how to write methods in a research paper

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• How to Write Your Methods

Ensure understanding, reproducibility and replicability

What should you include in your methods section, and how much detail is appropriate?

Why Methods Matter

The methods section was once the most likely part of a paper to be unfairly abbreviated, overly summarized, or even relegated to hard-to-find sections of a publisher’s website. While some journals may responsibly include more detailed elements of methods in supplementary sections, the movement for increased reproducibility and rigor in science has reinstated the importance of the methods section. Methods are now viewed as a key element in establishing the credibility of the research being reported, alongside the open availability of data and results.

A clear methods section impacts editorial evaluation and readers’ understanding, and is also the backbone of transparency and replicability.

For example, the Reproducibility Project: Cancer Biology project set out in 2013 to replicate experiments from 50 high profile cancer papers, but revised their target to 18 papers once they understood how much methodological detail was not contained in the original papers.

What to include in your methods section

What you include in your methods sections depends on what field you are in and what experiments you are performing. However, the general principle in place at the majority of journals is summarized well by the guidelines at PLOS ONE : “The Materials and Methods section should provide enough detail to allow suitably skilled investigators to fully replicate your study. ” The emphases here are deliberate: the methods should enable readers to understand your paper, and replicate your study. However, there is no need to go into the level of detail that a lay-person would require—the focus is on the reader who is also trained in your field, with the suitable skills and knowledge to attempt a replication.

A constant principle of rigorous science

A methods section that enables other researchers to understand and replicate your results is a constant principle of rigorous, transparent, and Open Science. Aim to be thorough, even if a particular journal doesn’t require the same level of detail . Reproducibility is all of our responsibility. You cannot create any problems by exceeding a minimum standard of information. If a journal still has word-limits—either for the overall article or specific sections—and requires some methodological details to be in a supplemental section, that is OK as long as the extra details are searchable and findable .

Imagine replicating your own work, years in the future

As part of PLOS’ presentation on Reproducibility and Open Publishing (part of UCSF’s Reproducibility Series ) we recommend planning the level of detail in your methods section by imagining you are writing for your future self, replicating your own work. When you consider that you might be at a different institution, with different account logins, applications, resources, and access levels—you can help yourself imagine the level of specificity that you yourself would require to redo the exact experiment. Consider:

• Which details would you need to be reminded of? 
• Which cell line, or antibody, or software, or reagent did you use, and does it have a Research Resource ID (RRID) that you can cite?
• Which version of a questionnaire did you use in your survey? 
• Exactly which visual stimulus did you show participants, and is it publicly available? 
• What participants did you decide to exclude? 
• What process did you adjust, during your work? 

Tip: Be sure to capture any changes to your protocols

You yourself would want to know about any adjustments, if you ever replicate the work, so you can surmise that anyone else would want to as well. Even if a necessary adjustment you made was not ideal, transparency is the key to ensuring this is not regarded as an issue in the future. It is far better to transparently convey any non-optimal methods, or methodological constraints, than to conceal them, which could result in reproducibility or ethical issues downstream.

Visual aids for methods help when reading the whole paper

Consider whether a visual representation of your methods could be appropriate or aid understanding your process. A visual reference readers can easily return to, like a flow-diagram, decision-tree, or checklist, can help readers to better understand the complete article, not just the methods section.

Ethical Considerations

In addition to describing what you did, it is just as important to assure readers that you also followed all relevant ethical guidelines when conducting your research. While ethical standards and reporting guidelines are often presented in a separate section of a paper, ensure that your methods and protocols actually follow these guidelines. Read more about ethics .

Existing standards, checklists, guidelines, partners

While the level of detail contained in a methods section should be guided by the universal principles of rigorous science outlined above, various disciplines, fields, and projects have worked hard to design and develop consistent standards, guidelines, and tools to help with reporting all types of experiment. Below, you’ll find some of the key initiatives. Ensure you read the submission guidelines for the specific journal you are submitting to, in order to discover any further journal- or field-specific policies to follow, or initiatives/tools to utilize.

Tip: Keep your paper moving forward by providing the proper paperwork up front

Be sure to check the journal guidelines and provide the necessary documents with your manuscript submission. Collecting the necessary documentation can greatly slow the first round of peer review, or cause delays when you submit your revision.

Randomized Controlled Trials – CONSORT The Consolidated Standards of Reporting Trials (CONSORT) project covers various initiatives intended to prevent the problems of  inadequate reporting of randomized controlled trials. The primary initiative is an evidence-based minimum set of recommendations for reporting randomized trials known as the CONSORT Statement . 

Systematic Reviews and Meta-Analyses – PRISMA The Preferred Reporting Items for Systematic Reviews and Meta-Analyses ( PRISMA ) is an evidence-based minimum set of items focusing  on the reporting of  reviews evaluating randomized trials and other types of research.

Research using Animals – ARRIVE The Animal Research: Reporting of In Vivo Experiments ( ARRIVE ) guidelines encourage maximizing the information reported in research using animals thereby minimizing unnecessary studies. (Original study and proposal , and updated guidelines , in PLOS Biology .) 

Laboratory Protocols Protocols.io has developed a platform specifically for the sharing and updating of laboratory protocols , which are assigned their own DOI and can be linked from methods sections of papers to enhance reproducibility. Contextualize your protocol and improve discovery with an accompanying Lab Protocol article in PLOS ONE .

Consistent reporting of Materials, Design, and Analysis – the MDAR checklist A cross-publisher group of editors and experts have developed, tested, and rolled out a checklist to help establish and harmonize reporting standards in the Life Sciences . The checklist , which is available for use by authors to compile their methods, and editors/reviewers to check methods, establishes a minimum set of requirements in transparent reporting and is adaptable to any discipline within the Life Sciences, by covering a breadth of potentially relevant methodological items and considerations. If you are in the Life Sciences and writing up your methods section, try working through the MDAR checklist and see whether it helps you include all relevant details into your methods, and whether it reminded you of anything you might have missed otherwise.

Summary Writing tips

The main challenge you may find when writing your methods is keeping it readable AND covering all the details needed for reproducibility and replicability. While this is difficult, do not compromise on rigorous standards for credibility!

• Keep in mind future replicability, alongside understanding and readability.
• Follow checklists, and field- and journal-specific guidelines.
• Consider a commitment to rigorous and transparent science a personal responsibility, and not just adhering to journal guidelines.
• Establish whether there are persistent identifiers for any research resources you use that can be specifically cited in your methods section.
• Deposit your laboratory protocols in Protocols.io, establishing a permanent link to them. You can update your protocols later if you improve on them, as can future scientists who follow your protocols.
• Consider visual aids like flow-diagrams, lists, to help with reading other sections of the paper.
• Be specific about all decisions made during the experiments that someone reproducing your work would need to know.

Don’t

• Summarize or abbreviate methods without giving full details in a discoverable supplemental section.
• Presume you will always be able to remember how you performed the experiments, or have access to private or institutional notebooks and resources.
• Attempt to hide constraints or non-optimal decisions you had to make–transparency is the key to ensuring the credibility of your research.
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• What Is a Research Methodology? | Steps & Tips

What Is a Research Methodology? | Steps & Tips

Published on 25 February 2019 by Shona McCombes . Revised on 10 October 2022.

Your research methodology discusses and explains the data collection and analysis methods you used in your research. A key part of your thesis, dissertation, or research paper, the methodology chapter explains what you did and how you did it, allowing readers to evaluate the reliability and validity of your research.

It should include:

• The type of research you conducted
• How you collected and analysed your data
• Any tools or materials you used in the research
• Why you chose these methods
• Your methodology section should generally be written in the past tense .
• Academic style guides in your field may provide detailed guidelines on what to include for different types of studies.
• Your citation style might provide guidelines for your methodology section (e.g., an APA Style methods section ).

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Table of contents

How to write a research methodology, why is a methods section important, step 1: explain your methodological approach, step 2: describe your data collection methods, step 3: describe your analysis method, step 4: evaluate and justify the methodological choices you made, tips for writing a strong methodology chapter, frequently asked questions about methodology.

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Your methods section is your opportunity to share how you conducted your research and why you chose the methods you chose. It’s also the place to show that your research was rigorously conducted and can be replicated .

It gives your research legitimacy and situates it within your field, and also gives your readers a place to refer to if they have any questions or critiques in other sections.

You can start by introducing your overall approach to your research. You have two options here.

Option 1: Start with your “what”

What research problem or question did you investigate?

• Aim to describe the characteristics of something?
• Explore an under-researched topic?
• Establish a causal relationship?

And what type of data did you need to achieve this aim?

• Quantitative data , qualitative data , or a mix of both?
• Primary data collected yourself, or secondary data collected by someone else?
• Experimental data gathered by controlling and manipulating variables, or descriptive data gathered via observations?

Option 2: Start with your “why”

Depending on your discipline, you can also start with a discussion of the rationale and assumptions underpinning your methodology. In other words, why did you choose these methods for your study?

• Why is this the best way to answer your research question?
• Is this a standard methodology in your field, or does it require justification?
• Were there any ethical considerations involved in your choices?
• What are the criteria for validity and reliability in this type of research ?

Once you have introduced your reader to your methodological approach, you should share full details about your data collection methods .

Quantitative methods

In order to be considered generalisable, you should describe quantitative research methods in enough detail for another researcher to replicate your study.

Here, explain how you operationalised your concepts and measured your variables. Discuss your sampling method or inclusion/exclusion criteria, as well as any tools, procedures, and materials you used to gather your data.

Surveys Describe where, when, and how the survey was conducted.

• How did you design the questionnaire?
• What form did your questions take (e.g., multiple choice, Likert scale )?
• Were your surveys conducted in-person or virtually?
• What sampling method did you use to select participants?
• What was your sample size and response rate?

Experiments Share full details of the tools, techniques, and procedures you used to conduct your experiment.

• How did you design the experiment ?
• How did you recruit participants?
• How did you manipulate and measure the variables ?
• What tools did you use?

Existing data Explain how you gathered and selected the material (such as datasets or archival data) that you used in your analysis.

• Where did you source the material?
• How was the data originally produced?
• What criteria did you use to select material (e.g., date range)?

The survey consisted of 5 multiple-choice questions and 10 questions measured on a 7-point Likert scale.

The goal was to collect survey responses from 350 customers visiting the fitness apparel company’s brick-and-mortar location in Boston on 4–8 July 2022, between 11:00 and 15:00.

Here, a customer was defined as a person who had purchased a product from the company on the day they took the survey. Participants were given 5 minutes to fill in the survey anonymously. In total, 408 customers responded, but not all surveys were fully completed. Due to this, 371 survey results were included in the analysis.

Qualitative methods

In qualitative research , methods are often more flexible and subjective. For this reason, it’s crucial to robustly explain the methodology choices you made.

Be sure to discuss the criteria you used to select your data, the context in which your research was conducted, and the role you played in collecting your data (e.g., were you an active participant, or a passive observer?)

Interviews or focus groups Describe where, when, and how the interviews were conducted.

• How did you find and select participants?
• How many participants took part?
• What form did the interviews take ( structured , semi-structured , or unstructured )?
• How long were the interviews?
• How were they recorded?

Participant observation Describe where, when, and how you conducted the observation or ethnography .

• What group or community did you observe? How long did you spend there?
• How did you gain access to this group? What role did you play in the community?
• How long did you spend conducting the research? Where was it located?
• How did you record your data (e.g., audiovisual recordings, note-taking)?

Existing data Explain how you selected case study materials for your analysis.

• What type of materials did you analyse?
• How did you select them?

In order to gain better insight into possibilities for future improvement of the fitness shop’s product range, semi-structured interviews were conducted with 8 returning customers.

Here, a returning customer was defined as someone who usually bought products at least twice a week from the store.

Surveys were used to select participants. Interviews were conducted in a small office next to the cash register and lasted approximately 20 minutes each. Answers were recorded by note-taking, and seven interviews were also filmed with consent. One interviewee preferred not to be filmed.

Mixed methods

Mixed methods research combines quantitative and qualitative approaches. If a standalone quantitative or qualitative study is insufficient to answer your research question, mixed methods may be a good fit for you.

Mixed methods are less common than standalone analyses, largely because they require a great deal of effort to pull off successfully. If you choose to pursue mixed methods, it’s especially important to robustly justify your methods here.

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Next, you should indicate how you processed and analysed your data. Avoid going into too much detail: you should not start introducing or discussing any of your results at this stage.

In quantitative research , your analysis will be based on numbers. In your methods section, you can include:

• How you prepared the data before analysing it (e.g., checking for missing data , removing outliers , transforming variables)
• Which software you used (e.g., SPSS, Stata or R)
• Which statistical tests you used (e.g., two-tailed t test , simple linear regression )

In qualitative research, your analysis will be based on language, images, and observations (often involving some form of textual analysis ).

Specific methods might include:

• Content analysis : Categorising and discussing the meaning of words, phrases and sentences
• Thematic analysis : Coding and closely examining the data to identify broad themes and patterns
• Discourse analysis : Studying communication and meaning in relation to their social context

Mixed methods combine the above two research methods, integrating both qualitative and quantitative approaches into one coherent analytical process.

Above all, your methodology section should clearly make the case for why you chose the methods you did. This is especially true if you did not take the most standard approach to your topic. In this case, discuss why other methods were not suitable for your objectives, and show how this approach contributes new knowledge or understanding.

In any case, it should be overwhelmingly clear to your reader that you set yourself up for success in terms of your methodology’s design. Show how your methods should lead to results that are valid and reliable, while leaving the analysis of the meaning, importance, and relevance of your results for your discussion section .

• Quantitative: Lab-based experiments cannot always accurately simulate real-life situations and behaviours, but they are effective for testing causal relationships between variables .
• Qualitative: Unstructured interviews usually produce results that cannot be generalised beyond the sample group , but they provide a more in-depth understanding of participants’ perceptions, motivations, and emotions.
• Mixed methods: Despite issues systematically comparing differing types of data, a solely quantitative study would not sufficiently incorporate the lived experience of each participant, while a solely qualitative study would be insufficiently generalisable.

Remember that your aim is not just to describe your methods, but to show how and why you applied them. Again, it’s critical to demonstrate that your research was rigorously conducted and can be replicated.

1. Focus on your objectives and research questions

The methodology section should clearly show why your methods suit your objectives  and convince the reader that you chose the best possible approach to answering your problem statement and research questions .

2. Cite relevant sources

Your methodology can be strengthened by referencing existing research in your field. This can help you to:

• Show that you followed established practice for your type of research
• Discuss how you decided on your approach by evaluating existing research
• Present a novel methodological approach to address a gap in the literature

3. Write for your audience

Consider how much information you need to give, and avoid getting too lengthy. If you are using methods that are standard for your discipline, you probably don’t need to give a lot of background or justification.

Regardless, your methodology should be a clear, well-structured text that makes an argument for your approach, not just a list of technical details and procedures.

Methodology refers to the overarching strategy and rationale of your research. Developing your methodology involves studying the research methods used in your field and the theories or principles that underpin them, in order to choose the approach that best matches your objectives.

Methods are the specific tools and procedures you use to collect and analyse data (e.g. interviews, experiments , surveys , statistical tests ).

In a dissertation or scientific paper, the methodology chapter or methods section comes after the introduction and before the results , discussion and conclusion .

Depending on the length and type of document, you might also include a literature review or theoretical framework before the methodology.

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to test a hypothesis by systematically collecting and analysing data, while qualitative methods allow you to explore ideas and experiences in depth.

A sample is a subset of individuals from a larger population. Sampling means selecting the group that you will actually collect data from in your research.

For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

Statistical sampling allows you to test a hypothesis about the characteristics of a population. There are various sampling methods you can use to ensure that your sample is representative of the population as a whole.

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How to Write a Methods Section for a Psychology Paper

Tips and Examples of an APA Methods Section

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

Emily is a board-certified science editor who has worked with top digital publishing brands like Voices for Biodiversity, Study.com, GoodTherapy, Vox, and Verywell.

Verywell / Brianna Gilmartin 

The methods section of an APA format psychology paper provides the methods and procedures used in a research study or experiment . This part of an APA paper is critical because it allows other researchers to see exactly how you conducted your research.

Method refers to the procedure that was used in a research study. It included a precise description of how the experiments were performed and why particular procedures were selected. While the APA technically refers to this section as the 'method section,' it is also often known as a 'methods section.'

The methods section ensures the experiment's reproducibility and the assessment of alternative methods that might produce different results. It also allows researchers to replicate the experiment and judge the study's validity.

This article discusses how to write a methods section for a psychology paper, including important elements to include and tips that can help.

What to Include in a Method Section

So what exactly do you need to include when writing your method section? You should provide detailed information on the following:

• Research design
• Participants
• Participant behavior

The method section should provide enough information to allow other researchers to replicate your experiment or study.

Components of a Method Section

The method section should utilize subheadings to divide up different subsections. These subsections typically include participants, materials, design, and procedure.

Participants 

In this part of the method section, you should describe the participants in your experiment, including who they were (and any unique features that set them apart from the general population), how many there were, and how they were selected. If you utilized random selection to choose your participants, it should be noted here.

For example: "We randomly selected 100 children from elementary schools near the University of Arizona."

At the very minimum, this part of your method section must convey:

• Basic demographic characteristics of your participants (such as sex, age, ethnicity, or religion)
• The population from which your participants were drawn
• Any restrictions on your pool of participants
• How many participants were assigned to each condition and how they were assigned to each group (i.e., randomly assignment , another selection method, etc.)
• Why participants took part in your research (i.e., the study was advertised at a college or hospital, they received some type of incentive, etc.)

Information about participants helps other researchers understand how your study was performed, how generalizable the result might be, and allows other researchers to replicate the experiment with other populations to see if they might obtain the same results.

In this part of the method section, you should describe the materials, measures, equipment, or stimuli used in the experiment. This may include:

• Testing instruments
• Technical equipment
• Any psychological assessments that were used
• Any special equipment that was used

For example: "Two stories from Sullivan et al.'s (1994) second-order false belief attribution tasks were used to assess children's understanding of second-order beliefs."

For standard equipment such as computers, televisions, and videos, you can simply name the device and not provide further explanation.

Specialized equipment should be given greater detail, especially if it is complex or created for a niche purpose. In some instances, such as if you created a special material or apparatus for your study, you might need to include an illustration of the item in the appendix of your paper.

In this part of your method section, describe the type of design used in the experiment. Specify the variables as well as the levels of these variables. Identify:

• The independent variables
• Dependent variables
• Control variables
• Any extraneous variables that might influence your results.

Also, explain whether your experiment uses a  within-groups  or between-groups design.

For example: "The experiment used a 3x2 between-subjects design. The independent variables were age and understanding of second-order beliefs."

The next part of your method section should detail the procedures used in your experiment. Your procedures should explain:

• What the participants did
• How data was collected
• The order in which steps occurred

For example: "An examiner interviewed children individually at their school in one session that lasted 20 minutes on average. The examiner explained to each child that he or she would be told two short stories and that some questions would be asked after each story. All sessions were videotaped so the data could later be coded."

Keep this subsection concise yet detailed. Explain what you did and how you did it, but do not overwhelm your readers with too much information.

Tips for How to Write a Methods Section

In addition to following the basic structure of an APA method section, there are also certain things you should remember when writing this section of your paper. Consider the following tips when writing this section:

• Use the past tense : Always write the method section in the past tense.
• Be descriptive : Provide enough detail that another researcher could replicate your experiment, but focus on brevity. Avoid unnecessary detail that is not relevant to the outcome of the experiment.
• Use an academic tone : Use formal language and avoid slang or colloquial expressions. Word choice is also important. Refer to the people in your experiment or study as "participants" rather than "subjects."
• Use APA format : Keep a style guide on hand as you write your method section. The Publication Manual of the American Psychological Association is the official source for APA style.
• Make connections : Read through each section of your paper for agreement with other sections. If you mention procedures in the method section, these elements should be discussed in the results and discussion sections.
• Proofread : Check your paper for grammar, spelling, and punctuation errors.. typos, grammar problems, and spelling errors. Although a spell checker is a handy tool, there are some errors only you can catch.

After writing a draft of your method section, be sure to get a second opinion. You can often become too close to your work to see errors or lack of clarity. Take a rough draft of your method section to your university's writing lab for additional assistance.

A Word From Verywell

The method section is one of the most important components of your APA format paper. The goal of your paper should be to clearly detail what you did in your experiment. Provide enough detail that another researcher could replicate your study if they wanted.

Finally, if you are writing your paper for a class or for a specific publication, be sure to keep in mind any specific instructions provided by your instructor or by the journal editor. Your instructor may have certain requirements that you need to follow while writing your method section.

Frequently Asked Questions

While the subsections can vary, the three components that should be included are sections on the participants, the materials, and the procedures.

• Describe who the participants were in the study and how they were selected.
• Define and describe the materials that were used including any equipment, tests, or assessments
• Describe how the data was collected

To write your methods section in APA format, describe your participants, materials, study design, and procedures. Keep this section succinct, and always write in the past tense. The main heading of this section should be labeled "Method" and it should be centered, bolded, and capitalized. Each subheading within this section should be bolded, left-aligned and in title case.

The purpose of the methods section is to describe what you did in your experiment. It should be brief, but include enough detail that someone could replicate your experiment based on this information. Your methods section should detail what you did to answer your research question. Describe how the study was conducted, the study design that was used and why it was chosen, and how you collected the data and analyzed the results.

Erdemir F. How to write a materials and methods section of a scientific article ? Turk J Urol . 2013;39(Suppl 1):10-5. doi:10.5152/tud.2013.047

Kallet RH. How to write the methods section of a research paper . Respir Care . 2004;49(10):1229-32. PMID: 15447808.

American Psychological Association.  Publication Manual of the American Psychological Association  (7th ed.). Washington DC: The American Psychological Association; 2019.

American Psychological Association. APA Style Journal Article Reporting Standards . Published 2020.

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

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• INTRODUCTION

Writing a "good" methods section

"methods checklist" from: how to write a good scientific paper. chris a. mack. spie. 2018..

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The purpose is to provide enough detail that a competent worker could repeat the experiment. Many of your readers will skip this section because they already know from the Introduction the general methods you used. However careful writing of this section is important because for your results to be of scientific merit they must be reproducible. Otherwise your paper does not represent good science.

• Exact technical specifications and quantities and source or method of preparation
• Describe equipment used and provide illustrations where relevant.
• Chronological presentation (but related methods described together)
• Questions about "how" and "how much" are answered for the reader and not left for them to puzzle over
• Discuss statistical methods only if unusual or advanced
• When a large number of components are used prepare tables for the benefit of the reader
• Do not state the action without stating the agent of the action
• Describe how the results were generated with sufficient detail so that an independent researcher (working in the same field) could reproduce the results sufficiently to allow validation of the conclusions.
• Can the reader assess internal validity (conclusions are supported by the results presented)?
• Can the reader assess external validity (conclusions are properly generalized beyond these specific results)?
• Has the chosen method been justified?
• Are data analysis and statistical approaches justified, with assumptions and biases considered?
• Avoid: including results in the Method section; including extraneous details (unnecessary to enable reproducibility or judge validity); treating the method as a chronological history of events; unneeded references to commercial products; references to “proprietary” products or processes unavailable to the reader. 
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4 Writing the Materials and Methods (Methodology) Section

The Materials and Methods section briefly describes how you did your research. In other words, what did you do to answer your research question? If there were materials used for the research or materials experimented on you list them in this section. You also describe how you did the research or experiment. The key to a methodology is that another person must be able to replicate your research—follow the steps you take. For example if you used the internet to do a search it is not enough to say you “searched the internet.” A reader would need to know which search engine and what key words you used.

Open this section by describing the overall approach you took or the materials used. Then describe to the readers step-by-step the methods you used including any data analysis performed. See Fig. 2.5 below for an example of materials and methods section.

Writing tips:

• Explain procedures, materials, and equipment used
• Example: “We used an x-ray fluorescence spectrometer to analyze major and trace elements in the mystery mineral samples.”
• Order events chronologically, perhaps with subheadings (Field work, Lab Analysis, Statistical Models)
• Use past tense (you did X, Y, Z)
• Quantify measurements
• Include results in the methods! It’s easy to make this mistake!
• Example: “W e turned on the machine and loaded in our samples, then calibrated the instrument and pushed the start button and waited one hour. . . .”

Technical Writing @ SLCC Copyright © 2020 by Department of English, Linguistics, and Writing Studies at SLCC is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License , except where otherwise noted.

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How to Write a Methods Section for a Research Paper

A common piece of advice for authors preparing their first journal article for publication is to start with the methods section: just list everything that was done and go from there. While that might seem like a very practical approach to a first draft, if you do this without a clear outline and a story in mind, you can easily end up with journal manuscript sections that are not logically related to each other. 

Since the methods section constitutes the core of your paper, no matter when you write it, you need to use it to guide the reader carefully through your story from beginning to end without leaving questions unanswered. Missing or confusing details in this section will likely lead to early rejection of your manuscript or unnecessary back-and-forth with the reviewers until eventual publication. Here, you will find some useful tips on how to make your methods section the logical foundation of your research paper.

Not just a list of experiments and methods

While your introduction section provides the reader with the necessary background to understand your rationale and research question (and, depending on journal format and your personal preference, might already summarize the results), the methods section explains what exactly you did and how you did it. The point of this section is not to list all the boring details just for the sake of completeness. The purpose of the methods sections is to enable the reader to replicate exactly what you did, verify or corroborate your results, or maybe find that there are factors you did not consider or that are more relevant than expected. 

To make this section as easy to read as possible, you must clearly connect it to the information you provide in the introduction section before and the results section after, it needs to have a clear structure (chronologically or according to topics), and you need to present your results according to the same structure or topics later in the manuscript. There are also official guidelines and journal instructions to follow and ethical issues to avoid to ensure that your manuscript can quickly reach the publication stage.

Table of Contents:

• General Methods Structure: What is Your Story? 
• What Methods Should You Report (and Leave Out)? 
• Details Frequently Missing from the Methods Section

More Journal Guidelines to Consider 

• Accurate and Appropriate Language in the Methods

General Methods Section Structure: What Is Your Story? 

You might have conducted a number of experiments, maybe also a pilot before the main study to determine some specific factors or a follow-up experiment to clarify unclear details later in the process. Throwing all of these into your methods section, however, might not help the reader understand how everything is connected and how useful and appropriate your methodological approach is to investigate your specific research question. You therefore need to first come up with a clear outline and decide what to report and how to present that to the reader.

The first (and very important) decision to make is whether you present your experiments chronologically (e.g., Experiment 1, Experiment 2, Experiment 3… ), and guide the reader through every step of the process, or if you organize everything according to subtopics (e.g., Behavioral measures, Structural imaging markers, Functional imaging markers… ). In both cases, you need to use clear subheaders for the different subsections of your methods, and, very importantly, follow the same structure or focus on the same topics/measures in the results section so that the reader can easily follow along (see the two examples below).

If you are in doubt which way of organizing your experiments is better for your study, just ask yourself the following questions:

• Does the reader need to know the timeline of your study? 
• Is it relevant that one experiment was conducted first, because the outcome of this experiment determined the stimuli or factors that went into the next?
• Did the results of your first experiment leave important questions open that you addressed in an additional experiment (that was maybe not planned initially)?
• Is the answer to all of these questions “no”? Then organizing your methods section according to topics of interest might be the more logical choice.

If you think your timeline, protocol, or setup might be confusing or difficult for the reader to grasp, consider adding a graphic, flow diagram, decision tree, or table as a visual aid.

What Methods Should You Report (and Leave Out)?

The answer to this question is quite simple–you need to report everything that another researcher needs to know to be able to replicate your study. Just imagine yourself reading your methods section in the future and trying to set up the same experiments again without prior knowledge. You would probably need to ask questions such as:

• Where did you conduct your experiments (e.g., in what kind of room, under what lighting or temperature conditions, if those are relevant)? 
• What devices did you use? Are there specific settings to report?
• What specific software (and version of that software) did you use?
• How did you find and select your participants?
• How did you assign participants into groups?  
• Did you exclude participants from the analysis? Why and how?
• Where did your reagents or antibodies come from? Can you provide a Research Resource Identifier (RRID) ?
• Did you make your stimuli yourself or did you get them from somewhere?
• Are the stimuli you used available for other researchers?
• What kind of questionnaires did you use? Have they been validated?
• How did you analyze your data? What level of significance did you use?
• Were there any technical issues and did you have to adjust protocols?

Note that for every experimental detail you provide, you need to tell the reader (briefly) why you used this type of stimulus/this group of participants/these specific amounts of reagents. If there is earlier published research reporting the same methods, cite those studies. If you did pilot experiments to determine those details, describe the procedures and the outcomes of these experiments. If you made assumptions about the suitability of something based on the literature and common practice at your institution, then explain that to the reader.

In a nutshell, established methods need to be cited, and new methods need to be clearly described and briefly justified. However, if the fact that you use a new approach or a method that is not traditionally used for the data or phenomenon you study is one of the main points of your study (and maybe already reflected in the title of your article), then you need to explain your rationale for doing so in the introduction already and discuss it in more detail in the discussion section .

Note that you also need to explain your statistical analyses at the end of your methods section. You present the results of these analyses later, in the results section of your paper, but you need to show the reader in the methods section already that your approach is either well-established or valid, even if it is new or unusual. 

When it comes to the question of what details you should leave out, the answer is equally simple ‒ everything that you would not need to replicate your study in the future. If the educational background of your participants is listed in your institutional database but is not relevant to your study outcome, then don’t include that. Other things you should not include in the methods section:

• Background information that you already presented in the introduction section.
• In-depth comparisons of different methods ‒ these belong in the discussion section.
• Results, unless you summarize outcomes of pilot experiments that helped you determine factors for your main experiment.

Also, make sure your subheadings are as clear as possible, suit the structure you chose for your methods section, and are in line with the target journal guidelines. If you studied a disease intervention in human participants, then your methods section could look similar to this:

Since the main point of interest here are your patient-centered outcome variables, you would center your results section on these as well and choose your headers accordingly (e.g., Patient characteristics, Baseline evaluation, Outcome variable 1, Outcome variable 2, Drop-out rate ). 

If, instead, you did a series of visual experiments investigating the perception of faces including a pilot experiment to create the stimuli for your actual study, you would need to structure your methods section in a very different way, maybe like this:

Since here the analysis and outcome of the pilot experiment are already described in the methods section (as the basis for the main experimental setup and procedure), you do not have to mention it again in the results section. Instead, you could choose the two main experiments to structure your results section ( Discrimination and classification, Familiarization and adaptation ), or divide the results into all your test measures and/or potential interactions you described in the methods section (e.g., Discrimination performance, Classification performance, Adaptation aftereffects, Correlation analysis ).

Details Commonly Missing from the Methods Section

Manufacturer information.

For laboratory or technical equipment, you need to provide the model, name of the manufacturer, and company’s location. The usual format for these details is the product name (company name, city, state) for US-based manufacturers and the product name (company name, city/town, country) for companies outside the US.

Sample size and power estimation

Power and sample size estimations are measures for how many patients or participants are needed in a study in order to detect statistical significance and draw meaningful conclusions from the results. Outside of the medical field, studies are sometimes still conducted with a “the more the better” approach in mind, but since many journals now ask for those details, it is better to not skip this important step.

Ethical guidelines and approval

In addition to describing what you did, you also need to assure the editor and reviewers that your methods and protocols followed all relevant ethical standards and guidelines. This includes applying for approval at your local or national ethics committee, providing the name or location of that committee as well as the approval reference number you received, and, if you studied human participants, a statement that participants were informed about all relevant experimental details in advance and signed consent forms before the start of the study. For animal studies, you usually need to provide a statement that all procedures included in your research were in line with the Declaration of Helsinki. Make sure you check the target journal guidelines carefully, as these statements sometimes need to be placed at the end of the main article text rather than in the method section.

Structure & word limitations

While many journals simply follow the usual style guidelines (e.g., APA for the social sciences and psychology, AMA for medical research) and let you choose the headers of your method section according to your preferred structure and focus, some have precise guidelines and strict limitations, for example, on manuscript length and the maximum number of subsections or header levels. Make sure you read the instructions of your target journal carefully and restructure your method section if necessary before submission. If the journal does not give you enough space to include all the details that you deem necessary, then you can usually submit additional details as “supplemental” files and refer to those in the main text where necessary.

Standardized checklists

In addition to ethical guidelines and approval, journals also often ask you to submit one of the official standardized checklists for different study types to ensure all essential details are included in your manuscript. For example, there are checklists for randomized clinical trials, CONSORT (Consolidated Standards of Reporting Trials) , cohort, case-control, cross‐sectional studies, STROBE (STrengthening the Reporting of OBservational studies in Epidemiology ), diagnostic accuracy, STARD (STAndards for the Reporting of Diagnostic accuracy studies) , systematic reviews and meta‐analyses PRISMA (Preferred Reporting Items for Systematic reviews and Meta‐Analyses) , and Case reports, CARE (CAse REport) .

Make sure you check if the manuscript uses a single- or double-blind review procedure , and delete all information that might allow a reviewer to guess where the authors are located from the manuscript text if necessary. This means that your method section cannot list the name and location of your institution, the names of researchers who conducted specific tests, or the name of your institutional ethics committee.  

Accurate and Appropriate Language in the Methods Section

Like all sections of your research paper, your method section needs to be written in an academic tone . That means it should be formal, vague expressions and colloquial language need to be avoided, and you need to correctly cite all your sources. If you describe human participants in your method section then you should be especially careful about your choice of words. For example, “participants” sounds more respectful than “subjects,” and patient-first language, that is, “patients with cancer,” is considered more appropriate than “cancer patients” by many journals.

Passive voice is often considered the standard for research papers, but it is completely fine to mix passive and active voice, even in the method section, to make your text as clear and concise as possible. Use the simple past tense to describe what you did, and the present tense when you refer to diagrams or tables. Have a look at this article if you need more general input on which verb tenses to use in a research paper . 

Lastly, make sure you label all the standard tests and questionnaires you use correctly (look up the original publication when in doubt) and spell genes and proteins according to the common databases for the species you studied, such as the HUGO Gene Nomenclature Committee database for human studies .  

Visit Wordvice AI’s AI Text Editor to receive a free grammar check and English editing services (including manuscript editing , paper editing , and dissertation editing ) before submitting your manuscript to journal editors.

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Organizing Your Social Sciences Research Paper

• 6. The Methodology
• Purpose of Guide
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• Glossary of Research Terms
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The methods section describes actions taken to investigate a research problem and the rationale for the application of specific procedures or techniques used to identify, select, process, and analyze information applied to understanding the problem, thereby, allowing the reader to critically evaluate a study’s overall validity and reliability. The methodology section of a research paper answers two main questions: How was the data collected or generated? And, how was it analyzed? The writing should be direct and precise and always written in the past tense.

Kallet, Richard H. "How to Write the Methods Section of a Research Paper." Respiratory Care 49 (October 2004): 1229-1232.

Importance of a Good Methodology Section

You must explain how you obtained and analyzed your results for the following reasons:

• Readers need to know how the data was obtained because the method you chose affects the results and, by extension, how you interpreted their significance in the discussion section of your paper.
• Methodology is crucial for any branch of scholarship because an unreliable method produces unreliable results and, as a consequence, undermines the value of your analysis of the findings.
• In most cases, there are a variety of different methods you can choose to investigate a research problem. The methodology section of your paper should clearly articulate the reasons why you have chosen a particular procedure or technique.
• The reader wants to know that the data was collected or generated in a way that is consistent with accepted practice in the field of study. For example, if you are using a multiple choice questionnaire, readers need to know that it offered your respondents a reasonable range of answers to choose from.
• The method must be appropriate to fulfilling the overall aims of the study. For example, you need to ensure that you have a large enough sample size to be able to generalize and make recommendations based upon the findings.
• The methodology should discuss the problems that were anticipated and the steps you took to prevent them from occurring. For any problems that do arise, you must describe the ways in which they were minimized or why these problems do not impact in any meaningful way your interpretation of the findings.
• In the social and behavioral sciences, it is important to always provide sufficient information to allow other researchers to adopt or replicate your methodology. This information is particularly important when a new method has been developed or an innovative use of an existing method is utilized.

Bem, Daryl J. Writing the Empirical Journal Article. Psychology Writing Center. University of Washington; Denscombe, Martyn. The Good Research Guide: For Small-Scale Social Research Projects . 5th edition. Buckingham, UK: Open University Press, 2014; Lunenburg, Frederick C. Writing a Successful Thesis or Dissertation: Tips and Strategies for Students in the Social and Behavioral Sciences . Thousand Oaks, CA: Corwin Press, 2008.

Structure and Writing Style

I.  Groups of Research Methods

There are two main groups of research methods in the social sciences:

• The e mpirical-analytical group approaches the study of social sciences in a similar manner that researchers study the natural sciences . This type of research focuses on objective knowledge, research questions that can be answered yes or no, and operational definitions of variables to be measured. The empirical-analytical group employs deductive reasoning that uses existing theory as a foundation for formulating hypotheses that need to be tested. This approach is focused on explanation.
• The i nterpretative group of methods is focused on understanding phenomenon in a comprehensive, holistic way . Interpretive methods focus on analytically disclosing the meaning-making practices of human subjects [the why, how, or by what means people do what they do], while showing how those practices arrange so that it can be used to generate observable outcomes. Interpretive methods allow you to recognize your connection to the phenomena under investigation. However, the interpretative group requires careful examination of variables because it focuses more on subjective knowledge.

II.  Content

The introduction to your methodology section should begin by restating the research problem and underlying assumptions underpinning your study. This is followed by situating the methods you used to gather, analyze, and process information within the overall “tradition” of your field of study and within the particular research design you have chosen to study the problem. If the method you choose lies outside of the tradition of your field [i.e., your review of the literature demonstrates that the method is not commonly used], provide a justification for how your choice of methods specifically addresses the research problem in ways that have not been utilized in prior studies.

The remainder of your methodology section should describe the following:

• Decisions made in selecting the data you have analyzed or, in the case of qualitative research, the subjects and research setting you have examined,
• Tools and methods used to identify and collect information, and how you identified relevant variables,
• The ways in which you processed the data and the procedures you used to analyze that data, and
• The specific research tools or strategies that you utilized to study the underlying hypothesis and research questions.

In addition, an effectively written methodology section should:

• Introduce the overall methodological approach for investigating your research problem . Is your study qualitative or quantitative or a combination of both (mixed method)? Are you going to take a special approach, such as action research, or a more neutral stance?
• Indicate how the approach fits the overall research design . Your methods for gathering data should have a clear connection to your research problem. In other words, make sure that your methods will actually address the problem. One of the most common deficiencies found in research papers is that the proposed methodology is not suitable to achieving the stated objective of your paper.
• Describe the specific methods of data collection you are going to use , such as, surveys, interviews, questionnaires, observation, archival research. If you are analyzing existing data, such as a data set or archival documents, describe how it was originally created or gathered and by whom. Also be sure to explain how older data is still relevant to investigating the current research problem.
• Explain how you intend to analyze your results . Will you use statistical analysis? Will you use specific theoretical perspectives to help you analyze a text or explain observed behaviors? Describe how you plan to obtain an accurate assessment of relationships, patterns, trends, distributions, and possible contradictions found in the data.
• Provide background and a rationale for methodologies that are unfamiliar for your readers . Very often in the social sciences, research problems and the methods for investigating them require more explanation/rationale than widely accepted rules governing the natural and physical sciences. Be clear and concise in your explanation.
• Provide a justification for subject selection and sampling procedure . For instance, if you propose to conduct interviews, how do you intend to select the sample population? If you are analyzing texts, which texts have you chosen, and why? If you are using statistics, why is this set of data being used? If other data sources exist, explain why the data you chose is most appropriate to addressing the research problem.
• Provide a justification for case study selection . A common method of analyzing research problems in the social sciences is to analyze specific cases. These can be a person, place, event, phenomenon, or other type of subject of analysis that are either examined as a singular topic of in-depth investigation or multiple topics of investigation studied for the purpose of comparing or contrasting findings. In either method, you should explain why a case or cases were chosen and how they specifically relate to the research problem.
• Describe potential limitations . Are there any practical limitations that could affect your data collection? How will you attempt to control for potential confounding variables and errors? If your methodology may lead to problems you can anticipate, state this openly and show why pursuing this methodology outweighs the risk of these problems cropping up.

NOTE :   Once you have written all of the elements of the methods section, subsequent revisions should focus on how to present those elements as clearly and as logically as possibly. The description of how you prepared to study the research problem, how you gathered the data, and the protocol for analyzing the data should be organized chronologically. For clarity, when a large amount of detail must be presented, information should be presented in sub-sections according to topic. If necessary, consider using appendices for raw data.

ANOTHER NOTE : If you are conducting a qualitative analysis of a research problem , the methodology section generally requires a more elaborate description of the methods used as well as an explanation of the processes applied to gathering and analyzing of data than is generally required for studies using quantitative methods. Because you are the primary instrument for generating the data [e.g., through interviews or observations], the process for collecting that data has a significantly greater impact on producing the findings. Therefore, qualitative research requires a more detailed description of the methods used.

YET ANOTHER NOTE :   If your study involves interviews, observations, or other qualitative techniques involving human subjects , you may be required to obtain approval from the university's Office for the Protection of Research Subjects before beginning your research. This is not a common procedure for most undergraduate level student research assignments. However, i f your professor states you need approval, you must include a statement in your methods section that you received official endorsement and adequate informed consent from the office and that there was a clear assessment and minimization of risks to participants and to the university. This statement informs the reader that your study was conducted in an ethical and responsible manner. In some cases, the approval notice is included as an appendix to your paper.

III.  Problems to Avoid

Irrelevant Detail The methodology section of your paper should be thorough but concise. Do not provide any background information that does not directly help the reader understand why a particular method was chosen, how the data was gathered or obtained, and how the data was analyzed in relation to the research problem [note: analyzed, not interpreted! Save how you interpreted the findings for the discussion section]. With this in mind, the page length of your methods section will generally be less than any other section of your paper except the conclusion.

Unnecessary Explanation of Basic Procedures Remember that you are not writing a how-to guide about a particular method. You should make the assumption that readers possess a basic understanding of how to investigate the research problem on their own and, therefore, you do not have to go into great detail about specific methodological procedures. The focus should be on how you applied a method , not on the mechanics of doing a method. An exception to this rule is if you select an unconventional methodological approach; if this is the case, be sure to explain why this approach was chosen and how it enhances the overall process of discovery.

Problem Blindness It is almost a given that you will encounter problems when collecting or generating your data, or, gaps will exist in existing data or archival materials. Do not ignore these problems or pretend they did not occur. Often, documenting how you overcame obstacles can form an interesting part of the methodology. It demonstrates to the reader that you can provide a cogent rationale for the decisions you made to minimize the impact of any problems that arose.

Literature Review Just as the literature review section of your paper provides an overview of sources you have examined while researching a particular topic, the methodology section should cite any sources that informed your choice and application of a particular method [i.e., the choice of a survey should include any citations to the works you used to help construct the survey].

It’s More than Sources of Information! A description of a research study's method should not be confused with a description of the sources of information. Such a list of sources is useful in and of itself, especially if it is accompanied by an explanation about the selection and use of the sources. The description of the project's methodology complements a list of sources in that it sets forth the organization and interpretation of information emanating from those sources.

Azevedo, L.F. et al. "How to Write a Scientific Paper: Writing the Methods Section." Revista Portuguesa de Pneumologia 17 (2011): 232-238; Blair Lorrie. “Choosing a Methodology.” In Writing a Graduate Thesis or Dissertation , Teaching Writing Series. (Rotterdam: Sense Publishers 2016), pp. 49-72; Butin, Dan W. The Education Dissertation A Guide for Practitioner Scholars . Thousand Oaks, CA: Corwin, 2010; Carter, Susan. Structuring Your Research Thesis . New York: Palgrave Macmillan, 2012; Kallet, Richard H. “How to Write the Methods Section of a Research Paper.” Respiratory Care 49 (October 2004):1229-1232; Lunenburg, Frederick C. Writing a Successful Thesis or Dissertation: Tips and Strategies for Students in the Social and Behavioral Sciences . Thousand Oaks, CA: Corwin Press, 2008. Methods Section. The Writer’s Handbook. Writing Center. University of Wisconsin, Madison; Rudestam, Kjell Erik and Rae R. Newton. “The Method Chapter: Describing Your Research Plan.” In Surviving Your Dissertation: A Comprehensive Guide to Content and Process . (Thousand Oaks, Sage Publications, 2015), pp. 87-115; What is Interpretive Research. Institute of Public and International Affairs, University of Utah; Writing the Experimental Report: Methods, Results, and Discussion. The Writing Lab and The OWL. Purdue University; Methods and Materials. The Structure, Format, Content, and Style of a Journal-Style Scientific Paper. Department of Biology. Bates College.

Writing Tip

Statistical Designs and Tests? Do Not Fear Them!

Don't avoid using a quantitative approach to analyzing your research problem just because you fear the idea of applying statistical designs and tests. A qualitative approach, such as conducting interviews or content analysis of archival texts, can yield exciting new insights about a research problem, but it should not be undertaken simply because you have a disdain for running a simple regression. A well designed quantitative research study can often be accomplished in very clear and direct ways, whereas, a similar study of a qualitative nature usually requires considerable time to analyze large volumes of data and a tremendous burden to create new paths for analysis where previously no path associated with your research problem had existed.

To locate data and statistics, GO HERE .

Another Writing Tip

Knowing the Relationship Between Theories and Methods

There can be multiple meaning associated with the term "theories" and the term "methods" in social sciences research. A helpful way to delineate between them is to understand "theories" as representing different ways of characterizing the social world when you research it and "methods" as representing different ways of generating and analyzing data about that social world. Framed in this way, all empirical social sciences research involves theories and methods, whether they are stated explicitly or not. However, while theories and methods are often related, it is important that, as a researcher, you deliberately separate them in order to avoid your theories playing a disproportionate role in shaping what outcomes your chosen methods produce.

Introspectively engage in an ongoing dialectic between the application of theories and methods to help enable you to use the outcomes from your methods to interrogate and develop new theories, or ways of framing conceptually the research problem. This is how scholarship grows and branches out into new intellectual territory.

Reynolds, R. Larry. Ways of Knowing. Alternative Microeconomics . Part 1, Chapter 3. Boise State University; The Theory-Method Relationship. S-Cool Revision. United Kingdom.

Yet Another Writing Tip

Methods and the Methodology

Do not confuse the terms "methods" and "methodology." As Schneider notes, a method refers to the technical steps taken to do research . Descriptions of methods usually include defining and stating why you have chosen specific techniques to investigate a research problem, followed by an outline of the procedures you used to systematically select, gather, and process the data [remember to always save the interpretation of data for the discussion section of your paper].

The methodology refers to a discussion of the underlying reasoning why particular methods were used . This discussion includes describing the theoretical concepts that inform the choice of methods to be applied, placing the choice of methods within the more general nature of academic work, and reviewing its relevance to examining the research problem. The methodology section also includes a thorough review of the methods other scholars have used to study the topic.

Bryman, Alan. "Of Methods and Methodology." Qualitative Research in Organizations and Management: An International Journal 3 (2008): 159-168; Schneider, Florian. “What's in a Methodology: The Difference between Method, Methodology, and Theory…and How to Get the Balance Right?” PoliticsEastAsia.com. Chinese Department, University of Leiden, Netherlands.

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APA Methods Section – How To Write It With Examples

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The APA methods section is a very important part of your academic paper, displaying how you conducted your research by providing a precise description of the methods and procedures you used for the study. This section ensures transparency, allowing other researchers to see exactly how you conducted your experiments. In APA style , the methods section usually includes subsections on participants, materials or measures, and procedures. This article discusses the APA methods section in detail.

Inhaltsverzeichnis

• 1 APA Methods Section – In a Nutshell
• 2 Definition: APA Methods Section
• 3 APA Methods Section: Structure
• 4 APA Methods Section: Participants
• 5 APA Methods Section: Materials
• 6 APA Methods Section: Procedure

APA Methods Section – In a Nutshell

• The APA methods section covers the participants, materials, and procedures.
• Under the ‘Participants’ heading of the APA methods section, you should state the relevant demographic characteristics of your participants.
• Accurately reporting the facts of the study can help other researchers determine how much the results can be generalized.

Definition: APA Methods Section

The APA methods section describes the procedures you used to carry out your research and explains why particular processes were selected. It allows other researchers to replicate the study and make their own conclusions on the validity of the experiment.

APA Methods Section: Structure

• The main heading of the APA methods section should be written in bold and should be capitalized. It also has to be centered.
• All subheadings should be aligned to the left and must be boldfaced. You should select subheadings that are suitable for your essay, and the most commonly used include ‘Participants’, ‘Materials’, and ‘Procedure’.

Heading formats:

APA format has certain requirements for reporting different research designs. You should go through these guidelines to determine what you should mention for research using longitudinal designs , replication studies, and experimental designs .

APA Methods Section: Participants

Under this subheading, you will have to report on the sample characteristics, the procedures used to collect samples, and the sample size selected.

Subject or Participant Characteristics

In academic studies, ‘participants’ refers to the people who take part in a study. If animals are used instead of human beings, the researcher can use the term ‘subjects’. In this subheading of the APA methods section, you have to describe the demographic characteristics of the participants, including their age, sex, race, ethnic group, education level, and gender identity. Depending on the nature of the study, other characteristics may be important. Some of these include:

• Education levels
• Language preference
• Immigration status

By describing the characteristics of the participants, readers will be able to determine how much the results can be generalized. Make sure you use bias-free language when writing this part of the APA methods section.

The study included 100 homosexual men and 100 homosexual women aged between 30 and 50 years from the city of London, UK.

Sampling Procedures

When selecting participants for your study, you will have to use certain sampling procedures. If the study could access all members of the population, you can say that you used random sampling methods. This section of the APA methods section should cover the percentage of respondents who participated in the research, and how they were chosen. You also need to state how participants were compensated and the ethical standard followed.

• Transgender male students from London were invited to participate in a study.
• Invites were sent to the students via email, social media posts, and posters in the schools.
• Each participant received $10 for the time spent in the study.
• The research obtained ethical approval before the participants were recruited.

Sample Size and Statistical Power

In this part of the APA methods section, you should give details on the sample size and statistical power you aimed at achieving. You should mention whether the final sample was the same as the intended sample. This section should show whether your research had enough statistical power to find any effects.

• The study aimed at a statistical power of 75% to detect an effect of 10% with an alpha of .05.
• 200 participants were required, and the study fulfilled these conditions.

APA Methods Section: Materials

Readers also need to know the materials you used for the study. This part of the APA methods section will give other researchers a good picture of the methods used to conduct the study.

Primary and secondary measures

Here, you should indicate the instruments used in the study, as well as the constructs they were meant to measure. Some of these are inventories, scales, tests, software, and hardware. Make sure you cover the following aspects:

• Reliability
• The Traumatic Stress Schedule (TSS) was used to measure the exposure to traumatic events.
• This 10-item chart requires participants to report lifelong exposure to traumatic stress.
• For example, they could indicate whether they suffered the traumatic death of a loved one.
• The Davidson Trauma Scale was also used to assess the symptoms of trauma.

Under this subheading of the APA methods section, you should also mention covariates or additional variables that can explain the outcomes.

Quality of measurements

You can mention the strategies you applied to ensure data integrity and reliability. These may include:

• Training the interviewers
• Establishing clear data nominalization procedures
• Rigorous data handling and analysis processes
• Having multiple people assess the data

If the data was subjectively coded, you should indicate the interrater reliability scores in the APA methods section.

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APA Methods Section: Procedure

This part of the APA methods section indicates the methods you used to carry out the research, process the data, and analyze the results.

Research Design and Data Collection Methods

Data collection is the systematic gathering of observations and measurements, and you have to describe all procedures used in this process. You can use supplementary materials to describe long and complicated data collection methods.

When reporting the research design, you should mention the framework of the study. This could be experimental, longitudinal, correlational, or descriptive. Additionally, you should mention whether you used a between-subjects design or within-subjects design .

In this part of the APA methods section, you should also mention whether any masking methods were used to hide condition assignments from the participants.

• Participants are told the research takes an hour covers their personal experiences in school.
• They were assured that the reports would be confidential and were asked to give consent.
• The participants were asked to fill in questionnaires .
• The control group was given an unrelated filler task, after which they filled a questionnaire.
• It was determined the experiences of homosexual and CIS-gendered students varied.

Data diagnostics

This part of the APA method section outlines the steps taken to process the data. It includes:

• Methods of identifying and controlling outliers
• Data transformation procedures
• Methods of compensating for missing values

Analytic strategies

This subheading of the APA methods section describes the analytic strategies used, but you shouldn’t mention the outcomes. The primary and secondary hypotheses use past studies or theoretical frameworks , while exploratory hypotheses focus on the data in the study.

We started by assessing the demographic differences between the two groups. We also performed an independent samples t-test on the test scores .

What are the parts of an APA methods section?

In this section, you should include the study participants, the methods used, and the procedures.

What is included in the APA methods section?

The methods section covers the participants or subject characteristics, the sampling procedures, the sample size, the measures used, the data collection methods, the research design, the data analysis strategy, and the data processing method.

Should I use the Oxford comma when writing the APA methods section?

Yes, the serial comma is required when writing the APA methods section.

Should I use the first person to write the APA methods section?

Yes, the APA language guidelines encourage researchers to use first-person pronouns when writing the methods section.

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How to write the methods section of a research paper

Affiliation.

• 1 Respiratory Care Services, San Francisco General Hospital, NH:GA-2, 1001 Potrero Avenue, San Francisco, CA 94110, USA. [email protected]
• PMID: 15447808

The methods section of a research paper provides the information by which a study's validity is judged. Therefore, it requires a clear and precise description of how an experiment was done, and the rationale for why specific experimental procedures were chosen. The methods section should describe what was done to answer the research question, describe how it was done, justify the experimental design, and explain how the results were analyzed. Scientific writing is direct and orderly. Therefore, the methods section structure should: describe the materials used in the study, explain how the materials were prepared for the study, describe the research protocol, explain how measurements were made and what calculations were performed, and state which statistical tests were done to analyze the data. Once all elements of the methods section are written, subsequent drafts should focus on how to present those elements as clearly and logically as possibly. The description of preparations, measurements, and the protocol should be organized chronologically. For clarity, when a large amount of detail must be presented, information should be presented in sub-sections according to topic. Material in each section should be organized by topic from most to least important.

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Advanced Research Methods

Writing the research paper.

• What Is Research?
• Library Research
• Writing a Research Proposal

Before Writing the Paper

Methods, thesis and hypothesis, clarity, precision and academic expression, format your paper, typical problems, a few suggestions, avoid plagiarism.

• Presenting the Research Paper

Find a topic.

• Try to find a subject that really interests you.
• While you explore the topic, narrow or broaden your target and focus on something that gives the most promising results.
• Don't choose a huge subject if you have to write a 3 page long paper, and broaden your topic sufficiently if you have to submit at least 25 pages.
• Consult your class instructor (and your classmates) about the topic.

Explore the topic.

• Find primary and secondary sources in the library.
• Read and critically analyse them.
• Take notes.
• Compile surveys, collect data, gather materials for quantitative analysis (if these are good methods to investigate the topic more deeply).
• Come up with new ideas about the topic. Try to formulate your ideas in a few sentences.
• Review your notes and other materials and enrich the outline.
• Try to estimate how long the individual parts will be.
• Do others understand what you want to say?
• Do they accept it as new knowledge or relevant and important for a paper?
• Do they agree that your thoughts will result in a successful paper?
• Qualitative: gives answers on questions (how, why, when, who, what, etc.) by investigating an issue
• Quantitative:requires data and the analysis of data as well
• the essence, the point of the research paper in one or two sentences.
• a statement that can be proved or disproved.
• Be specific.
• Avoid ambiguity.
• Use predominantly the active voice, not the passive.
• Deal with one issue in one paragraph.
• Be accurate.
• Double-check your data, references, citations and statements.

Academic Expression

• Don't use familiar style or colloquial/slang expressions.
• Write in full sentences.
• Check the meaning of the words if you don't know exactly what they mean.
• Avoid metaphors.
• Almost the rough content of every paragraph.
• The order of the various topics in your paper.
• On the basis of the outline, start writing a part by planning the content, and then write it down.
• Put a visible mark (which you will later delete) where you need to quote a source, and write in the citation when you finish writing that part or a bigger part.
• Does the text make sense?
• Could you explain what you wanted?
• Did you write good sentences?
• Is there something missing?
• Check the spelling.
• Complete the citations, bring them in standard format.

Use the guidelines that your instructor requires (MLA, Chicago, APA, Turabian, etc.).

• Adjust margins, spacing, paragraph indentation, place of page numbers, etc.
• Standardize the bibliography or footnotes according to the guidelines.

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(Based on English Composition 2 from Illinois Valley Community College):

• Weak organization
• Poor support and development of ideas
• Weak use of secondary sources
• Excessive errors
• Stylistic weakness

When collecting materials, selecting research topic, and writing the paper:

• Be systematic and organized (e.g. keep your bibliography neat and organized; write your notes in a neat way, so that you can find them later on.
• Use your critical thinking ability when you read.
• Write down your thoughts (so that you can reconstruct them later).
• Stop when you have a really good idea and think about whether you could enlarge it to a whole research paper. If yes, take much longer notes.
• When you write down a quotation or summarize somebody else's thoughts in your notes or in the paper, cite the source (i.e. write down the author, title, publication place, year, page number).
• If you quote or summarize a thought from the internet, cite the internet source.
• Write an outline that is detailed enough to remind you about the content.
• Read your paper for yourself or, preferably, somebody else. 
• When you finish writing, check the spelling;
• Use the citation form (MLA, Chicago, or other) that your instructor requires and use it everywhere.

Plagiarism : somebody else's words or ideas presented without citation by an author

• Cite your source every time when you quote a part of somebody's work.
• Cite your source  every time when you summarize a thought from somebody's work.
• Cite your source  every time when you use a source (quote or summarize) from the Internet.

Consult the Citing Sources research guide for further details.

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How to Write the Methods Section of a Research Paper

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The methods section of a research paper provides the information by which a study's validity is judged. Therefore, it requires a clear and precise description of how an experiment was done, and the rationale for why specific experimental procedures were chosen. The methods section should describe what was done to answer the research question, describe how it was done, justify the experimental design, and explain how the results were analyzed. Scientific writing is direct and orderly. Therefore, the methods section structure should: describe the materials used in the study, explain how the materials were prepared for the study, describe the research protocol, explain how measurements were made and what calculations were performed, and state which statistical tests were done to analyze the data. Once all elements of the methods section are written, subsequent drafts should focus on how to present those elements as clearly and logically as possibly. The description of preparations, measurements, and the protocol should be organized chronologically. For clarity, when a large amount of detail must be presented, information should be presented in sub-sections according to topic. Material in each section should be organized by topic from most to least important.

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• Correspondence: Richard H Kallet MS RRT FAARC, Respiratory Care Services, San Francisco General Hospital, NH:GA-2, 1001 Potrero Avenue, San Francisco CA. 94110. E-mail: rkallet{at}sfghsom.ucsf.edu .
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Home » Research Paper – Structure, Examples and Writing Guide

Research Paper – Structure, Examples and Writing Guide

Table of Contents

Research Paper

Definition:

Research Paper is a written document that presents the author’s original research, analysis, and interpretation of a specific topic or issue.

It is typically based on Empirical Evidence, and may involve qualitative or quantitative research methods, or a combination of both. The purpose of a research paper is to contribute new knowledge or insights to a particular field of study, and to demonstrate the author’s understanding of the existing literature and theories related to the topic.

Structure of Research Paper

The structure of a research paper typically follows a standard format, consisting of several sections that convey specific information about the research study. The following is a detailed explanation of the structure of a research paper:

The title page contains the title of the paper, the name(s) of the author(s), and the affiliation(s) of the author(s). It also includes the date of submission and possibly, the name of the journal or conference where the paper is to be published.

The abstract is a brief summary of the research paper, typically ranging from 100 to 250 words. It should include the research question, the methods used, the key findings, and the implications of the results. The abstract should be written in a concise and clear manner to allow readers to quickly grasp the essence of the research.

Introduction

The introduction section of a research paper provides background information about the research problem, the research question, and the research objectives. It also outlines the significance of the research, the research gap that it aims to fill, and the approach taken to address the research question. Finally, the introduction section ends with a clear statement of the research hypothesis or research question.

Literature Review

The literature review section of a research paper provides an overview of the existing literature on the topic of study. It includes a critical analysis and synthesis of the literature, highlighting the key concepts, themes, and debates. The literature review should also demonstrate the research gap and how the current study seeks to address it.

The methods section of a research paper describes the research design, the sample selection, the data collection and analysis procedures, and the statistical methods used to analyze the data. This section should provide sufficient detail for other researchers to replicate the study.

The results section presents the findings of the research, using tables, graphs, and figures to illustrate the data. The findings should be presented in a clear and concise manner, with reference to the research question and hypothesis.

The discussion section of a research paper interprets the findings and discusses their implications for the research question, the literature review, and the field of study. It should also address the limitations of the study and suggest future research directions.

The conclusion section summarizes the main findings of the study, restates the research question and hypothesis, and provides a final reflection on the significance of the research.

The references section provides a list of all the sources cited in the paper, following a specific citation style such as APA, MLA or Chicago.

How to Write Research Paper

You can write Research Paper by the following guide:

• Choose a Topic: The first step is to select a topic that interests you and is relevant to your field of study. Brainstorm ideas and narrow down to a research question that is specific and researchable.
• Conduct a Literature Review: The literature review helps you identify the gap in the existing research and provides a basis for your research question. It also helps you to develop a theoretical framework and research hypothesis.
• Develop a Thesis Statement : The thesis statement is the main argument of your research paper. It should be clear, concise and specific to your research question.
• Plan your Research: Develop a research plan that outlines the methods, data sources, and data analysis procedures. This will help you to collect and analyze data effectively.
• Collect and Analyze Data: Collect data using various methods such as surveys, interviews, observations, or experiments. Analyze data using statistical tools or other qualitative methods.
• Organize your Paper : Organize your paper into sections such as Introduction, Literature Review, Methods, Results, Discussion, and Conclusion. Ensure that each section is coherent and follows a logical flow.
• Write your Paper : Start by writing the introduction, followed by the literature review, methods, results, discussion, and conclusion. Ensure that your writing is clear, concise, and follows the required formatting and citation styles.
• Edit and Proofread your Paper: Review your paper for grammar and spelling errors, and ensure that it is well-structured and easy to read. Ask someone else to review your paper to get feedback and suggestions for improvement.
• Cite your Sources: Ensure that you properly cite all sources used in your research paper. This is essential for giving credit to the original authors and avoiding plagiarism.

Research Paper Example

Note : The below example research paper is for illustrative purposes only and is not an actual research paper. Actual research papers may have different structures, contents, and formats depending on the field of study, research question, data collection and analysis methods, and other factors. Students should always consult with their professors or supervisors for specific guidelines and expectations for their research papers.

Research Paper Example sample for Students:

Title: The Impact of Social Media on Mental Health among Young Adults

Abstract: This study aims to investigate the impact of social media use on the mental health of young adults. A literature review was conducted to examine the existing research on the topic. A survey was then administered to 200 university students to collect data on their social media use, mental health status, and perceived impact of social media on their mental health. The results showed that social media use is positively associated with depression, anxiety, and stress. The study also found that social comparison, cyberbullying, and FOMO (Fear of Missing Out) are significant predictors of mental health problems among young adults.

Introduction: Social media has become an integral part of modern life, particularly among young adults. While social media has many benefits, including increased communication and social connectivity, it has also been associated with negative outcomes, such as addiction, cyberbullying, and mental health problems. This study aims to investigate the impact of social media use on the mental health of young adults.

Literature Review: The literature review highlights the existing research on the impact of social media use on mental health. The review shows that social media use is associated with depression, anxiety, stress, and other mental health problems. The review also identifies the factors that contribute to the negative impact of social media, including social comparison, cyberbullying, and FOMO.

Methods : A survey was administered to 200 university students to collect data on their social media use, mental health status, and perceived impact of social media on their mental health. The survey included questions on social media use, mental health status (measured using the DASS-21), and perceived impact of social media on their mental health. Data were analyzed using descriptive statistics and regression analysis.

Results : The results showed that social media use is positively associated with depression, anxiety, and stress. The study also found that social comparison, cyberbullying, and FOMO are significant predictors of mental health problems among young adults.

Discussion : The study’s findings suggest that social media use has a negative impact on the mental health of young adults. The study highlights the need for interventions that address the factors contributing to the negative impact of social media, such as social comparison, cyberbullying, and FOMO.

Conclusion : In conclusion, social media use has a significant impact on the mental health of young adults. The study’s findings underscore the need for interventions that promote healthy social media use and address the negative outcomes associated with social media use. Future research can explore the effectiveness of interventions aimed at reducing the negative impact of social media on mental health. Additionally, longitudinal studies can investigate the long-term effects of social media use on mental health.

Limitations : The study has some limitations, including the use of self-report measures and a cross-sectional design. The use of self-report measures may result in biased responses, and a cross-sectional design limits the ability to establish causality.

Implications: The study’s findings have implications for mental health professionals, educators, and policymakers. Mental health professionals can use the findings to develop interventions that address the negative impact of social media use on mental health. Educators can incorporate social media literacy into their curriculum to promote healthy social media use among young adults. Policymakers can use the findings to develop policies that protect young adults from the negative outcomes associated with social media use.

References :

• Twenge, J. M., & Campbell, W. K. (2019). Associations between screen time and lower psychological well-being among children and adolescents: Evidence from a population-based study. Preventive medicine reports, 15, 100918.
• Primack, B. A., Shensa, A., Escobar-Viera, C. G., Barrett, E. L., Sidani, J. E., Colditz, J. B., … & James, A. E. (2017). Use of multiple social media platforms and symptoms of depression and anxiety: A nationally-representative study among US young adults. Computers in Human Behavior, 69, 1-9.
• Van der Meer, T. G., & Verhoeven, J. W. (2017). Social media and its impact on academic performance of students. Journal of Information Technology Education: Research, 16, 383-398.

Appendix : The survey used in this study is provided below.

Social Media and Mental Health Survey

• How often do you use social media per day?
• Less than 30 minutes
• 30 minutes to 1 hour
• 1 to 2 hours
• 2 to 4 hours
• More than 4 hours
• Which social media platforms do you use?
• Others (Please specify)
• How often do you experience the following on social media?
• Social comparison (comparing yourself to others)
• Cyberbullying
• Fear of Missing Out (FOMO)
• Have you ever experienced any of the following mental health problems in the past month?
• Do you think social media use has a positive or negative impact on your mental health?
• Very positive
• Somewhat positive
• Somewhat negative
• Very negative
• In your opinion, which factors contribute to the negative impact of social media on mental health?
• Social comparison
• In your opinion, what interventions could be effective in reducing the negative impact of social media on mental health?
• Education on healthy social media use
• Counseling for mental health problems caused by social media
• Social media detox programs
• Regulation of social media use

Thank you for your participation!

Applications of Research Paper

Research papers have several applications in various fields, including:

• Advancing knowledge: Research papers contribute to the advancement of knowledge by generating new insights, theories, and findings that can inform future research and practice. They help to answer important questions, clarify existing knowledge, and identify areas that require further investigation.
• Informing policy: Research papers can inform policy decisions by providing evidence-based recommendations for policymakers. They can help to identify gaps in current policies, evaluate the effectiveness of interventions, and inform the development of new policies and regulations.
• Improving practice: Research papers can improve practice by providing evidence-based guidance for professionals in various fields, including medicine, education, business, and psychology. They can inform the development of best practices, guidelines, and standards of care that can improve outcomes for individuals and organizations.
• Educating students : Research papers are often used as teaching tools in universities and colleges to educate students about research methods, data analysis, and academic writing. They help students to develop critical thinking skills, research skills, and communication skills that are essential for success in many careers.
• Fostering collaboration: Research papers can foster collaboration among researchers, practitioners, and policymakers by providing a platform for sharing knowledge and ideas. They can facilitate interdisciplinary collaborations and partnerships that can lead to innovative solutions to complex problems.

When to Write Research Paper

Research papers are typically written when a person has completed a research project or when they have conducted a study and have obtained data or findings that they want to share with the academic or professional community. Research papers are usually written in academic settings, such as universities, but they can also be written in professional settings, such as research organizations, government agencies, or private companies.

Here are some common situations where a person might need to write a research paper:

• For academic purposes: Students in universities and colleges are often required to write research papers as part of their coursework, particularly in the social sciences, natural sciences, and humanities. Writing research papers helps students to develop research skills, critical thinking skills, and academic writing skills.
• For publication: Researchers often write research papers to publish their findings in academic journals or to present their work at academic conferences. Publishing research papers is an important way to disseminate research findings to the academic community and to establish oneself as an expert in a particular field.
• To inform policy or practice : Researchers may write research papers to inform policy decisions or to improve practice in various fields. Research findings can be used to inform the development of policies, guidelines, and best practices that can improve outcomes for individuals and organizations.
• To share new insights or ideas: Researchers may write research papers to share new insights or ideas with the academic or professional community. They may present new theories, propose new research methods, or challenge existing paradigms in their field.

Purpose of Research Paper

The purpose of a research paper is to present the results of a study or investigation in a clear, concise, and structured manner. Research papers are written to communicate new knowledge, ideas, or findings to a specific audience, such as researchers, scholars, practitioners, or policymakers. The primary purposes of a research paper are:

• To contribute to the body of knowledge : Research papers aim to add new knowledge or insights to a particular field or discipline. They do this by reporting the results of empirical studies, reviewing and synthesizing existing literature, proposing new theories, or providing new perspectives on a topic.
• To inform or persuade: Research papers are written to inform or persuade the reader about a particular issue, topic, or phenomenon. They present evidence and arguments to support their claims and seek to persuade the reader of the validity of their findings or recommendations.
• To advance the field: Research papers seek to advance the field or discipline by identifying gaps in knowledge, proposing new research questions or approaches, or challenging existing assumptions or paradigms. They aim to contribute to ongoing debates and discussions within a field and to stimulate further research and inquiry.
• To demonstrate research skills: Research papers demonstrate the author’s research skills, including their ability to design and conduct a study, collect and analyze data, and interpret and communicate findings. They also demonstrate the author’s ability to critically evaluate existing literature, synthesize information from multiple sources, and write in a clear and structured manner.

Characteristics of Research Paper

Research papers have several characteristics that distinguish them from other forms of academic or professional writing. Here are some common characteristics of research papers:

• Evidence-based: Research papers are based on empirical evidence, which is collected through rigorous research methods such as experiments, surveys, observations, or interviews. They rely on objective data and facts to support their claims and conclusions.
• Structured and organized: Research papers have a clear and logical structure, with sections such as introduction, literature review, methods, results, discussion, and conclusion. They are organized in a way that helps the reader to follow the argument and understand the findings.
• Formal and objective: Research papers are written in a formal and objective tone, with an emphasis on clarity, precision, and accuracy. They avoid subjective language or personal opinions and instead rely on objective data and analysis to support their arguments.
• Citations and references: Research papers include citations and references to acknowledge the sources of information and ideas used in the paper. They use a specific citation style, such as APA, MLA, or Chicago, to ensure consistency and accuracy.
• Peer-reviewed: Research papers are often peer-reviewed, which means they are evaluated by other experts in the field before they are published. Peer-review ensures that the research is of high quality, meets ethical standards, and contributes to the advancement of knowledge in the field.
• Objective and unbiased: Research papers strive to be objective and unbiased in their presentation of the findings. They avoid personal biases or preconceptions and instead rely on the data and analysis to draw conclusions.

Advantages of Research Paper

Research papers have many advantages, both for the individual researcher and for the broader academic and professional community. Here are some advantages of research papers:

• Contribution to knowledge: Research papers contribute to the body of knowledge in a particular field or discipline. They add new information, insights, and perspectives to existing literature and help advance the understanding of a particular phenomenon or issue.
• Opportunity for intellectual growth: Research papers provide an opportunity for intellectual growth for the researcher. They require critical thinking, problem-solving, and creativity, which can help develop the researcher’s skills and knowledge.
• Career advancement: Research papers can help advance the researcher’s career by demonstrating their expertise and contributions to the field. They can also lead to new research opportunities, collaborations, and funding.
• Academic recognition: Research papers can lead to academic recognition in the form of awards, grants, or invitations to speak at conferences or events. They can also contribute to the researcher’s reputation and standing in the field.
• Impact on policy and practice: Research papers can have a significant impact on policy and practice. They can inform policy decisions, guide practice, and lead to changes in laws, regulations, or procedures.
• Advancement of society: Research papers can contribute to the advancement of society by addressing important issues, identifying solutions to problems, and promoting social justice and equality.

Limitations of Research Paper

Research papers also have some limitations that should be considered when interpreting their findings or implications. Here are some common limitations of research papers:

• Limited generalizability: Research findings may not be generalizable to other populations, settings, or contexts. Studies often use specific samples or conditions that may not reflect the broader population or real-world situations.
• Potential for bias : Research papers may be biased due to factors such as sample selection, measurement errors, or researcher biases. It is important to evaluate the quality of the research design and methods used to ensure that the findings are valid and reliable.
• Ethical concerns: Research papers may raise ethical concerns, such as the use of vulnerable populations or invasive procedures. Researchers must adhere to ethical guidelines and obtain informed consent from participants to ensure that the research is conducted in a responsible and respectful manner.
• Limitations of methodology: Research papers may be limited by the methodology used to collect and analyze data. For example, certain research methods may not capture the complexity or nuance of a particular phenomenon, or may not be appropriate for certain research questions.
• Publication bias: Research papers may be subject to publication bias, where positive or significant findings are more likely to be published than negative or non-significant findings. This can skew the overall findings of a particular area of research.
• Time and resource constraints: Research papers may be limited by time and resource constraints, which can affect the quality and scope of the research. Researchers may not have access to certain data or resources, or may be unable to conduct long-term studies due to practical limitations.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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How to write a materials and methods section of a scientific article?

In contrast to past centuries, scientific researchers have been currently conducted systematically in all countries as part of an education strategy. As a consequence, scientists have published thousands of reports. Writing an effective article is generally a significant problem for researchers. All parts of an article, specifically the abstract, material and methods, results, discussion and references sections should contain certain features that should always be considered before sending a manuscript to a journal for publication. It is generally known that the material and methods section is a relatively easy section of an article to write. Therefore, it is often a good idea to begin by writing the materials and methods section, which is also a crucial part of an article. Because “reproducible results” are very important in science, a detailed account of the study should be given in this section. If the authors provide sufficient detail, other scientists can repeat their experiments to verify their findings. It is generally recommended that the materials and methods should be written in the past tense, either in active or passive voice. In this section, ethical approval, study dates, number of subjects, groups, evaluation criteria, exclusion criteria and statistical methods should be described sequentially. It should be noted that a well-written materials and methods section markedly enhances the chances of an article being published.

How to Write a Materials and Methods Section of a Scientific Article?

Up to the 18 th Century scientific researches were performed on a voluntary basis by certain scientists. However from the second half of the 19 th century, scientific development has gained momentum with the contributions of numerous scientists including Edison, Fleming, and Koch. In parallel with these developments, apparently each scientific field, and even their branches made, and still making magnificent progressions from the end of the 18 th century. Secondary to these developments, scientific researches have been implemented systematically by universities, and various institutions in every part of the world as an integral component of national strategies. Naturally, the number of researchers who performed scientific investigations or sponsored by various institutions increased considerably. Also, as is known very well, all over the world scientists, and researchers move from one place to another to disseminate scientific knowledge. All of these scientific efforts, and activities reflect on clinical practice, and hundreds of thousands, and millions scientific articles which we can currently gain access into all of them online. As indicated by the investigator Gerard Piel, “Without publication, science is dead” which explains the importance of publication. In other words, if you don’t share your investigation and knowledge, they don’t mean anything by themselves. Although sharing the knowledge is essential for writing a scientific paper, nowadays writing a scientific article is mostly learnt as a master-apprentice relationship, and therefore certain standards have not been established. This phenomenon creates serious stress especially for young investigators in their early stage of writing scientific papers. Indeed investigators receiving their residency training confront this reality finally during writing of their dissertations. Though sharing knowledge is known as a fundamental principle in writing a scientific paper, it creates difficulties in the whole world. Relevant to this issue, in the whole world investigations have been performed, and books have been written on the subject of how to write a scientific paper. Accordingly, in our country mostly local meetings, and courses have been organized. These organizations, and investigations should be performed. Indeed, nowadays, in the first assessments, the rejection rate of the journals by internationally acknowledged scientific indexes as “Science Citation İndex (SCI)” and “Science Citation İndex Expanded (SCI-extended” which have certain scientific standards, increases to 62 percent. As a matter of fact only 25% of Class A journals have been included in the lists of SCI, and SCI-extended.

As we all know very well, scientific articles consist of sections of summary, introduction, material, and methods, discussion, and references. Among them, conventionally Materials and Methods section has been reported as the most easily written or will be written section. Although it is known as the most easily written section, nearly 30% of the reasons for rejection are related to this section per se. Therefore due care, and attention should be given to the writing of this section. In the writing process of the ‘Material and Methods’ section, all achievements performed throughout the study period should be dealt with in consideration of certain criteria in a specific sequence. Since as a globally anticipated viewpoint, ‘Materials and Methods’ section can be written quite easily, it has been indicated that if difficulties are encountered in writing a manuscript, then one should start writing from this section. In writing this section, study design describing the type of the article, study subjects to be investigated, methods, and procedures of measurements should be provided under four main headings. [ 1 , 2 ] Accordingly, in brief, we can emphasize the importance of providing clear-cut, adequate, and detailed information in the ‘Materials and Methods’ section to the scientists who will read this scientific article. Meeting these criteria carries great importance with respect to the evaluation of reliability of the investigation by the readers, and reviewers, and also informing them about procedural method, design, data collection, and assessment methods of the investigation, Priorly, as is the case in all scientific investigations, one should be reminded about the importance, and indispensability of compliance with certain standard writing rules. Accordingly, rules of grammar should be obeyed, and if possible passive voice of simple past tense should be used. Related to these rules, use of verbs ‘investigated’, ‘evaluated’ or ‘performed’ will be appropriate. Recently, expressions showing the ownership of the investigation as ‘we performed’, ‘we evaluated’, ‘we implemented’ have taken priority. Since the important point is communication of the message contained in the scientific study, the message should be clearly comprehensible. While ensuring clarity of the message, use of flourishing, and irrelevant sentences should be avoided. [ 1 , 3 ] According to another approach, since our article will be read by professionals of other disciplines, it is important to comply with certain rules of writing. To that end, standard units of measurements, and international abbreviations should be used. Abbreviations should be explained within parentheses at their first mention in the manuscript. For instance let’s analyze the following sentence” The patients were evaluated with detailed medical history, physical examination, complete urinalysis, PSA, and urinary system ultrasound” The abbreviation PSA is very well known by the urologist. However we shouldn’t forget that this article will be read by the professionals in other medical disciplines. Similarly this sentence should not be written as: “The patients were evaluated with detailed medical history, physical examination, complete urinalysis PSA (prostate-specific antigen), and urinary system ultrasound.” Indeed the abbreviation should follow the explanation of this abbreviation. Then the appropriate expression of the sentence should be. “The patients were evaluated with detailed medical history, physical examination, complete urinalysis, prostate-specific antigen (PSA), and urinary system ultrasound.”

In addition to the abovementioned information, in the beginning paragraphs of ‘Materials and Methods’ section of a clinical study the answers to the following questions should be absolutely provided:

• The beginning, and termination dates of the study period.
• Number of subjects/patients/experimental animals etc. enrolled in the study,
• Has the approval of the ethics committee been obtained?
• Study design (prospective, retrospective or other). [ 1 , 2 , 4 – 7 ]

Still additional features of the study design (cross-sectional) should be indicated. Apart from this, other types of study designs (randomized, double-blind, placebo-controlled or double-blind, parallel control etc.) should be revealed.

The heading of the section “Materials and Methods” can be changed to “Patients and the Method” in accordance with writing rules of the journal in question. Indication of starting, and termination dates of a clinical study will facilitate scientific interpretation of the article. Accordingly, outcomes obtained during development phase of a newly implemented method might be considered differently from those acquired during conventional use of this method. Besides, incidence of the diseases, and number of affected people might vary under the impact of social fluctuations, and environmental factors. Therefore with this justification study period should be specified. Number of cases included in the study should be absolutely indicated in the ‘Materials and Methods’ section. It will be appropriate to determine study population after consultation to a statistician-and if required-following “power analysis” Accordingly, the need for a control group will be indicated based on the study design. Nowadays, as a requirement of patient rights, obtainment of approval from ethics committee should be indicated with its registration number. In addition, acquirement of informed consent forms from patients should be indicated. Ethics Committee approval should be obtained in prospective studies performed with study drugs. Otherwise in case of occurrence of adverse effects, it should be acknowledged that in compliance with Article #90 of the Turkish Criminal Law, a 3-year prison sentence is given to the guilty parties. [ 8 ] Since issues related to the Ethics Committee are the subject of another manuscript, they won’t be handled herein.

The following paragraph exemplifies clearly the aforementioned arguments: “After approval of the local ethics committee (BADK-22), informed consent forms from the patients were obtained, and a total of 176 cases with lower urinary tract symptoms (LUTS) were retrospectively evaluated between January 2011, and December 2012.” In a prospectively designed study, methods used to communicate with the cases including face-to-face interviews, phone calls and/or e-mail should be indicated. [ 1 , 2 ] Each paragraph or subheading in the ‘Materials and Methods’ section should be in accordance with the related ones in the ‘Results’ section. In other words, the sequence of paragraphs, and subheadings in the ‘Results’ section should be the same in the ‘Materials and Methods’ section.

As a next step, names of the groups, and distribution of the cases in these groups should be indicated. For instance: the statement “Cases were divided into 3 groups based on their LUTS scores as. Groups 1 (0–9; n=91), 2 (10–18; n=66), and 3 (≥19; n=20)” clearly delineates the scope of the study at baseline.. In the ‘Materials and Methods’ section the number of study subjects should be absolutely documented. Herein, after assignment of names to groups, in the rest of the manuscript, these names should be used. For example instead of saying: “Mean ages of the cases with LUTS scores between 0–9, 10–18, and ≥19 were determined to be 63.2±2.1, 62.8±4.5, and 65.7±3.9 years, respectively” it will be more comprehensible to use the expression: “Mean ages of the Groups 1, 2, and 3 were specified as 63.2±2.1, 62.8±4.5, and 65.7±3.9 years.” (p=0.478). Expressions indicated in the ‘Materials and Methods’ section should not be repeated in the “Results” section. Thus, errors of repetition will be precluded. Following the abovementioned information, the evaluation method of the cases enrolled in the study should be indicated. Hence, results of medical history, physical examination, and if performed laboratory or radiological evaluations-in that order-should be indicated. The application of survey study-if any-should be investigated, and documented. Therefore, the following sentences encompass all the information stated above: “The cases were evaluated with detailed medical history, physical examination, measurements of serum follicle stimulating hormone (FSH), luteinizing hormone (LH), testosterone (T) levels, complete urinalysis, urinary flow rate, direct urinary system roentgenograms, urinary system ultrasound, and if required cyctoscopy. Lower urinary system complaints, and erectile dysfunction were evaluated using International Prostate Symptom Score (IPSS), and International Erectile Function Scale (IIEF), respectively.” Apparently, questionnaire forms were used in the above-cited study. However, methods used for the evaluation of questionnaire forms, and significance of the results obtained, and if possible, the first performer of this survey should be written with accompanying references. In relation to the abovementioned questionnaires the following statements constitute standard expressions for the ‘Materials and Methods’ section: “International Prostate Symptom Score (IPPS) was used in the determination of the severity of prostatic symptoms. IPSS used to determine the severity of the disease, evaluate treatment response, and ascertain the symptomatic progression, is the most optimal scoring system recommended by European Association of Urology (EAU) which classifies the severity of the disease based on IPSS scores as mild (0–7), moderate (8–19), and severe symptomatic (20–35) disease. In the evaluation of sexual function International Erectile Function Scale (IIEF) was used. IIEF is one of the most prevalently used form for the patients who consulted for the complaints of sexual dysfunction Based on IIEF scores, the severity of the disease was classified as severe (1–10), moderate (11–16), mild to moderate (17–21), mild (22–25), and no ED (26–30).”

Whether the institutions of the authors working for should be written in the ‘Materials and Methods’ section can be a subject of debate, generally viewpoints favour provision of this information. However, in compliance with their writing rules, some journals do not favour open-label studies where name of the study site is indicated, and this principle is communicated to the author during editorial evaluation Besides, in the ‘Materials and Methods’ section, the brand of the study object, and its country of origin should be indicated. (ie. if radiological methods are used, then the brand of radiological equipment, and its manufacturing country should be specified. In a study entitled ‘The Impact of Computed Tomography in the Prediction of Post-Radical Nephrectomy Stage in Renal Tumours’ since the main topic of the study is computed tomography, the specifications of the equipment used should be explicitely indicated. On the other hand, the details of the medical method which can effect the outcomes of the study should be also recorded. Accordingly, the methods applied for percutaneous nephrolithotomy, ureterorenoscopy, varicocelectomy, transurethral prostatectomy, radical prostatectomy (perineal, open, laparoscopic or robotic should be absolutely indicated. Then inclusion, and exclusion criteria, and if used control group, and its characteristics should be documented. Thus the following paragraph about exclusion criteria will be appropriate: Patients with a history of neurogenic bladder, prostatic or abdominal operation, and transrectal ultrasound guided prostate biopsy (within the previous 6 months), those aged <40 or >70 years, individuals with a peak urine flow rate below 10 ml/sec, and residual urine more than 150 cc were not included in the study.” [ 1 – 3 , 9 ]

Some diseases mentioned in the “Materials and Methods” section require special monitorization procedures. In these cases the procedure of monitorization should be documented for the sake of the validity of the study in question. Accordingly, in conditions such as “nephrectomy, prostatectomy, orchidectomy, pyeloplasty, varicocelectomy, drug therapies, penile prosthesis, and urethral stricture” clinical follow-up protocols should be provided.

The abovementioned rules, and recommendations are most frequently valid for a clinical study, and some points indicated in experimental studies should be also considered. Types, weights, gender, and number of the animals used in animal studies should be absolutely specified. Besides condition of evaluation of experimental animals should be noted. Then as is the case with clinical studies, approval of the ethics committee should be obtained, and documented. Accordingly, the beginning paragraphs of the ‘Materials and Methods’ can be expressed as follows:

“In the study, 40 Wistar-Albino 6-month-old rats each weighing 350–400 g were used. After approval of the ethics committee (HADYEK-41) the study was performed within the frame of rules specified by the National Institute for animal experiments. The rats were divided into 3 groups. Hence, Group 1 (n=7) was accepted as the control group. The rats subjected to partial ureteral obstruction with or without oral carvedilol therapy at daily doses of 2 mg/kg maintained for 7 days constituted Groups 3 (n=8), and 2 (n=8), respectively. Each group of 4 rats was housed in standard cages with an area of 40×60 cm. The animals were fed with standard 8 mm food pellets, and fresh daily tap water. The rats were kept in the cages under 12 hours of light, and 12 hours of dark. Ambient temperature, and humidity were set at 22±2°C, and 50±10%, respectively.”

Herein, the method, and agent of anesthesia used (local or general anesthesia) in surgical procedures, and then the experimental method applied should be clearly indicated. For example the following sentences explain our abovementioned arguments; “All surgical procedures were performed under xylazine-ketamine anesthesia. In all groups, ureters were approached through midline abdominal incision. In Group 1, ureters were manipulated without causing obstruction. Results of biochemical, and pathological evaluations performed in Group 1 were considered as baseline values.”

“Through a midline abdominal incision partial ureteral obstruction was achieved by embedding two-thirds of the distal part of the left ureter into psoas muscle using 4/0 silk sutures as described formerly by Wen et al. [ 10 ] ( Figure 1 ). [ 11 ] All rats were subjected to left nephrectomies at the end of the experimental study.” As formulated by the above paragraph, if the method used is not widely utilized, then the first researcher who describes the method should be indicated with relevant references. One or more than one figures with a good resolution, and easily comprehensible legends should be also included in the explanation of the experimental model. For very prevalently used experimental models as torsion models cited in the “Materials and Methods” section, there is no need to include figures in the manuscript.

Partial ureteral obstruction model [ 11 ]

Appropriate signs, and marks placed on the figure will facilitate comprehension of the legends ( Figure 2 ).

Ureteral segments (black arrows) seen in a rat partial ureteral obstruction model [ 11 ]

The signs used will also improve intelligibility of the target. The figures should be indicated within parentheses in their first mention in the “Materials and Methods” section. Headings and as a prevalent convention legends of the figures should be indicated at the end of the manuscript.

If a different method is used in the study, this should be explained in detail. For instance, in a study where the effect of smoking on testes was investigated, the method, and the applicator used to expose rats to cigarette smoke should be indicated in the ‘Methods’ section following classical description. Relevant to the study in question, the following paragraph explaining the study method should be written: “A glass chamber with dimensions of 75 × 50 × 50 cm was prepared, and divided into 4 compartments with wire fences. The rats in the 2., and 4. cages were placed in these compartments. Each compartment contained 4 rats. Cigarette smoke was produced using one cigarette per hour, and smoke coming from the tip, and the filter of the lighted cigarette was pumped into the gas chamber with a pneumatic motor. The rats were exposed to smoke of 6 cigarettes for 6 hours. The compartments of the rats were changed every day so as to achieve balanced exposure of the rats to cigarette smoke.” [ 12 ]

Meanwhile, chemical names, doses, and routes of administration of the substances used in experimental studies should be indicated. If the substance used is a solution or an antibody, then manufacturing firm, and its country should be indicated in parenthesis. This approach can be exemplified as “Animals used in experiments were randomized into 4 groups of 8 animals. Each group was housed in 2 cages each containing 4 animals. The first group did not undergo any additional procedure (Group 1). The second group was exposed to cigarette smoke (Group 2). The third (Group 3), and the fourth (Group 4) groups received daily intraperitoneal injectable doses of 10 mg/kg resveratrol (Sigma-Aldrich, St. Louis, MO, USA). The Group 4 was also exposed to cigarette smoke. [ 12 ]

After all of these procedures, method, and analytical procedure of histopathological examination used should be described-if possible-by a pathologist Similarly, biochemical method used should be referenced, and written by the department of clinical chemistry. It can be inferred that each division should describe its own method. In other words, histopathological, microbiological, and pharmacological method should be described in detail by respective divisions.

If we summarize all the information stated above, understandably sharing of the scientific knowledge is essential.. Since reproducibility of a study demonstrates the robustness of a study, with the detailed approaches indicated above, reproducibility of our study is provided, and the relevant questions of “How?”, and “How much?” are answered. Besides, since ‘Materials, and Methods’, and ‘Results’ sections will constitute a meaningful whole, explanations of all information related to the data mentioned in the ‘Results’ section should be provided. As an important point not to be forgotten, evaluation or measurement method used for each parameter indicated in the ‘Results’ section should be expounded in the “Materials and Methods” section. For example if you used an expression in the” Results” section like “median body mass index (BMI) of the patients was 27.42 kg/m 2 ”, then you should beforehand indicate that comparative evaluation of BMIs will be done in the “Materials and Methods” section. In addition, the description, and significance of the values expressed in the “Results” section should be indicated in the “Materials and Methods” section. In other words, it should be stated that the patients were evaluated based on their BMIs as normal (18–24.9 kg/m 2 ), overweight (25 kg/m 2 –40 kg/m 2 ), and morbid obesity (>40 kg/m 2 ). If you encounter difficulties in writing “Materials and Methods” section, also a valid approach for other sections, firstly simple headings can be written, then you can go into details. In brief, for every parameter, the reader should get clear-cut answers to the questions such as “How did they evaluate this parameter, and which criteria were used?”. [ 1 , 3 , 13 – 15 ]

The last paragraph of the ‘Materials, and Methods’ section should naturally involve statistical evaluations. This section should be written by statisticians. Accordingly, the preferred statistical method, and the justifications for this preference should be indicated. In conventional statistical evaluations, provision of details is not required. In information indicated above, the statement “For statistical analysis, ANOVA test, chi-square test, T test, Kruskal-Wallis test have been used.” is not required very much. Instead, more appropriate expression will be a statement indicating that recommendations of a knowledgeable, and an experienced statistician were taken into consideration or advanced statistical information was reflected on the statistical evaluations as follows: “Chi-square tests were used in intergroup comparisons of categorical variables, and categorical variables were expressed as numbers, and percentages. In comparisons between LUTS, and ED as for age, independent two samples t-test was used. In the evaluation of the factors effective on erectile dysfunction multivariate logistic regresssion test was used. P values lower than 0.05 were considered as statistically significant The calculations were performed using a statistical package program (PASW v18, SPSS Inc, Chicago, IL).” Herein, the type of statistical package used for statistical methods should be emphasized.

The One Method That Changes Your—and All Students’—Writing

Science-based writing methods can achieve dramatic results..

Posted May 14, 2024 | Reviewed by Abigail Fagan

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I remember spending hours commenting painstakingly on my students’ papers when I was a graduate student teaching in the Expository Writing Program at New York University. My students loved our classes, and they filled my sections and gave me terrific course evaluations. Yet I could see that their writing failed to change significantly over the course of the semester. I ended up feeling as if I should refund their money, haunted by the blunt instruments we had to teach writing.

As I’ve learned from directing five writing programs at three different universities, methods matter. When I reviewed comments on papers from instructors who taught in my programs, I discovered that the quantity and quality of comments on students’ papers made only a slight impact on writing outcomes. For instance, one notoriously lazy instructor took several weeks to return assignments and only used spelling and grammar checkers to automate comments. But his conscientious colleague made dozens of sharp observations about students’ arguments, paragraphs, and sentences. However, Mr. Conscientious’ students improved perhaps only 10% over Mr. Minimalist’s students. Even then, the differences stemmed from basic guidelines Mr. Conscientious insisted his students write to, which included providing context sentences at the outset of their essay introductions.

Educators have also poured resources into teaching writing, with increasing numbers of hours dedicated to teaching writing across primary, secondary, and higher education . Yet studies continue to find writing skills inadequate . In higher education, most universities require at least a year of writing-intensive courses, with many universities also requiring writing across the curriculum or writing in the disciplines to help preserve students’ writing skills. However, writing outcomes have remained mostly unchanged .

While pursuing my doctorate, I dedicated my research to figuring out how writing worked. As a graduate student also teaching part-time, I was an early convert to process writing. I also taught those ancient principles of logos, ethos, and pathos, as well as grammar and punctuation. Nevertheless, these frameworks only created a canvas for students’ writing. What was missing: how writers should handle words, sentence structure, and relationships between sentences.

Yet researchers published the beginnings of a science-based writing method over 30 years ago. George Gopen, Gregory Colomb, and Joseph Williams created a framework for identifying how to maximize the clarity, coherence, and continuity of writing. In particular, Gopen and Swan (1990) created a methodology for making scientific writing readable . This work should have been a revelation to anyone teaching in or directing a writing program. But, weirdly, comparatively few writing programs or faculty embraced this work, despite Williams, Colomb, and Gopen publishing both research and textbooks outlining the method and process.

Peculiarly, this framework—represented by Williams’ Style series of textbooks and Gopen’s reader expectation approach—failed to become standard in writing courses, likely because of two limitations. First, both Gopen and Williams hewed to a relativistic stance on writing methods, noting that rule-flouting often creates a memorable style. This stance created a raft of often-contradictory principles for writing. For example, Williams demonstrated that beginning sentences with There is or There are openings hijacked the clarity of sentences, then argued writers should use There is or There are to shunt important content into sentence emphasis positions, where readers recall content best. Second, these researchers failed to tie this writing framework to the wealth of data in psycholinguistics, cognitive neuroscience , or cognitive psychology on how our reading brains process written English. For instance, textbooks written by these three principal researchers avoid any mention of why emphasis positions exist at the ends of sentences and paragraphs—despite the concept clearly originating in the recency effect. This limitation may stem from the humanities’ long-held antipathy to the idea that writing is a product, rather than a process. Or even that science-based methods can help teachers and programs measure the effectiveness of writing, one reason why university First-Year Writing programs have failed to improve students’ writing in any measurable way.

Nevertheless, when you teach students how our reading brains work, you create a powerful method for rapidly improving their writing—in any course that requires writing and at all levels of education. Students can grasp how writing works as a system and assess the costs and benefits of decisions writers face, even as they choose their first words. This method also works powerfully to help students immediately understand how, for instance, paragraph heads leverage priming effects to shape readers’ understanding of paragraph content.

Using this method, I and my colleagues have helped students use a single writing assignment to secure hundreds of jobs, win millions in grant funding, and advance through the ranks in academia. However, we’ve also used the same method without modifications in elementary and secondary classrooms to bolster students’ writing by as much as three grade levels in a single year.

Perhaps the time has arrived for this well-kept secret to revolutionizing student writing outcomes to begin making inroads into more writing classrooms.

Gopen, G. D. and J. A. Swan (1990). "The Science of Scientific Writing." American Scientist 78(6): 550-558.

Gopen, George. The Sense of Structure: Writing from the Reader’s Perspective . Pearson, 2004.

Gopen, George. Expectations: Teaching Writing from the Reader’s Perspective . Pearson, 2004.

Williams, Joseph. Style: Toward Clarity and Grace . University of Chicago Press, 1995.

Williams, Joseph. Style: Ten Lessons in Clarity and Grace . Harper Collins, 1994.

Williams, Joseph. Style: The Basics of Clarity and Grace . Longman, 2002.

Jane Yellowlees Douglas, Ph.D. , is a consultant on writing and organizations. She is also the author, with Maria B. Grant, MD, of The Biomedical Writer: What You Need to Succeed in Academic Medicine .

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• Published: 16 May 2024

Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts

• Jeremy Segrott   ORCID: orcid.org/0000-0001-6215-0870 1 ,
• Sue Channon 2 ,
• Amy Lloyd 4 ,
• Eleni Glarou 2 , 3 ,
• Josie Henley 5 ,
• Jacqueline Hughes 2 ,
• Nina Jacob 2 ,
• Sarah Milosevic 2 ,
• Yvonne Moriarty 2 ,
• Bethan Pell 6 ,
• Mike Robling 2 ,
• Heather Strange 2 ,
• Julia Townson 2 ,
• Qualitative Research Group &
• Lucy Brookes-Howell 2  

Trials volume  25 , Article number:  323 ( 2024 ) Cite this article

Metrics details

Background/aims

The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University’s Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration.

We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper.

Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies.

Conclusions

Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit’s experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.

Peer Review reports

The value of using qualitative methods within randomised control trials (RCTs) is widely recognised [ 1 , 2 , 3 ]. Qualitative research generates important evidence on factors affecting trial recruitment/retention [ 4 ] and implementation, aiding interpretation of quantitative data [ 5 ]. Though RCTs have traditionally been viewed as sitting within a positivist paradigm, recent methodological innovations have developed new trial designs that draw explicitly on both quantitative and qualitative methods. For instance, in the field of complex public health interventions, realist RCTs seek to understand the mechanisms through which interventions generate hypothesised impacts, and how interactions across different implementation contexts form part of these mechanisms. Proponents of realist RCTs—which integrate experimental and realist paradigms—highlight the importance of using quantitative and qualitative methods to fully realise these aims and to generate an understanding of intervention mechanisms and how context shapes them [ 6 ].

A need for guidance on how to conduct good quality qualitative research is being addressed, particularly in relation to feasibility studies for RCTs [ 7 ] and process evaluations embedded within trials of complex interventions [ 5 ]. There is also guidance on the conduct of qualitative research within trials at different points in the research cycle, including development, conduct and reporting [ 8 , 9 ].

A high proportion of trials are based within or involve clinical trials units (CTUs). In the UK the UKCRC Registered CTU Network describes them as:

… specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. They have the capability to provide specialist expert statistical, epidemiological, and other methodological advice and coordination to undertake successful clinical trials. In addition, most CTUs will have expertise in the coordination of trials involving investigational medicinal products which must be conducted in compliance with the UK Regulations governing the conduct of clinical trials resulting from the EU Directive for Clinical Trials.

Thus, CTUs provide the specialist methodological expertise needed for the conduct of trials, and in the case of trials of investigational medicinal products, their involvement may be mandated to ensure compliance with relevant regulations. As the definition above suggests, CTUs also conduct and support other types of study apart from RCTs, providing a range of methodological and subject-based expertise.

However, despite their central role in the conduct and design of trials, (and other evaluation designs) little has been written about how CTUs have integrated qualitative work within their organisation at a time when such methods are, as stated above, now recognised as an important aspect of RCTs and evaluation studies more generally. This is a significant gap, since integration at the organisational level arguably shapes how qualitative research is integrated within individual studies, and thus it is valuable to understand how CTUs have approached the task. There are different ways of involving qualitative work in trials units, such as partnering with other departments (e.g. social science) or employing qualitative researchers directly. Qualitative research can be imagined and configured in different ways—as a method that generates data to inform future trial and intervention design, as an embedded component within an RCT or other evaluation type, or as a parallel strand of research focusing on lived experiences of illness, for instance. Understanding how trials units have integrated qualitative research is valuable, as it can shed light on which strategies show promise, and in which contexts, and how qualitative research is positioned within the field of trials research, foregrounding the value of qualitative research. However, although much has been written about its use within trials, few accounts exist of how trials units have integrated qualitative research within their systems and structures.

This paper discusses the process of embedding qualitative research within the work of one CTU—Cardiff University’s Centre for Trials Research (CTR). It highlights facilitators of this process and identifies challenges to integration. We use the Normalisation Process Theory (NPT) as a framework to structure our experience and approach. The key gap addressed by this paper is the implementation of strategies to integrate qualitative research (a relatively newly adopted set of practices and processes) within CTU systems and structures. We acknowledge from the outset that there are multiple ways of approaching this task. What follows therefore is not a set of recommendations for a preferred or best way to integrate qualitative research, as this will comprise diverse actions according to specific contexts. Rather, we examine the processes through which integration occurred in our own setting and highlight the potential value of these insights for others engaged in the work of promoting qualitative research within trials units.

Background to the integration of qualitative research within CTR

The CTR was formed in 2015 [ 10 ]. It brought together three existing trials units at Cardiff University: the South East Wales Trials Unit, the Wales Cancer Trials Unit, and the Haematology Clinical Trials Unit. From its inception, the CTR had a stated aim of developing a programme of qualitative research and integrating it within trials and other studies. In the sections below, we map these approaches onto the framework offered by Normalisation Process Theory to understand the processes through which they helped achieve embedding and integration of qualitative research.

CTR’s aims (including those relating to the development of qualitative research) were included within its strategy documents and communicated to others through infrastructure funding applications, annual reports and its website. A Qualitative Research Group (QRG), which had previously existed within the South East Wales Trials Unit, with dedicated funding for methodological specialists and group lead academics, was a key mechanism through which the development of a qualitative portfolio was put into action. Integration of qualitative research within Centre systems and processes occurred through the inclusion of qualitative research in study adoption processes and representation on committees. The CTR’s study portfolio provided a basis to track qualitative methods in new and existing studies, identify opportunities to embed qualitative methods within recently adopted studies (at the funding application stage) and to manage staff resources. Capacity building and training were an important focus of the QRG’s work, including training courses, mentoring, creation of an academic network open to university staff and practitioners working in the field of healthcare, presentations at CTR staff meetings and securing of PhD studentships. Standard operating procedures and methodological guidance on the design and conduct of qualitative research (e.g. templates for developing analysis plans) aimed to create a shared understanding of how to undertake high-quality research, and a means to monitor the implementation of rigorous approaches. As the QRG expanded its expertise it sought to develop innovative approaches, including the use of visual [ 11 ] and ethnographic methods [ 12 ].

Understanding implementation—Normalisation Process Theory (NPT)

Normalisation Process Theory (NPT) provides a model with which to understand the implementation of new sets of practices and their normalisation within organisational settings. The term ‘normalisation’ refers to how new practices become routinised (part of the everyday work of an organisation) through embedding and integration [ 13 , 14 ]. NPT defines implementation as ‘the social organisation of work’ and is concerned with the social processes that take place as new practices are introduced. Embedding involves ‘making practices routine elements of everyday life’ within an organisation. Integration takes the form of ‘sustaining embedded practices in social contexts’, and how these processes lead to the practices becoming (or not becoming) ‘normal and routine’ [ 14 ]. NPT is concerned with the factors which promote or ‘inhibit’ attempts to embed and integrate the operationalisation of new practices [ 13 , 14 , 15 ].

Embedding new practices is therefore achieved through implementation—which takes the form of interactions in specific contexts. Implementation is operationalised through four ‘generative mechanisms’— coherence , cognitive participation , collective action and reflexive monitoring [ 14 ]. Each mechanism is characterised by components comprising immediate and organisational work, with actions of individuals and organisations (or groups of individuals) interdependent. The mechanisms operate partly through forms of investment (i.e. meaning, commitment, effort, and comprehension) [ 14 ].

Coherence refers to how individuals/groups make sense of, and give meaning to, new practices. Sense-making concerns the coherence of a practice—whether it ‘holds together’, and its differentiation from existing activities [ 15 ]. Communal and individual specification involve understanding new practices and their potential benefits for oneself or an organisation. Individuals consider what new practices mean for them in terms of tasks and responsibilities ( internalisation ) [ 14 ].

NPT frames the second mechanism, cognitive participation , as the building of a ‘community of practice’. For a new practice to be initiated, individuals and groups within an organisation must commit to it [ 14 , 15 ]. Cognitive participation occurs through enrolment —how people relate to the new practice; legitimation —the belief that it is right for them to be involved; and activation —defining which actions are necessary to sustain the practice and their involvement [ 14 ]. Making the new practices work may require changes to roles (new responsibilities, altered procedures) and reconfiguring how colleagues work together (changed relationships).

Third, Collective Action refers to ‘the operational work that people do to enact a set of practices’ [ 14 ]. Individuals engage with the new practices ( interactional workability ) reshaping how members of an organisation interact with each other, through creation of new roles and expectations ( relational interaction ) [ 15 ]. Skill set workability concerns how the work of implementing a new set of practices is distributed and the necessary roles and skillsets defined [ 14 ]. Contextual integration draws attention to the incorporation of a practice within social contexts, and the potential for aspects of these contexts, such as systems and procedures, to be modified as a result [ 15 ].

Reflexive monitoring is the final implementation mechanism. Collective and individual appraisal evaluate the value of a set of practices, which depends on the collection of information—formally and informally ( systematisation ). Appraisal may lead to reconfiguration in which procedures of the practice are redefined or reshaped [ 14 , 15 ].

We sought to map the following: (1) the strategies used to embed qualitative research within the Centre, (2) key facilitators, and (3) barriers to their implementation. Through focused group discussions during the monthly meetings of the CTR QRG and in discussion with the CTR senior management team throughout 2019–2020 we identified nine types of documents (22 individual documents in total) produced within the CTR which had relevant information about the integration of qualitative research within its work (Table  1 ). The QRG had an ‘open door’ policy to membership and welcomed all staff/students with an interest in qualitative research. It included researchers who were employed specifically to undertake qualitative research and other staff with a range of study roles, including trial managers, statisticians, and data managers. There was also diversity in terms of career stage, including PhD students, mid-career researchers and members of the Centre’s Executive team. Membership was therefore largely self-selected, and comprised of individuals with a role related to, or an interest in, embedding qualitative research within trials. However, the group brought together diverse methodological perspectives and was not solely comprised of methodological ‘champions’ whose job it was to promote the development of qualitative research within the centre. Thus whilst the group (and by extension, the authors of this paper) had a shared appreciation of the value of qualitative research within a trials centre, they also brought varied methodological perspectives and ways of engaging with it.

All members of the QRG ( n  = 26) were invited to take part in a face-to-face, day-long workshop in February 2019 on ‘How to optimise and operationalise qualitative research in trials: reflections on CTR structure’. The workshop was attended by 12 members of staff and PhD students, including members of the QRG and the CTR’s senior management team. Recruitment to the workshop was therefore inclusive, and to some extent opportunistic, but all members of the QRG were able to contribute to discussions during regular monthly group meetings and the drafting of the current paper.

The aim of the workshop was to bring together information from the documents in Table  1 to generate discussion around the key strategies (and their component activities) that had been adopted to integrate qualitative research into CTR, as well as barriers to, and facilitators of, their implementation. The agenda for the workshop involved four key areas: development and history of the CTR model; mapping the current model within CTR; discussing the structure of other CTUs; and exploring the advantages and disadvantages of the CTR model.

During the workshop, we discussed the use of NPT to conceptualise how qualitative research had been embedded within CTR’s systems and practices. The group produced spider diagrams to map strategies and actions on to the four key domains (or ‘generative mechanisms’ of NPT) summarised above, to aid the understanding of how they had functioned, and the utility of NPT as a framework. This is summarised in Table  2 .

Detailed notes were made during the workshop. A core writing group then used these notes and the documents in Table  1 to develop a draft of the current paper. This was circulated to all members of the CTR QRG ( n  = 26) and stored within a central repository accessible to them to allow involvement and incorporate the views of those who were not able to attend the workshop. This draft was again presented for comments in the monthly CTR QRG meeting in February 2021 attended by n  = 10. The Standards for QUality Improvement Reporting Excellence 2.0 (SQUIRE) guidelines were used to inform the structure and content of the paper (see supplementary material) [ 16 ].

In the following sections, we describe the strategies CTR adopted to integrate qualitative research. These are mapped against NPT’s four generative mechanisms to explore the processes through which the strategies promoted integration, and facilitators of and barriers to their implementation. A summary of the strategies and their functioning in terms of the generative mechanisms is provided in Table  2 .

Coherence—making sense of qualitative research

In CTR, many of the actions taken to build a portfolio of qualitative research were aimed at enabling colleagues, and external actors, to make sense of this set of methodologies. Centre-level strategies and grant applications for infrastructure funding highlighted the value of qualitative research, the added benefits it would bring, and positioned it as a legitimate set of practices alongside existing methods. For example, a 2014 application for renewal of trials unit infrastructure funding stated:

We are currently in the process of undertaking […] restructuring for our qualitative research team and are planning similar for trial management next year. The aim of this restructuring is to establish greater hierarchical management and opportunities for staff development and also provide a structure that can accommodate continuing growth.

Within the CTR, various forms of communication on the development of qualitative research were designed to enable staff and students to make sense of it, and to think through its potential value for them, and ways in which they might engage with it. These included presentations at staff meetings, informal meetings between project teams and the qualitative group lead, and the visibility of qualitative research on the public-facing Centre website and Centre committees and systems. For instance, qualitative methods were included (and framed as a distinct set of practices) within study adoption forms and committee agendas. Information for colleagues described how qualitative methods could be incorporated within funding applications for RCTs and other evaluation studies to generate new insights into questions research teams were already keen to answer, such as influences on intervention implementation fidelity. Where externally based chief investigators approached the Centre to be involved in new grant applications, the existence of the qualitative team and group lead enabled the inclusion of qualitative research to be actively promoted at an early stage, and such opportunities were highlighted in the Centre’s brochure for new collaborators. Monthly qualitative research network meetings—advertised across CTR and to external research collaborators, were also designed to create a shared understanding of qualitative research methods and their utility within trials and other study types (e.g. intervention development, feasibility studies, and observational studies). Training events (discussed in more detail below) also aided sense-making.

Several factors facilitated the promotion of qualitative research as a distinctive and valuable entity. Among these was the influence of the broader methodological landscape within trial design which was promoting the value of qualitative research, such as guidance on the evaluation of complex interventions by the Medical Research Council [ 17 ], and the growing emphasis placed on process evaluations within trials (with qualitative methods important in understanding participant experience and influences on implementation) [ 5 ]. The attention given to lived experience (both through process evaluations and the move to embed public involvement in trials) helped to frame qualitative research within the Centre as something that was appropriate, legitimate, and of value. Recognition by research funders of the value of qualitative research within studies was also helpful in normalising and legitimising its adoption within grant applications.

The inclusion of qualitative methods within influential methodological guidance helped CTR researchers to develop a ‘shared language’ around these methods, and a way that a common understanding of the role of qualitative research could be generated. One barrier to such sense-making work was the varying extent to which staff and teams had existing knowledge or experience of qualitative research. This varied across methodological and subject groups within the Centre and reflected the history of the individual trials units which had merged to form the Centre.

Cognitive participation—legitimising qualitative research

Senior CTR leaders promoted the value and legitimacy of qualitative research. Its inclusion in centre strategies, infrastructure funding applications, and in public-facing materials (e.g. website, investigator brochures), signalled that it was appropriate for individuals to conduct qualitative research within their roles, or to support others in doing so. Legitimisation also took place through informal channels, such as senior leadership support for qualitative research methods in staff meetings and participation in QRG seminars. Continued development of the QRG (with dedicated infrastructure funding) provided a visible identity and equivalence with other methodological groups (e.g. trial managers, statisticians).

Staff were asked to engage with qualitative research in two main ways. First, there was an expansion in the number of staff for whom qualitative research formed part of their formal role and responsibilities. One of the three trials units that merged to form CTR brought with it a qualitative team comprising methodological specialists and a group lead. CTR continued the expansion of this group with the creation of new roles and an enlarged nucleus of researchers for whom qualitative research was the sole focus of their work. In part, this was linked to the successful award of projects that included a large qualitative component, and that were coordinated by CTR (see Table  3 which describes the PUMA study).

Members of the QRG were encouraged to develop their own research ideas and to gain experience as principal investigators, and group seminars were used to explore new ideas and provide peer support. This was communicated through line management, appraisal, and informal peer interaction. Boundaries were not strictly demarcated (i.e. staff located outside the qualitative team were already using qualitative methods), but the new team became a central focus for developing a growing programme of work.

Second, individuals and studies were called upon to engage in new ways with qualitative research, and with the qualitative team. A key goal for the Centre was that groups developing new research ideas should give more consideration in general to the potential value and inclusion of qualitative research within their funding applications. Specifically, they were asked to do this by thinking about qualitative research at an early point in their application’s development (rather than ‘bolting it on’ after other elements had been designed) and to draw upon the expertise and input of the qualitative team. An example was the inclusion of questions on qualitative methods within the Centre’s study adoption form and representation from the qualitative team at the committee which reviewed new adoption requests. Where adoption requests indicated the inclusion of qualitative methods, colleagues were encouraged to liaise with the qualitative team, facilitating the integration of its expertise from an early stage. Qualitative seminars offered an informal and supportive space in which researchers could share initial ideas and refine their methodological approach. The benefits of this included the provision of sufficient time for methodological specialists to be involved in the design of the proposed qualitative component and ensuring adequate costings had been drawn up. At study adoption group meetings, scrutiny of new proposals included consideration of whether new research proposals might be strengthened through the use of qualitative methods where these had not initially been included. Meetings of the QRG—which reviewed the Centre’s portfolio of new studies and gathered intelligence on new ideas—also helped to identify, early on, opportunities to integrate qualitative methods. Communication across teams was useful in identifying new research ideas and embedding qualitative researchers within emerging study development groups.

Actions to promote greater use of qualitative methods in funding applications fed through into a growing number of studies with a qualitative component. This helped to increase the visibility and legitimacy of qualitative methods within the Centre. For example, the PUMA study [ 12 ], which brought together a large multidisciplinary team to develop and evaluate a Paediatric early warning system, drew heavily on qualitative methods, with the qualitative research located within the QRG. The project introduced an extensive network of collaborators and clinical colleagues to qualitative methods and how they could be used during intervention development and the generation of case studies. Further information about the PUMA study is provided in Table  3 .

Increasing the legitimacy of qualitative work across an extensive network of staff, students and collaborators was a complex process. Set within the continuing dominance of quantitative methods with clinical trials, there were variations in the extent to which clinicians and other collaborators embraced the value of qualitative methods. Research funding schemes, which often continued to emphasise the quantitative element of randomised controlled trials, inevitably fed through into the focus of new research proposals. Staff and external collaborators were sometimes uncertain about the added value that qualitative methods would bring to their trials. Across the CTR there were variations in the speed at which qualitative research methods gained legitimacy, partly based on disciplinary traditions and their influences. For instance, population health trials, often located within non-health settings such as schools or community settings, frequently involved collaboration with social scientists who brought with them experience in qualitative methods. Methodological guidance in this field, such as MRC guidance on process evaluations, highlighted the value of qualitative methods and alternatives to the positivist paradigm, such as the value of realist RCTs. In other, more clinical areas, positivist paradigms had greater dominance. Established practices and methodological traditions across different funders also influenced the ease of obtaining funding to include qualitative research within studies. For drugs trials (CTIMPs), the influence of regulatory frameworks on study design, data collection and the allocation of staff resources may have played a role. Over time, teams gained repeated experience of embedding qualitative research (and researchers) within their work and took this learning with them to subsequent studies. For example, the senior clinician quoted within the PUMA case study (Table  3 below) described how they had gained an appreciation of the rigour of qualitative research and an understanding of its language. Through these repeated interactions, embedding of qualitative research within studies started to become the norm rather than the exception.

Collective action—operationalising qualitative research

Collective action concerns the operationalisation of new practices within organisations—the allocation and management of the work, how individuals interact with each other, and the work itself. In CTR the formation of a Qualitative Research Group helped to allocate and organise the work of building a portfolio of studies. Researchers across the Centre were called upon to interact with qualitative research in new ways. Presentations at staff meetings and the inclusion of qualitative research methods in portfolio study adoption forms were examples of this ( interactive workability ). It was operationalised by encouraging study teams to liaise with the qualitative research lead. Development of standard operating procedures, templates for costing qualitative research and methodological guidance (e.g. on analysis plans) also helped encourage researchers to interact with these methods in new ways. For some qualitative researchers who had been trained in the social sciences, working within a trials unit meant that they needed to interact in new and sometimes unfamiliar ways with standard operating procedures, risk assessments, and other trial-based systems. Thus, training needs and capacity-building efforts were multidirectional.

Whereas there had been a tendency for qualitative research to be ‘bolted on’ to proposals for RCTs, the systems described above were designed to embed thinking about the value and design of the qualitative component from the outset. They were also intended to integrate members of the qualitative team with trial teams from an early stage to promote effective integration of qualitative methods within larger trials and build relationships over time.

Standard Operating Procedures (SOPs), formal and informal training, and interaction between the qualitative team and other researchers increased the relational workability of qualitative methods within the Centre—the confidence individuals felt in including these methods within their studies, and their accountability for doing so. For instance, study adoption forms prompted researchers to interact routinely with the qualitative team at an early stage, whilst guidance on costing grants provided clear expectations about the resources needed to deliver a proposed set of qualitative data collection.

Formation of the Qualitative Research Group—comprised of methodological specialists, created new roles and skillsets ( skill set workability ). Research teams were encouraged to draw on these when writing funding applications for projects that included a qualitative component. Capacity-building initiatives were used to increase the number of researchers with the skills needed to undertake qualitative research, and for these individuals to develop their expertise over time. This was achieved through formal training courses, academic seminars, mentoring from experienced colleagues, and informal knowledge exchange. Links with external collaborators and centres engaged in building qualitative research supported these efforts. Within the Centre, the co-location of qualitative researchers with other methodological and trial teams facilitated knowledge exchange and building of collaborative relationships, whilst grouping of the qualitative team within a dedicated office space supported a collective identity and opportunities for informal peer support.

Some aspects of the context in which qualitative research was being developed created challenges to operationalisation. Dependence on project grants to fund qualitative methodologists meant that there was a continuing need to write further grant applications whilst limiting the amount of time available to do so. Similarly, researchers within the team whose role was funded largely by specific research projects could sometimes find it hard to create sufficient time to develop their personal methodological interests. However, the cultivation of a methodologically varied portfolio of work enabled members of the team to build significant expertise in different approaches (e.g. ethnography, discourse analysis) that connected individual studies.

Reflexive monitoring—evaluating the impact of qualitative research

Inclusion of questions/fields relating to qualitative research within the Centre’s study portfolio database was a key way in which information was collected ( systematisation ). It captured numbers of funding applications and funded studies, research design, and income generation. Alongside this database, a qualitative resource planner spreadsheet was used to link individual members of the qualitative team with projects and facilitate resource planning, further reinforcing the core responsibilities and roles of qualitative researchers within CTR. As with all staff in the Centre, members of the qualitative team were placed on ongoing rather than fixed-term contracts, reflecting their core role within CTR. Planning and strategy meetings used the database and resource planner to assess the integration of qualitative research within Centre research, identify opportunities for increasing involvement, and manage staff recruitment and sustainability of researcher posts. Academic meetings and day-to-day interaction fulfilled informal appraisal of the development of the group, and its position within the Centre. Individual appraisal was also important, with members of the qualitative team given opportunities to shape their role, reflect on progress, identify training needs, and further develop their skillset, particularly through line management systems.

These forms of systematisation and appraisal were used to reconfigure the development of qualitative research and its integration within the Centre. For example, group strategies considered how to achieve long-term integration of qualitative research from its initial embedding through further promoting the belief that it formed a core part of the Centre’s business. The visibility and legitimacy of qualitative research were promoted through initiatives such as greater prominence on the Centre’s website. Ongoing review of the qualitative portfolio and discussion at academic meetings enabled the identification of areas where increased capacity would be helpful, both for qualitative staff, and more broadly within the Centre. This prompted the qualitative group to develop an introductory course to qualitative methods open to all Centre staff and PhD students, aimed at increasing understanding and awareness. As the qualitative team built its expertise and experience it also sought to develop new and innovative approaches to conducting qualitative research. This included the use of visual and diary-based methods [ 11 ] and the adoption of ethnography to evaluate system-level clinical interventions [ 12 ]. Restrictions on conventional face-to-face qualitative data collection due to the COVID-19 pandemic prompted rapid adoption of virtual/online methods for interviews, observation, and use of new internet platforms such as Padlet—a form of digital note board.

In this paper, we have described the work undertaken by one CTU to integrate qualitative research within its studies and organisational culture. The parallel efforts of many trials units to achieve these goals arguably come at an opportune time. The traditional designs of RCTs have been challenged and re-imagined by the increasing influence of realist evaluation [ 6 , 18 ] and the widespread acceptance that trials need to understand implementation and intervention theory as well as assess outcomes [ 17 ]. Hence the widespread adoption of embedded mixed methods process evaluations within RCTs. These broad shifts in methodological orthodoxies, the production of high-profile methodological guidance, and the expectations of research funders all create fertile ground for the continued expansion of qualitative methods within trials units. However, whilst much has been written about the importance of developing qualitative research and the possible approaches to integrating qualitative and quantitative methods within studies, much less has been published on how to operationalise this within trials units. Filling this lacuna is important. Our paper highlights how the integration of a new set of practices within an organisation can become embedded as part of its ‘normal’ everyday work whilst also shaping the practices being integrated. In the case of CTR, it could be argued that the integration of qualitative research helped shape how this work was done (e.g. systems to assess progress and innovation).

In our trials unit, the presence of a dedicated research group of methodological specialists was a key action that helped realise the development of a portfolio of qualitative research and was perhaps the most visible evidence of a commitment to do so. However, our experience demonstrates that to fully realise the goal of developing qualitative research, much work focuses on the interaction between this ‘new’ set of methods and the organisation into which it is introduced. Whilst the team of methodological specialists was tasked with, and ‘able’ to do the work, the ‘work’ itself needed to be integrated and embedded within the existing system. Thus, alongside the creation of a team and methodological capacity, promoting the legitimacy of qualitative research was important to communicate to others that it was both a distinctive and different entity, yet similar and equivalent to more established groups and practices (e.g. trial management, statistics, data management). The framing of qualitative research within strategies, the messages given out by senior leaders (formally and informally) and the general visibility of qualitative research within the system all helped to achieve this.

Normalisation Process Theory draws our attention to the concepts of embedding (making a new practice routine, normal within an organisation) and integration —the long-term sustaining of these processes. An important process through which embedding took place in our centre concerned the creation of messages and systems that called upon individuals and research teams to interact with qualitative research. Research teams were encouraged to think about qualitative research and consider its potential value for their studies. Critically, they were asked to do so at specific points, and in particular ways. Early consideration of qualitative methods to maximise and optimise their inclusion within studies was emphasised, with timely input from the qualitative team. Study adoption systems, centre-level processes for managing financial and human resources, creation of a qualitative resource planner, and awareness raising among staff, helped to reinforce this. These processes of embedding and integration were complex and they varied in intensity and speed across different areas of the Centre’s work. In part this depended on existing research traditions, the extent of prior experience of working with qualitative researchers and methods, and the priorities of subject areas and funders. Centre-wide systems, sometimes linked to CTR’s operation as a CTU, also helped to legitimise and embed qualitative research, lending it equivalence with other research activity. For example, like all CTUs, CTR was required to conform with the principles of Good Clinical Practice, necessitating the creation of a quality management system, operationalised through standard operating procedures for all areas of its work. Qualitative research was included, and became embedded, within these systems, with SOPs produced to guide activities such as qualitative analysis.

NPT provides a helpful way of understanding how trials units might integrate qualitative research within their work. It highlights how new practices interact with existing organisational systems and the work needed to promote effective interaction. That is, alongside the creation of a team or programme of qualitative research, much of the work concerns how members of an organisation understand it, engage with it, and create systems to sustain it. Embedding a new set of practices may be just as important as the quality or characteristics of the practices themselves. High-quality qualitative research is of little value if it is not recognised and drawn upon within new studies for instance. NPT also offers a helpful lens with which to understand how integration and embedding occur, and the mechanisms through which they operate. For example, promoting the legitimacy of a new set of practices, or creating systems that embed it, can help sustain these practices by creating an organisational ambition and encouraging (or requiring) individuals to interact with them in certain ways, redefining their roles accordingly. NPT highlights the ways in which integration of new practices involves bi-directional exchanges with the organisation’s existing practices, with each having the potential to re-shape the other as interaction takes place. For instance, in CTR, qualitative researchers needed to integrate and apply their methods within the quality management and other systems of a CTU, such as the formalisation of key processes within standard operating procedures, something less likely to occur outside trials units. Equally, project teams (including those led by externally based chief investigators) increased the integration of qualitative methods within their overall study design, providing opportunities for new insights on intervention theory, implementation and the experiences of practitioners and participants.

We note two aspects of the normalisation processes within CTR that are slightly less well conceptualised by NPT. The first concerns the emphasis within coherence on identifying the distinctiveness of new practices, and how they differ from existing activities. Whilst differentiation was an important aspect of the integration of qualitative research in CTR, such integration could be seen as operating partly through processes of de-differentiation, or at least equivalence. That is, part of the integration of qualitative research was to see it as similar in terms of rigour, coherence, and importance to other forms of research within the Centre. To be viewed as similar, or at least comparable to existing practices, was to be legitimised.

Second, whilst NPT focuses mainly on the interaction between a new set of practices and the organisational context into which it is introduced, our own experience of introducing qualitative research into a trials unit was shaped by broader organisational and methodological contexts. For example, the increasing emphasis placed upon understanding implementation processes and the experiences of research participants in the field of clinical trials (e.g. by funders), created an environment conducive to the development of qualitative research methods within our Centre. Attempts to integrate qualitative research within studies were also cross-organisational, given that many of the studies managed within the CTR drew together multi-institutional teams. This provided important opportunities to integrate qualitative research within a portfolio of studies that extended beyond CTR and build a network of collaborators who increasingly included qualitative methods within their funding proposals. The work of growing and integrating qualitative research within a trials unit is an ongoing one in which ever-shifting macro-level influences can help or hinder, and where the organisations within which we work are never static in terms of barriers and facilitators.

The importance of utilising qualitative methods within RCTs is now widely recognised. Increased emphasis on the evaluation of complex interventions, the influence of realist methods directing greater attention to complexity and the widespread adoption of mixed methods process evaluations are key drivers of this shift. The inclusion of qualitative methods within individual trials is important and previous research has explored approaches to their incorporation and some of the challenges encountered. Our paper highlights that the integration of qualitative methods at the organisational level of the CTU can shape how they are taken up by individual trials. Within CTR, it can be argued that qualitative research achieved high levels of integration, as conceptualised by Normalisation Process Theory. Thus, qualitative research became recognised as a coherent and valuable set of practices, secured legitimisation as an appropriate focus of individual and organisational activity and benefitted from forms of collective action which operationalised these organisational processes. Crucially, the routinisation of qualitative research appeared to be sustained, something which NPT suggests helps define integration (as opposed to initial embedding). However, our analysis suggested that the degree of integration varied by trial area. This variation reflected a complex mix of factors including disciplinary traditions, methodological guidance, existing (un)familiarity with qualitative research, and the influence of regulatory frameworks for certain clinical trials.

NPT provides a valuable framework with which to understand how these processes of embedding and integration occur. Our use of NPT draws attention to the importance of sense-making and legitimisation as important steps in introducing a new set of practices within the work of an organisation. Integration also depends, across each mechanism of NPT, on the building of effective relationships, which allow individuals and teams to work together in new ways. By reflecting on our experiences and the decisions taken within CTR we have made explicit one such process for embedding qualitative research within a trials unit, whilst acknowledging that approaches may differ across trials units. Mindful of this fact, and the focus of the current paper on one trials unit’s experience, we do not propose a set of recommendations for others who are working to achieve similar goals. Rather, we offer three overarching reflections (framed by NPT) which may act as a useful starting point for trials units (and other infrastructures) seeking to promote the adoption of qualitative research.

First, whilst research organisations such as trials units are highly heterogenous, processes of embedding and integration, which we have foregrounded in this paper, are likely to be important across different contexts in sustaining the use of qualitative research. Second, developing a plan for the integration of qualitative research will benefit from mapping out the characteristics of the extant system. For example, it is valuable to know how familiar staff are with qualitative research and any variations across teams within an organisation. Thirdly, NPT frames integration as a process of implementation which operates through key generative mechanisms— coherence , cognitive participation , collective action and reflexive monitoring . These mechanisms can help guide understanding of which actions help achieve embedding and integration. Importantly, they span multiple aspects of how organisations, and the individuals within them, work. The ways in which people make sense of a new set of practices ( coherence ), their commitment towards it ( cognitive participation ), how it is operationalised ( collective action ) and the evaluation of its introduction ( reflexive monitoring ) are all important. Thus, for example, qualitative research, even when well organised and operationalised within an organisation, is unlikely to be sustained if appreciation of its value is limited, or people are not committed to it.

We present our experience of engaging with the processes described above to open dialogue with other trials units on ways to operationalise and optimise qualitative research in trials. Understanding how best to integrate qualitative research within these settings may help to fully realise the significant contribution which it makes the design and conduct of trials.

Availability of data and materials

Some documents cited in this paper are either freely available from the Centre for Trials Research website or can be requested from the author for correspondence.

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Acknowledgements

Members of the Centre for Trials Research (CTR) Qualitative Research Group were collaborating authors: C Drew (Senior Research Fellow—Senior Trial Manager, Brain Health and Mental Wellbeing Division), D Gillespie (Director, Infection, Inflammation and Immunity Trials, Principal Research Fellow), R Hale (now Research Associate, School of Social Sciences, Cardiff University), J Latchem-Hastings (now Lecturer and Postdoctoral Fellow, School of Healthcare Sciences, Cardiff University), R Milton (Research Associate—Trial Manager), B Pell (now PhD student, DECIPHer Centre, Cardiff University), H Prout (Research Associate—Qualitative), V Shepherd (Senior Research Fellow), K Smallman (Research Associate), H Stanton (Research Associate—Senior Data Manager). Thanks are due to Kerry Hood and Aimee Grant for their involvement in developing processes and systems for qualitative research within CTR.

No specific grant was received to support the writing of this paper.

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JS contributed to the design of the work and interpretation of data and was responsible for leading the drafting and revision of the paper. SC contributed to the design of the work, the acquisition of data and the drafting and revision of the paper. AL contributed to the design of the work, the acquisition of data and the drafting and revision of the paper. EG contributed to a critical review of the manuscript and provided additional relevant references. JH provided feedback on initial drafts of the paper and contributed to subsequent revisions. JHu provided feedback on initial drafts of the paper and contributed to subsequent revisions. NG provided feedback on initial drafts of the paper and contributed to subsequent revisions. SM was involved in the acquisition and analysis of data and provided a critical review of the manuscript. YM was involved in the acquisition and analysis of data and provided a critical review of the manuscript. MR was involved in the interpretation of data and critical review and revision of the paper. HS contributed to the conception and design of the work, the acquisition and analysis of data, and the revision of the manuscript. JT provided feedback on initial drafts of the paper and contributed to subsequent revisions. LB-H made a substantial contribution to the design and conception of the work, led the acquisition and analysis of data, and contributed to the drafting and revision of the paper.

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All authors are or were members of staff or students in the Centre for Trials Research. JS is an associate editor of Trials .

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Segrott, J., Channon, S., Lloyd, A. et al. Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts. Trials 25 , 323 (2024). https://doi.org/10.1186/s13063-024-08124-7

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Received : 20 October 2023

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Published : 16 May 2024

DOI : https://doi.org/10.1186/s13063-024-08124-7

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