand; it's profitability, rising costs and financial pressures such as lingering COVID debt," he said. 

"Far too many breweries are simply trying to survive rather than thrive, so while there are many positives signs highlighted in the report, for now it's cautious optimism."

Earlier this year, our Money reporter Emily Mee explored whether the UK's big night out culture was dying out. 

Nightlife experts warned we're losing one club every two days at the moment - and if we stay on this trajectory, we will have none left by 2030.

You can read more about her findings here...

A total of 583 skyscrapers are "queuing up in the pipeline" to be built across central London, a development thinktank has said. 

That is more than double the 270 built in the past decade. 

In the eastern borough of Tower Hamlets alone, 71 tall buildings were completed in that time that time, the report by New London Architecture found. 

A further 24 were in the City of London and 27 in Canary Wharf and Isle of Dogs. 

The report said the rapid change has been fuelled by a "burgeoning demand" for office and residential space, overseas investment and a supporting planning environment. 

"Tall buildings have changed the face of London substantially over the last 20 years and will continue to do so - the pipeline that NLA has tracked means there is at least 10 years' supply that has already been defined," Peter Murray, the organisation's co-founder, said. 

"London's population continues to grow, passing the 10 million mark at the end of this decade.

"We'll still need tall buildings; and NLA will continue to keep a close watch on what's going on." 

Restaurants might only be able to open three or four days a week due to staffing problems, Michel Roux Jr has warned. 

Speaking to The Telegraph as he gears up to open his new restaurant Chez Rouz, the Michelin starred chef admitted the industry needs to change to accommodate flexible working hours. 

"Just because I worked 80 hours a week or more doesn't mean the next generation should," he said. 

"Quite the contrary. That is something that we have to address in our industry."

But, he warned that the move will come at a cost... 

"It will mean ultimately that going out is going to be more expensive, and that maybe your favourite restaurant is no longer open seven days a week - it's only open three or four days a week," he said. 

The industry is known for its long, unsociable working hours, and Roux Jr explained that the real issue hit after the pandemic, with people no longer wanting to work weekends. 

"People don't want to work unsociable hours and would rather work delivering parcels as and when they want to. It's as simple as that," he added. 

Earlier this year, Roux Jr said goodbye to his famous restaurant Le Gavroche in London. 

It had been opened by his father Albert Roux and uncle Michel Roux in 1967. 

Now, he said it's "brave" to open a new restaurant, with the market "very, very tough". 

"I really feel for anyone that is brave enough to open up a restaurant now. It's incredibly difficult," he added. 

Chez Rouz at The Langham in Marylebone, central London, is due to open on 22 May. 

By James Sillars , business news reporter

A pause for breath on the FTSE 100 after a 3% gain over the course of past week that took the index to a fresh record closing high.

The rally of recent weeks - significant for London's standing and pension pots alike - has been broad based and reflects several factors.

A major driver has been sterling's weakness versus the US dollar.

The US currency has been strong as the Federal Reserve, its central bank, has hinted it will be some time yet before it begins to cut interest rates.

Language out of the Bank of England last week sparked a flurry of bets that UK rates could be cut as early as next month.

A weaker pound boosts dollar-earning constituents on the FTSE 100 because they get more for their money when dollars are converted to pounds.

Also at play is the view that UK stocks represent good value, as they are cheaper compared to many of their international peers.

A few moments ago, the FTSE 100 was trading 6 points lower at 8,423.

A major talking point is the possibility of the Chinese fast fashion firm Shein listing in London.

According to Reuters, the company has shifted its focus to the UK after receiving a lukewarm reception in the United States.

The news agency, citing two sources, reported that Shein was stepping up its preparations for an initial public offering in London that would be expected to be one of the biggest carried out globally this year.

By Emily Mee , Money team

No one likes the date in their calendar when their MOT rolls around. 

But to make things a little less stressful, consumer expert Scott Dixon - known as The Complaints Resolver - has given us some tips on what to look out for to help your vehicle pass with flying colours. 

Some of the most common failures are faulty steering, brakes, suspension, worn or damaged tyres, cracked windscreens and faulty lights. 

Mr Dixon recommends you get your car serviced a couple of weeks before your MOT, in case there are any complex or costly issues. 

This will give you time to get them fixed and get your car through first time without any advisories. 

Aside from taking your car for a service, there are also some easy checks you can run yourself... 

Listen for unusual clunks while you're driving - this could be a sign of a damaged suspension. 

You could also check by pushing the car down on each corner. It should return to normal without bouncing a few times. 

Another option is to look with a torch under the wheel arch, as this should reveal any obvious defects. 

Blown bulbs are a common MOT failure, but they're cheap to fix. 

Walk around your car and check all the bulbs are working - this includes the headlights, sidelights, brake lights, indicators and the number plate bulb.

Mr Dixon says it's "not an easy job" to change the lightbulbs yourself on most modern cars, as the MOT will also check the positioning of the light. Therefore he recommends getting this done professionally. 

Squealing or grinding noises may be a sign your brake pads need replacing. 

You should also check whether your car stops in a straight line, or whether it pulls in different directions. 

Don't forget about the handbrake, too. Test it out on a slope and see if it securely holds the car. If it doesn't, you should get it adjusted. 

It's easy to check if your wipers work okay, but you should also make sure to inspect the blades for tears and rips. 

They should be able to clean the windows with no smears. 

Mr Dixon says you don't need to pay Halfords to change your wiper blade as you can "do it yourself in seconds". All you need to do is look for a YouTube tutorial. 

He also recommends buying the Bosch wiper blades, as he says these are good quality and will also be a sign you've looked after your car well when you come to sell it. 

One thing to look out for is tread depth. You can do this by looking for the "wear bar" that sits between the tread. 

If it's close to 1.6mm and is low, you should get the tyre replaced so it's not flagged as an advisory. 

Also check for perished tyre walls, which can happen when a vehicle is standing for any length of time. 

Uneven tyre wear is another potential issue, and if there are signs of this you should get the tyre replaced and tracking and suspension checked. 

These must be in good condition and working order, with no tears or knots. 

Registration plates

Your number plates should be clean and visible with a working light bulb at the rear. You may need to give them a wipe and replace the bulb if necessary. 

This should be in good condition, without damage such as loose bumpers or sharp edges. 

Mr Dixon advises against using automatic car washes during your car's lifetime, saying they "wreck your car". 

"It's not just your paintwork but they can also damage the wiper blades and the bodywork," he says. 

Check for warning lights

You'll need to take your vehicle to a trusted garage or mechanic for this. 

Exhaust emissions

Some diesel vehicles can fail their MOTs based on emissions. To avoid this, you can buy a fuel treatment pack and take your car for a good run to clear the fuel lines and tank.

Driving for at least 30 to 50 minutes at a sustained speed on a motorway or A-road should help to clear the filter. 

You should make sure the driver's view of the road isn't obstructed, so check for stone chips at eye level and remove any obstructions such as air fresheners and mobile phone cradles. 

What else should you think about? 

Make sure your car is clean beforehand, as a tester can refuse to do your MOT if the vehicle is filthy and full of rubbish. 

Giving your car a clean can also give you a chance to inspect it, Mr Dixon says. 

Another thing to do is to check last year's MOT for any advisories that might crop up this time. 

These potential issues will still be there - so it's best not to ignore them. 

You can check your vehicle's MOT history using  https://car-check.co.uk . 

Every Monday we get an expert to answer your money problems or consumer disputes. Find out how to submit yours at the bottom of this post. Today's question is...

I have worked at a bank for 24 years - the facilities are outsourced. This new company is bringing in a system where the staff have to click in and out and are then paid by the minute? Is this allowed? Amber

Ian Jones, director and principal solicitor at Spencer Shaw Solicitors, has picked this one up...

Your rights depend on your contract and what it says about payment. Does it specify an annual salary, or payment by time? Does it allow for changes to how payment is calculated?

If the contract does not allow for this type of payment, your employer may be trying to vary the contract of employment unlawfully.

If you're directly employed by the bank, and your pay arrangements are changing because of a new monitoring system, this would be an internal contract variation. If you work in the facilities department and the new contractor is taking over as your employer, the Transfer of Undertakings (Protection of Employment) Regulations (TUPE) 2006 may apply. 

In this case, your current terms, conditions and previous service will transfer to the new employer.

TUPE may make the issue sound more complicated but, in practice, either way the changes will be valid only if the employee agrees to them.

If you have not agreed to the change, then this could be a breach of contract. This could give rise to a successful claim in the civil courts or the employment tribunal. 

If the breach is serious (for example, you're paid less than agreed in the original contract) and you resign in response, this could amount to constructive dismissal for which a claim can be made in the employment tribunal. 

It would be sensible to get the contract reviewed by a solicitor for advice. But act swiftly - if you continue working for the employer, you are effectively waiving the breach and accepting the change to your contract.

To make it possible to pay by the minute, employees may be monitored while at work. When collecting and processing data and using it to make a decision, the employer must comply with data protection laws. If not, the employee could be entitled to compensation, depending on the breach, or the employer could be at risk of a sanction by the regulator the Information Commissioner's Office.

This feature is not intended as financial advice - the aim is to give an overview of the things you should think about.  Submit your dilemma or consumer dispute via:

• The form above - make sure you leave a phone number or email address
• Email [email protected] with the subject line "Money blog"
• WhatsApp us  here .

Please make sure you leave your contact details as we cannot follow up consumer disputes without them.

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