how to create a medical case study

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Medical Studies

How to Write a Medical Case Study Report

Last Updated: April 18, 2024 Fact Checked

This article was medically reviewed by Mark Ziats, MD, PhD and by wikiHow staff writer, Jennifer Mueller, JD . Dr. Mark Ziats is an Internal Medicine Physician, Scientist, Entrepreneur, and the Medical Director of xBiotech. With over five years of experience, he specializes in biotechnology, genomics, and medical devices. He earned a Doctor of Medicine degree from Baylor College of Medicine, a Ph.D. in Genetics from the University of Cambridge, and a BS in Biochemistry and Chemistry from Clemson University. He also completed the INNoVATE Program in Biotechnology Entrepreneurship at The Johns Hopkins University - Carey Business School. Dr. Ziats is board certified by the American Board of Internal Medicine. There are 15 references cited in this article, which can be found at the bottom of the page. This article has been fact-checked, ensuring the accuracy of any cited facts and confirming the authority of its sources. This article has been viewed 187,894 times.

You've encountered an interesting and unusual case on your rounds, and a colleague or supervising physician says, "Why don't you write up a case study report?" If you've never written one before, that might sound intimidating, but it's a great way to get started in medical writing. Case studies always follow a standard structure and format, so the writing is very formulaic once you get the hang of it. Read on for a step-by-step guide to writing your first case study report.

What is a case study report?

Step 1 A case study report is an academic publication describing an unusual or unique case.

Medical students or residents typically do the bulk of the writing of the report. If you're just starting your medical career, a case study report is a great way to get a publication under your belt. [2] X Research source

Step 2 Your report discusses the case presented by one patient.

If the patient is a minor or is incapable of giving informed consent, get consent from their parents or closest relative. [4] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source
Your hospital likely has specific consent forms to use. Ask your supervising physician if you're not sure where to get one.
Some journals also have their own consent form. Check your target journal's author or submission information to make sure. [5] X Research source

How is a case study report structured?

Step 1 A typical report consists of an abstract, intro, case description, discussion, and conclusion.

Even though the introduction is the first part of a case study report, doctors typically write it last. You'll have a better idea of how to introduce your case study to readers after you've written it.
Your abstract comes at the top, before the introduction, and provides a brief summary of the entire report. Unless your case study is published in an open-access journal, the abstract is the only part of the article many readers will see.

Step 2 Check your target journal for possible variations.

Many journals offer templates and checklists you can use to make sure your case study includes everything necessary and is formatted properly—take advantage of these! Some journals, such as BMJ Case Reports , require all case studies submitted to use their templates.

Drafting Your Medical Case Study Report

Step 1 Pull all of the hospital records for the case.

Patient description
Chronological case history
Physical exam results
Results of any pathological tests, imaging, or other investigations
Treatment plan
Expected outcome of treatment
Actual outcome of treatment

Step 2 Write a draft of the case presentation.

Why the patient sought medical help (you can even use their own words)
Important information that helped you settle on your diagnosis
The results of your clinical examination, including diagnostic tests and their results, along with any helpful images
A description of the treatment plan
The outcome, including how and why treatment ended and how long the patient was under your care [11] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source

Step 3 Research the existing literature on the patient's condition and treatment.

You will need references to back up symptoms of the condition, common treatment, and the expected outcome of that common treatment.
Use your research to paint a picture of the usual case of a patient with a similar condition—it'll help you show how unusual and different your patient's case is.
Generally, aim for around 20 references—no fewer than 15, but no more than 25. [13] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source

Step 4 Write a section discussing the case in light of your research.

Close your discussion section with a summary of the lessons learned from the case and why it's significant to consider when treating similar cases in the future.
Outline any open questions that remain. You might also provide suggestions for future research.

Step 5 Complete your introduction and conclusion after you've written the body.

In your conclusion, you might also give suggestions or recommendations to readers based on what you learned as a result of the case.
Some journals don't want a separate conclusion section. If that's the case for one of your target journals, just move this paragraph to the end of your discussion section.

Polishing Your Report for Submission to Publishers

Step 1 Come up with a title for your case study.

Most titles are fewer than 10 words long and include the name of the disease or condition treated.
You might also include the treatment used and whether the outcome was successful. When deciding what to include, think about the reason you wrote the case study in the first place and why you think it's important for other clinicians to read.

Step 2 Identify the authors of the report on the title page.

Made a significant intellectual contribution to the case study report
Was involved in the medical care of the patient reported
Can explain and defend the data presented in the report
Has approved the final manuscript before submission for publication

Step 3 Write an abstract summarizing the entire article.

Keep in mind that the abstract is not just going to be the first thing people read—it will often be the only thing people read. Make sure that if someone is going to walk away having only read the abstract, they'll still get the same message they would have if they read the whole thing.
There are 2 basic types of abstract: narrative and structured. A narrative abstract is a single paragraph written in narrative prose. A structured abstract includes headings that correspond with the sections of the paper, then a brief summary of each section. Use the format preferred by your target journal.

Step 4 Choose keywords that will help readers find your case study.

Look for keywords that are relevant to your field or sub-field and directly related to the content of your article, such as the name of the condition or specific treatments you used.
Most journals allow 4-8 keywords but check the submission guidelines of your target journal to make sure.

Blur out the patient's face as well as any tattoos, birthmarks, or unrelated scars that are visible in diagnostic images.

Step 6 Include your acknowledgments and conflict of interest statement.

It's common to thank the patient, but that's up to you. Even if you don't, include a statement indicating that you have the patient's written, informed consent to publish the information.
Read the journal's submission guidelines for a definition of what that journal considers a conflict of interest. They're generally the same, but some might be stricter than others. [22] X Research source

Step 7 Compile and format your reference section.

If you're not familiar with the citation style used by your target journal, check online for a guide. There might also be one available at your hospital or medical school library.
Medical librarians can also help with citation style and references if you run into something tricky—don't just wing it! Correct citation style insures that readers can access the materials you cite.

Step 8 Get feedback on your final draft.

It's also a good idea to get a beta reader who isn't a medical professional. Their comments can help you figure out where you need to clarify your points.
Read a lot of case studies published in your target journals—it will help you internalize the tone and style that journal is looking for.

Submitting Your Report to Publishers

Step 1 Choose target journals that publish similar content.

Look into the background and reputation of journals before you decide to submit to them. Only seek publication from reputable journals in which articles go through a peer-review process.
Find out what publishing fees the journals charge. Keep in mind that open-access journals tend to charge higher publishing fees. [26] X Research source
Read each journal's submission and editorial guidelines carefully. They'll tell you exactly how to format your case study, how long each section should be, and what citation style to use. [27] X Research source
For electronic journals that only publish case reports, try BMJ Case Reports , Journal of Medical Case Reports , or Radiology Case Reports .

Step 2 Submit your manuscript according to the journal's requirements.

If your manuscript isn't suitable for the journal you submitted to, the journal might offer to forward it to an associated journal where it would be a better fit.
When your manuscript is provisionally accepted, the journal will send it to other doctors for evaluation under the peer-review process.
Most medical journals don't accept simultaneous submissions, meaning you'll have to submit to your first choice, wait for their decision, then move to the next journal on the list if they don't bite.

Step 3 Revise your manuscript based on peer review comments.

Along with your revised manuscript, include a letter with your response to each of the reviewer's comments. Where you made revisions, add page numbers to indicate where the revisions are that address that reviewer's comments.
Sometimes, doctors involved in the peer review process will indicate that the journal should reject the manuscript. If that's the case, you'll get a letter explaining why your case study report won't be published and you're free to submit it elsewhere.

Step 4 Complete final copy-editing if the editors approve your article.

Some journals require you to have your article professionally copy-edited at your own cost while others do this in-house. The editors will let you know what you're responsible for.

Step 5 Pay the article processing charge if your article is accepted.

With your acceptance letter, you'll get instructions on how to make payment and how much you owe. Take note of the deadline and make sure you pay it as soon as possible to avoid publication delays.
Some journals will publish for free, with an "open-access option" that allows you to pay a fee only if you want open access to your article. [32] X Research source

Through the publishing agreement, you assign your copyright in the article to the journal. This allows the journal to legally publish your work. That assignment can be exclusive or non-exclusive and may only last for a specific term. Read these details carefully!
If you published an open-access article, you don't assign the copyright to the publisher. The publishing agreement merely gives the journal the right to publish the "Version of Record." [33] X Research source

How do I find a suitable case for a report?

Step 1 Keep your eye out for unusual or interesting cases.

A rare disease, or unusual presentation of any disease
An unusual combination of diseases or conditions
A difficult or inconclusive diagnosis
Unexpected developments or responses to treatment
Personal impact
Observations that shed new light on the patient's disease or condition

Step 2 Discuss possible cases with your medical team.

There might be other members of your medical team that want to help with writing. If so, use one of these brainstorming sessions to divvy up writing responsibilities in a way that makes the most sense given your relative skills and experience.
Senior doctors might also be able to name some journals that would potentially publish your case study. [36] X Research source

Expert Q&A

↑ https://www.elsevier.com/connect/authors-update/the-dos-and-donts-of-writing-and-publishing-case-reports
↑ https://www.bmj.com/content/350/bmj.h2693
↑ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5686928/
↑ https://health.usf.edu/medicine/internalmedicine/im-impact/~/media/B3A3421F4C144FA090AE965C21791A3C.ashx
↑ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2597880/
↑ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6476221/
↑ https://www.springer.com/gp/authors-editors/authorandreviewertutorials/writing-a-journal-manuscript/title-abstract-and-keywords/10285522
↑ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2597880/
↑ https://thelancet.com/pb/assets/raw/Lancet/authors/tl-info-for-authors.pdf
↑ https://jmedicalcasereports.biomedcentral.com/articles/10.1186/s13256-017-1351-y
↑ https://guides.himmelfarb.gwu.edu/casereports
↑ https://casereports.bmj.com/pages/authors/
↑ https://jmedicalcasereports.biomedcentral.com/articles/10.1186/1752-1947-7-239
↑ https://research.chm.msu.edu/students-residents/writing-a-case-report
↑ https://authorservices.taylorandfrancis.com/publishing-your-research/moving-through-production/copyright-for-journal-authors/#

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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

Open access
Published: 27 November 2013

A guide to writing case reports for the Journal of Medical Case Reports and BioMed Central Research Notes

Richard A Rison 1

Journal of Medical Case Reports volume 7 , Article number: 239 ( 2013 ) Cite this article

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Case reports are a time-honored, important, integral, and accepted part of the medical literature. Both the Journal of Medical Case Reports and the Case Report section of BioMed Central Research Notes are committed to case report publication, and each have different criteria. Journal of Medical Case Reports was the world’s first international, PubMed-listed medical journal devoted to publishing case reports from all clinical disciplines and was launched in 2007. The Case Report section of BioMed Central Research Notes was created and began publishing case reports in 2012. Between the two of them, thousands of peer-reviewed case reports have now been published with a worldwide audience. Authors now also have Cases Database, a continually updated, freely accessible database of thousands of medical case reports from multiple publishers. This informal editorial outlines the process and mechanics of how and when to write a case report, and provides a brief look into the editorial process behind each of these complementary journals along with the author’s anecdotes in the hope of inspiring all authors (both novice and experienced) to write and continue writing case reports of all specialties. Useful hyperlinks are embedded throughout for easy and quick reference to style guidelines for both journals.

Peer Review reports

Introduction: the importance of case reports

Case reports are a time-honored tradition in the medical profession. From Hippocrates (460 B.C. to 370 B.C.), and even arguably further back since the papyrus records of ancient Egyptian medicine (c. 1600 B.C.) to modern day, physicians of all specialties have described interesting cases involving all specialties [ 1 , 2 ]. Published case reports provide essential information for optimal patient care because they can describe important scientific observations that are missed or undetected in clinical trials, and provide individual clinical insights thus expanding our knowledge base [ 3 ].

The publication of case reports has indeed become a standard lexicon of the medical literature. Examples abound. Few practicing physicians would not know for instance the significance and subsequent discovery of a disease whose first description in 1981 began with the title in the medical case report literature as: “A preliminary communication on extensively disseminated Kaposi’s sarcoma in a young homosexual man” [ 4 ]. There is no neurologist that I know who is unfamiliar with the disease whose description began in 1817 by James Parkinson (1755 to 1824) with the title “An essay on the shaking palsy.” [ 5 ].

Yes, both of the above-mentioned famous diseases (the acquired immunodeficiency syndrome and Parkinson’s disease) were first described in the case study format. The act of recording, discussion with colleagues, and publishing our clinical observations with patients remains essential to the art of medicine and patient care. As Osler once said “Always note and record the unusual…Publish it. Place it on permanent record as a short, concise note. Such communications are always of value.” [ 6 ].

But how and when should we do this? Early case reports were little more than personal communications between colleagues about unique and interesting patients seen in their respective medical practices. This anecdotal reporting has evolved into an accepted form of scholarly publication with the ability to rapidly disseminate knowledge to a broad medical audience [ 7 ] using the generally accepted format of a title, abstract, introduction (background), case presentation, discussion, conclusions, and references. Many biomedical journals publish case reports and provide authors with guidelines that provide instruction for acceptance criteria, content, and format and give advice on relevant patient case reports that merit publication [ 3 ].

There are already many well-written published articles on how and when to write a good case report (please see Recommended further reading section at the end). I will not re-invent the wheel, but within this editorial I hope to provide an informal guide on how and when to write a case report for BioMed Central (BMC), in particular the Journal of Medical Case Reports ( JMCR ) and BioMed Central Research Notes ( BMCRN ). The utility of the newly created Cases Database will also be discussed. Relevant and useful website links will be used throughout to allow the reader easy access to further information on BMC requirements. I also hope to impart to the reader a brief overview of case report editorial flow in both JMCR and BMCRN along with the complementary relationship between both journals. I will also give anecdotes of how I personally approach things.

Definitions

What exactly is a case report? From peer-reviewed journals to Wikipedia (and yes, I read Wikipedia like we all do) definitions are readily available and generally agreed upon. A simple online search shows the following definition from “thefreedictionary.com” [ 8 ]: “Case Report A report of a single case of a disease, usually with an unexpected presentation, which typically describes the findings, clinical course, and prognosis of the case, often accompanied by a review of other cases previously reported in the biomedical literature to put the reported case in context.” Wikipedia [ 9 ] has this to say: “In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.” Whether one uses the above definitional references or older more classic ones [ 10 ], all are in agreement.

How to start: the patient

Things start at the bedside or in the office with the most important person involved: the patient. Patients and their stories (including from their friends, coworkers, and family) are our portal to writing the case report. Patients (both in-patients and out-patients) are assessed, we confer with colleagues, appropriate investigations then follow, and treatment if possible begins. If I encounter an in-patient on call then I follow him or her throughout his or her hospitalization and, I hope, timely discharge. The patient is then followed and reexamined in the office over the course of time to see how the clinical course evolves. I usually wait 6 months over the course of multiple visits before I actually begin to write a case report so as to allow enough time for the clinical course to play out. Of course if the patient is hospitalized with an acute and rapid illness then this time may be much shorter, but I still follow him or her with daily neurologic examinations.

Collegial discussion and the Internet: our modern day water cooler

When an interesting condition is encountered in either the hospital or the office setting, I discuss the case in person with both my local neurology colleagues and colleagues of other specialties to see if they have encountered before the clinical scenario that I am dealing with at the time. This is usually a quick face-to-face nursing station conversation. If the case is particularly challenging then I will contact my local university colleagues for their opinion (especially if an urgent transfer needs to be arranged). I then “hit the books”, or at least I used to. Nowadays I usually “hit the keyboards” which are plentiful at every hospital nursing station and in my office. Indeed, the Internet seems to have become our modern day replacement for office water cooler conversations. Since it is readily available (and free to me because I am a member of the staff) in the hospital in which I see patients and in my office, I usually start with UpToDate® [ 11 ] and then click the links to individual references. Further reading is then supplemented by both PubMed [ 12 ] (free) and Cases Database (also free) [ 13 ] (see later). If I feel that a particular patient warrants a case report, then I continue to read more and more. There are also medical list servers and medical online communities to which one can post a case with de-identified images online and petition the advice of colleagues worldwide. I use both Neurolist [ 14 ] (a membership-only service, but membership is free) and The American Academy of Neurology (AAN) for my specialty and/or subspecialties [ 15 ] (also a membership-only service, the fee of which comes out of my yearly AAN dues). Another useful list server is sermo® [ 16 ], which has free membership. Teaching grand rounds at one’s local university or hospital, poster presentations, and simple discussion with professors giving lectures at local seminars are also good (and previously “traditional”) places to start. I have always preferred an in-person encounter to discuss a case with a colleague or professor, but given the current day and age (daily workload, travel costs, time away from the office and family, and so on), I have found Internet-based discussion (keeping all patient information anonymous of course) very helpful.

The BMC series, JMCR , and BMCRN : a brief history

The BMC series is a group of open access, peer-reviewed journals that spans most areas of biological and clinical research. There are currently 65 journals in the series, including (alphabetically) BMC Anesthesiology to BMC Women’s Health. Some of these publish case reports within their respective disciplines, and some do not [ 17 ].

JMCR is an online, open access journal under BMC auspices dedicated mainly to the publication of high quality case reports, and aims to contribute to the expansion of current medical knowledge (please see specific publication criteria below). It was created and founded by Michael Kidd and colleagues in 2007 and at the time was believed to be the world’s first international medical journal devoted to publishing case reports from all clinical disciplines. In the 5 years since its launch, JMCR has published over 2000 case reports. In 2011, case reports were downloaded from the journal’s website over 1,500,000 times [ 18 ].

BMCRN is also an online, open access journal under BMC auspices publishing scientifically sound research across all fields of biology and medicine. The journal provides a home for short publications, case series, and incremental updates to previous work with the intention of reducing the loss suffered by the research community when such results remain unpublished. BMCRN began publishing case reports in 2012 and now has a dedicated section for case reports [ 19 ].

Please read on to see the complementary relationship of case reporting between the two journals, how they relate to other journals in the BMC series, and further information on editorial work flow including specific publication criteria.

Cases Database: an invaluable resource

Since the launch of JMCR in 2007 and the more recent introduction of case reports to the BMCRN , which aims to have a broader scope, BMC has acknowledged and continues to acknowledge the value of case reports to the scientific literature. To further strengthen this commitment, BMC in conjunction with Michael Kidd have developed the invaluable new resource of Cases Database, a continually updated, freely accessible database of thousands of medical case reports from multiple other publishers, including Springer, British Medical Journal, and PubMed Central. By aggregating case reports and facilitating comparison, Cases Database provides a simple resource to clinicians, researchers, regulators and patients to explore content and identify emerging trends [ 20 ].

http://www.casesdatabase.com/

I find Cases Database indispensable when I research a particular patient’s condition. It is very helpful in seeing if a particular condition has been reported before and what treatment the authors have performed. It is an invaluable resource which can be used to check and see if previous cases have been reported before and how other authors have managed their patients with similar clinical conditions. When I last checked, Cases Database had in its repository 27,915 peer-reviewed medical case reports from 250 journals (!) [ 13 ]. Cases Database is quickly becoming my first go to when reading about a patient’s condition and symptoms.

When to write a case report

How does one determine when to write an actual case report? What constitutes and what are the criteria for publication? Different journals have different criteria, but here are the criteria for JMCR and BMCRN .

JMCR [ 21 ] publishes original and interesting case reports that contribute significantly to medical knowledge. Manuscripts must meet one of the following criteria: unreported or unusual side effects or adverse interactions involving medications; unexpected or unusual presentations of a disease; new associations or variations in disease processes; presentations, diagnoses and/or management of new and emerging diseases; an unexpected association between diseases or symptoms; an unexpected event in the course of observing or treating a patient; findings that shed new light on the possible pathogenesis of a disease or an adverse effect.

http://www.jmedicalcasereports.com/authors/instructions/casereport

BMCRN [ 22 ] has somewhat different publication criteria: BMCRN considers medical case reports that describe any clinical case. Case reports submitted to BMCRN do not need to be novel, but must be authentic cases and have some educational value along with representing at least an incremental advance in the field. BMCRN will not consider case reports describing preventive or therapeutic interventions because these generally require stronger evidence.

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport

Neither BMCRN nor JMCR will consider case reports where there are ethical concerns.

JMCR and BMCRN have the following definitions that authors should know: a single case report, two case reports, or a case series (greater than two reported cases). Both journals follow this format and accept submissions with these title structures.

I tend to classify case reports in my mind generally as follows: diagnosis-related, management-related, or both [ 10 ]. Either type should have clear and concise take-home messages and teaching points. I personally keep a stack of charts labeled “Curious Cases” on a bookshelf within my small office next to my desk which is always within my field of view at work, adhering to the “out of sight, out of mind” principle. Over the years that space has grown and, admittedly, I have cases dating back over the entire span of my years in practice (now over 13 years) which I simply have not gotten around to yet (!).

BMC editorial workflow for case reports: a brief glimpse

If a BMC Series journal editorial team considers a submitted case report unsuitable for their respective specialty journal (and now a growing list of Springer journals that BMC is now affiliated with), the authors are given the option to transfer their manuscript to BMCRN . If this option is exercised, then the BMC editorial team (usually the Case Report Section Editor for BMCRN in conjunction with the appropriate Associate Editor) determines if the manuscript is suitable for BMCRN or if it is more suitable for JMCR (based on the criteria listed above). The manuscripts will then be forwarded on to the respective Deputy and/or Associate Editors for peer review depending on which of the journals the author(s) agree(s) to. Peer reviewers are solicited (usually at least one at BMCRN and at least two at JMCR ). The peer review comments (which are open and identifiable at JMCR and blinded at BMCRN ) are then usually sent to the authors for appropriate revisions and rebuttals (unless it is felt that the manuscript should be rejected outright, at which time the editorial office sends the authors an explanatory letter). After these revisions and rebuttals have been performed, the revised manuscript and rebuttals are sent back to the respective editors for a final decision and recommendations. These decisions and recommendations are then forwarded on to the Editor-in-Chief for final approval for publication. At JMCR , manuscripts are professionally copyedited before being sent off to the production team for publication, whereas at BMCRN the authors are requested to obtain their own professional copyediting (if needed) before publication (the respective costs being reflected within the different article processing charges for both journals). When the manuscripts are published in both journals, they are in the preliminary form before being converted to the final form after production.

Author satisfaction consistently ranks high for the overall process in both journals.

The actual case report

Now let us discuss the brass tacks of writing the actual case report by going through the individual sections that will comprise the manuscript. I will present them in a sequence that matches the journals’ website requirements and provide easily accessible hyperlinks to both respective journals.

The first page of the manuscript should be a dedicated title page, including the title of the article. The title should be a clear and short description of the case with a list of the full names, institutional addresses and email addresses for all authors. There should always be at least one corresponding author who is clearly identified. Abbreviations within the title should always be avoided.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-title

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#title

I usually end the title with “…: a case report” or “…: two case reports” or “…: a case series”. I also try to avoid any puns or overly cute wording within the title and try to keep things strictly descriptive and clear. The title needs to accurately describe the case – after all, this may be all that someone reads. If a cute or clever title is used that obscures what the case is really about, then it may be even less likely that the manuscript is read.

The Abstract should be “short and sweet”. It should not exceed 350 words. Abbreviations or references within the Abstract should not be used. The Abstract should be structured into three sections: Background, an introduction about why this case is important and needs to be reported. Please include information on whether this is the first report of this kind in the literature; Case presentation, brief details of what the patient(s) presented with, including the patient’s age, sex and ethnic background; Conclusions, a brief conclusion of what the reader should learn from the case report and what the clinical impact will be. Is it an original case report of interest to a particular clinical specialty of medicine or will it have a broader clinical impact across medicine? Are any teaching points identified?

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-abstract

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#abstract

I find this is the most important part because this is often all that people will read and its availability will allow easy retrieval from electronic databases and help researchers decide their level of interest in the case report. The Abstract should be a concise and condensed version of the case report and should include the same main sections of the main text and be as succinct as possible [ 3 ]. This is the last thing that I usually write as it tends to flow easily after I have invested my time in thought and writing of the manuscript.

This section is comprised of three to ten keywords representing the main content of the article. It is important for indexing the manuscript and easy online retrieval.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-keywords

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-keywords

Introduction (Background)

The Introduction ( JMCR ) or Background ( BMCRN ) section should explain the background of the case, including the disorder, usual presentation and progression, and an explanation of the presentation if it is a new disease. If it is a case discussing an adverse drug interaction the Introduction should give details of the drug’s common use and any previously reported side effects. It should also include a brief literature review. This should give an introduction to the case report from the standpoint of those without specialist knowledge in the area, clearly explaining the background of the topic. It should end with a very brief statement of what is being reported in the article.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-intro

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#background

The Introduction or Background serves as the sales pitch for the rest of the manuscript. It should be concise and salient [ 3 ] and immediately attract the reader’s attention to entice him or her to read on.

Case presentation

This should present all relevant details concerning the case. The Case presentation section should contain a description of the patient’s relevant demographic information (without adding any details that could lead to the identification of the patient); any relevant medical history of the patient; the patient's symptoms and signs; any tests that were carried out and a description of any treatment or intervention. If it is a case series, then details must be included for all patients. This section may be broken into subsections with appropriate subheadings.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-case

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#presentation

This is one of the most integral sections. The case should be described in a concise and chronological order. One should usually begin with the primary complaint, salient history (including significant family, occupational, and other social history along with any significant medications taken or allergies), followed by the physical examination, starting with the vital signs presented at the examination, along with pertinent investigations and results. There should be enough detail (but not too much) for the reader to establish his or her own conclusions about the validity. It should contain only pertinent information and nothing superfluous or confusing [ 3 ].

This is an optional section in JMCR for additional comments that provide additional relevant information not included in the case presentation, and that put the case in context or that explain specific treatment decisions.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-discussion

This section should evaluate the patient case for accuracy, validity, and uniqueness and compare and contrast the case report with the published literature. The authors should briefly summarize the published literature with contemporary references [ 3 ].

Although this section is optional in JMCR (and not even listed separately on the BMCRN guidelines website), I find that most authors write this section, or an expanded conclusions section incorporating the elements listed above.

I personally write a separate discussion section and conclusions section for each case report that I author.

Conclusions

This should state clearly the main conclusions of the case report and give a clear explanation of their importance and relevance. Is it an original case report of interest to a particular clinical specialty of medicine or will it have a broader clinical impact across medicine? Information should be included on how it will significantly advance our knowledge of a particular disease etiology or drug mechanism (if appropriate).

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-conclusion

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#conclusions

This should be short and concise with clear take-home messages and teaching points [ 3 ].

Patient’s perspective

This section is an opportunity for patients to add a description of a case from their own perspective. The patients should be encouraged to state what originally made them seek medical advice, give a description of their symptoms, whether the symptoms were better or worse at different times, how tests and treatments affected them, and how the problem is now. This section can be written as deemed appropriate by the patients, but should not include identifying information that is irrelevant to the case reported. As medicine becomes more person-centered, the voice of the individual patient becomes even more important, both to assist in clinical decision making, and for medical education.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-patients

This optional section is unique to JMCR , and I believe adds an important new dimension to the traditional case report. Most authors still do not yet take advantage of this, but I hope as time goes on and more and more open access case report manuscripts are published that this section will be routinely used, not just in JMCR but also in BMCRN and all other BMC clinical journals. I recall one manuscript in particular where the patient himself was requesting publication as soon as possible because of his terminal disease. He wanted his message out there and be available to all to read before he died.

List of abbreviations

When abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations can be provided, which should precede the Competing interests and Authors’ contributions sections.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-abbreviations

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-abbreviations

Both JMCR and BMCRN publish case reports over a wide range of medical and surgical specialties, and it is important for the reader who may not be within that particular specialty to readily access a quick list of commontechnical abbreviations. Also, given the open access nature of both journals, please keep in mind that nonmedical professionals may read the manuscript as well.

This section is compulsory for BMC. It should provide a statement to confirm that the patient has given their informed consent for the case report to be published. The written consent should not routinely be sent in along with the manuscript submission (because of patient privacy issues), but the BMC editorial office may request copies of the consent documentation at any time. The following wording is recommended: “Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal.” If the individual described in the case report is a minor, or unable to provide consent, then consent must be sought from his or her parents or legal guardians. In these cases, the statement in the ‘Consent’ section of the manuscript should be amended accordingly. Please keep in mind that manuscripts will not be peer reviewed if a statement of patient consent is not present.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-consent

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#consent

In practice, I always start with written consent from the patient. If the patient is incapacitated or deceased, then I obtain consent from the patient’s next-of-kin. Once this is obtained then I place it in the patient’s chart for safe keeping. I find that most patients and family members are quite agreeable to publication as long as their details are anonymous. BMC has very clear and explicit consent criteria and consent forms in multiple languages. I always keep a consent form within my office (and carry a few in my doctor’s handbag for hospital consults) for ready access. After I have obtained consent, I place it in the patient’s chart and keep it my office.

If the patient has died, then I try to obtain consent from the patient’s next-of-kin. This is usually done via telephone or postal mail. If the deceased patient’s family is amenable (and usually they are), then I send them (I never use email when it comes to patient-identifying information) the pre-filled out consent form in their language with a return envelope and paid for postage via the postal service. If I am unable to obtain consent this way in a case involving a patient who has died, then I write in the Consent section the following: “Written informed consent could not be obtained from the deceased patient’s next-of-kin for publication of this case report and accompanying images despite all reasonable attempts. Every effort has been made to protect the patient’s identity and there is no reason to believe that our patient would have objected to publication.”

If the patient was last known to be living but untraceable (or mentally incapacitated without next-of-kin consent), then I just simply do not publish the case.

For further information, please see JMCR and BMCRN website consent section hyperlinks as listed above.

Authors’ information

This section includes any relevant information about the author(s) that may aid the reader’s interpretation of the article and understanding of the standpoint of the author(s). This may include details about the authors’ qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-information

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-information

In practice, I have frankly also personally used this section to advertise my services and “tout” my certifications and subspecialties (along with any co-authors and affiliated institutions) to my surrounding local community. This has in turn given me a modest increase in business (which has been completely non-monetary to date), usually in the form of email-based queries, many of which come from patients outside of my locality.

Acknowledgements

Authors should acknowledge anyone who contributed towards the article by making substantial contributions to conception, design, acquisition of data, or analysis and interpretation of data, or who was involved in drafting the manuscript or revising it critically for important intellectual content, but who does not meet the criteria for authorship. Also included should be the source(s) of funding for each author, and for the manuscript preparation. Authors must describe the role of the funding body, if any, in the: design, collection, analysis, and interpretation of data; writing of the manuscript; and decision to submit the manuscript for publication. Please also acknowledge anyone who contributed materials essential for the study. If a language editor has made significant revision of the manuscript, I recommend that you acknowledge the editor by name, where possible. Authors may also like to acknowledge (anonymously) the patient on whom the case report is based. If a scientific (medical) writer is used, this person should be included in the Acknowledgements section, including their source(s) of funding. Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-acknowledgements

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-acknowledgements

I have had colleagues who do not want to participate in the actual writing of the manuscript or do any actual “work” who have instead preferred to be mentioned in this section only.

Authors must search for and cite published case reports that are relevant to the case they are presenting. There should be no more than 15 references usually, although BMC does publish manuscripts with more references particularly if there is an extended literature review. Unless it is of historic interest, please keep the references as contemporary as feasible (for example, within the last 5 years or so). Please avoid excessive referencing.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-references

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-references

Cover letter

This is a separate document that should be written and uploaded with the main manuscript submission. I usually write this after I have written the Abstract. The cover letter should be addressed to the Editor-in-Chief in a formal manner and include all of the authors’ contact information. It should clearly and concisely state the title of the manuscript, and why the authors feel that their case report should be published based on any already available literature on the topic at hand. From an editor’s viewpoint, the cover letter is exceptionally important as that is the first thing that he or she reads and serves as the gateway to the Abstract and then the rest of the manuscript.

BMC author academy: help for all

Both JMCR and BMCRN have a large number of non-native English-speaking authors. Since JMCR and BMCRN are both BMC publications whose editorial offices are based in England, the language of publication is of course English. The BMC author academy is a joint program by BMC and Edanz [ 23 ] aimed at equipping writers for successful publication. Their materials have been developed from training workshops that Edanz gives to researchers worldwide and are not just limited to case reports. BMC recommends Edanz for authors who want to have their manuscript edited by a native speaker of English who is a scientific expert. Edanz provides scientific editing and related services that raise the quality of manuscripts to the standard needed to be understood at peer review.

http://www.biomedcentral.com/authors/authoracademy

I find that most non-native English-speaking authors have their manuscripts reviewed informally by a native English-speaking colleague and/or friend who is usually mentioned within the Acknowledgements section. This is understandable to keep costs down. However, please be aware that poor grammar and frequent spelling mistakes can be an impediment to editorial work flow and peer review. The editorial staff for both JMCR and BMCRN are acutely aware and sensitive to this given the large number of international submissions. At both JMCR and BMCRN , submitted manuscripts with questionable grammar and spelling are returned back to the authors by the editorial staff if it is felt that the grammar and spelling mistakes would impede peer review. If these issues are minor and it is felt that they would not impede peer review, then the manuscripts are sent off to peer reviewers (when appropriate).

Final checklist and the rule of C s

After I have completed a case report, I like to run through my long-winded (but useful) “rule of Cs” which is as follows.

Is it C lear, C oncise, and C oherent? Does it C onvey your message? Have you used C ases Database to look for any previously similar reported cases, and included them, if appropriate, in your references? Have you C onferred with your C olleagues on the C ontent? Will it C ause the reader to be C urious? Did you obtain C onsent? Does it C ontain all of the necessary information? Does it C omply with BM C guidelines? Do you think that it may need C opyediting? Do your C o-authors C oncur with the C ompleted paper? C an you C ut anything unnecessary out? Are your findings likely to be a C oincidence or by C hance alone? If so, then mention this in the Discussion section. Is the writing style C onsistent? Many times I find co-authored manuscripts have different writing styles within the same paper depending on who wrote what section. There should be a C entral, C orresponding author who is in C harge and oversees all of this. Is the C ase report written in a C hronological fashion with respect to the patient’s history and C hain of events? Is there anything that can be C ut out and have it still C ontain the C ompulsory information? Is it C oncise? Have you C onveyed C uriosity for your C ase report within your C over letter to the editorial team? Remember: your C over letter is the sales pitch to the editorial team! Make it C ount! Have you used within the manuscript C opyrighted information from another source? If so, do you need and/or have permission for use? After C ompletion, wait a C ouple of days before final submission to C lear your mind and read the manuscript again to C atch any mistakes that you may have made while you were C aught up in the C ompletion of it. Are the references C ontemporary? C an it be C omprehended by the average (“ C ”) reader? Remember, both JMCR and BMCRN are open access and freely available to anyone with an Internet C onnection and C omputer. C ast as wide a net as possible and C apture your C olleagues’ and other readers’ C uriosity. And first and foremost as a C linician: was the C are of your patient C ompetent and C ompassionate? (that is, are there any ethical concerns that may preclude peer review and publication?).

Summary and parting advice

Case reporting can be fun and a lifelong hobby, both for novice and experienced authors alike. It is now integral and widely accepted within published medical literature and today’s electronic information and data-sharing age. By following the above recommended steps and general overview, I hope to encourage BMC authors to continue to write and submit manuscripts to both JMCR and BMCRN . After your manuscript is complete, please follow the rule of “Cs”, especially “ C lear, C oncise, C oherent, C onsent, C ompassion, and C ompetence”, which will be appreciated by both reviewers and editors. Do not be afraid to obtain help from native English speakers for your manuscript. Also, please adhere to deadlines and follow instructions given by the editorial office, especially regarding any revisions. Editors read many different manuscripts and the longer it takes to get back a manuscript after revisions have been requested the less fresh that manuscript is in mind. Lastly, consider volunteering as an Associate Editor and/or reviewer within your specialty for both journals. I do for both, and the experience has improved both my writing and editing skills and daily interactions with patients.

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Additional information

Competing interests.

A competing interest exists when one’s interpretation of data or presentation of information may be influenced by a personal or financial relationship with other people or organizations. Authors must disclose any financial competing interests and should also reveal any non-financial competing interests that may cause embarrassment were they to become public after the publication of the manuscript. Authors are required to complete a declaration of competing interests. All competing interests that are declared will be listed at the end of published article. Where an author gives no competing interests, the listing should read “The author(s) declare that they have no competing interests”.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-competing

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-competing

I do not usually find any problems with competing interests in the case reports that I publish, but the section should always be completed in our era and in the spirit of complete disclosure.

Authors’ contributions

In order to give appropriate credit to each author of a paper, the individual contributions of authors to the manuscript should be specified in this section.

An ‘author’ is generally considered to be someone who has made substantive intellectual contributions to a published study. To qualify as an author one should: 1) have made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) have been involved in drafting the manuscript or revising it critically for important intellectual content; and 3) have given final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship. All contributors who do not meet the criteria for authorship should be listed in an Acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-contributions

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-contributions

I have found over the years a trend towards multi-authored case report manuscripts by many different individuals involved in the care of a patient(s). In my setting, it is usually me, a medical student or resident, a second-opinion tertiary colleague, and/or a pathologist or radiologist (if applicable). But I also recognize that there are situations that warrant more co-authors. The above criteria though for co-authorship should always be followed, and I have seen editorial situations where peer reviewers (including Associate Editors) have questioned what they felt was excessive authorship.

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Rison, R.A. A guide to writing case reports for the Journal of Medical Case Reports and BioMed Central Research Notes . J Med Case Reports 7 , 239 (2013). https://doi.org/10.1186/1752-1947-7-239

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DOI : https://doi.org/10.1186/1752-1947-7-239

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Case Report: A Beginner’s Guide with Examples

A case report is a descriptive study that documents an unusual clinical phenomenon in a single patient. It describes in details the patient’s history, signs, symptoms, test results, diagnosis, prognosis and treatment. It also contains a short literature review, discusses the importance of the case and how it improves the existing knowledge on the subject.

A similar design involving a group of patients (with the similar problem) is referred to as case series.

Advantages of case reports

Case reports offer, in general a fast, easy and cheap way to report an unusual observation or a rare event in a clinical setting, as these have very small probability of being detected in an experimental study because of limitations on the number of patients that can be included.

These events deserve to be reported since they might provide insights on some exceptions to general rules and theories in the field.

Case reports are great to get first impressions that can generate new hypotheses (e.g. detecting a potential side effect of a drug) or challenge existing ones (e.g. shedding the light on the possibility of a different biological mechanism of a disease).

In many of these cases, additional investigation is needed such as designing large observational studies or randomized experiments or even going back and mining data from previous research looking for evidence for theses hypotheses.

Limitations of case reports

Observing a relationship between an exposure and a disease in a case report does not mean that it is causal in nature.

This is because of:

The absence of a control group that provides a benchmark or a point of reference against which we compare our results. A control group is important to eliminate the role of external factors which can interfere with the relationship between exposure and disease
Unmeasured Confounding caused by variables that influence both the exposure and the disease

A case report can have a powerful emotional effect (see examples of case reports below). This can lead to overrate the importance of the evidence provided by such case. In his book Against Empathy: The Case for Rational Compassion , Paul Bloom explains how a powerful story affects our emotions, can distort our judgement and even lead us to make bad moral choices.

When a case report describes a rare event it is important to remember that what we’re reading about is exceptional and most importantly resist generalizations especially because a case report is, by definition, a study where the sample is only 1 patient.

Selection bias is another issue as the cases in case reports are not chosen at random, therefore some members of the population may have a higher probability of being included in the study than others.

So, results from a case report cannot be representative of the entire population.

Because of these limitations, case reports have the lowest level of evidence compared to other study designs as represented in the evidence pyramid below:

Pyramid representing the levels of evidence for each study design

Real-world examples of case reports

Example 1: normal plasma cholesterol in an 88-year-old man who eats 25 eggs a day.

This is the case of an old man with Alzheimer’s disease who has been eating 20-30 eggs every day for almost 15 years. [ Source ]

The man had an LDL-cholesterol level of only 142 mg/dL (3.68 mmol/L) and no significant clinical atherosclerosis (deposition of cholesterol in arterial walls)!

His body adapted by reducing the intestinal absorption of cholesterol, lowering the rate of its synthesis and increasing the rate of its conversion into bile acid.

This is indeed an unusual case of biological adaptation to a major change in dietary intake.

Example 2: Recovery from the passage of an iron bar through the head

This is an interesting case of a construction foreman named Phineas Gage. [ Source ]

In 1848, due to an explosion at work, an iron bar passed through his head destroying a large portion of his brain’s frontal lobe. He survived the event and the injury only affected 1 thing: His personality!

After the accident, Gage became profane, rough and disrespectful to the extent that he was no longer tolerable to people around him. So he lost his job and his family.

His case inspired further research that focused on the relationship between specific parts of the brain and personality.

Sayre JW, Toklu HZ, Ye F, Mazza J, Yale S. Case Reports, Case Series – From Clinical Practice to Evidence-Based Medicine in Graduate Medical Education . Cureus . 2017;9(8):e1546. Published 2017 Aug 7. doi:10.7759/cureus.1546.
Nissen T, Wynn R. The clinical case report: a review of its merits and limitations . BMC Res Notes . 2014;7:264. Published 2014 Apr 23. doi:10.1186/1756-0500-7-264.

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

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

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What is it?

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

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

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

Benefits and limitations of case studies

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

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

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

Examples of case studies

Example 1: nurses’ paediatric pain management practices.

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

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

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

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

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

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

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

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

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

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

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

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

Gustafsson J
Calanzaro M
Sandelowski M

Competing interests None declared.

Provenance and peer review Commissioned; internally peer reviewed.

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Mary Ni Lochlainn , foundation year 2 doctor 1 ,
Ibrahim Balogun , healthcare of older people/stroke medicine consultant 1
1 East Kent Foundation Trust, UK

A guide on how to structure a case presentation

This article contains...

-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

-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 …

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How to Write a Nursing Case Study Paper (A Guide)

Most nursing students dread writing a nursing case study analysis paper, yet it is a mandatory assignment; call it a rite of passage in nursing school. This is because it is a somewhat tricky process that is often overwhelming for nursing students. Nevertheless, by reading this guide prepared by our best nursing students, you should be able to easily and quickly write a nursing case study that can get you an excellent grade.

How different is this guide from similar guides all over the internet? Very different!

This guide provides all the pieces of information that one would need to write an A-grade nursing case study. These include the format for a nursing case study, a step-by-step guide on how to write a nursing case study, and all the important tips to follow when writing a nursing case study.

This comprehensive guide was developed by the top nursing essay writers at NurseMyGrade, so you can trust that the information herein is a gem that will catapult your grades to the next level. Expect updates as we unravel further information about writing a nursing case study.

Now that you know youâ€™ve discovered a gold mine , letâ€™s get right into it.

What Is a Nursing Case Study?

A nursing case study is a natural or imagined patient scenario designed to test the knowledge and skills of student nurses. Nursing case study assignments usually focus on testing knowledge and skills in areas of nursing study related to daily nursing practice.

As a nursing student, you must expect a nursing case study assignment at some point in your academic life. The fact that you are reading this post means that point is now.

While there is no standard structure for writing a nursing case study assignment, some things or elements must be present in your nursing assignment for your professor to consider it complete.

In the next section, you will discover what your instructor n expects in your nursing case study analysis. Remember, these are assignments where you are given a case study and are expected to write a case analysis report explaining how to handle such scenarios in real-life settings.

The Nursing Case Study Template

The typical nursing case study has nine sections. These are:

Introduction
Case presentation (Patient info, history, and medical condition)
Diagnosis/Nursing assessment
Intervention/Nursing care plan
Discussion and recommendations

The Structure of a Nursing Case Study Analysis

You now know what nursing professors expect in a nursing case study analysis. In this section, we will explain what to include in each section of your nursing case study analysis to make it an excellent one.

1. Title page

The title page is essential in all types of academic writing. You must include it in your nursing case study analysis or any other essay or paper. And you must include it in the format recommended by your college.

If your college has no specific title page format, use the title page format of the style requested in the assignment prompt. In nursing college, virtually all assignments should be written in Harvard or APA format .

So, check your assignment prompt and create your title page correctly. The typical title page should include the topic of your paper, your name, the name of your professor, the course name, the date you are submitting the paper, and the name of your college.

2. Abstract

Most nursing professors require you to include an abstract in your nursing case study analysis. And even when you are not explicitly required to write one, it is good to do so. Of course, you should consult with your professor before doing so.

When writing an abstract for your paper, make sure it is about 200 words long. The abstract should include a brief summary of the case study, including all the essential information in the patient presentation, such as the history, age, and current diagnosis.

The summary should also include the nursing assessment, the current interventions, and recommendations.

3. Introduction

After writing the title page and the abstract, start writing the introduction. The introduction of a nursing case study analysis must briefly include the patientâ€™s presentation, current diagnosis and medication, and recommendations. It must also include a strong thesis statement that shows what the paper is all about.

You shouldnâ€™t just write an introduction for the sake of it. If you do so, your introduction will be bland. You need to put in good effort when writing your introduction. The best way to do this is to use your introduction to show you understand the case study perfectly and that you will analyze it right.

You can always write your introduction last. Many students do this because they believe writing an introduction last makes it more precise and accurate.

4. Case Presentation (Status of the Patient)

After introducing your nursing case study analysis, you should present the case where you outline the patient's status. It is usually straightforward to present a case.

You must paraphrase the patient scenario in the assignment prompt or brief. Focus on the demographic data of the patient (who they are, age, race, height, skin tone, occupation, relationships, marital status, appearance, etc.), why they are in the case study or scenario, reasons they sought medical attention, chief complaint, and current diagnosis and treatment. You should also discuss the actions performed on the patient, such as admission to the ICU, taking vital signs, recommending tests, etc.

In short, everything necessary in the patient scenario should be in your case presentation. You only need to avoid copying the patient scenario or case study word-for-word when writing your case presentation.

5. Diagnosis and Assessment

After the case presentation, you should explain the diagnosis. In other words, you should explain the condition, disease, or medical situation highlighted in the case presentation. For example, if the patient is a heavy smoker and he has COPD, it is at this point that you explain how COPD is linked to heavy smoking.

This is the section where you thoroughly discuss the disease process (pathophysiology) by highlighting the causes, symptoms, observations, and treatment methods. You should relate these to the patientâ€™s status and give concrete evidence. You should describe the progression of the disease from when the client was admitted to a few hours or days after they were stabilized. Consider the first indication of the disease that prompted the patient to seek further medical assistance.

Your paper should also elucidate the diagnostic tests that should be conducted and the differential diagnosis. Ensure that each is given a well-founded rationale.

When explaining the condition, go deep into the pathophysiology. Focus specifically on the patientâ€™s risk factors. Ensure you get your explanation from recent nursing literature (peer-reviewed scholarly journals published in the last 5 years). And do not forget to cite all the literature you get your facts from.

In short, this section should explain the patientâ€™s condition or suffering.

6. Nursing Intervention

After the diagnosis and nursing assessment section, your nursing case study analysis should have an intervention section. This section is also known as the nursing care planning section. What you are supposed to do in this section is to present a nursing care plan for the patient presented in the patient scenario. You should describe the nursing care plan and goals for the patient. Record all the anticipated positive changes and assess whether the care plan addresses the patient's condition.

A good nursing care plan details the patientâ€™s chief complaints or critical problems. It then describes the causes of these problems using evidence from recent medical or nursing literature. It then details the potential intervention for each problem. Lastly, it includes goals and evaluation strategies for the measures. Most professors, predominantly Australian and UK professors, prefer if this section is in table format.

Some nursing professors regard the intervention section (or nursing care plan section) as the most critical part of a nursing case study. This is because this part details precisely how the student nurse will react to the patient scenario (which is what the nursing professors want to know). So, ensure you make a reasonable effort when developing this section to get an excellent grade.

7. Discussion and Recommendations

The intervention section in a nursing case study is followed by a discussion and recommendations section. In this section, you are supposed to expound on the patient scenario, the diagnosis, and the nursing care plan. You should also expound on the potential outcomes if the care plan is followed correctly. The discussion should also explain the rationale for the care plan or its significant bits.

Recommendations should follow the discussion. Recommendations usually involve everything necessary that can be done or changed to manage a patientâ€™s condition or prevent its reoccurrence. Anything that enhances the patientâ€™s well-being can be a recommendation. Just make sure your key recommendations are supported by evidence.

8. Conclusion

This is the second last section of a typical nursing case study. What you need here is to summarize the entire case study. Ensure your summary has at least the case presentation, the nursing assessment/diagnosis, the intervention, and the key recommendations.

At the very end of your conclusion, add a closing statement. The statement should wrap up the whole thing nicely. Try to make it as impressive as possible.

9. References

This is the last section of a nursing case study. No nursing case study is complete without a references section. You should ensure your case study has in-text citations and a references page.

And you should make sure both are written as recommended in the assignment. The style section is usually Harvard or APA. Follow the recommended style to get a good grade on your essay.

Step-By-Step Guide to Writing a Nursing Case Study

You know all the key sections you must include in a nursing case study. You also know what exactly you need to do in each section. It is time to learn how to write a nursing case study. The process detailed below should be easy to follow because you know the typical nursing case study structure.

1. Understand the Assignment

When given a nursing case study assignment, the first thing you need to do is to read. You need to read two pieces of information slowly and carefully.

First, you need to read the prompt itself slowly and carefully. This is important because the prompt will have essential bits of information you need to know, including the style, the format, the word count, and the number of references needed. All these bits of information are essential to ensure your writing is correct.

Second, you need to read the patient scenario slowly and carefully. You should do this to understand it clearly so that you do not make any mistakes in your analysis.

2. Create a Rough Outline

Failure to plan is a plan to fail. That is not what you are in it for anyway! In other words, do not fail to create an outline for your case study analysis. Use the template provided in this essay to create a rough outline for your nursing case study analysis.

Ensure your outline is as detailed as it can be at this stage. You can do light research to achieve this aim. However, this is not exactly necessary because this is just a rough outline.

3. Conduct thorough research

After creating a rough outline, you should conduct thorough research. Your research should especially focus on providing a credible and evidence-based nursing assessment of the patient problem(s). You should only use evidence from recent nursing or medical literature.

You must also conduct thorough research to develop an effective intervention or nursing care plan. So when researching the patientâ€™s problem and its diagnosis, you should also research the most suitable intervention or do it right after.

When conducting research, you should always note down your sources. So for every piece of information you find, and what to use, you should have its reference.

After conducting thorough research, you should enhance your rough outline using the new information you have discovered. Make sure it is as comprehensive as possible.

4. Write your nursing case study

You must follow your comprehensive outline to write your case study analysis at this stage. If you created a good outline, you should find it very easy to write your nursing case study analysis.

If you did not, writing your nursing case study will be challenging. Whenever you are stuck writing your case study analysis paper, you should re-read the part where we explain what to include in every section of your analysis. Doing so will help you know what to write to continue your essay. Writing a nursing case study analysis usually takes only a few hours.

5. Reference your case study

After writing your case study, ensure you add all in-text citations if you have not already. And when adding them, you should follow the style/format recommended in the assignment prompt (usually APA or Harvard style).

After adding in-text citations exactly where they need to be and in the correct format, add all the references you have used in a references page. And you should add them correctly as per the rules of the style you were asked to use.

Do not forget to organize your references alphabetically after creating your references page.

6. Thoroughly edit your case study

After STEP 5 above, you need to edit your case study. You should edit it slowly and carefully. Do this by proofreading it twice. Proofread it slowly each time to discover all the grammar, style, and punctuation errors. Remove all the errors you find.

After proofreading your essay twice, recheck it to ensure every sentence is straightforward. This will transform your ordinary case study into an A-grade one. Of course, it must also have all the standard sections expected in a case study.

Recheck your case study using a grammarly.com or a similar computer grammar checker to ensure it is perfect. Doing this will help you catch and eliminate all the remaining errors in your work.

7. Submit your case study analysis

After proofreading and editing your case study analysis, it will be 100% ready for submission. Just convert it into the format it is required in and submit it.

Nursing Case Study Tips and Tricks

The guide above and other information in this article should help you develop a good nursing case study analysis. Note that this guide focuses entirely on nursing case scenario-based papers, not research study-based nursing case studies. The tips and tricks in this section should help you ensure that the nursing case study analysis you create is excellent.

1. Begin early

The moment you see a nursing case study assignment prompt, identify a date to start writing it and create your own deadline to beat before the deadline stated in the prompt.

Do this and start writing your case study analysis early before your deadline. You will have plenty of time to do excellent research, develop an excellent paper, and edit your final paper as thoroughly as you want.

Most student nurses combine work and study. Therefore, if you decide to leave a nursing case study assignment until late to complete it, something could come up, and you could end up failing to submit it or submitting a rushed case study analysis.

2. Use the proper terminology

When writing an essay or any other academic paper, you are always encouraged to use the most straightforward language to make your work easy to understand. However, this is not true when writing a nursing case study analysis. While your work should certainly be easy to understand, you must use the right nursing terminology at every point where it is necessary. Failure to do this could damage your work or make it look less professional or convincing.

3. Avoid copying and pasting

If you are a serious nursing student, you know that copying and pasting are prohibited in assignments. However, sometimes copying and pasting can seem okay in nursing case studies. For example, it can seem okay to copy-paste the patient presentation. However, this is not okay. You are supposed to paraphrase the verbatim when presenting the patient presentation in your essay. You should also avoid copy-pasting information or texts directly. Every fact or evidence you research and find should be paraphrased to appear in your work. And it should be cited correctly.

4. Always ask for help if stuck

This is very important. Students are usually overwhelmed with academic work, especially a month or two to the end of the semester. If you are overwhelmed and think you will not have the time to complete your nursing case study analysis or submit a quality one, ask for help. Ask for help from a nursing assignment-help website like ours, and you will soon have a paper ready that you can use as you please. If you choose to get help from us, you will get a well-researched, well-planned, well-developed, and fully edited nursing case study.

5. Format your paper correctly

Many students forget to do proper formatting after writing their nursing case study analyses. Before you submit your paper, make sure you format it correctly. If you do not format your paper correctly, you will lose marks because of poor formatting. If you feel you are not very confident with your APA or Harvard formatting skills, send your paper to us to get it correctly formatted and ready for submission.

Now that you are all set up â€¦

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How to write a medical case study?

Medical students eventually face the need of writing a medical case study, the main goal of which is to prove the proper analysis of the project topic and to show their ability to apply the knowledge gained while conducting independent research.

Types of Medical Researches

For research tasks, doctors use different variants of the research organization, choosing special control groups, distributing the studied types of treatment between patients, planning repeated, sometimes multiple examinations.Classical scientific research is built in such a way as to eliminate the influence of all random (extraneous) factors, to equalize all possible features of the subjects, besides one studied factor. Then it is possible to assume that the difference between the surveyed is explained precisely by this factor. For example, if two identical groups of patients receive different treatment and recover differently, it can be assumed that the difference is due to the type of treatment. This way of a scientific research and publications took shape in the 17th century.

In the 20th century, the classical model of research ceased to be the only one, as new methods of analyzing data appeared. Today in most biomedical research, the question is considered: can the relationship of phenomenon B with feature A be explained by the influence of an extraneous factor C?In the modern biological and medical literature, there are many diverse research structures.Cross-sectional structure refers to studies in which each patient is examined once. As a result, you can describe the picture of the disease in one patient or in a combination of patients, clarify the symptoms, and relate individual symptoms to the underlying diagnosis and severity of the disease. This structure is widely used in clinical epidemiology.In the past centuries, monitoring the development of diseases was the main method of studying them.

This method made it possible to obtain correct ideas about transient infectious diseases. In the twentieth century, chronic diseases became the main object of medical research. The duration of their course is comparable with the duration of the creative life of the doctor. Therefore, simply observing the totality of patients, the doctor can easily make a mistake. The main tool to avoid it is the organization of longitudinal studies.

Longitudinal are structures in which a group of people is singled out, in order to constantly observe and monitor their condition.

How to Write a Medical Research?

The first thing a student should do is to determine the topic of the paper. It should be clear in order to eliminate any problems with the preparation of the research. To avoid unpleasant surprises, it is better to prepare for medical case study report throughout the course of training, paying enough attention to each topic of the discipline.The next step is to draw up a plan of work on medicine, following the standard medical case study format. The first part of which should be theoretical.

In this section of the paper, the student covers the history of the issue and its main concepts, reveals the relevance of the topic and gives specific examples from the field of medicine.The second part of the research is analytical; it means that the student should independently analyze the state of the problem he is studying at a given time.In the third, practical part of a project, the student can calculate the effectiveness of the proposed activities, or provide his own forecast of the prospects for their development in the future. It is also important to agree on a ready research plan with a professor. Otherwise, the paper will have to be altered either in parts or in whole.

Write My Medical Case Study – Presentation

Many students make the same mistake in the preparation of this part of the project and write too vague sentences that can hardly be connected with the topic of work. It is better to start the section with the following phrase: “The relevance of the topic is due …”, continuing own thought in a clear and concise manner.Have You seen Perfect Descriptive Essay already?After this, it is necessary to specify the research objectives and goals.

It is recommended to compose the project in such a way that the tasks are the points of the chapters. Further, it is necessary to prepare a small literary review, to indicate in it the authors of scientific papers and publications dealing with the study of the chosen problem, to describe their scientific views briefly.The main part of the research usually consists of three chapters: the first one describes the theory, the second one holds the analytics, and the third part compiles the practical part of the paper. It is obligatory to write a conclusion at the end of each chapter, and do it in such a way that the last sentence of the previous chapter would be a smooth transition to the following one. The conclusion at the end of each chapter will make it much easier for the student to write the final part of the study.

It will be necessary simply to put them together, adding a personal vision of the subsequent development of the problem under study.The case study reference lists all literary sources used during the preparation of the study. Such sources should be relevant. It is not recommended to use literature issued more than three years ago.

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A step-by-step guide to causal study design using real-world data

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Published: 19 June 2024

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Sarah Ruth Hoffman 1 ,
Nilesh Gangan 1 ,
Xiaoxue Chen 2 ,
Joseph L. Smith 1 ,
Arlene Tave 1 ,
Yiling Yang 1 ,
Christopher L. Crowe 1 ,
Susan dosReis 3 &
Michael Grabner 1

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Due to the need for generalizable and rapidly delivered evidence to inform healthcare decision-making, real-world data have grown increasingly important to answer causal questions. However, causal inference using observational data poses numerous challenges, and relevant methodological literature is vast. We endeavored to identify underlying unifying themes of causal inference using real-world healthcare data and connect them into a single schema to aid in observational study design, and to demonstrate this schema using a previously published research example. A multidisciplinary team (epidemiology, biostatistics, health economics) reviewed the literature related to causal inference and observational data to identify key concepts. A visual guide to causal study design was developed to concisely and clearly illustrate how the concepts are conceptually related to one another. A case study was selected to demonstrate an application of the guide. An eight-step guide to causal study design was created, integrating essential concepts from the literature, anchored into conceptual groupings according to natural steps in the study design process. The steps include defining the causal research question and the estimand; creating a directed acyclic graph; identifying biases and design and analytic techniques to mitigate their effect, and techniques to examine the robustness of findings. The cardiovascular case study demonstrates the applicability of the steps to developing a research plan. This paper used an existing study to demonstrate the relevance of the guide. We encourage researchers to incorporate this guide at the study design stage in order to elevate the quality of future real-world evidence.

Examples of Applying Causal-Inference Roadmap to Real-World Studies

Selection Mechanisms and Their Consequences: Understanding and Addressing Selection Bias

Assessing causality in epidemiology: revisiting Bradford Hill to incorporate developments in causal thinking

Avoid common mistakes on your manuscript.

1 Introduction

Approximately 50 new drugs are approved each year in the United States (Mullard 2022 ). For all new drugs, randomized controlled trials (RCTs) are the gold-standard by which potential effectiveness (“efficacy”) and safety are established. However, RCTs cannot guarantee how a drug will perform in a less controlled context. For this reason, regulators frequently require observational, post-approval studies using “real-world” data, sometimes even as a condition of drug approval. The “real-world” data requested by regulators is often derived from insurance claims databases and/or healthcare records. Importantly, these data are recorded during routine clinical care without concern for potential use in research. Yet, in recent years, there has been increasing use of such data for causal inference and regulatory decision making, presenting a variety of methodologic challenges for researchers and stakeholders to consider (Arlett et al. 2022 ; Berger et al. 2017 ; Concato and ElZarrad 2022 ; Cox et al. 2009 ; European Medicines Agency 2023 ; Franklin and Schneeweiss 2017 ; Girman et al. 2014 ; Hernán and Robins 2016 ; International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2022 ; International Society for Pharmacoepidemiology (ISPE) 2020 ; Stuart et al. 2013 ; U.S. Food and Drug Administration 2018 ; Velentgas et al. 2013 ).

Current guidance for causal inference using observational healthcare data articulates the need for careful study design (Berger et al. 2017 ; Cox et al. 2009 ; European Medicines Agency 2023 ; Girman et al. 2014 ; Hernán and Robins 2016 ; Stuart et al. 2013 ; Velentgas et al. 2013 ). In 2009, Cox et al. described common sources of bias in observational data and recommended specific strategies to mitigate these biases (Cox et al. 2009 ). In 2013, Stuart et al. emphasized counterfactual theory and trial emulation, offered several approaches to address unmeasured confounding, and provided guidance on the use of propensity scores to balance confounding covariates (Stuart et al. 2013 ). In 2013, the Agency for Healthcare Research and Quality (AHRQ) released an extensive, 200-page guide to developing a protocol for comparative effectiveness research using observational data (Velentgas et al. 2013 ). The guide emphasized development of the research question, with additional chapters on study design, comparator selection, sensitivity analyses, and directed acyclic graphs (Velentgas et al. 2013 ). In 2014, Girman et al. provided a clear set of steps for assessing study feasibility including examination of the appropriateness of the data for the research question (i.e., ‘fit-for-purpose’), empirical equipoise, and interpretability, stating that comparative effectiveness research using observational data “should be designed with the goal of drawing a causal inference” (Girman et al. 2014 ). In 2017 , Berger et al. described aspects of “study hygiene,” focusing on procedural practices to enhance confidence in, and credibility of, real-world data studies (Berger et al. 2017 ). Currently, the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) maintains a guide on methodological standards in pharmacoepidemiology which discusses causal inference using observational data and includes an overview of study designs, a chapter on methods to address bias and confounding, and guidance on writing statistical analysis plans (European Medicines Agency 2023 ). In addition to these resources, the “target trial framework” provides a structured approach to planning studies for causal inferences from observational databases (Hernán and Robins 2016 ; Wang et al. 2023b ). This framework, published in 2016, encourages researchers to first imagine a clinical trial for the study question of interest and then to subsequently design the observational study to reflect the hypothetical trial (Hernán and Robins 2016 ).

While the literature addresses critical issues collectively, there remains a need for a framework that puts key components, including the target trial approach, into a simple, overarching schema (Loveless 2022 ) so they can be more easily remembered, and communicated to all stakeholders including (new) researchers, peer-reviewers, and other users of the research findings (e.g., practicing providers, professional clinical societies, regulators). For this reason, we created a step-by-step guide for causal inference using administrative health data, which aims to integrate these various best practices at a high level and complements existing, more specific guidance, including those from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) (Berger et al. 2017 ; Cox et al. 2009 ; Girman et al. 2014 ). We demonstrate the application of this schema using a previously published paper in cardiovascular research.

This work involved a formative phase and an implementation phase to evaluate the utility of the causal guide. In the formative phase, a multidisciplinary team with research expertise in epidemiology, biostatistics, and health economics reviewed selected literature (peer-reviewed publications, including those mentioned in the introduction, as well as graduate-level textbooks) related to causal inference and observational healthcare data from the pharmacoepidemiologic and pharmacoeconomic perspectives. The potential outcomes framework served as the foundation for our conception of causal inference (Rubin 2005 ). Information was grouped into the following four concepts: (1) Defining the Research Question; (2) Defining the Estimand; (3) Identifying and Mitigating Biases; (4) Sensitivity Analysis. A step-by-step guide to causal study design was developed to distill the essential elements of each concept, organizing them into a single schema so that the concepts are clearly related to one another. References for each step of the schema are included in the Supplemental Table.

In the implementation phase we tested the application of the causal guide to previously published work (Dondo et al. 2017 ). The previously published work utilized data from the Myocardial Ischaemia National Audit Project (MINAP), the United Kingdom’s national heart attack register. The goal of the study was to assess the effect of β-blockers on all-cause mortality among patients hospitalized for acute myocardial infarction without heart failure or left ventricular systolic dysfunction. We selected this paper for the case study because of its clear descriptions of the research goal and methods, and the explicit and methodical consideration of potential biases and use of sensitivity analyses to examine the robustness of the main findings.

3.1 Overview of the eight steps

The step-by-step guide to causal inference comprises eight distinct steps (Fig. 1 ) across the four concepts. As scientific inquiry and study design are iterative processes, the various steps may be completed in a different order than shown, and steps may be revisited.

A step-by-step guide for causal study design

Abbreviations: GEE: generalized estimating equations; IPC/TW: inverse probability of censoring/treatment weighting; ITR: individual treatment response; MSM: marginal structural model; TE: treatment effect

Please refer to the Supplemental Table for references providing more in-depth information.

1 Ensure that the exposure and outcome are well-defined based on literature and expert opinion.

2 More specifically, measures of association are not affected by issues such as confounding and selection bias because they do not intend to isolate and quantify a single causal pathway. However, information bias (e.g., variable misclassification) can negatively affect association estimates, and association estimates remain subject to random variability (and are hence reported with confidence intervals).

3 This list is not exhaustive; it focuses on frequently encountered biases.

4 To assess bias in a nonrandomized study following the target trial framework, use of the ROBINS-I tool is recommended ( https://www.bmj.com/content/355/bmj.i4919 ).

5 Only a selection of the most popular approaches is presented here. Other methods exist; e.g., g-computation and g-estimation for both time-invariant and time-varying analysis; instrumental variables; and doubly-robust estimation methods. There are also program evaluation methods (e.g., difference-in-differences, regression discontinuities) that can be applied to pharmacoepidemiologic questions. Conventional outcome regression analysis is not recommended for causal estimation due to issues determining covariate balance, correct model specification, and interpretability of effect estimates.

6 Online tools include, among others, an E-value calculator for unmeasured confounding ( https://www.evalue-calculator.com /) and the P95 outcome misclassification estimator ( http://apps.p-95.com/ISPE /).

3.2 Defining the Research question (step 1)

The process of designing a study begins with defining the research question. Research questions typically center on whether a causal relationship exists between an exposure and an outcome. This contrasts with associative questions, which, by their nature, do not require causal study design elements because they do not attempt to isolate a causal pathway from a single exposure to an outcome under study. It is important to note that the phrasing of the question itself should clarify whether an association or a causal relationship is of interest. The study question “Does statin use reduce the risk of future cardiovascular events?” is explicitly causal and requires that the study design addresses biases such as confounding. In contrast, the study question “Is statin use associated with a reduced risk of future cardiovascular events?” can be answered without control of confounding since the word “association” implies correlation. Too often, however, researchers use the word “association” to describe their findings when their methods were created to address explicitly causal questions (Hernán 2018 ). For example, a study that uses propensity score-based methods to balance risk factors between treatment groups is explicitly attempting to isolate a causal pathway by removing confounding factors. This is different from a study that intends only to measure an association. In fact, some journals may require that the word “association” be used when causal language would be more appropriate; however, this is beginning to change (Flanagin et al. 2024 ).

3.3 Defining the estimand (steps 2, 3, 4)

The estimand is the causal effect of research interest and is described in terms of required design elements: the target population for the counterfactual contrast, the kind of effect, and the effect/outcome measure.

In Step 2, the study team determines the target population of interest, which depends on the research question of interest. For example, we may want to estimate the effect of the treatment in the entire study population, i.e., the hypothetical contrast between all study patients taking the drug of interest versus all study patients taking the comparator (the average treatment effect; ATE). Other effects can be examined, including the average treatment effect in the treated or untreated (ATT or ATU).When covariate distributions are the same across the treated and untreated populations and there is no effect modification by covariates, these effects are generally the same (Wang et al. 2017 ). In RCTs, this occurs naturally due to randomization, but in non-randomized data, careful study design and statistical methods must be used to mitigate confounding bias.

In Step 3, the study team decides whether to measure the intention-to-treat (ITT), per-protocol, or as-treated effect. The ITT approach is also known as “first-treatment-carried-forward” in the observational literature (Lund et al. 2015 ). In trials, the ITT measures the effect of treatment assignment rather than the treatment itself, and in observational data the ITT can be conceptualized as measuring the effect of treatment as started . To compute the ITT effect from observational data, patients are placed into the exposure group corresponding to the treatment that they initiate, and treatment switching or discontinuation are purposely ignored in the analysis. Alternatively, a per-protocol effect can be measured from observational data by classifying patients according to the treatment that they initiated but censoring them when they stop, switch, or otherwise change treatment (Danaei et al. 2013 ; Yang et al. 2014 ). Finally, “as-treated” effects are estimated from observational data by classifying patients according to their actual treatment exposure during follow-up, for example by using multiple time windows to measure exposure changes (Danaei et al. 2013 ; Yang et al. 2014 ).

Step 4 is the final step in specifying the estimand in which the research team determines the effect measure of interest. Answering this question has two parts. First, the team must consider how the outcome of interest will be measured. Risks, rates, hazards, odds, and costs are common ways of measuring outcomes, but each measure may be best suited to a particular scenario. For example, risks assume patients across comparison groups have equal follow-up time, while rates allow for variable follow-up time (Rothman et al. 2008 ). Costs may be of interest in studies focused on economic outcomes, including as inputs to cost-effectiveness analyses. After deciding how the outcome will be measured, it is necessary to consider whether the resulting quantity will be compared across groups using a ratio or a difference. Ratios convey the effect of exposure in a way that is easy to understand, but they do not provide an estimate of how many patients will be affected. On the other hand, differences provide a clearer estimate of the potential public health impact of exposure; for example, by allowing the calculation of the number of patients that must be treated to cause or prevent one instance of the outcome of interest (Tripepi et al. 2007 ).

3.4 Identifying and mitigating biases (steps 5, 6, 7)

Observational, real-world studies can be subject to multiple potential sources of bias, which can be grouped into confounding, selection, measurement, and time-related biases (Prada-Ramallal et al. 2019 ).

In Step 5, as a practical first approach in developing strategies to address threats to causal inference, researchers should create a visual mapping of factors that may be related to the exposure, outcome, or both (also called a directed acyclic graph or DAG) (Pearl 1995 ). While creating a high-quality DAG can be challenging, guidance is increasingly available to facilitate the process (Ferguson et al. 2020 ; Gatto et al. 2022 ; Hernán and Robins 2020 ; Rodrigues et al. 2022 ; Sauer 2013 ). The types of inter-variable relationships depicted by DAGs include confounders, colliders, and mediators. Confounders are variables that affect both exposure and outcome, and it is necessary to control for them in order to isolate the causal pathway of interest. Colliders represent variables affected by two other variables, such as exposure and outcome (Griffith et al. 2020 ). Colliders should not be conditioned on since by doing so, the association between exposure and outcome will become distorted. Mediators are variables that are affected by the exposure and go on to affect the outcome. As such, mediators are on the causal pathway between exposure and outcome and should also not be conditioned on, otherwise a path between exposure and outcome will be closed and the total effect of the exposure on the outcome cannot be estimated. Mediation analysis is a separate type of analysis aiming to distinguish between direct and indirect (mediated) effects between exposure and outcome and may be applied in certain cases (Richiardi et al. 2013 ). Overall, the process of creating a DAG can create valuable insights about the nature of the hypothesized underlying data generating process and the biases that are likely to be encountered (Digitale et al. 2022 ). Finally, an extension to DAGs which incorporates counterfactual theory is available in the form of Single World Intervention Graphs (SWIGs) as described in a 2013 primer (Richardson and Robins 2013 ).

In Step 6, researchers comprehensively assess the possibility of different types of bias in their study, above and beyond what the creation of the DAG reveals. Many potential biases have been identified and summarized in the literature (Berger et al. 2017 ; Cox et al. 2009 ; European Medicines Agency 2023 ; Girman et al. 2014 ; Stuart et al. 2013 ; Velentgas et al. 2013 ). Every study can be subject to one or more biases, each of which can be addressed using one or more methods. The study team should thoroughly and explicitly identify all possible biases with consideration for the specifics of the available data and the nuances of the population and health care system(s) from which the data arise. Once the potential biases are identified and listed, the team can consider potential solutions using a variety of study design and analytic techniques.

In Step 7, the study team considers solutions to the biases identified in Step 6. “Target trial” thinking serves as the basis for many of these solutions by requiring researchers to consider how observational studies can be designed to ensure comparison groups are similar and produce valid inferences by emulating RCTs (Labrecque and Swanson 2017 ; Wang et al. 2023b ). Designing studies to include only new users of a drug and an active comparator group is one way of increasing the similarity of patients across both groups, particularly in terms of treatment history. Careful consideration must be paid to the specification of the time periods and their relationship to inclusion/exclusion criteria (Suissa and Dell’Aniello 2020 ). For instance, if a drug is used intermittently, a longer wash-out period is needed to ensure adequate capture of prior use in order to avoid bias (Riis et al. 2015 ). The study team should consider how to approach confounding adjustment, and whether both time-invariant and time-varying confounding may be present. Many potential biases exist, and many methods have been developed to address them in order to improve causal estimation from observational data. Many of these methods, such as propensity score estimation, can be enhanced by machine learning (Athey and Imbens 2019 ; Belthangady et al. 2021 ; Mai et al. 2022 ; Onasanya et al. 2024 ; Schuler and Rose 2017 ; Westreich et al. 2010 ). Machine learning has many potential applications in the causal inference discipline, and like other tools, must be used with careful planning and intentionality. To aid in the assessment of potential biases, especially time-related ones, and the development of a plan to address them, the study design should be visualized (Gatto et al. 2022 ; Schneeweiss et al. 2019 ). Additionally, we note the opportunity for collaboration across research disciplines (e.g., the application of difference-in-difference methods (Zhou et al. 2016 ) to the estimation of comparative drug effectiveness and safety).

3.5 Quality Control & sensitivity analyses (step 8)

Causal study design concludes with Step 8, which includes planning quality control and sensitivity analyses to improve the internal validity of the study. Quality control begins with reviewing study output for prima facie validity. Patient characteristics (e.g., distributions of age, sex, region) should align with expected values from the researchers’ intuition and the literature, and researchers should assess reasons for any discrepancies. Sensitivity analyses should be conducted to determine the robustness of study findings. Researchers can test the stability of study estimates using a different estimand or type of model than was used in the primary analysis. Sensitivity analysis estimates that are similar to those of the primary analysis might confirm that the primary analysis estimates are appropriate. The research team may be interested in how changes to study inclusion/exclusion criteria may affect study findings or wish to address uncertainties related to measuring the exposure or outcome in the administrative data by modifying the algorithms used to identify exposure or outcome (e.g., requiring hospitalization with a diagnosis code in a principal position rather than counting any claim with the diagnosis code in any position). As feasible, existing validation studies for the exposure and outcome should be referenced, or new validation efforts undertaken. The results of such validation studies can inform study estimates via quantitative bias analyses (Lanes and Beachler 2023 ). The study team may also consider biases arising from unmeasured confounding and plan quantitative bias analyses to explore how unmeasured confounding may impact estimates. Quantitative bias analysis can assess the directionality, magnitude, and uncertainty of errors arising from a variety of limitations (Brenner and Gefeller 1993 ; Lash et al. 2009 , 2014 ; Leahy et al. 2022 ).

3.6 Illustration using a previously published research study

In order to demonstrate how the guide can be used to plan a research study utilizing causal methods, we turn to a previously published study (Dondo et al. 2017 ) that assessed the causal relationship between the use of 𝛽-blockers and mortality after acute myocardial infarction in patients without heart failure or left ventricular systolic dysfunction. The investigators sought to answer a causal research question (Step 1), and so we proceed to Step 2. Use (or no use) of 𝛽-blockers was determined after discharge without taking into consideration discontinuation or future treatment changes (i.e., intention-to-treat). Considering treatment for whom (Step 3), both ATE and ATT were evaluated. Since survival was the primary outcome, an absolute difference in survival time was chosen as the effect measure (Step 4). While there was no explicit directed acyclic graph provided, the investigators specified a list of confounders.

Robust methodologies were established by consideration of possible sources of biases and addressing them using viable solutions (Steps 6 and 7). Table 1 offers a list of the identified potential biases and their corresponding solutions as implemented. For example, to minimize potential biases including prevalent-user bias and selection bias, the sample was restricted to patients with no previous use of 𝛽-blockers, no contraindication for 𝛽-blockers, and no prescription of loop diuretics. To improve balance across the comparator groups in terms of baseline confounders, i.e., those that could influence both exposure (𝛽-blocker use) and outcome (mortality), propensity score-based inverse probability of treatment weighting (IPTW) was employed. However, we noted that the baseline look-back period to assess measured covariates was not explicitly listed in the paper.

Quality control and sensitivity analysis (Step 8) is described extensively. The overlap of propensity score distributions between comparator groups was tested and confounder balance was assessed. Since observations in the tail-end of the propensity score distribution may violate the positivity assumption (Crump et al. 2009 ), a sensitivity analysis was conducted including only cases within 0.1 to 0.9 of the propensity score distribution. While not mentioned by the authors, the PS tails can be influenced by unmeasured confounders (Sturmer et al. 2021 ), and the findings were robust with and without trimming. An assessment of extreme IPTW weights, while not included, would further help increase confidence in the robustness of the analysis. An instrumental variable approach was employed to assess potential selection bias due to unmeasured confounding, using hospital rates of guideline-indicated prescribing as the instrument. Additionally, potential bias caused by missing data was attenuated through the use of multiple imputation, and separate models were built for complete cases only and imputed/complete cases.

4 Discussion

We have described a conceptual schema for designing observational real-world studies to estimate causal effects. The application of this schema to a previously published study illuminates the methodologic structure of the study, revealing how each structural element is related to a potential bias which it is meant to address. Real-world evidence is increasingly accepted by healthcare stakeholders, including the FDA (Concato and Corrigan-Curay 2022 ; Concato and ElZarrad 2022 ), and its use for comparative effectiveness and safety assessments requires appropriate causal study design; our guide is meant to facilitate this design process and complement existing, more specific, guidance.

Existing guidance for causal inference using observational data includes components that can be clearly mapped onto the schema that we have developed. For example, in 2009 Cox et al. described common sources of bias in observational data and recommended specific strategies to mitigate these biases, corresponding to steps 6–8 of our step-by-step guide (Cox et al. 2009 ). In 2013, the AHRQ emphasized development of the research question, corresponding to steps 1–4 of our guide, with additional chapters on study design, comparator selection, sensitivity analyses, and directed acyclic graphs which correspond to steps 7 and 5, respectively (Velentgas et al. 2013 ). Much of Girman et al.’s manuscript (Girman et al. 2014 ) corresponds with steps 1–4 of our guide, and the matter of equipoise and interpretability specifically correspond to steps 3 and 7–8. The current ENCePP guide on methodological standards in pharmacoepidemiology contains a section on formulating a meaningful research question, corresponding to step 1, and describes strategies to mitigate specific sources of bias, corresponding to steps 6–8 (European Medicines Agency 2023 ). Recent works by the FDA Sentinel Innovation Center (Desai et al. 2024 ) and the Joint Initiative for Causal Inference (Dang et al. 2023 ) provide more advanced exposition of many of the steps in our guide. The target trial framework contains guidance on developing seven components of the study protocol, including eligibility criteria, treatment strategies, assignment procedures, follow-up period, outcome, causal contrast of interest, and analysis plan (Hernán and Robins 2016 ). Our work places the target trial framework into a larger context illustrating its relationship with other important study planning considerations, including the creation of a directed acyclic graph and incorporation of prespecified sensitivity and quantitative bias analyses.

Ultimately, the feasibility of estimating causal effects relies on the capabilities of the available data. Real-world data sources are complex, and the investigator must carefully consider whether the data on hand are sufficient to answer the research question. For example, a study that relies solely on claims data for outcome ascertainment may suffer from outcome misclassification bias (Lanes and Beachler 2023 ). This bias can be addressed through medical record validation for a random subset of patients, followed by quantitative bias analysis (Lanes and Beachler 2023 ). If instead, the investigator wishes to apply a previously published, claims-based algorithm validated in a different database, they must carefully consider the transportability of that algorithm to their own study population. In this way, causal inference from real-world data requires the ability to think creatively and resourcefully about how various data sources and elements can be leveraged, with consideration for the strengths and limitations of each source. The heart of causal inference is in the pairing of humility and creativity: the humility to acknowledge what the data cannot do, and the creativity to address those limitations as best as one can at the time.

4.1 Limitations

As with any attempt to synthesize a broad array of information into a single, simplified schema, there are several limitations to our work. Space and useability constraints necessitated simplification of the complex source material and selections among many available methodologies, and information about the relative importance of each step is not currently included. Additionally, it is important to consider the context of our work. This step-by-step guide emphasizes analytic techniques (e.g., propensity scores) that are used most frequently within our own research environment and may not include less familiar study designs and analytic techniques. However, one strength of the guide is that additional designs and techniques or concepts can easily be incorporated into the existing schema. The benefit of a schema is that new information can be added and is more readily accessed due to its association with previously sorted information (Loveless 2022 ). It is also important to note that causal inference was approached as a broad overarching concept defined by the totality of the research, from start to finish, rather than focusing on a particular analytic technique, however we view this as a strength rather than a limitation.

Finally, the focus of this guide was on the methodologic aspects of study planning. As a result, we did not include steps for drafting or registering the study protocol in a public database or for communicating results. We strongly encourage researchers to register their study protocols and communicate their findings with transparency. A protocol template endorsed by ISPOR and ISPE for studies using real-world data to evaluate treatment effects is available (Wang et al. 2023a ). Additionally, the steps described above are intended to illustrate an order of thinking in the study planning process, and these steps are often iterative. The guide is not intended to reflect the order of study execution; specifically, quality control procedures and sensitivity analyses should also be formulated up-front at the protocol stage.

5 Conclusion

We outlined steps and described key conceptual issues of importance in designing real-world studies to answer causal questions, and created a visually appealing, user-friendly resource to help researchers clearly define and navigate these issues. We hope this guide serves to enhance the quality, and thus the impact, of real-world evidence.

Data availability

No datasets were generated or analysed during the current study.

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Hoffman, S.R., Gangan, N., Chen, X. et al. A step-by-step guide to causal study design using real-world data. Health Serv Outcomes Res Method (2024). https://doi.org/10.1007/s10742-024-00333-6

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Navigating the Healthcare MBA Application: A Step-by-Step Guide

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Transforming Records Management: A Founder's Approach to Modern Record Retrieval Systems Access to crucial documents can make or break a case in the fast-paced business world. The Records Company understands this complexity and has built an efficient process that facilitates a more accessible way of retrieving medical, billing, and other critical documents.

By Ramsy Swamy Jun 25, 2024

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Access to crucial documents can make or break a case in the fast-paced business world. The Records Company understands this complexity and has built an efficient process that facilitates a more accessible way of retrieving medical, billing, and other critical documents.

Through the vision of its founder, Grady Marin, an alumnus of Harvard Business School and Said Business School at Oxford University, The Records Company has delivered over a million documents and expanded its operations from Ohio to the bustling city of Miami.

In an interview with Entrepreneur, Marin shares the challenges he faced along the way, the secrets behind the company's growth, and the role he plays in the future of the record retrieval industry.

Q&A with Grady Marin

How did your professional background and experiences shape your approach to business and leadership?

I have a diverse professional background spanning multiple industries. Initially, I aspired to be a lawyer, driven by a passion for helping others. However, my career path was changed when I joined a small tech company specializing in the .NET framework at its inception.

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I was inspired to enter the records retrieval industry when I realized many manual processes in the legal field could be revolutionized through automation. Tasks such as handling files, contacting providers, and managing communication via fax, mail, or email consumed immense labor hours.

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How does The Records Company's technology solve the current issues in document retrieval and enhance its service delivery? What sets The Records Company apart from its competitors?

The Records Company leverages advanced technology to address the inefficiencies in medical record retrieval and enhance service delivery by integrating with providers to automate processes. This automation significantly reduces the manual effort traditionally required to handle records, such as making phone calls, sending faxes, or following up on requests.

Our dual focus on technology and personalized service sets The Records Company apart. We humanize our operations by working directly and personally with our customers and providers, emphasizing accountability and promptness.

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We do this through a strategic blend of technology and personalized interaction. Our approach ensures that while we leverage advanced automation to streamline processes, we still strongly focus on delivering personalized service.

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What were some of the biggest challenges you faced when starting The Records Company, and how did you overcome them?

Finding customers was one of our biggest challenges when starting the business. My business partner, Agata Zachary, and I leveraged our legal contacts to pitch our service's value. Despite the familiarity, convincing them of the benefits and cost savings of outsourcing their record retrieval was challenging.

Many legal professionals hesitated to pay for our service, not realizing the hidden costs of having their employees handle the work.

To overcome this challenge, we emphasized the efficiency and reliability of our service, demonstrating how it pays for itself. For plaintiff attorneys, in particular, we highlighted that the settlement often covers our service costs as an out-of-pocket expense, further justifying the investment.

Under your leadership, The Records Company has expanded significantly. What are some of the milestones you are most proud of?

I am particularly proud of creating a modern, expansive workspace that is comfortable and productive. We've moved into a larger office with new amenities, such as a coffee bar and a break room, all set within a charming downtown area outside Cincinnati.

Expanding our operations to Miami, Florida, is another incredible milestone. This expansion has allowed us to diversify our team and better serve a broader range of clients. This has broadened our reach and embraced a more inclusive workforce, enriching our company culture and enhancing our service delivery.

Throughout our growth, we have built a reputation for excellence. While we may not be the cheapest option in the industry, our clients recognize the value of our comprehensive services. Beyond record retrieval, we provide accounting and reconciliation services, accuracy and performance reports, and consultative services.

How do you see the records retrieval industry evolving in the next five to 10 years, and what role do you envision The Records Company playing in that future?

The records retrieval industry will transform in the coming years, driven by technological advancements and an increasing demand for efficient data management. The current system in the US and globally is often antiquated and fragmented. Data is dispersed across various platforms and locations, making accessing comprehensive information quickly and efficiently challenging. This dispersed data is crucial for decision-making, whether for emergent health needs, insurance claims processing, or legal matters.

As artificial intelligence (AI) and machine learning technologies become more sophisticated, overhauling existing systems and creating a more advanced, efficient, and centralized means of retrieving information will become increasingly necessary.

Also, as I am currently testing as a CPA, we will soon offer more advanced accounting and auditing services. We plan to continue our advocacy efforts to push for systemic changes in data management practices. Our goal is to contribute to creating a more centralized and streamlined system for healthcare and legal data retrieval.

What are your long-term goals for The Records Company, and what steps are you taking to achieve them?

Our goal remains to solve businesses' problems by offering expert guidance and reliable services. To achieve this, we are leveraging our team of dedicated professionals, including individuals with advanced degrees, MBAs, and various certifications. Our team's expertise allows us to offer helpful advice to make businesses more financially successful.

We are also committed to maintaining the human touch in all our interactions. This means providing personalized, hands-on support to our clients, ensuring they feel valued and understood.

We at The Records Company are dedicated to helping our clients achieve their full potential while maintaining a personal and human touch in all our dealings.

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TEACHING TIPS: TWELVE TIPS FOR MAKING CASE PRESENTATIONS MORE INTERESTING *

1. set the stage.

Prepare the audience for what is to come. If the audience is composed of people of mixed expertise, spend a few minutes forming them into small mixed groups of novices and experts. Explain that this is an opportunity for the more junior to learn from the more senior people. Tell them that the case to be presented is extremely interesting, why it is so and what they may learn from it. The primary objective is to analyze the clinical reasoning that was used rather than the knowledge required, although the acquisition of such knowledge is an added benefit of the session. A “well organized case presentation or clinicopathological conference incorporates the logic of the workup implicitly and thus makes the diagnostic process seem almost preordained”.

A psychiatry resident began by introducing the case as an exciting one, explaining the process and dividing the audience into teams mixing people with varied expertise. He urged everyone to think in ‘real time’ rather than jump ahead and to refrain from considering information that is not normally available at the time: for example, a laboratory report that takes 24 hours to obtain be assessed in the initial workup.

2. PROVIDE ONLY INITIAL CUES AT FIRST

Give them the first two to live cues that were picked up in the first minute or two of the patient encounter either verbally, or written on a transparency. For example, age, sex race and reason for seeking medical help. Ask each group to discuss their first diagnostic hypotheses. Experts and novices will learn a great deal from each other at this stage and the discussions will be animated. The initial cues may number only one or two and hypothesis generation occurs very quickly even in the novices. Indeed, the only difference between the hypotheses of novices and those of experts is in the degree of refinement, not in number.

It is Saturday afternoon and you are the psychiatric emergency physician. A 25-year-old male arrives by ambulance and states that he is feeling suicidal. Groups talked for 4 minutes before the resident called for order to commence step three.

3. ASK FOR HYPOTHESES AND WRITE THEM UP ON THE BLACKBOARD

Call for order and ask people to offer their suggested diagnoses and write these up on a board or transparency.

The following hypotheses were suggested by the groups and the resident wrote them on a flip chart: depression, substance abuse, recent social stressors-crisis, adjustment disorder, organic problem, dysthymia, schizophrenia, bipolar affective disorder. The initial three or four bits of information generated eight hypotheses.

4. ALLOW THE AUDIENCE TO ASK FOR INFORMATION

After all hypotheses have been listed instruct the audience to ask for the information they need to confirm or refute these hypotheses. Do not allow them to ‘jump the gun’ by asking for a test result, for example, that would not have been received within the time frame that is being re-lived. There will be a temptation to move too fast and the exercise is wasted if information is given too soon. Recall that the purpose is to help them go through a thinking process which requires time.

Teachers participating in this exercise will receive much diagnostic information about students’ thinking at this stage. Indeed, an interesting teaching session can be conducted by simply asking students to generate hypotheses without proceeding further. There is evidence to suggest that when a diagnosis is not considered initially it is unlikely to be reached over time, Hence it is worth spending time with students to discuss the hypotheses they generate before they proceed with an enquiry.

Directions to the group were to determine what questions they would like to ask, based on gender, age and probabilities, to support or exclude the listed diagnostic possibilities. A sample of question follow:

Does he work? No, he's unemployed.
Does he drink? one to three beers a week.
Why now? He's been feeling worse and worse for the last 3 weeks.
Social support? He gives alone. Has no girlfriend.
Appearance? Looks his age. Not shaved today. No shower in 3 days.
Cultural background? Refugee from Iraq. Muslim.
How did he get here? He spent 4 years in a refugee camp after spending 4 months walking to Pakistan from Iraq. He left Iraq to avoid military service.
Suicide thoughts? Increasing the last 3 weeks. He was admitted in December and has been taking chloral hydrate.

This step took 13 minutes.

5. HAVE THE AUDIENCE RE-FORMULATE THEIR LIST OF HYPOTHESES

After enough information has been gained to proceed, ask them to resume their discussion about the problem and reformulate their diagnostic hypotheses in light of the new information. Instruct them to discuss which pieces of information changed the working diagnosis and why. Call for order again and ask people what they now think.

After allowing the group to talk for a few minutes, the resident asked them if there was enough information to strike off any hypotheses or if new hypotheses should be added to the list. One more possibility was added, post-traumatic stress disorder (PTSD). One group's list of priorities was major affective disorder with psychosis, schizophrenia, personality disorder. Another group also placed affective disorder first followed by organic mood disorder.

This step took 25 minutes.

6. FACILITATE A DISCUSSION ABOUT REASONING

Alter the original lists of hypotheses on the board in light of the discussion, or allow one member from each group to alter their own lists. By the use of open-ended questions encourage a general discussion about the reasons a group has for preferring one diagnosis over another.

A general discussion ensued about reasons for these priorities. Then the list was altered so that it read: schizophrenia, personality disorder, PTSD, major affective disorder with psychosis, organic mood disorder.

7. ALLOW ANOTHER ROUND OF INFORMATION SEEKING

Continue with another round of information and small-group discussion or else allow the whole group to interact. By giving information only when asked for and only in correct sequence, each person is challenged to think through the problem.

More information was sought, such as: form of speech? eye contact? affect? substance use? After 5 minutes the resident asked if there were only lab tests they would like. The group asked for thyroid stimulating hormone, T4, electrolytes and were given the results. They also asked for the results of the physical examination and were told that the pulse was 110 and the thyroid was enlarged. At this point some hypotheses were removed from the list.

8. ASK GROUPS TO REACH A FINAL DIAGNOSIS

When there is a lull in the search for information, ask the groups to reach consensus on their final diagnosis, given the information they have. Allow discussion within the groups.

9. CALL FOR EACH GROUP'S FINAL DIAGNOSIS

On each group's list of hypothesis, star or underline the final diagnosis.

The group decided that the most likely diagnosis was affective disorder with psychosis, the actual working diagnosis of the patient.

10. ASK FOR MANAGEMENT OPTIONS

If there is enough time, ask them to form small groups again to discuss treatment options, or conduct the discussion as a large group. Again ask for the reasons why one approach is preferred over another. Particularly ask the experts in the room for their reasoning so that the novices can learn from them.

11. SUMMARIZE

By the time the end is in sight the audience will be so involved that they will not wish to leave. However, 5 minutes before time, call for order and summarize the session. Highlight the key points that have been raised and refer to the objective of the session.

We are now at the end of our time. You have all had the opportunity to use your clinical reasoning skills to generate several hypotheses which are shown on the board. Initially you thought it possible that this man could have any one of a number of diagnoses including depression, substance abuse, adjustment disorder with depressed mood, organic mood disorder or post-traumatic stress disorder. With further information the possible diagnosis shifted to include schizophrenia and personality disorder as well as depression with psychotic features. Finally the diagnosis of depression or mood disorder with psychosis was most strongly supported because of the history of consistently depressed mood over several months, along with disturbed sleep, poor appetite, weight loss, decreased energy and diminished interest in most activities. The initially abnormal thyroid test proved to be a red herring so organic mood disorder related to hyper- or hypo-thyroidism was excluded. Additionally absence of vivid dreams involving a traumatic event made a diagnosis of post-traumatic stress disorder unlikely. Although a diagnosis of schizophrenia could not be totally excluded, this seemed less likely given the findings.

12. CLOSE THE SESSION WITH POSITIVE FEEDBACK

In some respects, but only some, teaching is like acting and one should strive to leave them not laughing as you go, but feeling that they have learned something.

The more novice members of the group have learned from the more experienced and all your suggestions have been valid. It has been interesting for me to follow your reasoning and compare it with mine when I actually saw this man. You have given me a different perspective as you thought of things I had not, and I thank you for your participation.

Although case presentation should be a major learning experience for both novice and experienced physicians they are often conducted in a stultifying way that defies thought. We have presented a series of steps which, if followed, guarantee active participation from the audience and ensure that if experts are in the room their expertise is used. Physicians have been moulded to believe that teaching means telling and, as a consequence, adopt a remote listening stance during case presentations. Indeed the back row often use the time to catch up on much needed sleep! Changing the format requires courage. We urge you to try out these steps so that both you and your audience will learn from and enjoy the process.

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Guidelines To Writing A Clinical Case Report
A case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports usually describe an unusual or novel occurrence and as such, remain one of the cornerstones of medical progress and provide many new ideas in medicine. Some reports contain an extensive review of the relevant ...
Writing a case report in 10 steps
First steps. Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline ...
Writing a Medical Case Study: From Inspiration to Publication
5. Complete your introduction and conclusion after you've written the body. Since these sections summarize key points of your case study, it's best to write them last. The introduction gives a brief overview of the basic condition of your patient and the problem you'll address in your case study.
Guideline on writing a case report
In preparing the title, avoid unnecessary words, wordplay, double meaning, cute wording, and never uses abbreviations in the title. It is always advisable to add "case report" in your title. Beneath the title, list all authors and their affiliations on the same page including their E-mails account.
Developing a Beginner's Guide to Writing a Clinical Case Report: A
The aim of this study was to get junior doctors to evaluate an online presentation as part of the process of developing a beginner's guide to writing a clinical case report. Materials and methods. In response to our previous studies an online presentation concerning how to write a clinical case report was provided for junior doctors.
A young researcher's guide to writing a clinical case report
A clinical case report or case study is a means of disseminating new knowledge gained from clinical practice. Medical practitioners often come across patient cases that are different or unusual such as a previously unknown condition, a complication of a known disease, an unusual side effect or adverse response to a mode of treatment, or a new ...
How to write a medical case report
Writing a case report is an excellent way of documenting these findings for the wider medical community—sharing new knowledge that will lead to better and safer patient care. For many medical students and junior doctors, a case report may be their first attempt at medical writing. A published case report will look impressive on your ...
Writing 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.
A guide to writing case reports for the Journal of Medical Case Reports
Case reports are a time-honored tradition in the medical profession. From Hippocrates (460 B.C. to 370 B.C.), and even arguably further back since the papyrus records of ancient Egyptian medicine (c. 1600 B.C.) to modern day, physicians of all specialties have described interesting cases involving all specialties [1, 2].Published case reports provide essential information for optimal patient ...
PDF How to write a clinical case report
It is best to write the actual report in one stretch if possible, including as much detail as you think is relevant. You can always edit the discussion and trim down the article at a later stage. Below is the general format adopted for most case reports. Introduction. Summarise your case report in a sentence. Mention how rare this condition is ...
Case Report: A Beginner's Guide with Examples
A case report is a descriptive study that documents an unusual clinical phenomenon in a single patient. It describes in details the patient's history, signs, symptoms, test results, diagnosis, prognosis and treatment. It also contains a short literature review, discusses the importance of the case and how it improves the existing knowledge on the subject.
PDF How to Write & Publish a Medical Case Report Using CARE Guidelines
Step 2 - Select a Journal. What target audience (doctors & patients) would best benefit from the info? If indexed in PubMed, it is peer reviewed and locatable. Some journals do NOT publish case reports. FIRST double-check the journal's "Author's Guidelines," or "Author's Instructions" to see "Types of Articles".
How to Write a Case Study (Templates and Tips)
A case study is a detailed analysis of a specific topic in a real-world context. It can pertain to a person, place, event, group, or phenomenon, among others. The purpose is to derive generalizations about the topic, as well as other insights. Case studies find application in academic, business, political, or scientific research.
What is a case study?
Case study is a research methodology, typically seen in social and life sciences. There is no one definition of case study research.1 However, very simply… 'a case study can be defined as an intensive study about a person, a group of people or a unit, which is aimed to generalize over several units'.1 A case study has also been described as an intensive, systematic investigation of a ...
Guidelines to the writing of case studies
It is best to simply tell the story and let the outcome speak for itself. With these points in mind, let's begin the process of writing the case study: Title page: Title: The title page will contain the full title of the article. Remember that many people may find our article by searching on the internet.
How to present patient cases
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 ...
How to Write a Nursing Case Study Paper (A Guide)
Ensure your summary has at least the case presentation, the nursing assessment/diagnosis, the intervention, and the key recommendations. At the very end of your conclusion, add a closing statement. The statement should wrap up the whole thing nicely. Try to make it as impressive as possible. 9.
PDF How to write a case study
Case studies can help others (e.g., students, other organizations, employees) learn about • new concepts, • best practices, and • situations they might face. Writing a case study also allows you to critically examine your organizational practices. Examples The following pages provide examples of different types of case study formats. ...
Case Analysis in Health Sciences
The case analysis gives you the opportunity to explore, make mistakes, and learn. 0:32: In most cases, your professor will provide a case study that describes the facts of a patient's health situation. 0:38: Sometimes, the case study will focus on a particular community or organization instead of just a single person. 0:44
How to write a medical case study?
Write My Medical Case Study - Presentation. The next stage of the work will be writing the introduction to the case study on a medical topic. There is nothing difficult in this. The most important thing is to highlight the relevance of the topic of the course. Many students make the same mistake in the preparation of this part of the project ...
A step-by-step guide to causal study design using real-world data
A case study was selected to demonstrate an application of the guide. An eight-step guide to causal study design was created, integrating essential concepts from the literature, anchored into conceptual groupings according to natural steps in the study design process. ... This bias can be addressed through medical record validation for a random ...
How to Write Your First Clinical Case Report
Structure Your Report. Once you have selected the journal of submission, carefully reread the author instructions to structure your submission. The JACC: Case Reports authors instructions suggest a specific structure for a clinical case: history of presentation, physical examination, past medical history, differential diagnosis, investigations, management (medical/interventions), discussion ...
Clinical Trials
Clinical trials are research studies that explore whether a medical strategy, treatment or device is safe and effective for humans. These studies may also show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce information that helps patients and their health-care providers make better health ...
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Navigating the Healthcare MBA Application: A Step-by-Step Guide
The growing demand for healthcare services is creating opportunities for business professionals specializing in healthcare management. The U.S. Bureau of Labor Statistics predicts the job market for medical and health services managers will increase by 28% by 2032, resulting in approximately 54,700 job openings annually.. Professionals looking to enter or advance in healthcare management ...
Tips for writing a case report for the novice author
Introduction. For many doctors and other healthcare professionals, writing a case report represents the first effort at getting articles published in medical journals and it is considered a useful exercise in learning how to write scientifically due to similarity of the basic methodology.1 Case reports aim to convey a clinical message.2,3 Despite different types of case reports, they all aim ...
Transforming Records Management: A Founder's Approach to Modern Record
Access to crucial documents can make or break a case in the fast-paced business world. The Records Company understands this complexity and has built an efficient process that facilitates a more ...
Teaching Tips: Twelve Tips for Making Case Presentations More
1. SET THE STAGE. Prepare the audience for what is to come. If the audience is composed of people of mixed expertise, spend a few minutes forming them into small mixed groups of novices and experts. Explain that this is an opportunity for the more junior to learn from the more senior people. Tell them that the case to be presented is extremely ...

How to Write a Medical Case Study Report

What is a case study report?

How is a case study report structured?

Drafting Your Medical Case Study Report

Polishing Your Report for Submission to Publishers

Submitting Your Report to Publishers

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Writing a Case Report

A guide to writing case reports for the Journal of Medical Case Reports and BioMed Central Research Notes

Introduction: the importance of case reports

Definitions

How to start: the patient

Collegial discussion and the Internet: our modern day water cooler

The BMC series, JMCR , and BMCRN : a brief history

Cases Database: an invaluable resource

When to write a case report

BMC editorial workflow for case reports: a brief glimpse

The actual case report

Introduction (Background)

Case presentation

Conclusions

Patient’s perspective

List of abbreviations

Authors’ information

Acknowledgements

Cover letter

BMC author academy: help for all

Final checklist and the rule of C s

Summary and parting advice

Recommended further reading

Author information

Corresponding author

Additional information

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Journal of Medical Case Reports

Case Report: A Beginner’s Guide with Examples

Advantages of case reports

Limitations of case reports

Real-world examples of case reports

Example 2: Recovery from the passage of an iron bar through the head

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How to Write a Nursing Case Study Paper (A Guide)

What Is a Nursing Case Study?

The Nursing Case Study Template

The Structure of a Nursing Case Study Analysis

1. Title page

2. Abstract

3. Introduction

4. Case Presentation (Status of the Patient)

5. Diagnosis and Assessment

6. Nursing Intervention

7. Discussion and Recommendations

8. Conclusion

9. References

Step-By-Step Guide to Writing a Nursing Case Study

1. Understand the Assignment