what is a patient case study

Writing a Case Report

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

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

Case reports are commonly of the following categories :

- Rare diseases

- Unusual presentation of disease

- Unexpected events

- Unusual combination of diseases or conditions

- Difficult or inconclusive diagnosis

- Treatment or management challenges

- Personal impact

- Observations that shed new light on a disease or condition

- Anatomical variations

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

Case reports generally take the format of :

1. Background

2. Case presentation

3. Observations and investigation

4. Diagnosis

5. Treatment

7. Discussion

Does a case report require IRB approval?

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

Are there other rules for writing a case report?

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

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

How do I get started?

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

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

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

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

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

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

How do I write a case report?

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

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

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

Do I have to obtain informed consent from the patient?

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

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

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

Seek feedback

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

Selecting a journal

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

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

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

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

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

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

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

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

Is it free to publish ?

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

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

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

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

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

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

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

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

*content developed by Mark Trottier, PhD

Health Case Studies

(29 reviews)

Glynda Rees, British Columbia Institute of Technology

Rob Kruger, British Columbia Institute of Technology

Janet Morrison, British Columbia Institute of Technology

Publisher: BCcampus

Language: English

Formats Available

Conditions of use.

Learn more about reviews.

Reviewed by Jessica Sellars, Medical assistant office instructor, Blue Mountain Community College on 10/11/23

Comprehensiveness rating: 5 see less

This is a book of compiled and very well organized patient case studies. The author has broken it up by disease patient was experiencing and even the healthcare roles that took place in this patients care. There is a well thought out direction and plan. There is an appendix to refer to as well if you are needing to find something specific quickly. I have been looking for something like this to help my students have a base to do their project on. This is the most comprehensive version I have found on the subject.

Content Accuracy rating: 5

This is a book compiled of medical case studies. It is very accurate and can be used to learn from great care and mistakes.

Relevance/Longevity rating: 5

This material is very relevant in this context. It also has plenty of individual case studies to utilize in many ways in all sorts of medical courses. This is a very useful textbook and it will continue to be useful for a very long time as you can still learn from each study even if medicine changes through out the years.

Clarity rating: 5

The author put a lot of thought into the ease of accessibility and reading level of the target audience. There is even a "how to use this resource" section which could be extremely useful to students.

Consistency rating: 5

The text follows a very consistent format throughout the book.

Modularity rating: 5

Each case study is individual broken up and in a group of similar case studies. This makes it extremely easy to utilize.

Organization/Structure/Flow rating: 5

The book is very organized and the appendix is through. It flows seamlessly through each case study.

Interface rating: 5

I had no issues navigating this book, It was clearly labeled and very easy to move around in.

Grammatical Errors rating: 5

I did not catch any grammar errors as I was going through the book

Cultural Relevance rating: 5

This is a challenging question for any medical textbook. It is very culturally relevant to those in medical or medical office degrees.

I have been looking for something like this for years. I am so happy to have finally found it.

Reviewed by Cindy Sun, Assistant Professor, Marshall University on 1/7/23

Interestingly, this is not a case of ‘you get what you pay for’. Instead, not only are the case studies organized in a fashion for ease of use through a detailed table of contents, the authors have included more support for both faculty and students. For faculty, the introduction section titled ‘How to use this resource’ and individual notes to educators before each case study contain application tips. An appendix overview lists key elements as issues / concepts, scenario context, and healthcare roles for each case study. For students, learning objectives are presented at the beginning of each case study to provide a framework of expectations.

The content is presented accurately and realistic.

The case studies read similar to ‘A Day In the Life of…’ with detailed intraprofessional communications similar to what would be overheard in patient care areas. The authors present not only the view of the patient care nurse, but also weave interprofessional vantage points through each case study by including patient interaction with individual professionals such as radiology, physician, etc.

In addition to objective assessment findings, the authors integrate standard orders for each diagnosis including medications, treatments, and tests allowing the student to incorporate pathophysiology components to their assessments.

Each case study is arranged in the same framework for consistency and ease of use.

This compilation of eight healthcare case studies focusing on new onset and exacerbation of prevalent diagnoses, such as heart failure, deep vein thrombosis, cancer, and chronic obstructive pulmonary disease advancing to pneumonia.

Each case study has a photo of the ‘patient’. Simple as this may seem, it gives an immediate mental image for the student to focus.

Interface rating: 4

As noted by previous reviewers, most of the links do not connect active web pages. This may be due to the multiple options for accessing this resource (pdf download, pdf electronic, web view, etc.).

Grammatical Errors rating: 4

A minor weakness that faculty will probably need to address prior to use is regarding specific term usages differences between Commonwealth countries and United States, such as lung sound descriptors as ‘quiet’ in place of ‘diminished’ and ‘puffers’ in place of ‘inhalers’.

The authors have provided a multicultural, multigenerational approach in selection of patient characteristics representing a snapshot of today’s patient population. Additionally, one case study focusing on heart failure is about a middle-aged adult, contrasting to the average aged patient the students would normally see during clinical rotations. This option provides opportunities for students to expand their knowledge on risk factors extending beyond age.

This resource is applicable to nursing students learning to care for patients with the specific disease processes presented in each case study or for the leadership students focusing on intraprofessional communication. Educators can assign as a supplement to clinical experiences or as an in-class application of knowledge.

Reviewed by Stephanie Sideras, Assistant Professor, University of Portland on 8/15/22

The eight case studies included in this text addressed high frequency health alterations that all nurses need to be able to manage competently. While diabetes was not highlighted directly, it was included as a potential comorbidity. The five overarching learning objectives pulled from the Institute of Medicine core competencies will clearly resonate with any faculty familiar with Quality and Safety Education for Nurses curriculum.

The presentation of symptoms, treatments and management of the health alterations was accurate. Dialogue between the the interprofessional team was realistic. At times the formatting of lab results was confusing as they reflected reference ranges specific to the Canadian healthcare system but these occurrences were minimal and could be easily adapted.

The focus for learning from these case studies was communication - patient centered communication and interprofessional team communication. Specific details, such as drug dosing, was minimized, which increases longevity and allows for easy individualization of the case data.

While some vocabulary was specific to the Canadian healthcare system, overall the narrative was extremely engaging and easy to follow. Subjective case data from patient or provider were formatted in italics and identified as 'thoughts'. Objective and behavioral case data were smoothly integrated into the narrative.

The consistency of formatting across the eight cases was remarkable. Specific learning objectives are identified for each case and these remain consistent across the range of cases, varying only in the focus for the goals for each different health alterations. Each case begins with presentation of essential patient background and the progress across the trajectory of illness as the patient moves from location to location encountering different healthcare professionals. Many of the characters (the triage nurse in the Emergency Department, the phlebotomist) are consistent across the case situations. These consistencies facilitate both application of a variety of teaching methods and student engagement with the situated learning approach.

Case data is presented by location and begins with the patient's first encounter with the healthcare system. This allows for an examination of how specific trajectories of illness are manifested and how care management needs to be prioritized at different stages. This approach supports discussions of care transitions and the complexity of the associated interprofessional communication.

The text is well organized. The case that has two levels of complexity is clearly identified

The internal links between the table of contents and case specific locations work consistently. In the EPUB and the Digital PDF the external hyperlinks are inconsistently valid.

The grammatical errors were minimal and did not detract from readability

Cultural diversity is present across the cases in factors including race, ethnicity, socioeconomic status, family dynamics and sexual orientation.

The level of detail included in these cases supports a teaching approach to address all three spectrums of learning - knowledge, skills and attitudes - necessary for the development of competent practice. I also appreciate the inclusion of specific assessment instruments that would facilitate a discussion of evidence based practice. I will enjoy using these case to promote clinical reasoning discussions of data that is noticed and interpreted with the resulting prioritizes that are set followed by reflections that result from learner choices.

Reviewed by Chris Roman, Associate Professor, Butler University on 5/19/22

It would be extremely difficult for a book of clinical cases to comprehensively cover all of medicine, and this text does not try. Rather, it provides cases related to common medical problems and introduces them in a way that allows for various... read more

Comprehensiveness rating: 4 see less

The narrative form of the cases is less subject to issues of accuracy than a more content-based book would be. That said, the cases are realistic and reasonable, avoiding being too mundane or too extreme.

These cases are narrative and do not include many specific mentions of drugs, dosages, or other aspects of clinical care that may grow/evolve as guidelines change. For this reason, the cases should be “evergreen” and can be modified to suit different types of learners.

Clarity rating: 4

The text is written in very accessible language and avoids heavy use of technical language. Depending on the level of learner, this might even be too simplistic and omit some details that would be needed for physicians, pharmacists, and others to make nuanced care decisions.

The format is very consistent with clear labeling at transition points.

The authors point out in the introductory materials that this text is designed to be used in a modular fashion. Further, they have built in opportunities to customize each cases, such as giving dates of birth at “19xx” to allow for adjustments based on instructional objectives, etc.

The organization is very easy to follow.

I did not identify any issues in navigating the text.

The text contains no grammatical errors, though the language is a little stiff/unrealistic in some cases.

Cases involve patients and members of the care team that are of varying ages, genders, and racial/ethnic backgrounds

Reviewed by Trina Larery, Assistant Professor, Pittsburg State University on 4/5/22

The book covers common scenarios, providing allied health students insight into common health issues. The information in the book is thorough and easily modified if needed to include other scenarios not listed. The material was easy to understand... read more

Content Accuracy rating: 4

The treatments were explained and rationales were given, which can be very helpful to facilitate effective learning for a nursing student or novice nurse. The case studies were accurate in explanation. The DVT case study incorrectly identifies the location of the clot in the popliteal artery instead of in the vein.

The content is relevant to a variety of different types of health care providers and due to the general nature of the cases, will remain relevant over time. Updates should be made annually to the hyperlinks and to assure current standard of practice is still being met.

Clear, simple and easy to read.

Consistent with healthcare terminology and framework throughout all eight case studies.

The text is modular. Cases can be used individually within a unit on the given disease process or relevant sections of a case could be used to illustrate a specific point providing great flexibility. The appendix is helpful in locating content specific to a certain diagnosis or a certain type of health care provider.

The book is well organized, presenting in a logical clear fashion. The appendix allows the student to move about the case study without difficulty.

The interface is easy and simple to navigate. Some links to external sources might need to be updated regularly since those links are subject to change based on current guidelines. A few hyperlinks had "page not found".

Few grammatical errors were noted in text.

The case studies include people of different ethnicities, socioeconomic status, ages, and genders to make this a very useful book.

I enjoyed reading the text. It was interesting and relevant to today's nursing student. There are roughly 25 broken online links or "pages not found", care needs to be taken to update at least annually and assure links are valid and utilizing the most up to date information.

Reviewed by Benjamin Silverberg, Associate Professor/Clinician, West Virginia University on 3/24/22

Comprehensiveness rating: 3 see less

The appendix reviews the "key roles" and medical venues found in all 8 cases, but is fairly spartan on medical content. The table of contents at the beginning only lists the cases and locations of care. It can be a little tricky to figure out what is going on where, especially since each case is largely conversation-based. Since this presents 8 cases (really 7 with one being expanded upon), there are many medical topics (and venues) that are not included. It's impossible to include every kind of situation, but I'd love to see inclusion of sexual health, renal pathology, substance abuse, etc.

Though there are differences in how care can be delivered based on personal style, changing guidelines, available supplies, etc, the medical accuracy seems to be high. I did not detect bias or industry influence.

Relevance/Longevity rating: 4

Medications are generally listed as generics, with at least current dosing recommendations. The text gives a picture of what care looks like currently, but will be a little challenging to update based on new guidelines (ie, it can be hard to find the exact page in which a medication is dosed/prescribed). Even if the text were to be a little out of date, an instructor can use that to point out what has changed (and why).

Clear text, usually with definitions of medical slang or higher-tier vocabulary. Minimal jargon and there are instances where the "characters" are sorting out the meaning as well, making it accessible for new learners, too.

Overall, the style is consistent between cases - largely broken up into scenes and driven by conversation rather than descriptions of what is happening.

There are 8 (well, again, 7) cases which can be reviewed in any order. Case #2 builds upon #1, which is intentional and a good idea, though personally I would have preferred one case to have different possible outcomes or even a recurrence of illness. Each scene within a case is reasonably short.

Organization/Structure/Flow rating: 4

These cases are modular and don't really build on concepts throughout. As previously stated, case #2 builds upon #1, but beyond that, there is no progression. (To be sure, the authors suggest using case #1 for newer learners and #2 for more advanced ones.) The text would benefit from thematic grouping, a longer introduction and debriefing for each case (there are learning objectives but no real context in medical education nor questions to reflect on what was just read), and progressively-increasing difficulty in medical complexity, ethics, etc.

I used the PDF version and had no interface issues. There are minimal photographs and charts. Some words are marked in blue but those did not seem to be hyperlinked anywhere.

No noticeable errors in grammar, spelling, or formatting were noted.

I appreciate that some diversity of age and ethnicity were offered, but this could be improved. There were Canadian Indian and First Nations patients, for example, as well as other characters with implied diversity, but there didn't seem to be any mention of gender diverse or non-heterosexual people, or disabilities. The cases tried to paint family scenes (the first patient's dog was fairly prominently mentioned) to humanize them. Including more cases would allow for more opportunities to include sex/gender minorities, (hidden) disabilities, etc.

The text (originally from 2017) could use an update. It could be used in conjunction with other Open Texts, as a compliment to other coursework, or purely by itself. The focus is meant to be on improving communication, but there are only 3 short pages at the beginning of the text considering those issues (which are really just learning objectives). In addition to adding more cases and further diversity, I personally would love to see more discussion before and after the case to guide readers (and/or instructors). I also wonder if some of the ambiguity could be improved by suggesting possible health outcomes - this kind of counterfactual comparison isn't possible in real life and could be really interesting in a text. Addition of comprehension/discussion questions would also be worthwhile.

Reviewed by Danielle Peterson, Assistant Professor, University of Saint Francis on 12/31/21

This text provides readers with 8 case studies which include both chronic and acute healthcare issues. Although not comprehensive in regard to types of healthcare conditions, it provides a thorough look at the communication between healthcare workers in acute hospital settings. The cases are primarily set in the inpatient hospital setting, so the bulk of the clinical information is basic emergency care and inpatient protocol: vitals, breathing, medication management, etc. The text provides a table of contents at opening of the text and a handy appendix at the conclusion of the text that outlines each case’s issue(s), scenario, and healthcare roles. No index or glossary present.

Although easy to update, it should be noted that the cases are taking place in a Canadian healthcare system. Terms may be unfamiliar to some students including “province,” “operating theatre,” “physio/physiotherapy,” and “porter.” Units of measurement used include Celsius and meters. Also, the issue of managed care, health insurance coverage, and length of stay is missing for American students. These are primary issues that dictate much of the healthcare system in the US and a primary job function of social workers, nurse case managers, and medical professionals in general. However, instructors that wish to add this to the case studies could do so easily.

The focus of this text is on healthcare communication which makes it less likely to become obsolete. Much of the clinical information is stable healthcare practice that has been standard of care for quite some time. Nevertheless, given the nature of text, updates would be easy to make. Hyperlinks should be updated to the most relevant and trustworthy sources and checked frequently for effectiveness.

The spacing that was used to note change of speaker made for ease of reading. Although unembellished and plain, I expect students to find this format easy to digest and interesting, especially since the script is appropriately balanced with ‘human’ qualities like the current TV shows and songs, the use of humor, and nonverbal cues.

A welcome characteristic of this text is its consistency. Each case is presented in a similar fashion and the roles of the healthcare team are ‘played’ by the same character in each of the scenarios. This allows students to see how healthcare providers prioritize cases and juggle the needs of multiple patients at once. Across scenarios, there was inconsistency in when clinical terms were hyperlinked.

The text is easily divisible into smaller reading sections. However, since the nature of the text is script-narrative format, if significant reorganization occurs, one will need to make sure that the communication of the script still makes sense.

The text is straightforward and presented in a consistent fashion: learning objectives, case history, a script of what happened before the patient enters the healthcare setting, and a script of what happens once the patient arrives at the healthcare setting. The authors use the term, “ideal interactions,” and I would agree that these cases are in large part, ‘best case scenarios.’ Due to this, the case studies are well organized, clear, logical, and predictable. However, depending on the level of student, instructors may want to introduce complications that are typical in the hospital setting.

The interface is pleasing and straightforward. With exception to the case summary and learning objectives, the cases are in narrative, script format. Each case study supplies a photo of the ‘patient’ and one of the case studies includes a link to a 3-minute video that introduces the reader to the patient/case. One of the highlights of this text is the use of hyperlinks to various clinical practices (ABG, vital signs, transfer of patient). Unfortunately, a majority of the links are broken. However, since this is an open text, instructors can update the links to their preference.

Although not free from grammatical errors, those that were noticed were minimal and did not detract from reading.

Cultural Relevance rating: 4

Cultural diversity is visible throughout the patients used in the case studies and includes factors such as age, race, socioeconomic status, family dynamics, and sexual orientation. A moderate level of diversity is noted in the healthcare team with some stereotypes: social workers being female, doctors primarily male.

As a social work instructor, I was grateful to find a text that incorporates this important healthcare role. I would have liked to have seen more content related to advance directives, mediating decision making between the patient and care team, emotional and practical support related to initial diagnosis and discharge planning, and provision of support to colleagues, all typical roles of a medical social worker. I also found it interesting that even though social work was included in multiple scenarios, the role was only introduced on the learning objectives page for the oncology case.

Reviewed by Crystal Wynn, Associate Professor, Virginia State University on 7/21/21

The text covers a variety of chronic diseases within the cases; however, not all of the common disease states were included within the text. More chronic diseases need to be included such as diabetes, cancer, and renal failure. Not all allied health care team members are represented within the case study. Key terms appear throughout the case study textbook and readers are able to click on a hyperlink which directs them to the definition and an explanation of the key term.

Content is accurate, error-free and unbiased.

The content is up-to-date, but not in a way that will quickly make the text obsolete within a short period of time. The text is written and/or arranged in such a way that necessary updates will be relatively easy and straightforward to implement.

The text is written in lucid, accessible prose, and provides adequate context for any jargon/technical terminology used

The text is internally consistent in terms of terminology and framework.

The text is easily and readily divisible into smaller reading sections that can be assigned at different points within the course. Each case can be divided into a chronic disease state unit, which will allow the reader to focus on one section at a time.

Organization/Structure/Flow rating: 3

The topics in the text are presented in a logical manner. Each case provides an excessive amount of language that provides a description of the case. The cases in this text reads more like a novel versus a clinical textbook. The learning objectives listed within each case should be in the form of questions or activities that could be provided as resources for instructors and teachers.

Interface rating: 3

There are several hyperlinks embedded within the textbook that are not functional.

The text contains no grammatical errors.

Cultural Relevance rating: 3

The text is not culturally insensitive or offensive in any way. More examples of cultural inclusiveness is needed throughout the textbook. The cases should be indicative of individuals from a variety of races and ethnicities.

Reviewed by Rebecca Hillary, Biology Instructor, Portland Community College on 6/15/21

This textbook consists of a collection of clinical case studies that can be applicable to a wide range of learning environments from supplementing an undergraduate Anatomy and Physiology Course, to including as part of a Medical or other health care program. I read the textbook in E-reader format and this includes hyperlinks that bring the students to subsequent clinical study if the book is being used in a clinical classroom. This book is significantly more comprehensive in its approach from other case studies I have read because it provides a bird’s eye view of the many clinicians, technicians, and hospital staff working with one patient. The book also provides real time measurements for patients that change as they travel throughout the hospital until time of discharge.

Each case gave an accurate sense of the chaos that would be present in an emergency situation and show how the conditions affect the practitioners as well as the patients. The reader gets an accurate big picture--a feel for each practitioner’s point of view as well as the point of view of the patient and the patient’s family as the clock ticks down and the patients are subjected to a number of procedures. The clinical information contained in this textbook is all in hyperlinks containing references to clinical skills open text sources or medical websites. I did find one broken link on an external medical resource.

The diseases presented are relevant and will remain so. Some of the links are directly related to the Canadian Medical system so they may not be applicable to those living in other regions. Clinical links may change over time but the text itself will remain relevant.

Each case study clearly presents clinical data as is it recorded in real time.

Each case study provides the point of view of several practitioners and the patient over several days. While each of the case studies covers different pathology they all follow this same format, several points of view and data points, over a number of days.

The case studies are divided by days and this was easy to navigate as a reader. It would be easy to assign one case study per body system in an Anatomy and Physiology course, or to divide them up into small segments for small in class teaching moments.

The topics are presented in an organized way showing clinical data over time and each case presents a large number of view points. For example, in the first case study, the patient is experiencing difficulty breathing. We follow her through several days from her entrance to the emergency room. We meet her X Ray Technicians, Doctor, Nurses, Medical Assistant, Porter, Physiotherapist, Respiratory therapist, and the Lab Technicians running her tests during her stay. Each practitioner paints the overall clinical picture to the reader.

I found the text easy to navigate. There were not any figures included in the text, only clinical data organized in charts. The figures were all accessible via hyperlink. Some figures within the textbook illustrating patient scans could have been helpful but I did not have trouble navigating the links to visualize the scans.

I did not see any grammatical errors in the text.

The patients in the text are a variety of ages and have a variety of family arrangements but there is not much diversity among the patients. Our seven patients in the eight case studies are mostly white and all cis gendered.

Some of the case studies, for example the heart failure study, show clinical data before and after drug treatments so the students can get a feel for mechanism in physiological action. I also liked that the case studies included diet and lifestyle advice for the patients rather than solely emphasizing these pharmacological interventions. Overall, I enjoyed reading through these case studies and I plan to utilize them in my Anatomy and Physiology courses.

Reviewed by Richard Tarpey, Assistant Professor, Middle Tennessee State University on 5/11/21

As a case study book, there is no index or glossary. However, medical and technical terms provide a useful link to definitions and explanations that will prove useful to students unfamiliar with the terms. The information provided is appropriate for entry-level health care students. The book includes important health problems, but I would like to see coverage of at least one more chronic/lifestyle issue such as diabetes. The book covers adult issues only.

Content is accurate without bias

The content of the book is relevant and up-to-date. It addresses conditions that are prevalent in today's population among adults. There are no pediatric cases, but this does not significantly detract from the usefulness of the text. The format of the book lends to easy updating of data or information.

The book is written with clarity and is easy to read. The writing style is accessible and technical terminology is explained with links to more information.

Consistency is present. Lack of consistency is typically a problem with case study texts, but this book is consistent with presentation, format, and terminology throughout each of the eight cases.

The book has high modularity. Each of the case studies can be used independently from the others providing flexibility. Additionally, each case study can be partitioned for specific learning objectives based on the learning objectives of the course or module.

The book is well organized, presenting students conceptually with differing patient flow patterns through a hospital. The patient information provided at the beginning of each case is a wonderful mechanism for providing personal context for the students as they consider the issues. Many case studies focus on the problem and the organization without students getting a patient's perspective. The patient perspective is well represented in these cases.

The navigation through the cases is good. There are some terminology and procedure hyperlinks within the cases that do not work when accessed. This is troubling if you intend to use the text for entry-level health care students since many of these links are critical for a full understanding of the case.

There are some non-US variants of spelling and a few grammatical errors, but these do not detract from the content of the messages of each case.

The book is inclusive of differing backgrounds and perspectives. No insensitive or offensive references were found.

I like this text for its application flexibility. The book is useful for non-clinical healthcare management students to introduce various healthcare-related concepts and terminology. The content is also helpful for the identification of healthcare administration managerial issues for students to consider. The book has many applications.

Reviewed by Paula Baldwin, Associate Professor/Communication Studies, Western Oregon University on 5/10/21

The different case studies fall on a range, from crisis care to chronic illness care. read more

The different case studies fall on a range, from crisis care to chronic illness care.

The contents seems to be written as they occurred to represent the most complete picture of each medical event's occurence.

These case studies are from the Canadian medical system, but that does not interfere with it's applicability.

It is written for a medical audience, so the terminology is mostly formal and technical.

Some cases are shorter than others and some go in more depth, but it is not problematic.

The eight separate case studies is the perfect size for a class in the quarter system. You could combine this with other texts, videos or learning modalities, or use it alone.

As this is a case studies book, there is not a need for a logical progression in presentation of topics.

No problems in terms of interface.

I have not seen any grammatical errors.

I did not see anything that was culturally insensitive.

I used this in a Health Communication class and it has been extraordinarily successful. My studies are analyzing the messaging for the good, the bad, and the questionable. The case studies are widely varied and it gives the class insights into hospital experiences, both front and back stage, that they would not normally be able to examine. I believe that because it is based real-life medical incidents, my students are finding the material highly engaging.

Reviewed by Marlena Isaac, Instructor, Aiken Technical College on 4/23/21

This text is great to walk through patient care with entry level healthcare students. The students are able to take in the information, digest it, then provide suggestions to how they would facilitate patient healing. Then when they are faced with... read more

The case studies provided accurate information that relates to the named disease.

It is relevant to health care studies and the development of critical thinking.

Cases are straightforward with great clinical information.

Clinical information is provided concisely.

Appropriate for clinical case study.

Presented to facilitate information gathering.

Takes a while to navigate in the browser.

Cultural Relevance rating: 1

Text lacks adequate representation of minorities.

Reviewed by Kim Garcia, Lecturer III, University of Texas Rio Grande Valley on 11/16/20

The book has 8 case studies, so obviously does not cover the whole of medicine, but the cases provided are descriptive and well developed. Cases are presented at different levels of difficulty, making the cases appropriate for students at different levels of clinical knowledge. The human element of both patient and health care provider is well captured. The cases are presented with a focus on interprofessional interaction and collaboration, more so than teaching medical content.

Content is accurate and un-biased. No errors noted. Most diagnostic and treatment information is general so it will remain relevant over time. The content of these cases is more appropriate for teaching interprofessional collaboration and less so for teaching the medical care for each diagnosis.

The content is relevant to a variety of different types of health care providers (nurses, radiologic technicians, medical laboratory personnel, etc) and due to the general nature of the cases, will remain relevant over time.

Easy to read. Clear headings are provided for sections of each case study and these section headings clearly tell when time has passed or setting has changed. Enough description is provided to help set the scene for each part of the case. Much of the text is written in the form of dialogue involving patient, family and health care providers, making it easy to adapt for role play. Medical jargon is limited and links for medical terms are provided to other resources that expound on medical terms used.

The text is consistent in structure of each case. Learning objectives are provided. Cases generally start with the patient at home and move with the patient through admission, testing and treatment, using a variety of healthcare services and encountering a variety of personnel.

The text is modular. Cases could be used individually within a unit on the given disease process or relevant sections of a case could be used to illustrate a specific point. The appendix is helpful in locating content specific to a certain diagnosis or a certain type of health care provider.

Each case follows a patient in a logical, chronologic fashion. A clear table of contents and appendix are provided which allows the user to quickly locate desired content. It would be helpful if the items in the table of contents and appendix were linked to the corresponding section of the text.

The hyperlinks to content outside this book work, however using the back arrow on your browser returns you to the front page of the book instead of to the point at which you left the text. I would prefer it if the hyperlinks opened in a new window or tab so closing that window or tab would leave you back where you left the text.

No grammatical errors were noted.

The text is culturally inclusive and appropriate. Characters, both patients and care givers are of a variety of races, ethnicities, ages and backgrounds.

I enjoyed reading the cases and reviewing this text. I can think of several ways in which I will use this content.

Reviewed by Raihan Khan, Instructor/Assistant Professor, James Madison University on 11/3/20

The book contains several important health issues, however still missing some chronic health issues that the students should learn before they join the workforce, such as diabetes-related health issues suffered by the patients. read more

The health information contained in the textbook is mostly accurate.

I think the book is written focusing on the current culture and health issues faced by the patients. To keep the book relevant in the future, the contexts especially the culture/lifestyle/health care modalities, etc. would need to be updated regularly.

The language is pretty simple, clear, and easy to read.

There is no complaint about consistency. One of the main issues of writing a book, consistency was well managed by the authors.

The book is easy to explore based on how easy the setup is. Students can browse to the specific section that they want to read without much hassle of finding the correct information.

The organization is simple but effective. The authors organized the book based on what can happen in a patient's life and what possible scenarios students should learn about the disease. From that perspective, the book does a good job.

The interface is easy and simple to navigate. Some links to external sources might need to be updated regularly since those links are subject to change that is beyond the author's control. It's frustrating for the reader when the external link shows no information.

The book is free of any major language and grammatical errors.

The book might do a little better in cultural competency. e.g. Last name Singh is mainly for Sikh people. In the text Harj and Priya Singh are Muslim. the authors can consult colleagues who are more familiar with those cultures and revise some cultural aspects of the cases mentioned in the book.

The book is a nice addition to the open textbook world. Hope to see more health issues covered by the book.

Reviewed by Ryan Sheryl, Assistant Professor, California State University, Dominguez Hills on 7/16/20

This text contains 8 medical case studies that reflect best practices at the time of publication. The text identifies 5 overarching learning objectives: interprofessional collaboration, client centered care, evidence-based practice, quality improvement, and informatics. While the case studies do not cover all medical conditions or bodily systems, the book is thorough in conveying details of various patients and medical team members in a hospital environment. Rather than an index or glossary at the end of the text, it contains links to outside websites for more information on medical tests and terms referenced in the cases.

The content provided is reflective of best practices in patient care, interdisciplinary collaboration, and communication at the time of publication. It is specifically accurate for the context of hospitals in Canada. The links provided throughout the text have the potential to supplement with up-to-date descriptions and definitions, however, many of them are broken (see notes in Interface section).

The content of the case studies reflects the increasingly complex landscape of healthcare, including a variety of conditions, ages, and personal situations of the clients and care providers. The text will require frequent updating due to the rapidly changing landscape of society and best practices in client care. For example, a future version may include inclusive practices with transgender clients, or address ways medical racism implicitly impacts client care (see notes in Cultural Relevance section).

The text is written clearly and presents thorough, realistic details about working and being treated in an acute hospital context.

The text is very straightforward. It is consistent in its structure and flow. It uses consistent terminology and follows a structured framework throughout.

Being a series of 8 separate case studies, this text is easily and readily divisible into smaller sections. The text was designed to be taken apart and used piece by piece in order to serve various learning contexts. The parts of each case study can also be used independently of each other to facilitate problem solving.

The topics in the case studies are presented clearly. The structure of each of the case studies proceeds in a similar fashion. All of the cases are set within the same hospital so the hospital personnel and service providers reappear across the cases, giving a textured portrayal of the experiences of the various service providers. The cases can be used individually, or one service provider can be studied across the various studies.

The text is very straightforward, without complex charts or images that could become distorted. Many of the embedded links are broken and require updating. The links that do work are a very useful way to define and expand upon medical terms used in the case studies.

Grammatical errors are minimal and do not distract from the flow of the text. In one instance the last name Singh is spelled Sing, and one patient named Fred in the text is referred to as Frank in the appendix.

The cases all show examples of health care personnel providing compassionate, client-centered care, and there is no overt discrimination portrayed. Two of the clients are in same-sex marriages and these are shown positively. It is notable, however, that the two cases presenting people of color contain more negative characteristics than the other six cases portraying Caucasian people. The people of color are the only two examples of clients who smoke regularly. In addition, the Indian client drinks and is overweight, while the First Nations client is the only one in the text to have a terminal diagnosis. The Indian client is identified as being Punjabi and attending a mosque, although there are only 2% Muslims in the Punjab province of India. Also, the last name Singh generally indicates a person who is a Hindu or Sikh, not Muslim.

Reviewed by Monica LeJeune, RN Instructor, LSUE on 4/24/20

Has comprehensive unfolding case studies that guide the reader to recognize and manage the scenario presented. Assists in critical thinking process. read more

Has comprehensive unfolding case studies that guide the reader to recognize and manage the scenario presented. Assists in critical thinking process.

Accurately presents health scenarios with real life assessment techniques and patient outcomes.

Relevant to nursing practice.

Clearly written and easily understood.

Consistent with healthcare terminology and framework

Has a good reading flow.

Topics presented in logical fashion

Easy to read.

No grammatical errors noted.

Text is not culturally insensitive or offensive.

Good book to have to teach nursing students.

Reviewed by april jarrell, associate professor, J. Sargeant Reynolds Community College on 1/7/20

The text is a great case study tool that is appropriate for nursing school instructors to use in aiding students to learn the nursing process. read more

The text is a great case study tool that is appropriate for nursing school instructors to use in aiding students to learn the nursing process.

The content is accurate and evidence based. There is no bias noted

The content in the text is relevant, up to date for nursing students. It will be easy to update content as needed because the framework allows for addition to the content.

The text is clear and easy to understand.

Framework and terminology is consistent throughout the text; the case study is a continual and takes the student on a journey with the patient. Great for learning!

The case studies can be easily divided into smaller sections to allow for discussions, and weekly studies.

The text and content progress in a logical, clear fashion allowing for progression of learning.

No interface issues noted with this text.

No grammatical errors noted in the text.

No racial or culture insensitivity were noted in the text.

I would recommend this text be used in nursing schools. The use of case studies are helpful for students to learn and practice the nursing process.

Reviewed by Lisa Underwood, Practical Nursing Instructor, NTCC on 12/3/19

The text provides eight comprehensive case studies that showcase the different viewpoints of the many roles involved in patient care. It encompasses the most common seen diagnoses seen across healthcare today. Each case study comes with its own set of learning objectives that can be tweaked to fit several allied health courses. Although the case studies are designed around the Canadian Healthcare System, they are quite easily adaptable to fit most any modern, developed healthcare system.

Content Accuracy rating: 3

Overall, the text is quite accurate. There is one significant error that needs to be addressed. It is located in the DVT case study. In the study, a popliteal artery clot is mislabeled as a DVT. DVTs are located in veins, not in arteries. That said, the case study on the whole is quite good. This case study could be used as a learning tool in the classroom for discussion purposes or as a way to test student understanding of DVTs, on example might be, "Can they spot the error?"

At this time, all of the case studies within the text are current. Healthcare is an ever evolving field that rests on the best evidence based practice. Keeping that in mind, educators can easily adapt the studies as the newest evidence emerges and changes practice in healthcare.

All of the case studies are well written and easy to understand. The text includes several hyperlinks and it also highlights certain medical terminology to prompt readers as a way to enhance their learning experience.

Across the text, the language, style, and format of the case studies are completely consistent.

The text is divided into eight separate case studies. Each case study may be used independently of the others. All case studies are further broken down as the focus patient passes through each aspect of their healthcare system. The text's modularity makes it possible to use a case study as individual work, group projects, class discussions, homework or in a simulation lab.

The case studies and the diagnoses that they cover are presented in such a way that educators and allied health students can easily follow and comprehend.

The book in itself is free of any image distortion and it prints nicely. The text is offered in a variety of digital formats. As noted in the above reviews, some of the hyperlinks have navigational issues. When the reader attempts to access them, a "page not found" message is received.

There were minimal grammatical errors. Some of which may be traced back to the differences in our spelling.

The text is culturally relevant in that it includes patients from many different backgrounds and ethnicities. This allows educators and students to explore cultural relevance and sensitivity needs across all areas in healthcare. I do not believe that the text was in any way insensitive or offensive to the reader.

By using the case studies, it may be possible to have an open dialogue about the differences noted in healthcare systems. Students will have the ability to compare and contrast the Canadian healthcare system with their own. I also firmly believe that by using these case studies, students can improve their critical thinking skills. These case studies help them to "put it all together".

Reviewed by Melanie McGrath, Associate Professor, TRAILS on 11/29/19

The text covered some of the most common conditions seen by healthcare providers in a hospital setting, which forms a solid general base for the discussions based on each case. read more

The text covered some of the most common conditions seen by healthcare providers in a hospital setting, which forms a solid general base for the discussions based on each case.

I saw no areas of inaccuracy

As in all healthcare texts, treatments and/or tests will change frequently. However, everything is currently up-to-date thus it should be a good reference for several years.

Each case is written so that any level of healthcare student would understand. Hyperlinks in the text is also very helpful.

All of the cases are written in a similar fashion.

Although not structured as a typical text, each case is easily assigned as a stand-alone.

Each case is organized clearly in an appropriate manner.

I did not see any issues.

I did not see any grammatical errors

The text seemed appropriately inclusive. There are no pediatric cases and no cases of intellectually-impaired patients, but those types of cases introduce more advanced problem-solving which perhaps exceed the scope of the text. May be a good addition to the text.

I found this text to be an excellent resource for healthcare students in a variety of fields. It would be best utilized in inter professional courses to help guide discussion.

Reviewed by Lynne Umbarger, Clinical Assistant Professor, Occupational Therapy, Emory and Henry College on 11/26/19

While the book does not cover every scenario, the ones in the book are quite common and troublesome for inexperienced allied health students. The information in the book is thorough enough, and I have found the cases easy to modify for educational purposes. The material was easily understood by the students but challenging enough for classroom discussion. There are no mentions in the book about occupational therapy, but it is easy enough to add a couple words and make inclusion simple.

Very nice lab values are provided in the case study, making it more realistic for students.

These case studies focus on commonly encountered diagnoses for allied health and nursing students. They are comprehensive, realistic, and easily understood. The only difference is that the hospital in one case allows the patient's dog to visit in the room (highly unusual in US hospitals).

The material is easily understood by allied health students. The cases have links to additional learning materials for concepts that may be less familiar or should be explored further in a particular health field.

The language used in the book is consistent between cases. The framework is the same with each case which makes it easier to locate areas that would be of interest to a particular allied health profession.

The case studies are comprehensive but well-organized. They are short enough to be useful for class discussion or a full-blown assignment. The students seem to understand the material and have not expressed that any concepts or details were missing.

Each case is set up like the other cases. There are learning objectives at the beginning of each case to facilitate using the case, and it is easy enough to pull out material to develop useful activities and assignments.

There is a quick chart in the Appendix to allow the reader to determine the professions involved in each case as well as the pertinent settings and diagnoses for each case study. The contents are easy to access even while reading the book.

As a person who attends carefully to grammar, I found no errors in all of the material I read in this book.

There are a greater number of people of different ethnicities, socioeconomic status, ages, and genders to make this a very useful book. With each case, I could easily picture the person in the case. This book appears to be Canadian and more inclusive than most American books.

I was able to use this book the first time I accessed it to develop a classroom activity for first-year occupational therapy students and a more comprehensive activity for second-year students. I really appreciate the links to a multitude of terminology and medical lab values/issues for each case. I will keep using this book.

Reviewed by Cindy Krentz, Assistant Professor, Metropolitan State University of Denver on 6/15/19

The book covers eight case studies of common inpatient or emergency department scenarios. I appreciated that they had written out the learning objectives. I liked that the patient was described before the case was started, giving some understanding of the patient's background. I think it could benefit from having a glossary. I liked how the authors included the vital signs in an easily readable bar. I would have liked to see the labs also highlighted like this. I also felt that it would have been good written in a 'what would you do next?' type of case study.

The book is very accurate in language, what tests would be prudent to run and in the day in the life of the hospital in all cases. One inaccuracy is that the authors called a popliteal artery clot a DVT. The rest of the DVT case study was great, though, but the one mistake should be changed.

The book is up to date for now, but as tests become obsolete and new equipment is routinely used, the book ( like any other health textbook) will need to be updated. It would be easy to change, however. All that would have to happen is that the authors go in and change out the test to whatever newer, evidence-based test is being utilized.

The text is written clearly and easy to understand from a student's perspective. There is not too much technical jargon, and it is pretty universal when used- for example DVT for Deep Vein Thrombosis.

The book is consistent in language and how it is broken down into case studies. The same format is used for highlighting vital signs throughout the different case studies. It's great that the reader does not have to read the book in a linear fashion. Each case study can be read without needing to read the others.

The text is broken down into eight case studies, and within the case studies is broken down into days. It is consistent and shows how the patient can pass through the different hospital departments (from the ER to the unit, to surgery, to home) in a realistic manner. The instructor could use one or more of the case studies as (s)he sees fit.

The topics are eight different case studies- and are presented very clearly and organized well. Each one is broken down into how the patient goes through the system. The text is easy to follow and logical.

The interface has some problems with the highlighted blue links. Some of them did not work and I got a 'page not found' message. That can be frustrating for the reader. I'm wondering if a glossary could be utilized (instead of the links) to explain what some of these links are supposed to explain.

I found two or three typos, I don't think they were grammatical errors. In one case I think the Canadian spelling and the United States spelling of the word are just different.

This is a very culturally competent book. In today's world, however, one more type of background that would merit delving into is the trans-gender, GLBTQI person. I was glad that there were no stereotypes.

I enjoyed reading the text. It was interesting and relevant to today's nursing student. Since we are becoming more interprofessional, I liked that we saw what the phlebotomist and other ancillary personnel (mostly different technicians) did. I think that it could become even more interdisciplinary so colleges and universities could have more interprofessional education- courses or simulations- with the addition of the nurse using social work, nutrition, or other professional health care majors.

Reviewed by Catherine J. Grott, Interim Director, Health Administration Program, TRAILS on 5/5/19

The book is comprehensive but is specifically written for healthcare workers practicing in Canada. The title of the book should reflect this. read more

The book is comprehensive but is specifically written for healthcare workers practicing in Canada. The title of the book should reflect this.

The book is accurate, however it has numerous broken online links.

Relevance/Longevity rating: 3

The content is very relevant, but some links are out-dated. For example, WHO Guidelines for Safe Surgery 2009 (p. 186) should be updated.

The book is written in clear and concise language. The side stories about the healthcare workers make the text interesting.

The book is consistent in terms of terminology and framework. Some terms that are emphasized in one case study are not emphasized (with online links) in the other case studies. All of the case studies should have the same words linked to online definitions.

Modularity rating: 3

The book can easily be parsed out if necessary. However, the way the case studies have been written, it's evident that different authors contributed singularly to each case study.

The organization and flow are good.

Interface rating: 1

There are numerous broken online links and "pages not found."

The grammar and punctuation are correct. There are two errors detected: p. 120 a space between the word "heart" and the comma; also a period is needed after Dr (p. 113).

I'm not quite sure that the social worker (p. 119) should comment that the patient and partner are "very normal people."

There are roughly 25 broken online links or "pages not found." The BC & Canadian Guidelines (p. 198) could also include a link to US guidelines to make the text more universal . The basilar crackles (p. 166) is very good. Text could be used compare US and Canadian healthcare. Text could be enhanced to teach "soft skills" and interdepartmental communication skills in healthcare.

Reviewed by Lindsey Henry, Practical Nursing Instructor, Fletcher on 5/1/19

I really appreciated how in the introduction, five learning objectives were identified for students. These objectives are paramount in nursing care and they are each spelled out for the learner. Each Case study also has its own learning... read more

As a seasoned nurse, I believe that the content regarding pathophysiology and treatments used in the case studies were accurate. I really appreciated how many of the treatments were also explained and rationales were given, which can be very helpful to facilitate effective learning for a nursing student or novice nurse.

The case studies are up to date and correlate with the current time period. They are easily understood.

I really loved how several important medical terms, including specific treatments were highlighted to alert the reader. Many interventions performed were also explained further, which is great to enhance learning for the nursing student or novice nurse. Also, with each scenario, a background and history of the patient is depicted, as well as the perspectives of the patient, patients family member, and the primary nurse. This really helps to give the reader a full picture of the day in the life of a nurse or a patient, and also better facilitates the learning process of the reader.

These case studies are consistent. They begin with report, the patient background or updates on subsequent days, and follow the patients all the way through discharge. Once again, I really appreciate how this book describes most if not all aspects of patient care on a day to day basis.

Each case study is separated into days. While they can be divided to be assigned at different points within the course, they also build on each other. They show trends in vital signs, what happens when a patient deteriorates, what happens when they get better and go home. Showing the entire process from ER admit to discharge is really helpful to enhance the students learning experience.

The topics are all presented very similarly and very clearly. The way that the scenarios are explained could even be understood by a non-nursing student as well. The case studies are very clear and very thorough.

The book is very easy to navigate, prints well on paper, and is not distorted or confusing.

I did not see any grammatical errors.

Each case study involves a different type of patient. These differences include race, gender, sexual orientation and medical backgrounds. I do not feel the text was offensive to the reader.

I teach practical nursing students and after reading this book, I am looking forward to implementing it in my classroom. Great read for nursing students!

Reviewed by Leah Jolly, Instructor, Clinical Coordinator, Oregon Institute of Technology on 4/10/19

Good variety of cases and pathologies covered. read more

Good variety of cases and pathologies covered.

Content Accuracy rating: 2

Some examples and scenarios are not completely accurate. For example in the DVT case, the sonographer found thrombus in the "popliteal artery", which according to the book indicated presence of DVT. However in DVT, thrombus is located in the vein, not the artery. The patient would also have much different symptoms if located in the artery. Perhaps some of these inaccuracies are just typos, but in real-life situations this simple mistake can make a world of difference in the patient's course of treatment and outcomes.

Good examples of interprofessional collaboration. If only it worked this way on an every day basis!

Clear and easy to read for those with knowledge of medical terminology.

Good consistency overall.

Broken up well.

Topics are clear and logical.

Would be nice to simply click through to the next page, rather than going through the table of contents each time.

Minor typos/grammatical errors.

No offensive or insensitive materials observed.

Reviewed by Alex Sargsyan, Doctor of Nursing Practice/Assistant Professor , East Tennessee State University on 10/8/18

Because of the case study character of the book it does not have index or glossary. However it has summary for each health case study outlining key elements discussed in each case study. read more

Because of the case study character of the book it does not have index or glossary. However it has summary for each health case study outlining key elements discussed in each case study.

Overall the book is accurately depicting the clinical environment. There are numerous references to external sites. While most of them are correct, some of them are not working. For example Homan’s test link is not working "404 error"

Book is relevant in its current version and can be used in undergraduate and graduate classes. That said, the longevity of the book may be limited because of the character of the clinical education. Clinical guidelines change constantly and it may require a major update of the content.

Cases are written very clearly and have realistic description of an inpatient setting.

The book is easy to read and consistent in the language in all eight cases.

The cases are very well written. Each case is subdivided into logical segments. The segments reflect different setting where the patient is being seen. There is a flow and transition between the settings.

Book has eight distinct cases. This is a great format for a book that presents distinct clinical issues. This will allow the students to have immersive experiences and gain better understanding of the healthcare environment.

Book is offered in many different formats. Besides the issues with the links mentioned above, overall navigation of the book content is very smooth.

Book is very well written and has no grammatical errors.

Book is culturally relevant. Patients in the case studies come different cultures and represent diverse ethnicities.

Reviewed by Justin Berry, Physical Therapist Assistant Program Director, Northland Community and Technical College, East Grand Forks, MN on 8/2/18

This text provides eight patient case studies from a variety of diagnoses, which can be utilized by healthcare students from multiple disciplines. The cases are comprehensive and can be helpful for students to determine professional roles, interprofessional roles, when to initiate communication with other healthcare practitioners due to a change in patient status, and treatment ideas. Some additional patient information, such as lab values, would have been beneficial to include.

Case study information is accurate and unbiased.

Content is up to date. The case studies are written in a way so that they will not be obsolete soon, even with changes in healthcare.

The case studies are well written, and can be utilized for a variety of classroom assignments, discussions, and projects. Some additional lab value information for each patient would have been a nice addition.

The case studies are consistently organized to make it easy for the reader to determine the framework.

The text is broken up into eight different case studies for various patient diagnoses. This design makes it highly modular, and would be easy to assign at different points of a course.

The flow of the topics are presented consistently in a logical manner. Each case study follows a patient chronologically, making it easy to determine changes in patient status and treatment options.

The text is free of interface issues, with no distortion of images or charts.

The text is not culturally insensitive or offensive in any way. Patients are represented from a variety of races, ethnicities, and backgrounds

This book would be a good addition for many different health programs.

Reviewed by Ann Bell-Pfeifer, Instructor/Program Director, Minnesota State Community and Technical College on 5/21/18

The book gives a comprehensive overview of many types of cases for patient conditions. Emergency Room patients may arrive with COPD, heart failure, sepsis, pneumonia, or as motor vehicle accident victims. It is directed towards nurses, medical laboratory technologists, medical radiology technologists, and respiratory therapists and their roles in caring for patients. Most of the overview is accurate. One suggestion is to provide an embedded radiologist interpretation of the exams which are performed which lead to the patients diagnosis.

Overall the book is accurate. Would like to see updates related to the addition of direct radiography technology which is commonly used in the hospital setting.

Many aspects of medicine will remain constant. The case studies seem fairly accurate and may be relevant for up to 3 years. Since technology changes so quickly in medicine, the CT and x-ray components may need minor updates within a few years.

The book clarity is excellent.

The case stories are consistent with each scenario. It is easy to follow the structure and learn from the content.

The book is quite modular. It is easy to break it up into cases and utilize them individually and sequentially.

The cases are listed by disease process and follow a logical flow through each condition. They are easy to follow as they have the same format from the beginning to the end of each case.

The interface seems seamless. Hyperlinks are inserted which provide descriptions and references to medical procedures and in depth definitions.

The book is free of most grammatical errors. There is a place where a few words do not fit the sentence structure and could be a typo.

The book included all types of relationships and ethnic backgrounds. One type which could be added is a transgender patient.

I think the book was quite useful for a variety of health care professionals. The authors did an excellent job of integrating patient cases which could be applied to the health care setting. The stories seemed real and relevant. This book could be used to teach health care professionals about integrated care within the emergency department.

Reviewed by Shelley Wolfe, Assistant Professor, Winona State University on 5/21/18

This text is comprised of comprehensive, detailed case studies that provide the reader with multiple character views throughout a patient’s encounter with the health care system. The Table of Contents accurately reflected the content. It should be noted that the authors include a statement that conveys that this text is not like traditional textbooks and is not meant to be read in a linear fashion. This allows the educator more flexibility to use the text as a supplement to enhance learning opportunities.

The content of the text appears accurate and unbiased. The “five overarching learning objectives” provide a clear aim of the text and the educator is able to glean how these objectives are captured into each of the case studies. While written for the Canadian healthcare system, this text is easily adaptable to the American healthcare system.

Overall, the content is up-to-date and the case studies provide a variety of uses that promote longevity of the text. However, not all of the blue font links (if using the digital PDF version) were still in working order. I encountered links that led to error pages or outdated “page not found” websites. While the links can be helpful, continued maintenance of these links could prove time-consuming.

I found the text easy to read and understand. I enjoyed that the viewpoints of all the different roles (patient, nurse, lab personnel, etc.) were articulated well and allowed the reader to connect and gain appreciation of the entire healthcare team. Medical jargon was noted to be appropriate for the intended audience of this text.

The terminology and organization of this text is consistent.

The text is divided into 8 case studies that follow a similar organizational structure. The case studies can further be divided to focus on individual learning objectives. For example, the case studies could be looked at as a whole for discussing communication or could be broken down into segments to focus on disease risk factors.

The case studies in this text follow a similar organizational structure and are consistent in their presentation. The flow of individual case studies is excellent and sets the reader on a clear path. As noted previously, this text is not meant to be read in a linear fashion.

This text is available in many different forms. I chose to review the text in the digital PDF version in order to use the embedded links. I did not encounter significant interface issues and did not find any images or features that would distract or confuse a reader.

No significant grammatical errors were noted.

The case studies in this text included patients and healthcare workers from a variety of backgrounds. Educators and students will benefit from expanding the case studies to include discussions and other learning opportunities to help develop culturally-sensitive healthcare providers.

I found the case studies to be very detailed, yet written in a way in which they could be used in various manners. The authors note a variety of ways in which the case studies could be employed with students; however, I feel the authors could also include that the case studies could be used as a basis for simulated clinical experiences. The case studies in this text would be an excellent tool for developing interprofessional communication and collaboration skills in a variety healthcare students.

Reviewed by Darline Foltz, Assistant Professor, University of Cincinnati - Clermont College on 3/27/18

This book covers all areas listed in the Table of Contents. In addition to the detailed patient case studies, there is a helpful section of "How to Use this Resource". I would like to note that this resource "aligns with the open textbooks... read more

The book appears to be accurate. Although one of the learning outcomes is as follows: "Demonstrate an understanding of the Canadian healthcare delivery system.", I did not find anything that is ONLY specific to the Canadian healthcare delivery system other than some of the terminology, i.e. "porter" instead of "transporter" and a few french words. I found this to make the book more interesting for students rather than deter from it. These are patient case studies that are relevant in any country.

The content is up-to-date. Changes in medical science may occur, i.e. a different test, to treat a diagnosis that is included in one or more of the case studies, however, it would be easy and straightforward to implement these changes.

This book is written in lucid, accessible prose. The technical/medical terminology that is used is appropriate for medical and allied health professionals. Something that would improve this text would to provide a glossary of terms for the terms in blue font.

This book is consistent with current medical terminology

This text is easily divided into each of the 6 case studies. The case studies can be used singly according to the body system being addressed or studied.

Because this text is a collection of case studies, flow doesn't pertain, however the organization and structure of the case studies are excellent as they are clear and easy to read.

There are no distractions in this text that would distract or confuse the reader.

I did not identify any grammatical errors.

This text is not culturally insensitive or offensive in any way and uses patients and healthcare workers that are of a variety of races, ethnicities and backgrounds.

I believe that this text would not only be useful to students enrolled in healthcare professions involved in direct patient care but would also be useful to students in supporting healthcare disciplines such as health information technology and management, medical billing and coding, etc.

Introduction

Case Study #1: Chronic Obstructive Pulmonary Disease (COPD)

Learning Objectives
Patient: Erin Johns
Emergency Room

Case Study #2: Pneumonia

Day 0: Emergency Room
Day 1: Emergency Room
Day 1: Medical Ward
Day 2: Medical Ward
Day 3: Medical Ward
Day 4: Medical Ward

Case Study #3: Unstable Angina (UA)

Patient: Harj Singh

Case Study #4: Heart Failure (HF)

Patient: Meryl Smith
In the Supermarket
Day 0: Medical Ward

Case Study #5: Motor Vehicle Collision (MVC)

Patient: Aaron Knoll
Crash Scene
Operating Room
Post Anaesthesia Care Unit (PACU)
Surgical Ward

Case Study #6: Sepsis

Patient: George Thomas
Sleepy Hollow Care Facility

Case Study #7: Colon Cancer

Patient: Fred Johnson
Two Months Ago
Pre-Surgery Admission

Case Study #8: Deep Vein Thrombosis (DVT)

Patient: Jamie Douglas

Appendix: Overview About the Authors

Ancillary Material

About the book.

Health Case Studies is composed of eight separate health case studies. Each case study includes the patient narrative or story that models the best practice (at the time of publishing) in healthcare settings. Associated with each case is a set of specific learning objectives to support learning and facilitate educational strategies and evaluation.

The case studies can be used online in a learning management system, in a classroom discussion, in a printed course pack or as part of a textbook created by the instructor. This flexibility is intentional and allows the educator to choose how best to convey the concepts presented in each case to the learner.

Because these case studies were primarily developed for an electronic healthcare system, they are based predominantly in an acute healthcare setting. Educators can augment each case study to include primary healthcare settings, outpatient clinics, assisted living environments, and other contexts as relevant.

About the Contributors

Glynda Rees teaches at the British Columbia Institute of Technology (BCIT) in Vancouver, British Columbia. She completed her MSN at the University of British Columbia with a focus on education and health informatics, and her BSN at the University of Cape Town in South Africa. Glynda has many years of national and international clinical experience in critical care units in South Africa, the UK, and the USA. Her teaching background has focused on clinical education, problem-based learning, clinical techniques, and pharmacology.

Glynda‘s interests include the integration of health informatics in undergraduate education, open accessible education, and the impact of educational technologies on nursing students’ clinical judgment and decision making at the point of care to improve patient safety and quality of care.

Faculty member in the critical care nursing program at the British Columbia Institute of Technology (BCIT) since 2003, Rob has been a critical care nurse for over 25 years with 17 years practicing in a quaternary care intensive care unit. Rob is an experienced educator and supports student learning in the classroom, online, and in clinical areas. Rob’s Master of Education from Simon Fraser University is in educational technology and learning design. He is passionate about using technology to support learning for both faculty and students.

Part of Rob’s faculty position is dedicated to providing high fidelity simulation support for BCIT’s nursing specialties program along with championing innovative teaching and best practices for educational technology. He has championed the use of digital publishing and was the tech lead for Critical Care Nursing’s iPad Project which resulted in over 40 multi-touch interactive textbooks being created using Apple and other technologies.

Rob has successfully completed a number of specialist certifications in computer and network technologies. In 2015, he was awarded Apple Distinguished Educator for his innovation and passionate use of technology to support learning. In the past five years, he has presented and published abstracts on virtual simulation, high fidelity simulation, creating engaging classroom environments, and what the future holds for healthcare and education.

Janet Morrison is the Program Head of Occupational Health Nursing at the British Columbia Institute of Technology (BCIT) in Burnaby, British Columbia. She completed a PhD at Simon Fraser University, Faculty of Communication, Art and Technology, with a focus on health information technology. Her dissertation examined the effects of telehealth implementation in an occupational health nursing service. She has an MA in Adult Education from St. Francis Xavier University and an MA in Library and Information Studies from the University of British Columbia.

Janet’s research interests concern the intended and unintended impacts of health information technologies on healthcare students, faculty, and the healthcare workforce.

She is currently working with BCIT colleagues to study how an educational clinical information system can foster healthcare students’ perceptions of interprofessional roles.

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Home » Case Study – Methods, Examples and Guide

Case Study – Methods, Examples and Guide

Table of Contents

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

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

Types of Case Study

Types and Methods of Case Study are as follows:

Single-Case Study

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

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

Multiple-Case Study

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

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

Exploratory Case Study

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

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

Descriptive Case Study

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

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

Instrumental Case Study

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

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

Case Study Data Collection Methods

Here are some common data collection methods for case studies:

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

Observations

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

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

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

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

How to conduct Case Study Research

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

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

Examples of Case Study

Here are some examples of case study research:

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

Application of Case Study

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

Business and Management

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

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

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

Social Sciences

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

Law and Ethics

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

Purpose of Case Study

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

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

Case studies can also serve other purposes, including:

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

Advantages of Case Study Research

There are several advantages of case study research, including:

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

Limitations of Case Study Research

There are several limitations of case study research, including:

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

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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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-Management

Presenting patient cases is a key part of everyday clinical practice. A well delivered presentation has the potential to facilitate patient care and improve efficiency on ward rounds, as well as a means of teaching and assessing clinical competence. 1

The purpose of a case presentation is to communicate your diagnostic reasoning to the listener, so that he or she has a clear picture of the patient’s condition and further management can be planned accordingly. 2 To give a high quality presentation you need to take a thorough history. Consultants make decisions about patient care based on information presented to them by junior members of the team, so the importance of accurately presenting your patient cannot be overemphasised.

As a medical student, you are likely to be asked to present in numerous settings. A formal case presentation may take place at a teaching session or even at a conference or scientific meeting. These presentations are usually thorough and have an accompanying PowerPoint presentation or poster. More often, case presentations take place on the wards or over the phone and tend to be brief, using only memory or short, handwritten notes as an aid.

Everyone has their own presenting style, and the context of the presentation will determine how much detail you need to put in. You should anticipate what information your senior colleagues will need to know about the patient’s history and the care he or she has received since admission, to enable them to make further management decisions. In this article, I use a fictitious case to show how you can structure case presentations, which can be adapted to different clinical and teaching settings (box 1).

Box 1: Structure for presenting patient cases

Presenting problem, history of presenting problem, medical and surgical history.

Drugs, including allergies to drugs

Family history

Social history, review of systems.

Findings on examination, including vital signs and observations

Differential diagnosis/impression

Investigations

Case: tom murphy.

You should start with a sentence that includes the patient’s name, sex (Mr/Ms), age, and presenting symptoms. In your presentation, you may want to include the patient’s main diagnosis if known—for example, “admitted with shortness of breath on a background of COPD [chronic obstructive pulmonary disease].” You should include any additional information that might give the presentation of symptoms further context, such as the patient’s profession, ethnic origin, recent travel, or chronic conditions.

“ Mr Tom Murphy is a 56 year old ex-smoker admitted with sudden onset central crushing chest pain that radiated down his left arm.”

In this section you should expand on the presenting problem. Use the SOCRATES mnemonic to help describe the pain (see box 2). If the patient has multiple problems, describe each in turn, covering one system at a time.

Box 2: SOCRATES—mnemonic for pain

Associations

Time course

Exacerbating/relieving factors

“ The pain started suddenly at 1 pm, when Mr Murphy was at his desk. The pain was dull in nature, and radiated down his left arm. He experienced shortness of breath and felt sweaty and clammy. His colleague phoned an ambulance. He rated the pain 9/10 in severity. In the ambulance he was given GTN [glyceryl trinitrate] spray under the tongue, which relieved the pain to 5/10. The pain lasted 30 minutes in total. No exacerbating factors were noted. Of note: Mr Murphy is an ex-smoker with a 20 pack year history”

Some patients have multiple comorbidities, and the most life threatening conditions should be mentioned first. They can also be categorised by organ system—for example, “has a long history of cardiovascular disease, having had a stroke, two TIAs [transient ischaemic attacks], and previous ACS [acute coronary syndrome].” For some conditions it can be worth stating whether a general practitioner or a specialist manages it, as this gives an indication of its severity.

In a surgical case, colleagues will be interested in exercise tolerance and any comorbidity that could affect the patient’s fitness for surgery and anaesthesia. If the patient has had any previous surgical procedures, mention whether there were any complications or reactions to anaesthesia.

“Mr Murphy has a history of type 2 diabetes, well controlled on metformin. He also has hypertension, managed with ramipril, and gout. Of note: he has no history of ischaemic heart disease (relevant negative) (see box 3).”

Box 3: Relevant negatives

Mention any relevant negatives that will help narrow down the differential diagnosis or could be important in the management of the patient, 3 such as any risk factors you know for the condition and any associations that you are aware of. For example, if the differential diagnosis includes a condition that you know can be hereditary, a relevant negative could be the lack of a family history. If the differential diagnosis includes cardiovascular disease, mention the cardiovascular risk factors such as body mass index, smoking, and high cholesterol.

Highlight any recent changes to the patient’s drugs because these could be a factor in the presenting problem. Mention any allergies to drugs or the patient’s non-compliance to a previously prescribed drug regimen.

To link the medical history and the drugs you might comment on them together, either here or in the medical history. “Mrs Walsh’s drugs include regular azathioprine for her rheumatoid arthritis.”Or, “His regular drugs are ramipril 5 mg once a day, metformin 1g three times a day, and allopurinol 200 mg once a day. He has no known drug allergies.”

If the family history is unrelated to the presenting problem, it is sufficient to say “no relevant family history noted.” For hereditary conditions more detail is needed.

“ Mr Murphy’s father experienced a fatal myocardial infarction aged 50.”

Social history should include the patient’s occupation; their smoking, alcohol, and illicit drug status; who they live with; their relationship status; and their sexual history, baseline mobility, and travel history. In an older patient, more detail is usually required, including whether or not they have carers, how often the carers help, and if they need to use walking aids.

“He works as an accountant and is an ex-smoker since five years ago with a 20 pack year history. He drinks about 14 units of alcohol a week. He denies any illicit drug use. He lives with his wife in a two storey house and is independent in all activities of daily living.”

Do not dwell on this section. If something comes up that is relevant to the presenting problem, it should be mentioned in the history of the presenting problem rather than here.

“Systems review showed long standing occasional lower back pain, responsive to paracetamol.”

Findings on examination

Initially, it can be useful to practise presenting the full examination to make sure you don’t leave anything out, but it is rare that you would need to present all the normal findings. Instead, focus on the most important main findings and any abnormalities.

“On examination the patient was comfortable at rest, heart sounds one and two were heard with no additional murmurs, heaves, or thrills. Jugular venous pressure was not raised. No peripheral oedema was noted and calves were soft and non-tender. Chest was clear on auscultation. Abdomen was soft and non-tender and normal bowel sounds were heard. GCS [Glasgow coma scale] was 15, pupils were equal and reactive to light [PEARL], cranial nerves 1-12 were intact, and he was moving all four limbs. Observations showed an early warning score of 1 for a tachycardia of 105 beats/ min. Blood pressure was 150/90 mm Hg, respiratory rate 18 breaths/min, saturations were 98% on room air, and he was apyrexial with a temperature of 36.8 ºC.”

Differential diagnoses

Mentioning one or two of the most likely diagnoses is sufficient. A useful phrase you can use is, “I would like to rule out,” especially when you suspect a more serious cause is in the differential diagnosis. “History and examination were in keeping with diverticular disease; however, I would like to rule out colorectal cancer in this patient.”

Remember common things are common, so try not to mention rare conditions first. Sometimes it is acceptable to report investigations you would do first, and then base your differential diagnosis on what the history and investigation findings tell you.

“My impression is acute coronary syndrome. The differential diagnosis includes other cardiovascular causes such as acute pericarditis, myocarditis, aortic stenosis, aortic dissection, and pulmonary embolism. Possible respiratory causes include pneumonia or pneumothorax. Gastrointestinal causes include oesophageal spasm, oesophagitis, gastro-oesophageal reflux disease, gastritis, cholecystitis, and acute pancreatitis. I would also consider a musculoskeletal cause for the pain.”

This section can include a summary of the investigations already performed and further investigations that you would like to request. “On the basis of these differentials, I would like to carry out the following investigations: 12 lead electrocardiography and blood tests, including full blood count, urea and electrolytes, clotting screen, troponin levels, lipid profile, and glycated haemoglobin levels. I would also book a chest radiograph and check the patient’s point of care blood glucose level.”

You should consider recommending investigations in a structured way, prioritising them by how long they take to perform and how easy it is to get them done and how long it takes for the results to come back. Put the quickest and easiest first: so bedside tests, electrocardiography, followed by blood tests, plain radiology, then special tests. You should always be able to explain why you would like to request a test. Mention the patient’s baseline test values if they are available, especially if the patient has a chronic condition—for example, give the patient’s creatinine levels if he or she has chronic kidney disease This shows the change over time and indicates the severity of the patient’s current condition.

“To further investigate these differentials, 12 lead electrocardiography was carried out, which showed ST segment depression in the anterior leads. Results of laboratory tests showed an initial troponin level of 85 µg/L, which increased to 1250 µg/L when repeated at six hours. Blood test results showed raised total cholesterol at 7.6 mmol /L and nil else. A chest radiograph showed clear lung fields. Blood glucose level was 6.3 mmol/L; a glycated haemoglobin test result is pending.”

Dependent on the case, you may need to describe the management plan so far or what further management you would recommend.“My management plan for this patient includes ACS [acute coronary syndrome] protocol, echocardiography, cardiology review, and treatment with high dose statins. If you are unsure what the management should be, you should say that you would discuss further with senior colleagues and the patient. At this point, check to see if there is a treatment escalation plan or a “do not attempt to resuscitate” order in place.

“Mr Murphy was given ACS protocol in the emergency department. An echocardiogram has been requested and he has been discussed with cardiology, who are going to come and see him. He has also been started on atorvastatin 80 mg nightly. Mr Murphy and his family are happy with this plan.”

The summary can be a concise recap of what you have presented beforehand or it can sometimes form a standalone presentation. Pick out salient points, such as positive findings—but also draw conclusions from what you highlight. Finish with a brief synopsis of the current situation (“currently pain free”) and next step (“awaiting cardiology review”). Do not trail off at the end, and state the diagnosis if you are confident you know what it is. If you are not sure what the diagnosis is then communicate this uncertainty and do not pretend to be more confident than you are. When possible, you should include the patient’s thoughts about the diagnosis, how they are feeling generally, and if they are happy with the management plan.

“In summary, Mr Murphy is a 56 year old man admitted with central crushing chest pain, radiating down his left arm, of 30 minutes’ duration. His cardiac risk factors include 20 pack year smoking history, positive family history, type 2 diabetes, and hypertension. Examination was normal other than tachycardia. However, 12 lead electrocardiography showed ST segment depression in the anterior leads and troponin rise from 85 to 250 µg/L. Acute coronary syndrome protocol was initiated and a diagnosis of NSTEMI [non-ST elevation myocardial infarction] was made. Mr Murphy is currently pain free and awaiting cardiology review.”

Originally published as: Student BMJ 2017;25:i4406

Competing interests: None declared.

Provenance and peer review: Not commissioned; externally peer reviewed

↵ Green EH, Durning SJ, DeCherrie L, Fagan MJ, Sharpe B, Hershman W. Expectations for oral case presentations for clinical clerks: opinions of internal medicine clerkship directors. J Gen Intern Med 2009 ; 24 : 370 - 3 . doi:10.1007/s11606-008-0900-x pmid:19139965 . OpenUrl CrossRef PubMed Web of Science
↵ Olaitan A, Okunade O, Corne J. How to present clinical cases. Student BMJ 2010;18:c1539.
↵ Gaillard F. The secret art of relevant negatives, Radiopedia 2016; http://radiopaedia.org/blog/the-secret-art-of-relevant-negatives .

Open access
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.

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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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Sarah Crowe & Anthony Avery

Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK

Kathrin Cresswell, Ann Robertson & Aziz Sheikh

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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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Received : 29 November 2010

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DOI : https://doi.org/10.1186/1471-2288-11-100

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Clinical Trials

NIH Definition of Clinical Trial Case Studies

The case studies provided below are designed to help you identify whether your study would be considered by NIH to be a clinical trial. Expect the case studies and related guidance to evolve over the upcoming year. For continuity and ease of reference, case studies will retain their original numbering and will not be renumbered if cases are revised or removed.

The simplified case studies apply the following four questions to determine whether NIH would consider the research study to be a clinical trial:

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 answer to all four questions is “yes,” then the clinical study would be considered a clinical trial according to the NIH definition.

See this page for more information about the NIH definition of a clinical trial.

General Case Studies

Institute or center specific case studies.

The study involves the recruitment of research participants who are randomized to receive one of two approved drugs. It is designed to compare the effects of the drugs on the blood level of a protein.

Does the study involve human participants? Yes, the study involves human participants.
Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, one of two drugs.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the drugs on the level of the protein in the participants’ blood.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a protein, is a health-related biomedical outcome.

The study involves the recruitment of research participants with condition Y to receive a drug that has been approved for another indication. It is designed to measure the drug’s effects on the level of a biomarker associated with the severity of condition Y.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the approved drug.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the drug’s effect on the level of the biomarker.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the level of a biomarker, is a health-related biomedical outcome.

The study involves the recruitment of research participants with condition X to receive investigational compound A. It is designed to assess the pharmacokinetic properties of compound A.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, compound A.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how the body interacts with compound A
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, pharmacokinetic properties, is a health-related biomedical outcome.

The study involves the recruitment of research participants with disease X to receive an investigational drug. It is designed to assess safety and determine the maximum tolerated dose of the drug.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to assess safety and determine the maximum tolerated dose of the investigational drug.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, safety and maximum tolerated dose, is a health-related biomedical outcome.

The study involves the recruitment of research participants with disease X to receive a chronic disease management program. It is designed to assess usability and to determine the maximum tolerated dose of the chronic disease program (e.g., how many in-person and telemedicine visits with adequate adherence).

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the chronic disease management program.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine the maximum tolerated dose of the program to obtain adequate adherence.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, tolerable intensity and adequate adherence of the intervention, is a health-related outcome.

The study involves the recruitment of research participants with disease X to receive either an investigational drug or a placebo. It is designed to evaluate the efficacy of the investigational drug to relieve disease symptoms.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, the investigational drug or placebo.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the participants’ symptoms.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, relief of symptoms, is a health-related outcome.

The study involves the recruitment of research participants with disease X to receive an investigational drug. It is designed to assess whether there is a change in disease progression compared to baseline. There is no concurrent control used in this study.

Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the investigational drug on the subject’s disease progression.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, disease progression, is a health-related outcome.

The study involves the recruitment of research participants with disease X to test an investigational in vitro diagnostic device (IVD). It is designed to evaluate the ability of the device to measure the level of an antibody in blood.

Are the participants prospectively assigned to an intervention? No, in this context the IVD would not be considered an intervention. The IVD is being used to test its ability to measure antibody levels, but not to test its effects on any health-related biomedical or behavioral outcomes.

The study involves the recruitment of research participants with disease X to be evaluated with an investigational in vitro diagnostic device (IVD). The study is designed to evaluate how knowledge of certain antibody levels impacts clinical management of disease.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, measurement of an antibody level, with the idea that knowledge of that antibody level might affect clinical management.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate how knowledge of the level of an antibody might inform treatment.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being measured, how blood antibody levels inform treatment, is a health-related outcome.

The study involves the recruitment of healthy volunteers who will be randomized to different durations of sleep deprivation (including no sleep deprivation as a control) and who will have stress hormone levels measured. It is designed to determine whether the levels of stress hormones in blood rise in response to different durations of sleep deprivation.

Does the study involve human participants? Yes, the healthy volunteers are human participants.
Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, different durations of sleep deprivation followed by a blood draw.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of different durations of sleep deprivation on stress hormone levels.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, stress hormone levels, is a health-related biomedical outcome.

The study involves the analysis of de-identified, stored blood samples and de-identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.

Does the study involve human participants? No, the study does not involve human participants because only de-identified samples and information are used.

The study involves the analysis of identifiable, stored blood samples and identified medical records of patients with disease X who were treated with an approved drug. The study is designed to evaluate the level of a protein in the blood of patients that is associated with therapeutic effects of the drug.

Does the study involve human participants? Yes, patients are human participants because the blood and information are identifiable.
Are the participants prospectively assigned to an intervention? No, secondary research with biospecimens or health information is not a clinical trial.

The study involves the recruitment of a healthy volunteers whose blood is drawn for genomic analysis. It is designed to identify the prevalence of a genetic mutation in the cohort and evaluate potential association between the presence of the mutation and the risk of developing a genetic disorder.

Are the participants prospectively assigned to an intervention? No, sample collection (blood draw) is not an intervention in this context.

Physicians report that some patients being treated with drug A for disease X are also experiencing some improvement in a second condition, condition Y. The study involves the recruitment of research participants who have disease X and condition Y and are being treated with drug A. The participants are surveyed to ascertain whether they are experiencing an improvement in condition Y.

Are the participants prospectively assigned to an intervention? No, participants are not prospectively assigned to receive an intervention as they are receiving drugs as part of their clinical care. The surveys are being used for measurement, not to modify a biomedical or behavioral outcome.

The study involves the recruitment of patients with disease X who are receiving one of three standard therapies as part of their clinical care. It is designed to assess the relative effectiveness of the three therapies by monitoring survival rates using medical records over a few years.

Are the participants prospectively assigned to an intervention? No, there is no intervention. The therapies are prescribed as part of clinical care; they are not prospectively assigned for the purpose of the study. The study is observational.

The study involves the recruitment of research participants with disease X vs. healthy controls and comparing these participants on a range of health processes and outcomes including genomics, biospecimens, self-report measures, etc. to explore differences that may be relevant to the development of disease X.

Are the participants prospectively assigned to an intervention? No, the measures needed to assess the outcomes are not interventions in this context, as the study is not intended to determine whether the measures modify a health-related biomedical or behavioral outcome.

The study involves the recruitment of healthy volunteers for a respiratory challenge study; participants are randomized to receive different combinations of allergens. The study evaluates the severity and mechanism of the immune response to different combinations of allergens introduced via inhalation.

Does the study involve human participants? Yes, healthy volunteers are human participants.
Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to randomly selected combinations of allergens.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of different combinations of allergens on the immune response in healthy individuals.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates the severity and mechanism of the immune reaction to allergens, which are health-related biomedical outcomes.

The study involves the recruitment of research participants with Alzheimer’s disease (AD) to evaluate the effects of an investigational drug on memory, and retention and recall of information.

Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive the investigational drug.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the drug on participants’ memory.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates memory, and retention and recall of information in the context of AD.

The study involves the recruitment of individuals to receive a new behavioral intervention for sedentary behavior. It is designed to measure the effect of the intervention on hypothesized differential mediators of behavior change.

Are the participants prospectively assigned to an intervention? Yes, participants are prospectively assigned to receive a behavioral intervention.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of the intervetion on mediators of behavior change.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, mediators of behavior change, are behavioral outcomes relevant to health.

The study involves the recruitment of patients with disease X to be evaluated with a new visual acuity task. It is designed to evaluate the ability of the new task to measure visual acuity as compared with the gold standard Snellen Test

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, the new visual acuity test.
Is the study designed to evaluate the effect of the intervention on the participants? No, the study is designed to evaluate the ability of the new visual acuity test to measure visual acuity as compared to the gold standard Snellen Test, but not to modify visual acuity.

The study involves the recruitment of research participants with CHF who were hospitalized before or after implementation of the Medicare incentives to reduce re-hospitalizations. Morbidity, mortality, and quality of life of these participants are evaluated to compare the effects of these Medicare incentives on these outcomes.

Are the participants prospectively assigned to an intervention? No, the intervention (incentives to reduce re-hospitalization) were assigned by Medicare, not by the research study.

The study involves the recruitment of healthcare providers to assess the extent to which being provided with genomic sequence information about their patients informs their treatment of those patients towards improved outcomes.

Does the study involve human participants? Yes, both the physicians and the patients are human participants.
Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to receive genomic sequence information, which is the intervention.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on the treatment they provide to their patients.
Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the extent to which providing specific information to physicians informs the treatment of patients, is a health-related outcome.

The study involves the recruitment of research participants with a behavioral condition to receive either an investigational behavioral intervention or a behavioral intervention in clinical use. It is designed to evaluate the effectiveness of the investigational intervention compared to the intervention in clinical use in reducing the severity of the obsessive compulsive disorder.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, either the investigational intervention or an intervention in clinical use.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate whether the investigational intervention is as effective as the standard intervention, at changing behavior.
Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the interventions’ effectiveness in reducing the severity of the condition, is a health-related behavioral outcome.

The study involves the recruitment of physicians who will be randomly assigned to use a new app or an existing app, which cues directed interviewing techniques. The study is designed to determine whether the new app is better than the existing app at assisting physicians in identifying families in need of social service support. The number of community service referrals will be measured.

Does the study involve human participants? Yes, both the physicians and the families are human participants.
Are the participants prospectively assigned to an intervention? Yes, physicians are prospectively assigned to use one of two apps, which are the interventions.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of intervening with physicians, on social service support referral for families.
Is the effect being evaluated a health-related, biomedical, or behavioral outcome? Yes, the effect being evaluated, the number of referrals, is a health-related outcome.

The study involves the recruitment of parents to participate in focus groups to discuss topics related to parental self-efficacy and positive parenting behaviors. It is designed to gather information needed to develop an intervention to promote parental self-efficacy and positive parenting behaviors.

Does the study involve human participants? Yes, the parents are human participants.
Are the participants prospectively assigned to an intervention? No, a focus group is not an intervention.

The study involves the recruitment of healthy volunteers to test a new behavioral intervention. It is designed to evaluate the effect of a meditation intervention on adherence to exercise regimens and quality of life to inform the design of a subsequent, fully-powered trial.

Does the study involve human participants? Yes, study participants are human participants.
Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to a behavioral intervention.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the intervention on adherence, and quality of life.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, adherence and quality of life are health-related outcomes.

A study will test the feasibility a mobile phone app designed to increase physical activity. A group of sedentary individuals will use the app for a week while their interactions with the app are monitored. The number of interactions with the app will be measured, as well as any software issues. Participants will also complete a survey indicating their satisfaction with and willingness to use the app, as well as any feedback for improvement. The app’s effect on physical activity, weight, or cardiovascular fitness will not be evaluated.

Does the study involve human participants? Yes, sedentary individuals will be enrolled.
Are the participants prospectively assigned to an intervention? The participants will interact with the app for a week.
Is the study designed to evaluate the effect of the intervention on the participants? No. While the participants’ interactions are monitored (steps or heart rate may be recorded in this process), the study is NOT measuring the effect of using the app ON the participant. The study is only measuring the usability and acceptability of the app, and testing for bugs in the software. The effect on physical activity is NOT being measured.
Is the effect being evaluated a health-related biomedical or behavioral outcome? N/A

The study involves the recruitment of healthy family members of patients hospitalized for disease X to test two CPR training strategies. Participants will receive one of two training strategies. The outcome is improved CPR skills retention.

Does the study involve human participants? Yes, family members of patients are human participants.
Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to one of two CPR educational strategies.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of educational strategies on CPR skills.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, retention of CPR skills is a health-related behavioral outcome.

The study involves the recruitment of research participants in three different communities (clusters) to test three CPR training strategies. The rate of out-of- hospital cardiac arrest survival will be compared.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive one of three types of CPR training, which is the intervention.
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 CPR training strategies on patient survival rates post cardiac arrest.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, out-of-hospital cardiac arrest survival is a health-related outcome.

A study involves the recruitment of school children to evaluate two different tools for monitoring food intake. Food consumption behavior will be measured by asking children to activate a pocket camera during meals and to use a diary to record consumed food. The accuracy of the two food monitoring methods in measuring energy intake will be assessed.

Does the study involve human participants? Yes, children are human participants.
Are the participants prospectively assigned to an intervention? No, in this context the monitoring methods would not be considered an intervention. The study is designed to test the accuracy of two monitoring methods, but not to test the effect on any health-related biomedical or behavioral outcomes.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to two food monitoring methods.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether using the monitoring methods changes eating behavior.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, eating behavior is a health-related outcome.

A study involves the recruitment of children at two schools to monitor eating behavior. Children’s food choices will be monitored using a remote food photography method. Food consumption and the accuracy of food monitoring methods will be assessed.

Does the study involve human participants? Yes, the children participating in this study are human participants.
Are the participants prospectively assigned to an intervention? No, not in this context. The study involves observing and measuring eating behavior, but not modifying it. This is an observational study.

A study involves the recruitment of children at two schools to evaluate their preferences for graphics and colors used in healthy food advertisements. Children will be presented with multiple health advertisements and their preferences for graphics and colors will be assessed.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to see different advertisements.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the advertisements.
Is the effect being evaluated a health-related biomedical or behavioral outcome? No, preferences are not health-related biomedical or behavioral outcomes.

The study involves ambulatory patients who have new-onset stable angina and who are recruited from community practices. They are randomized to undergo CT angiography or an exercise stress test of the doctor’s choice. To keep the trial pragmatic, the investigators do not prescribe a protocol for how physicians should respond to test results. The study is designed to determine whether the initial test (CT angiography or stress test) affects long-term rates of premature death, stroke, or myocardial infarctions.

Are the participants prospectively assigned to an intervention? Yes, the participants are randomized to undergo CT angiography or an exercise stress test.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether the initial test done affects long-term rates of certain clinical events.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, premature death, stroke, and myocardial infarction are health-related biomedical outcomes.

The study involves patients who present with stable angina to community practices. As part of their routine care some of their physicians refer them for CT angiography, while others refer them for exercise stress tests. The study is designed to see whether or not there's an association between the type of test that is chosen and long-term risk of death, stroke, or myocardial infarction.

Are the participants prospectively assigned to an intervention? No, the intervention is not prospectively assigned by the investigators. Rather, the intervention, in this case diagnostic study, occurs as part of routine clinical care.

The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians, as part of their standard clinical care, prescribe antipsychotic medication. The investigators conduct an imaging session before starting treatment; they repeat imaging 4-6 weeks later.

Does the study involve human participants? Yes.
Are the participants prospectively assigned to an intervention? No, not in this context. Antipsychotic medications are given as part of clinical care, not as part of a prospective, approved research protocol.

The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians, as part of their standard clinical care, prescribe antipsychotic medication. As part of the research protocol, all participants will be prescribed the same dose of the antipsychotic medication. The investigators conduct an imaging session before starting treatment; they repeat imaging 4-6 weeks later.

Are the participants prospectively assigned to an intervention? Yes, although participants are all receiving antipsychotic medication as part of their standard medical care, the dose of the antipsychotic medication is determined by the research protocol, rather than individual clinical need.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of a dose of antipsychotic medication on brain function.
Is the effect being evaluated a health-related biomedical or behavioral outcome ? Yes, brain function measured by imaging is a health-related outcome.

The study involves recruitment of healthy volunteers who will wear a thermal compression device around their legs. This pilot study is designed to examine preliminary performance and safety of a thermal compression device worn during surgery. Investigators will measure core temperature, comfort, and presence of skin injury in 15-minute intervals.

Are the participants prospectively assigned to an intervention? Yes, participants are assigned to wear a thermal compression device.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the thermal compression device on participant core temperature, comfort, and presence of skin injury.
Is the effect being evaluated a health-related biomedical or behavioral outcome ? Yes, participant core temperature, comfort, and presence of skin injury are health-related biomedical outcomes.

The study involves collection of data on hospitalizations for various acute illnesses among people who live close to a border between two states that have recently implemented different laws related to public health (e.g. smoking regulations, soda taxes). The investigators want to take advantage of this “natural experiment” to assess the health impact of the laws.

Does the study involve human participants? Yes, the study involves human participants.
Are the participants prospectively assigned to an intervention? No, the interventions were assigned by state laws and state of residence, not by the research study.

The study involves recruitment of healthy volunteers to engage in working memory tasks while undergoing transcranial magnetic stimulation (TMS) to induce competing local neuronal activity. The study is measuring task performance to investigate the neural underpinnings of working memory storage and processing.

Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive TMS stimulation protocols during a working memory task.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of local TMS stimulation on working memory performance and oscillatory brain activity in healthy individuals.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the study evaluates working memory processes, which are health-related biomedical outcomes.

The study involves recruitment of healthy volunteers to engage in a social valuation task while dopamine tone in the brain is manipulated using tolcapone, an FDA-approved medication. The study aims to understand the role of dopamine in social decision-making and to search for neural correlates of this valuation using fMRI.

Are the participants prospectively assigned to an intervention? Yes, healthy volunteers are prospectively assigned to receive tolcapone during a social valuation task.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is evaluating the effects of modulating dopamine tone on social decision-making. Although this study uses an FDA-approved drug to modulate dopamine tone, the goal of this intervention is to understand the role of dopamine in a fundamental phenomenon (social valuation), and not to study the mechanism of action of the drug or its clinical effects.

The career development candidate proposes to independently lead a study to test a new drug A on patients with disease X. Patients will be randomized to a test and control group, with the test group receiving one dose of drug A per week for 12 months and controls receiving placebo. To assess presence, number, and type of any polyps, a colonoscopy will be performed. To assess biomarkers of precancerous lesions, colon mucosal biopsies will be collected. Complete blood count will be measured, and plasma will be stored for potential biomarker evaluation.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drug A or placebo.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drug A and placebo on the presence and type of polyps.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, the presence and type of polyps, is a health-related biomedical outcome.

Ancillary Study to Case Study #42b: Some types of drug A being evaluated in Case Study #42a have been reported to impact renal function. An internal medicine fellow performs an ancillary study where stored plasma from Case Study #42a will be evaluated for multiple biomarkers of renal function.

Does the study involve human participants? Yes, patients are human participants because the plasma and information are identifiable.
Are the participants prospectively assigned to an intervention? No, because the assignment of participants to an intervention occurs as part of an existing, separately funded clinical trial. This proposal would be considered an ancillary study that is not an independent clinical trial.

Ancillary Study to Case Study #42a: An internal medicine fellow designs an independent ancillary trial where a subset of patients from the parent trial in Case Study #42a will also receive drug B, based on the assumption that a two-drug combination will work significantly better than a single drug at both improving renal function and reducing polyps. The test subjects will be evaluated for renal function via plasma clearance rates at 6 and 12 months after initiation of drugs A and B.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to receive an intervention, drugs A and B.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of drugs A and B on renal function.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the effect being evaluated, renal function, is a health-related biomedical outcome.

A group of healthy young adults will perform a Go/No-Go task while undergoing fMRI scans. The purpose of the study is to characterize the pattern of neural activation in the frontal cortex during response inhibition, and the ability of the participant to correctly withhold a response on no-go

Does the study involve human participants? Yes, healthy young adults will be enrolled in this study.
Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a Go/No-Go task, which involves different levels of inhibitory control.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the Go/No-Go task on neural activation in the frontal cortex. The study will measure inhibitory control and the neural systems being engaged. In this study, the Go/No-Go task is the independent variable, and behavioral performance and the associated fMRI activations are the dependent variables.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the neural correlates of inhibitory control and behavioral performance are health-related biomedical outcomes.

A group of adolescents will participate in a longitudinal study examining changes in executive function over the course of a normal school year. Color naming performance on the standard version of the Stroop test will be obtained. All measures will be compared at multiple time points during the school year to examine changes in executive function. The purpose is to observe changes in executive function and to observe if differences exist in the Stroop effect over the course of the school year for these adolescents.

Does the study involve human participants? Yes, adolescents will be enrolled in this study.
Are the participants prospectively assigned to an intervention? No, there is no intervention in this study and no independent variable manipulated. The adolescents are not prospectively assigned to an intervention, but instead the investigator will examine variables of interest (including the Stroop test) over time. The Stroop effect is used as a measurement of point-in-time data.
Is the study designed to evaluate the effect of the intervention on the participants? No, there is no intervention. Performance on the Stroop test is a well-established measure of executive function and the test is not providing an independent variable of interest here. It is not being used to manipulate the participants or their environment. The purpose is simply to obtain a measure of executive function in adolescents over the course of the school year.
Is the effect being evaluated a health-related biomedical or behavioral outcome? N/A. No effect of an intervention is being evaluated.

A group of participants with social anxiety will perform an experimentally manipulated Stroop test. In this variant of the Stroop test, the stimuli presented are varied to include emotional and neutral facial expressions presented in different colors. Participants are instructed to name the colors of the faces presented, with the expectation that they will be slower to name the color of the emotional face than the neutral face. The purpose of the study is to examine the degree to which participants with social anxiety will be slower to process emotional faces than neutral faces.

Does the study involve human participants? Yes, participants with social anxiety will be enrolled in this study.
Are the participants prospectively assigned to an intervention? Yes, the participants will be prospectively assigned to perform a modified Stroop test using different colored emotional/neutral faces to explore emotional processing in people with social anxiety. Note that the independent variable is the presentation of emotional vs neutral faces.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to measure the effect of emotional valence (i.e. emotional faces) on participant response time to name the color. The purpose is to determine whether the response time to emotional faces is exaggerated for people with social anxiety as compared to neutral faces. Note that the response time to name the colors is the dependent variable in this study.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the processing of emotional information is a health-related biomedical outcome.

The study involves healthy volunteers and compares temporal SNR obtained with a new fMRI pulse sequence with that from another sequence.

Are the participants prospectively assigned to an intervention? No, in this context the different pulse sequences would not be considered an intervention. The pulse sequences are not being used to modify any biomedical or behavioral outcome; rather the investigator is comparing performance characteristics of the two pulse sequences.

The study is designed to demonstrate that a new imaging technology (e.g. MRI, PET, ultrasound technologies, or image processing algorithm) is equivalent to, or has better sensitivity/specificity than a standard of care imaging technology. Aim one will use the new imaging technology and the gold standard in ten healthy volunteers. Aim Two will use the new imaging technology and the gold standard before and after a standard care procedure in ten patients. In both aims the performance of the new technology will be compared to the gold standard. No clinical care decisions will be made based on the use of the device in this study.

Does the study involve human participants? YES. Aim one will study ten healthy volunteers, and aim two will study ten patient volunteers.
Are the participants prospectively assigned to an intervention? Yes, participants will be prospectively assigned to be evaluated with a new imaging technology and the gold standard technology.
Is the study designed to evaluate the effect of the intervention on the participants? No, the study is not measuring the effect of the technologies ON the human subjects. The study is determining if the new technology is equivalent or better than the gold standard technology. No effect on the participant is being measured.

An investigator proposes to add secondary outcomes to an already funded clinical trial of a nutritional intervention. The trial is supported by other funding, but the investigator is interested in obtaining NIH funding for studying oral health outcomes. Participants in the existing trial would be assessed for oral health outcomes at baseline and at additional time points during a multi-week dietary intervention. The oral health outcomes would include measures of gingivitis and responses to oral health related quality of life questionnaires. Oral fluids would be collected for analysis of inflammatory markers and microbiome components.

Are the participants prospectively assigned to an intervention? No, because the assignment of participants to an intervention (and the administration of the intervention) occur as part of an existing, separately funded clinical trial. This proposal would be considered an ancillary study that leverages an already existing clinical trial.

The goal of the project is to use functional neuroimaging to distinguish patients with temporomandibular disorders (TMD) who experience TMD pain through centralized pain processes from those with TMD related to peripheral pain. Pain processing in a study cohort of TMD patients and healthy controls will be measured through functional magnetic resonance neuroimaging (fMRI) following transient stimulation of pain pathways through multimodal automated quantitative sensory testing (MAST QST). TMD patients will receive study questionnaires to better correlate the extent to which TMD pain centralization influences TMD prognosis and response to standard of care peripherally targeted treatment (prescribed by physicians, independently of the study).

Are the participants prospectively assigned to an intervention? No, not in this context. The transient stimulation of pain pathways and the fMRI are being performed to measure and describe brain activity, but not to modify it.

An investigator proposes to perform a study of induced gingivitis in healthy humans, to study microbial colonization and inflammation under conditions of health and disease. During a 3-week gingivitis induction period, each study participant will use a stent to cover the teeth in one quadrant during teeth brushing. A contralateral uncovered quadrant will be exposed to the individual's usual oral hygiene procedures, to serve as a control. Standard clinical assessments for gingivitis will be made and biospecimens will be collected at the point of maximal induced gingivitis, and again after normal oral hygiene is resumed. Biospecimens will be assessed for microbial composition and levels of inflammation-associated chemokines.

Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to an intervention, abstaining from normal oral hygiene for a portion of the mouth, to induce gingivitis.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the induced gingivitis on microbial composition and levels of inflammatory chemokines in oral samples.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, the microbial composition and chemokine levels in oral samples are health-related biomedical outcomes.

The study will enroll older adults with hearing loss, comparing the effectiveness of enhanced hearing health care (HHC) to usual HHC. In addition to routine hearing-aid consultation and fitting, participants randomized to enhanced HCC will be provided patient-centered information and education about a full range of hearing assistive technologies and services. Study outcomes include the utilization of technology or services, quality of life, communication abilities, and cognitive function.

Does the study involve human participants? Yes, the study enrolls older adults with hearing loss.
Are the participants prospectively assigned to an intervention? Yes, participants are randomized to receive enhanced HCC or usual HCC interventions.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study will evaluate enhanced HCC’s effectiveness in modifying participant behavior and biomedical outcomes.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, rate of technology/service utilization is a behavioral outcome and quality of life, communications, and cognition are biomedical outcomes that may be impacted by the interventions.

The study involves the recruitment of obese individuals who will undergo a muscle biopsy before and after either exercise training or diet-induced weight loss. Sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species and mitochondrial function will be measured. Levels will be correlated with insulin sensitivity.

Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to either exercise training or a diet.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the interventions on muscle metabolism.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, muscle metabolism/signaling is a health-related outcome.

The study involves the recruitment of participants with type 2 diabetes who will undergo a muscle biopsy before and after a fast to measure acetylation on lysine 23 of the mitochondrial solute carrier adenine nucleotide translocase 1 (ANT1). Levels will be related to rates of fat oxidation.

Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to undergo a fast.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the fast on molecular parameters of metabolism.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, metabolism is a health-related outcome.

Insulin-resistant and insulin-sensitive nondiabetic adults who have a parent with type 2 diabetes will be followed over time to understand the role of mitochondrial dysfunction in the development of diabetes. Oral glucose tolerance tests will be performed annually to measure insulin sensitivity and glycemic status. Participants will also undergo a brief bout of exercise, and mitochondrial ATP synthesis rates will be measured by assessing the rate of recovery of phosphocreatine in the leg muscle, using 31P magnetic resonance spectroscopy.

Are the participants prospectively assigned to an intervention? No, the participants are not assigned to an intervention; the OGTT and 31P MRS are measures.

Participants with chronic kidney disease will be recruited to receive one of two drug agents. After 6 weeks of therapy, subjects will undergo vascular function testing and have measures of oxidative stress evaluated in their plasma and urine. Results of the function testing and the oxidative stress biomarkers will be related to drug treatment.

Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive two different drugs.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function is a health-related outcome.

Participants with Autosomal Dominant Polycystic Kidney Disease will be recruited to receive an oral curcumin therapy or placebo and the participants will undergo vascular function testing, renal imaging to assess kidney size, and assessment of oxidative stress biomarkers in urine and plasma after an ascorbic acid challenge. Changes in these outcomes will be related to oral therapy.

Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive medication or placebo.
Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to compare the effects of the drugs on vascular function and kidney size.
Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, vascular function and kidney size are health-related outcomes.

Kidney transplant recipients will be recruited to undergo an experimental imaging procedure at several timepoints up to 4 months post-transplantation. Output from the images will be related to pathological assessments of the transplant as well as clinical measures of renal function.

Are the participants prospectively assigned to an intervention? No, the participants are not assigned to receive an intervention. They undergo transplantation as part of their routine clinical care. The imaging procedure is a measure and not an intervention.

The study proposes the development of a novel probe to assess clearance of a nutritional metabolite in a given disease state. The probe is a GMP grade, deuterated, intravenously administered tracer and clearance is assessed by mass spectrometry analysis of serial blood draws. Participants will either receive a micronutrient supplement or will receive no supplementation. The clearance rate of the probe will be compared in the two groups, to understand the performance of the probe.

Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive either a micronutrient supplement or nothing.
Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention is being used to assess the performance of the probe and is not looking at an effect on the participant.
Are the participants prospectively assigned to an intervention? Yes, the participants are assigned to receive a controlled diet for three days.
Is the study designed to evaluate the effect of the intervention on the participants? No, the intervention (controlled diet) is being used to minimize exogenous dietary sources of oxalate in the participants prior to the labeled tracer infusion. The study will not be evaluating the effect of the diet on the participants.

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NIH... Turning Discovery Into Health

Henry Gustav Molaison: The Curious Case of Patient H.M.

Erin Heaning

Clinical Safety Strategist at Bristol Myers Squibb

Psychology Graduate, Princeton University

Erin Heaning, a holder of a BA (Hons) in Psychology from Princeton University, has experienced as a research assistant at the Princeton Baby Lab.

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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.

On This Page:

Henry Gustav Molaison, known as Patient H.M., is a landmark case study in psychology. After a surgery to alleviate severe epilepsy, which removed large portions of his hippocampus , he was left with anterograde amnesia , unable to form new explicit memories , thus offering crucial insights into the role of the hippocampus in memory formation.

Henry Gustav Molaison (often referred to as H.M.) is a famous case of anterograde and retrograde amnesia in psychology.
H. M. underwent brain surgery to remove his hippocampus and amygdala to control his seizures. As a result of his surgery, H.M.’s seizures decreased, but he could no longer form new memories or remember the prior 11 years of his life.
He lost his ability to form many types of new memories (anterograde amnesia), such as new facts or faces, and the surgery also caused retrograde amnesia as he was able to recall childhood events but lost the ability to recall experiences a few years before his surgery.
The case of H.M. and his life-long participation in studies gave researchers valuable insight into how memory functions and is organized in the brain. He is considered one of the most studied medical and psychological history cases.

3d rendered medically accurate illustration of the hippocampus

Who is H.M.?

Henry Gustav Molaison, or “H.M” as he is commonly referred to by psychology and neuroscience textbooks, lost his memory on an operating table in 1953.

For years before his neurosurgery, H.M. suffered from epileptic seizures believed to be caused by a bicycle accident that occurred in his childhood. The seizures started out as minor at age ten, but they developed in severity when H.M. was a teenager.

Continuing to worsen in severity throughout his young adulthood, H.M. was eventually too disabled to work. Throughout this period, treatments continued to turn out unsuccessful, and epilepsy proved a major handicap and strain on H.M.’s quality of life.

And so, at age 27, H.M. agreed to undergo a radical surgery that would involve removing a part of his brain called the hippocampus — the region believed to be the source of his epileptic seizures (Squire, 2009).

For epilepsy patients, brain resection surgery refers to removing small portions of brain tissue responsible for causing seizures. Although resection is still a surgical procedure used today to treat epilepsy, the use of lasers and detailed brain scans help ensure valuable brain regions are not impacted.

In 1953, H.M.’s neurosurgeon did not have these tools, nor was he or the rest of the scientific or medical community fully aware of the true function of the hippocampus and its specific role in memory. In one regard, the surgery was successful, as H.M. did, in fact, experience fewer seizures.

However, family and doctors soon noticed he also suffered from severe amnesia, which persisted well past when he should have recovered. In addition to struggling to remember the years leading up to his surgery, H.M. also had gaps in his memory of the 11 years prior.

Furthermore, he lacked the ability to form new memories — causing him to perpetually live an existence of moment-to-moment forgetfulness for decades to come.

In one famous quote, he famously and somberly described his state as “like waking from a dream…. every day is alone in itself” (Squire et al., 2009).

H.M. soon became a major case study of interest for psychologists and neuroscientists who studied his memory deficits and cognitive abilities to better understand the hippocampus and its function.

When H.M. died on December 2, 2008, at the age of 82, he left behind a lifelong legacy of scientific contribution.

Surgical Procedure

Neurosurgeon William Beecher Scoville performed H.M.’s surgery in Hartford, Connecticut, in August 1953 when H.M. was 27 years old.

During the procedure, Scoville removed parts of H.M.’s temporal lobe which refers to the portion of the brain that sits behind both ears and is associated with auditory and memory processing.

More specifically, the surgery involved what was called a “partial medial temporal lobe resection” (Scoville & Milner, 1957). In this resection, Scoville removed 8 cm of brain tissue from the hippocampus — a seahorse-shaped structure located deep in the temporal lobe .

Bilateral resection of the anterior temporal lobe in patient HM.

Further research conducted after this removal showed Scoville also probably destroyed the brain structures known as the “uncus” (theorized to play a role in the sense of smell and forming new memories) and the “amygdala” (theorized to play a crucial role in controlling our emotional responses such as fear and sadness).

As previously mentioned, the removal surgery partially reduced H.M.’s seizures; however, he also lost the ability to form new memories.

At the time, Scoville’s experimental procedure had previously only been performed on patients with psychosis, so H.M. was the first epileptic patient and showed no sign of mental illness. In the original case study of H.M., which is discussed in further detail below, nine of Scoville’s patients from this experimental surgery were described.

However, because these patients had disorders such as schizophrenia, their symptoms were not removed after surgery. In this regard, H.M. was the only patient with “clean” amnesia along with no other apparent mental problems.

H.M’s Amnesia

H.M.’s apparent amnesia after waking from surgery presented in multiple forms. For starters, H.M. suffered from retrograde amnesia for the 11-year period prior to his surgery.

Retrograde describes amnesia, where you can’t recall memories that were formed before the event that caused the amnesia. Important to note, current research theorizes that H.M.’s retrograde amnesia was not actually caused by the loss of his hippocampus, but rather from a combination of antiepileptic drugs and frequent seizures prior to his surgery (Shrader 2012).

In contrast, H.M.’s inability to form new memories after his operation, known as anterograde amnesia, was the result of the loss of the hippocampus.

This meant that H.M. could not learn new words, facts, or faces after his surgery, and he would even forget who he was talking to the moment he walked away.

However, H.M. could perform tasks, and he could even perform those tasks easier after practice. This important finding represented a major scientific discovery when it comes to memory and the hippocampus. The memory that H.M. was missing in his life included the recall of facts, life events, and other experiences.

This type of long-term memory is referred to as “explicit” or “ declarative ” memories and they require conscious thinking.

In contrast, H.M.’s ability to improve in tasks after practice (even if he didn’t recall that practice) showed his “implicit” or “ procedural ” memory remained intact (Scoville & Milner, 1957). This type of long-term memory is unconscious, and examples include riding a bike, brushing your teeth, or typing on a keyboard.

Most importantly, after removing his hippocampus, H.M. lost his explicit memory but not his implicit memory — establishing that implicit memory must be controlled by some other area of the brain and not the hippocampus.

After the severity of the side effects of H.M.’s operation became clear, H.M. was referred to neurosurgeon Dr. Wilder Penfield and neuropsychologist Dr. Brenda Milner of Montreal Neurological Institute (MNI) for further testing.

As discussed, H.M. was not the only patient who underwent this experimental surgery, but he was the only non-psychotic patient with such a degree of memory impairment. As a result, he became a major study and interest for Milner and the rest of the scientific community.

Since Penfield and Milner had already been conducting memory experiments on other patients at the time, they quickly realized H.M.’s “dense amnesia, intact intelligence, and precise neurosurgical lesions made him a perfect experimental subject” (Shrader 2012).

Milner continued to conduct cognitive testing on H.M. for the next fifty years, primarily at the Massachusetts Institute of Technology (MIT). Her longitudinal case study of H.M.’s amnesia quickly became a sensation and is still one of the most widely-cited psychology studies.

In publishing her work, she protected Henry’s identity by first referring to him as the patient H.M. (Shrader 2012).

In the famous “star tracing task,” Milner tested if H.M.’s procedural memory was affected by the removal of the hippocampus during surgery.

In this task, H.M. had to trace an outline of a star, but he could only trace the star based on the mirrored reflection. H.M. then repeated this task once a day over a period of multiple days.

Over the course of these multiple days, Milner observed that H.M. performed the test faster and with fewer errors after continued practice. Although each time he performed the task, he had no memory of having participated in the task before, his performance improved immensely (Shrader 2012).

As this task showed, H.M. had lost his declarative/explicit memory, but his unconscious procedural/implicit memory remained intact. Given the damage to his hippocampus in surgery, researchers concluded from tasks such as these that the hippocampus must play a role in declarative but not procedural memory.

Therefore, procedural memory must be localized somewhere else in the brain and not in the hippocampus.

H.M’s Legacy

Milner’s and hundreds of other researchers’ work with H.M. established fundamental principles about how memory functions and is organized in the brain.

Without the contribution of H.M. in volunteering the study of his mind to science, our knowledge today regarding the separation of memory function in the brain would certainly not be as strong.

Until H.M.’s watershed surgery, it was not known that the hippocampus was essential for making memories and that if we lost this valuable part of our brain, we would be forced to live only in the moment-to-moment constraints of our short-term memory .

Once this was realized, the findings regarding H.M. were widely publicized so that this operation to remove the hippocampus would never be done again (Shrader 2012).

H.M.’s case study represents a historical time period for neuroscience in which most brain research and findings were the result of brain dissections, lesioning certain sections, and seeing how different experimental procedures impacted different patients.

Therefore, it is paramount we recognize the contribution of patients like H.M., who underwent these dangerous operations in the mid-twentieth century and then went on to allow researchers to study them for the rest of their lives.

Even after his death, H.M. donated his brain to science. Researchers then took his unique brain, froze it, and then in a 53-hour procedure, sliced it into 2,401 slices which were then individually photographed and digitized as a three-dimensional map.

Through this map, H.M.’s brain could be preserved for posterity (Wb et al., 2014). As neuroscience researcher Suzanne Corkin once said it best, “H.M. was a pleasant, engaging, docile man with a keen sense of humor, who knew he had a poor memory but accepted his fate.

There was a man behind the data. Henry often told me that he hoped that research into his condition would help others live better lives. He would have been proud to know how much his tragedy has benefitted science and medicine” (Corkin, 2014).

Corkin, S. (2014). Permanent present tense: The man with no memory and what he taught the world. Penguin Books.

Hardt, O., Einarsson, E. Ö., & Nader, K. (2010). A bridge over troubled water: Reconsolidation as a link between cognitive and neuroscientific memory research traditions. Annual Review of Psychology, 61, 141–167.

Scoville, W. B., & Milner, B. (1957). Loss of recent memory after bilateral hippocampal lesions . Journal of neurology, neurosurgery, and psychiatry, 20 (1), 11.

Shrader, J. (2012, January). HM, the man with no memory | Psychology Today. Retrieved from, https://www.psychologytoday.com/us/blog/trouble-in-mind/201201/hm-the-man-no-memory

Squire, L. R. (2009). The legacy of patient H. M. for neuroscience . Neuron, 61 , 6–9.

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Correspondence
Published: 16 April 2024

A framework for implementing patient-reported outcomes in clinical care: the PROTEUS-practice guide

Norah L. Crossnohere ORCID: orcid.org/0000-0002-2811-1330 1 ,
Nicola Anderson 2 ,
Judith Baumhauer ORCID: orcid.org/0000-0003-2142-7778 3 ,
Melanie Calvert ORCID: orcid.org/0000-0002-1856-837X 2 ,
Rebecca Esparza 4 ,
Sandi Gulbransen 5 ,
Lotte Haverman 6 ,
Yuchen Li 7 ,
Carolyn Petersen ORCID: orcid.org/0000-0002-2136-1273 8 ,
Ameeta Retzer ORCID: orcid.org/0000-0002-4156-8386 2 ,
Christopher Sidey-Gibbons 9 ,
Angela M. Stover 10 ,
Elissa Thorner 11 ,
Garrett Ursin 12 ,
Galina Velikova 13 ,
Elliott Sparkman Walker 14 ,
Michael Brundage 15 &
Claire Snyder 16

Nature Medicine ( 2024 ) Cite this article

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Patient-reported outcomes (PROs) are a powerful tool for clinical practice that directly measure patient experiences, enabling providers to tailor care to patients’ needs and priorities. PROs are patients’ own reports of how they feel, function, and live their lives 1 , collected using standardized, validated questionnaires. Compelling evidence demonstrates the value of using PROs in clinical practice, whereby a healthcare provider and a patient together use the patient’s PROs to inform care. Implementing PROs as part of routine care can facilitate patient–provider communication, help to identify and address healthcare problems, increase efficiency, and improve patient outcomes, such as symptom burden, functioning, quality of life, and even survival 2 . Measurement of PROs is an integral part of innovative payment models, including the Centers for Medicare and Medicaid Services ‘Enhancing Oncology Model’ and ‘Comprehensive Primary Care Plus’ (CPC+) model 3 , and contributes to quality metrics such as Newsweek ’s 2023 ranking of the world’s best specialized hospitals 4 .

Despite being enthusiastic to use PROs to inform care, many healthcare systems lack understanding of the considerations involved in designing, implementing, and managing PRO systems. Furthermore, there is no one-size-fits-all approach to integrating PROs into clinical practice, and PRO systems can (and should) vary according to factors such as healthcare setting, PRO system goals, and patient characteristics. Established resources provide data-driven and consensus-based guidance on specific aspects of using PROs in clinical practice. However, a unified framework with updated and comprehensive guidance is needed to support the use of PROs in clinical practice.

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US DHHS, FDA, CDER, CBER & CDRH. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support https://www.fda.gov/media/77832/download (December 2009).

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World’s Best Hospitals 2023. Newsweek https://go.nature.com/3PuNZSP (2023).

International Society for Quality of Life Research (prepared by Aaronson N. et al.) User’s Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice https://go.nature.com/4a1gbFa (January 2015).

Snyder, C. & Wu, A. W. Users’ Guide for Integrating Patient-Reported Outcomes in Electronic Health Records https://go.nature.com/4crXxYw (2017).

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Snyder, C., Brundage, M., Rivera, Y. & Wu, A. W. (eds.) Medical Care 57 (suppl. 1); https://journals.lww.com/lwwmedicalcare/toc/2019/05001 (2019).

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PROTEUS Consortium. Practice Guide ; https://go.nature.com/4ch6Kmq (2023).

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Acknowledgements

We thank members of the PROTEUS Consortium and the original developers of the foundational resources synthesized in the PROTEUS-Practice Guide for their contributions.

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Authors and affiliations.

Division of General Internal Medicine, The Ohio State University College of Medicine, Columbus, OH, USA

Norah L. Crossnohere

Centre for Patient Reported Outcomes Research, NIHR Birmingham Biomedical Research Centre and NIHR Applied Research Collaboration West Midlands, Institute of Applied Health Research, University of Birmingham, Birmingham, UK

Nicola Anderson, Melanie Calvert & Ameeta Retzer

Department of Orthopedics and Physical Performance, University of Rochester Medical Center, Rochester, NY, USA

Judith Baumhauer

Patient Advocate, National Coalition for Cancer Survivorship, Silver Spring, MD, USA

Rebecca Esparza

University of Utah Health, Salt Lake City, UT, USA

Sandi Gulbransen

Psychosocial Department, Emma Children’s Hospital Academic Medical Center, Amsterdam, The Netherlands

Lotte Haverman

Princess Margaret Cancer Center, Toronto, Ontario, Canada

Department of Artificial Intelligence and Informatics, Mayo Clinic, Rochester, MN, USA

Carolyn Petersen

MD Anderson Center for INSPiRED Cancer Care, University of Texas, Houston, TX, USA

Christopher Sidey-Gibbons

University of North Carolina, Department of Health Policy and Management, and Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA

Angela M. Stover

Patient Advocate, The PROTEUS Consortium, Baltimore, MD, USA

Elissa Thorner

Epic Systems, Verona, WI, USA

Garrett Ursin

University of Leeds, Leeds, UK

Galina Velikova

Strategic Communications & Planning, Philadelphia, PA, USA

Elliott Sparkman Walker

Queen’s University Cancer Research Institute, Cancer Care and Epidemiology, Kingston, ON, Canada

Michael Brundage

Johns Hopkins Schools of Medicine and Public Health, Baltimore, MD, USA

Claire Snyder

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Corresponding author

Correspondence to Norah L. Crossnohere .

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Competing interests.

The PROTEUS Consortium is funded by unrestricted support from Pfizer Inc., who had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. M.C. receives funding from the National Institute for Health and Care Research (NIHR), UKRI, NIHR Biomedical Research Centre, NIHR Applied Research Collaboration West Midlands, NIHR Birmingham–Oxford Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, GSK and Merck, and has received personal fees from Aparito, CIS Oncology, Halfloop, Merck, Pfizer, Vertex and Gilead outside the submitted work. A.M.S. has, in the past two years, received related funding from Pfizer Global and unrelated funding from UroGen Pharma Ltd, Sivan Innovation, Hematology/Oncology Pharmacy Foundation, Cancer and Aging Research Group (CARG) Infrastructure grants (R21AG059206 and R33AG059206), and the American Society of Clinical Oncology, and was a paid consultant with Navigating Cancer in 2021. C.S. has consulting funding from Shionogi. N.C. has unrelated consulting support from Boehringer Ingelheim.

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Crossnohere, N.L., Anderson, N., Baumhauer, J. et al. A framework for implementing patient-reported outcomes in clinical care: the PROTEUS-practice guide. Nat Med (2024). https://doi.org/10.1038/s41591-024-02909-8

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Case study: 33-year-old female presents with chronic sob and cough.

Sandeep Sharma ; Muhammad F. Hashmi ; Deepa Rawat .

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Last Update: February 20, 2023 .

Case Presentation

History of Present Illness: A 33-year-old white female presents after admission to the general medical/surgical hospital ward with a chief complaint of shortness of breath on exertion. She reports that she was seen for similar symptoms previously at her primary care physician’s office six months ago. At that time, she was diagnosed with acute bronchitis and treated with bronchodilators, empiric antibiotics, and a short course oral steroid taper. This management did not improve her symptoms, and she has gradually worsened over six months. She reports a 20-pound (9 kg) intentional weight loss over the past year. She denies camping, spelunking, or hunting activities. She denies any sick contacts. A brief review of systems is negative for fever, night sweats, palpitations, chest pain, nausea, vomiting, diarrhea, constipation, abdominal pain, neural sensation changes, muscular changes, and increased bruising or bleeding. She admits a cough, shortness of breath, and shortness of breath on exertion.

Social History: Her tobacco use is 33 pack-years; however, she quit smoking shortly prior to the onset of symptoms, six months ago. She denies alcohol and illicit drug use. She is in a married, monogamous relationship and has three children aged 15 months to 5 years. She is employed in a cookie bakery. She has two pet doves. She traveled to Mexico for a one-week vacation one year ago.

Allergies: No known medicine, food, or environmental allergies.

Past Medical History: Hypertension

Past Surgical History: Cholecystectomy

Medications: Lisinopril 10 mg by mouth every day

Physical Exam:

Vitals: Temperature, 97.8 F; heart rate 88; respiratory rate, 22; blood pressure 130/86; body mass index, 28

General: She is well appearing but anxious, a pleasant female lying on a hospital stretcher. She is conversing freely, with respiratory distress causing her to stop mid-sentence.

Respiratory: She has diffuse rales and mild wheezing; tachypneic.

Cardiovascular: She has a regular rate and rhythm with no murmurs, rubs, or gallops.

Gastrointestinal: Bowel sounds X4. No bruits or pulsatile mass.

Initial Evaluation

Laboratory Studies: Initial work-up from the emergency department revealed pancytopenia with a platelet count of 74,000 per mm3; hemoglobin, 8.3 g per and mild transaminase elevation, AST 90 and ALT 112. Blood cultures were drawn and currently negative for bacterial growth or Gram staining.

Chest X-ray

Impression: Mild interstitial pneumonitis

Differential Diagnosis
Aspiration pneumonitis and pneumonia
Bacterial pneumonia
Immunodeficiency state and Pneumocystis jiroveci pneumonia
Carcinoid lung tumors
Tuberculosis
Viral pneumonia
Chlamydial pneumonia
Coccidioidomycosis and valley fever
Recurrent Legionella pneumonia
Mediastinal cysts
Mediastinal lymphoma
Recurrent mycoplasma infection
Pancoast syndrome
Pneumococcal infection
Sarcoidosis
Small cell lung cancer
Aspergillosis
Blastomycosis
Histoplasmosis
Actinomycosis
Confirmatory Evaluation

CT of the chest was performed to further the pulmonary diagnosis; it showed a diffuse centrilobular micronodular pattern without focal consolidation.

On finding pulmonary consolidation on the CT of the chest, a pulmonary consultation was obtained. Further history was taken, which revealed that she has two pet doves. As this was her third day of broad-spectrum antibiotics for a bacterial infection and she was not getting better, it was decided to perform diagnostic bronchoscopy of the lungs with bronchoalveolar lavage to look for any atypical or rare infections and to rule out malignancy (Image 1).

Bronchoalveolar lavage returned with a fluid that was cloudy and muddy in appearance. There was no bleeding. Cytology showed Histoplasma capsulatum .

Based on the bronchoscopic findings, a diagnosis of acute pulmonary histoplasmosis in an immunocompetent patient was made.

Pulmonary histoplasmosis in asymptomatic patients is self-resolving and requires no treatment. However, once symptoms develop, such as in our above patient, a decision to treat needs to be made. In mild, tolerable cases, no treatment other than close monitoring is necessary. However, once symptoms progress to moderate or severe, or if they are prolonged for greater than four weeks, treatment with itraconazole is indicated. The anticipated duration is 6 to 12 weeks total. The response should be monitored with a chest x-ray. Furthermore, observation for recurrence is necessary for several years following the diagnosis. If the illness is determined to be severe or does not respond to itraconazole, amphotericin B should be initiated for a minimum of 2 weeks, but up to 1 year. Cotreatment with methylprednisolone is indicated to improve pulmonary compliance and reduce inflammation, thus improving work of respiration. [1] [2] [3]

Histoplasmosis, also known as Darling disease, Ohio valley disease, reticuloendotheliosis, caver's disease, and spelunker's lung, is a disease caused by the dimorphic fungi Histoplasma capsulatum native to the Ohio, Missouri, and Mississippi River valleys of the United States. The two phases of Histoplasma are the mycelial phase and the yeast phase.

Etiology/Pathophysiology

Histoplasmosis is caused by inhaling the microconidia of Histoplasma spp. fungus into the lungs. The mycelial phase is present at ambient temperature in the environment, and upon exposure to 37 C, such as in a host’s lungs, it changes into budding yeast cells. This transition is an important determinant in the establishment of infection. Inhalation from soil is a major route of transmission leading to infection. Human-to-human transmission has not been reported. Infected individuals may harbor many yeast-forming colonies chronically, which remain viable for years after initial inoculation. The finding that individuals who have moved or traveled from endemic to non-endemic areas may exhibit a reactivated infection after many months to years supports this long-term viability. However, the precise mechanism of reactivation in chronic carriers remains unknown.

Infection ranges from an asymptomatic illness to a life-threatening disease, depending on the host’s immunological status, fungal inoculum size, and other factors. Histoplasma spp. have grown particularly well in organic matter enriched with bird or bat excrement, leading to the association that spelunking in bat-feces-rich caves increases the risk of infection. Likewise, ownership of pet birds increases the rate of inoculation. In our case, the patient did travel outside of Nebraska within the last year and owned two birds; these are her primary increased risk factors. [4]

Non-immunocompromised patients present with a self-limited respiratory infection. However, the infection in immunocompromised hosts disseminated histoplasmosis progresses very aggressively. Within a few days, histoplasmosis can reach a fatality rate of 100% if not treated aggressively and appropriately. Pulmonary histoplasmosis may progress to a systemic infection. Like its pulmonary counterpart, the disseminated infection is related to exposure to soil containing infectious yeast. The disseminated disease progresses more slowly in immunocompetent hosts compared to immunocompromised hosts. However, if the infection is not treated, fatality rates are similar. The pathophysiology for disseminated disease is that once inhaled, Histoplasma yeast are ingested by macrophages. The macrophages travel into the lymphatic system where the disease, if not contained, spreads to different organs in a linear fashion following the lymphatic system and ultimately into the systemic circulation. Once this occurs, a full spectrum of disease is possible. Inside the macrophage, this fungus is contained in a phagosome. It requires thiamine for continued development and growth and will consume systemic thiamine. In immunocompetent hosts, strong cellular immunity, including macrophages, epithelial, and lymphocytes, surround the yeast buds to keep infection localized. Eventually, it will become calcified as granulomatous tissue. In immunocompromised hosts, the organisms disseminate to the reticuloendothelial system, leading to progressive disseminated histoplasmosis. [5] [6]

Symptoms of infection typically begin to show within three to17 days. Immunocompetent individuals often have clinically silent manifestations with no apparent ill effects. The acute phase of infection presents as nonspecific respiratory symptoms, including cough and flu. A chest x-ray is read as normal in 40% to 70% of cases. Chronic infection can resemble tuberculosis with granulomatous changes or cavitation. The disseminated illness can lead to hepatosplenomegaly, adrenal enlargement, and lymphadenopathy. The infected sites usually calcify as they heal. Histoplasmosis is one of the most common causes of mediastinitis. Presentation of the disease may vary as any other organ in the body may be affected by the disseminated infection. [7]

The clinical presentation of the disease has a wide-spectrum presentation which makes diagnosis difficult. The mild pulmonary illness may appear as a flu-like illness. The severe form includes chronic pulmonary manifestation, which may occur in the presence of underlying lung disease. The disseminated form is characterized by the spread of the organism to extrapulmonary sites with proportional findings on imaging or laboratory studies. The Gold standard for establishing the diagnosis of histoplasmosis is through culturing the organism. However, diagnosis can be established by histological analysis of samples containing the organism taken from infected organs. It can be diagnosed by antigen detection in blood or urine, PCR, or enzyme-linked immunosorbent assay. The diagnosis also can be made by testing for antibodies again the fungus. [8]

Pulmonary histoplasmosis in asymptomatic patients is self-resolving and requires no treatment. However, once symptoms develop, such as in our above patient, a decision to treat needs to be made. In mild, tolerable cases, no treatment other than close monitoring is necessary. However, once symptoms progress to moderate or severe or if they are prolonged for greater than four weeks, treatment with itraconazole is indicated. The anticipated duration is 6 to 12 weeks. The patient's response should be monitored with a chest x-ray. Furthermore, observation for recurrence is necessary for several years following the diagnosis. If the illness is determined to be severe or does not respond to itraconazole, amphotericin B should be initiated for a minimum of 2 weeks, but up to 1 year. Cotreatment with methylprednisolone is indicated to improve pulmonary compliance and reduce inflammation, thus improving the work of respiration.

The disseminated disease requires similar systemic antifungal therapy to pulmonary infection. Additionally, procedural intervention may be necessary, depending on the site of dissemination, to include thoracentesis, pericardiocentesis, or abdominocentesis. Ocular involvement requires steroid treatment additions and necessitates ophthalmology consultation. In pericarditis patients, antifungals are contraindicated because the subsequent inflammatory reaction from therapy would worsen pericarditis.

Patients may necessitate intensive care unit placement dependent on their respiratory status, as they may pose a risk for rapid decompensation. Should this occur, respiratory support is necessary, including non-invasive BiPAP or invasive mechanical intubation. Surgical interventions are rarely warranted; however, bronchoscopy is useful as both a diagnostic measure to collect sputum samples from the lung and therapeutic to clear excess secretions from the alveoli. Patients are at risk for developing a coexistent bacterial infection, and appropriate antibiotics should be considered after 2 to 4 months of known infection if symptoms are still present. [9]

Prognosis

If not treated appropriately and in a timely fashion, the disease can be fatal, and complications will arise, such as recurrent pneumonia leading to respiratory failure, superior vena cava syndrome, fibrosing mediastinitis, pulmonary vessel obstruction leading to pulmonary hypertension and right-sided heart failure, and progressive fibrosis of lymph nodes. Acute pulmonary histoplasmosis usually has a good outcome on symptomatic therapy alone, with 90% of patients being asymptomatic. Disseminated histoplasmosis, if untreated, results in death within 2 to 24 months. Overall, there is a relapse rate of 50% in acute disseminated histoplasmosis. In chronic treatment, however, this relapse rate decreases to 10% to 20%. Death is imminent without treatment.

Pearls of Wisdom

While illnesses such as pneumonia are more prevalent, it is important to keep in mind that more rare diseases are always possible. Keeping in mind that every infiltrates on a chest X-ray or chest CT is not guaranteed to be simple pneumonia. Key information to remember is that if the patient is not improving under optimal therapy for a condition, the working diagnosis is either wrong or the treatment modality chosen by the physician is wrong and should be adjusted. When this occurs, it is essential to collect a more detailed history and refer the patient for appropriate consultation with a pulmonologist or infectious disease specialist. Doing so, in this case, yielded workup with bronchoalveolar lavage and microscopic evaluation. Microscopy is invaluable for definitively diagnosing a pulmonary consolidation as exemplified here where the results showed small, budding, intracellular yeast in tissue sized 2 to 5 microns that were readily apparent on hematoxylin and eosin staining and minimal, normal flora bacterial growth.

Enhancing Healthcare Team Outcomes

This case demonstrates how all interprofessional healthcare team members need to be involved in arriving at a correct diagnosis. Clinicians, specialists, nurses, pharmacists, laboratory technicians all bear responsibility for carrying out the duties pertaining to their particular discipline and sharing any findings with all team members. An incorrect diagnosis will almost inevitably lead to incorrect treatment, so coordinated activity, open communication, and empowerment to voice concerns are all part of the dynamic that needs to drive such cases so patients will attain the best possible outcomes.

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Histoplasma Contributed by Sandeep Sharma, MD

Disclosure: Sandeep Sharma declares no relevant financial relationships with ineligible companies.

Disclosure: Muhammad Hashmi declares no relevant financial relationships with ineligible companies.

Disclosure: Deepa Rawat declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

Cite this Page Sharma S, Hashmi MF, Rawat D. Case Study: 33-Year-Old Female Presents with Chronic SOB and Cough. [Updated 2023 Feb 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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CASE STUDY: Linguistic Validation of Patient Reported Outcomes for Drug Trial

Japanese pharmaceutical partners with Welocalize in a 50-country drug trial. This case study highlights how a private Japanese pharmaceutical company collaborated with Welocalize to support its global clinical trial to measure the effectiveness of a new psychiatric drug. The trial was conducted across 50 countries and in 40 languages. Together, we achieved: Demonstrably accurate &…

Japanese pharmaceutical partners with Welocalize in a 50-country drug trial.

This case study highlights how a private Japanese pharmaceutical company collaborated with Welocalize to support its global clinical trial to measure the effectiveness of a new psychiatric drug. The trial was conducted across 50 countries and in 40 languages. Together, we achieved:

Demonstrably accurate & on-time translation of PROs from English into over 40 languages
The complete removal of a reas of cognitive difficulty, grammatical mistakes, or culturally inappropriate statements
Greater patient compliance resulting in higher quality trial data across all 50 countries

Scroll 👇 to view the case study. If you have any questions, reach out to us here.

The Challenge

Our client, a private Japanese pharmaceutical company, was conducting a 50-country clinical study to measure the effectiveness of a new psychiatric drug.

Instruments used to gather data directly from the patients – patient-reported outcomes (PROs) – must be translated into the patient’s native language. For an instrument to be used in international studies, it must address the same concepts in all languages to make it possible to pool data and compare results across countries, avoiding inconsistencies.

The client required PROs to be translated into 40 languages for the 50-country drug trial. These translations needed to be linguistically validated through pilot testing involving actual participants, conducted via culturally sensitive focus groups in 40 languages across more than 20 countries.

The Solution

To successfully pool data across the multinational clinical trials, Welocalize worked with multiple teams of local, native language translators, as well as focus groups, to ensure accuracy across languages, dialects, and cultures.

More than one forward translation of the instruments was conducted, and these translations were then reconciled into a single forward translation using the best components of each. Another team then completed a back translation into English, which was then compared to the original source file.

Based on these findings, mistakes or ambiguities were corrected. Then, the single language file was culturally adapted into the local dialects.

Cognitive Debriefing

With so many linguistic differences and cultural nuances – even within the same trial country – it was crucial to validate trial documents for linguistic and cultural accuracy.

To test the translation, or validate the accuracy of an instrument, Welocalize performed cognitive debriefing of the translation on real people.

The focus group, run by a moderator, consisted of people across diverse economic, education, and demographics to make up a general population for the testing.

The Results

Greater patient compliance resulting in higher quality trial data
The successful pooling of data from over 50 countries

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Case Study – Methods, Examples and Guide

Types of Case Study

Single-Case Study

Multiple-Case Study

Descriptive Case Study

Instrumental Case Study

Case Study Data Collection Methods

Observations

How to conduct Case Study Research

Examples of Case Study

Application of Case Study

Business and Management

Social Sciences

Law and Ethics

Purpose of Case Study

Advantages of Case Study Research

Limitations of Case Study Research

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Muhammad Hassan

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Section 1: A Case History

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How to present patient cases

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Box 1: Structure for presenting patient cases

Family history

Investigations

Box 2: SOCRATES—mnemonic for pain

Box 3: Relevant negatives

Findings on examination

Differential diagnoses

The case study approach

Introduction

What is a case study?

What are case studies used for?

How are case studies conducted?

Defining the case

Selecting the case(s)

Collecting the data

Analysing, interpreting and reporting case studies

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

Conclusions

Pre-publication history

Acknowledgements

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BMC Medical Research Methodology

NIH Definition of Clinical Trial Case Studies

General Case Studies

Henry Gustav Molaison: The Curious Case of Patient H.M.

Who is H.M.?

Surgical Procedure

H.M’s Amnesia

H.M’s Legacy

A framework for implementing patient-reported outcomes in clinical care: the PROTEUS-practice guide