research study material

J Can Chiropr Assoc 2008; 52(4) 199

Commentary

Guidelines to the writing of case studiesDr. Brian Budgell, DC, PhD*

Dr. Brian Budgell, DC, PhD

JCCA Editorial Board

IntroductionCase studies are an invaluable record of the clinical prac-tices of a profession. While case studies cannot providespecific guidance for the management of successive pa-tients, they are a record of clinical interactions whichhelp us to frame questions for more rigorously designedclinical studies. Case studies also provide valuable teach-

ing material, demonstrating both classical and unusualpresentations which may confront the practitioner. Quiteobviously, since the overwhelming majority of clinicalinteractions occur in the field, not in teaching or researchfacilities, it falls to the field practitioner to record andpass on their experiences. However, field practitionersgenerally are not well-practised in writing for publica-tion, and so may hesitate to embark on the task of carry-ing a case study to publication. These guidelines areintended to assist the relatively novice writer – practition-er or student – in efficiently navigating the relatively easycourse to publication of a quality case study. Guidelinesare not intended to be proscriptive, and so throughout thisdocument we advise what authors “may” or “should” do,rather than what they “must” do. Authors may decide thatthe particular circumstances of their case study justify di-gression from our recommendations.

Additional and useful resources for chiropractic casestudies include:1 Waalen JK. Single subject research designs. J Can Chirop

Assoc 1991; 35(2):95–97.2 Gleberzon BJ. A peer-reviewer’s plea. J Can Chirop Assoc

2006; 50(2):107.3 Merritt L. Case reports: an important contribution to

chiropractic literature. J Can Chiropr Assoc 2007; 51(2):72–74.

Portions of these guidelines were derived from BudgellB. Writing a biomedical research paper. Tokyo: SpringerJapan KK, 2008.

General InstructionsThis set of guidelines provides both instructions and atemplate for the writing of case reports for publication.You might want to skip forward and take a quick look at

* Département chiropratique, Université du Québec à Trois-Rivières, 3351, boul des Forges, Trois-Rivières, Qc, Canada G9A 5H7.© JCCA 2008

Commentary

200 J Can Chiropr Assoc 2008; 52(4)

the template now, as we will be using it as the basis foryour own case study later on. While the guidelines andtemplate contain much detail, your finished case studyshould be only 500 to 1,500 words in length. Therefore,you will need to write efficiently and avoid unnecessarilyflowery language.

These guidelines for the writing of case studies are de-signed to be consistent with the “Uniform Requirementsfor Manuscripts Submitted to Biomedical Journals” ref-erenced elsewhere in the JCCA instructions to authors.

After this brief introduction, the guidelines below willfollow the headings of our template. Hence, it is possibleto work section by section through the template to quick-ly produce a first draft of your study. To begin with, how-ever, you must have a clear sense of the value of the studywhich you wish to describe. Therefore, before beginningto write the study itself, you should gather all of the ma-terials relevant to the case – clinical notes, lab reports, x-rays etc. – and form a clear picture of the story that youwish to share with your profession. At the most superfi-cial level, you may want to ask yourself “What is inter-esting about this case?” Keep your answer in mind asyour write, because sometimes we become lost in ourwriting and forget the message that we want to convey.

Another important general rule for writing case studiesis to stick to the facts. A case study should be a fairlymodest description of what actually happened. Specula-tion about underlying mechanisms of the disease processor treatment should be restrained. Field practitioners andstudents are seldom well-prepared to discuss physiologyor pathology. This is best left to experts in those fields.The thing of greatest value that you can provide to yourcolleagues is an honest record of clinical events.

Finally, remember that a case study is primarily achronicle of a patient’s progress, not a story about chiro-practic. Editorial or promotional remarks do not belongin a case study, no matter how great our enthusiasm. It isbest to simply tell the story and let the outcome speak foritself. With these points in mind, let’s begin the processof writing the case study:

1. Title page:a) Title: The title page will contain the full title of the

article. Remember that many people may find ourarticle by searching on the internet. They mayhave to decide, just by looking at the title, whether

or not they want to access the full article. A titlewhich is vague or non-specific may not attracttheir attention. Thus, our title should contain thephrase “case study,” “case report” or “case series”as is appropriate to the contents. The two mostcommon formats of titles are nominal and com-pound. A nominal title is a single phrase, for ex-ample “A case study of hypertension whichresponded to spinal manipulation.” A compoundtitle consists of two phrases in succession, for ex-ample “Response of hypertension to spinal manip-ulation: a case study.” Keep in mind that titles ofarticles in leading journals average between 8 and9 words in length.

b) Other contents for the title page should be as in thegeneral JCCA instructions to authors. Rememberthat for a case study, we would not expect to havemore than one or two authors. In order to be listedas an author, a person must have an intellectualstake in the writing – at the very least they must beable to explain and even defend the article. Some-one who has only provided technical assistance, asvaluable as that may be, may be acknowledged atthe end of the article, but would not be listed as anauthor. Contact information – either home or insti-tutional – should be provided for each authoralong with the authors’ academic qualifications. Ifthere is more than one author, one author must beidentified as the corresponding author – the personwhom people should contact if they have ques-tions or comments about the study.

c) Key words: Provide key words under which the ar-ticle will be listed. These are the words whichwould be used when searching for the article usinga search engine such as Medline. When practical,we should choose key words from a standard listof keywords, such as MeSH (Medical subjectheadings). A copy of MeSH is available in most li-braries. If we can’t access a copy and we want tomake sure that our keywords are included in theMeSH library, we can visit this address: http://www.ncbi.nlm.nih.gov:80/entrez/meshbrowser.cgi

2. Abstract: Abstracts generally follow one of twostyles, narrative or structured.

A narrative abstract consists of a short version of

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the whole paper. There are no headings within thenarrative abstract. The author simply tries to summa-rize the paper into a story which flows logically.

A structured abstract uses subheadings. Structuredabstracts are becoming more popular for basic scien-tific and clinical studies, since they standardize theabstract and ensure that certain information is includ-ed. This is very useful for readers who search for ar-ticles on the internet. Often the abstract is displayedby a search engine, and on the basis of the abstractthe reader will decide whether or not to download thefull article (which may require payment of a fee).With a structured abstract, the reader is more likelyto be given the information which they need to de-cide whether to go on to the full article, and so thisstyle is encouraged. The JCCA recommends the useof structured abstracts for case studies.

Since they are summaries, both narrative andstructured abstracts are easier to write once we havefinished the rest of the article. We include a templatefor a structured abstract and encourage authors tomake use of it. Our sub-headings will be:a) Introduction: This consists of one or two sentences

to describe the context of the case and summarizethe entire article.

b) Case presentation: Several sentences describe thehistory and results of any examinations performed.The working diagnosis and management of thecase are described.

c) Management and Outcome: Simply describe thecourse of the patient’s complaint. Where possible,make reference to any outcome measures whichyou used to objectively demonstrate how the pa-tient’s condition evolved through the course ofmanagement.

d) Discussion: Synthesize the foregoing subsectionsand explain both correlations and apparent incon-sistencies. If appropriate to the case, within one ortwo sentences describe the lessons to be learned.

3. Introduction: At the beginning of these guidelines wesuggested that we need to have a clear idea of what isparticularly interesting about the case we want to de-scribe. The introduction is where we convey this tothe reader. It is useful to begin by placing the study ina historical or social context. If similar cases havebeen reported previously, we describe them briefly. If

there is something especially challenging about thediagnosis or management of the condition that weare describing, now is our chance to bring that out.Each time we refer to a previous study, we cite thereference (usually at the end of the sentence). Our in-troduction doesn’t need to be more than a few para-graphs long, and our objective is to have the readerunderstand clearly, but in a general sense, why it isuseful for them to be reading about this case.

4. Case presentation: This is the part of the paper inwhich we introduce the raw data. First, we describethe complaint that brought the patient to us. It is of-ten useful to use the patient’s own words. Next, weintroduce the important information that we obtainedfrom our history-taking. We don’t need to includeevery detail – just the information that helped us tosettle on our diagnosis. Also, we should try topresent patient information in a narrative form – fullsentences which efficiently summarize the results ofour questioning. In our own practice, the history usu-ally leads to a differential diagnosis – a short list ofthe most likely diseases or disorders underlying thepatient’s symptoms. We may or may not choose toinclude this list at the end of this section of the casepresentation.

The next step is to describe the results of our clini-cal examination. Again, we should write in an effi-cient narrative style, restricting ourselves to therelevant information. It is not necessary to includeevery detail in our clinical notes.

If we are using a named orthopedic or neurologi-cal test, it is best to both name and describe the test(since some people may know the test by a differentname). Also, we should describe the actual results,since not all readers will have the same understand-ing of what constitutes a “positive” or “negative” re-sult.

X-rays or other images are only helpful if they areclear enough to be easily reproduced and if they areaccompanied by a legend. Be sure that any informa-tion that might identify a patient is removed beforethe image is submitted.

At this point, or at the beginning of the next sec-tion, we will want to present our working diagnosisor clinical impression of the patient.

5. Management and Outcome: In this section, we

Commentary


should clearly describe the plan for care, as well asthe care which was actually provided, and the out-come.

It is useful for the reader to know how long the pa-tient was under care and how many times they weretreated. Additionally, we should be as specific aspossible in describing the treatment that we used. Itdoes not help the reader to simply say that the patientreceived “chiropractic care.” Exactly what treatmentdid we use? If we used spinal manipulation, it is bestto name the technique, if a common name exists, andalso to describe the manipulation. Remember thatour case study may be read by people who are not fa-miliar with spinal manipulation, and, even withinchiropractic circles, nomenclature for technique isnot well standardized.

We may want to include the patient’s own reportsof improvement or worsening. However, wheneverpossible we should try to use a well-validated meth-od of measuring their improvement. For case studies,it may be possible to use data from visual analoguescales (VAS) for pain, or a journal of medication us-age.

It is useful to include in this section an indicationof how and why treatment finished. Did we decide toterminate care, and if so, why? Did the patient with-draw from care or did we refer them to another prac-titioner?

6. Discussion: In this section we may want to identifyany questions that the case raises. It is not our duty toprovide a complete physiological explanation foreverything that we observed. This is usually impossi-ble. Nor should we feel obligated to list or generateall of the possible hypotheses that might explain thecourse of the patient’s condition. If there is a wellestablished item of physiology or pathology whichilluminates the case, we certainly include it, but re-member that we are writing what is primarily a clini-cal chronicle, not a basic scientific paper. Finally, wesummarize the lessons learned from this case.

7. Acknowledgments: If someone provided assistancewith the preparation of the case study, we thank thembriefly. It is neither necessary nor conventional tothank the patient (although we appreciate what theyhave taught us). It would generally be regarded as ex-cessive and inappropriate to thank others, such asteachers or colleagues who did not directly partici-pate in preparation of the paper.

8. References: References should be listed as describedelsewhere in the instructions to authors. Only use ref-erences that you have read and understood, and actu-ally used to support the case study. Do not use morethan approximately 15 references without some clearjustification. Try to avoid using textbooks as refer-ences, since it is assumed that most readers would al-ready have this information. Also, do not refer topersonal communication, since readers have no wayof checking this information.

A popular search engine for English-language ref-erences is Medline: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

9. Legends: If we used any tables, figures or photo-graphs, they should be accompanied by a succinctexplanation. A good rule for graphs is that theyshould contain sufficient information to be generallydecipherable without reference to a legend.

10. Tables, figures and photographs should be includedat the end of the manuscript.

11. Permissions: If any tables, figures or photographs, orsubstantial quotations, have been borrowed from oth-er publications, we must include a letter of permissionfrom the publisher. Also, if we use any photographswhich might identify a patient, we will need theirwritten permission.

In addition, patient consent to publish the case re-port is also required.

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Title:

Running Header:

Authors:a) Name, academic degrees and affiliationb) Name, academic degrees and affiliationc) ...

Name, address and telephone number of correspondingauthor

Disclaimers

Statement that patient consent was obtained

Sources of financial support, if any

Key words: (limit of five)

Abstract: (maximum of 150 words)• Introduction• Case Presentation• Management and Outcome• Discussion

Introduction:Provide a context for the case and describe any similarcases previously reported.

Case Presentation:a) Introductory sentence: e.g. This 25 year old female of-

fice worker presented for the treatment of recurrentheadaches.

b) Describe the essential nature of the complaint, includ-ing location, intensity and associated symptoms: e.g.Her headaches are primarily in the suboccipital region,bilaterally but worse on the right. Sometimes there isradiation towards the right temple. She describes thepain as having an intensity of up to 5 out of ten, ac-companied by a feeling of tension in the back of thehead. When the pain is particularly bad, she feels thather vision is blurred.

c) Further development of history including details oftime and circumstances of onset, and the evolution ofthe complaint: e.g. This problem began to develop

three years ago when she commenced work as a dataentry clerk. Her headaches have increased in frequen-cy in the past year, now occurring three to four daysper week.

d) Describe relieving and aggravating factors, includingresponses to other treatment: e.g. The pain seems to beworse towards the end of the work day and is aggra-vated by stress. Aspirin provides some relieve. She hasnot sought any other treatment.

e) Include other health history, if relevant: e.g. Other-wise the patient reports that she is in good health.

f) Include family history, if relevant: e.g. There is nofamily history of headaches.

g) Summarize the results of examination, which mightinclude general observation and postural analysis, or-thopedic exam, neurological exam and chiropracticexamination (static and motion palpation): e.g. Exami-nation revealed an otherwise fit-looking young womanwith slight anterior carriage of the head. Cervical ac-tive ranges of motion were full and painless except forsome slight restriction of left lateral bending and rota-tion of the head to the left. These motions were ac-companied by discomfort in the right side of the neck.Cervical compression of the neck in the neutral posi-tion did not create discomfort. However, compressionof the neck in right rotation and extension producedsome right suboccipital pain. Cranial nerve examina-tion was normal. Upper limb motor, sensory and reflexfunctions were normal. With the patient in the supineposition, static palpation revealed tender trigger pointsbilaterally in the cervical musculature and right trape-zius. Motion palpation revealed restrictions of rightand left rotation in the upper cervical spine, and re-striction of left lateral bending in the mid to lower cer-vical spine. Blood pressure was 110/70. Houle’s test(holding the neck in extension and rotation for 30 sec-onds) did not produce nystagmus or dizziness. Therewere no carotid bruits.

h) The patient was diagnosed with cervicogenic head-ache due to chronic postural strain.

Management and Outcome:a) Describe as specifically as possible the treatment pro-

vided, including the nature of the treatment, and thefrequency and duration of care: e.g. The patient under-took a course of treatment consisting of cervical and

Template

Commentary


upper thoracic spinal manipulation three times perweek for two weeks. Manipulation was accompaniedby trigger point therapy to the paraspinal muscles andstretching of the upper trapezius. Additionally, advicewas provided concerning maintenance of proper pos-ture at work. The patient was also instructed in the useof a cervical pillow.

b) If possible, refer to objective measures of the patient’sprogress: e.g. The patient maintained a headache diaryindicating that she had two headaches during the firstweek of care, and one headache the following week.Furthermore the intensity of her headaches declinedthroughout the course of treatment.

c) Describe the resolution of care: e.g. Based on the pa-tient’s reported progress during the first two weeks ofcare, she received an additional two treatments in eachof the subsequent two weeks. During the last week ofcare she experienced no headaches and reported feel-ing generally more energetic than before commencingcare. Following a total of four weeks of care (10 treat-ments) she was discharged.

Discussion:Synthesize foregoing sections: e.g. The distinction be-tween migraine and cervicogenic headache is not alwaysclear. However, this case demonstrates several features ...

Summarize the case and any lessons learned: e.g. Thiscase demonstrates a classical presentation of cervicogenicheadache which resolved quickly with a course of spinalmanipulation, supportive soft-tissue therapy and posturaladvice.

References: (using Vancouver style) e.g.1 Terret AGJ. Vertebrogenic hearing deficit, the spine

and spinal manipulation therapy: a search to validate the DD Palmer/Harvey Lillard experience. Chiropr J Aust 2002; 32:14–26.

23

Legends: (tables, figures or images are numbered accord-ing to the order in which they appear in the text.) e.g.

Figure 1: Intensity of headaches as recorded on a visualanalogue scale (vertical axis) versus time (horizontal ax-is) during the four weeks that the patient was under care.Treatment was given on days 1, 3, 5, 8, 10, 12, 15, 18, 22and 25. Headache frequency and intensity is seen to fallover time.

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PRIMER Patient case report

1888 Am J Health-Syst Pharm—Vol 63 Oct 1, 2006

P R I M E R

How to write a patient case reportHENRY COHEN

Purpose. Guidelines for writing patient case reports, with a focus on medication-related reports, are provided.Summary. The format of a patient case report encompasses the following five sections: an abstract, an introduction and objective that contain a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, a summary of the case, and a conclusion. The abstract of a patient case report should succinctly include the four sections of the main text of the report. The introduction section should provide the subject, purpose, and merit of the case report. It must explain why the case report is novel or merits review, and it should include a comprehensive literature review that corroborates the author’s claims. The case presentation section should describe the case in chronological order and in

HENRY COHEN, M.S., PHARM.D., FCCM, BCPP, CGP, is Associate Professor of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy & Health Sciences, Long Island University, Brooklyn, NY; and Director of Pharmacotherapy Education, Research, and Residen-cy Programs, Departments of Pharmacy and Medicine, Kingsbrook Jewish Medical Center, Brooklyn.

Address correspondence to Dr. Cohen at the Department of Phar-

macy, Kingsbrook Jewish Medical Center, 585 Schenectady Avenue, Brooklyn, NY 11203 ([email protected]).

Copyright © 2006, American Society of Health-System Pharma-cists, Inc. All rights reserved. 1079-2082/06/1001-1888$06.00.

DOI 10.2146/ajhp060182

enough detail for the reader to establish his or her own conclusions about the case’s validity. The discussion section is the most important section of the case report. It ought to evaluate the patient case for accu-racy, validity, and uniqueness; compare and contrast the case report with the published literature; derive new knowledge; summa-rize the essential features of the report; and draw recommendations. The conclusion section should be brief and provide a con-clusion with evidence-based recommenda-tions and applicability to practice.Conclusion. Patient case reports are valu-able resources of new and unusual infor-mation that may lead to vital research.

Index terms: Drugs, adverse reactions; Guidelines; Reports; WritingAm J Health-Syst Pharm. 2006; 63:1888-92

Published patient case reports provide essential sources of information for the optimum

care of patients because case reports can describe important scientifi c ob-servations that are missed or are un-detectable in clinical trials, provide insightful information that expands our knowledge and spawns new re-search, and provide information that strays from the classical textbook case and leads to better and safer patient care. Indeed, a case report of Kaposi’s sarcoma in a young homosexual man is the seminal observation to the development of acquired im-mune defi ciency syndrome.1 Seminal patient case reports linked the Food and Drug Administration-approved indication for the anorexic agents, fenfl uramine and dexfenfl uramine, with primary pulmonary hyperten-sion and subsequently spawned tri-als that evaluated the mechanism, incidence, and risk factors of this adverse effect, culminating in their withdrawal from the market.2-5

Many biomedical journals publish case reports and provide authors with guidelines that provide instruction for acceptance criteria, content, and format. The types of relevant patient case reports that merit publication are listed in Appendix A. This article

will provide guidelines for writing patient case reports, with a focus on medication-related reports.

Format of the patient case reportCase reports should encompass

the following fi ve sections: an ab-stract, an introduction and objective with a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, a summary of

the case, and a conclusion.6,7 Supple-mentary parts such as tables, fi gures, graphs, and illustrations provide es-sential data and will enhance the arti-cle’s fl ow and clarity. Generally, most of the data contained in supplemen-tary parts should not be duplicated in the text.6,7 Patient case reports can describe a single case report or a se-ries of case reports. Case reports are generally 1500–2500 words in length with 20–30 references. The title of the


1889Am J Health-Syst Pharm—Vol 63 Oct 1, 2006

case report should be descriptive, ac-curate, and succinct.

Abstract. Case reports should in-clude an abstract of 100–250 words. The availability of an abstract will allow for easier retrieval from elec-tronic databases and help research-ers discern their levels of interest in the case report. The abstract should include the same four sec-tions as the main text in a succinct form—introduction and objective, case presentation, discussion, and conclusion—but the format may vary depending on a journal’s style if submitted for publication.

Introduction. The introduction section should be concise and salient and immediately attract the atten-tion and interest of the reader. The introduction should provide the sub-ject, purpose, and merit of the case report. It should present background information that provides clarity to the subject of discussion. This should be followed by an explanation of why the case report is novel or merits review. A focused comprehensive lit-erature review that corroborates the author’s claims should accompany the introduction. If few citations are found, they should all be cited chron-ologically; however, if many citations are found, the seminal, historical, and most pertinent references should be cited. The significant details from the literature review and how those details compare and contrast to the current case should be explained in the discussion, not in the introduc-tion. A brief one- or two-sentence description of the patient case should be provided and is an excellent segue for the case presentation section. The introduction should not be more than three paragraphs and does not need to be labeled with a heading (i.e., Introduction).

A literature review should list the strategy and extent of the search and should include the database searched, the dates that the data-base was searched, the languages covered, and the search terms used.

The literature search should provide enough detail for the reader to easily reproduce the search. Databases that are commonly searched because of their comprehensiveness of biomedi-cal content include MEDLINE and EMBASE. However, it is important that the breadth of the search uses databases that contain information that may not be found in MEDLINE or EMBASE. For example, a case report of an adverse drug event or medication error should include a re-view of an adverse reaction database such as Clin-Alert or databases that review pharmacy publications such as International Pharmaceutical Ab-stracts and Iowa Drug Information Service. A case report describing the collaboration of a pharmacist and a nurse that improves a patient’s care should include a search in the nurs-ing database such as the Cumulative Index to Nursing and Allied Health Literature. Furthermore, to maximize the literature search findings, authors should meticulously search the refer-ence lists of review articles and meta-analyses. Finally, clinicians ought to be cognizant that early reports may not be detected in a literature search because of changes in concepts, no-menclature, and terminology since their publication date.

Case presentation. The descrip-tion of the patient case is one of the most integral sections of the case report. It should describe the case in chronological order and in enough detail for the reader to establish his or her own conclusions about the case’s validity. A case report that contains detailed and relevant pa-tient information allows the reader with a different clinical expertise to uncover idiosyncracies that are not detected or described by the author and stimulates further inquiry and commentary. The case presentation should only include information that pertains to the case and refrain from providing confusing and su-perfluous data. Daily patient prog-ress including normal vital signs,

routine laboratory results, typical consultation with other disciplines, step-down transfers to wards, and other irrelevant patient information must be avoided. The author should establish a causal and temporal re-lationship and indicate the effect of treatment, any unanticipated effects, the patient’s final outcome, any fur-ther proposed treatments, and the patient’s present status at the time of the report.

Patient’s demographics and history. Patient demographics such as age, height, weight, sex, race, and occupa-tion must be included. Although the race or occupation of the patient may appear as superfluous, this type of in-formation may uncover pharmacoge-nomic or environmental influences. In order to limit the possibility of identifying the patient, the patient’s initials, date of birth, and other identifiers must not be used. Precise dates, including the month, day, and year of admission or other important events, should be avoided—they can aid in identifying the patient and de-tract the reader from the case report by calculating elapsed time. In a brief summary and in a narrative form, the patient’s chief complaint, present illness, medical history, family and social history, and use of recreational drugs should be listed. Headings for each part of the patient’s history should not be used. The type of phys-ical examination performed should be described, and any abnormalities should be reported.

Patient’s laboratory and diagnostic data. The patient’s laboratory values and diagnostic data that support the case report and rule out a differential diagnosis should be reported. Perti-nent positive or negative laboratory results must be provided. When the reference range of a laboratory value is not widely known or established, it should be provided in parentheses. Diagnostic procedures, the timeline in which they were administered, and a brief report of the results should be included. A verbatim description



of a pathologist’s report must not be used; instead, a salient report of the results should be included. Pictures of histopathology, roentgenograms, electrocardiographs, and other di-agnostic tests; skin manifestations; wounds; and other anatomical parts may be provided and add to the in-terest of the report. Any identifying features of a patient’s photograph should be blocked out. Institutional policies and patient permission for obtaining and using photographs must be followed.

Patient’s medication history. The patient’s medication history should include the medication’s name, strength, dosage form, route, and dates of administration. The brand or generic name of the drug and the name of the manufacturer may be relevant to the case and should be listed. Brand and generic drugs may have different bioavailability fac-tors or may contain different fi llers, preservatives, additives, or dyes—all of which may be pertinent to cases regarding the drugs’ pharmacokinet-ics, effi cacy, and adverse effects. Since a medication history may often omit herbals, vaccines, depot injections, and nonprescription medications, the author should specify the history of each of these medication types. The dates a medication was discon-tinued should be identified, since medications may have lasting effects for months after discontinuation. The author should verify and inform the reader of the patient’s history of medication adherence.

In order to evaluate the appropri-ateness of a medication’s dosage regi-men, laboratory values that describe renal and hepatic organ functions should be provided. Renal function values should include serum cre-atinine, blood urea nitrogen, and the total fl uid volume intake and excre-tion when a urinary catheter is in place. Calculation methods used to estimate the patient’s renal function should be identifi ed. Liver function tests such as the International Nor-

malized Ratio, serum albumin, and albumin:globulin ratio and hepatic enzyme tests such as aspartate and alanine aminotransferases should be provided.

A comprehensive medication his-tory should also include the patient’s allergy status. The allergy history should include the date of the reac-tion, the name of the drug, and the type of allergic manifestation. The name of the drug should be listed as either the generic or brand name, and combination products should be list-ed as such. Allergies to combination products such as Unasyn and Zosyn can be mislabeled as a penicillin al-lergy rather than a sulfone allergy or vice versa. Similarly, an allergy to Septra or Bactrim can be mislabeled as an allergy to sulfonamide rather than to trimethoprim or vice versa. Some nonallergic adverse drug reac-tions such as drug-induced seizures may not be included in the allergy his-tory; nevertheless, the author should investigate and report such data.

When available, drug serum levels ought to be listed along with the time they were drawn and their relation-ship to the dosage of the medication administered (e.g., trough, peak). Drug serum levels should delineate between total and free levels (e.g., phenytoin, valproic acid). Since there may be intralaboratory varia-tions in drug serum reference ranges, the reference range should always be provided in parentheses. When pertinent to the case, the method of drug serum level assay should also be included.

Patient’s diet. The patient’s diet history ought to be included in the case report. Food can interact with medications, yielding lower or higher serum drug levels or increasing or decreasing the drug’s pharmacologic effect. The patient’s diet can have consequential effects on a disease state. Dietary causes of adverse events, such as allergic reactions, should be ruled out before suspect-ing a drug allergy.

Discussion. The discussion sec-tion is the most important section of the case report. The discussion should evaluate the patient case for accuracy, validity, and uniqueness; compare and contrast the case re-port with the published literature; and derive new knowledge and ap-plicability to practice. The author must confi rm that the case report is valid by ensuring the accuracy of the data presented and by establishing a temporal and causal relationship. For drug-induced adverse effects, a validated nomogram to establish the probability of causality such as the Naranjo nomogram must be used.8

The author should comprehensively list the limitations of the case and should describe the signifi cance of each limitation.

The author should briefl y summa-rize the published literature derived from the literature review and may provide a detailed summary of a few citations. A table listing the pertinent facts of the cases detected from the literature review is a simple method for providing extensive, detailed data in an interpretable form. The author should compare and contrast the nuances of the case report with the published literature and should ex-plain and justify the differences and similarities. The discussion section of a case report is in no way designed to provide comprehensive details of each citation of an all-inclusive and extensive literature review—this should be saved for review articles. All the references cited should be critically evaluated. Transferring an unread reference cited in another article is unethical and will place the author of the case report at risk of er-ror and embarrassment.

The author should next summa-rize the essential features of the case report, justify why this case is unique, and draw recommendations and conclusions.

Conclusion. Based on the evi-dence reviewed in the discussion sec-tion, the author must provide a justi-


1891Am J Health-Syst Pharm—Vol 63 Oct 1, 2006

fied conclusion. The author must be careful not to make firm judgments and sweeping recommendations based on speculation, on limited and tenuous information, or on a few case reports. However, justifiable evidence-based recommendations should be stated. The author may suggest that clinicians be cognizant of the insight learned from the case or suggest heightened vigilance, prudent management, avoidance, further study before taking action, or new ideas for investigation. How the information discovered from the case report will apply to the author’s prac-tice should be described. This section should be concise and not exceed one paragraph. Guidelines for writ-ing patient case reports in a checklist format (Appendix B) can facilitate and enhance the manuscript writing process.

SummaryPatient case reports are valuable

resources of new and unusual infor-mation that may lead to vital research and advances in clinical practice that improve patient outcomes. Case re-ports should contain an abstract and four sections—an introduction, case presentation, discussion, and conclu-sion. The introduction provides the subject, purpose, and merit of the case report and the strategy used for the literature review. The patient case presentation should be descriptive, organized chronologically, accurate, salient, and presented in a narrative form. The discussion should com-pare and contrast the case report’s findings with the literature review, establish a causal and temporal rela-tionship, and validate the case with a probability scale. The literature re-view should be extensive and should support the justification of the case report. The discussion section should end with a brief summary of the case with rational recommendations and conclusions. The conclusion section must provide a brief conclusion with evidence-based recommendations.

ConclusionPatient case reports are valuable re-

sources of new and unusual informa-tion that may lead to vital research.

References1. Gottleib GJ, Rogoz A, Vogel JV et al. A pre-

liminary communication on extensively disseminated Kaposi’s sarcoma in a young homosexual man. Am J Dermatopathol. 1981; 3:111-4.

2. Douglas J, Munro J, Kitchin A et al. Pul-monary hypertension and fenfluramine. Br Med J. 1981; 283:881-3.

3. Atanasson P, Weiss B, Schmid E et al. Pulmonary hypertension and dexfenflura-mine. Lancet. 1992; 339:436. Letter.

4. Weir EK, Reeve HL, Huang JM et al. Anorexic agents aminorex, fenfluramine, and dexfenfluramine inhibit potassium current in rat pulmonary vascular smooth muscle and cause pulmonary vasocon-striction. Circulation. 1996; 94:2216-20.

5. Abenhaim L, Moride Y, Brenot F et al. Appetite-suppressant drugs and the risk of primary pulmonary hypertension. N Engl J Med. 1996; 335:609-16.

6. DeBakey L, DeBakey S. The case report. I. Guidelines for preparation. Int J Cardiol. 1983; 4:357-64.

7. McCarthy LH, Reilly KE. How to write a case report. Fam Med. 2000; 329:190-5.

8. Naranjo CA, Busto U, Sellers EM et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981; 30:239-45.

Appendix A—Criteria for publishable case reports

Publishable patient case reports include cases that:

• Advance medical science and spawn research;• Describe rare, perplexing, or novel diagnostic

features of a disease state;• Report therapeutic challenges, controversies,

or dilemmas;• Describe a new surgical procedure;• Report how a drug can enhance a surgical

procedure; • Teach humanistic lessons to the health care

professional;• Review a unique job description of a health

care professional that improves patient care;• Report new medical errors or medication

errors;• Discover a device malfunction that results in

patient harm;• Describe adverse effects and patient toxicity

of a radiopaque agent;• Describe life-threatening adverse events;• Describe dangerous and predictable adverse

effects that are poorly appreciated and rarely recognized;

• Describe rare or novel adverse drug reactions;• Describe a therapeutic failure or a lack of

therapeutic efficacy;

• Describe rare or novel drug–drug, drug–food, or drug–nutrient interactions;

• Report unlabeled or unapproved uses of a medication;

• Explore the use of pharmacogenomics to manage diseases;

• Use life-saving techniques not previously documented;

• Use pharmacoeconomic principles that im-prove patient care;

• Uncover barriers to patient adherence;• Discover an interaction between a drug and a

laboratory test that yields a false-positive or false-negative result;

• Describe the effect of drugs in pregnancy and lactation;

• Detect novel pharmacokinetic or pharmaco-dynamic principles; and

• Use technology to improve patient outcomes.

Appendix B—Guidelines for writing patient case report manuscripts

(The following checklist is comprehensive; some items may not apply to all types of case reports.)

I. Abstract Introduction and objective. Case report. Discussion. Conclusion.

II. Introduction Describe the subject matter. State the purpose of the case report. Provide background information. Provide pertinent definitions. Describe the strategy of the literature review

and provide search terms. Justify the merit of the case report by using

the literature review. Introduce the patient case to the reader. Make the introduction brief and less than

three paragraphs.

III. Patient case presentation Describe the case in a narrative form. Provide patient demographics (age, sex,

height, weight, race, occupation). Avoid patient identifiers (date of birth, ini-

tials). Describe the patient’s complaint. List the patient’s present illness. List the patient’s medical history. List the patient’s family history. List the patient’s social history. List the patient’s medication history before

admission and throughout the case report. Ensure that the medication history includes

herbals, vaccines, depot injections, and non-prescription medications, and state that the patient was asked for this history.

List each drug’s name, strength, dosage form, route, and dates of administration.

Verify the patient’s medication adherence. Provide renal and hepatic organ function

data in order to determine the appropriate-ness of medication dosing regimens.



List the patient’s drug allergy status, including the name of the drug (brand or generic) and the date and type of reaction.

List the patient’s adverse drug reaction history and the dates of the reaction.

Provide pertinent serum drug levels and include the time of each level taken and its relationship to a dose.

Provide the patient’s dietary history. Provide pertinent fi ndings on physical examination. Provide pertinent laboratory values that support the case. Provide the reference range for laboratory values that are not

widely known or established. List the completed diagnostic procedures that are pertinent and sup-

port the case. Paraphrase the salient results of the diagnostic procedures. Provide photographs of histopathology, roentgenograms, electrocar-

diograms, skin manifestations, or anatomy as they relate to the case. Obtain permission from the patient to use the patient’s photographs,

or follow institutional guidelines. Provide the patient’s events in chronological order. Ensure a temporal relationship. Ensure a causal relationship. Ensure that the patient case presentation provides enough detail for

the reader to establish the case’s validity.

IV. Discussion Compare and contrast the nuances of the case report with the litera-

ture review. Explain or justify the similarities and differences between the case

report and the literature. List the limitations of the case report and describe their relevance. Confi rm the accuracy of the descriptive patient case report. Establish a temporal relationship. Establish a causal relationship. Report the validity of the case report by applying a probability scale

such as the Naranjo nomogram. Summarize the salient features of the case report. Justify the uniqueness of the case. Draw recommendations and conclusions.

V. Conclusion Provide a justifi ed conclusion. Provide evidence-based recommendations. Describe how the information learned applies to one’s own practice. List opportunities for research. Ensure that this section is brief and does not exceed one paragraph.

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SPECIAL ARTICLE

Tips and Tricks to Make Case ReportIdrus Alwi

ABSTRACTThe main purpose of a case report is to educate

clinicians about the clinical features, investigation, and/or the treatment of patients with unusual problems. It is important to remember that all the rules that apply to other forms of medical writing, also apply equally to case reports. The IMRAD format (introduction, methods, results, and discussion) that one sees in reports of clinical research might not always be appropriate for case reports. Article of case report usually contains a title, authorship, introduction, case description, discussion, references, and acknowledgements.

Author decision between submitting to a general, specialist, or even subspecialty journal will depend on the rarity of the case and its specic features. Keep in mind the basic reason for writing a case report: namely, that it should have a message for the reader. It consider who the message is aimed at, and then select a journal whose readership will include the target audience.

Key words: case report, medical writing.

INTRODUCTIONVirtually every physician in the world has, at one

time or another, read the case report in the journal.1,2 Case reports have their own role in the progress of medical science.3 Most clinical journals publish case reports that explain how patients presented for medical care, how the course of the illness progressed, and what treatment was given.4

Explanation of a case history is one of the skill that acquired early in undergraduate training and one that most clinicians use troughout their careers. For many clinicians, a case report is the first entry into print and because the basic method is familiar, it is a useful exercise in learning how to write.1

The main purpose of a case report is to educate clinicians about the clinical features, investigation,

Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, University of Indonesia-dr. Cipto Mangunkusumo Hospital, Jakarta

and/or the treatment of patients with unusual problems.4 It is important to remember that all the rules that apply to other forms of medical writing, also apply equally to case reports. The reader must have a clear understanding of : what happened to the patient, the time course of these events and why management followed the lines that it did.1

Key feature of a good case report is that it should help the reader to recognize and deal with a similar problem should one ever present itself. In preparing a case report, the writer should be asking three questions: What am I going to report?, how should I report it?, and in which journal am I aiming to publish the report?1

WHAT TO REPORTThe case must be special and have a message for the

reader. It could be raise awareness of the condition so that the diagnosis may be made more readily in the future, or the report might indicate how one line of treatment was more suitable and effective than another.1Topics that may be reported in case reports: 4

• Clinical conditions that have not been described before

• Unusual and unreported presentations of known clinical conditions

• Unexpected benecial responses to a treatment• Previously unreported adverse reactions to a

treatment• Errors in diagnosis as a result of use of incorrect

tests or presentation with unusual symptoms• New uses of a diagnostic tool or use of novel

diagnostic tools• Phenotypes associated with a newly found gene.

You would do well to remember from the beginning that the rst reader of the report will be the editor. Although some editors are totally averse, many feel that case reports help attract readers by making their journals seem a little more relevant to ordinary clinicians who feel that the more scientic contributions do not interest them immediately.1

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Vol 39 • Number 2 • April - June 2007 Tips and Tricks to Make Case Report

Most editors whose journals include case reports receive many more than they have space to publish, so the writer must ensure that the report is unusual, interesting, and readable, to give it the best chance of being accepted.1

HOW TO REPORTAfter you have established that your case is of

interest to others, you need to ensure that the material is presented in a fashion that will make others share your interest. It is probably wise to start by writing down (for your initial verbal presentation) the details of the case, then to develop the discussion, and nally to add the other components. This is not the way in which the reader will encounter the report, however, and the overall sequence must be kept in mind throughout.1

FORMAT OF CASE REPORTThe usual IMRAD format (Introduction, Methods,

Results, and Discussion) that one sees in reports of clinical research might not always be appropriate for case reports.3

TitleMost journal readers decide which papers they are

going to read by skimming the titles. If the title of a case report is too full, the reader may feel it has said all there is to know. Ideally the title should be short, descriptive, and eye catching.1

AuthorshipEstablishing authorship is an increasing problem in

medical publication, and this applies particularly to case reports. Only one person should actually write the paper, with the other authors restricted to those who had a signicant input to the management of those aspects that were unusual. A case report written by two or three individuals may be reasonable, but it is difcult to see any justication for a list of ve or sick authors to describe the management of one patient.1

IntroductionThere is a tendency to write short history of the

condition when introducing a case report, but this is either unnecessary material or it should be put in the discussion.

Certainly, the introduction may be used to place the case in context or indicate its relevance, but often there is no need to have an opening section at all. The report may begin simply with the case description.1

Case DescriptionWhen you write the core part of the paper, it is

essential that you keep to the basic rules of clinical practice. The details will vary a little according to the specialty, but report should be chronological and detail the presenting history, examination ndings, and investigation result before going on to describe the patient’s progress. The description should be complete, but the real skill is to accentuate the positive features without obscuring them in a mass of negative and mostly irrelevant ndings.

Consider what question of fact a colleague might ask (this is one reason for an initial verbal presentation) and ensure that the answers are presented clearly within the report. Illustrations can be particularly helpful, and in some circumtances they are essential. A photograph of the patient or the equipment used, line diagrams of operative procedures, graphs of physiological measurements, and summary tables of events can all, when used appropriately, add much to the reader’s understanding.1

Whatever the format of a case report it is important to ensure that the patient is described as a person and not as a case,4 and that condentiality must be absolute.1 Age, occupation, and geographical location the patient, yet much information can be essential to the report. Similarly, blanking over the eyes may be enough to obscure identity only if the reader does not know the individual. Increasingly, it may be wise to obtain written consent from the patient at an early stage in the preparation of the report, particularly if photographic material is to be used. Many journals now insist on this.1

DiscussionWhen you are preparing a report of an unusual

condition, it will often be tempting to expand the paper and produce a review of the literature – particularly if a great deal of work has been put into gathering all the published information on the condition. This is a temptation that should be resisted (by editors as well as authors).

The main purpose of the discussion is to explain how and why decisions were made and what lesson is to be learn from this experience. Some reference to other cases may be required, but, again, the tendency to produce a review must be resisted. The aim should be to rene and dene the message for the reader. A good case report will make it quite clear how such a patient would be managed in the future.1

98

Idrus Alwi Acta Med Indones-Indones J Intern Med

ReferencesAs indicated above, reference to the work of others

should be made only where needed to make a clear point. If a standard textbook has indicated that one line of treatment should have been followed, then it should be quoted. Reports by others should be mentioned only where they actively support (or contradict) the particular experience and conclusion.

No matter how exhaustive your search of the literature has been, something may have been missed out. Only a very brave, or perhaps foolhardy, author claims absolute priority in the description of some clinical phenomenon.1

AcknowledgementsAcknowledgement of the assistance and support of

others is almost as difcult an area as the decision about who should be included as authors of a case report. The key question is whether the patient would have been managed or the paper written without the assistance of that specic individual.

A particular problem is deciding whether it is necessary to thank the consultant or other individual clinically responsible for the patient for permission to publish details. With the modern tendency to seek permission from the patient, this rather old fashioned practice is dying out.1

WHERE TO PUBLISHA provisional decision about which journal the

report will be submitted to should be made before starting to write. The next stage must be to read the guidelines to contributors. Journals vary in style and it is helpful to try and picture how the report will appear in print while you are preparing it. The author should always aim for a peer reviewed journal and one that he or she already reads regularly. Familiarity with the journal will provide a better idea of what the editor, and thus the readers, nd interesting, and will help with the whole process of preparation.

Thereafter, your decision will be between submitting to a general, specialist, or even subspecialty journal. The choice will depend on the rarity of the case and its specic features. Keep in mind the basic reason for writing a case report: namely, that it should have a message for the reader. Decide what the message is, consider who the message is aimed at, and then select a journal whose readership will include the target audience.1

GUIDELINES FOR A CASE REPORT• The report should detail:

• What happened to the patient• The time course of events• Why the particular management was chosen

• An opening section may not be needed. Begin with the case description if possible

• Positive features should be accentuated and irrelevant details avoided

• A photograph or other illustration may be useful• Condentiality must be absolute• The discussion should be useful and not overlong• Reference other work only when necessary to make

a specic point• Cases that really merit publication always have an

educational message.

THE FINAL STAGES OF PREPARATIONOnce the rst draft is written you should put it away

for a week or two, then rene it and revise it several times. Reading the report aloud – rst in private and later to one or two others who have not heard the case before – is an invaluable exercise. This will help improve the clarity of the report and its English, as well as bringing out any inconsistencies of fact or interpretation.

The text should be checked and rechecked for errors in spelling, punctuation, and adherence to the journal’s instruction on style. Finally, the requisite number of clear copies, correctly paginated, should be sent with a polite covering letter to the editor – accompanied by a silent prayer that the next issue of that journal.1

REFERENCES1. Wildsmith JAW. How to write a case report. In: Hall GM,

ed. How to write a paper. 3th edition. London: BMJ; 2006. p. 85-91.

2. Harris NL. Case records of the Massachusetts General Hospital-continuing to learn from the patient. N Engl J Med. 2003;348(22):2252-4.

3. Vandenbroucke JP. In defense of case reports and case series. Ann Intern Med. 2001;134:330-4.

4. Peat J, Elliott E, Baur L, Keena V. Scientic writing, easy when you know how. London: BMJ; 2006. p. 176-8.

Yes No

Yes No Yes No

Exposure and

Exposure Outcome Outcome at the

Same time

Exposure Outcome

Figure: Algorithm for classification of types of clinical research

(Reference- The Lancet handbook of essential concepts in clinical research, Fig 1.1)

Did investigator assign exposures?

Experimental Study

Random selection

Observational Study

Comparison group?

Randomized controlled

trial

Non-Randomized controlled

trial

Analytical study Descriptive study

Direction?

Cohort study

Case - control study

Cross - sectional

study

Maharashtra University of Health Sciences, Nashik Department of AYUSH Template for Synopsis

Synopsis Head Instructions

1. Research Question Source for the research question

It should follow A) FINER criteria: Feasible, Interesting, Novel, Ethical, Relevant B) PICO criteria : Participant / Patients, Intervention/Treatment, Comparator / Control, Out come of research

2. Hypothesis “A hypothesis can be defined as a tentative explanation of the research problem, a possible outcome of the research, or an educated guess about the research outcome.”(Sarantakos, 1993: 1991)

It is useful at the outset to specify the hypotheses in terms of the assumed relations between variables so as to clarify the position and pre-understanding of the researcher.

Hypotheses can be derived from theory, experience or knowledge concerning contextual factors. In purely quantitative, deductive research hypotheses are tested statistically, whereas in qualitative, inductive research hypotheses formulated.

3. Title Description of variables ( Dependable/ Independable)

It should relate directly to the main objective of the proposed research.

A more specific and descriptive sub-title can be added if necessary, for example to indicate the main methodology that will be applied.

Title should follow the ABC criteria - Accurate, Brief, and Clear

4. Abstract The abstract should briefly state the problem, the main objective(s), the theories/conceptual framework used (if relevant), and the method(s).

The abstract alone should give the reader a clear idea about the research

5. Introduction This usually consists of outlining the question addressed by the research.

Magnitude of stated problem. With earlier attempts to solve it.

Epidemiological data at state, national and international level.

Relevance with continual research, national priorities.

Provide a concise review of what is known about the problem addressed by the researcher, what remains unknown, and how your research project fills the knowledge gaps.

Brief description of solutions of research question.

6. Literature review In this section one should include the ongoing research status available nationally or internationally.

You should present documentation of the existence of the problem and the theories typically used to frame research on the subject area, knowledge available and research methods used with what degree of success.

The review can add to the justification of choice of the subject included in the Introduction.

It is important that the review includes recent literature relevant to the subject.

Source for literature: Text book, Govt. reports, Reference books, Journals, Database, Websites

7. Objectives The objectives should focus on concepts and problems mentioned in the literature review.

Primary & Secondary

Objectives should meet SMART criteria : Specific, Measurable, Achievable, Relevant, Time bound

8. Methodology Appropriate study design

Study flow chart

Specify the research methodology for data collection.

A description of the methodology used does not mean a reproduction of standard textbook definitions; instead, references should be used. A reference will be sufficient for commonly used methods, whereas it is relevant to describe the specific data to be collected.

The description of data collection methods should always be as specific and realistic as possible.

Statistical methods planned for study (Descriptive /Inferential )

It should be clear that the chosen methods are appropriate and suitable for achieving the objective. A useful step in that regard is to identify what data is required to answer the specific objectives/research questions.

Outcomes of research.

End points of research.

Responsibilities of individual researcher.

9. Observations Qualitative

Quantitative

Table

Graph

Chart

10. References Harvard style of the reference and the Vancouver 11. Annexure Case record form

Informed consent form ( including vernacular language)

Abbrivations

List of Ardverse Drugs Reactions ( ADRs)

Validated and authentic parameters for assessment of study outcomes (questionnaire, instruments, scale, laboratory investigations, ect.)

Approval from ethics committee

Authentic documents of collaborative research work (Utilization infrastructure, human resources, etc.)

References of Synopsis Template:

Guidelines for Biomedical Research

National priorities by Govt. of India for research

National institutes in Maharashtra

Journals for Biomedical Research

Databases for Biomedical Research

Portals for Biomedical Research

1

STROBE Statement—checklist of items that should be included in reports of observational studies Item

No Recommendation (a) Indicate the study’s design with a commonly used term in the title or the abstract Title and abstract 1 (b) Provide in the abstract an informative and balanced summary of what was done and what was found

Introduction Background/rationale 2 Explain the scientific background and rationale for the investigation being reported Objectives 3 State specific objectives, including any prespecified hypotheses

Methods Study design 4 Present key elements of study design early in the paper Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment,

exposure, follow-up, and data collection (a) Cohort study—Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up Case-control study—Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls Cross-sectional study—Give the eligibility criteria, and the sources and methods of selection of participants

Participants 6

(b) Cohort study—For matched studies, give matching criteria and number of exposed and unexposed Case-control study—For matched studies, give matching criteria and the number of controls per case

Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable

Data sources/ measurement

8* For each variable of interest, give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group

Bias 9 Describe any efforts to address potential sources of bias Study size 10 Explain how the study size was arrived at Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If applicable,

describe which groupings were chosen and why (a) Describe all statistical methods, including those used to control for confounding (b) Describe any methods used to examine subgroups and interactions (c) Explain how missing data were addressed (d) Cohort study—If applicable, explain how loss to follow-up was addressed Case-control study—If applicable, explain how matching of cases and controls was addressed Cross-sectional study—If applicable, describe analytical methods taking account of sampling strategy

Statistical methods 12

(e) Describe any sensitivity analyses Continued on next page

2

Results (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed (b) Give reasons for non-participation at each stage

Participants 13*

(c) Consider use of a flow diagram (a) Give characteristics of study participants (eg demographic, clinical, social) and information on exposures and potential confounders (b) Indicate number of participants with missing data for each variable of interest

Descriptive data

14*

(c) Cohort study—Summarise follow-up time (eg, average and total amount) Cohort study—Report numbers of outcome events or summary measures over time Case-control study—Report numbers in each exposure category, or summary measures of exposure

Outcome data 15*

Cross-sectional study—Report numbers of outcome events or summary measures (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included (b) Report category boundaries when continuous variables were categorized

Main results 16

(c) If relevant, consider translating estimates of relative risk into absolute risk for a meaningful time period

Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity analyses

Discussion Key results 18 Summarise key results with reference to study objectives Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision.

Discuss both direction and magnitude of any potential bias Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity

of analyses, results from similar studies, and other relevant evidence Generalisability 21 Discuss the generalisability (external validity) of the study results

Other information Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable,

for the original study on which the present article is based *Give information separately for cases and controls in case-control studies and, if applicable, for exposed and unexposed groups in cohort and cross-sectional studies. Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at www.strobe-statement.org.

STROBE statement: Checklist of essential items Version 2 (April 2005)

Item # Cohort Case-control Cross-sectional

(a) Identify the article as a cohortstudy in the title or the abstract.

(a) Identify the article as acase-control study in the title orthe abstract.

(a) Identify the article as a cross-sectional study in the title or theabstract.

TITLE & ABSTRACT 1

(b) The abstract should be a highly informative structured summary of the article, taking account of allissues in the checklist below.

INTRODUCTION

Background / Rationale 2 Explain scientific background and rationale for the study.

Objectives 3 State specific objectives and hypotheses.

METHODS

Study design 4 Present key elements of study design.State purpose of original study, if article is one of several from an ongoing study.

Setting 5 Describe setting, locations and dates defining periods of data collection.

Participants 6 Give eligibility and exclusioncriteria, source and methods ofselection of participants.If applicable, describe exposed andunexposed separately.Give period of follow-up.

For cases and controlsseparately, give eligibility andexclusion criteria, source andmethods of selection of casesand controls.Give precise diagnostic criteriafor cases, and rationale forchoice of controls.For matched studies, givematching criteria and number ofcontrols per case.

Give eligibility and exclusioncriteria, source and methods ofselection of participants.

Variables of interest 7 List and clearly define alloutcomes, potential predictors andconfounders, and predefinedsubgroups.

List and clearly define allexposures, potentialconfounders, and predefinedsubgroups.

List and clearly define alloutcomes, potential predictors andconfounders, and predefinedsubgroups.

(a) For each variable of interest give details of methods of assessment.Measurement 8

(b) Describe comparability ofprocedures across groups, ifapplicable.

(b) Describe comparability ofprocedures in cases andcontrols.

(b) Describe comparability ofprocedures across groups, ifapplicable.

Bias 9 Describe any measures taken to address potential sources of bias.

Sample size 10 Describe rationale for study size, including practical and statistical considerations.

(a) Describe all statistical methods,including those to control forconfounding, and how loss tofollow-up and missing data wereaddressed.

(a) Describe all statisticalmethods including those tocontrol for confounding.Account for matching andmissing data.

(a) Describe all statisticalmethods, including those tocontrol for confounding andaccount for any design effects andmissing data.

Statistical methods 11

(b) If applicable, describe methods for subgroup analyses and sensitivity analyses.

Quantitativeexposures

12 (a) Give a clear explanation of how quantitative exposures are analyzed, e.g. which groupings are chosen,and why.

(b) Present results from continuous analyses as well as from grouped analyses, if appropriate.

Funding 13 Give source of funding and role of funder(s) for the present study and, if applicable, the original study onwhich the present report is based.

RESULTS

(a) For each group, report thenumber of potentially eligibleindividuals, the numberexamined for eligibility (if known),the number eligible, the numberincluded in the study, thenumbers completing follow up,and the number analysed.Report dates defining the follow-up.

(a) For cases and controlsseparately, report the numberof potentially eligible individuals(if known), the numberexamined for eligibility, thenumber eligible, the numberincluded in the study, and thenumber analysed.For matched studies, givedistribution of number ofcontrols per case.

(a) Report the number of potentiallyeligible individuals, the numberexamined for eligibility (if known), thenumber eligible, the number includedin the study, and the numberanalysed.

Participants 14

(b) Give reasons for non-participation at each stage of process. A flow diagram is recommended.

(a) Give baseline characteristicsof study participants (e.g.demographic, clinical, social) andinformation on exposures andpotential confounders, bycomparison group if applicable.Summarize average and totalamount of follow up.

(a) Give characteristics ofcases and controls (e.g.demographic, clinical, social)and information on exposuresand potential confounders.

(a) Give characteristics of studyparticipants (e.g. demographic,clinical, social) and information onexposures and potentialconfounders, by comparison group ifapplicable.

Descriptive data 15

(b) Indicate for each variable of interest the completeness of the data.

Outcome data 16 Report numbers of outcomeevents or summary measuresover time, for each comparisongroup (e.g. exposure category) ifapplicable.

Report numbers of cases andcontrols for each exposurecategory.

Report numbers of outcome eventsor summary measures, for eachcomparison group (e.g. exposurecategory) if applicable.

Main results 17 (a) Give unadjusted and confounder adjusted measures of association and their precision (e.g. 95%confidence intervals). Make clear which confounders were adjusted for and on what grounds they wereincluded and others were not.

(b) If applicable translate relative measures into absolute risk differences.

Other analyses 18 Report any other analyses performed, e.g. subgroup analyses and sensitivity analyses.

DISCUSSION

Key findings 19 Summarize key findings with reference to study hypotheses.

Limitations 20 Discuss limitations of the study, taking into account sources of potential bias or imprecision, and problemsthat could arise from multiplicity of analyses, exposures and outcomes.

Generalizability 21 Discuss the generalizability (external validity) of the study findings.

Interpretation 22 Give a cautious overall interpretation of the results in the context of current evidence and study limitations,paying attention to alternative interpretations.

CONSORT CHECKLIST

Table. Checklist of Items to Include When Reporting a Randomized Trial

Section and Topic Item No. Descriptor Reported on Page No.Title and Abstract 1 How participants were allocated to interventions (eg, “random

allocation,” “randomized,” or “randomly assigned”).Introduction

Background 2 Scientific background and explanation of rationale.Methods

Participants 3 Eligibility criteria for participants and the settings and locations wherethe data were collected.

Interventions 4 Precise details of the interventions intended for each group and howand when they were actually administered.

Objectives 5 Specific objectives and hypotheses.

Outcomes 6 Clearly defined primary and secondary outcome measures and,when applicable, any methods used to enhance the quality ofmeasurements (eg, multiple observations, training of assessors).

Sample size 7 How sample size was determined and, when applicable, explanationof any interim analyses and stopping rules.

RandomizationSequence generation 8 Method used to generate the random allocation sequence, including

details of any restriction (eg, blocking, stratification).Allocation concealment 9 Method used to implement the random allocation sequence (eg,

numbered containers or central telephone), clarifying whether thesequence was concealed until interventions were assigned.

Implementation 10 Who generated the allocation sequence, who enrolled participants,and who assigned participants to their groups.

Blinding (masking) 11 Whether or not participants, those administering the interventions,and those assessing the outcomes were blinded to groupassignment. If done, how the success of blinding was evaluated.

Statistical methods 12 Statistical methods used to compare groups for primary outcome(s);methods for additional analyses, such as subgroup analyses andadjusted analyses.

ResultsParticipant flow 13 Flow of participants through each stage (a diagram is strongly

recommended). Specifically, for each group report the numbersof participants randomly assigned, receiving intended treatment,completing the study protocol, and analyzed for the primaryoutcome. Describe protocol deviations from study as planned,together with reasons.

Recruitment 14 Dates defining the periods of recruitment and follow-up.Baseline data 15 Baseline demographic and clinical characteristics of each group.

Numbers analyzed 16 Number of participants (denominator) in each group included in eachanalysis and whether the analysis was by “intention-to-treat.”State the results in absolute numbers when feasible (eg, 10/20,not 50%).

Outcomes and estimation 17 For each primary and secondary outcome, a summary of results foreach group, and the estimated effect size and its precision (eg,95% confidence interval).

Ancillary analyses 18 Address multiplicity by reporting any other analyses performed,including subgroup analyses and adjusted analyses, indicatingthose prespecified and those exploratory.

Adverse events 19 All important adverse events or side effects in each interventiongroup.

CommentInterpretation 20 Interpretation of the results, taking into account study hypotheses,

sources of potential bias or imprecision, and the dangersassociated with multiplicity of analyses and outcomes.

Generalizability 21 Generalizability (external validity) of the trial findings.Overall evidence 22 General interpretation of the results in the context of current

evidence.

©2006 American Medical Association. All rights reserved. (Reprinted) JAMA, July 5, 2006—Vol 296, No. 1 E1

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