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Writing and Submitting yourScientific 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
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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 Fellows who do not publish during fellowship will often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 offellowship.
Publication success is the single biggest indicator ofacademic success Promotions
Promotions and Tenure committees place little emphasis onteaching 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
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The number of unpublished studies
is astounding.
Barriers to publication
Lack of mentorship
Writers inertia/block
Procrastination
Competing priorities
Personal
Professional
Rejection of first submission
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Solutions
Barriers to publication Lack of mentorship
Choose your mentors wisely Experience, priority, nurturing, pushy
Writers 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
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IRB/Guidelines for Consenting
Subjects for Research Authors must follow the ethical standards for human
experimentation established in the Declaration ofHelsinki (World Medical Association Declaration ofHelsinki: recommendations guiding physicians in
biomedical research involving human subjects. JAMA1997;277:925-6).
All journals now require that you affirm IRB approval inyour 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.
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Case Reports
Dont 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 retrospectivereviews or seeds for future studies.
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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 andresults 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
http://clinicaltrials.gov/ct2/info/understandhttp://clinicaltrials.gov/ct2/info/newhttp://clinicaltrials.gov/ct2/info/glossaryhttp://clinicaltrials.gov/ct2/search/browse?brwse=cond_cathttp://clinicaltrials.gov/ct2/search/browse?brwse=intr_cathttp://clinicaltrials.gov/ct2/search/browse?brwse=spns_cathttp://clinicaltrials.gov/ct2/search/browse?brwse=locn_cathttp://clinicaltrials.gov/ct2/search/browse?brwse=locn_cathttp://clinicaltrials.gov/ct2/search/browse?brwse=spns_cathttp://clinicaltrials.gov/ct2/search/browse?brwse=intr_cathttp://clinicaltrials.gov/ct2/search/browse?brwse=cond_cathttp://clinicaltrials.gov/ct2/info/glossaryhttp://clinicaltrials.gov/ct2/info/newhttp://clinicaltrials.gov/ct2/info/understand7/27/2019 Ga Rite Presen
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Rules for Authorship
Each author must qualify by having participated actively andsufficiently in the study reported. The inclusion of each author in theauthorship list of a report must be based only on 1) substantialcontributions to (a) the concept and design, or analysis andinterpretation 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 themanuscript being submitted. All conditions (1a, 1b, and 2) must bemet. Others contributing to the work, including participants incollaborative trials, should be recognized separately in theAcknowledgment(s) section. In the cover letter that accompaniesthe submitted manuscript, it must be confirmed that all bylinedauthors fulfill all conditions. Accordingly, authors are encouraged tolimit the number of authors listed.
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Order of authors Principle Investigator
Idea person Last is senior author
If idea person is senior author ask him/her which is preferred
Dont 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.
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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 thepresentation 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
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Writing an abstract
Sell the study in the introduction Unlike papers, dont assume the reviewer is an expert in
the field explain the problem clearly why is the studyso important
Dont include name of the institution in the abstract Adhere to the word limit and font size State your primary hypothesis clearly Dont tell them the end points you chose in your
methods section, your results will tell them
Dont tell them what statistical methods you used. Give them actual data Overstate your conclusions a little more than you would
in a paper.
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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 andconcern over potential risk. We present the first study evaluating the impact of a single rescue courseof ACS on neonatal outcome
Materials and methods:A multi-center, randomized, double blind, placebo controlled trial was performed. Eligible singletons ortwins were < 33 weeks (wks), had completed a single course of betamethasone before 30 wks and atleast 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 primaryoutcome was composite neonatal morbidity at < 34 wks.
Results:437 patients were randomized (223 study group, 214 placebo). 55% of patients in each groupdelivered 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 proportionof twins. There was a significant reduction in composite neonatal morbidity < 34 wks in the rescuesteroid 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 weresimilar in each group. Including all neonates (regardless of GA at delivery) in the analysis stilldemonstrated 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 otherdifferences in outcome including head size and birth weight.
Conclusions: Administration of a single rescue course of ACS before 33 wks improves neonataloutcome without apparent increased risk.
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Writing your paper
Write the abstract for presentation first The original protocol should essentially write your Materials and Methods
Dont overstate what you are going to analyze in the paper your results willdefine 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
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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 willhave 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
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Materials and Methods
Your protocol should basically write this section General outline
Type of study we performed a RCT of chicken soup vs. penicillin forthe 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 Dont 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
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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
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Guidelines for Specific Types of ReportsTrial and research guidelinesThe following guidelines must be adhered to when formulating the study. Upon submitting themanuscript, 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 (MoherD, Schulz KF, Altman D, for the CONSORT Group. The CONSORT Statement: revisedrecommendations for improving the quality of reports of parallel-group randomized trials. JAMA2001;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 toconsult 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 randomizedcontrolled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet1999;354:1896-1900).
Meta-analysis or systematic review of observational studies.Authors are to consult theMOOSE guidelines (Stroup DF, Berlin JA, Morton SC, et al, for the Meta-analysis of ObservationalStudies 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, BrunsDE, et al., for the STARD Group. Towards complete and accurate reporting of studies ofdiagnostic accuracy: the STARD
Health economics. In addition to the general instructions for authors and other guidelinesapplicable 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 andaddress them in the manuscript and/or submission letter. A health economics checklist is to beincluded with the eneral manuscri t checklist at the time of submission.
http://www.consort-statement.org/Statement/jama.pdfhttp://www.consort-statement.org/mod_product/uploads/QUOROM%20Statement%201999.pdfhttp://www.consort-statement.org/mod_product/uploads/MOOSE%20Statement%202000.pdfhttp://www.consort-statement.org/mod_product/uploads/STARD%20Statement%202003.pdfhttp://www.elsevier.com/framework_products/promis_misc/ajoghealth.pdfhttp://www.elsevier.com/framework_products/promis_misc/ajoghealth.pdfhttp://www.consort-statement.org/mod_product/uploads/STARD%20Statement%202003.pdfhttp://www.consort-statement.org/mod_product/uploads/MOOSE%20Statement%202000.pdfhttp://www.consort-statement.org/mod_product/uploads/QUOROM%20Statement%201999.pdfhttp://www.consort-statement.org/Statement/jama.pdf7/27/2019 Ga Rite Presen
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Flow Sheets
In preparing a study, dont forget to keep trackof all patients approached and eligible
Eligible
Approached Declined
Consented
Withdrawn reasons
Lost to follow up reasons Included
Analyzed
Not analyzed.
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Excluded:
- Incomplete Data (3)
- Withdrawn (5)
- Did not meet criteria (3)
Maternal age < 18 yr
(1)
Diabetic (1)
Preeclamptic (1)
289 SubjectsAnalyzed
Normal Saline
n = 97
300 Subjects
Randomized
5% Dextrose in
Normal Salinen = 94
10% Dextrose in
Normal Salinen = 98
Neonatal Data
n = 85
Neonatal Data
n = 82
Neonatal Data
n = 81
RCT of Dextrose and its effect on labor
Shrivistava et al
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Structured Discussion
Statement of principal findings
Strengths and weaknesses of the study
Strengths and weaknesses in relation to otherstudies, discussing particularly any differences in
results
Meaning of the study: possible mechanisms and
implications for clinicians or policymakers
Unanswered questions and future research
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Choosing a Journal
Audience
Subspecialty, general
Prestige
Studys Impact
Likelihood of acceptance
Connections?? Impact Factor, Citation Index
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Suggested Reviewers
Upon submitting a manuscript, authors are required to provide thename, address, and e-mail address of at least 3 potential reviewersfor editorial consideration. Suggested reviewers may include anyoneknowledgeable in the area of study presented. Authors should notknowingly recommend as a potential reviewer a person with apotential conflict of interest, either financial or personal (positive or
negative bias), such as a mentor or close associate. Additionally, theauthors should not recommend any individuals located at the sameinstitution 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 editors decision
Ask advice from an expert in the particular area and an expert injournal editing
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Ethical Imperative to be a Reviewer
If you want your papers reviewed, then youshould 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 reviewsand seeing what others do right and wrong
You share the knowledge you have acquiredwith others writing papers
Ultimately patient outcome is improved.
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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
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Evaluate methods
Study design appropriate for aim?
Sample size calculation
Is it clear Do statistics seem correct
E l t R lt Fi
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Evaluate Results, Figures,
Tables
Clear, orderly
Tables and figures clear
Do they add anything
Are the results duplicated in text and tables
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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
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Evaluate the Abstract
Do this after you have critiqued thepaper
Make sure abstract is accurate withpaper
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SCIENTIFIC MERIT: Quality of the science, adequacy of the sample size, hypothesisadequately stated and tested, and interpretation of the results
ORIGINALITY: Is the paper addressing a question not studied, or inadequately studiedin the past?
IMPORTANCE: Do the findings of the paper have significance in answering an importantclinical question; either with immediate applicability, or in directing future researchwhich 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 clearlypresented with appropriate tables/figures; Discussion through & sound, Statistics &References appropriate, and is the overall paper well-written & understandable?
P l
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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
Dont forget to involve people in the department (early in the study) who are experts
in the area
Dont oversell results of secondary analyses
Dont 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 dont forget clinicaltrials.gov
Always have all authors read and approve abstract/paper before submitting and all
revisions as well
Brevity reigns!
Dont hesitate to call Journal staff or write editors with questions
Prepublication consults are good things!
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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
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Five Year Comparison
Original Research Articles Received
2003 - 2007
992
932
898
856
997
750
800
850
900
950
1000
2003 2004 2005 2006 2007
ORIGINAL RESEARCH PAPERS
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Manuscripts processed in 2007
Original Research Manuscripts
Received in 2007 = 997
Decisions made in 2007
Accepted = 287 (29%)
Declined = 718 (71%)
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Acceptance Rates Regular
Non-Society Articles
43
37
32
29 29
0
5
10
15
20
25
30
35
40
45
2003 2004 2005 2006 2007
Five-Year Comparison of Domestic
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Five-Year Comparison of Domestic
and Non-Domestic Published
Articles 2003 - 2007
380
210
400
218
466
193
358
175
338
133
0
50
100
150
200
250
300
350
400
450
500
NumberofArticles
2003 2004 2005 2006 2007
USA FOREIGN
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Assign Reviewers/Reject without Review (5days)
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)
Editorial Review Time
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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
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Reviewer Assignment to Editor
Revise Decision
MS completed within #days# ofpapers %
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%
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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)
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