MED 8101: Clinical Epidemiology
Third-year Medical Student
Clinical Research Project
2 Credits
James R. Beal, PhD
Dir. Research & Prog. Development
Associate Professor
Dept. of Family & Community Medicine
UND School of Medicine & Health Sci.
P. O. Box 9037
Grand Forks, ND 58202 (701)777-3200
james.beal@med.und.edu
2014-15
TABLE OF CONTENTS
Epidemiology Sessions: Dates and Topics .......................................................................................1
Research Project Objective and General Requirements ...................................................................3
Grading.............................................................................................................................................6
Practical Tips....................................................................................................................................8
Common Mistakes Made By Those in Medical Research ................................................................9
Guidelines for Clinical-Research Protocols....................................................................................11
Sample Size Needed.......................................................................................................................13
Research Report: Concepts to Consider! ........................................................................................14
Writing and Publishing Research Articles by Marurice A. Hitchcock, Ed.D..................................15
Uniform Requirements for Manuscripts Submitted to Biomedical Journals:
Writing and Editing for Biomedical Publication ............................................................................22
Uniform Requirements for Manuscripts Submitted to Biomedical Journals:
Sample References .........................................................................................................................37
2014-15 Epidemiology Sessions
Bismarck/Minot/
Content
Fargo/Grand Forks
Lecture:
Part I. Project Requirements
Part II. Steps in Clinical
Research & Developing a
Research Question
Thursday, August 7
9 a.m. - 11 a.m. CS
ROME sites
Thursday, August 7
9 a.m. - 11 a.m. CST
Monday, Sept. 15
Topic Assignment Due – No
Class
Monday, Sept. 15
E-mail to Dr. Beal
Thursday, Sept. 25
9 a.m. - 5 p.m.
20 minute/group
Thursday, Oct. 9
9 a.m. - 11 a.m. CST
*Group Meetings 1:
Research Question
and feasible topic
Lecture:
Part I. Institutional Review
Board
2. Methods-Protocol
Friday, Sept. 26
9 a.m. - 5 p.m.
20 minute/group
Thursday Oct. 9
9 a.m. - 11 a.m. CST
Monday, November 3
IRB Forms Due - No Class
E-mail to Dr. Beal
Thursday, November 20
a.m. - 5 p.m.
20 minute/group
*Group Meetings 2:
IRB Forms
Friday, November 21
9 a.m. - 5 p.m.
20 minute/group
*Group Meetings 3:
Introduction and Methods
Friday, Feb. 13, 2015
9 a.m - 5 p.m.
20 minute/group
Thursday, Feb. 12, 2015
9 a.m. - 5 p.m.
20 minute/group
Monday, April 13, 2015
Data Due: To guarantee help
with Data Analysis
E-mail to Dr. Beal
1
Monday, November 3
Monday, April 13, 2015
Thursday, April 23,
2015
9 a.m. - 11 a.m. CST
Thursday, May 28, 2015
9 a.m. - 4:30 p.m.? Est.
Monday, June 5 by 5:00CST
(E-mail copy of paper and
presentation to Dr. Beal:
james.beal@med.und.edu)
Lecture:
Results
Lectures:
Presentations
Examples from last year:
Paper Due
Thursday, April 23,
2015
9 a.m. - 11 a.m. CST
Thursday, May 29, 2015
9 a.m. - 4:30 p.m.? Est
Monday, June 5 by 5:00pm
CST
(E-mail copy of paper and
presentation to Dr. Beal:
james.beal@med.und.edu)
*Group Meetings: 20 minutes/group from 9 a.m.-5 p.m. Schedule through Lonna (Bismarck,
Grand Forks and ROME) or Carla (Fargo).
Locations:
Bismarck- SW Campus Conference Room, 701 East Rosser Avenue.
Grand Forks- Department of Family & Community Medicine Conference Rm, UND SMSHS
Rm. 2515
ROME sites- Devils Lake, Hettinger, Jamestown and Williston
Fargo -Medical Education Center Auditorium, 1919 Elm St.
2
Clinical Epidemiology
Third-year Medical Student Clinical Research Project
MED 8101. Clinical Epidemiology. 2 credits
Clinical Epidemiology is a required third-year course that consists of students developing and
conducting a clinical research project conducted at a hospital or clinical at the student's respective
campus.
The objective of this course is to develop an understanding of clinical research while utilizing the
supervision and support of faculty from the Department of Family and Community Medicine,
Medical Education and campuses. Furthermore, the project is designed to give students an
opportunity, which they previously may not have had, to investigate a topic of interest. All
medical students are required to formulate a hypothesis; design a study and collect data, via chart
review, to test and/or verify their hypotheses; complete a written report; and present their findings,
all under faculty guidance and mentoring.
It is hoped this early exposure to research will encourage students to undertake research projects
during residency and while in practice.
Objective: Develop an Understanding of Clinical Research
Activities:
1. Identify a topic of personal interest and curiosity.
2. Develop a research question(s) which is limited in focus, but adequately addresses your
topic.
3. Design a study
4. Collect data via chart review.
5. Use appropriate analysis to answer the research question(s).
6. Present the research findings
7. Complete a well-written project report.
3
GENERAL REQUIREMENTS
1. 1. Students must be a primary investigator. Pick a classmate to jointly conduct the project.
2. Approval of your project by Dr. Beal and UND/hospital IRB.
3. Define a need for new or continued research in an area of interest. Develop questions that a
study may answer.
4. Conduct a Chart Review on a selected topic.
**IMPORTANT**It is necessary to obtain Institutional Review Board IRB) approval from
UND AND the respective Hospital(s) prior to the start of data gathering.
IRB Forms:
IRB Forms can be found on the Epidemiology Schedule Page .
St. Alexius and Trinity Hospitals Research: Any student conducting research at
St. Alexius or Trinity Hospitals are required to present to the hospital IRB, which
only meets once-a-month, so plan ahead.
CITI Human Subjects Education:
All students are required to complete the CITI Online Basic Course and forward a copy
of the Completion Report to Dr. Beal. Citi Course instructions for UND.
5. Complete a concise, well-written report:






medical journal format
250 abstract summarizing project and findings
IRMAD- Introduction, Methods, Results, and Discussion
approximately 8-12 pages or about 2,000-2,500 words of text not including Abstract &
Reference
double-spaced using a 12-point font
adequate citations to thoroughly explore topic
6. Presentation



15 minutes total
10-12 minutes presentation of information
2-5 for questions/comments
4
7. Deadlines





Topic: Monday, September 15, 2014
IRB Forms: Monday, November 3, 2014
Data Due: Monday, April 13, 2015
Presentation of project to class and faculty
Bismarck/Minot- Thursday, May 28, 2015
Fargo/Grand Forks- Friday, May 29, 2015
Final paper: Monday, June 5, 2015
8. E-mails copies of the paper and presentation to Dr. Beal.
Paper- preferably in Microsoft Word, of the manuscript. Figures, tables and/or graphs
should be separate pages/files.
9. All Abstracts will be published on the DFM Research & Grants website, with manuscripts
available upon request, unless written notification is given stating that you do not wish your
manuscript to be shared.
5
GRADING
Final grades for the Epidemiology Course will be Honors (90% and 90th percentile), Satisfactory (8970%), or Unsatisfactory (<70%). The following following criteria will be used.
Honors(90-100% and 90th percentile) - completion of all components by due dates, plus an average
equal to or greater than 90% on all components and 90th percentile.
Satisfactory (70-89%) - completion of all components, plus an average equal to 70-89% on all
components.
Unsatisfactory if total score is less than 69%, or not completing all of the components.
The Epidemiology Course grade is comprised of the following required components:
Research Paper (70%), Presentation (25%), and Homework (5%). Final Research Papers that are viewed
as "Unsatisfactory" will be returned for revision until a "Satisfactory" grade is achieved. Please see
Research Paper and Presentation sections below for areas to address.
Epidemiology Course Components
Research Papert-70% of final grade
The following scale rating of your field research project is meant as an overview of the strengths
and nonstrengths of the project. For specific recommendations for publication/presentation,
please contact the Department of Family and Community Medicine.
Research paper will use the following criteria (100 pts total):
Low - - - - - - - - - - - - - High
Definition of Problem and Development of
Hypothesis
1
2
3
4
5
6
7
8
9
10
Literature Review (currency, breadth,
& depth)
1
2
3
4
5
6
7
8
9
10
Adequacy of Methods – including data
collection and Selection/Use of Research Tools
2
4
6
8
10
12 14 16 18
20
Analysis of Data/Adequacy of Reported Results
(including adequacy of tables/figures)
2
4
6
8
10
12 14 16 18
20
Adequacy of conclusions with respect to data
2
4
6
8
10
12 14 16 18
20
Limitations/Recommendations for Future Study
1
2
3
4
5
6
7
8
9
10
General Organization, Format, & Writing Skills
1
2
3
4
5
6
7
8
9
10
6
Presentation-25% of final grade
Presentation grading will use the following criteria (60 pts total):
Poor--------------------------- Excellent
Title and introduction adequately described
problem/topic
Adequacy and suitability of methods
Adequacy and suitability of data analysis/reported results
Clarity of graphs and/or tables
Adequacy of conclusions drawn data with respect data
Overall quality of presentation-Clear, concise
organization; easy to follow
1
2
3
4
5
6
7
8
9
10
1
1
1
1
2
2
2
2
3
3
3
3
4
4
4
4
5
5
5
5
6
6
6
6
7
7
7
7
8
8
8
8
9
9
9
9
10
10
10
10
1
2
3
4
5
6
7
8
9
10
Homework-5% of final grade
As assigned during the Epidemiology Course Lectures, includes IRB forms
7
PRACTICAL TIPS
Below are some practical tips for the novice researcher. Pay attention to these! They may divert
intense frustration and depression.

Good research questions are based upon a thorough understanding of the relevant medical
literature. Start your literature search and reading early.

Find a research mentor! Working with a good research mentor can go a long way towards
conducting a successful research project.

Developing the research question is an iterative process that includes researching the medical
literature, consulting with friends and mentors, and piloting studies. Questions change as a result
of this process.

Initial projects should be modest in scope. Too often, first projects attempt to do too much rather
than too little. Descriptive studies, local or regional surveys, or chart reviews may logically
precede analytical studies, national surveys or cohort studies.

Don't hesitate to call other investigators in your area of interest. Even experienced investigators
are often willing to share their time and advice with novice researchers.

Just because your research question has been the focus of previous investigations, do not despair!
Examine the weaknesses of the previous studies: What questions remain unanswered? Was the
power of the previous research adequate? Are the results generalizable to all patients or to your
environment? Answers to these questions may serve as the basis of further research in the same
area.

Good research questions come at odd times. Keep a notebook to write questions down as soon as
you think of them. Procrastination may cost you a study!
Vancouver et al. (1993). Planning a Research Study. Michigan State University, Office of Education Research and Development.
8
COMMON MISTAKES MADE BY THOSE IN MEDICAL RESEARCH
A. Common errors in formulating a research study.
1. Putting off the selection of a problem; in other words, never quite getting started.
2. Uncritically accepting the first research ideas that come to mind.
3. Selecting a problem that is too vast or too vague to investigate meaningfully.
4. Preparing an untestable hypothesis.
5. Failing to consider methods of analysis procedures in developing a tentative research plan.
B. Common errors in reviewing the literature.
1. Carries out a hurried review of the literature.
2. Relies too heavily upon secondary sources.
3. Overlooking information on methods and measurements when reading research articles.
4. Failure to define satisfactorily the topic limits of the review of the literature.
5. Copying bibliographic data incorrectly and is thus unable to locate the references needed.
6. Copying far too much material.
C. Common errors in use of standard measuring instruments.
1. Paying insufficient attention to establishing and maintaining rapport with the subjects.
2. Weaken research design by making changes for administrative convenience.
3. Failure to explain the purpose of measures used in the research to those collecting the data.
4. Failure to evaluate measures thoroughly before selecting those to be used in research.
5. Selects measures to use in research of such low reliability that true differences are hidden.
6. Selects measures to use in research that he/she is unqualified to review.
9
D. Common errors in gathering research data.
1. The research fails to define the research population.
2. Changes design in ways that weaken the research in order to make data collection more
convenient.
3. Attempts to collect too much data, making excessive demands upon the subjects.
4. Attempts to carry out the study in one short period of time with no regard to actual time
needed.
5. Starts collecting research data without carrying out a pilot study.
E. Common errors in the use of statistical tools.
1. Selects statistical tool that is not appropriate or correct.
2. Collects research data and then finds a statistical technique that can be used in analysis.
3. Uses only one statistical procedure when several can be applied to the data.
4. Uses statistical tools in situations in which the data grossly fails to meet the assumptions
upon which the tools are based.
5. Overstates the importance of small differences.
6. Uses the incorrect correlation techniques.
7. Uses an incorrect correlation significance table to interpret importance of findings.
8. Does not take advantage of statisticians available to assist in computing importance of the
study.
F. Common errors in research design and methodology.
1. The researcher fails to define the research population.
2. Uses a sample too small to permit analysis of the performance of interesting sub-groups.
3. Attempts to conduct his/her research using volunteer subjects.
4. Changes his/her design in ways that weaken the research in order to make data collection
more convenient.
5. Attempts to collect too much data, making excessive demands upon the subjects.
6. Attempts to carry out the study in one short period of time with no regard to actual time
needed.
7. Starts collecting higher research data without carrying, out a pilot shady.
Source: Isaac S. & Michael WB (1995). Handbook in Research & Evaluation: a Collection of Principles, Methods, &
Strategies Useful in the Planning, Design, & Evaluation of Studies in Education & the Behavioral Sciences.
10
GUIDELINES FOR CLINICAL-RESEARCH PROTOCOLS
This guide was originally intended to help complete Institutional Review Board (IRB) Forms,
however, it should be useful as way to Astep through@ the Methods of your project. Many
researchers are uncertain about how much information or what kinds of information they need to
provide when they describe their protocols for clinical research. The following outline is offered as a
guideline for clinical research proposals. The Protocol section of your Institutional Review Board
Forms can follow this format or some other format, but the information you provide must address all the
topics listed here that are relevant to your own particular research design. Covering relevant topics
briefly is better than failing to mention them at all.
I.
Introduction and background information: Why are you undertaking this research?
II.
Objectives (specific aims) of the study: Explain the specific hypotheses you plan to test or
the specific questions you hope to answer.
III.
Selection of participants:
A. How many individuals will participate, of what ages?
B. What are your criteria for selecting participants and for excluding people from the
study?
C. From where will the participants be recruited? If they will be patients, how will you
find them?
D. How will the participants be invited to participate in the study, and by whom?
E. How long will participants be recruited? (Are there plans to replace or add
participants after the study is underway?)
F. Are you taking any precautions so that participants will not feel coerced or
pressured to participate in the study?
G. Will participants receive any inducements to participate, such as payments, services
without charge, course credits, etc.? If so, explain the amounts and reasons for
inducements.
IV.
Procedures for obtaining informed consent of participants: Summarize your methods
briefly, and provide a copy of your consent statement with the Human Subjects Review
Form.
V.
Procedures for treatment, examination, intervention, or experimentation:
A. Where will the research procedures be carried out?
B. Who will carry out the research procedures, and what are their qualifications for
doing so?
C. Briefly describe the procedures and techniques that will be used with the
participants, in sequence.
D. 1. Indicate how long and how frequently the procedures and techniques will be
used, and any pretesting and posttesting.
2. Will procedures or techniques be randomized in any way?
3. Will the research require any use of deception? If so, be sure to explain why
this is necessary and how participants will be debriefed.
4. Will materials with potential radiation risk be used, e.g., x-rays or exposure to
radioisotopes?
5. Will medical, academic, or other confidential records be used?
6. Will the research involve making any visual or audio recordings of the
participants (including still photographs)?
7. If the research will involve administering drugs, explain:
a. The nature of the drugs and their most commonly observed effects, including
unintended or "side" effects.
b. How the drugs will be obtained, prepared, and administered.
c. The dosages and schedules by which the drugs will be administered.
d. The status of the drugs according to the Food and Drug Administration.
e. Under what circumstances administration of the drugs will be modified or
discontinued.
E. What plans are there for responding to specific hazards, adverse effects, or toxicity of
the research procedures?
VI.
Criteria for outcomes: How will the results of the research be detected and measured?
A. What methods and criteria will be used to measure the major variables and effects in
the research design?
B. What criteria will be used to determine when the research is completed or should no
longer be continued?
C. What strategies of data analysis (such as statistical methods) do you plan to use?
D. Are there any plans for a pathology review?
VII.
How will records of the research be maintained? In what form? Where?
VIII.
References: What prior published research provides the major context or precedents for this
proposal?
12
SIZE OF SAMPLE NEEDED TO YIELD ERROR OF
5% OR LESS IN 95 OUT OF 100 SAMPLES
Population
Size
Obtained
Sample Size
Percent of
Population
50
45
90
100
80
80
200
132
66
300
168
56
400
196
49
500
218
43
600
234
39
800
240
32
1,000
278
27
2,000
323
16
3,000
341
11
5,000
357
7
6,000
361
6
8,000
367
4
10,000
370
3
15,000
375
2
20,000
377
1.8
30,000
379
1.2
50,000
381
0.7
75,000
382
0.4
100,000
383
0.03
Source:
Michigan State Univeristy
OMERAD
Medical Education Section
13
RESEARCH REPORT
< Define a need for new or continued research in an area of interest.
< Develop questions that a study may answer.
Concepts to Consider!
Introduction
< Explain the general problem or describe the need.
< Describe previous studies.
C review what is known about topic from prior studies
C draw generalizations from the literature
< State the purpose and research problem/questions (hypothesis).
C often last paragraph in the AIntroduction@ section
C provide rationale for the study
Methods
< Explain what was done.
C allows reader to judge the validity of the study & its findings
< Allow for independent replication of the study.
C Include:
C description of research design
C delimitations regarding selection of subjects or collection of data
C describe participants of the study
C how subjects were selected
C what instrumentation was used
C what measurements or observations were made
C describe how study data were analyzed and reported
Results
< Begin with an overview of only relevant data using research questions as a guide.
C not necessary to review all data collected
< Do not present data if it does not relate directly to answering the research questions.
< Include specific findings.
< State data as facts without interpretation.
< Tables and figures should stand alone; no narrative is needed to interpret results.
C use tables for data too lengthy for clarity
C should supplement, not duplicate, the text
Discussion
< Concise statements of findings.
C Facts presented previously as results are interpreted, along with any identified
relationships.
C Describe meaning and implications of the study findings
< Relate findings to earlier cited literature
C Compare and contrast with findings of others to highlight areas of support and
conflict.
< Generalize results to the larger population of interest.
< Describe any limitations or biases that may have affected study outcomes.
< Suggest issues for further research.
< Draw conclusions about the topic of focus.
Sources:
Gabel, Lawrence(1991, Feb). Research Process: Reporting Results of the Research. Journal of the American Podiatric Medical Association. V81,
n2, p.93-97.
Hitchcock, Maurice (1988, Fall/Winter). Writing and Publishing Research Articles. Family Practice Research Journal. V8, n1, p.3-16.
Coleridge, Samuel (1993, Sept). Teaching residents to write a research paper. JAOA. V93, n9, p.936-940.
14
Family Practice Research Journal
Vol. 8. No. 1. Fall/winter 1988, pp3-16.
Writing and Publishing
Research Articles
Maurice A. Hitchcock, Ed.D.
ABSTRACT: The purpose of this article is to assist tardily medicine researchers in writing organized and concise articles. While the basis of
arty good article is the quality of the study it describes, the chances of the article being published and communicating results effectively to
readers can be improved through effective writing. The IMRAD (Introduction. Methods, Results, and Discussion) format is used to instruct
authors as to the contents of an article. Suggestions for improving the writing and publishing of articles include: outline the article, format the
article for submission in the style specified by the journal, obtain reviews from coauthors and colleagues, and use an editor.
KEY WORDS: Research, Family Medicine, Faculty Development, Writing Skills
Each day researchers have their articles rejected by professional journals. These articles represent the culmination of one or more
years of work designing the project, collecting and analyzing data, and writing the article. Many of these authors are in university
tenure track positions that require publications for promotion and tenure. The rejections of their papers represent failures for these
authors, not just in terms of lost time, but also in decisions about their salary, promotion, and tenure statuses.
Why is it that so many articles are rejected by journals? Some say that a high percentage of rejections is inevitable since journals
have limited space and receive more articles than can be published. This does not explain, however, the fact that some authors get
almost all of their articles published. Journals do not reject good articles because they have too many. Good articles describing
quality studies are accepted for future publication. particles that get rejected: 1) describe poorly designed or conducted studies, 2)
are poorly written, or 3) do not conform to the journal=s guidelines or areas of focus. Two of the reasons, then, that many articles
get rejected are that they are poorly written or submitted inappropriately to a journal.
Researchers need to write better articles and submit them so that they have the best chance of being accepted for publication.
Research has indicated that many successful authors learned to write and publish articles by collaborating with research mentors.1
Most researchers in family medicine, however, have not had an opportunity to work with a mentor because there are not yet
sufficient numbers of research mentors in the discipline. Culpepper and Franks (1984)2 found only 43 physicians spending 50% of
their time in research activities at family medicine residencies and departments nationwide. Many family medicine researchers
have had to teach themselves about writing and submitting articles for publication.
The purpose of this article is to assist family medicine researchers to White research articles that communicate effectively myth
readers and have a good chance of being accepted for publication by a journal. To clarify the instructions provided, examples are
drawn from drafts of a manuscript being written by the author entitled AFactors Influencing Student Selection of Family Practice
Residency Programs in Texas.@ It should be noted that quality articles are written in numerous ways. This article describes one
3-13
such method, the author=s. Other good sources for Whiting articles are listed in the AReferences@ section of this article.
CONTENTS 0F A RESEARCH ARTICLE
The most popular format used for writing research articles today is the IMRAD method, named for the sections of the article
(Introduction, Methods, Results, and Discussion). It may be helpful to think of the sections as analogous to the system model
(Input, Process, Output, Feedback). The AIntroduction section of the article describes the Ainput@ into the research project (What
is the subject of the study? What do we already know about the subject of focus? What is the Purpose, question, or hypothesis of
the study?). The AMethods@ section describes the Aprocess@ of the research (Who were the subjects of the study? How was the
project designed? What measurement instruments were used? How was the data analyzed?). The Aoutput@ of the project is
described in the AResult@ sections of the article. Finally, the ADiscussion@ section provides Afeedback@ about the subject of
focus in the article (How do the findings of this study relate to findings of previous research on the topic? What issues should
be researched next on this topic?). Authors should take care not to mix the contents of the sections (e g, do not discuss
implications of a study=s findings in AResults@ or tell methods in ADiscussion@). A more complete description of the
contents of each section of the research article follows. A summary of the contents and suggestions is provided in Table 1.
15
Table 1
Contents of a Research Article
1. INTRODUCTION
Purpose: describe the topic, previous literature and purpose of the study
Sections:
First Sentence
<arouse the reader s interest
<avoid truisms
<stress the importance of the topic
First Paragraph
<expand upon the first sentence
<describe the subject of focus in the article
Review of Literature
<review what is known about topic from prior studies
<may be as short as one paragraph or as long as several
<draw generalizations from the literature
<provide a rationale for the study
<lead into a statement of the purpose of the project
Purpose of the Study
<can be questions, hypotheses, or simple declarative statement
<often final paragraph in the Aintroduction@ section
2. METHODS
Purpose: allow readers to judge the validity of the study & its findings
Sections:
Subjects
<purpose is to allow judging of whether sample was biased
<include a description of the participants of the study
<describe how the sample was selected
<if a survey, the response rate should be given
Design
<purpose is to judge if extraneous variables biased study
<may include formal name of design (Case-Control study)
<may include techniques used to eliminate bias (Blinding)
Instrumentation
<purpose is to describe the study instruments and their qualities
<describe pilot-testing, reliability, validity, item types
Data Analysis
<describe how study data were analyzed and reported
3. RESULTS
Purpose present data outcome of the study
Sections:
Data Description
<not necessary to review all data collected
<review study questions to decide on data to include
<state data as facts without interpretation
<delay comment on data until the ADiscussion@ section
Tables & Figures
<use tables for data too lengthy for tent
<use figures to illustrate data for clarity
<tables & figures must be coherent on their own
<tables & figures should supplement, not duplicate, the text
<use tables & figures judiciously; they are costly to publish
<journals often suggest eliminating tables & figures
4. DISCUSSION
Purpose: describe the meaning and implications of the study results
Sections: content varies greatly from article to article
Interpretation of Results
<authors often describe the meaning of study outcomes
<be direct; avoid qualifying phrases such as: AIt appears thatY@
Limitations of Study
<purpose is to assist reader in judging validity of study findings
<describe any limitations or biases that affected study outcomes
16
Comparisons to Previous Research
<authors often describe how outcomes relate to previous research
Summarize, Generalize or Conclude
<often the closing paragraph of an article
<authors often:
<summarize the research findings
<generalize results to the larger population of interest
<draw conclusions about the topic of focus
<suggest issues for further research
Introduction
First Sentence. The first sentence of an article should arouse the reader s interest in the topic of focus. A good way to
start is by stressing the importance of the topic to the reader. Avoid truisms such as: AFamily medicine is a new and
exciting discipline,@ or AThe sedative effect of antihistamines is well known.@ Here is an example of how an article
might begin:
The residency matching process may be the single most important event in family medicine education, both for
students seeking positions and for residency programs recruiting applicants....
First Paragraph. The first paragraph should expand upon the first sentence and precisely describe the subject of focus for
the article.
. . . Residents who do not match the philosophy, expectations, and personnel of a program are at risk of moving to
another resident or leaving family medicine for another specialty. This risk, along with a desire to acquire quality
training, motivates students entering family medicine to apply to an average of 11 programs and interview at eight
before ranking their program preferences for the National Residency Matching Program (NRMP).Ref x The staffs of
family practice residency programs also spend large amounts of time each year interviewing and ranking applicants to
acquire quality residents for their programs. Inordinate amounts of time and effort are invested in the matching
process, yet little is known about the variables that affect the matching of students with programs. This matching
could be improved by better understanding the factors that influence students= selections of particular residency
programs.
Review of Literature. A review of the literature may be as short as a paragraph or as long as several. Its purpose is to
review what is know-e from prior studies about the topic of the project. The review should draw generalizations from this
literature, rather than describing the research that has been done. It should provide a rationale for the study and lead into a
statement of purpose for the project.
Factors that influence students= selections of particular residency programs have been investigated in three
previous studies, one each in psychiatry,Ref orthopaedics,Ref and family medicine.Ref All of these studies suffer
from methodological problems that make generalization of the results troublesome.... Some of the common
factors that influenced students= selections of programs include: students= contacts with residents of the
program; the quality of the faculty and their commitment to clinical instruction of residents; students=
contacts with the program director or chairman; the geographical location of the program; and an organized
schedule of interviews at the program. In family medicine the most influential factors were current residents=
opinions of their program, the residency director, and the geographical location of the program; salary, benefits,
and university affiliation of the program were rated lower but influential in students= decisions.
Purpose of Study. Whether done through study questions, hypotheses, or simple declarative statement, the function of this
paragraph is to describe the purpose of the study. Often the statement of purpose is the final paragraph in the
AIntroduction@ section of an article.
The purposes of this study were: 1) to identify the relative influence of various factors in students= selections of
family practice residency programs in Texas; and 2) to determine if the factors that influenced students= selections
of various types of residency programs differed.
17
Methods
The traditional purpose of the AMethods@ section of a research report was to provide other researchers with a blueprint
of the study so that it could be replicated and the findings vernier. It is doubtful that many studies published today could
be replicated entirely from the AMethods@ description. The more important use of this section today is to provide
readers with the information necessary to judge the quality of the study design and procedures and hence the
validity of the findings.
There are generally four areas that should be addressed in the AMethods@ section of an ample.
Subjects. The author should provide a complete description of the participants of the study, including how they were selected or
assigned. If a survey was constructed, the rate of questionnaire return should be given and the follow-up procedure described. The
reader should be provided sufficient detail to judge whether the study outcomes could have been biased by the sample studied.
The subjects of this study were the new residents (127) selected through the NRMP by the 22 Texas family
practice residency programs in 1987. Three residency programs did not take residents through NRMP or did not
indicate those taken through NRMP. Responses from these programs were eliminated from the study. This left
usable responses from 19 of 22 family practice residency programs. A total of 116 residents taken through NRMP
responded, yielding a response rate of ninety-one percent. The majority of responses (66) were received from 12
Medical School Affiliated programs, the largest group of program type in Texas. The next largest group of
responses (32) were from the four Medical School Based programs. The smallest number of responses (18) were
received from the three Medical School Administered programs. There are currently no Community Based
programs in Texas as defined by the NRMP criteria.Ref
Design. A description of the experimental design should be provided to allow assessment of whether bias could have
been introduced into the study by way of extraneous variables. This description may include the formal name of the
design (e.g. clinical trail, case-control study) and may include a descriptor of special techniques used to eliminate bias
(e.g.. blocking, blinding).
Study questionnaires were mailed to directors of each program for administration to residence during the first
week of July, 1987. This timing was considered crucial to capture residents= reasons for selecting programs while
still recent in their memories and before residents were influenced by other experiences at their programs.
Directors were called after one week to encourage prompt reply to the study.
Instrumentation. This section should contain a description of the measurement instruments used in the study and their
quality. If an instrument was designed for the study, a description of its construction (e.g.. pilot-testing,
reliability/validity, types of items, should be included. If a standardized instrument was used (e.g., Myers-Briggs Type
Indicator), the author should describe the reliability and validity of the instrument for populations similar to the ones
included in the present study.
The study questionnaire was constructed by the authors and consisted of 52 rating-scale items. Residents were
asked to indicate the importance of each item in the selections of their residencies by circling numerical responses
ranging from zero to six. A graphic rating scale was placed at the top of the questionnaire for residents to refer to
in rating all items. The scale had descriptive anchors at 0 (Anot an important factor in my selecting this
residency@), 2 (Aa slightly important factor . . . A), 4 (Aan important factor . . . A), and 6 (Aan extremely
important factor . . .@). Questionnaire items were constructed primarily from the literature review.Ref Other
items were suggested by faculty and residents in the pilot-testing of the questionnaire.
The questionnaire was pilot-tested on three first-year residents in each of three family practice residency
programs of different types in Texas during the Spring of 1987. After completing the pilot questionnaire,
residents were interviewed by the faculty member or director administering the instrument. Questions were asked
about: 1) the content of the questionnaire (Which, if any, items are ambiguous?; Which items are redundant?; Are
there some items that you considered important which were not included?); 2) the scale (Is the scale clear, easy to
understand and use?); 3, the process (Was the questionnaire easy to complete?); and 4) general comments (Any
comments for improvement of the questionnaire?). The final questionnaire was derived from revisions based on
feedback from this pilot-testing.
18
Data Analysis. A description of how the data were analyzed should be included in this section.
Two methods of analysis were used on the study data. First, mean scores of residents= ratings of each item were
computed, and items were rank-ordered in terms of relative importance in influencing students= selections of
programs. These data are reported for each program type and for all programs combined. Second, mean scores of
each item rating were compared across different program types using Tukey=s Studentized Range (HSD) tests to
determine if factors influencing students= selections of types of programs differed.
Results
Data Description: The results section of the article should contain a presentation of the data, but not necessarily all of
the data obtained in the study. It is often useful to review, the research questions as guides for selecting the data to
include in the article. The data should be stated as facts without interpretive or qualifying information. Delay comment on
the data until the ADiscussion@ section.
Bad Example: Clearly, students selected various types of resident programs for very different reasons. For
example, students who selected Medical School Based programs were drawn by the university affiliation of the
program and the expert training they would receive, whereas students who selected Medical School Affiliated
programs depended more on recommendations of others about the program and were more concerned about the
attitude of other specialists in the community toward family practice....
Better: Significant differences were found in the level of importance of seven items in students= consideration of
different program types. (See Table 1) While it was rated an important factor by students who selected all
program types, the Aphilosophy of training@ was rated significantly less important by students who selected
Medical School Based programs as compared to students who selected Medical School Affiliated programs and
all programs combined (F=3.l3; p<.05)....
Tables and Figures. Tables are used for presentation of data that would be difficult or lengthy to explain fully in text.
Figures are used to illustrate data for purposes of clarity. Each table and figure, with its legend, must be coherent on its
own, not dependent on the narrative for understanding. Tables and figures should supplement, not duplicate, the written
text. If the data can be explained fully and clearly in text, there is no reason to use a table or figure. Journals often
suggest elimination of as many tables and figures as possible, because they occupy considerable space and are expensive
to publish.
Discussion
The content of the ADiscussion@ section varies greatly from article to article. There are, however, some common
elements in many articles.
Interpretation of Results. Authors often explain the meaning of the study results for the reader. Be direct; avoid
qualifying phrases such as Ait appears that . . .@ or Aour data suggest the possibility . . .@
The factor that attracted most students to particular family practice residency programs related to the
opportunities for students to get quality family practice training (e.g., commitment of family medicine faculty to
clinical instruction of residents, quality of the family practice clinic experience, morale of staff, competence of
family medicine faculty, philosophy of training, overall curriculum of program). At the other extreme, factors that
were least influential in attracting students to programs related to the extrinsic rewards that one might be more
interested in when seeking employment (e.g., salary, benefits, cost of living).
Limitations of Study. To assist readers of an article in judging the validity of the research results, many authors describe
any limitations or biases which may have affected the outcome of the study.
While this study produced the intended ranking of factors influential in students= selections of family practice
programs in Texas and a comparison of these factors across program types, several cautions are offered for
interpreting the results. First, while the rating scale used in this study was developed from previous research and
pilot-tested on first-year residents, the reliability of the instrument was not checked. Second, the present study
was of students selecting family practice residency programs in Texas; therefore, the results may not be applicable
to programs in other areas of the United States....
19
Comparisons to Previous Research. Many authors describe how the outcomes of a study relate to previously published
research on the topic. This previous research is likely to have been described in the AIntroduction@ section of the
article.
In comparing findings from this study to previous research, some similarities and differences were noted. In terms
of similarities, the importance of Acommitment of faculty to clinical instruction of residents,@ and the Amorale
of the staff@ were each identified previously by Bunch et al.Ref. . . In terms of differences, Sacks et al.Ref noted
the importance of females having Aat least one woman interviewer@ and the importance of an Aorganized
day of interviews,@ while Bunch et al.Ref pointed out that Afuture prospects for fellowship training@ and the
Aopportunities of residents to do research@ were important factors in students= consideration of residency
programs. These issues were rated as less important in the present study . . .
Summarize, Generalize or Conclude. As a closing paragraph for an article, authors often summarize the research findings,
generalize the results to the larger population of interest, or draw conclusions about the topic of focus. Sometimes authors
suggest issues needing further research.
In summary, three major accomplishments were achieved by the present study in extending knowledge of
students= selections of family practice residency programs. First, the present study confirmed many of the factors
previously identified in other specialty areas as influential in students= selections of family practice residence
programs but also identified some factors unique to students selecting family practice programs. Some of the
characteristics that are influential in students= selections of any residency program, regardless of the specialty, are:
the commitment of the faculty to clinical instruction of residents; the morale of the staff of the program; students=
exposure to the residents of the program; the professional courtesy extended to applicants; and the leadership of
the program. Factors unique to students= decisions of family practice programs include:. . .
Abstract
The last section written is an abstract of the article. Many journals limit the length of the abstract to 100 or 150 words.
Abstracts should describe the research that was done but also include the findings of the study. Specifically, the abstract
should summarize the purpose, methods, and results of a study, as well as the conclusions drawn.
This study identified the relative influence of 52 factors on students= selections of family practice residency
programs in Texas. All students (127) selected through the National Residency Matching Program in 1987 by 22
residency programs in Texas were surveyed. Based on a 91% response rate, factors which influenced students=
selections of programs were rank-ordered according to program type (e.g., Medical School Based). Factors most
influential in students= selections of programs overall related to the quality of training they would receive:
Acommitment of family medicine faculty to clinical instruction of residents@; Aquality of family practice clinic
experience@; Amorale of staff@; and Acompetence of family medicine faculty.@ The least important issues
involved extrinsic rewards: Asalary@; Abenefits@; and Acost of living.@ Significant differences were found
in the level of importance placed on seven factors by residents who selected different program types,
indicating that students selected various types of family practice residency programs for deferent reasons.
References
Format the references in the style specified by the journal to which you plan to submit to the article. References should
not be included that have not been read by the author/s or cited in the article. Where writing the first draft of the article,
you may want to list the references in shorthand where they are used in the article (e.g., Johnson et al., 1985). Later, when
the revisions have been made in the draft, the references can be numbered sequentially and a formal reference list
constructed.
WRITING AND SUBMITTING ARTICLES FOR PUBLICATION
Several suggestions are offered below for improving the process of writing articles and submitting them for publication.
Outline the Article
Work from an outline when preparing the manuscript. Computer outlining programs allow the transfer of outlines directly
into word processing. The first draft of the article can be constructed directly from the outline created without duplicating
work. An article written from an outline is more likely to follow a specific logic and convey intended meanings to
readers. A good way to start the outline is to write the headings of the sections of the report (Introduction, Methods,
Results, Discussion), then come back to the AIntroduction@ section and, following the plan described here, outline the
20
first sentence, first paragraph, review of literature, statement of purpose, and so on until the outline is complete.
Prior to
21
outlining the AResults@ section, it is often useful to construct the tables to be included in the report. This may help you
to describe the results of the study and draw conclusions.
Format the Article for Submission
As you conceptualize the article, scan journals that might be appropriate for your article. Look for similar topics,
analyses, and length. Most journals clearly explain the types and topics of articles they are interested in publishing in the
AInformation for Authors@ section, which is often included in issues of the journal or can be obtained by request.
Begin formatting your article in accordance with the guidelines specified by the journal you select as you are drafting the
article. By selecting a journal early, the author can write to the readership (audience) of the journal and avoid the extra
work of cutting out content not allowed by a specific journal format or pertinent to its audience.
Obtain Reviews from Coauthors and Colleagues
When the first draft is complete, the article should be submitted to all authors for review. The principal author is usually
responsible for writing the first draft, circulating drafts to coauthors, and integrating suggested changes into the article.
This review process may take as many as three iterations to get the article to the point where all authors are satisfied.
After the authors have reviewed the article, submit it to external reviewers. These reviewers may include faculty in your
program/institution, fellows, and experts on the topic selected from the review of literature.
Use an Editor
There is no certification or degree process for editors. Anyone can be an editor. Look for someone with a strong
background in grammar, sentence structure, spelling, and punctuation. Also look for an editor with a successful
background in reviewing articles for publication. Ask for a vita. You may find that such an editor is employed at your
university to assist faculty with their publications.
An editor=s review of your paper may be limited to grammar and spelling or may extend to formatting and conceptual
design of the article. Give your editor specific instructions concerning the type of review you want. After you work with
an editor several times, this becomes less important. Each editor uses a slightly different marking system in reviewing
papers; be sure to request a glossary of the proofreading markings used by your editor. As suggested for reviews by authors and colleagues, the principal author is usually responsible for liaison with the editor and integrating any suggested
revisions into the draft of the article.
Select Coauthors of the Article
The decision as to who will be authors of the article you plan to publish is perhaps the most difficult decision you must
make as a senior author, as it has potential for conflict. If you use statistical consultants or technical advisors and do not
include them as authors, the next time you ask for their help they may not be available. Perhaps this helps explain the
recent trend toward multiple-authored papers. The following guidelines were synthesized from the author=s experience
and several articles on the topic of authorship of papers.14-17 A thorough reading of these articles is recommended for a
complete understanding of the issue.
1.
2.
Problems over coauthorship are less likely to occur when decisions about authorship, or at least tentative decisions,
are made before a study is started. These decisions should be initiated by the person who is to be most responsible
for designing and executing the project (senior author). Any conflicts over authorship or content of the paper should
be resolved among co-workers with the senior author chairing the discussion.
A good place to clarify authorship and individual responsibilities for the project is in a pre-study protocol. It is
an excellent idea to write a description of your project which includes the design of the project (e.g., research
objective, sample selection, independent and dependent variables). This protocol can also describe the roles of
individual researchers and authors= names in tentative order for the eventual publication. It should be noted that
individuals may change roles on the project or drop out completely. Changes in authorship may have to be made
during the drafting of the article.
22
Uniform Requirements for Manuscripts
Submitted to Biomedical Journals: Writing and
Editing for Biomedical Publication
aspects of preparing and submitting manuscripts. The ICMJE
believes the entire document is relevant to the concerns of
both authors and editors.
The Uniform Requirements can provide many other
stakeholders - peer reviewers, publishers, the media, patients
and their families, and general readers - with useful insights
into the biomedical authoring and editing process.
Updated November 2003
International Committee of Medical Journal Editors
I. Statement Of Purpose
I. A. About the Uniform Requirements
A small group of editors of general medical journals met
informally in Vancouver, British Columbia, in 1978 to
establish guidelines for the format of manuscripts submitted to
their journals. The group became known as the Vancouver
Group. Its requirements for manuscripts, including formats for
bibliographic references developed by the National Library of
Medicine, were first published in 1979. The Vancouver Group
expanded and evolved into the International Committee of
Medical Journal Editors (ICMJE), which meets annually. The
ICMJE gradually has broadened its concerns to include ethical
principles related to publication in biomedical journals.
The ICJME has produced multiple editions of the Uniform
Requirements for Manuscripts Submitted to Biomedical
Journals. Over the years, issues have arisen that go beyond
manuscript preparation, resulting in the development of a
number of Separate Statements on editorial policy. The entire
Uniform Requirements document was revised in 1997;
sections were updated in May 1999 and May 2000. In May
2001, the ICMJE revised the sections related to potential
conflict of interest. For the present revision (2003), the
committee revised and reorganized the entire document and
incorporated the Separate Statements into the text.
The total content of the Uniform Requirements for
Manuscripts Submitted to Biomedical Journals may be
reproduced for educational, not-for-profit purposes without
regard for copyright; the committee encourages distribution of
the material.
Journals that agree to use the Uniform Requirements are
encouraged to state in their instructions to authors that their
requirements are in accordance with the Uniform
Requirements and to cite this version.
I.B. Potential Users of the Uniform Requirements
The ICMJE created the Uniform Requirements primarily to
help authors and editors in their mutual task of creating and
distributing accurate, clear, easily accessible reports of
biomedical studies. The initial sections address the ethical
principles related to the process of evaluating, improving, and
publishing manuscripts in biomedical journals and the
relationships between editors and authors, peer reviewers, and
the media. The latter sections address the more technical
22
I. C. How to Use the Uniform Requirements
The Uniform Requirements state the ethical principles in the
conduct and reporting of research and provide
recommendations relating to specific elements of editing and
writing. These recommendations are based largely on the
shared experience of a moderate number of editors and
authors, collected over many years, rather than on the results
of methodical, planned investigation that aspires to be
"evidence-based." Wherever possible, recommendations are
accompanied by a rationale that justifies them; as such, the
document serves an educational purpose.
Authors will find it helpful to follow the recommendations in
this document whenever possible because, as described in the
explanations, doing so improves the quality and clarity of
reporting in manuscripts submitted to any journal, as well as
the ease of editing. At the same time, every journal has
editorial requirements uniquely suited to its purposes. Authors
therefore need to become familiar with the specific
instructions to authors published by the journal they have
chosen for their manuscript - for example, the topics suitable
for that journal, and the types of papers that may be submitted
(for example, original articles, reviews, or case reports) - and
should follow those instructions. The Mulford Library at the
Medical College of Ohio maintains a useful compendium of
instructions to authors at www.mco.edu/lib/instr/libinsta.html.
II. Ethical Considerations in the Conduct and
Reporting of Research
II.A Authorship and Contributorship
II.A.1. Byline Authors
An "author" is generally considered to be someone who has
made substantive intellectual contributions to a published
study, and biomedical authorship continues to have important
academic, social, and financial implications. (1) In the past,
readers were rarely provided with information about
contributions to studies from those listed as authors and in
acknowledgments. (2) Some journals now request and publish
information about the contributions of each person named as
having participated in a submitted study, at least for original
research. Editors are strongly encouraged to develop and
implement a contributorship policy, as well as a policy on
identifying who is responsible for the integrity of the work as
a whole.
While contributorship and guarantorship policies obviously
remove much of the ambiguity surrounding contributions, it
leaves unresolved the question of the quantity and quality of
contribution that qualify for authorship. The International
Committee of Medical Journal Editors has recommended the
following criteria for authorship; these criteria are still
appropriate for those journals that distinguish authors from
other contributors.
1. Authorship credit should be based on 1) substantial
contributions to conception and design, or
acquisition of data, or analysis and interpretation of
data; 2) drafting the article or revising it critically for
important intellectual content; and 3) final approval
of the version to be published. Authors should meet
conditions 1, 2, and 3.
2. When a large, multi-center group has conducted the
work, the group should identify the individuals who
accept direct responsibility for the manuscript (3).
These individuals should fully meet the criteria for
authorship defined above and editors will ask these
individuals to complete journal-specific author and
conflict of interest disclosure forms. When
submitting a group author manuscript, the
corresponding author should clearly indicate the
preferred citation and should clearly identify all
individual authors as well as the group name.
Journals will generally list other members of the
group in the acknowledgements. The National
Library of Medicine indexes the group name and the
names of individuals the group has identified as
being directly responsible for the manuscript.
3. Acquisition of funding, collection of data, or general
supervision of the research group, alone, does not
justify authorship.
4. All persons designated as authors should qualify for
authorship, and all those who qualify should be
listed.
5. Each author should have participated sufficiently in
the work to take public responsibility for appropriate
portions of the content.
Some journals now also request that one or more authors,
referred to as "guarantors," be identified as the persons who
take responsibility for the integrity of the work as a whole,
from inception to published article, and publish that
information.
Increasingly, authorship of multi-center trials is attributed to a
group. All members of the group who are named as authors
should fully meet the above criteria for authorship.
23
The order of authorship on the byline should be a joint
decision of the co-authors. Authors should be prepared to
explain the order in which authors are listed.
II.A.2. Contributors Listed in Acknowledgments
All contributors who do not meet the criteria for authorship
should be listed in an acknowledgments section. Examples of
those who might be acknowledged include a person who
provided purely technical help, writing assistance, or a
department chair who provided only general support.
Financial and material support should also be acknowledged.
Groups of persons who have contributed materially to the
paper but whose contributions do not justify authorship may
be listed under a heading such as "clinical investigators" or
"participating investigators," and their function or contribution
should be described - for example, "served as scientific
advisors," "critically reviewed the study proposal," "collected
data," or "provided and cared for study patients."
Because readers may infer their endorsement of the data and
conclusions, all persons must give written permission to be
acknowledged.
II.B Editorship
II.B.1. The Role of the Editor
The editor of a journal is the person responsible for its entire
content. Owners and editors of medical journals have a
common endeavor - the publication of a reliable and readable
journal, produced with due respect for the stated aims of the
journal and for costs. The functions of owners and editors,
however, are different. Owners have the right to appoint and
dismiss editors and to make important business decisions in
which editors should be involved to the fullest extent possible.
Editors must have full authority for determining the editorial
content of the journal. This concept of editorial freedom
should be resolutely defended by editors even to the extent of
their placing their positions at stake. To secure this freedom in
practice, the editor should have direct access to the highest
level of ownership, not only to a delegated manager.
Editors of medical journals should have a contract that clearly
states the editor's rights and duties in addition to the general
terms of the appointment and that defines mechanisms for
resolving conflict.
An independent editorial advisory board may be useful in
helping the editor establish and maintain editorial policy.
II.B.2. Editorial Freedom
The ICMJE adopts the World Association of Medical Editors'
definition
of
editorial
freedom
(http://www.wame.org/wamestmt.htm). This definition states
that editorial freedom or independence is the concept that
editors-in chief should have full authority over the editorial
content of their journal. Journal owners should not interfere in
the evaluation; selection or editing of individual articles either
directly or by creating an environment that strongly influences
decisions. Editors should base decisions on the validity of the
work and its importance to the journal's readers not on the
commercial success of the journal. Editors should be free to
express critical but responsible views about all aspects of
medicine without fear of retribution, even if these views might
conflict with the commercial goals of the publisher. Editors
and editors' organizations have the obligation to support the
concept of editorial freedom and to draw major transgressions
of such freedom to the attention of the international medical,
academic, and lay communities.
II.C. Peer Review
Unbiased, independent, critical assessment is an intrinsic part
of all scholarly work, including the scientific process. Peer
review is the critical assessment of manuscripts submitted to
journals by experts who are not part of the editorial staff. Peer
review can therefore be viewed as an important extension of
the scientific process. Although its actual value has been little
studied, and is widely debated (4), peer review helps editors
decide which manuscripts are suitable for their journals, and
helps authors and editors in their efforts to improve the quality
of reporting. A peer-reviewed journal is one that submits most
of its published research articles for outside review. The
number and kind of manuscripts sent for review, the number
of reviewers, the reviewing procedures, and the use made of
the reviewers' opinions may vary. In the interests of
transparency, each journal should publicly disclose its policies
in its instructions to authors.
II.D. Conflicts of Interest
Public trust in the peer review process and the credibility of
published articles depend in part on how well conflict of
interest is handled during writing, peer review, and editorial
decision making. Conflict of interest exists when an author (or
the author's institution), reviewer, or editor has financial or
personal relationships that inappropriately influence (bias) his
or her actions (such relationships are also known as dual
commitments, competing interests, or competing loyalties).
These relationships vary from those with negligible potential
to those with great potential to influence judgment, and not all
relationships represent true conflict of interest. The potential
for conflict of interest can exist whether or not an individual
believes that the relationship affects his or her scientific
judgment. Financial relationships (such as employment,
consultancies, stock ownership, honoraria, paid expert
testimony) are the most easily identifiable conflicts of interest
and the most likely to undermine the credibility of the journal,
the authors, and of science itself. However, conflicts can occur
for other reasons, such as personal relationships, academic
competition, and intellectual passion.
All participants in the peer review and publication process
must disclose all relationships that could be viewed as
presenting a potential conflict of interest. Disclosure of these
24
relationships is also important in connection with editorials
and review articles, because it is can be more difficult to
detect bias in these types of publications than in reports of
original research. Editors may use information disclosed in
conflict of interest and financial interest statements as a basis
for editorial decisions. Editors should publish this information
if they believe it is important in judging the manuscript.
II.D.1. Potential Conflicts of Interest Related to Individual
Authors' Commitments
When authors submit a manuscript, whether an article or a
letter, they are responsible for disclosing all financial and
personal relationships that might bias their work. To prevent
ambiguity, authors must state explicitly whether potential
conflicts do or do not exist. Authors should do so in the
manuscript on a conflict of interest notification page that
follows the title page, providing additional detail, if necessary,
in a cover letter that accompanies the manuscript. (See
Section IV.A.3. Conflict of Interest Notification Page)
Investigators must disclose potential conflicts to study
participants and should state in the manuscript whether they
have done so.
Editors also need to decide when to publish information
disclosed by authors about potential conflicts. If doubt exists,
it is best to err on the side of publication.
II.D.2. Potential Conflicts of Interest Related to Project
Support
Increasingly, individual studies receive funding from
commercial firms, private foundations, and government. The
conditions of this funding have the potential to bias and
otherwise discredit the research.
Scientists have an ethical obligation to submit creditable
research results for publication. Moreover, as the persons
directly responsible for their work, researchers should not
enter into agreements that interfere with their access to the
data and their ability to analyze it independently, to prepare
manuscripts, and to publish them. Authors should describe the
role of the study sponsor(s), if any, in study design; in the
collection, analysis, and interpretation of data; in the writing
of the report; and in the decision to submit the report for
publication. If the supporting source had no such involvement,
the authors should so state. Biases potentially introduced
when sponsors are directly involved in research are analogous
to methodological biases of other sorts. Some journals,
therefore, choose to include information about the sponsor's
involvement in the methods section.
Editors may request that authors of a study funded by an
agency with a proprietary or financial interest in the outcome
sign a statement such as, "I had full access to all of the data in
this study and I take complete responsibility for the integrity
of the data and the accuracy of the data analysis." Editors
should be encouraged to review copies of the protocol and/or
contracts associated with project-specific studies before
accepting such studies for publication. Editors may choose not
to consider an article if a sponsor has asserted control over the
authors' right to publish.
II.D.3. Potential Conflicts of Interest Related to
Commitments of Editors, Journal Staff, or Reviewers
Editors should avoid selecting external peer reviewers with
obvious potential conflicts of interest, for example, those who
work in the same department or institution as any of the
authors. Authors often provide editors with the names of
persons they feel should not be asked to review a manuscript
because of potential conflicts of interest, usually professional.
When possible, authors should be asked to explain or justify
their concerns; that information is important to editors in
deciding whether to honor such requests.
Reviewers must disclose to editors any conflicts of interest
that could bias their opinions of the manuscript, and they
should disqualify themselves from reviewing specific
manuscripts if they believe it to be appropriate. As in the case
of authors, silence on the part of reviewers concerning
potential conflicts may mean either that such conflicts exist
that they have failed to disclose, or that conflicts do not exist.
Reviewers must therefore also be asked to state explicitly
whether conflicts do or do not exist. Reviewers must not use
knowledge of the work, before its publication, to further their
own interests.
Editors who make final decisions about manuscripts must
have no personal, professional, or financial involvement in
any of the issues they might judge. Other members of the
editorial staff, if they participate in editorial decisions, must
provide editors with a current description of their financial
interests (as they might relate to editorial judgments) and
disqualify themselves from any decisions where they have a
conflict of interest. Editorial staff must not use the information
gained through working with manuscripts for private gain.
Editors should publish regular disclosure statements about
potential conflicts of interests related to the commitments of
journal staff.
II.E. Privacy and Confidentiality
II. E.1. Patients and Study Participants
Patients have a right to privacy that should not be infringed
without informed consent. Identifying information, including
patients' names, initials, or hospital numbers, should not be
published in written descriptions, photographs, and pedigrees
unless the information is essential for scientific purposes and
the patient (or parent or guardian) gives written informed
consent for publication. Informed consent for this purpose
requires that a patient who is identifiable be shown the
manuscript to be published.
Identifying details should be omitted if they are not essential.
Complete anonymity is difficult to achieve, however, and
25
informed consent should be obtained if there is any doubt. For
example, masking the eye region in photographs of patients is
inadequate protection of anonymity. If data are changed to
protect anonymity, authors should provide assurance that
alterations of the data do not distort scientific meaning.
The requirement for informed consent should be included in
the journal's instructions for authors. When informed consent
has been obtained it should be indicated in the published
article.
II.E.2. Authors and Reviewers
Manuscripts must be reviewed with due respect for authors'
confidentiality. In submitting their manuscripts for review,
authors entrust editors with the results of their scientific work
and creative effort, on which their reputation and career may
depend. Authors' rights may be violated by disclosure of the
confidential details of the review of their manuscript.
Reviewers also have rights to confidentiality, which must be
respected by the editor. Confidentiality may have to be
breached if dishonesty or fraud is alleged but otherwise must
be honored.
Editors must not disclose information about manuscripts
(including their receipt, content, status in the reviewing
process, criticism by reviewers, or ultimate fate) to anyone
other than the authors and reviewers. This includes requests to
use the materials for legal proceedings.
Editors must make clear to their reviewers that manuscripts
sent for review are privileged communications and are the
private property of the authors. Therefore, reviewers and
members of the editorial staff must respect the authors' rights
by not publicly discussing the authors' work or appropriating
their ideas before the manuscript is published. Reviewers must
not be allowed to make copies of the manuscript for their files
and must be prohibited from sharing it with others, except
with the permission of the editor. Reviewers should return or
destroy copies of manuscripts after submitting reviews.
Editors should not keep copies of rejected manuscripts.
Reviewer comments should not be published or otherwise
made public without permission of the reviewer, author, and
editor.
Opinions differ on whether reviewers should remain
anonymous. Authors should consult the information for
authors of the journal they have chosen to learn whether the
reviews are anonymous. When comments are not signed the
reviewers' identity must not be revealed to the author or
anyone else without the reviewer's permission.
Some journals publish reviewers' comments with the
manuscript. No such procedure should be adopted without the
consent of the authors and reviewers. However, reviewers'
comments should be sent to other reviewers of the same
manuscript, which helps reviewers learn from the review
process, and reviewers may be notified of the editor's
decision.
II.F. Protection of Human Subjects and Animals in
Research
When reporting experiments on human subjects, authors
should indicate whether the procedures followed were in
accordance with the ethical standards of the responsible
committee on human experimentation (institutional and
national) and with the Helsinki Declaration of 1975, as
revised in 2000 (5). If doubt exists whether the research was
conducted in accordance with the Helsinki Declaration, the
authors must explain the rationale for their approach, and
demonstrate that the institutional review body explicitly
approved the doubtful aspects of the study. When reporting
experiments on animals, authors should be asked to indicate
whether the institutional and national guide for the care and
use of laboratory animals was followed.
III. Publishing and Editorial Issues Related to
Publication in Biomedical Journals
III.A. Obligation to Publish Negative Studies
Editors should consider seriously for publication any carefully
done study of an important question, relevant to their readers,
whether the results are negative (that is, convincingly allow
the null hypothesis to be accepted) or positive (that is, allow
the null hypothesis to be rejected). Failure to submit or
publish negative studies, in particular, contributes to
publication bias. Many studies that purport to be negative are,
in fact, inconclusive; publication of inconclusive studies is
problematic, since they add little to biomedical knowledge
and consume journal resources. The Cochrane Library may be
interested
in
publishing
inconclusive
trials
(www.cochrane.org).
III.B. Corrections, Retractions and "Expressions of
Concern"
Editors must assume initially that authors are reporting work
based on honest observations. Nevertheless, two types of
difficulty may arise.
First, errors may be noted in published articles that require the
publication of a correction or erratum of part of the work. The
corrections should appear on a numbered page, be listed in the
contents page, include the complete original citation, and link
to the original article and vice versa if online. It is conceivable
that an error could be so serious as to vitiate the entire body of
the work, but this is unlikely and should be handled by editors
and authors on an individual basis. Such an error should not
be confused with inadequacies exposed by the emergence of
new scientific information in the normal course of research.
The latter require no corrections or withdrawals.
26
The second type of difficulty is scientific fraud. If substantial
doubts arise about the honesty or integrity of work, either
submitted or published, it is the editor's responsibility to
ensure that the question is appropriately pursued, usually by
the authors' sponsoring institution. However, it is not
ordinarily the task of editors to conduct a full investigation or
to make a determination; that responsibility lies with the
institution where the work was done or with the funding
agency. The editor should be promptly informed of the final
decision, and if a fraudulent paper has been published, the
journal must print a retraction. If this method of investigation
does not result in a satisfactory conclusion, the editor may
choose to conduct his or her own investigation. As an
alternative to retraction, the editor may choose to publish an
expression of concern about aspects of the conduct or integrity
of the work.
The retraction or expression of concern, so labeled, should
appear on a numbered page in a prominent section of the print
journal as well as in the online version, be listed in the
contents page, and include in its heading the title of the
original article. It should not simply be a letter to the editor.
Ideally, the first author should be the same in the retraction as
in the article, although under certain circumstances the editor
may accept retractions by other responsible persons. The text
of the retraction should explain why the article is being
retracted and include a full original citation reference to it.
The validity of previous work by the author of a fraudulent
paper cannot be assumed. Editors may ask the author's
institution to assure them of the validity of earlier work
published in their journals or to retract it. If this is not done
editors may choose to publish an announcement expressing
concern that the validity of previously published work is
uncertain.
III.C. Copyright
Many biomedical journals ask authors to transfer copyright to
the journal. However, an increasing number of "open access"
journals do not require authors to transfer copyright to the
journal. Editors should make their position on copyright
transfer clear to authors and to others who might be interested
in using editorial content from their journals. The copyright
status of articles in a given journal can vary: some content
cannot be copyrighted (articles written by employees of the
U.S. and some other governments in the course of their work,
for example); editors may agree to waive copyright on others;
still others may be protected under serial rights (that is, use in
publications other than journals, including electronic
publications, is permitted).
III.D. Overlapping Publications
III.D.1. Duplicate Submission
Most biomedical journals will not consider manuscripts that
are simultaneously being considered by other journals. Among
the principal considerations that have led to this policy are: 1)
the potential for disagreement when two (or more) journals
claim the right to publish a manuscript that has been submitted
simultaneously to more than one; and 2) the possibility that
two or more journals will unknowingly and unnecessarily
undertake the work of peer review and editing of the same
manuscript, and publish same article.
However, editors of different journals may decide to
simultaneously or jointly publish an article if they believe that
doing so would be in the best interest of the public's health.
III.D.2. Redundant Publication
Redundant (or duplicate) publication is publication of a paper
that overlaps substantially with one already published in print
or electronic media.
Readers of primary source periodicals, whether print or
electronic, deserve to be able to trust that what they are
reading is original unless there is a clear statement that the
article is being republished by the choice of the author and
editor. The bases of this position are international copyright
laws, ethical conduct, and cost-effective use of resources.
Duplicate publication of original research is particularly
problematic, since it can result in inadvertent double counting
or inappropriate weighting of the results of a single study,
which distorts the available evidence.
Most journals do not wish to receive papers on work that has
already been reported in large part in a published article or is
contained in another paper that has been submitted or
accepted for publication elsewhere, in print or in electronic
media. This policy does not preclude the journal considering a
paper that has been rejected by another journal, or a complete
report that follows publication of a preliminary report, such as
an abstract or poster displayed at a professional meeting. Nor
does it prevent journals considering a paper that has been
presented at a scientific meeting but not published in full or
that is being considered for publication in a proceedings or
similar format. Press reports of scheduled meetings will not
usually be regarded as breaches of this rule, but additional
data or copies of tables and illustrations should not amplify
such reports.
When submitting a paper, the author must always make a full
statement to the editor about all submissions and previous
reports that might be regarded as redundant or duplicate
publication of the same or very similar work. The author must
alert the editor if the manuscript includes subjects about which
the authors have published a previous report or have
submitted a related report to another publication. Any such
report must be referred to and referenced in the new paper.
Copies of such material should be included with the submitted
paper to help the editor decide how to handle the matter.
27
If redundant or duplicate publication is attempted or occurs
without such notification, authors should expect editorial
action to be taken. At the least, prompt rejection of the
submitted manuscript should be expected. If the editor was not
aware of the violations and the article has already been
published, then a notice of redundant or duplicate publication
will probably be published with or without the author's
explanation or approval.
Preliminary reporting to public media, governmental agencies,
or manufacturers, of scientific information described in a
paper or a letter to the editor that has been accepted but not
yet published violates the policies of many journals. Such
reporting may be warranted when the paper or letter describes
major therapeutic advances or public health hazards such as
serious adverse effects of drugs, vaccines, other biological
products, or medicinal devices, or reportable diseases. This
reporting should not jeopardize publication, but should be
discussed with and agreed upon by the editor in advance.
III.D.3. Acceptable Secondary Publication
Certain types of articles, such as guidelines produced by
governmental agencies and professional organizations, may
need to reach the widest possible audience. In such instances,
editors sometimes choose deliberately to publish material that
is also being published in other journals, with the agreement
of the authors and the editors of those other journals.
Secondary publication for various other reasons, in the same
or another language, especially in other countries, is
justifiable, and can be beneficial, provided all of the following
conditions are met.
1. The authors have received approval from the editors of both
journals; the editor concerned with secondary publication
must have a photocopy, reprint, or manuscript of the primary
version.
2. The priority of the primary publication is respected by a
publication interval of at least one week (unless specifically
negotiated otherwise by both editors).
3. The paper for secondary publication is intended for a
different group of readers; an abbreviated version could be
sufficient.
4. The secondary version faithfully reflects the data and
interpretations of the primary version.
5. The footnote on the title page of the secondary version
informs readers, peers, and documenting agencies that the
paper has been published in whole or in part and states the
primary reference. A suitable footnote might read: "This
article is based on a study first reported in the [title of journal,
with full reference]."
Permission for such secondary publication should be free of
charge.
III.D.4. Competing Manuscripts Based on the Same Study
Publication of manuscripts to air co-investigators disputes
may waste journal space and confuse readers. On the other
hand, if editors knowingly publish a manuscript written by
only some of a collaborating team, they could be denying the
rest of the team their legitimate co authorship rights; they
could also be denying the journal's readers access to legitimate
differences of opinion about the interpretation of a study.
Two kinds of competing submissions are considered:
submissions by coworkers who disagree on the analysis and
interpretation of their study, and submissions by coworkers
who disagree on what the facts are and which data should be
reported.
Setting aside the unresolved question of ownership of the data,
the following general observations may help editors and
others dealing with these problems.
III. D.4.a. Differences in Analysis or Interpretation
If the dispute centers on the analysis or interpretation of data,
the authors should submit a manuscript that clearly presents
both versions. The difference of opinion should be explained
in a cover letter. The normal process of peer and editorial
review of the manuscript may help the authors to resolve their
disagreement regarding analysis or interpretation.
If the dispute cannot be resolved and the study merits
publication, both versions should be published. Options
include publishing two papers on the same study, or a single
paper with two analyses or interpretations. In such cases it
would be appropriate for the editor to publish a statement
outlining the disagreement and the journal's involvement in
attempts to resolve it.
considered separately. Where interpretations of the same data
are very similar, it is reasonable but not necessary for editors
to give preference to the manuscript that was received earlier.
However, editorial consideration of multiple submissions may
be justified in this circumstance, and there may even be a
good reason for publishing more than one manuscript because
different analytical approaches may be complementary and
equally valid.
III.E. Correspondence
Biomedical journals should provide its readership with a
mechanism for submitting comments, questions, or criticisms
about published articles, as well as brief reports and
commentary unrelated to previously published articles. This
will likely, but not necessarily, take the form of a
correspondence section or column. The authors of articles
discussed in correspondence should be given an opportunity
to respond, preferably in the same issue in which the original
correspondence appears. Authors of correspondence should be
asked to declare any competing or conflicting interests.
Published correspondence may be edited for length,
grammatical correctness, and journal style. Alternatively,
editors may choose to publish correspondence unedited for
length or style, as for example in rapid response sections on
the Internet; the journal should declare its editorial practice in
this regard. Authors should approve editorial changes that
alter the substance or tone of a letter or response.
Although editors have the prerogative to sift out
correspondence material that is irrelevant, uninteresting, or
lacking in cogency, they have a responsibility to allow a range
of opinion to be expressed. The correspondence column
should not be used merely to promote the journal's, or the
editors', point of view. In all instances, editors must make an
effort to screen out discourteous, inaccurate, or libelous
statements, and should not allow ad hominem arguments
intended to discredit opinions or findings.
III.D.4. b. Differences in Reported Methods or Results
If the dispute centers on differing opinions of what was
actually done or observed during the study, the journal editor
should refuse publication until the disagreement is resolved.
Peer review cannot be expected to resolve such problems. If
there are allegations of dishonesty or fraud, editors should
inform the appropriate authorities; authors should be notified
of an editor's intention to report a suspicion of research
misconduct.
III.D.5. Competing Manuscripts Based on the Same
Database
Editors sometimes receive manuscripts from separate research
groups that have analyzed the same data set, e.g., from a
public database. The manuscripts may differ in their analytic
methods, conclusions, or both. Each manuscript should be
28
In the interests of fairness and to keep correspondence within
manageable proportions, journals may want to set time limits
for responding to articles and correspondence, and for debate
on a given topic. Journals should also decide whether they
would notify authors when correspondence bearing on their
published work is going to appear in standard or rapid
response sections. Journals should also set policy with regard
to the archiving of unedited correspondence that appears on
line. These policies should be published both in print and
electronic versions of the journal.
III.F. Supplements, Theme Issues, and Special Series
Supplements are collections of papers that deal with related
issues or topics, are published as a separate issue of the
journal or as part of a regular issue, and are usually funded by
sources other than the journal's publisher. Supplements can
serve useful purposes: education, exchange of research
information, ease of access to focused content, and improved
cooperation between academic and corporate entities. Because
funding sources can bias the content of supplements through
the choice of topics and viewpoints, journals should consider
adopting the following principles. These same principles
apply to theme issues or special series that have external
funding and/or guest editors.
1.
The journal editor must take full responsibility for
the policies, practices, and content of supplements,
including complete control of the decision to publish
all portions of the supplement. Editing by the
funding organization should not be permitted.
2.
The journal editor must retain the authority to send
supplement manuscripts for external peer review and
to reject manuscripts submitted for the supplement.
These conditions should be made known to authors
and external supplement editors before beginning
editorial work on the supplement.
3.
The journal editor must approve the appointment of
any external editor of the supplement and take
responsibility for the work of the external editor.
4.
The sources of funding for the research, publication,
and the products the funding source make that are
considered in the supplement should be clearly stated
and prominently located in the supplement,
preferably on each page. Whenever possible, funding
should come from more than one sponsor.
5.
Advertising in supplements should follow the same
policies as those of the rest of the journal.
6.
Journal editors must enable readers to distinguish
readily between ordinary editorial pages and
supplement pages.
7.
Journal editors and supplement editors must not
accept personal favors or personal remuneration
from sponsors of supplements.
8.
Secondary publication in supplements (republication
of papers previously published elsewhere) should be
clearly identified by the citation of the original
paper. Supplements should avoid redundant or
duplicate publication. Supplements should not
republish research results, but the republication of
guidelines or other material in the public interest
might be appropriate.
9.
The principles of authorship and potential conflict of
interest disclosure articulated elsewhere in this
document should apply to supplements.
29
III.G. Electronic Publishing
Most biomedical journals are now published in electronic as
well as print versions, and some are published in electronic
form only. Electronic publishing (which includes the Internet)
is publishing. In the interests of clarity and consistency, the
medical and health information published on the Internet
should follow the recommendations in this document
whenever possible.
The nature of electronic publication requires some special
considerations, both within and beyond this document. At a
minimum, websites should indicate the following: names,
appropriate credentials, affiliations, and relevant conflicts of
interest of editors, authors, and contributors; documentation
and attribution of references and sources for all content;
information about copyright; disclosure of site ownership; and
disclosure of sponsorship, advertising, and commercial
funding.
Linking from one health or medical Internet site to another
may be perceived as an implicit recommendation of the
quality of the second site. Journals thus should exercise
caution in linking to other sites; when users are linking to
another site, it may be helpful to provide an explicit message
to that they are leaving the journal's site. If links to other sites
are posted as a result of financial considerations, such should
be clearly indicated. All dates of content posting and updating
should be indicated. In electronic layout as in print,
advertising and promotional messages should not be
juxtaposed with editorial content, and commercial content
should be clearly identifiable as such.
Electronic publication is an area that is in flux. Editors should
develop, make available to authors, and implement policies on
issues unique to electronic publishing. These issues include
archiving, error correction, version control, and choice of the
electronic or print version of the journal as the journal of
record, publication of ancillary material, and electronic
publication
III.H. Advertising
Most medical journals carry advertising, which generates
income for their publishers, but advertising must not be
allowed to influence editorial decisions. Journals should have
formal, explicit, written policies for advertising in both print
and electronic versions; website advertising policy should
parallel policy for the print version as much as possible.
Editors must have full and final authority for approving
advertisements and enforcing advertising policy. Where
independent bodies for reviewing advertising exist editors
should make use of their judgments.
Readers should be able to distinguish readily between
advertising and editorial material. The juxtaposition of
editorial and advertising material on the same products or
subjects should be avoided. Interleafing advertising pages
within articles discourages readers by interrupting the flow of
editorial content, and should be discouraged. Advertising
should not be sold on the condition that it will appear in the
same issue as a particular article.
Editors may find the following recommendations useful as
they seek to establish policies on these issues.

Editors can foster the orderly transmission of
medical information from researchers, through peerreviewed journals, to the public. This can be
accomplished by an agreement with authors that they
will not publicize their work while their manuscript
is under consideration or awaiting publication and an
agreement with the media that they will not release
stories before publication in the journal, in return for
which the journal will cooperate with them in
preparing accurate stories.

Editors need to keep in mind that an embargo system
works on the honor system; no formal enforcement
or policing mechanism exists. The decision of any
significant number of media outlets, or of biomedical
journals, not to respect the embargo system would
therefore lead to its rapid dissolution.

Very little medical research has such clear and
urgently important clinical implications for the
public's health that the news must be released before
full publication in a journal. In such exceptional
circumstances, however, appropriate authorities
responsible for public health should make the
decision and should be responsible for the advance
dissemination of information to physicians and the
media. If the author and the appropriate authorities
wish to have a manuscript considered by a particular
journal, the editor should be consulted before any
public release. If editors accept the need for
immediate release, they should waive their policies
limiting prepublication publicity.

Policies designed to limit prepublication publicity
should not apply to accounts in the media of
presentations at scientific meetings or to the abstracts
from these meetings (see Redundant Publication).
Researchers who present their work at a scientific
meeting should feel
free to discuss their
presentations with reporters, but they should be
discouraged from offering more detail about their
study than was presented in their talk.

When an article is soon to be published, editors
should help the media prepare accurate reports by
providing news releases, answering questions,
supplying advance copies of the journal, or referring
reporters to the appropriate experts. Most
responsible reporters find this assistance should be
contingent on the media's cooperation in timing their
Journals should not be dominated by advertising, but editors
should be careful about publishing advertisements from only
one or two advertisers, as readers may perceive that these
advertisers have influenced the editor.
Journals should not carry advertisements for products that
have proved to be seriously harmful to health-for example,
tobacco. Editors should ensure that existing regulatory or
industry standards for advertisements specific to their country
are enforced, or develop their own standards. The interests of
organizations or agencies should not control classified and
other non-display advertising, except where required by law.
Finally, editors should consider all criticisms of
advertisements for publication.
III. I. Medical Journals and the General Media
The public's interest in news of medical research has led the
popular media to compete vigorously to get information about
research as soon as possible. Researchers and institutions
sometimes encourage the reporting of research in the nonmedical media before full publication in a scientific journal by
holding a press conference or giving interviews.
The public is entitled to important medical information
without unreasonable delay, and editors have a responsibility
to play their part in this process. Biomedical journals are
published primarily for their readers, but the general public
has a legitimate interest in their content; an appropriate
balance should therefore guide journals' interaction with the
media between these complementary interests. Doctors in
practice need to have reports available in full detail before
they can advise their patients about the reports' conclusions.
Moreover, media reports of scientific research before the work
has been peer reviewed and fully published may lead to the
dissemination of inaccurate or premature conclusions.
An embargo system has been established in some countries to
prevent publication of stories in the general media before the
original paper on which they are based appears in the journal.
The embargo creates a "level playing field," which most
reporters appreciate since it minimizes the pressure on them to
publish stories which they have not had time to prepare
carefully. Consistency in the timing of public release of
biomedical information is also important in minimizing
economic chaos, since some articles contain information that
has great potential to influence financial markets. On the other
hand, the embargo system has been challenged as being selfserving of journals' interests, and impeding the rapid
dissemination of scientific information.
30
release of stories to coincide with the publication of
the article.

Editors, authors, and the media should apply the
above stated principles to material released early in
electronic versions of journals.
IV. Manuscript Preparation and Submission
IV.A. Preparing a Manuscript for Submission to a
Biomedical Journal
Editors and reviewers spend many hours reading manuscripts,
and therefore appreciate receiving with manuscripts that are
easy to read and edit. Much of the information in journals'
instructions to authors is designed to accomplish that goal in
ways that meet each journal's particular editorial needs. The
guidance that follows provides a general background and
rationale for preparing manuscripts for any journal.
IV.A.1.a. General Principles
The text of observational and experimental articles is usually
(but not necessarily) divided into sections with the headings
Introduction, Methods, Results, and Discussion. This socalled "IMRAD" structure is not simply an arbitrary
publication format, but rather a direct reflection of the process
of scientific discovery. Long articles may need subheadings
within some sections (especially the Results and Discussion
sections) to clarify their content. Other types of articles, such
as case reports, reviews, and editorials, are likely to need
other formats.
Publication in electronic formats has created opportunities for
adding details or whole sections in the electronic version only,
layering information, cross-linking or extracting portions of
articles, and the like. Authors need to work closely with
editors in developing or using such new publication formats
and should submit material for potential supplementary
electronic formats for peer review.
Double spacing of all portions of the manuscript - including
the title page, abstract, text, acknowledgments, references,
individual tables, and legends - and generous margins make it
possible for editors and reviewers to edit the text line by line,
and add comments and queries, directly on the paper copy. If
manuscripts are submitted electronically, the files should be
double spaced, because the manuscript may need to be printed
out for reviewing and editing.
During the editorial process reviewers and editors frequently
need to refer to specific portions of the manuscript, which is
difficult unless the pages are numbered. Authors should
therefore number all of the pages of the manuscript
consecutively, beginning with the title page.
IV.A.1.b. Reporting Guidelines for Specific Study Designs
31
Research reports frequently omit important information. The
general requirements listed in the next section relate to
reporting essential elements for all study designs. Authors are
encouraged in addition to consult reporting guidelines relevant
to their specific research design. For reports of randomized
controlled trials authors should refer to the CONSORT
statement (www.consort-statement.org). This guideline
provides a set of recommendations comprising a list of items
to report and a patient flow diagram. Reporting guidelines
have also been developed for a number of other study designs
that some journals may ask authors to follow. Authors should
consult the information for authors of the journal they have
chosen.
IV.A.2. Title Page
The title page should carry the following information:
1.
The title of the article. Concise titles are easier to
read than long, convoluted ones. Titles that are too
short may, however, lack important information,
such as study design (which is particularly important
in identifying randomized controlled trials). Authors
should include all information in the title that will
make electronic retrieval of the article both sensitive
and specific.
2.
Authors' names and institutional affiliations. Some
journals publish each author's highest academic
degree(s), while others do not.
3.
The name of the department(s) and institution(s) to
which the work should be attributed.
4.
Disclaimers, if any.
5.
Corresponding authors. The name, mailing address,
telephone and fax numbers, and e-mail address of the
author responsible for correspondence about the
manuscript (the "corresponding author;" this author
may or may not be the "guarantor" for the integrity
of the study as a whole, if someone is identified in
that role. The corresponding author should indicate
clearly whether his or her e-mail address is to be
published.
6.
The name and address of the author to whom
requests for reprints should be addressed or a
statement that reprints will not be available from the
authors.
7.
Source(s) of support in the form of grants,
equipment, drugs, or all of these.
8.
A running head. Some journals request a short
running head or foot line, usually of no more than 40
characters (count letters and spaces) at the foot of the
title page. Running heads are published in most
journals, but are also sometimes used within the
editorial office for filing and locating manuscripts.
9.
Word counts. A word count for the text only
(excluding abstract, acknowledgments, figure
legends, and references) allows editors and reviewers
to assess whether the information contained in the
paper warrants the amount of space devoted to it,
and whether the submitted manuscript fits within the
journal's word limits. A separate word count for the
Abstract is also useful for the same reason.
10. The number of figures and tables. It is difficult for
editorial staff and reviewers to tell if the figures and
tables that should have accompanied a manuscript
were actually included unless the numbers of figures
and tables that belong to the manuscript are noted on
the title page.
IV.A.3. Conflict of Interest Notification Page
To prevent the information on potential conflict of interest for
authors from being overlooked or misplaced, it is necessary
for that information to be part of the manuscript. It should
therefore also be included on a separate page or pages
immediately following the title page. However, individual
journals may differ in where they ask authors to provide this
information and some journals do not send information on
conflicts of interest to reviewers. (See Section II.D. Conflicts
of Interest)
IV.A.4. Abstract and Key Words
An abstract (requirements for length and structured format
vary by journal) should follow the title page. The abstract
should provide the context or background for the study and
should state the study's purposes, basic procedures (selection
of study subjects or laboratory animals, observational and
analytical methods), main findings (giving specific effect sizes
and their statistical significance, if possible), and principal
conclusions. It should emphasize new and important aspects
of the study or observations.
Because abstracts are the only substantive portion of the
article indexed in many electronic databases, and the only
portion many readers read, authors need to be careful that
abstracts reflect the content of the article accurately.
Unfortunately, many abstracts disagree with the text of the
article (6). The format required for structured abstracts differs
from journal to journal, and some journals use more than one
structure; authors should make it a point to prepare their
abstracts in the format specified by the journal they have
chosen.
Some journals request that, following the abstract, authors
provide, and identify as such, 3 to 10 key words or short
phrases that capture the main topics of the article. These will
assist indexers in cross-indexing the article and may be
published with the abstract. Terms from the Medical Subject
Headings (MeSH) list of Index Medicus should be used; if
suitable MeSH terms are not yet available for recently
introduced terms, present terms may be used.
IV.A.5. Introduction
Provide a context or background for the study (i.e., the nature
of the problem and its significance). State the specific purpose
or research objective of, or hypothesis tested by, the study or
observation; the research objective is often more sharply
focused when stated as a question. Both the main and
secondary objectives should be made clear, and any prespecified subgroup analyses should be described. Give only
strictly pertinent references and do not include data or
conclusions from the work being reported.
IV.A.6. Methods
The Methods section should include only information that was
available at the time the plan or protocol for the study was
written; all information obtained during the conduct of the
study belongs in the Results section.
IV.A.6.a. Selection and Description of Participants
Describe your selection of the observational or experimental
participants (patients or laboratory animals, including
controls) clearly, including eligibility and exclusion criteria
and a description of the source population. Because the
relevance of such variables as age and sex to the object of
research is not always clear, authors should explain their use
when they are included in a study report; for example, authors
should explain why only subjects of certain ages were
included or why women were excluded. The guiding principle
should be clarity about how and why a study was done in a
particular way. When authors use variables such as race or
ethnicity, they should define how they measured the variables
and justify their relevance.
IV.A.6.b. Technical information
Identify the methods, apparatus (give the manufacturer's name
and address in parentheses), and procedures in sufficient detail
to allow other workers to reproduce the results. Give
references to established methods, including statistical
methods (see below); provide references and brief
descriptions for methods that have been published but are not
well known; describe new or substantially modified methods,
give reasons for using them, and evaluate their limitations.
Identify precisely all drugs and chemicals used, including
generic name(s), dose(s), and route(s) of administration.
Authors submitting review manuscripts should include a
section describing the methods used for locating, selecting,
32
extracting, and synthesizing data. These methods should also
be summarized in the abstract.
IV.A.6.c. Statistics
Describe statistical methods with enough detail to enable a
knowledgeable reader with access to the original data to verify
the reported results. When possible, quantify findings and
present them with appropriate indicators of measurement error
or uncertainty (such as confidence intervals). Avoid relying
solely on statistical hypothesis testing, such as the use of P
values, which fails to convey important information about
effect size. References for the design of the study and
statistical methods should be to standard works when possible
(with pages stated). Define statistical terms, abbreviations, and
most symbols. Specify the computer software used.
IV.A.7. Results
Present your results in logical sequence in the text, tables, and
illustrations, giving the main or most important findings first.
Do not repeat in the text all the data in the tables or
illustrations; emphasize or summarize only important
observations. Extra or supplementary materials and technical
detail can be placed in an appendix where it will be accessible
but will not interrupt the flow of the text; alternatively, it can
be published only in the electronic version of the journal.
When data are summarized in the Results section, give
numeric results not only as derivatives (for example,
percentages) but also as the absolute numbers from which the
derivatives were calculated, and specify the statistical methods
used to analyze them. Restrict tables and figures to those
needed to explain the argument of the paper and to assess its
support. Use graphs as an alternative to tables with many
entries; do not duplicate data in graphs and tables. Avoid nontechnical uses of technical terms in statistics, such as
"random" (which implies a randomizing device), "normal,"
"significant," "correlations," and "sample."
Where scientifically appropriate, analyses of the data by
variables such as age and sex should be included.
IV.A.8. Discussion
Emphasize the new and important aspects of the study and the
conclusions that follow from them. Do not repeat in detail
data or other material given in the Introduction or the Results
section. For experimental studies it is useful to begin the
discussion by summarizing briefly the main findings, then
explore possible mechanisms or explanations for these
findings, compare and contrast the results with other relevant
studies, state the limitations of the study, and explore the
implications of the findings for future research and for clinical
practice.
Link the conclusions with the goals of the study but avoid
unqualified statements and conclusions not adequately
supported by the data. In particular, authors should avoid
33
making statements on economic benefits and costs unless their
manuscript includes the appropriate economic data and
analyses. Avoid claiming priority and alluding to work that
has not been completed. State new hypotheses when
warranted, but clearly label them as such.
IV.A.9. References
IV.A.9.a. General Considerations Related to References
Although references to review articles can be an efficient way
of guiding readers to a body of literature, review articles do
not always reflect original work accurately. Readers should
therefore be provided with direct references to original
research sources whenever possible. On the other hand,
extensive lists of references to original work on a topic can
use excessive space on the printed page. Small numbers of
references to key original papers will often serve as well as
more exhaustive lists, particularly since references can now be
added to the electronic version of published papers, and since
electronic literature searching allows readers to retrieve
published literature efficiently.
Avoid using abstracts as references. References to papers
accepted but not yet published should be designated as "in
press" or "forthcoming"; authors should obtain written
permission to cite such papers as well as verification that they
have been accepted for publication. Information from
manuscripts submitted but not accepted should be cited in the
text as "unpublished observations" with written permission
from the source.
Avoid citing a "personal communication" unless it provides
essential information not available from a public source, in
which case the name of the person and date of communication
should be cited in parentheses in the text. For scientific
articles, authors should obtain written permission and
confirmation of accuracy from the source of a personal
communication.
Some journals check the accuracy of all reference citations,
but not all journals do so, and citation errors sometimes
appear in the published version of articles. To minimize such
errors, authors should therefore verify references against the
original documents.
IV.A.9.b. Reference Style and Format
The Uniform Requirements style is based largely on an ANSI
standard style adapted by the National Library of Medicine
(NLM) for its databases. (7) For samples of reference citation
formats,
authors
should
consult
http://www.nlm.nih.gov/bsd/uniform_requirements.html.
References should be numbered consecutively in the order in
which they are first mentioned in the text. Identify references
in text, tables, and legends by Arabic numerals in parentheses.
References cited only in tables or figure legends should be
numbered in accordance with the sequence established by the
first identification in the text of the particular table or figure.
The titles of journals should be abbreviated according to the
style used in Index Medicus. Consult the List of Journals
Indexed in Index Medicus, published annually as a separate
publication by the library and as a list in the January issue of
Index Medicus. The list can also be obtained through the
library's web site (http://www.nlm.nih.gov).
Journals vary on whether they ask authors to cite electronic
references within parentheses in the text or in numbered
references following the text. Authors should consult with the
journal that they plan to submit their work to.
IV.A.10. Tables
Tables capture information concisely, and display it
efficiently; they also provide information at any desired level
of detail and precision. Including data in tables rather than text
frequently makes it possible to reduce the length of the text.
Type or print each table with double spacing on a separate
sheet of paper. Number tables consecutively in the order of
their first citation in the text and supply a brief title for each.
Do not use internal horizontal or vertical lines. Give each
column a short or abbreviated heading. Authors should place
explanatory matter in footnotes, not in the heading. Explain in
footnotes all nonstandard abbreviations. For footnotes use the
following symbols, in sequence:
*,†,‡,§,||,¶,**,††,‡‡
Identify statistical measures of variations, such as standard
deviation and standard error of the mean.
Be sure that each table is cited in the text.
If you use data from another published or unpublished source,
obtain permission and acknowledge them fully.
Additional tables containing backup data too extensive to
publish in print may be appropriate for publication in the
electronic version of the journal, deposited with an archival
service, or made available to readers directly by the authors.
In that event an appropriate statement will be added to the
text. Submit such tables for consideration with the paper so
that they will be available to the peer reviewers.
IV.A.11. Illustrations (Figures)
Figures should be either professionally drawn and
photographed, or submitted as photographic quality digital
prints. In addition to requiring a version of the figures suitable
for printing, some journals now ask authors for electronic files
of figures in a format (e.g., JPEG or GIF) that will produce
high quality images in the web version of the journal; authors
should review the images of such files on a computer screen
before submitting them, to be sure they meet their own quality
standard.
34
For x-ray films, scans, and other diagnostic images, as well as
pictures of pathology specimens or photomicrographs, send
sharp, glossy, black-and-white or color photographic prints,
usually 127 × 173 mm (5 × 7 inches). Although some journals
redraw figures, many do not. Letters, numbers, and symbols
on Figures should therefore be clear and even throughout, and
of sufficient size that when reduced for publication each item
will still be legible. Figures should be made as selfexplanatory as possible, since many will be used directly in
slide presentations. Titles and detailed explanations belong in
the legends, however, not on the illustrations themselves.
Photomicrographs should have internal scale markers.
Symbols, arrows, or letters used in photomicrographs should
contrast with the background.
If photographs of people are used, either the subjects must not
be identifiable or their pictures must be accompanied by
written permission to use the photograph (see Section
III.D.4.a). Whenever possible permission for publication
should be obtained.
Figures should be numbered consecutively according to the
order in which they have been first cited in the text. If a figure
has been published, acknowledge the original source and
submit written permission from the copyright holder to
reproduce the material. Permission is required irrespective of
authorship or publisher except for documents in the public
domain.
For illustrations in color, ascertain whether the journal
requires color negatives, positive transparencies, or color
prints. Accompanying drawings marked to indicate the region
to be reproduced might be useful to the editor. Some journals
publish illustrations in color only if the author pays for the
extra cost.
Authors should consult the journal about requirements for
figures submitted in electronic formats.
IV.A.12. Legends for Illustrations (Figures)
Type or print out legends for illustrations using double
spacing, starting on a separate page, with Arabic numerals
corresponding to the illustrations. When symbols, arrows,
numbers, or letters are used to identify parts of the
illustrations, identify and explain each one clearly in the
legend. Explain the internal scale and identify the method of
staining in photomicrographs.
IV.A.13. Units of Measurement
Measurements of length, height, weight, and volume should be
reported in metric units (meter, kilogram, or liter) or their
decimal multiples.
Temperatures should be in degrees Celsius. Blood pressures
should be in millimeters of mercury, unless other units are
specifically required by the journal.
Journals vary in the units they use for reporting hematological,
clinical chemistry, and other measurements. Authors must
consult the information for authors for the particular journal
and should report laboratory information in both the local and
International System of Units (SI). Editors may request that
the authors before publication add alternative or non-SI units,
since SI units are not universally used. Drug concentrations
may be reported in either SI or mass units, but the alternative
should be provided in parentheses where appropriate.
IV.A.14. Abbreviations and Symbols
Use only standard abbreviations; the use of non-standard
abbreviations can be extremely confusing to readers. Avoid
abbreviations in the title. The full term for which an
abbreviation stands should precede its first use in the text
unless it is a standard unit of measurement.
IV.B Sending the Manuscript to the Journal
An increasing number of journals now accept electronic
submission of manuscripts, whether on disk, as attachments to
electronic mail, or by downloading directly onto the journal
website. Electronic submission saves time as well as postage
costs, and allows the manuscript to be handled in electronic
form throughout the editorial process (for example, when it is
sent out for review). When submitting a manuscript
electronically, authors should consult with the instructions for
authors of the journal they have chosen for their manuscript.
If a paper version of the manuscript is submitted, send the
required number of copies of the manuscript and figures; they
are all needed for peer review and editing, and editorial office
staff cannot be expected to make the required copies.
Manuscripts must be accompanied by a cover letter, which
should include the following information.



A full statement to the editor about all submissions
and previous reports that might be regarded as
redundant publication of the same or very similar
work. Any such work should be referred to
specifically, and referenced in the new paper. Copies
of such material should be included with the
submitted paper, to help the editor decide how to
handle the matter.
A statement of financial or other relationships that
might lead to a conflict of interest, if that information
is not included in the manuscript itself or in an
authors' form
A statement that the manuscript has been read and
approved by all the authors, that the requirements for
35
authorship as stated earlier in this document have
been met, and that each author believes that the
manuscript represents honest work, if that
information is not provided in another form (see
below); and

The name, address, and telephone number of the
corresponding author, who is responsible for
communicating with the other authors about
revisions and final approval of the proofs, if that
information is not included on the manuscript itself.
The letter should give any additional information that may be
helpful to the editor, such as the type or format of article in the
particular journal that the manuscript represents. If the
manuscript has been submitted previously to another journal,
it is helpful to include the previous editor's and reviewers'
comments with the submitted manuscript, along with the
authors' responses to those comments. Editors encourage
authors to submit these previous communications and doing
so may expedite the review process.
Many journals now provide a pre-submission checklist that
assures that all the components of the submission have been
included. Some journals now also require that authors
complete checklists for reports of certain study types (e.g., the
CONSORT checklist for reports of randomized controlled
trials). Authors should look to see if the journal uses such
checklists, and send them with the manuscript if they are
requested.
Copies of any permission to reproduce published material, to
use illustrations or report information about identifiable
people, or to name people for their contributions must
accompany the manuscript.
V. References
A. References Cited in this Document
1. Davidoff F for the CSE Task Force on Authorship. . Who's
the Author? Problems with Biomedical Authorship, and Some
Possible Solutions. Science Editor. July-August 2000: Volume
23 - Number 4: 111-119.
2. Yank V, Rennie D. Disclosure of researcher contributions:
a study of original research articles in The Lancet. Ann Intern
Med. 1999 Apr 20;130(8):661-70.
3. Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship
for research groups. JAMA. 2002;288:3166-68.
4. Peer Review in Health Sciences. F Godlee, T Jefferson.
London: BMJ Books, 1999.
5. World Medical Association Declaration of Helsinki: ethical
principles for medical research involving human subjects.
JAMA. 2000 Dec 20;284(23):3043-5.
6. Pitkin RM, Branagan MA, Burmeister LF. Accuracy of data
in abstracts of published research articles. JAMA. 1999 Mar
24-31;281(12):1110-1.
7. Patrias K. National Library of Medicine recommended
formats for bibliographic citation. Bethesda (MD): The
Library; 1991.
B. Other Sources of Information Related to Biomedical
Journals
World Association of Medical Editors (WAME)
www.WAME.org
Council
of
Science
www.councilscienceeditors.org
European Association
www.ease.org.uk
of
Science
Editors
Editors
(CSE)
(EASE)
Cochrane Collaboration www.cochrane.org
The Mulford Library, Medical
www.mco.edu/lib/instr/libinsta.html
College
of
Ohio
VI.About The International Committee of Medical
Journal Editors
The International Committee of Medical Journal Editors
(ICMJE) is a group of general medical journal editors whose
participants meet annually and fund their work on the Uniform
Requirements for Manuscripts. The ICMJE invites comments
on this document and suggestions for agenda items.
VII. Authors of The Uniform Requirements for
Manuscripts Submitted to Biomedical Journals
The ICMJE participating journals and organizations and their
representatives who approved the revised Uniform
Requirements for manuscripts in June 2003 include Annals of
Internal Medicine, Canadian Medical Association Journal,
Croatian Medical Journal, Journal of the American Medical
Association, Nederlands Tijdschrift voor Geneeskunde, New
England Journal of Medicine, New Zealand Medical Journal,
The Lancet, The Medical Journal of Australia,Tidsskrift for
Den Norske Llegeforening, Ugeskrift for Laeger, and the U.S.
National Library of Medicine.
VIII. Use, Distribution, and Translation of the Uniform
Requirements
Users may print, copy, and distribute this document without
charge for not-for-profit, educational purpose. The ICMJE
does not stock paper copies (reprints) of this document.
The ICMJE policy is for interested organizations to link to the
official English language document at www.ICMJE.org. The
ICMJE does not endorse posting of the document on web sites
other than www.ICMJE.org.
36
The ICMJE welcomes organizations to translate this
document into languages other than English for non-profit
purposes. However, the ICMJE does not have the resources to
translate, to back translate, or to approve translated versions
of the document. Thus, any translations should prominently
include the following statement: "This is a (insert language
name) language translation of the ICMJE Uniform
Requirements for Manuscripts Submitted to Biomedical
Journals. (insert name of organization) prepared this
translation with support from (insert name of funding source,
if any). The ICMJE has not endorsed nor approved the
contents of this translation. The official version of the
Uniform Requirements for Manuscripts Submitted to
Biomedical Journals is located at www.ICMJE.org."
IX. Inquiries
Inquiries about the Uniform Requirements should be sent to
Christine Laine, MD, MPH at the ICMJE Secretariat office,
American College of Physicians, 190 N. Independence Mall
West, Philadelphia, PA 19106-1572, USA. phone, 215-3512660; fax 215-351-2644; e-mail claine@acponline.org. Please
do not direct inquiries about individual journal styles or
policies to the ICMJE secretariat office.
Uniform Requirements for Manuscripts
Submitted to Biomedical Journals: Sample
References
International Committee of Medical Journal Editors
6. Volume with supplement
Geraud G, Spierings EL, Keywood C. Tolerability and safety
of frovatriptan with short- and long-term use for treatment of
migraine and in comparison with sumatriptan. Headache.
2002;42 Suppl 2:S93-9.
7. Issue with supplement
Glauser TA. Integrating clinical trial data into clinical
practice. Neurology. 2002;58(12 Suppl 7):S6-12.
Updated July 9, 2003
Articles in Journals
1. Standard journal article
List the first six authors followed by et al. (Note: NLM now
lists all authors.)
Halpern SD, Ubel PA, Caplan AL. Solid-organ transplantation
in HIV-infected patients. N Engl J Med. 2002 Jul
25;347(4):284-7.
As an option, if a journal carries continuous pagination
throughout a volume (as many medical journals do) the month
and issue number may be omitted.
Halpern SD, Ubel PA, Caplan AL. Solid-organ transplantation
in HIV-infected patients. N Engl J Med. 2002;347:284-7.
More than six authors:
Rose ME, Huerbin MB, Melick J, Marion DW, Palmer AM,
Schiding JK, et al. Regulation of interstitial excitatory amino
acid concentrations after cortical contusion injury. Brain Res.
2002;935(1-2):40-6.
2. Organization as author
Diabetes Prevention Program Research Group. Hypertension,
insulin, and proinsulin in participants with impaired glucose
tolerance. Hypertension. 2002;40(5):679-86.
3. Both personal authors and an organization as author (This
example does not conform to NISO standards.)
Vallancien G, Emberton M, Harving N, van Moorselaar RJ;
Alf-One Study Group. Sexual dysfunction in 1,274 European
men suffering from lower urinary tract symptoms. J Urol.
2003;169(6):2257-61.
4. No author given
21st century heart solution may have a sting in the tail. BMJ.
2002;325(7357):184.
5. Article not in English
(Note: NLM translates the title into English, encloses the
translation in square brackets, and adds an abbreviated
language designator.)
Ellingsen AE, Wilhelmsen I. Sykdomsangst blant medisin- og
jusstudenter. Tidsskr Nor Laegeforen. 2002;122(8):785-7.
37
8. Volume with part
Abend SM, Kulish N. The psychoanalytic method from an
epistemological viewpoint. Int J Psychoanal. 2002;83(Pt
2):491-5.
9. Issue with part
Ahrar K, Madoff DC, Gupta S, Wallace MJ, Price RE, Wright
KC. Development of a large animal model for lung tumors. J
Vasc Interv Radiol. 2002;13(9 Pt 1):923-8.
10. Issue with no volume
Banit DM, Kaufer H, Hartford JM. Intraoperative frozen
section analysis in revision total joint arthroplasty. Clin
Orthop. 2002;(401):230-8.
11. No volume or issue
Outreach: bringing HIV-positive individuals into care. HRSA
Careaction. 2002 Jun:1-6.
12. Pagination in roman numerals
Chadwick R, Schuklenk U. The politics of ethical consensus
finding. Bioethics. 2002;16(2):iii-v.
13. Type of article indicated as needed
Tor M, Turker H. International approaches to the prescription
of long-term oxygen therapy [letter]. Eur Respir J.
2002;20(1):242.
Lofwall MR, Strain EC, Brooner RK, Kindbom KA, Bigelow
GE. Characteristics of older methadone maintenance (MM)
patients [abstract]. Drug Alcohol Depend. 2002;66 Suppl
1:S105.
14. Article containing retraction
Feifel D, Moutier CY, Perry W. Safety and tolerability of a
rapidly escalating dose-loading regimen for risperidone. J Clin
Psychiatry. 2002;63(2):169. Retraction of: Feifel D, Moutier
CY, Perry W. J Clin Psychiatry. 2000;61(12):909-11.
15. Article retracted
Feifel D, Moutier CY, Perry W. Safety and tolerability of a
rapidly escalating dose-loading regimen for risperidone. J Clin
Psychiatry. 2000;61(12):909-11. Retraction in: Feifel D,
Moutier CY, Perry W. J Clin Psychiatry. 2002;63(2):169.
16. Article republished with corrections
Mansharamani M, Chilton BS. The reproductive importance
of P-type ATPases. Mol Cell Endocrinol. 2002;188(1-2):22-5.
Corrected and republished from: Mol Cell Endocrinol.
2001;183(1-2):123-6.
17. Article with published erratum
Malinowski JM, Bolesta S. Rosiglitazone in the treatment of
type 2 diabetes mellitus: a critical review. Clin Ther.
2000;22(10):1151-68; discussion 1149-50. Erratum in: Clin
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Yu WM, Hawley TS, Hawley RG, Qu CK. Immortalization of
yolk sac-derived precursor cells. Blood. 2002 Nov
15;100(10):3828-31. Epub 2002 Jul 5.
Books and Other Monographs
19. Personal author(s)
Murray PR, Rosenthal KS, Kobayashi GS, Pfaller MA.
Medical microbiology. 4th ed. St. Louis: Mosby; 2002.
20. Editor(s), compiler(s) as author
Gilstrap LC 3rd, Cunningham FG, VanDorsten JP, editors.
Operative obstetrics. 2nd ed. New York: McGraw-Hill; 2002.
the 5th European Conference on Genetic Programming; 2002
Apr 3-5; Kinsdale, Ireland. Berlin: Springer; 2002. p. 182-91.
26. Scientific or technical report
Issued by funding/sponsoring agency:
Yen GG (Oklahoma State University, School of Electrical and
Computer Engineering, Stillwater, OK). Health monitoring on
vibration signatures. Final report. Arlington (VA): Air Force
Office of Scientific Research (US), Air Force Research
Laboratory; 2002 Feb. Report No.: AFRLSRBLTR020123.
Contract No.: F496209810049.
Issued by performing agency:
Russell ML, Goth-Goldstein R, Apte MG, Fisk WJ. Method
for measuring the size distribution of airborne Rhinovirus.
Berkeley (CA): Lawrence Berkeley National Laboratory,
Environmental Energy Technologies Division; 2002 Jan.
Report No.: LBNL49574. Contract No.: DEAC0376SF00098.
Sponsored by the Department of Energy.
27. Dissertation
Borkowski MM. Infant sleep and feeding: a telephone survey
of Hispanic Americans [dissertation]. Mount Pleasant (MI):
Central Michigan University; 2002.
21. Author(s) and editor(s)
Breedlove GK, Schorfheide AM. Adolescent pregnancy. 2nd
ed. Wieczorek RR, editor. White Plains (NY): March of
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28. Patent
Pagedas AC, inventor; Ancel Surgical R&D Inc., assignee.
Flexible endoscopic grasping and cutting device and
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22. Organization(s) as author
Royal Adelaide Hospital; University of Adelaide, Department
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Other Published Material
29. Newspaper article
Tynan T. Medical improvements lower homicide rate: study
sees drop in assault rate. The Washington Post. 2002 Aug
12;Sect. A:2 (col. 4).
23. Chapter in a book
Meltzer PS, Kallioniemi A, Trent JM. Chromosome
alterations in human solid tumors. In: Vogelstein B, Kinzler
KW, editors. The genetic basis of human cancer. New York:
McGraw-Hill; 2002. p. 93-113.
30. Audiovisual material
Chason KW, Sallustio S. Hospital preparedness for
bioterrorism [videocassette]. Secaucus (NJ): Network for
Continuing Medical Education; 2002.
24. Conference proceedings
Harnden P, Joffe JK, Jones WG, editors. Germ cell tumours
V. Proceedings of the 5th Germ Cell Tumour Conference;
2001 Sep 13-15; Leeds, UK. New York: Springer; 2002.
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Christensen S, Oppacher F. An analysis of Koza's
computational effort statistic for genetic programming. In:
Foster JA, Lutton E, Miller J, Ryan C, Tettamanzi AG,
editors. Genetic programming. EuroGP 2002: Proceedings of
38
31. Legal Material
Public law:
Veterans Hearing Loss Compensation Act of 2002, Pub. L.
No. 107-9, 115 Stat. 11 (May 24, 2001).
Unenacted bill:
Healthy Children Learn Act, S. 1012, 107th Cong., 1st Sess.
(2001). Code of Federal Regulations: Cardiopulmonary
Bypass Intracardiac Suction Control, 21 C.F.R. Sect.
870.4430 (2002).
Hearing:
Arsenic in Drinking Water: An Update on the Science,
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