clinical definition of case study

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Roberta Heale 1 ,
Alison Twycross 2
1 School of Nursing , Laurentian University , Sudbury , Ontario , Canada
2 School of Health and Social Care , London South Bank University , London , UK
Correspondence to Dr Roberta Heale, School of Nursing, Laurentian University, Sudbury, ON P3E2C6, Canada; rheale{at}laurentian.ca

https://doi.org/10.1136/eb-2017-102845

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What is it?

Case study is a research methodology, typically seen in social and life sciences. There is no one definition of case study research. 1 However, very simply… ‘a case study can be defined as an intensive study about a person, a group of people or a unit, which is aimed to generalize over several units’. 1 A case study has also been described as an intensive, systematic investigation of a single individual, group, community or some other unit in which the researcher examines in-depth data relating to several variables. 2

Often there are several similar cases to consider such as educational or social service programmes that are delivered from a number of locations. Although similar, they are complex and have unique features. In these circumstances, the evaluation of several, similar cases will provide a better answer to a research question than if only one case is examined, hence the multiple-case study. Stake asserts that the cases are grouped and viewed as one entity, called the quintain . 6 ‘We study what is similar and different about the cases to understand the quintain better’. 6

The steps when using case study methodology are the same as for other types of research. 6 The first step is defining the single case or identifying a group of similar cases that can then be incorporated into a multiple-case study. A search to determine what is known about the case(s) is typically conducted. This may include a review of the literature, grey literature, media, reports and more, which serves to establish a basic understanding of the cases and informs the development of research questions. Data in case studies are often, but not exclusively, qualitative in nature. In multiple-case studies, analysis within cases and across cases is conducted. Themes arise from the analyses and assertions about the cases as a whole, or the quintain, emerge. 6

Benefits and limitations of case studies

If a researcher wants to study a specific phenomenon arising from a particular entity, then a single-case study is warranted and will allow for a in-depth understanding of the single phenomenon and, as discussed above, would involve collecting several different types of data. This is illustrated in example 1 below.

Using a multiple-case research study allows for a more in-depth understanding of the cases as a unit, through comparison of similarities and differences of the individual cases embedded within the quintain. Evidence arising from multiple-case studies is often stronger and more reliable than from single-case research. Multiple-case studies allow for more comprehensive exploration of research questions and theory development. 6

Despite the advantages of case studies, there are limitations. The sheer volume of data is difficult to organise and data analysis and integration strategies need to be carefully thought through. There is also sometimes a temptation to veer away from the research focus. 2 Reporting of findings from multiple-case research studies is also challenging at times, 1 particularly in relation to the word limits for some journal papers.

Examples of case studies

Example 1: nurses’ paediatric pain management practices.

One of the authors of this paper (AT) has used a case study approach to explore nurses’ paediatric pain management practices. This involved collecting several datasets:

Observational data to gain a picture about actual pain management practices.

Questionnaire data about nurses’ knowledge about paediatric pain management practices and how well they felt they managed pain in children.

Questionnaire data about how critical nurses perceived pain management tasks to be.

These datasets were analysed separately and then compared 7–9 and demonstrated that nurses’ level of theoretical did not impact on the quality of their pain management practices. 7 Nor did individual nurse’s perceptions of how critical a task was effect the likelihood of them carrying out this task in practice. 8 There was also a difference in self-reported and observed practices 9 ; actual (observed) practices did not confirm to best practice guidelines, whereas self-reported practices tended to.

Example 2: quality of care for complex patients at Nurse Practitioner-Led Clinics (NPLCs)

The other author of this paper (RH) has conducted a multiple-case study to determine the quality of care for patients with complex clinical presentations in NPLCs in Ontario, Canada. 10 Five NPLCs served as individual cases that, together, represented the quatrain. Three types of data were collected including:

Review of documentation related to the NPLC model (media, annual reports, research articles, grey literature and regulatory legislation).

Interviews with nurse practitioners (NPs) practising at the five NPLCs to determine their perceptions of the impact of the NPLC model on the quality of care provided to patients with multimorbidity.

Chart audits conducted at the five NPLCs to determine the extent to which evidence-based guidelines were followed for patients with diabetes and at least one other chronic condition.

The three sources of data collected from the five NPLCs were analysed and themes arose related to the quality of care for complex patients at NPLCs. The multiple-case study confirmed that nurse practitioners are the primary care providers at the NPLCs, and this positively impacts the quality of care for patients with multimorbidity. Healthcare policy, such as lack of an increase in salary for NPs for 10 years, has resulted in issues in recruitment and retention of NPs at NPLCs. This, along with insufficient resources in the communities where NPLCs are located and high patient vulnerability at NPLCs, have a negative impact on the quality of care. 10

These examples illustrate how collecting data about a single case or multiple cases helps us to better understand the phenomenon in question. Case study methodology serves to provide a framework for evaluation and analysis of complex issues. It shines a light on the holistic nature of nursing practice and offers a perspective that informs improved patient care.

Gustafsson J
Calanzaro M
Sandelowski M

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

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Methodology

What Is a Case Study? | Definition, Examples & Methods

What Is a Case Study? | Definition, Examples & Methods

Published on May 8, 2019 by Shona McCombes . Revised on November 20, 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organization, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating and understanding different aspects of a research problem .

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyze the case, other interesting articles.

A case study is an appropriate research design when you want to gain concrete, contextual, in-depth knowledge about a specific real-world subject. It allows you to explore the key characteristics, meanings, and implications of the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

Provide new or unexpected insights into the subject
Challenge or complicate existing assumptions and theories
Propose practical courses of action to resolve a problem
Open up new directions for future research

TipIf your research is more practical in nature and aims to simultaneously investigate an issue as you solve it, consider conducting action research instead.

Unlike quantitative or experimental research , a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

Example of an outlying case studyIn the 1960s the town of Roseto, Pennsylvania was discovered to have extremely low rates of heart disease compared to the US average. It became an important case study for understanding previously neglected causes of heart disease.

However, you can also choose a more common or representative case to exemplify a particular category, experience or phenomenon.

Example of a representative case studyIn the 1920s, two sociologists used Muncie, Indiana as a case study of a typical American city that supposedly exemplified the changing culture of the US at the time.

While case studies focus more on concrete details than general theories, they should usually have some connection with theory in the field. This way the case study is not just an isolated description, but is integrated into existing knowledge about the topic. It might aim to:

Exemplify a theory by showing how it explains the case under investigation
Expand on a theory by uncovering new concepts and ideas that need to be incorporated
Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

To ensure that your analysis of the case has a solid academic grounding, you should conduct a literature review of sources related to the topic and develop a theoretical framework . This means identifying key concepts and theories to guide your analysis and interpretation.

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews , observations , and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data.

Example of a mixed methods case studyFor a case study of a wind farm development in a rural area, you could collect quantitative data on employment rates and business revenue, collect qualitative data on local people’s perceptions and experiences, and analyze local and national media coverage of the development.

The aim is to gain as thorough an understanding as possible of the case and its context.

In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis , with separate sections or chapters for the methods , results and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyze its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

Normal distribution
Degrees of freedom
Null hypothesis
Discourse analysis
Control groups
Mixed methods research
Non-probability sampling
Quantitative research
Ecological validity

Research bias

Rosenthal effect
Implicit bias
Cognitive bias
Selection bias
Negativity bias
Status quo bias

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Further Refining Case Studies and FAQs about the NIH Definition of a Clinical Trial in Response to Your Questions

22 comments.

In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials , including the need to pick clinical trial -specific funding opportunity announcements for due dates of January 25, 2018 and beyond.

We have made no changes to the NIH definition of a clinical trial , or how the definition is interpreted. What we have done is revise existing case studies and add a few new ones to help clarify how the definition of clinical trial does or does not apply to: studies of delivery of standard clinical care, device studies, natural experiments, preliminary studies for study procedures, and studies that are primarily focused on the nature or quality of measurements as opposed to biomedical or behavioral outcomes..

As a reminder , the case studies illustrate how to apply the four questions researchers involved in human studies need to ask, and answer, to determine if their study meets the NIH definition of a clinical trial. These questions are:

Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then we consider your research a clinical trial.

Note that If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…

You are studying healthy participants
Your study does not have a comparison group (e.g., placebo or control)
Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
Your study is utilizing a behavioral intervention

Studies intended solely to refine measures are not considered clinical trials.

The adjustments to the case studies include the following:

#7a, #8a, #24, #31a: Clarified whether it meets definition of intervention
#18c: Replaced with a more illustrative case study
#18d, 24, and 33: Clarified whether study was designed to assess the nature or quality of a measurement, as opposed to the effect of an intervention on a behavioral or biomedical outcome.
#18g: New case study about testing procedures
#36 a-b: New case studies about standard clinical care
#37: New case study about Phase 1 device studies
#38: New case study about natural experiments.
#39: Proposed case study about preliminary tests for study procedures.
New case studies specific to select NIH Institutes and Centers

We recognize that sometimes in an attempt to be helpful we end up providing a lot of material to look through. So to help you quickly find the case studies that are most relevant to your research we have added the ability to filter the case studies by keyword.

We also added two new FAQs on standard clinical care and Phase 1 devices.

Thank you for your continuing dialog on this topic. We look forward to continuing to work with you as we move towards higher levels of trust and transparency with our clinical trials.

Update: Some of these case studies have been revised since this publication.

RELATED NEWS

“We have made no changes to the NIH definition of a clinical trial, or how the definition is interpreted.”

Heaven forbid the NIH responds to investigators’ concerns.

I appreciate the fact that the NIH is working to refine it’s case studies, which have been largely helpful. However, I would like to point out what I think is not so helpful in your revision of 18c, and compare it to 18a. In the former, the case study states that feedback to subjects of winning or losing in a gambling task would be an intervention qualifying as a clinical trial. But in 18a, which could involve a working memory task, is not a clinical trial. However, what happens if after each memory trial, a subject were to receive correct/incorrect feedback? This would affect some of the same brain areas as the win/lose feedback in a gambling task. The implication of this is that studying working memory with feedback is a clinical trial, but without feedback, it’s not a clinical trial? Why is it that studying reward processes makes it a clinical trial, but studying memory processes are not? It becomes very hard to discern the rules that you are using as to what constitutes an intervention, and what does not.

Steve Taylor

The distinction between 18A (an fMRI study that is not a clinical trial) and 18C (an fMRI study that is a clinical trial) is not at all clearcut. Please consider:

– In case 18A, fMRI is used (“Participants are administered … brain scans (e.g., fMRI)”), and the determination is made that the research project is not a clinical trial.

– However, in case 18C, fMRI is used (“The investigators will measure the comparative effects of ‘ wins’ and ‘losses’ on brain function (fMRI in striatal regions) during the gambling task.”), and the determination is made that the research project is a clinical trial.

This naturally raises the question: Would the findings of case 18C apply if the (unspecified) fMRI task in case 18A involved ‘wins’ and ‘losses’? If so, then how shall fMRI studies be assessed? Do all tasks designed to probe (say) working memory and early visual processing fall under case 18A, while tasks designed to probe the reward system are to be considered clinical trials, per Case 18C?

How did we get here?

The real issue is that such nit-picking arguments should be unnecessary, given the clear divide between basic research and clinical trials.

In biology, the idea of a “manipulation” is fundamental to the definition of experimental (vs. observational) science. Basic experimental science is about seeing how manipulations affect measurements, while clinical trials are about seeing how interventions affect health or biomedical-related outcomes. Historically, there has been little confusion regarding these distinctions, but NIH’s published “Cases” avoid this historical understanding and instead manifest expansive readings of “intervention” and “health outcomes” so as to create a vast enlargement of the category of clinical trials, in a manner that diverges from NIH’s original statement of purpose, as the 2014 definition stated that new definition “is not intended to expand the scope of the category of clinical trials”.

The (now twice-revised) “Cases” continue to disregard historical understanding, remain inconsistent with NIH’s 2014 statement of purpose, and create unnecessary and harmful confusion.

James J. Pekar, Ph.D. Professor of Radiology, Johns Hopkins University

Amen- I completely agree with Dr Pekar’s statements. Clinical Trials designation should be reserved for “long term’ intervention (i.e. in the case of behavioral or a drug administration clinical trial should encompass continuous and long-term administration, not single discrete administration and measurement) at least in my opinion.

In my opinion, to say that anything involving human subjects except observational or epi studies are clinical trials is a gross change in definition of clinical trials as well as accepted experimental procedure. Also, I don’t think all these changes will accomplish the underlying problem of clinical trial results not being published and publicaly available. NIH could accomplish that by just making final grant report abstracts available on the REPORTER system

Jennifer Nasser, PhD, RD Drexel University

The comment by James Pekar above is completely on the mark.

Cases 18a, 18b, and 18c reveal the confusion about what is ‘modifying’ vs. ‘measuring’ behavior. The problem is that *every* experiment (say a brain scanning fMRI experiment) is designed to ‘modify’ the behavior in some sense.

18b says that if you administer standard cognitive tasks then it is not a clinical trial, because ‘The standard cognitive tasks and the fMRI are being performed to measure and describe brain activity, but not to modify it.’ But of course any task modifies the brain activity: that is the whole point of the task. You would not do a task if it had no effect on brain activity or behavior. If you administer a standard sustained attention task, you will induce activation in attention related areas of the brain, which is a modification from the normal state. You then measure and describe it.

18c says that if you assign subjects to ‘win’ and ‘loss’ conditions it is a clinical trial because you are modifying brain activity. Again, every task modifies brain activity. How is win/loss different from say attend/not attend, read words/read nonwords, see faces/see houses?

If you see faces, that includes activity in face-processing areas of brain. If you win, that induces activity in reward related areas. Why exactly is the latter a clinical trial and the former not (I assume)?

Vastly expanding the definition of clinical trial is clearly harmful and burdensome.

What are the requirements for the NIH definition for FDA clinical trials that involve a medical device. For example, evaluation of a rapid HIV test on prospectively collected samples from subjects, as compared with results from a reference test?

It is deeply disappointing to see the NIH callously disregard and dismiss such overwhelming concerns. Personally, I have yet to meet a single practicing researcher who agrees with the NIH’s approach or responses.

The APA and FABBS sent letters last July on this matter, yet their concerns were apparently not seriously considered. Was there a public, point-by-point response? This isn’t an issue of clarifying boundary conditions or edge-cases, but of wholesale, fundamental issues with the structure of this policy.

The NIH leadership needs to do some serious self-reflection about the negative impacts their conflation of basic, translational and clinical science. This goes far beyond administrative bloat and bureaucratic burden.

What will happen if NIH and/or reviewers disagree with an investigator’s assessment of whether their research is a clinical trial or not? That is, what if NIH and/or the reviewers think the application was submitted under the wrong PA?

Four comments 1) How all this effort will solve the stated problem of non-publication is manifestly unclear. 2) When a policy requires complex explanations illustrated by debatable cases there is a problem. 3) We all want to do the right thing but there must be a better way to do it. The FTEs involved in all this effort could be better spent. 4) NIDDK case #3 is classified as not a clinical trial because “a brief bout of exercise” is not regarded as an intervention. What if it was “a bout of exercise” or “a bout of prolonged exercise” or “running 2 miles” or “an exercise program” – which of these would these be interventions? (In the previous NIDDK case #2 fasting is regarded as an intervention).

Mike. Dude. Please for the love of all holy consult with some more human cognition researchers before continuing to refine these case studies in response to our collective outrage and confusion. As many of us pointed out last round, the case studies are inconsistent with one another. Now, #18c just makes no sense compared to the other examples under #18. There is no way to “assess brain activity under standard laboratory conditions” without having some kind of manipulation involved. The “wins vs. losses” in #18c is just one of the many ways that brain activity is assessed under standard laboratory conditions. These examples continue to fail to capture basic aspects of the experimental logic of fMRI (and related methods). I am still not sure how my next grant will be categorized and who at NIH I will have to argue with when trying to figure out if my “standard laboratory conditions” do or do not count as a “manipulation.”

While I appreciate the efforts that NIH has made to make the case studies more useful for applicants, I believe there are still improvements that can be made and that will minimize the questions that program officers and other staff will need to address under these new policies.

Since the revised (September 2017) version of the case studies was released, NIH has started to divide clinical trials into two categories: mechanistic and clinical efficacy. It would be very useful if the case studies could reflect this distinction, since some FOAs are specifically designated for one or the other, since it would add depth to the definitions and draw distinctions between the two.

More generally, I’d like to see the logic behind some of the new and revised case studies expanded on and clarified. Looking at some of the subcases in Case 18 (particularly 18c and 18e), it appears that the underlying rule for whether a study is a clinical trial is whether there is any brain activity that can be detected as part of the study procedure. This is an interesting standard, as any task (including passively being in the MRI) will result in brain activity, which is considered a biomedical outcome under this standard.

The logic here seems more curious in contrast with Case 24, where asking someone about the legibility of a text is not a clinical trial, but Case 26, which asks about comprehension, rather than legibility, is. Overall, the current standard – that brain activity of any sort, resulting from any experimental manipulation – requires compliance with clinical trial registration and reporting requirements seems to be used somewhat unevenly.

I do appreciate seeing Case 18g and Case 39, which provide guidance on pilot studies, which are essential for developing good experiments, and I appreciate that pilot studies are exempted from the need to register.

I want to end by saying that I believe that requiring registration of studies, as both a matter of diligence in government-funded research, and out of respect for our subjects, is essential. That said, I believe that NIH could achieve this goal with respect to what are now being labeled “mechanistic clinical trials” by moving away from the clinical trials language, and simply calling those experiments “mechanistic trials” to reflect their basic, non-clinical nature.

I’m particularly concerned here that, to people outside the research community, the phrase “clinical trial” has justifiable weight, and that by including these basic science studies under that umbrella, we are collectively opening ourselves to problems down the line. In general, drugs and treatments tested with clinical trials are considered, by the public, to be efficacious, and I am concerned that “mechanistic clinical trials” will be used to misrepresent basic research to the public, and potentially to Congress. I fully support NIH’s push for preregistration of basic science studies, under the designation of “mechanistic trials”, but I believe they should be separated from clinical trials, to both reflect the different goals of clinical and basic research, and to prevent confusion.

Benjamin Wolfe, PhD CSAIL, MIT

I appreciate NIH’s continued efforts to refine the case examples. I concur with the concerns that continue to be expressed about Case 18 and its variants. I believe that Case 9, which is a clinical trial simply because the experimenters assign participants to various sleep durations and measure changes in stress hormone levels, also merits further consideration. For Case 18 variants and Case 9, there seems to be no room for distinguishing between a biomedical consequence that is measured as part of a basic research design aiming to test a theory about mechanisms of action or involved systems, as compared to an outcome measure specifically targeted for change, due to its potential for therapeutic benefit.

Regarding the ever-broadening NIH clinical trial definition case studies: As a behavioral scientist, I¹m worried that Cases 24 & 26 contradict each other, and neither should be a clinical trial. The substantive difference appears to be that #24 involves opinions (so not a trial) and #26 involves memory, which is suddenly a health-related outcome (yes a trial). All memory, really? No opinions, really? What if #24 were about the readability of consent forms; would it suddenly be a clinical trial? What if #26 were about memory for announcements; would it no longer be a clinical trial? These examples confound modality (opinion/memory) with content (announcement/consent), so the examples are ambiguous as to which dimension is decisive.

Quoting from the webpage: Case 24 The study involves evaluating different types of printed announcements to identify the best designs for ensuring comprehension and retention of information in adults. Visitors to public libraries will be selected at random and asked to read one of the two announcements and then to take a short survey to elicit their perspectives about readability.

* Does the study involve human participants? Yes, the visitors to the library are human participants. * Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to an intervention, reading printed materials. * Is the study designed to evaluate the effect of the intervention on the participants? No, the study is designed to learn about participants¹ opinions. It is not designed to evaluate the effect of the printed materials on the participants health-related biomedical or behavioral outcomes. There is no change to the participant as a result of providing an opinion about readability of the printed materials.

Case 26 The study involves randomizing individuals to different processes for informed consent. It is designed to assess the effectiveness of interactive and multimedia components in enhancing participants¹ understanding of the study¹s purpose and procedures.

* Does the study involve human participants? Yes, the individuals assigned to the different consent processes are human participants. * Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, different consent processes. * Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of different informed consent processes on understanding the study. * Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, enhanced comprehension of information is a health-related behavioral outcome.

I agree with the other comments made above. It is deeply disappointing and disheartening that NIH is unable to address concerns from the scientific community in order to modify the clinical trial definition with logic and humility.

Regarding case 18 (in particular 18c), we’ve heard your constructive feedback regarding inadequate clarity, engaged in follow-up discussion with outside stakeholders involved in this field of research, and, with their help revised case #18(a-g).

Mike, can you please do a blog that addresses what constitutes a “study” and “study record” in the new PHS HS/CT Form. I’m an administrator, and I’m getting this question quite a bit from faculty. The instructions state to add a separate study record for each protocol involving human subjects, but what constitutes a protocol? Is it each separate hypothesis? Each aim may have several hypotheses, does a study record have to be completed for each one? Is it per aim or per hypothesis? I understand that every study is unique and may require different approaches. Or, the specific FOA may even dictate what to do! Can I direct researchers directly to NIH program staff for further clarification for specific studies? Any clarification would help. Thank you!

Mike addressed a similar question recently in an Nature Human Behavior Interview. In that interview he provides the following guidance. “Your question gets to the tension between lumping and splitting. We would encourage lumping. That is, to the extent possible, describe a series of experiments as a set of variants of a single design. Then one registration can cover all of them. The FORMS-E grant proposal will work in a similar way; you could describe several studies as variations of one basic experiment.

Thus it is certainly possible, indeed likely, that one protocol will cover multiple hypotheses. It’s certainly conceivable that one study record could cover multiple aims. Think lumping, not splitting.

Do I understand correctly that a single-session study with repeated measures would NOT count as a clinical trial, because it does not meet criterion #2? Thanks.

As we are not familiar with your specific study design, we recommend you speak with program officials at your prospective funding NIH Institute or Center to determine if it would be considered a clinical trial.

Has NIH issued any updates regarding the interpretation of the NIH clinical trial definition and registration and reporting requirements since the omnibus budget passed last month?

“The 2018 Omnibus is referencing the September 21, 2016 (not 2017) NIH policy on registering and reporting clinical trial results in ClinicalTrials.gov. NIH is working with Congressional members and professional societies to address specific concerns about reporting basic science trials to ClinicalTrials.gov as we move forward. We hope to have more to share after these discussions.”

It would be helpful if all the case answered all 4 questions, not just the cases that are clinical trials. Additionally, it would be helpful if the NEI could provide some example cases to add to this list. Thanks.

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Case Study Research Method in Psychology

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul Mcleod, PhD., is a qualified psychology teacher with over 18 years of experience in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

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Olivia Guy-Evans, MSc

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Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

On This Page:

Case studies are in-depth investigations of a person, group, event, or community. Typically, data is gathered from various sources using several methods (e.g., observations & interviews).

The case study research method originated in clinical medicine (the case history, i.e., the patient’s personal history). In psychology, case studies are often confined to the study of a particular individual.

The information is mainly biographical and relates to events in the individual’s past (i.e., retrospective), as well as to significant events that are currently occurring in his or her everyday life.

The case study is not a research method, but researchers select methods of data collection and analysis that will generate material suitable for case studies.

Freud (1909a, 1909b) conducted very detailed investigations into the private lives of his patients in an attempt to both understand and help them overcome their illnesses.

This makes it clear that the case study is a method that should only be used by a psychologist, therapist, or psychiatrist, i.e., someone with a professional qualification.

There is an ethical issue of competence. Only someone qualified to diagnose and treat a person can conduct a formal case study relating to atypical (i.e., abnormal) behavior or atypical development.

Famous Case Studies

Anna O – One of the most famous case studies, documenting psychoanalyst Josef Breuer’s treatment of “Anna O” (real name Bertha Pappenheim) for hysteria in the late 1800s using early psychoanalytic theory.
Little Hans – A child psychoanalysis case study published by Sigmund Freud in 1909 analyzing his five-year-old patient Herbert Graf’s house phobia as related to the Oedipus complex.
Bruce/Brenda – Gender identity case of the boy (Bruce) whose botched circumcision led psychologist John Money to advise gender reassignment and raise him as a girl (Brenda) in the 1960s.
Genie Wiley – Linguistics/psychological development case of the victim of extreme isolation abuse who was studied in 1970s California for effects of early language deprivation on acquiring speech later in life.
Phineas Gage – One of the most famous neuropsychology case studies analyzes personality changes in railroad worker Phineas Gage after an 1848 brain injury involving a tamping iron piercing his skull.

Clinical Case Studies

Studying the effectiveness of psychotherapy approaches with an individual patient
Assessing and treating mental illnesses like depression, anxiety disorders, PTSD
Neuropsychological cases investigating brain injuries or disorders

Child Psychology Case Studies

Studying psychological development from birth through adolescence
Cases of learning disabilities, autism spectrum disorders, ADHD
Effects of trauma, abuse, deprivation on development

Types of Case Studies

Explanatory case studies : Used to explore causation in order to find underlying principles. Helpful for doing qualitative analysis to explain presumed causal links.
Exploratory case studies : Used to explore situations where an intervention being evaluated has no clear set of outcomes. It helps define questions and hypotheses for future research.
Descriptive case studies : Describe an intervention or phenomenon and the real-life context in which it occurred. It is helpful for illustrating certain topics within an evaluation.
Multiple-case studies : Used to explore differences between cases and replicate findings across cases. Helpful for comparing and contrasting specific cases.
Intrinsic : Used to gain a better understanding of a particular case. Helpful for capturing the complexity of a single case.
Collective : Used to explore a general phenomenon using multiple case studies. Helpful for jointly studying a group of cases in order to inquire into the phenomenon.

Where Do You Find Data for a Case Study?

There are several places to find data for a case study. The key is to gather data from multiple sources to get a complete picture of the case and corroborate facts or findings through triangulation of evidence. Most of this information is likely qualitative (i.e., verbal description rather than measurement), but the psychologist might also collect numerical data.

1. Primary sources

Interviews – Interviewing key people related to the case to get their perspectives and insights. The interview is an extremely effective procedure for obtaining information about an individual, and it may be used to collect comments from the person’s friends, parents, employer, workmates, and others who have a good knowledge of the person, as well as to obtain facts from the person him or herself.
Observations – Observing behaviors, interactions, processes, etc., related to the case as they unfold in real-time.
Documents & Records – Reviewing private documents, diaries, public records, correspondence, meeting minutes, etc., relevant to the case.

2. Secondary sources

News/Media – News coverage of events related to the case study.
Academic articles – Journal articles, dissertations etc. that discuss the case.
Government reports – Official data and records related to the case context.
Books/films – Books, documentaries or films discussing the case.

3. Archival records

Searching historical archives, museum collections and databases to find relevant documents, visual/audio records related to the case history and context.

Public archives like newspapers, organizational records, photographic collections could all include potentially relevant pieces of information to shed light on attitudes, cultural perspectives, common practices and historical contexts related to psychology.

4. Organizational records

Organizational records offer the advantage of often having large datasets collected over time that can reveal or confirm psychological insights.

Of course, privacy and ethical concerns regarding confidential data must be navigated carefully.

However, with proper protocols, organizational records can provide invaluable context and empirical depth to qualitative case studies exploring the intersection of psychology and organizations.

Organizational/industrial psychology research : Organizational records like employee surveys, turnover/retention data, policies, incident reports etc. may provide insight into topics like job satisfaction, workplace culture and dynamics, leadership issues, employee behaviors etc.
Clinical psychology : Therapists/hospitals may grant access to anonymized medical records to study aspects like assessments, diagnoses, treatment plans etc. This could shed light on clinical practices.
School psychology : Studies could utilize anonymized student records like test scores, grades, disciplinary issues, and counseling referrals to study child development, learning barriers, effectiveness of support programs, and more.

How do I Write a Case Study in Psychology?

Follow specified case study guidelines provided by a journal or your psychology tutor. General components of clinical case studies include: background, symptoms, assessments, diagnosis, treatment, and outcomes. Interpreting the information means the researcher decides what to include or leave out. A good case study should always clarify which information is the factual description and which is an inference or the researcher’s opinion.

1. Introduction

Provide background on the case context and why it is of interest, presenting background information like demographics, relevant history, and presenting problem.
Compare briefly to similar published cases if applicable. Clearly state the focus/importance of the case.

2. Case Presentation

Describe the presenting problem in detail, including symptoms, duration,and impact on daily life.
Include client demographics like age and gender, information about social relationships, and mental health history.
Describe all physical, emotional, and/or sensory symptoms reported by the client.
Use patient quotes to describe the initial complaint verbatim. Follow with full-sentence summaries of relevant history details gathered, including key components that led to a working diagnosis.
Summarize clinical exam results, namely orthopedic/neurological tests, imaging, lab tests, etc. Note actual results rather than subjective conclusions. Provide images if clearly reproducible/anonymized.
Clearly state the working diagnosis or clinical impression before transitioning to management.

3. Management and Outcome

Indicate the total duration of care and number of treatments given over what timeframe. Use specific names/descriptions for any therapies/interventions applied.
Present the results of the intervention,including any quantitative or qualitative data collected.
For outcomes, utilize visual analog scales for pain, medication usage logs, etc., if possible. Include patient self-reports of improvement/worsening of symptoms. Note the reason for discharge/end of care.

4. Discussion

Analyze the case, exploring contributing factors, limitations of the study, and connections to existing research.
Analyze the effectiveness of the intervention,considering factors like participant adherence, limitations of the study, and potential alternative explanations for the results.
Identify any questions raised in the case analysis and relate insights to established theories and current research if applicable. Avoid definitive claims about physiological explanations.
Offer clinical implications, and suggest future research directions.

5. Additional Items

Thank specific assistants for writing support only. No patient acknowledgments.
References should directly support any key claims or quotes included.
Use tables/figures/images only if substantially informative. Include permissions and legends/explanatory notes.
Provides detailed (rich qualitative) information.
Provides insight for further research.
Permitting investigation of otherwise impractical (or unethical) situations.

Case studies allow a researcher to investigate a topic in far more detail than might be possible if they were trying to deal with a large number of research participants (nomothetic approach) with the aim of ‘averaging’.

Because of their in-depth, multi-sided approach, case studies often shed light on aspects of human thinking and behavior that would be unethical or impractical to study in other ways.

Research that only looks into the measurable aspects of human behavior is not likely to give us insights into the subjective dimension of experience, which is important to psychoanalytic and humanistic psychologists.

Case studies are often used in exploratory research. They can help us generate new ideas (that might be tested by other methods). They are an important way of illustrating theories and can help show how different aspects of a person’s life are related to each other.

The method is, therefore, important for psychologists who adopt a holistic point of view (i.e., humanistic psychologists ).

Limitations

Lacking scientific rigor and providing little basis for generalization of results to the wider population.
Researchers’ own subjective feelings may influence the case study (researcher bias).
Difficult to replicate.
Time-consuming and expensive.
The volume of data, together with the time restrictions in place, impacted the depth of analysis that was possible within the available resources.

Because a case study deals with only one person/event/group, we can never be sure if the case study investigated is representative of the wider body of “similar” instances. This means the conclusions drawn from a particular case may not be transferable to other settings.

Because case studies are based on the analysis of qualitative (i.e., descriptive) data , a lot depends on the psychologist’s interpretation of the information she has acquired.

This means that there is a lot of scope for Anna O , and it could be that the subjective opinions of the psychologist intrude in the assessment of what the data means.

For example, Freud has been criticized for producing case studies in which the information was sometimes distorted to fit particular behavioral theories (e.g., Little Hans ).

This is also true of Money’s interpretation of the Bruce/Brenda case study (Diamond, 1997) when he ignored evidence that went against his theory.

Breuer, J., & Freud, S. (1895). Studies on hysteria . Standard Edition 2: London.

Curtiss, S. (1981). Genie: The case of a modern wild child .

Diamond, M., & Sigmundson, K. (1997). Sex Reassignment at Birth: Long-term Review and Clinical Implications. Archives of Pediatrics & Adolescent Medicine , 151(3), 298-304

Freud, S. (1909a). Analysis of a phobia of a five year old boy. In The Pelican Freud Library (1977), Vol 8, Case Histories 1, pages 169-306

Freud, S. (1909b). Bemerkungen über einen Fall von Zwangsneurose (Der “Rattenmann”). Jb. psychoanal. psychopathol. Forsch ., I, p. 357-421; GW, VII, p. 379-463; Notes upon a case of obsessional neurosis, SE , 10: 151-318.

Harlow J. M. (1848). Passage of an iron rod through the head. Boston Medical and Surgical Journal, 39 , 389–393.

Harlow, J. M. (1868). Recovery from the Passage of an Iron Bar through the Head . Publications of the Massachusetts Medical Society. 2 (3), 327-347.

Money, J., & Ehrhardt, A. A. (1972). Man & Woman, Boy & Girl : The Differentiation and Dimorphism of Gender Identity from Conception to Maturity. Baltimore, Maryland: Johns Hopkins University Press.

Money, J., & Tucker, P. (1975). Sexual signatures: On being a man or a woman.

Further Information

Case Study Approach
Case Study Method
Enhancing the Quality of Case Studies in Health Services Research
“We do things together” A case study of “couplehood” in dementia
Using mixed methods for evaluating an integrative approach to cancer care: a case study

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What Is a Case Study?

Weighing the pros and cons of this method of research

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

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

Pros and Cons

What Types of Case Studies Are Out There?

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

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

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

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

At a Glance

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

What Are the Benefits and Limitations of Case Studies?

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

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

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

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

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

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

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

Case Study Examples

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

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

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

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

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

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

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

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

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

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

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

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

Section 1: A Case History

This section will have the following structure and content:

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

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

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

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

Section 2: Treatment Plan

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

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

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

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

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

Need More Tips?

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

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

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

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

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

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

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

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Case Study | Definition, Examples & Methods

Case Study | Definition, Examples & Methods

Published on 5 May 2022 by Shona McCombes . Revised on 30 January 2023.

A case study is a detailed study of a specific subject, such as a person, group, place, event, organisation, or phenomenon. Case studies are commonly used in social, educational, clinical, and business research.

A case study research design usually involves qualitative methods , but quantitative methods are sometimes also used. Case studies are good for describing , comparing, evaluating, and understanding different aspects of a research problem .

When to do a case study, step 1: select a case, step 2: build a theoretical framework, step 3: collect your data, step 4: describe and analyse the case.

Case studies are often a good choice in a thesis or dissertation . They keep your project focused and manageable when you don’t have the time or resources to do large-scale research.

You might use just one complex case study where you explore a single subject in depth, or conduct multiple case studies to compare and illuminate different aspects of your research problem.

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Once you have developed your problem statement and research questions , you should be ready to choose the specific case that you want to focus on. A good case study should have the potential to:

Provide new or unexpected insights into the subject
Challenge or complicate existing assumptions and theories
Propose practical courses of action to resolve a problem
Open up new directions for future research

Unlike quantitative or experimental research, a strong case study does not require a random or representative sample. In fact, case studies often deliberately focus on unusual, neglected, or outlying cases which may shed new light on the research problem.

If you find yourself aiming to simultaneously investigate and solve an issue, consider conducting action research . As its name suggests, action research conducts research and takes action at the same time, and is highly iterative and flexible.

However, you can also choose a more common or representative case to exemplify a particular category, experience, or phenomenon.

Exemplify a theory by showing how it explains the case under investigation
Expand on a theory by uncovering new concepts and ideas that need to be incorporated
Challenge a theory by exploring an outlier case that doesn’t fit with established assumptions

There are many different research methods you can use to collect data on your subject. Case studies tend to focus on qualitative data using methods such as interviews, observations, and analysis of primary and secondary sources (e.g., newspaper articles, photographs, official records). Sometimes a case study will also collect quantitative data .

The aim is to gain as thorough an understanding as possible of the case and its context.

In writing up the case study, you need to bring together all the relevant aspects to give as complete a picture as possible of the subject.

How you report your findings depends on the type of research you are doing. Some case studies are structured like a standard scientific paper or thesis, with separate sections or chapters for the methods , results , and discussion .

Others are written in a more narrative style, aiming to explore the case from various angles and analyse its meanings and implications (for example, by using textual analysis or discourse analysis ).

In all cases, though, make sure to give contextual details about the case, connect it back to the literature and theory, and discuss how it fits into wider patterns or debates.

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NIH uses the answers to four key questions to determine Clinical Trial designation.

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The answers to these questions are based on the purpose and design of the clinical study being proposed. To help clarify the uncertainties in this determination for clinical trials that study imaging research, consider the following definitions and case studies provided:

NIH Clinical Trial Definitions and Human Subjects Research
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For further guidance, applicants should consult a program officer within the Cancer Imaging Program or the scientific contact person listed on the FOA.

NIH-defined clinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

This definition distinguishes between interventional and observational studies. Applicants should also check the “ Clinical Trial Requirements for Grants and Contracts ” content on NIH’s Office of Extramural Research website for a complete listing of clinical trial-related policies, other helpful resources, FAQs, and additional case studies.

NIH non-exempt human subjects research: Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are reduced and are outweighed by potential benefits. IRBs are committees that are responsible for reviewing research to protect the rights and safety of people who take part in research, both before the research starts and as it proceeds.

Since NIH does not require IRB approval of a protocol and informed consent documents at the time an application is submitted, applicants should consult their institution’s IRB before writing and applying to help answer whether your imaging research proposal is a clinical trial involving non-exempt human subjects. Most requirements for protecting human subjects are codified in the law, 45 CFR Part 46.

Mechanistic Clinical Trials: A clinical trial designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (e.g., trials that study the mechanisms or pathways by which the treatment produces its effect). The NIH gave examples of mechanistic studies that likely qualify as clinical trials in the October 25, 2017 Guide notice . Below are imaging-specific examples that experimentally manipulates the biological environment to understand relationships and characterize the pathophysiology of a disease:

(1) NCT01562223: Studying Repeated Magnetic Resonance Imaging (MRI) using Dynamic-Contrast Enhanced (DCE-MRI) and Diffusion-Weighted Imaging (DW-MRI) in Patients Diagnosed with Prostate Cancer

This mechanistic imaging study is designed to assess the use of novel MRI contrast methods for prostate cancer diagnosis. Participants with a recent diagnosis of adenocarcinoma of the prostate will undergo successive DCE-MRI and DWI-MRI examinations. The purpose is to establish the relationship between tumor aggressiveness and novel biomarkers for angiogenesis identified on DCE-MRI and changes in cellular density identified on DWI-MRI. The establishment of these noninvasive imaging tools for characterization of tumor presence, growth, and aggressiveness may help improve the clinicians’ ability to stage and treat the disease.

(2) NCT03412630: Computed Tomography Perfusion Imaging in Predicting Outcomes in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Receiving Bevacizumab

This mechanistic study will evaluate changes in tumor blood flow and its relationship to progression free survival in the primary and recurrent ovarian cancer setting. This study seeks to establish perfusion CT as a non-invasive biomarker for early response to bevacizumab combination chemotherapy for ovarian, fallopian tube and peritoneal carcinoma. Perfusion CT is being evaluated for its ability to accurately assess changes in tumor angiogenesis. This will allow the identification of candidates unlikely to incur benefit from bevacizumab early during initial therapy thus predicting long-term efficacy.

(3) NCT02796729: CEST- Glucose Enhanced MRI for Metastatic Brain Tumors

This mechanistic study compares the ability of two advance MR methods to detect metastatic brain tumors. Participants on study will undergo the Chemical Exchange Saturation Transfer MRI procedure first and then receive an injection of Gd-DTPA for gadolinium-enhanced MRI. Project aims at exploring the relationship MRI relaxation caused by CESTAUC maps will be generated over time and maximum instantaneous tumor contrast calculated using before and after contrast injection MR images to determine detectability of small tumor masses.

Note, NCI does not participate in the NIH R01 and R21 Research Project Grants FOAs. Trials of safety, efficacy, and mechanistic exploratory can be supported via NCI’s PAR-18-560 or PAR-18-020 FOAs.

Basic Experimental Studies with Humans (BESH) FOA — Basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants” include studies that meet the NIH definition of a clinical trial and meet the definition of basic research. Basic research is defined as a “systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.” NCI does not participate in the BESH FOAs currently.

Investigator-initiated Interventional Clinical Trials: A study where the intervention(s) being tested is allocated to a group of study subjects to evaluate its effect on a biomedical or health-related outcome and the subjects are followed prospectively. NIH defined interventions include both therapeutic and diagnostic strategies. Below are two imaging-based interventional studies that seek to guide treatment decisions:

(1) NCT01333033: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

This randomized phase II trial with a cross-over study design investigates the role of FDG PET/CT in assessing response and directing therapy in patients with esophageal cancer receiving different combinations of chemotherapy: a modified FOLFOX-6 therapy or a carboplatin/paclitaxel treatment. PET/CT imaging is repeated during treatment cycles to identify patients that do not respond for crossing over. The results will determine whether changing chemotherapy during pre-operative chemoradiation improves pathologic complete response.

(2) NCT00983697: FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients with Newly Diagnosed Head & Neck Cancer

The study involves the recruitment of patients with newly diagnosed head and neck squamous cell carcinoma being considered for surgical resection. The participants will undergo a FDG-PET/CT scan prior to surgical resection and the results will be used by surgeons for surgical planning. The study will collect data on how the inclusion of the PET/CT results impact the determination of extent of disease, disease characterization and prognosis, and compares with the surgical plan originally devised from clinical nodal assessment and CT and/or MRI results.

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Published: 27 June 2011

The case study approach

Sarah Crowe 1 ,
Kathrin Cresswell 2 ,
Ann Robertson 2 ,
Guro Huby 3 ,
Anthony Avery 1 &
Aziz Sheikh 2

BMC Medical Research Methodology volume 11 , Article number: 100 ( 2011 ) Cite this article

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The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design, the specific research questions this approach can help answer, the data sources that tend to be used, and the particular advantages and disadvantages of employing this methodological approach. The paper concludes with key pointers to aid those designing and appraising proposals for conducting case study research, and a checklist to help readers assess the quality of case study reports.

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Introduction

The case study approach is particularly useful to employ when there is a need to obtain an in-depth appreciation of an issue, event or phenomenon of interest, in its natural real-life context. Our aim in writing this piece is to provide insights into when to consider employing this approach and an overview of key methodological considerations in relation to the design, planning, analysis, interpretation and reporting of case studies.

The illustrative 'grand round', 'case report' and 'case series' have a long tradition in clinical practice and research. Presenting detailed critiques, typically of one or more patients, aims to provide insights into aspects of the clinical case and, in doing so, illustrate broader lessons that may be learnt. In research, the conceptually-related case study approach can be used, for example, to describe in detail a patient's episode of care, explore professional attitudes to and experiences of a new policy initiative or service development or more generally to 'investigate contemporary phenomena within its real-life context' [ 1 ]. Based on our experiences of conducting a range of case studies, we reflect on when to consider using this approach, discuss the key steps involved and illustrate, with examples, some of the practical challenges of attaining an in-depth understanding of a 'case' as an integrated whole. In keeping with previously published work, we acknowledge the importance of theory to underpin the design, selection, conduct and interpretation of case studies[ 2 ]. In so doing, we make passing reference to the different epistemological approaches used in case study research by key theoreticians and methodologists in this field of enquiry.

This paper is structured around the following main questions: What is a case study? What are case studies used for? How are case studies conducted? What are the potential pitfalls and how can these be avoided? We draw in particular on four of our own recently published examples of case studies (see Tables 1 , 2 , 3 and 4 ) and those of others to illustrate our discussion[ 3 – 7 ].

What is a case study?

A case study is a research approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context. It is an established research design that is used extensively in a wide variety of disciplines, particularly in the social sciences. A case study can be defined in a variety of ways (Table 5 ), the central tenet being the need to explore an event or phenomenon in depth and in its natural context. It is for this reason sometimes referred to as a "naturalistic" design; this is in contrast to an "experimental" design (such as a randomised controlled trial) in which the investigator seeks to exert control over and manipulate the variable(s) of interest.

Stake's work has been particularly influential in defining the case study approach to scientific enquiry. He has helpfully characterised three main types of case study: intrinsic , instrumental and collective [ 8 ]. An intrinsic case study is typically undertaken to learn about a unique phenomenon. The researcher should define the uniqueness of the phenomenon, which distinguishes it from all others. In contrast, the instrumental case study uses a particular case (some of which may be better than others) to gain a broader appreciation of an issue or phenomenon. The collective case study involves studying multiple cases simultaneously or sequentially in an attempt to generate a still broader appreciation of a particular issue.

These are however not necessarily mutually exclusive categories. In the first of our examples (Table 1 ), we undertook an intrinsic case study to investigate the issue of recruitment of minority ethnic people into the specific context of asthma research studies, but it developed into a instrumental case study through seeking to understand the issue of recruitment of these marginalised populations more generally, generating a number of the findings that are potentially transferable to other disease contexts[ 3 ]. In contrast, the other three examples (see Tables 2 , 3 and 4 ) employed collective case study designs to study the introduction of workforce reconfiguration in primary care, the implementation of electronic health records into hospitals, and to understand the ways in which healthcare students learn about patient safety considerations[ 4 – 6 ]. Although our study focusing on the introduction of General Practitioners with Specialist Interests (Table 2 ) was explicitly collective in design (four contrasting primary care organisations were studied), is was also instrumental in that this particular professional group was studied as an exemplar of the more general phenomenon of workforce redesign[ 4 ].

What are case studies used for?

According to Yin, case studies can be used to explain, describe or explore events or phenomena in the everyday contexts in which they occur[ 1 ]. These can, for example, help to understand and explain causal links and pathways resulting from a new policy initiative or service development (see Tables 2 and 3 , for example)[ 1 ]. In contrast to experimental designs, which seek to test a specific hypothesis through deliberately manipulating the environment (like, for example, in a randomised controlled trial giving a new drug to randomly selected individuals and then comparing outcomes with controls),[ 9 ] the case study approach lends itself well to capturing information on more explanatory ' how ', 'what' and ' why ' questions, such as ' how is the intervention being implemented and received on the ground?'. The case study approach can offer additional insights into what gaps exist in its delivery or why one implementation strategy might be chosen over another. This in turn can help develop or refine theory, as shown in our study of the teaching of patient safety in undergraduate curricula (Table 4 )[ 6 , 10 ]. Key questions to consider when selecting the most appropriate study design are whether it is desirable or indeed possible to undertake a formal experimental investigation in which individuals and/or organisations are allocated to an intervention or control arm? Or whether the wish is to obtain a more naturalistic understanding of an issue? The former is ideally studied using a controlled experimental design, whereas the latter is more appropriately studied using a case study design.

Case studies may be approached in different ways depending on the epistemological standpoint of the researcher, that is, whether they take a critical (questioning one's own and others' assumptions), interpretivist (trying to understand individual and shared social meanings) or positivist approach (orientating towards the criteria of natural sciences, such as focusing on generalisability considerations) (Table 6 ). Whilst such a schema can be conceptually helpful, it may be appropriate to draw on more than one approach in any case study, particularly in the context of conducting health services research. Doolin has, for example, noted that in the context of undertaking interpretative case studies, researchers can usefully draw on a critical, reflective perspective which seeks to take into account the wider social and political environment that has shaped the case[ 11 ].

How are case studies conducted?

Here, we focus on the main stages of research activity when planning and undertaking a case study; the crucial stages are: defining the case; selecting the case(s); collecting and analysing the data; interpreting data; and reporting the findings.

Defining the case

Carefully formulated research question(s), informed by the existing literature and a prior appreciation of the theoretical issues and setting(s), are all important in appropriately and succinctly defining the case[ 8 , 12 ]. Crucially, each case should have a pre-defined boundary which clarifies the nature and time period covered by the case study (i.e. its scope, beginning and end), the relevant social group, organisation or geographical area of interest to the investigator, the types of evidence to be collected, and the priorities for data collection and analysis (see Table 7 )[ 1 ]. A theory driven approach to defining the case may help generate knowledge that is potentially transferable to a range of clinical contexts and behaviours; using theory is also likely to result in a more informed appreciation of, for example, how and why interventions have succeeded or failed[ 13 ].

For example, in our evaluation of the introduction of electronic health records in English hospitals (Table 3 ), we defined our cases as the NHS Trusts that were receiving the new technology[ 5 ]. Our focus was on how the technology was being implemented. However, if the primary research interest had been on the social and organisational dimensions of implementation, we might have defined our case differently as a grouping of healthcare professionals (e.g. doctors and/or nurses). The precise beginning and end of the case may however prove difficult to define. Pursuing this same example, when does the process of implementation and adoption of an electronic health record system really begin or end? Such judgements will inevitably be influenced by a range of factors, including the research question, theory of interest, the scope and richness of the gathered data and the resources available to the research team.

Selecting the case(s)

The decision on how to select the case(s) to study is a very important one that merits some reflection. In an intrinsic case study, the case is selected on its own merits[ 8 ]. The case is selected not because it is representative of other cases, but because of its uniqueness, which is of genuine interest to the researchers. This was, for example, the case in our study of the recruitment of minority ethnic participants into asthma research (Table 1 ) as our earlier work had demonstrated the marginalisation of minority ethnic people with asthma, despite evidence of disproportionate asthma morbidity[ 14 , 15 ]. In another example of an intrinsic case study, Hellstrom et al.[ 16 ] studied an elderly married couple living with dementia to explore how dementia had impacted on their understanding of home, their everyday life and their relationships.

For an instrumental case study, selecting a "typical" case can work well[ 8 ]. In contrast to the intrinsic case study, the particular case which is chosen is of less importance than selecting a case that allows the researcher to investigate an issue or phenomenon. For example, in order to gain an understanding of doctors' responses to health policy initiatives, Som undertook an instrumental case study interviewing clinicians who had a range of responsibilities for clinical governance in one NHS acute hospital trust[ 17 ]. Sampling a "deviant" or "atypical" case may however prove even more informative, potentially enabling the researcher to identify causal processes, generate hypotheses and develop theory.

In collective or multiple case studies, a number of cases are carefully selected. This offers the advantage of allowing comparisons to be made across several cases and/or replication. Choosing a "typical" case may enable the findings to be generalised to theory (i.e. analytical generalisation) or to test theory by replicating the findings in a second or even a third case (i.e. replication logic)[ 1 ]. Yin suggests two or three literal replications (i.e. predicting similar results) if the theory is straightforward and five or more if the theory is more subtle. However, critics might argue that selecting 'cases' in this way is insufficiently reflexive and ill-suited to the complexities of contemporary healthcare organisations.

The selected case study site(s) should allow the research team access to the group of individuals, the organisation, the processes or whatever else constitutes the chosen unit of analysis for the study. Access is therefore a central consideration; the researcher needs to come to know the case study site(s) well and to work cooperatively with them. Selected cases need to be not only interesting but also hospitable to the inquiry [ 8 ] if they are to be informative and answer the research question(s). Case study sites may also be pre-selected for the researcher, with decisions being influenced by key stakeholders. For example, our selection of case study sites in the evaluation of the implementation and adoption of electronic health record systems (see Table 3 ) was heavily influenced by NHS Connecting for Health, the government agency that was responsible for overseeing the National Programme for Information Technology (NPfIT)[ 5 ]. This prominent stakeholder had already selected the NHS sites (through a competitive bidding process) to be early adopters of the electronic health record systems and had negotiated contracts that detailed the deployment timelines.

It is also important to consider in advance the likely burden and risks associated with participation for those who (or the site(s) which) comprise the case study. Of particular importance is the obligation for the researcher to think through the ethical implications of the study (e.g. the risk of inadvertently breaching anonymity or confidentiality) and to ensure that potential participants/participating sites are provided with sufficient information to make an informed choice about joining the study. The outcome of providing this information might be that the emotive burden associated with participation, or the organisational disruption associated with supporting the fieldwork, is considered so high that the individuals or sites decide against participation.

In our example of evaluating implementations of electronic health record systems, given the restricted number of early adopter sites available to us, we sought purposively to select a diverse range of implementation cases among those that were available[ 5 ]. We chose a mixture of teaching, non-teaching and Foundation Trust hospitals, and examples of each of the three electronic health record systems procured centrally by the NPfIT. At one recruited site, it quickly became apparent that access was problematic because of competing demands on that organisation. Recognising the importance of full access and co-operative working for generating rich data, the research team decided not to pursue work at that site and instead to focus on other recruited sites.

Collecting the data

In order to develop a thorough understanding of the case, the case study approach usually involves the collection of multiple sources of evidence, using a range of quantitative (e.g. questionnaires, audits and analysis of routinely collected healthcare data) and more commonly qualitative techniques (e.g. interviews, focus groups and observations). The use of multiple sources of data (data triangulation) has been advocated as a way of increasing the internal validity of a study (i.e. the extent to which the method is appropriate to answer the research question)[ 8 , 18 – 21 ]. An underlying assumption is that data collected in different ways should lead to similar conclusions, and approaching the same issue from different angles can help develop a holistic picture of the phenomenon (Table 2 )[ 4 ].

Brazier and colleagues used a mixed-methods case study approach to investigate the impact of a cancer care programme[ 22 ]. Here, quantitative measures were collected with questionnaires before, and five months after, the start of the intervention which did not yield any statistically significant results. Qualitative interviews with patients however helped provide an insight into potentially beneficial process-related aspects of the programme, such as greater, perceived patient involvement in care. The authors reported how this case study approach provided a number of contextual factors likely to influence the effectiveness of the intervention and which were not likely to have been obtained from quantitative methods alone.

In collective or multiple case studies, data collection needs to be flexible enough to allow a detailed description of each individual case to be developed (e.g. the nature of different cancer care programmes), before considering the emerging similarities and differences in cross-case comparisons (e.g. to explore why one programme is more effective than another). It is important that data sources from different cases are, where possible, broadly comparable for this purpose even though they may vary in nature and depth.

Analysing, interpreting and reporting case studies

Making sense and offering a coherent interpretation of the typically disparate sources of data (whether qualitative alone or together with quantitative) is far from straightforward. Repeated reviewing and sorting of the voluminous and detail-rich data are integral to the process of analysis. In collective case studies, it is helpful to analyse data relating to the individual component cases first, before making comparisons across cases. Attention needs to be paid to variations within each case and, where relevant, the relationship between different causes, effects and outcomes[ 23 ]. Data will need to be organised and coded to allow the key issues, both derived from the literature and emerging from the dataset, to be easily retrieved at a later stage. An initial coding frame can help capture these issues and can be applied systematically to the whole dataset with the aid of a qualitative data analysis software package.

The Framework approach is a practical approach, comprising of five stages (familiarisation; identifying a thematic framework; indexing; charting; mapping and interpretation) , to managing and analysing large datasets particularly if time is limited, as was the case in our study of recruitment of South Asians into asthma research (Table 1 )[ 3 , 24 ]. Theoretical frameworks may also play an important role in integrating different sources of data and examining emerging themes. For example, we drew on a socio-technical framework to help explain the connections between different elements - technology; people; and the organisational settings within which they worked - in our study of the introduction of electronic health record systems (Table 3 )[ 5 ]. Our study of patient safety in undergraduate curricula drew on an evaluation-based approach to design and analysis, which emphasised the importance of the academic, organisational and practice contexts through which students learn (Table 4 )[ 6 ].

Case study findings can have implications both for theory development and theory testing. They may establish, strengthen or weaken historical explanations of a case and, in certain circumstances, allow theoretical (as opposed to statistical) generalisation beyond the particular cases studied[ 12 ]. These theoretical lenses should not, however, constitute a strait-jacket and the cases should not be "forced to fit" the particular theoretical framework that is being employed.

When reporting findings, it is important to provide the reader with enough contextual information to understand the processes that were followed and how the conclusions were reached. In a collective case study, researchers may choose to present the findings from individual cases separately before amalgamating across cases. Care must be taken to ensure the anonymity of both case sites and individual participants (if agreed in advance) by allocating appropriate codes or withholding descriptors. In the example given in Table 3 , we decided against providing detailed information on the NHS sites and individual participants in order to avoid the risk of inadvertent disclosure of identities[ 5 , 25 ].

What are the potential pitfalls and how can these be avoided?

The case study approach is, as with all research, not without its limitations. When investigating the formal and informal ways undergraduate students learn about patient safety (Table 4 ), for example, we rapidly accumulated a large quantity of data. The volume of data, together with the time restrictions in place, impacted on the depth of analysis that was possible within the available resources. This highlights a more general point of the importance of avoiding the temptation to collect as much data as possible; adequate time also needs to be set aside for data analysis and interpretation of what are often highly complex datasets.

Case study research has sometimes been criticised for lacking scientific rigour and providing little basis for generalisation (i.e. producing findings that may be transferable to other settings)[ 1 ]. There are several ways to address these concerns, including: the use of theoretical sampling (i.e. drawing on a particular conceptual framework); respondent validation (i.e. participants checking emerging findings and the researcher's interpretation, and providing an opinion as to whether they feel these are accurate); and transparency throughout the research process (see Table 8 )[ 8 , 18 – 21 , 23 , 26 ]. Transparency can be achieved by describing in detail the steps involved in case selection, data collection, the reasons for the particular methods chosen, and the researcher's background and level of involvement (i.e. being explicit about how the researcher has influenced data collection and interpretation). Seeking potential, alternative explanations, and being explicit about how interpretations and conclusions were reached, help readers to judge the trustworthiness of the case study report. Stake provides a critique checklist for a case study report (Table 9 )[ 8 ].

Conclusions

The case study approach allows, amongst other things, critical events, interventions, policy developments and programme-based service reforms to be studied in detail in a real-life context. It should therefore be considered when an experimental design is either inappropriate to answer the research questions posed or impossible to undertake. Considering the frequency with which implementations of innovations are now taking place in healthcare settings and how well the case study approach lends itself to in-depth, complex health service research, we believe this approach should be more widely considered by researchers. Though inherently challenging, the research case study can, if carefully conceptualised and thoughtfully undertaken and reported, yield powerful insights into many important aspects of health and healthcare delivery.

Yin RK: Case study research, design and method. 2009, London: Sage Publications Ltd., 4

Google Scholar

Keen J, Packwood T: Qualitative research; case study evaluation. BMJ. 1995, 311: 444-446.

Article CAS PubMed PubMed Central Google Scholar

Sheikh A, Halani L, Bhopal R, Netuveli G, Partridge M, Car J, et al: Facilitating the Recruitment of Minority Ethnic People into Research: Qualitative Case Study of South Asians and Asthma. PLoS Med. 2009, 6 (10): 1-11.

Article Google Scholar

Pinnock H, Huby G, Powell A, Kielmann T, Price D, Williams S, et al: The process of planning, development and implementation of a General Practitioner with a Special Interest service in Primary Care Organisations in England and Wales: a comparative prospective case study. Report for the National Co-ordinating Centre for NHS Service Delivery and Organisation R&D (NCCSDO). 2008, [ http://www.sdo.nihr.ac.uk/files/project/99-final-report.pdf ]

Robertson A, Cresswell K, Takian A, Petrakaki D, Crowe S, Cornford T, et al: Prospective evaluation of the implementation and adoption of NHS Connecting for Health's national electronic health record in secondary care in England: interim findings. BMJ. 2010, 41: c4564-

Pearson P, Steven A, Howe A, Sheikh A, Ashcroft D, Smith P, the Patient Safety Education Study Group: Learning about patient safety: organisational context and culture in the education of healthcare professionals. J Health Serv Res Policy. 2010, 15: 4-10. 10.1258/jhsrp.2009.009052.

Article PubMed Google Scholar

van Harten WH, Casparie TF, Fisscher OA: The evaluation of the introduction of a quality management system: a process-oriented case study in a large rehabilitation hospital. Health Policy. 2002, 60 (1): 17-37. 10.1016/S0168-8510(01)00187-7.

Stake RE: The art of case study research. 1995, London: Sage Publications Ltd.

Sheikh A, Smeeth L, Ashcroft R: Randomised controlled trials in primary care: scope and application. Br J Gen Pract. 2002, 52 (482): 746-51.

PubMed PubMed Central Google Scholar

King G, Keohane R, Verba S: Designing Social Inquiry. 1996, Princeton: Princeton University Press

Doolin B: Information technology as disciplinary technology: being critical in interpretative research on information systems. Journal of Information Technology. 1998, 13: 301-311. 10.1057/jit.1998.8.

George AL, Bennett A: Case studies and theory development in the social sciences. 2005, Cambridge, MA: MIT Press

Eccles M, the Improved Clinical Effectiveness through Behavioural Research Group (ICEBeRG): Designing theoretically-informed implementation interventions. Implementation Science. 2006, 1: 1-8. 10.1186/1748-5908-1-1.

Article PubMed Central Google Scholar

Netuveli G, Hurwitz B, Levy M, Fletcher M, Barnes G, Durham SR, Sheikh A: Ethnic variations in UK asthma frequency, morbidity, and health-service use: a systematic review and meta-analysis. Lancet. 2005, 365 (9456): 312-7.

Sheikh A, Panesar SS, Lasserson T, Netuveli G: Recruitment of ethnic minorities to asthma studies. Thorax. 2004, 59 (7): 634-

CAS PubMed PubMed Central Google Scholar

Hellström I, Nolan M, Lundh U: 'We do things together': A case study of 'couplehood' in dementia. Dementia. 2005, 4: 7-22. 10.1177/1471301205049188.

Som CV: Nothing seems to have changed, nothing seems to be changing and perhaps nothing will change in the NHS: doctors' response to clinical governance. International Journal of Public Sector Management. 2005, 18: 463-477. 10.1108/09513550510608903.

Lincoln Y, Guba E: Naturalistic inquiry. 1985, Newbury Park: Sage Publications

Barbour RS: Checklists for improving rigour in qualitative research: a case of the tail wagging the dog?. BMJ. 2001, 322: 1115-1117. 10.1136/bmj.322.7294.1115.

Mays N, Pope C: Qualitative research in health care: Assessing quality in qualitative research. BMJ. 2000, 320: 50-52. 10.1136/bmj.320.7226.50.

Mason J: Qualitative researching. 2002, London: Sage

Brazier A, Cooke K, Moravan V: Using Mixed Methods for Evaluating an Integrative Approach to Cancer Care: A Case Study. Integr Cancer Ther. 2008, 7: 5-17. 10.1177/1534735407313395.

Miles MB, Huberman M: Qualitative data analysis: an expanded sourcebook. 1994, CA: Sage Publications Inc., 2

Pope C, Ziebland S, Mays N: Analysing qualitative data. Qualitative research in health care. BMJ. 2000, 320: 114-116. 10.1136/bmj.320.7227.114.

Cresswell KM, Worth A, Sheikh A: Actor-Network Theory and its role in understanding the implementation of information technology developments in healthcare. BMC Med Inform Decis Mak. 2010, 10 (1): 67-10.1186/1472-6947-10-67.

Article PubMed PubMed Central Google Scholar

Malterud K: Qualitative research: standards, challenges, and guidelines. Lancet. 2001, 358: 483-488. 10.1016/S0140-6736(01)05627-6.

Article CAS PubMed Google Scholar

Yin R: Case study research: design and methods. 1994, Thousand Oaks, CA: Sage Publishing, 2

Yin R: Enhancing the quality of case studies in health services research. Health Serv Res. 1999, 34: 1209-1224.

Green J, Thorogood N: Qualitative methods for health research. 2009, Los Angeles: Sage, 2

Howcroft D, Trauth E: Handbook of Critical Information Systems Research, Theory and Application. 2005, Cheltenham, UK: Northampton, MA, USA: Edward Elgar

Book Google Scholar

Blakie N: Approaches to Social Enquiry. 1993, Cambridge: Polity Press

Doolin B: Power and resistance in the implementation of a medical management information system. Info Systems J. 2004, 14: 343-362. 10.1111/j.1365-2575.2004.00176.x.

Bloomfield BP, Best A: Management consultants: systems development, power and the translation of problems. Sociological Review. 1992, 40: 533-560.

Shanks G, Parr A: Positivist, single case study research in information systems: A critical analysis. Proceedings of the European Conference on Information Systems. 2003, Naples

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Acknowledgements

We are grateful to the participants and colleagues who contributed to the individual case studies that we have drawn on. This work received no direct funding, but it has been informed by projects funded by Asthma UK, the NHS Service Delivery Organisation, NHS Connecting for Health Evaluation Programme, and Patient Safety Research Portfolio. We would also like to thank the expert reviewers for their insightful and constructive feedback. Our thanks are also due to Dr. Allison Worth who commented on an earlier draft of this manuscript.

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AS conceived this article. SC, KC and AR wrote this paper with GH, AA and AS all commenting on various drafts. SC and AS are guarantors.

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Crowe, S., Cresswell, K., Robertson, A. et al. The case study approach. BMC Med Res Methodol 11 , 100 (2011). https://doi.org/10.1186/1471-2288-11-100

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Frequently Asked Questions: NIH Clinical Trial Definition

What is the difference between clinical research and a clinical trial.

Clinical trials are clinical research studies.

Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.

Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.

How can researchers determine whether a proposed study is a clinical trial?

The following questions should be used to determine whether a study meets the NIH clinical trial definition:

Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect being evaluated a health-related biomedical or behavioral outcome?

If the answers are all “ yes ” the study is a clinical trial. If any answers are “ no ” the study is not a clinical trial.

Does the primary outcome of a study need to be a health-related outcome in order for a study to be considered a clinical trial?

If any outcome is health-related and the answers to the four questions are all yes, then the study is meets the clinical trial definition. You should note, though, that all NIH-funded research investigating biomedical or behavioral outcomes is considered to be health- related. Hence, if the outcome is biomedical or behavioral, the study may be a clinical trial (if the answers to the other three questions are “yes”). Many clinical trials are “mechanistic” or “exploratory” falling outside the realm of efficacy or effectiveness trials.

What is the difference between the clinical trial definition in the revised Common Rule and the NIH clinical trial definition?

NIH considers the two definitions to have the same meaning.

Revised Common Rule § .102(b) : “Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”
NIH clinical trial definition : “A research study in which one or more human subjects are prospectively assigned to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” ( October 23, 2014)

Does risk to human participants factor into whether a study is considered to be a clinical trial?

Risk is not part of the NIH clinical trial definition. NIH considers the study to be a clinical trial as long as all elements of the NIH clinical trial definition are met.

What is the sub-definition of “intervention”?

An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face- to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

Are measurements the same as interventions?

No; measurements are used to evaluate outcomes.

Does the NIH clinical trial definition apply to foreign awards?

Yes; the NIH clinical trial definition applies to all NIH-funded studies.

How will NIH educate researchers?

https://grants.nih.gov/policy/clinical-trials.htm .

Additionally, NIH staff are prepared to help educate researchers on whether their studies meet the NIH clinical definition.

Specific Cases

If a proposed clinical study includes a plan for addressing incidental findings, is the study considered to be a clinical trial.

No; having a plan for addressing incidental findings does not determine whether a study is considered to be a clinical trial. To determine whether your study meets the NIH clinical trial definition, please refer to the four questions above that outline the criteria.

Are studies that propose to evaluate a clinical intervention or to develop a diagnostic tool considered to be clinical trials?

It depends; studies that involve prospective assignment of human participants to an intervention, which may be a clinical intervention or development of a diagnostic tool, and that are designed to evaluate an effect of the intervention on the participant, where the effect is a biomedical or behavioral health outcome, are clinical trials. ( See examples in these Case Studies ). Studies designed only to validate the sensitivity or specificity of a tool are not clinical trials ( See examples in these Case Studies ).

Are studies that elicit the opinions or preferences from human participants considered to be clinical trials?

No; studies eliciting opinions or preferences are not considered to be health-related outcomes.

Are observational studies, which do not include an intervention, considered to be clinical trials?

No; in order to meet the NIH clinical trial definition there must be an intervention.

Are studies that involve only healthy participants considered to be clinical trials?

Yes; studies involving healthy participants are considered clinical trials if all elements of the NIH clinical trial definition are met.

Are studies that are not designed to impact diagnoses or treatment of patients considered to be clinical trials?

It depends; studies that meet all elements of the NIH clinical trial definition are considered to be clinical trials. ( See examples in these Case Studies )

Are studies designed to investigate whether a technique can be used to measure a response in research participants considered to be clinical trials?

Are studies designed to compare two approved diagnostic or therapeutic devices considered to be clinical trials.

No; a study must be designed to evaluate the effect of the intervention on the human participant to meet the NIH clinical trial definition.

Must a health-related outcome be permanent or lasting in order for a study to be a clinical trial?

No; a transient health-related outcome is sufficient for a study to be considered a clinical trial, as long as all other elements of the NIH clinical trial definition are met.

Are studies that coordinate with health-care providers where the outcome is measured in their patients considered to be clinical trials?

Yes; in these studies, both the health-care providers and patients are human participants, and the health care providers become part of the intervention. The study is considered to be a clinical trial as long as all other elements of the NIH clinical trial definition are met. ( See examples in these Case Studies )

Are studies with just a few research participants considered to be clinical trials?

Yes; the NIH clinical trial definition specifies that there must be one or more human participants involved in the study. The study is considered to be a clinical trial if all elements of the NIH clinical trial definition are met.

Are studies ancillary to clinical trials considered to be clinical trials as well?

Yes; studies ancillary to clinical trials are themselves are considered to be clinical trials if all elements of the NIH clinical trial definition are met.

Are studies that use correlational designs considered to be clinical trials?

No; studies using correlational designs to prospectively associate biomedical parameters with other health-related measures, but do not involve an intervention, do not meet the NIH clinical trial definition.

Are studies designed to understand a disease mechanism considered to be clinical trials?

Yes; studies that are designed to evaluate the effect of an intervention on a research participant, and meet all other elements of the clinical trial definition, meet the NIH clinical trial definition.

Are studies that compare two different methods of diagnosing a disease in patients to determine the reliability of a new method, but have no intention of using the results to inform the clinical care of the patients considered to be clinical trials?

No; studies that involve a comparison of methods and that do not evaluate the effect of the interventions on the participant do not meet the NIH clinical trial definition.

Are studies that evaluate the effect of an intervention on research participants, but do not have a comparison group (e.g., placebo, control) considered to be clinical trials?

Studies need not include a comparison group to meet the NIH clinical trial definition. As long as all of the elements of the NIH clinical trial definition are met, the study would be considered to be a clinical trial.

This page was last updated on Wednesday, December 13, 2023

Case Reports Vs Clinical Studies

Uncategorized

This post discusses questions validity if authored by an employee of the reporting company, Roho. This blog will answer these questions regarding clinical studies and clinical evidence:

What is the difference between a clinical study and a case report?
Who can observe and document the results of a clinical study?
What circumstance would beg questioning the validity of a case report?

(Information below was take from the site clinical trials .gov a service of the National Institute of Health)

Definition of case report and clinical study

In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence.

The case report is written on one individual patient.

Clinical Study

A research study using human subjects to evaluate biomedical or health-related outcomes. Two types of clinical studies are Interventional Studies (or clinical trials) and Observational Studies . A clinical study involves multiple patients.

Observational Clinical Studies have a qualified investigator.

In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial).

The Key Responsibilities of a Clinical Study Investigator:

Be qualified to practice medicine or psychiatry and meet the qualifications specified by applicable national regulatory requirements(s)
Be qualified by education, training, and experience to assume responsibility for the proper conduct of the study,
Be familiar with and compliant with Good Clinical Practice (GCP) ICH E6 Guideline and applicable ethical and regulatory requirements prior to commencement of work on the study.
Provide evidence of his/her qualification using the Abbreviated TransCelerate Curriculum Vitae (CV) form

The internal validity of a medical device case report is questioned if bias is present. One must consider bias in a case report authored by an employee of the company that makes the device described in the report.

These are the facts on clinical studies published on the roho website.

There are 15 of what roho calls clinical studies on the roho website. Based on the above definitions, these are not clinical studies but rather case reports.
Of these 15 case reports only one pertains a seat cushion improving a pressure ulcer.

This one single case report is written by Cynthia Fleck, an employee of crown therapeutics which is a division of roho

After selling 1 million cushions over the span of 45 years in business roho has exactly 1 case report which was written by an employee of roho which then begs the question of validity of this report.

Pressure Injury Prevention , SofTech , Uncategorized

Considerations with a standing chair mechanism in fighting pressure sores.

Inspirational people in wheelchairs to follow on social media, get relief & healing from pressure injuries.

Order Your Pressure Relief Wheelchair Cushion Today

Nursing Case Studies with Answers

Explore Nursing Case Studies with Answers and examples in Carepatron's free downloadable PDF. Enhance your nursing knowledge and prepare for exams with practical scenarios.

By Wynona Jugueta on Mar 25, 2024.

Fact Checked by Ericka Pingol.

What is a case study?

A case study in medicine is a detailed report of a patient's experience with a disease, treatment, or condition. It typically includes the patient's medical history, symptoms, diagnostic tests, treatment course, and outcome.

Some key things to know about medical case studies template . First, they delve deep into the specifics of a single case, providing a rich understanding of a particular medical situation.

Medical professionals use case studies to learn about rare diseases, unusual presentations of common conditions, and the decision-making process involved in complex cases.

Case studies can identify exciting areas for further investigation through more rigorous clinical trials. While informative, they can't be used to develop general treatment guidelines because they only focus on a single case.

Overall, medical case studies are valuable tools for medical education and research, offering insights into human health and disease complexities.

Printable Nursing Case Studies with Answers

Download this Nursing Case Studies with Answers to analyze complex clinical situations, identify priority needs, and develop effective care plans tailored to individual patients.

What is in a nursing case study?

A nursing case study is a detailed examination of a patient's health condition, treatment plan, and overall care journey, specifically from the perspective of nursing practice. These case studies are essential components of nursing education and professional development, providing valuable insights into clinical scenarios and patient care experiences.

In a case nursing study template , various elements are typically included to comprehensively understand the patient's situation. First and foremost, the case study outlines the patient's demographic information, including age, gender, medical history, and presenting symptoms. This demographic overview sets the stage for understanding the context in which healthcare interventions occur.

Moreover, nursing case studies often delve into the nursing assessment process, highlighting the initial and ongoing assessments nurses conduct to gather relevant patient health status data. These assessments involve physical examinations, vital sign monitoring, and assessment tools to identify potential health issues and risk factors.

Critical thinking skills are essential in nursing case studies, as they enable nurses to analyze complex clinical situations, identify priority needs, and develop effective care plans tailored to individual patients. Nursing students and experienced nurses use case studies as opportunities to enhance their critical thinking abilities and clinical decision-making processes.

Nursing case studies serve several vital purposes within healthcare education and professional practice, whether they are a primary care physician or a group of nursing students. Let's explore each purpose in detail:

Enhancing clinical reasoning skills

One primary purpose of nursing case studies is to enhance nursing students' and practicing nurses' clinical reasoning skills. By presenting realistic patient scenarios, case studies challenge individuals to analyze clinical data, interpret findings, and develop appropriate nursing interventions. This process promotes critical thinking and problem-solving abilities essential for effective nursing practice.

Applying theoretical knowledge to practice

Nursing case studies provide a bridge between theoretical knowledge and practical application. They allow nursing students to apply concepts learned in the classroom to real-world patient care situations. By engaging with case studies, students can integrate theoretical principles with clinical practice, gaining a deeper understanding of nursing concepts and their relevance to patient care.

Facilitating interdisciplinary collaboration

Another purpose of nursing case studies is to facilitate interdisciplinary collaboration among healthcare professionals. Nurses often collaborate with physicians, specialists, therapists, and other team members in complex patient cases to deliver comprehensive care. Case studies offer opportunities for nurses to explore collaborative decision-making processes, communication strategies, and teamwork dynamics essential for providing quality patient care.

Promoting evidence-based practice

Nursing case studies are crucial in promoting evidence-based practice (EBP) within nursing and healthcare settings. Nurses can make informed decisions about patient care interventions by analyzing patient scenarios and considering current research evidence. Case studies encourage nurses to critically evaluate research findings, clinical guidelines, and best practices to ensure the delivery of safe, effective, and patient-centered care.

Fostering professional development

Engaging with nursing case studies contributes to the ongoing professional development of nurses at all stages of their careers. For nursing students, case studies provide valuable learning experiences that help prepare them for clinical practice. For experienced nurses, case studies offer opportunities to refine clinical skills, stay updated on emerging healthcare trends, and reflect on past experiences to improve future practice.

How to write a nursing case study?

Writing a nursing case study involves several essential steps to ensure accuracy, relevance, and clarity. Let's break down the process into actionable steps:

Step 1: Select a patient case

Begin by selecting a patient case that presents a relevant and compelling healthcare scenario. Consider factors such as the patient's demographic information, medical history, presenting symptoms (e.g., joint stiffness, pain), and healthcare needs (e.g., medication administration, vital signs monitoring). Choose a case that aligns with your learning objectives and offers meaningful analysis and discussion opportunities.

Step 2: Gather relevant data

Collect comprehensive data about the selected patient case, including medical records, test results, nursing assessments, and relevant healthcare documentation. Pay close attention to details such as the patient's current health status, past medical history (e.g., diabetes), treatment plans, and any ongoing concerns or challenges. Utilize assessment tools and techniques to evaluate the patient's condition thoroughly and identify areas of clinical significance.

Step 3: Assess the patient's needs

Based on the gathered data, evaluate the patient's needs, considering physical, emotional, social, and environmental factors. Assess the patient's pain levels, mobility, vital signs, and other relevant health indicators. Identify any potential complications, risks, or areas requiring immediate attention. Consider the patient's preferences, cultural background, and individualized care requirements in your assessment.

Step 4: Formulate nursing diagnoses

Formulate nursing diagnoses that accurately reflect the patient's health needs and priorities based on your assessment findings. Identify actual and potential nursing diagnoses related to the patient's condition, considering factors such as impaired mobility, ineffective pain management, medication adherence issues, and self-care deficits. Ensure your nursing diagnoses are specific, measurable, achievable, relevant, and time-bound (SMART).

Step 5: Develop a care plan

Develop a comprehensive care plan outlining the nursing interventions and strategies to address the patient's identified needs and nursing diagnoses. Prioritize interventions based on the patient's condition, preferences, and care goals. Include evidence-based nursing interventions to promote optimal health outcomes, manage symptoms, prevent complications, and enhance the patient's overall well-being. Collaborate with other healthcare professionals as needed to ensure coordinated care delivery.

Step 6: Implement and evaluate interventions

Implement the nursing interventions outlined in the care plan while closely monitoring the patient's response to treatment. Administer medications, provide patient education, perform nursing procedures, and coordinate care activities to effectively meet the patient's needs. Continuously evaluate the effectiveness of interventions, reassessing the patient's condition and adjusting the care plan as necessary. Document all interventions, observations, and outcomes accurately and comprehensively.

Step 7: Reflect and seek assistance

Reflect on the nursing case study process, considering what worked well, areas for improvement, and lessons learned. Seek assistance from nursing instructors, preceptors, or colleagues if you encounter challenges or have concerns about the patient's care. Collaborate with interdisciplinary team members to address complex patient issues and ensure holistic care delivery. Continuously strive to enhance your nursing practice through ongoing learning and professional development.

Nursing Case Studies with Answers example (sample)

Below is an example of a nursing case study sample created by the Carepatron team. This sample illustrates a structured framework for documenting patient cases, outlining nursing interventions, and providing corresponding answers to guide learners through the analysis process. Feel free to download the PDF and use it as a reference when formulating your own nursing case studies.

Download this free Nursing Case Studies with Answers PDF example here

Why use Carepatron as your nursing software?

Carepatron stands out as a comprehensive and reliable solution for nursing professionals seeking efficient and streamlined workflows in their practice. With a range of features tailored to the needs of nurses and healthcare teams, Carepatron offers unparalleled support and functionality for managing various aspects of patient care.

Nurse scheduling software

One of the key advantages of Carepatron is its nurse scheduling software , which simplifies the process of creating and managing schedules for nursing staff. With intuitive scheduling tools and customizable options, nurses can easily coordinate shifts, manage availability, and ensure adequate staffing levels to meet patient needs effectively.

Telehealth platform

In addition, Carepatron offers a robust telehealth platform that facilitates remote patient monitoring, virtual consultations, and telemedicine services. This feature enables nurses to provide continuity of care beyond traditional healthcare settings, reaching patients in remote areas or those unable to attend in-person appointments.

Clinical documentation software

Furthermore, Carepatron's clinical documentation software streamlines the documentation process, allowing nurses to easily capture patient data, record assessments, and document interventions. The platform supports accurate and efficient documentation practices, ensuring compliance with regulatory standards and promoting continuity of care across healthcare settings.

Commonly asked questions

In clinical terms, a case study is a detailed examination of a patient's medical history, symptoms, diagnosis, treatment, and outcomes, typically used for educational or research purposes.

Case studies are essential in nursing as they provide real-life scenarios for nurses to apply theoretical knowledge, enhance critical thinking skills, and develop practical clinical reasoning and decision-making abilities.

Case studies in nursing education offer benefits such as promoting active learning, encouraging problem-solving skills, facilitating interdisciplinary collaboration, and fostering a deeper understanding of complex healthcare situations.

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Int J Integr Care
v.16(4); Oct-Dec 2016

What Is Case Management? A Scoping and Mapping Review

Ms sue lukersmith.

1 Faculty of Health Sciences, Centre for Disability Research and Policy, University of Sydney, Sydney, Australia

2 Mental Health Policy Unit, Brain & Mind Centre, University of Sydney, Sydney, Australia

Dr Michael Millington

Luis salvador-carulla.

The description of case management in research and clinical practice is highly variable which impedes quality analysis, policy and planning. Case management makes a unique contribution towards the integration of health care, social services and other sector services and supports for people with complex health conditions. There are multiple components and variations of case management depending on the context and client population. This paper aims to scope and map case management in the literature to identify how case management is described in the literature for key complex health conditions (e.g., brain injury, diabetes, mental health, spinal cord injury). Following literature searches in multiple databases, grey literature and exclusion by health condition, community-based and adequate description, there were 661 potential papers for data extraction. Data from 79 papers (1988–2013) were analysed to the point of saturation (no new information) and mapped to the model, components and activities. The results included 22 definitions, five models, with 69 activities or tasks of case managers mapped to 17 key components (interventions). The results confirm the significant terminological variance in case management which produces role confusion, ambiguity and hinders comparability across different health conditions and contexts. There is an urgent need for an internationally agreed taxonomy for the coordination, navigation and management of care.

Introduction

Case management, also known as care coordination is a complex integrated health and social care intervention and makes a unique contribution to the health, social care and participation of people with complex health conditions.[ 1 , 2 , 3 , 4 ]. In the 1960’s case management emerged in response to the de-institutionalisation of large numbers of people with severe mental health conditions who required referral to outpatient health and other community services. During the 1970’s and 1980’s, the increasing cost of health care and de-centralisation of health services influenced the role of case managers [ 5 , 6 ]. Since the 1990’s, case management has existed in a range of settings including acute, post-acute hospital, rehabilitation, long term care and community-based settings. Case management tasks are now performed by people from various disciplines, for people with different problems in diverse contexts and communities. These multiple interdependent and interacting parameters of case management produce variability in the description of case management [ 5 , 7 , 8 , 9 ]. The significant terminological variance, lack of understanding and a common language for case management and care coordination has impeded quality analysis, policy and planning [ 4 , 10 , 11 , 12 ]. There is an urgent need for a common international language, but which first requires an understanding of the terms used to describe case management in the literature.

There are multiple parameters that influence case management. Case management operates in very different service sectors (health, social, correctional, work/vocational, veterans, legal sectors) and different settings (public sector, private and non-government organisations) and with different community and support resources (high and low resource settings). Its presence in diverse contexts demonstrates the importance of case management in the horizontal integration of care across health services, social services and other sectors as well as the vertical integration across primary, community, hospital and tertiary health care services [ 13 ].

In the health sector, case management and care coordination occurs within an inpatient setting, or mobile and community-based. In this scoping review we only considered community-based case management. Community-based case management is a mobile rather than office based health service. Case manager contact with the client (and/or their family) may occur in a different setting such as the client’s home, workplace or other community venue as considered appropriate by the case manager and client. Community-based case management is the most holistic and person-centred of the approaches (model) as it meets at the junction of the client in their own context. Due to its holistic and comprehensive approach, community-based case management is also likely to involve most of the components of case management of other models that have a narrower focus.

Health sector case managers are from different disciplines (e.g. nursing, occupational therapy, physiotherapy, psychology, rehabilitation counselling, social work, speech pathology) and different practice areas (social and welfare, primary care). Further, there are a number of case management models and theories underpinning practice approaches, due in part to the different sectors where case management operates, the age and health conditions of the client [ 9 ]. Hence, both in practice and the literature, a range of names are applied to the role and tasks of a case manager such as: community/care coordinator, support facilitator or broker, case monitor, discharge planner, planning facilitator, case worker, clinical/rehabilitation case manager. Other client characteristics and temporal factors (e.g. whether the client’s problem is new, acute or chronic) also affect the tasks and actions of the case manager. All these different factors related to the case manager, client and context influence what case managers do (i.e. case management tasks as interventions). Whilst there are differences between case management tasks and context, there are also similarities, yet there is no common language to describe these variations.

In spite of the abundance of literature on case management in all its forms, case management descriptors are often non-existent or poorly described with mixed concepts and constructs. There appears to be no consensus on what is, and importantly what is not case management. The heterogeneity, complexity and inadequate descriptions of the components of case management demands a flexible exploratory approach and consideration of a breadth of literature compared to the methods of a focused and narrower systematic review. This review aims to characterise and map how case management has been described in the literature. The review did not seek to assess the quality, nor synthesise the evidence on effectiveness of case management interventions. The focus in this research programme was on the components and definitions. It is the first step of a larger study to develop a taxonomy, a knowledge map and common language for community-based case management. Community-based case management was the focus because it is likely to contain elements of other approaches. People with key complex and chronic health conditions were selected, as case management is frequently used to support their management and the integration of their care.

Aim of the research

The objective of this study was to scope and map ‘How case management is described in the literature’ in particular the definition, the theoretical basis, the components and activities (interventions) performed by the case manager.

Theory and Methods

Study design.

The study design was a scoping and mapping review. As exploratory research, scoping reviews are particularly appropriate when the area is complex, and used to map the key concepts underpinning a research area [ 14 ]. A scoping study aims ‘to map the literature on a particular topic or research area and provide an opportunity to identify key concepts; gaps in the research; and types and sources of evidence to inform practice, policymaking, and research’ (p. 8) [ 15 ]. A scoping review balances the feasibility of the literature search with the breadth and comprehensiveness in the scoping process [ 16 ].

The scoping review used five of the six steps in the framework articulated by Arskey et al [ 17 ] and extended by Levac [ 16 ] which are: 1) identifying the research question; 2) identifying relevant studies; 3) study selection; 4) charting (mapping) the data; 5) collating, summarizing and reporting the results. Consistent with many scoping reviews, quality appraisal was not undertaken as the focus was on language and descriptions of the concepts and components of case management rather than the methodology, outcomes and efficacy of the included studies [ 15 , 16 , 18 , 19 , 20 ].

Scoping and mapping methodology

We used an iterative process in the scoping review that allowed for flexibility in the search, reviewing and mapping steps. A flexible approach was necessary due to the diversity in the terms around case management, the model or approach taken, the contexts in which it operates and the health conditions of the recipients of case management. The steps taken for the scoping review are outlined below:

1. The research question

The main research question was ‘How was case management described in the literature’. The sub-questions were:

How was case management for complex and chronic health conditions, described in the literature (brain injury, diabetes, mental health, spinal cord injury)?
What was the theoretical basis (the model) (if any) linked to the case management approach?
What were the components, and activities performed in case management; and how are they described?

2. Identify relevant studies

This scoping study used quantitative, qualitative research literature as well as the grey literature. Peer reviewed papers provide information from observational and experimental research. Grey literature provides information from expert practice knowledge and expert experience knowledge [ 21 ]. In this study we consider grey literature to be literature ‘ produced at all levels of government, academics, business, industry in print and electronic formats, but which is not controlled by commercial publishers ’ [ 22 ]. It includes papers, reports, technical notes or other documents produced and published by governmental agencies, academic institutions, professional associations such as case management societies, and other case management organisations and groups that develop standards or describe services and the activities of case managers.

The search terms and strategy were developed, trialled and discussed then refined with the co-authors and an information specialist. Over three meetings, the co-author team reviewed examples of the literature and refined the selection of studies. This refinement involved combining key words for case management and key words for definition in the final search strategy with limits to specific health conditions. Our decisions on key words and limits are outlined below:

– The variation in names, and complexities of contexts and health conditions posed challenges to systematic searching across multiple databases. We collectively identified the relevant descriptors of case management for the key word search terms based on our familiarity with the literature and community-based case management context.
– There were no limits on the type of study as the range of literature of interest included qualitative, quantitative intervention and non-intervention studies for key health conditions, reports on case management standards, service descriptions, literature reviews and theoretical papers.
– Literature on case management not provided in the community was excluded. However, research papers and grey literature that referred to general case management activities and actions were included.
– The number of descriptions for case management required limits established for the range of health conditions. Five complex or chronic health conditions were included: brain injury, diabetes, mental health conditions and spinal cord injury. Brain injury was included as it is complex health condition and potentially impacts multiple domains of health. It was also of interest to the industry partner (Lifetime Care) involved in the larger study [ 23 ]. Mental health conditions were included because of the complex impact of the conditions but also because of its history in case management. Diabetes was included as it is a common chronic health condition. Although less common, spinal cord injury was included as it provides its own set of unique challenges around long term community-based and integrated supports.

Multiple databases were searched for published literature, complemented by searches on key organisation websites and snowballing with hand searching of references lists. The database search was carried out in Week 3 July 2013. The databases were Medline, Cochrane, OTseeker, and PsycBITE. The grey literature key websites searches were conducted in August 2013 and February 2014. The organisational websites were: Australia : Case Management Society of Australian and New Zealand (CMSA); Transport Accident Commission (TAC); Lifetime Care and Support Authority (LTC); National Disability Insurance Agency (NDIA); WorkCover Authority (NSW), Brain Injury Rehabilitation Directorate (New South Wales – NSW); Department of Health NSW; Canada- National Case Management Network; United Kingdom (UK) – Case Management Society of the United Kingdom (CMSUK); British Association of Brain Injury Case Managers (BABICM); National Health Service (NHS); United States of America (USA) Agency for Healthcare Research and Quality; Commission for Case Manager Certification; Case Management Health System; Case Management Society of America; American Case Management Association.

The limits were English language, humans with no limits on study type. The inclusion criteria were:

– No limits on publication dates (Medline 1946- Week 2 July 2013)
– Community-based case management
– Case management related to health conditions of brain injury, diabetes, mental health conditions, spinal cord injury
– A definition of the case management and description of the actions, activities, interventions.

3. Study selection

The authors agreed that an iterative process to the exclusion, selection of studies and data extractions was appropriate. In order to manage the copious amounts of literature located, a hierarchy of steps for the exclusion of literature was developed in consultation with co-authors. A bibliographic manager database (EndNote X7) supported the management of the body of literature and exclusion process. The steps for exclusion after the removal of duplicated papers were:

Exclusion by health conditions, social issues (e.g. ex-prisoners or offenders, homeless persons), single health conditions in low health service resource settings (e.g. Malaria in a developing country),
Exclusion by case management setting (inpatient, acute care or residential settings such as nursing home, correctional institution), telehealth (no face to face).
Exclusion because of inadequate (or absence) of a description of case management, the case manager actions or interventions.

4. Mapping the data (charting)

The scoping review involved conceptual mapping to the point of saturation when no new descriptions, concepts or components were identified [ 17 , 24 ]. The focus was on the components and definitions of case management interventions. The information was extracted and stored on an Excel spreadsheet for data management and to enable numerical summation and qualitative analysis. SL extracted data from a sample of 6 papers, which was then reviewed and checked by LSC and MM. The information variables to be extracted were then revised and reduced in agreement with all authors. SL continued with the data extraction and mapping. The final extraction table was reviewed by all authors. Obvious inconsistencies noted were discussed and revisions made.

Extraction and mapping of the case management information began at a global level of the country and type of paper, followed by high level information on the model or approach, theoretical basis, then more detailed components and then finally the description of these components. The final variables mapped were: paper author, year of publication, title, type of study where relevant (or paper), health condition of population, country of study, name of case management model, linked theoretical basis, case management definition, components of case management, descriptors, actions/activities described (sometimes called steps, activities, actions or interventions in the literature) and additional comments. The mapping of information was done to the point of saturation, where no new information (concepts, descriptions, components) were identified. Once it was apparent that no new information was extracted, a further six papers were reviewed and data extracted and mapped, to ensure that the point of saturation had been reached.

5. Collating, summarizing and reporting the results

The information and mapping results from the studies were collated, analysed, summarised and reported. The results were also used as one step in a larger study to develop a taxonomy on case management [ 23 ].

Our search yielded a total of 6,847 peer reviewed research study papers and 22 grey literature papers, a total of 6,869 references. This was reduced to 6,314 after duplicates were removed (see Figure Figure1 1 for a summary of the screening and eligibility process). After reviewing the titles and abstracts from the search results for health condition (excluded n = 3,600), and removing practice context other than community-based (excluded n = 1,199), and finally removing those with inadequate description in the paper (excluded n = 854), we had 661 potential references for data extraction and mapping. A total of 12 grey literature papers and 61 randomly selected research papers were included in the data extraction and mapping to the point of saturation, when no new information was provided. We selected the grey literature papers because of their focus and the content related to the components to be mapped (model, definition, description of activities or interventions by case managers), such as model descriptions or statements from professional case management associations. To ensure the point of saturation was reached, the data from a further 6 research papers was extracted and mapped making a total of 79 papers.

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Flow of Study Selection.

The papers analysed included 65 papers from peer reviewed journals published 1988–2013 and 14 papers from the grey literature. Appendix 2 provides the details of the 79 included papers. Table Table1 1 describes the global analysis of the papers. In 63 papers there was 10 different countries of focus and 14 there was an international perspective (e.g. literature review). There were 26 papers on mental health, eight on diabetes or chronic/long term health conditions, 12 brain injury, two on spinal cord injury and 31 were not related to specific health conditions. There was one systematic review, 42 qualitative research methods papers, 7 intervention studies, 11 theoretical papers, 5 editorial perspectives or expert opinion, 11 papers were practice guidance and professional association standards and two conference papers.

Description of the mapped papers.

The next layer of data extraction resulted in an increasing level of detail on case management as described in the literature. Twenty-three specifically identified definitions of case management, (rather than general statements) are provided in Appendix 3. Some definitions were repeated in a number of papers, for example a case management society definition was used in a number of papers.

We found descriptions of different models and theoretical descriptions of the case management approaches in 23 papers. These were mapped to five different models. Exploration on the most common or frequently adopted model was not in the study scope. In some instances, there was a specific model or theoretical basis. For other papers, the approach was broadly described. On this basis, we could map the approach to a model. In other papers several models were discussed (e.g. systematic review). There was a total of 57 papers which did not identify the theoretical basis of the case management approach nor refer to a model. The mapped models of case management, related terms, theoretical description and case management features are provided in Table Table2. 2 . In this table, we have not provided examples of papers providing a description as many papers such as literature reviews, opinion or theoretical papers and systematic reviews referred to a number of these models or their variations.

Mapped models of case management, and related names, theoretical description and case management features.

*refer to Appendix 2 for details of the articles in scoping study.

The key components of case management described in the papers were extracted. Terms used for these components include activities, functions, tasks, responsibilities, duties, steps and interventions, standards. Across the 79 papers, we mapped 69 of the various terms used in the literature to 17 component headings, which were broadly defined. Only examples of the terms extracted from the literature and mapped to the component are provided in Table Table3 3 .

Examples of the terms in the literature mapped to component heading.

The results of the scoping and mapping review confirms that there is a huge body of peer reviewed and grey literature on case management, yet there is significant terminological variance. Following literature searches, exclusions by health conditions, case management context (community-based) and papers with inadequate descriptions we extracted data and mapped the components of case management from papers (n = 79) to the point of saturation. There was a broad range of literature included in the study (quantitative, qualitative, theoretical and practice guidance papers) and from 11 countries and international perspectives (n = 14).

The mapping of extracted data was complicated because of the variability in the language to describe case management. There was heterogeneity in the descriptions, terms and phrases to describe the models, which reflects the difficulties in the articulation of the differences and similarities between the models and the interventions provided by case managers. For the purposes of this scoping review, we mapped the models described to five key models of case management based on a theoretical description of each. Whilst there are more than five case management models, many are variations, adaptations and interpretations of a model to the specific context.

We extracted 69 components in the literature to describe what case managers do (the interventions/activities). We identified 17 key components and mapped the 69 descriptions to these. Each key component had multiple different but related terms to describe the intervention. There was also complexities mapping of the components (activities and interventions) performed by the case manager. In the literature, there was semantic confusion between the components (interventions) of case managers with skills, standards, aims and objectives. For example, ‘stable person- invested but not involved’ [ 54 ] is a description of a standard or skill of the case manager (the ‘how’) rather than a component of case management (the ‘what’ is done). The component descriptions were also variously defined from different perspectives of the client, case manager, project or team organisation, program, service or organisation. For example, the description of ‘gatekeeper’ (clinical and financial) [ 9 , 55 , 56 ] listed as a case manager activity, is aimed at the sustainability of the service or system, at most is an (administrative) responsibility of the case manager to the service or organisation rather than an intervention directed at the client. These difficulties confirm the complexity around case management resulting in terminological variance used. The literature in this scoping study spanned a 25 year period (1988 to 2013). While case management to coordinate services has been used since the late 19 th century and contemporary case management emerging since the 1960’s [ 57 ], this scoping review confirms that over time the description and terminological variance remains.

The terminological variance reflects the ambiguity and confusion about roles and the interventions performed by case managers. Specificity and replicability of case management are essential to evaluation of effectiveness [ 58 ]. There are complex interdependent and dependent factors influencing what case management interventions are done, when, with whom and in what context. A clear understanding and consensus on the components and a common language to describe these factors will provide the tool for measuring outcomes, and making comparisons for effectiveness and quality evaluations.

Limitations

The study was limited to the descriptions and terms used in the literature to refer to the same or similar concept including the model, theory and components. A limitation in the search strategy was not including all possible databases. Databases such as EMBASE were not searched as it is primarily a biomedical and pharmacological database and considered unlikely to host a significant body of community-based case management literature. Search of the database CINAHL may have revealed additional relevant literature. Whilst other databases could have been considered, the volume of literature from the four databases provided more than sufficient material to use for data extraction to the point of saturation. The extensive search for grey literature added to the volume of peer reviewed literature. However, the point of saturation was reached after the data extraction from 79 articles retrieved through the four databases and multiple grey literature websites.

The search restricted to only four health conditions is a study limitation. The trial of searches without health conditions limits produced in excess of 10,000 hits on Medline alone. For pragmatic reasons, the search strategy was subsequently limited to include four health conditions. Those selected by the authors were known to have community-based case managers involved in health, social care and education sectors.

The study did not undertake quality analysis of the research papers. It is recognised that this meant that equal weight was given to all papers and grey literature, which we consider was justified given the purpose of the scoping study to examine descriptors of case management components and context not efficacy of case management. There can also be concerns about potential bias in scoping reviews related to the reviewers own interests, lack of training and limited view due to discipline or language [ 59 ]. Others suggest that there is a ‘trade off’ of potential source of bias in perception and interpretation of a subject and conversely that subject matter experts are necessary [ 59 , 60 , 61 , 62 ]. In this instance, considering the complexity in case management, the three researchers background and expert knowledge was considered an advantage to the scoping and conceptual mapping.

The scoping review used five of the six steps in the framework articulated by Arskey et al [ 17 ] and extended by Levac [ 16 ]. The 6 th step it the Arskey/Levac methodology is consultation with a broader group of experts and stakeholders to discuss the findings. This step was not performed as part of the scoping review but did occur in a subsequent step of the larger study to develop a taxonomy on case management. In the larger study, a nominal group of case management experts extensively discussed the results of the scoping review to develop the Beta 2 version of the case management taxonomy [ 23 ].

Case management with all its different names, variations and contexts continues to support the coordination, integration and management of health and social care in many different contexts for different health conditions. The results of this scoping and mapping study confirms the significant terminological variance which produces role confusion, ambiguity and hinders comparability across different health. There is an urgent need for an internationally agreed taxonomy for the coordination, navigation and management of care. The result of this scoping and mapping review was the first of four steps to develop the case management taxonomy finalised in 2015. [ 23 ].

Future research

The results from this scoping and mapping study is part of a larger study to develop a knowledge map and common language, the case management taxonomy which has an intervention tree, service tree and glossary [ 23 ].

Supplementary Files

The supplementary files for this article can be found as follows:

Supplementary File 1: Appendix 1. ijic-16-4-2477-s1.pdf
Supplementary File 2: Appendix 2. ijic-16-4-2477-s2.pdf
Supplementary File 3: Appendix 3. ijic-16-4-2477-s3.pdf

Helen Killaspy, Professor of Rehabilitation Psychiatry, University College London, UK.

Two anonymous reviewers.

Competing Interests

The authors declare that they have no competing interests.

Author contribution

All authors contributed to the research and manuscript.

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