Commentary

Guidelines to the writing of case studies

Dr. Brian Budgell, DC, PhD*

ing material, demonstrating both classical and unusual

presentations which may confront the practitioner. Quite
obviously, since the overwhelming majority of clinical
interactions occur in the field, not in teaching or research
facilities, it falls to the field practitioner to record and
pass on their experiences. However, field practitioners
generally are not well-practised in writing for publication, and so may hesitate to embark on the task of carrying a case study to publication. These guidelines are
intended to assist the relatively novice writer practitioner or student in efficiently navigating the relatively easy
course to publication of a quality case study. Guidelines
are not intended to be proscriptive, and so throughout this
document we advise what authors may or should do,
rather than what they must do. Authors may decide that
the particular circumstances of their case study justify digression from our recommendations.
Additional and useful resources for chiropractic case
studies include:

Dr. Brian Budgell, DC, PhD

JCCA Editorial Board

Introduction
Case studies are an invaluable record of the clinical practices of a profession. While case studies cannot provide
specific guidance for the management of successive patients, they are a record of clinical interactions which
help us to frame questions for more rigorously designed
clinical studies. Case studies also provide valuable teach-

1 Waalen JK. Single subject research designs. J Can Chirop

Assoc 1991; 35(2):9597.
2 Gleberzon BJ. A peer-reviewers 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):7274.

Portions of these guidelines were derived from Budgell

B. Writing a biomedical research paper. Tokyo: Springer
Japan KK, 2008.
General Instructions
This set of guidelines provides both instructions and a
template for the writing of case reports for publication.
You might want to skip forward and take a quick look at

* Dpartement chiropratique, Universit du Qubec Trois-Rivires, 3351, boul des Forges, Trois-Rivires, Qc, Canada G9A 5H7.
JCCA 2008
J Can Chiropr Assoc 2008; 52(4)

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Commentary

the template now, as we will be using it as the basis for

your own case study later on. While the guidelines and
template contain much detail, your finished case study
should be only 500 to 1,500 words in length. Therefore,
you will need to write efficiently and avoid unnecessarily
flowery language.
These guidelines for the writing of case studies are designed to be consistent with the Uniform Requirements
for Manuscripts Submitted to Biomedical Journals referenced elsewhere in the JCCA instructions to authors.
After this brief introduction, the guidelines below will
follow the headings of our template. Hence, it is possible
to work section by section through the template to quickly produce a first draft of your study. To begin with, however, you must have a clear sense of the value of the study
which you wish to describe. Therefore, before beginning
to write the study itself, you should gather all of the materials relevant to the case clinical notes, lab reports, xrays etc. and form a clear picture of the story that you
wish to share with your profession. At the most superficial level, you may want to ask yourself What is interesting about this case? Keep your answer in mind as
your write, because sometimes we become lost in our
writing and forget the message that we want to convey.
Another important general rule for writing case studies
is to stick to the facts. A case study should be a fairly
modest description of what actually happened. Speculation about underlying mechanisms of the disease process
or treatment should be restrained. Field practitioners and
students are seldom well-prepared to discuss physiology
or pathology. This is best left to experts in those fields.
The thing of greatest value that you can provide to your
colleagues is an honest record of clinical events.
Finally, remember that a case study is primarily a
chronicle of a patients progress, not a story about chiropractic. Editorial or promotional remarks do not belong
in a case study, no matter how great our enthusiasm. It is
best to simply tell the story and let the outcome speak for
itself. With these points in mind, lets begin the process
of 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 our
article by searching on the internet. They may
have to decide, just by looking at the title, whether
200

or not they want to access the full article. A title

which is vague or non-specific may not attract
their attention. Thus, our title should contain the
phrase case study, case report or case series
as is appropriate to the contents. The two most
common formats of titles are nominal and compound. A nominal title is a single phrase, for example A case study of hypertension which
responded to spinal manipulation. A compound
title consists of two phrases in succession, for example Response of hypertension to spinal manipulation: a case study. Keep in mind that titles of
articles in leading journals average between 8 and
9 words in length.
b) Other contents for the title page should be as in the
general JCCA instructions to authors. Remember
that for a case study, we would not expect to have
more than one or two authors. In order to be listed
as an author, a person must have an intellectual
stake in the writing at the very least they must be
able to explain and even defend the article. Someone who has only provided technical assistance, as
valuable as that may be, may be acknowledged at
the end of the article, but would not be listed as an
author. Contact information either home or institutional should be provided for each author
along with the authors academic qualifications. If
there is more than one author, one author must be
identified as the corresponding author the person
whom people should contact if they have questions or comments about the study.
c) Key words: Provide key words under which the article will be listed. These are the words which
would be used when searching for the article using
a search engine such as Medline. When practical,
we should choose key words from a standard list
of keywords, such as MeSH (Medical subject
headings). A copy of MeSH is available in most libraries. If we cant access a copy and we want to
make sure that our keywords are included in the
MeSH library, we can visit this address:
http://www.ncbi.nlm.nih.gov:80/entrez/
meshbrowser.cgi
2. Abstract: Abstracts generally follow one of two
styles, narrative or structured.
A narrative abstract consists of a short version of
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B Budgell

the whole paper. There are no headings within the

narrative abstract. The author simply tries to summarize the paper into a story which flows logically.
A structured abstract uses subheadings. Structured
abstracts are becoming more popular for basic scientific and clinical studies, since they standardize the
abstract and ensure that certain information is included. This is very useful for readers who search for articles on the internet. Often the abstract is displayed
by a search engine, and on the basis of the abstract
the reader will decide whether or not to download the
full article (which may require payment of a fee).
With a structured abstract, the reader is more likely
to be given the information which they need to decide whether to go on to the full article, and so this
style is encouraged. The JCCA recommends the use
of structured abstracts for case studies.
Since they are summaries, both narrative and
structured abstracts are easier to write once we have
finished the rest of the article. We include a template
for a structured abstract and encourage authors to
make 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 summarize
the entire article.
b) Case presentation: Several sentences describe the
history and results of any examinations performed.
The working diagnosis and management of the
case are described.
c) Management and Outcome: Simply describe the
course of the patients complaint. Where possible,
make reference to any outcome measures which
you used to objectively demonstrate how the patients condition evolved through the course of
management.
d) Discussion: Synthesize the foregoing subsections
and explain both correlations and apparent inconsistencies. If appropriate to the case, within one or
two sentences describe the lessons to be learned.
3. Introduction: At the beginning of these guidelines we
suggested that we need to have a clear idea of what is
particularly interesting about the case we want to describe. The introduction is where we convey this to
the reader. It is useful to begin by placing the study in
a historical or social context. If similar cases have
been reported previously, we describe them briefly. If
J Can Chiropr Assoc 2008; 52(4)

there is something especially challenging about the

diagnosis or management of the condition that we
are describing, now is our chance to bring that out.
Each time we refer to a previous study, we cite the
reference (usually at the end of the sentence). Our introduction doesnt need to be more than a few paragraphs long, and our objective is to have the reader
understand clearly, but in a general sense, why it is
useful for them to be reading about this case.
4. Case presentation: This is the part of the paper in
which we introduce the raw data. First, we describe
the complaint that brought the patient to us. It is often useful to use the patients own words. Next, we
introduce the important information that we obtained
from our history-taking. We dont need to include
every detail just the information that helped us to
settle on our diagnosis. Also, we should try to
present patient information in a narrative form full
sentences which efficiently summarize the results of
our questioning. In our own practice, the history usually leads to a differential diagnosis a short list of
the most likely diseases or disorders underlying the
patients symptoms. We may or may not choose to
include this list at the end of this section of the case
presentation.
The next step is to describe the results of our clinical examination. Again, we should write in an efficient narrative style, restricting ourselves to the
relevant information. It is not necessary to include
every detail in our clinical notes.
If we are using a named orthopedic or neurological test, it is best to both name and describe the test
(since some people may know the test by a different
name). Also, we should describe the actual results,
since not all readers will have the same understanding of what constitutes a positive or negative result.
X-rays or other images are only helpful if they are
clear enough to be easily reproduced and if they are
accompanied by a legend. Be sure that any information that might identify a patient is removed before
the image is submitted.
At this point, or at the beginning of the next section, we will want to present our working diagnosis
or clinical impression of the patient.
5. Management and Outcome: In this section, we
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should clearly describe the plan for care, as well as

the care which was actually provided, and the outcome.
It is useful for the reader to know how long the patient was under care and how many times they were
treated. Additionally, we should be as specific as
possible in describing the treatment that we used. It
does not help the reader to simply say that the patient
received chiropractic care. Exactly what treatment
did we use? If we used spinal manipulation, it is best
to name the technique, if a common name exists, and
also to describe the manipulation. Remember that
our case study may be read by people who are not familiar with spinal manipulation, and, even within
chiropractic circles, nomenclature for technique is
not well standardized.
We may want to include the patients own reports
of improvement or worsening. However, whenever
possible we should try to use a well-validated method of measuring their improvement. For case studies,
it may be possible to use data from visual analogue
scales (VAS) for pain, or a journal of medication usage.
It is useful to include in this section an indication
of how and why treatment finished. Did we decide to
terminate care, and if so, why? Did the patient withdraw from care or did we refer them to another practitioner?
6. Discussion: In this section we may want to identify
any questions that the case raises. It is not our duty to
provide a complete physiological explanation for
everything that we observed. This is usually impossible. Nor should we feel obligated to list or generate
all of the possible hypotheses that might explain the
course of the patients condition. If there is a well
established item of physiology or pathology which
illuminates the case, we certainly include it, but remember that we are writing what is primarily a clinical chronicle, not a basic scientific paper. Finally, we
summarize the lessons learned from this case.

202

7. Acknowledgments: If someone provided assistance

with the preparation of the case study, we thank them
briefly. It is neither necessary nor conventional to
thank the patient (although we appreciate what they
have taught us). It would generally be regarded as excessive and inappropriate to thank others, such as
teachers or colleagues who did not directly participate in preparation of the paper.
8. References: References should be listed as described
elsewhere in the instructions to authors. Only use references that you have read and understood, and actually used to support the case study. Do not use more
than approximately 15 references without some clear
justification. Try to avoid using textbooks as references, since it is assumed that most readers would already have this information. Also, do not refer to
personal communication, since readers have no way
of checking this information.
A popular search engine for English-language references is Medline:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
9. Legends: If we used any tables, figures or photographs, they should be accompanied by a succinct
explanation. A good rule for graphs is that they
should contain sufficient information to be generally
decipherable without reference to a legend.
10. Tables, figures and photographs should be included
at the end of the manuscript.
11. Permissions: If any tables, figures or photographs, or
substantial quotations, have been borrowed from other publications, we must include a letter of permission
from the publisher. Also, if we use any photographs
which might identify a patient, we will need their
written permission.
In addition, patient consent to publish the case report is also required.

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B Budgell

Template
Title:
Running Header:
Authors:
a) Name, academic degrees and affiliation
b) Name, academic degrees and affiliation
c) ...

d)

Name, address and telephone number of corresponding

author

e)
f)

Disclaimers
g)
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 similar
cases previously reported.
Case Presentation:
a) Introductory sentence: e.g. This 25 year old female office worker presented for the treatment of recurrent
headaches.
b) Describe the essential nature of the complaint, including location, intensity and associated symptoms: e.g.
Her headaches are primarily in the suboccipital region,
bilaterally but worse on the right. Sometimes there is
radiation towards the right temple. She describes the
pain as having an intensity of up to 5 out of ten, accompanied by a feeling of tension in the back of the
head. When the pain is particularly bad, she feels that
her vision is blurred.
c) Further development of history including details of
time and circumstances of onset, and the evolution of
the complaint: e.g. This problem began to develop
J Can Chiropr Assoc 2008; 52(4)

h)

three years ago when she commenced work as a data

entry clerk. Her headaches have increased in frequency in the past year, now occurring three to four days
per week.
Describe relieving and aggravating factors, including
responses to other treatment: e.g. The pain seems to be
worse towards the end of the work day and is aggravated by stress. Aspirin provides some relieve. She has
not sought any other treatment.
Include other health history, if relevant: e.g. Otherwise the patient reports that she is in good health.
Include family history, if relevant: e.g. There is no
family history of headaches.
Summarize the results of examination, which might
include general observation and postural analysis, orthopedic exam, neurological exam and chiropractic
examination (static and motion palpation): e.g. Examination revealed an otherwise fit-looking young woman
with slight anterior carriage of the head. Cervical active ranges of motion were full and painless except for
some slight restriction of left lateral bending and rotation of the head to the left. These motions were accompanied by discomfort in the right side of the neck.
Cervical compression of the neck in the neutral position did not create discomfort. However, compression
of the neck in right rotation and extension produced
some right suboccipital pain. Cranial nerve examination was normal. Upper limb motor, sensory and reflex
functions were normal. With the patient in the supine
position, static palpation revealed tender trigger points
bilaterally in the cervical musculature and right trapezius. Motion palpation revealed restrictions of right
and left rotation in the upper cervical spine, and restriction of left lateral bending in the mid to lower cervical spine. Blood pressure was 110/70. Houles test
(holding the neck in extension and rotation for 30 seconds) did not produce nystagmus or dizziness. There
were no carotid bruits.
The patient was diagnosed with cervicogenic headache due to chronic postural strain.

Management and Outcome:

a) Describe as specifically as possible the treatment provided, including the nature of the treatment, and the
frequency and duration of care: e.g. The patient undertook a course of treatment consisting of cervical and
203

Commentary

upper thoracic spinal manipulation three times per

week for two weeks. Manipulation was accompanied
by trigger point therapy to the paraspinal muscles and
stretching of the upper trapezius. Additionally, advice
was provided concerning maintenance of proper posture at work. The patient was also instructed in the use
of a cervical pillow.
b) If possible, refer to objective measures of the patients
progress: e.g. The patient maintained a headache diary
indicating that she had two headaches during the first
week of care, and one headache the following week.
Furthermore the intensity of her headaches declined
throughout the course of treatment.
c) Describe the resolution of care: e.g. Based on the patients reported progress during the first two weeks of
care, she received an additional two treatments in each
of the subsequent two weeks. During the last week of
care she experienced no headaches and reported feeling generally more energetic than before commencing
care. Following a total of four weeks of care (10 treatments) she was discharged.
Discussion:
Synthesize foregoing sections: e.g. The distinction between migraine and cervicogenic headache is not always
clear. However, this case demonstrates several features ...

Summarize the case and any lessons learned: e.g. This

case demonstrates a classical presentation of cervicogenic
headache which resolved quickly with a course of spinal
manipulation, supportive soft-tissue therapy and postural
advice.
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; 32:1426.
2
3
Legends: (tables, figures or images are numbered according to the order in which they appear in the text.) e.g.
Figure 1: Intensity of headaches as recorded on a visual
analogue scale (vertical axis) versus time (horizontal axis) during the four weeks that the patient was under care.
Treatment was given on days 1, 3, 5, 8, 10, 12, 15, 18, 22
and 25. Headache frequency and intensity is seen to fall
over time.

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204

J Can Chiropr Assoc 2008; 52(4)

PRIMER

Patient case report

PRIMER

How to write a patient case report

HENRY COHEN

ublished patient case reports

provide essential sources of
information for the optimum
care of patients because case reports
can describe important scientic observations that are missed or are undetectable in clinical trials, provide
insightful information that expands
our knowledge and spawns new research, and provide information that
strays from the classical textbook case
and leads to better and safer patient
care. Indeed, a case report of Kaposis
sarcoma in a young homosexual
man is the seminal observation to
the development of acquired immune deciency syndrome.1 Seminal
patient case reports linked the Food
and Drug Administration-approved
indication for the anorexic agents,
fenuramine and dexfenuramine,
with primary pulmonary hypertension and subsequently spawned trials 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

Purpose. Guidelines for writing patient

case reports, with a focus on medicationrelated 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 authors claims. The
case presentation section should describe
the case in chronological order and in

will provide guidelines for writing

patient case reports, with a focus on
medication-related reports.
Format of the patient case report
Case reports should encompass
the following ve sections: an abstract, 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

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 Residency Programs, Departments of Pharmacy and Medicine, Kingsbrook
Jewish Medical Center, Brooklyn.
Address correspondence to Dr. Cohen at the Department of Phar-

1888

Am J Health-Syst PharmVol 63 Oct 1, 2006

enough detail for the reader to establish

his or her own conclusions about the cases
validity. The discussion section is the most
important section of the case report. It
ought to evaluate the patient case for accuracy, validity, and uniqueness; compare and
contrast the case report with the published
literature; derive new knowledge; summarize the essential features of the report; and
draw recommendations. The conclusion
section should be brief and provide a conclusion with evidence-based recommendations and applicability to practice.
Conclusion. Patient case reports are valuable resources of new and unusual information that may lead to vital research.
Index terms: Drugs, adverse reactions;
Guidelines; Reports; Writing
Am J Health-Syst Pharm. 2006; 63:188892

the case, and a conclusion.6,7 Supplementary parts such as tables, gures,

graphs, and illustrations provide essential data and will enhance the articles ow and clarity. Generally, most
of the data contained in supplementary parts should not be duplicated
in the text.6,7 Patient case reports can
describe a single case report or a series of case reports. Case reports are
generally 15002500 words in length
with 2030 references. The title of the

macy, Kingsbrook Jewish Medical Center, 585 Schenectady Avenue,

Brooklyn, NY 11203 (hcohenliu@aol.com).
Copyright 2006, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/06/1001-1888$06.00.
DOI 10.2146/ajhp060182

PRIMER

case report should be descriptive, accurate, and succinct.

Abstract. Case reports should include an abstract of 100250 words.
The availability of an abstract will
allow for easier retrieval from electronic databases and help researchers discern their levels of interest
in the case report. The abstract
should include the same four sections as the main text in a succinct
formintroduction and objective,
case presentation, discussion, and
conclusionbut the format may
vary depending on a journals style if
submitted for publication.
Introduction. The introduction
section should be concise and salient
and immediately attract the attention and interest of the reader. The
introduction should provide the subject, 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 literature review that corroborates the
authors claims should accompany
the introduction. If few citations are
found, they should all be cited chronologically; however, if many citations
are found, the seminal, historical,
and most pertinent references should
be cited. The signicant 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 introduction. 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 database 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 biomedical 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 review of an adverse reaction database
such as Clin-Alert or databases that
review pharmacy publications such
as International Pharmaceutical Abstracts and Iowa Drug Information
Service. A case report describing the
collaboration of a pharmacist and a
nurse that improves a patients care
should include a search in the nursing database such as the Cumulative
Index to Nursing and Allied Health
Literature. Furthermore, to maximize
the literature search ndings, authors
should meticulously search the reference lists of review articles and metaanalyses. Finally, clinicians ought to
be cognizant that early reports may
not be detected in a literature search
because of changes in concepts, nomenclature, and terminology since
their publication date.
Case presentation. The description 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
cases validity. A case report that
contains detailed and relevant patient 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 superuous data. Daily patient progress including normal vital signs,

Patient case report

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 relationship and indicate the effect of
treatment, any unanticipated effects,
the patients nal outcome, any further proposed treatments, and the
patients present status at the time
of the report.
Patients demographics and history.
Patient demographics such as age,
height, weight, sex, race, and occupation must be included. Although the
race or occupation of the patient may
appear as superuous, this type of information may uncover pharmacogenomic or environmental inuences.
In order to limit the possibility of
identifying the patient, the patients
initials, date of birth, and other
identiers must not be used. Precise
dates, including the month, day, and
year of admission or other important
events, should be avoidedthey can
aid in identifying the patient and detract the reader from the case report
by calculating elapsed time. In a brief
summary and in a narrative form,
the patients chief complaint, present
illness, medical history, family and
social history, and use of recreational
drugs should be listed. Headings
for each part of the patients history
should not be used. The type of physical examination performed should
be described, and any abnormalities
should be reported.
Patients laboratory and diagnostic
data. The patients laboratory values
and diagnostic data that support the
case report and rule out a differential
diagnosis should be reported. Pertinent 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

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PRIMER

Patient case report

of a pathologists report must not be

used; instead, a salient report of the
results should be included. Pictures
of histopathology, roentgenograms,
electrocardiographs, and other diagnostic tests; skin manifestations;
wounds; and other anatomical parts
may be provided and add to the interest of the report. Any identifying
features of a patients photograph
should be blocked out. Institutional
policies and patient permission for
obtaining and using photographs
must be followed.
Patients medication history. The
patients medication history should
include the medications 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 factors or may contain different llers,
preservatives, additives, or dyesall
of which may be pertinent to cases
regarding the drugs pharmacokinetics, efcacy, 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 discontinued should be identified, since
medications may have lasting effects
for months after discontinuation.
The author should verify and inform
the reader of the patients history of
medication adherence.
In order to evaluate the appropriateness of a medications dosage regimen, laboratory values that describe
renal and hepatic organ functions
should be provided. Renal function
values should include serum creatinine, blood urea nitrogen, and the
total uid volume intake and excretion when a urinary catheter is in
place. Calculation methods used to
estimate the patients renal function
should be identied. Liver function
tests such as the International Nor1890

malized Ratio, serum albumin, and

albumin:globulin ratio and hepatic
enzyme tests such as aspartate and
alanine aminotransferases should be
provided.
A comprehensive medication history should also include the patients
allergy status. The allergy history
should include the date of the reaction, 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 listed as such. Allergies to combination
products such as Unasyn and Zosyn
can be mislabeled as a penicillin allergy 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 reactions such as drug-induced seizures
may not be included in the allergy history; 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 relationship 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 variations 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.
Patients diet. The patients 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 drugs pharmacologic
effect. The patients diet can have
consequential effects on a disease
state. Dietary causes of adverse
events, such as allergic reactions,
should be ruled out before suspecting a drug allergy.

Am J Health-Syst PharmVol 63 Oct 1, 2006

Discussion. The discussion section 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 report with the published literature;
and derive new knowledge and applicability to practice. The author
must conrm 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 signicance of
each limitation.
The author should briey summarize 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 explain 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 reviewthis
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 error and embarrassment.
The author should next summarize the essential features of the case
report, justify why this case is unique,
and draw recommendations and
conclusions.
Conclusion. Based on the evidence reviewed in the discussion section, the author must provide a justi-

PRIMER

ed conclusion. The author must be

careful not to make rm judgments
and sweeping recommendations
based on speculation, on limited
and tenuous information, or on a
few case reports. However, justiable
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 authors practice should be described. This section
should be concise and not exceed
one paragraph. Guidelines for writing patient case reports in a checklist
format (Appendix B) can facilitate
and enhance the manuscript writing
process.
Summary
Patient case reports are valuable
resources of new and unusual information that may lead to vital research
and advances in clinical practice that
improve patient outcomes. Case reports should contain an abstract and
four sectionsan introduction, case
presentation, discussion, and conclusion. 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 compare and contrast the case reports
ndings with the literature review,
establish a causal and temporal relationship, and validate the case with
a probability scale. The literature review should be extensive and should
support the justication 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.

Conclusion
Patient case reports are valuable resources of new and unusual information that may lead to vital research.

References

1. Gottleib GJ, Rogoz A, Vogel JV et al. A preliminary communication on extensively

disseminated Kaposis sarcoma in a young
homosexual man. Am J Dermatopathol.
1981; 3:111-4.
2. Douglas J, Munro J, Kitchin A et al. Pulmonary hypertension and fenuramine.
Br Med J. 1981; 283:881-3.
3. Atanasson P, Weiss B, Schmid E et al.
Pulmonary hypertension and dexfenuramine. Lancet. 1992; 339:436. Letter.
4. Weir EK, Reeve HL, Huang JM et al.
Anorexic agents aminorex, fenuramine,
and dexfenuramine inhibit potassium
current in rat pulmonary vascular smooth
muscle and cause pulmonary vasoconstriction. 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 ACriteria 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 efcacy;

Patient case report

Describe rare or novel drugdrug, drugfood,

or drugnutrient 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 improve 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 pharmacodynamic principles; and
Use technology to improve patient outcomes.

Appendix BGuidelines 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 denitions.
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 identiers (date of birth, initials).
Describe the patients complaint.
List the patients present illness.
List the patients medical history.
List the patients family history.
List the patients social history.
List the patients medication history before
admission and throughout the case report.
Ensure that the medication history includes
herbals, vaccines, depot injections, and nonprescription medications, and state that the
patient was asked for this history.
List each drugs name, strength, dosage form,
route, and dates of administration.
Verify the patients medication adherence.
Provide renal and hepatic organ function
data in order to determine the appropriateness of medication dosing regimens.

Am J Health-Syst PharmVol 63 Oct 1, 2006

1891

PRIMER

Patient case report

List the patients drug allergy status, including the name of the drug
(brand or generic) and the date and type of reaction.
List the patients 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 patients dietary history.
Provide pertinent 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 support the case.
Paraphrase the salient results of the diagnostic procedures.
Provide photographs of histopathology, roentgenograms, electrocardiograms, skin manifestations, or anatomy as they relate to the case.
Obtain permission from the patient to use the patients photographs,
or follow institutional guidelines.
Provide the patients 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 cases validity.
IV. Discussion
Compare and contrast the nuances of the case report with the literature 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.
Conrm 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 justied conclusion.
Provide evidence-based recommendations.
Describe how the information learned applies to ones own practice.
List opportunities for research.
Ensure that this section is brief and does not exceed one paragraph.

1892

Am J Health-Syst PharmVol 63 Oct 1, 2006

SPECIAL ARTICLE

Tips and Tricks to Make Case Report

Idrus Alwi

ABSTRACT
The 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.
INTRODUCTION

Virtually 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

96

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 REPORT

The 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.1
Topics 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

Vol 39 Number 2 April - June 2007

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 REPORT

After 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 REPORT

The 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
Title

Most 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
Authorship

Establishing 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
Introduction

There 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

Tips and Tricks to Make Case Report

Case Description

When 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
patients 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 readers
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
Discussion

When 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

97

Idrus Alwi

References

As 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
Acknowledgements

Acknowledgement 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 PUBLISH

A 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

98

Acta Med Indones-Indones J Intern Med

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 PREPARATION

Once 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 journals
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
REFERENCES
1.
2.
3.
4.

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.
Harris NL. Case records of the Massachusetts General
Hospital-continuing to learn from the patient. N Engl J Med.
2003;348(22):2252-4.
Vandenbroucke JP. In defense of case reports and case series.
Ann Intern Med. 2001;134:330-4.
Peat J, Elliott E, Baur L, Keena V. Scientic writing, easy when
you know how. London: BMJ; 2006. p. 176-8.

Did investigator assign

exposures?
Yes

No

Experimental Study

Observational
Study

Random selection

Comparison group?

Yes

No

Randomized
controlled
trial

Yes

No

Analytical study

NonRandomized
controlled
trial

Descriptive study

Direction?

Exposure and
Exposure

Outcome

Outcome at the
Same time

Exposure
Cohort
study

Outcome
Case control
study

Cross sectional
study

Figure: Algorithm for classification of types of clinical research

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

Maharashtra University of Health Sciences, Nashik

Department of AYUSH
Template for Synopsis
Synopsis Head
1. Research Question

2. Hypothesis

Instructions

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

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 preunderstanding 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

4. Abstract

5. Introduction

6. Literature review

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
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
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.
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

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.

Qualitative
Quantitative
Table
Graph
Chart

9. Observations

10. References
11. Annexure

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

Harvard style of the reference and the Vancouver

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

STROBE Statementchecklist of items that should be included in reports of observational studies

Title and abstract

Item
No
1

Recommendation
(a) Indicate the studys design with a commonly used term in the title or the abstract
(b) Provide in the abstract an informative and balanced summary of what was done
and what was found

Introduction
Background/rationale

Explain the scientific background and rationale for the investigation being reported

Objectives

State specific objectives, including any prespecified hypotheses

Methods
Study design

Present key elements of study design early in the paper

Setting

Describe the setting, locations, and relevant dates, including periods of recruitment,
exposure, follow-up, and data collection

Participants

(a) Cohort studyGive the eligibility criteria, and the sources and methods of
selection of participants. Describe methods of follow-up
Case-control studyGive 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 studyGive the eligibility criteria, and the sources and methods of
selection of participants
(b) Cohort studyFor matched studies, give matching criteria and number of
exposed and unexposed
Case-control studyFor matched studies, give matching criteria and the number of
controls per case

Variables

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

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

Statistical methods

12

(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 studyIf applicable, explain how loss to follow-up was addressed
Case-control studyIf applicable, explain how matching of cases and controls was
addressed
Cross-sectional studyIf applicable, describe analytical methods taking account of
sampling strategy
(e) Describe any sensitivity analyses

Continued on next page

Results
Participants

13*

(a) Report numbers of individuals at each stage of studyeg 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
(c) Consider use of a flow diagram

Descriptive
data

14*

(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
(c) Cohort studySummarise follow-up time (eg, average and total amount)

Outcome data

15*

Cohort studyReport numbers of outcome events or summary measures over time

Case-control studyReport numbers in each exposure category, or summary measures of
exposure
Cross-sectional studyReport numbers of outcome events or summary measures

Main results

16

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

Other analyses

17

Report other analyses doneeg 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 #
TITLE & ABSTRACT

Cohort
(a) Identify the article as a cohort
study in the title or the abstract.

Case-control
(a) Identify the article as a
case-control study in the title or
the abstract.

Cross-sectional
(a) Identify the article as a crosssectional study in the title or the
abstract.

(b) The abstract should be a highly informative structured summary of the article, taking account of all
issues in the checklist below.
INTRODUCTION
Background / Rationale

Explain scientific background and rationale for the study.

Objectives

State specific objectives and hypotheses.

Study design

Present key elements of study design.

State purpose of original study, if article is one of several from an ongoing study.

Setting

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

Participants

Give eligibility and exclusion

criteria, source and methods of
selection of participants.
If applicable, describe exposed and
unexposed separately.
Give period of follow-up.

METHODS

For cases and controls

separately, give eligibility and
exclusion criteria, source and
methods of selection of cases
and controls.
Give precise diagnostic criteria
for cases, and rationale for
choice of controls.
For matched studies, give
matching criteria and number of
controls per case.

Give eligibility and exclusion

criteria, source and methods of
selection of participants.

Variables of interest

List and clearly define all

outcomes, potential predictors and
confounders, and predefined
subgroups.

Measurement

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

(b) Describe comparability of
procedures across groups, if
applicable.

List and clearly define all

exposures, potential
confounders, and predefined
subgroups.

(b) Describe comparability of

procedures in cases and
controls.

List and clearly define all

outcomes, potential predictors and
confounders, and predefined
subgroups.

(b) Describe comparability of

procedures across groups, if
applicable.

Bias

Describe any measures taken to address potential sources of bias.

Sample size

10

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

Statistical methods

11

(a) Describe all statistical methods,

including those to control for
confounding, and how loss to
follow-up and missing data were
addressed.

(a) Describe all statistical

methods including those to
control for confounding.
Account for matching and
missing data.

(a) Describe all statistical

methods, including those to
control for confounding and
account for any design effects and
missing data.

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

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 on
which the present report is based.

RESULTS
Participants

14

(a) For each group, report the

number of potentially eligible
individuals, the number
examined for eligibility (if known),
the number eligible, the number
included in the study, the
numbers completing follow up,
and the number analysed.
Report dates defining the followup.

(a) For cases and controls

separately, report the number
of potentially eligible individuals
(if known), the number
examined for eligibility, the
number eligible, the number
included in the study, and the
number analysed.
For matched studies, give
distribution of number of
controls per case.

(a) Report the number of potentially

eligible individuals, the number
examined for eligibility (if known), the
number eligible, the number included
in the study, and the number
analysed.

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

15

(a) Give baseline characteristics

of study participants (e.g.
demographic, clinical, social) and
information on exposures and
potential confounders, by
comparison group if applicable.
Summarize average and total
amount of follow up.

(a) Give characteristics of

cases and controls (e.g.
demographic, clinical, social)
and information on exposures
and potential confounders.

(a) Give characteristics of study

participants (e.g. demographic,
clinical, social) and information on
exposures and potential
confounders, by comparison group if
applicable.

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

16

Report numbers of outcome

events or summary measures
over time, for each comparison
group (e.g. exposure category) if
applicable.

Report numbers of cases and

controls for each exposure
category.

Report numbers of outcome events

or summary measures, for each
comparison group (e.g. exposure
category) 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 were
included 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 problems
that 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

Title and Abstract
Introduction
Background
Methods
Participants

Item No.
Descriptor
1
How participants were allocated to interventions (eg, random
allocation, randomized, or randomly assigned).
2

Scientific background and explanation of rationale.

Eligibility criteria for participants and the settings and locations where
the data were collected.
Precise details of the interventions intended for each group and how
and when they were actually administered.
Specific objectives and hypotheses.
Clearly defined primary and secondary outcome measures and,
when applicable, any methods used to enhance the quality of
measurements (eg, multiple observations, training of assessors).
How sample size was determined and, when applicable, explanation
of any interim analyses and stopping rules.

Interventions

Objectives
Outcomes

5
6

Sample size

Randomization
Sequence generation

Allocation concealment

Implementation

10

Blinding (masking)

11

Statistical methods

12

Results
Participant flow

13

Recruitment
Baseline data
Numbers analyzed

14
15
16

Outcomes and estimation

17

Ancillary analyses

18

Adverse events

19

Comment
Interpretation

Generalizability
Overall evidence

20

21
22

Reported on Page No.

Method used to generate the random allocation sequence, including

details of any restriction (eg, blocking, stratification).
Method used to implement the random allocation sequence (eg,
numbered containers or central telephone), clarifying whether the
sequence was concealed until interventions were assigned.
Who generated the allocation sequence, who enrolled participants,
and who assigned participants to their groups.
Whether or not participants, those administering the interventions,
and those assessing the outcomes were blinded to group
assignment. If done, how the success of blinding was evaluated.
Statistical methods used to compare groups for primary outcome(s);
methods for additional analyses, such as subgroup analyses and
adjusted analyses.
Flow of participants through each stage (a diagram is strongly
recommended). Specifically, for each group report the numbers
of participants randomly assigned, receiving intended treatment,
completing the study protocol, and analyzed for the primary
outcome. Describe protocol deviations from study as planned,
together with reasons.
Dates defining the periods of recruitment and follow-up.
Baseline demographic and clinical characteristics of each group.
Number of participants (denominator) in each group included in each
analysis and whether the analysis was by intention-to-treat.
State the results in absolute numbers when feasible (eg, 10/20,
not 50%).
For each primary and secondary outcome, a summary of results for
each group, and the estimated effect size and its precision (eg,
95% confidence interval).
Address multiplicity by reporting any other analyses performed,
including subgroup analyses and adjusted analyses, indicating
those prespecified and those exploratory.
All important adverse events or side effects in each intervention
group.
Interpretation of the results, taking into account study hypotheses,
sources of potential bias or imprecision, and the dangers
associated with multiplicity of analyses and outcomes.
Generalizability (external validity) of the trial findings.
General interpretation of the results in the context of current
evidence.

2006 American Medical Association. All rights reserved.

(Reprinted) JAMA, July 5, 2006Vol 296, No. 1 E1