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Writing and Submitting your
Scientific Papers
Thomas J. Garite, M.D.
Former E.J. Quilligan Professor and Chairman of Obstetrics and
Gynecology
University of California Irvine
Editor in Chief, American Journal of Obstetrics and Gyencology

Publication Success
Why Publish?
• Fellows who do not publish during fellowship will often
never take and pass their Boards
• Individuals do the vast majority of completing research
and writing papers in the first seven years out of
fellowship.
• Publication success is the single biggest indicator of
academic success
• Promotions
• Promotions and Tenure committees place little emphasis on
teaching and patient care
• Division Directors and Department Chairs
• Invitations to participate in committees and boards of national
societies
• Invitations to speak at national and international meetings

The number of unpublished studies
is astounding.
• Barriers to publication
• Lack of mentorship
• Writer’s inertia/block
• Procrastination
• Competing priorities
• Personal
• Professional
• Rejection of first submission

Solutions
• Barriers to publication
• Lack of mentorship
• Choose your mentors wisely
• Experience, priority, nurturing, pushy
• Writer’s inertia/block
• Learn good methods for writing papers
• Procrastination
• Write your paper before you present it
• Make it a team project
• Competing priorities
• Schedule specific times on your calendar to write
• Rejection of first submission
• Grow up – rejection is part of life
• Move on – get advice on the best place for the next submission
• Listen – take the advice of the reviewers before resubmission

IRB/Guidelines for Consenting
Subjects for Research
• Authors must follow the ethical standards for human
experimentation established in the Declaration of
Helsinki (World Medical Association Declaration of
Helsinki: recommendations guiding physicians in
biomedical research involving human subjects. JAMA
1997;277:925-6).
• All journals now require that you affirm IRB approval in
your paper and in your cover letter
• Will often require the IRB case number
• Includes retrospective, chart review and data base studies
• Most now also require patient consent for case reports.

Case Reports
• Don’t waste your time!
• VERY low acceptance rates
• If you do, they must be
• Highly unique, AND
• Have implications for
• Patient management and/or
• Important future research
• Example
• Irwin Merkatz, low AFP in Down syndrome
• Alternatively consider using the case for retrospective
reviews or seeds for future studies.

Clinicaltrials.gov
• ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and
around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations,
and phone numbers for more details. This information should be used in conjunction with advice from health care
professionals.
• Find trials for a specific medical condition or other criteria in the ClinicalTrials.gov registry. ClinicalTrials.gov
currently has 79,903 trials with locations in 170 countries. Get instructions for clinical trial
investigators/sponsors about how to register trials in ClinicalTrials.gov. Learn about mandatory registration and
results reporting requirements and US Public Law 110-85 (FDAAA). Learn about clinical trials and how to use
ClinicalTrials.gov, or access other consumer health information from the US National Institutes of Health.
• Resources:
• Understanding Clinical Trials
What's New
Glossary
• Study Topics:
• List studies by Condition
List studies by Drug Intervention
List studies by Sponsor
List studies by Location

Rules for Authorship
Each author must qualify by having participated actively and
sufficiently in the study reported. The inclusion of each author in the
authorship list of a report must be based only on 1) substantial
contributions to (a) the concept and design, or analysis and
interpretation of data and (b) the author's having drafted the
manuscript or revised it critically for important intellectual content;
and 2) final approval by each author of the version of the
manuscript being submitted. All conditions (1a, 1b, and 2) must be
met. Others contributing to the work, including participants in
collaborative trials, should be recognized separately in the
Acknowledgment(s) section. In the cover letter that accompanies
the submitted manuscript, it must be confirmed that all bylined
authors fulfill all conditions. Accordingly, authors are encouraged to
limit the number of authors listed.

Order of authors
• Principle Investigator
• Idea person
• Last is senior author
• If idea person is senior author ask him/her which is preferred
• Don’t include research nurses, statisticians, ghost writers unless they fulfilled all
criteria for authorship, include them as acknowledgements
• Authorship
Each author must qualify by having participated actively and sufficiently in the study
reported. The inclusion of each author in the authorship list of a report must be based only
on 1) substantial contributions to (a) the concept and design, or analysis and interpretation
of data and (b) the author's having drafted the manuscript or revised it critically for
important intellectual content; and 2) final approval by each author of the version of the
manuscript being submitted. All conditions (1a, 1b, and 2) must be met. Others contributing
to the work, including participants in collaborative trials, should be recognized separately in
the Acknowledgment(s) section. In the cover letter that accompanies the submitted
manuscript, it must be confirmed that all bylined authors fulfill all conditions.
• GIFT AUTHORSHIP IS A SIN!
• Determine order of and inclusion of authors at the BEGINNING of the study.

Abstract Submission
• Where: SMFM, ACOG, SGI, AIUM
• Why:
• Get significant input into strengths, flaws and issue
before submitting the paper
• Exposure
• Often more people know about your study from the
presentation than from the publication
• Always for junior authors, more people know who the author
was than with the publication
• Fun
• You get priority in going to the meeting
• You learn a lot more presenting than publishing

Writing an abstract
• Sell the study in the introduction
• Unlike papers, don’t assume the reviewer is an expert in
the field – explain the problem clearly – why is the study
so important
• Don’t include name of the institution in the abstract
• Adhere to the word limit and font size
• State your primary hypothesis clearly
• Don’t tell them the end points you chose in your
methods section, your results will tell them
• Don’t tell them what statistical methods you used.
• Give them actual data
• Overstate your conclusions a little more than you would
in a paper.

Impact of a “rescue course” of antenatal corticosteroids (ACS): A multi-center,
randomized, controlled trial.
Objective:
Previous studies using scheduled repetitive courses of ACS have demonstrated limited benefit and
concern over potential risk. We present the first study evaluating the impact of a single “rescue” course
of ACS on neonatal outcome
Materials and methods:
A multi-center, randomized, double blind, placebo controlled trial was performed. Eligible singletons or
twins were < 33 weeks (wks), had completed a single course of betamethasone before 30 wks and at
least 14 days prior, and were judged to have a recurring threat of preterm delivery in the coming week.
Patients were randomized to receive a single “rescue course” of ACS or placebo. Exclusion criteria
included: PROM, advanced dilation (> 5 cm), chorioamnionitis, and other steroid use. The primary
outcome was composite neonatal morbidity at < 34 wks.
Results:
437 patients were randomized (223 study group, 214 placebo). 55% of patients in each group
delivered at < 34 wks. The groups were similar in gestational age (GA) at randomization (29.4 wks)
and at delivery (33.0 wks), delivery route, delivery indications, APGAR scores, cord pH, and proportion
of twins. There was a significant reduction in composite neonatal morbidity < 34 wks in the “rescue
steroid” group vs. placebo (42.5% vs. 63.3%, (RR 0.67, 0.54.-0.83, p=0.0002) as well as significantly
decreased RDS, ventilator support, and surfactant use. Perinatal mortality and other morbidities were
similar in each group. Including all neonates (regardless of GA at delivery) in the analysis still
demonstrated a significant reduction in composite morbidity in the “rescue course” group (30.3 vs.
41.7 (RR 0.73, 0.58-0.91, P=.0055) and improvement in other respiratory morbidities, but no other
differences in outcome including head size and birth weight.
Conclusions: Administration of a single “rescue course” of ACS before 33 wks improves neonatal
outcome without apparent increased risk.

Writing your paper
• Write the abstract for presentation first
• The original protocol should essentially write your Materials and Methods
• Don’t overstate what you are going to analyze in the paper – your results will
define this
• Be sure to state the hypothesis(ses) here.
• Do the tables and figures next.
• You can then decide what to keep in tabular/figure form and what to put in the
wording or the results section
• Demographics first
• Location of study in the M and M section
• Number of patients and duration of study are in the results section
• Primary hypothesis data/results next
• Next can be secondary or in temporal order
• Write the introduction next – keep it brief
• State what the issue is
• What is known
• Why you decided to do the study
• What you studied
• Discussion
• See instructions for structured discussions
• Abstract last

Introduction
• Basic knowledge of subject
• Induction of labor is an increasingly common practice in the U.S.
• Remaining question
• One question in performing induction is the best method of determining who will
succeed
• Why is it a question
• Failure of induction among certain patients leads to higher c-section rates
• What is currently known
• Currently the best way of determining success is the Bishop score
• What alternative exists
• Recently some data suggest that Ffn be an indicator of the readiness of the
uterus for the onset of labor and as such may be a possible indicator of who will
have a successful induction of labor
• Why should this be studied/Who says this should be studied
• ACOG in its practice bulletin has noted that better markers of successful
induction are needed
• Or, since this is so common and the Bishop score only imprecisely measures
success of better markers are needed
• What you decided to do

Materials and Methods
• Your protocol should basically write this section
• General outline
• Type of study – we performed a RCT of chicken soup vs. penicillin for
the common cold
• Primary hypothesis – chicken soup is at least as good as penicillin
• IRB approval – was obtained from WIRB for all sites
• Eligible subjects
• Exclusions
• Randomization
• End points
• Data safety monitoring committee
• Adverse events
• Interim analyses
• Statistics
• Sample size
• Based on what premises
• Type of statistics
• Don’t say what you studied unless it is not included in the results section or
unless you need to define the end points – e.g. composite morbidity.
• Software used for statistics

Results
• Duration, dates
• Location(s)
• Describe population – high risk for ?, private practice,
middle west, etc
• How many studied, why
• Flow sheet if RCT
• How many in each group
• Demographics
• Primary end point outcome
• Secondary end point(s) outcome
• Temporal order

• Health economics. In addition to the general instructions for authors and other guidelines
applicable to their study (eg, CONSORT guidelines for a randomized, controlled trial), authors of
health economics manuscripts should consider the following issues specific to such studies and
address them in the manuscript and/or submission letter. A health economics checklist is to be
included with the general manuscript checklist at the time of submission.
Guidelines for Specific Types of Reports
Trial and research guidelines
The following guidelines must be adhered to when formulating the study. Upon submitting the
manuscript, authors are to indicate on the Submission Checklist the type of trial/research used.
• Randomized controlled trial. Authors are to consult the revised CONSORT statement (Moher
D, Schulz KF, Altman D, for the CONSORT Group. The CONSORT Statement: revised
recommendations for improving the quality of reports of parallel-group randomized trials. JAMA
2001;285:1987-91). A flowchart as a figure must be submitted in the manuscript.
• Meta-analysis or systematic review of randomized controlled trials. Authors are to
consult the QUOROM statement (Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF,
for the QUOROM Group. Improving the quality of reports of meta-analyses of randomized
controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet
1999;354:1896-1900).
• Meta-analysis or systematic review of observational studies. Authors are to consult the
MOOSE guidelines (Stroup DF, Berlin JA, Morton SC, et al, for the Meta-analysis of Observational
Studies in Epidemiology [MOOSE] group. Meta-analysis of observational studies in epidemiology:
a proposal for reporting. JAMA 2000;283:2008-12).
• Diagnostic tests. Authors are to consult the STARD Initiative (Bossuyt PM, Reitsma JB, Bruns
DE, et al., for the STARD Group. Towards complete and accurate reporting of studies of
diagnostic accuracy: the STARD

Flow Sheets
• In preparing a study, don’t forget to keep track
of all patients approached and eligible
• Eligible
• Approached
• Declined
• Consented
• Withdrawn – reasons
• Lost to follow up – reasons
• Included
• Analyzed
• Not analyzed.

RCT of Dextrose and its effect on labor
Shrivistava et al
300 Subjects
Randomized
289 Subjects
Analyzed
Excluded:
- Incomplete Data (3)
- Withdrawn (5)
- Did not meet criteria (3)
•Maternal age < 18 yr
(1)
•Diabetic (1)
•Preeclamptic (1)
Normal Saline
n = 97
5% Dextrose in
Normal Saline
n = 94
10% Dextrose in
Normal Saline
n = 98
Neonatal Data
n = 81
Neonatal Data
n = 85
Neonatal Data
n = 82

Structured Discussion
• • Statement of principal findings
• • Strengths and weaknesses of the study
• • Strengths and weaknesses in relation to other
studies, discussing particularly any differences in
results
• • Meaning of the study: possible mechanisms and
implications for clinicians or policymakers
• • Unanswered questions and future research

Choosing a Journal
• Audience
• Subspecialty, general
• Prestige
• Study’s Impact
• Likelihood of acceptance
• Connections??
• Impact Factor, Citation Index

Suggested Reviewers
• Upon submitting a manuscript, authors are required to provide the
name, address, and e-mail address of at least 3 potential reviewers
for editorial consideration. Suggested reviewers may include anyone
knowledgeable in the area of study presented. Authors should not
knowingly recommend as a potential reviewer a person with a
potential conflict of interest, either financial or personal (positive or
negative bias), such as a mentor or close associate. Additionally, the
authors should not recommend any individuals located at the same
institution as any of the authors.
• Other facts
• Editors variably use suggested reviewers
• Authors may ask certain reviewer(s) not be used
• Average acceptance of a reviewer invitation is about 60%
• Junior reviewers provide better reviews than senior reviewers
• Quality of the review is taken into account in editor’s decision
• Ask advice from an expert in the particular area and an expert in
journal editing

Ethical Imperative to be a Reviewer
• If you want your papers reviewed, then you
should be willing to return the favor
• If you want fair, constructive, authoritative
reviews you should provide this kind of review
• Exposure
• You learn how to write a paper by doing reviews
and seeing what others do right and wrong
• You share the knowledge you have acquired
with others writing papers
• Ultimately patient outcome is improved.

Process of review
• Read through paper
• Does it address important topic
• Appropriate design?
• Clear presentation?
• Evaluate each section of paper
• Title
• Aim
• Clearly stated
• Important to journal

Evaluate methods
• Study design appropriate for aim?
• Sample size calculation
• Is it clear
• Do statistics seem correct

Evaluate Results, Figures,
Tables
• Clear, orderly
• Tables and figures clear
• Do they add anything
• Are the results duplicated in text and tables

Evaluate Conclusions
• Should highlight authors results
• how data fit into literature
• why important
• Should be succinct
• not over reaching
• not too repetitive with the introduction

Evaluate the Abstract
• Do this after you have critiqued the
paper
• Make sure abstract is accurate with
paper

SCIENTIFIC MERIT: Quality of the science, adequacy of the sample size, hypothesis
adequately stated and tested, and interpretation of the results
ORIGINALITY: Is the paper addressing a question not studied, or inadequately studied
in the past?
IMPORTANCE: Do the findings of the paper have significance in answering an important
clinical question; either with immediate applicability, or in directing future research
which will do so?
READERSHIP INTEREST: Will this article be of interest to a majority of AJOG readers?
QUALITY: Is the Abstract sound & precise; Introduction brief & suitable; Results clearly
presented with appropriate tables/figures; Discussion through & sound, Statistics &
References appropriate, and is the overall paper well-written & understandable?

Pearls
• Oversell your abstract, undersell your paper
• Get advice from someone who has had abstracts and papers written and accepted
• Establish authorship when you design your study – both who and order of authorship
• Have someone outside the group of authors read your abstract/paper before
submission
• Don’t forget to involve people in the department (early in the study) who are experts
in the area
• Don’t oversell results of secondary analyses
• Don’t succumb to pressures real or perceived to include authors not really eligible
• Write you abstract first, then the paper, then do the presentation
• Read the Information for Authors thoroughly
• Do your literature search first when designing the study, intermittently during the
study and again when writing the abstract/paper – don’t forget clinicaltrials.gov
• Always have all authors read and approve abstract/paper before submitting and all
revisions as well
• Brevity reigns!
• Don’t hesitate to call Journal staff or write editors with questions
• Prepublication consults are good things!

Inappropriate Acts
• Fabrication
• Falsification
• Plagiarism
• Repetitive publication
• Violation of government rules of research
• Failure to retain original data
• Gift or honorary authorship
• Conflict of interest
• Order of authorship

Five Year Comparison
Original Research Articles Received
2003 - 2007
1000
950
992
997
900
850
800
932
898
856
750
2003 2004 2005 2006 2007
ORIGINAL RESEARCH PAPERS

Manuscripts processed in 2007
Original Research Manuscripts
Received in 2007 = 997
Decisions made in 2007
Accepted = 287 (29%)
Declined = 718 (71%)

Acceptance Rates Regular
Non-Society Articles
45
40
35
30
25
20
15
10
5
0
43
37
32
29 29
2003 2004 2005 2006 2007

Five-Year Comparison of Domestic
and Non-Domestic Published
Articles 2003 - 2007
466
500
450
400
380
400
358
338
Number of Articles
350
300
250
200
150
100
210
218
193
175
133
50
0
2003 2004 2005 2006 2007
USA
FOREIGN

Editorial Review Time
• Assign Reviewers/Reject without Review (5
days)
• Reviews Completed to Editors Decision (37
days)
• Revisions by Authors (44 days)
• Decision on Revisions (5 days)
Total days from submission to INITIAL Acceptance = (92.6 days)

Reviewers Time Alloted
• Invitation to Review
• Time allowed to respond – 7 days
• Reminder – 5 days
• Uninvite – past 7 days
• Perform the review
• Time allowed – 14 days
• Reminder – 9-10 days
• Past due – at 14 days

Reviewer Assignment to Editor
Revise Decision
MS completed within # days
# of
papers %
Average = 37.1 days
30 days 77 32.90%
60 days 121 51.70%
90 days 29 12.40%
More than 90 days (91-148 days) 7 3.00%
Totals 234 100.00%

Current Status (cont.)
• Publication Process
• Summary Production (26 days)
• Summary approval by author (18 days)
• Summary approval by editor (5 days)
• Final Acceptance (released to production) to
Publication (148 days / 4.9 months)
Total days from submission to publication
(316 days / 10 months)