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Fellows who do not publish during fellowship will often never take and pass their Boards Individuals do the vast majority of completing research and writing papers in the first seven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

Division Directors and Department Chairs Invitations to participate in committees and boards of national societies Invitations to speak at national and international meetings

Promotions and Tenure committees place little emphasis on teaching and patient care

The number of unpublished studies is astounding.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

Solutions

Barriers to publication

Lack of mentorship

Choose your mentors wisely

Writers inertia/block

Experience, priority, nurturing, pushy

Procrastination

Learn good methods for writing papers Write your paper before you present it Make it a team project Schedule specific times on your calendar to write 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

Competing priorities

Rejection of first submission

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

Dont waste your time!

VERY low acceptance rates Highly unique, AND Have implications for

If you do, they must be

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

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.

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, dont assume the reviewer is an expert in the field explain the problem clearly why is the study so 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.

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

Do the tables and figures next.

Dont overstate what you are going to analyze in the paper your results will define this Be sure to state the hypothesis(ses) here.

You can then decide what to keep in tabular/figure form and what to put in the wording or the results section
Demographics first

Write the introduction next keep it brief

Primary hypothesis data/results next Next can be secondary or in temporal order

Location of study in the M and M section Number of patients and duration of study are in the results section

Discussion

State what the issue is What is known Why you decided to do the study What you studied

Abstract last

See instructions for structured discussions

Introduction

Basic knowledge of subject

Remaining question

Induction of labor is an increasingly common practice in the U.S. One question in performing induction is the best method of determining who will succeed Failure of induction among certain patients leads to higher c-section rates Currently the best way of determining success is the Bishop score 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 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

Why is it a question

What is currently known

What alternative exists

Why should this be studied/Who says this should be studied

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

Statistics

Adverse events Interim analyses Sample size

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

Based on what premises

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

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 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.

Flow Sheets

In preparing a study, dont 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
Excluded: - Incomplete Data (3) - Withdrawn (5) - Did not meet criteria (3) Maternal age < 18 yr (1) Diabetic (1) Preeclamptic (1)

289 Subjects Analyzed

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 Studys 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 editors 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? Title Aim

Evaluate each section of paper

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 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!

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 950 900 850 800 750 2003 2004 2005 2006 2007 992 932 898 856 997

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

43 45 40 35 30 25 20 15 10 5 0 37 32 29 29

2003

2004

2005

2006

2007

Five-Year Comparison of Domestic and Non-Domestic Published Articles 2003 - 2007

466 500 450 380 358 210 218 193 175 133 338 400 350 300 250 200 150 100 50 0 2003 2004 USA 2005 FOREIGN 2006 2007 400

Number of Articles

Editorial Review Time

days)

Assign Reviewers/Reject without Review (5 Reviews Completed to Editors Decision (37 Revisions by Authors (44 days) Decision on Revisions (5 days)

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 Time allowed 14 days Reminder 9-10 days Past due at 14 days

Perform the review

Reviewer Assignment to Editor Revise Decision

MS completed within # days Average = 37.1 days 30 days 60 days 90 days More than 90 days (91-148 days) Totals # of papers

% 32.90% 51.70% 12.40% 3.00% 100.00%

77 121 29 7 234

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)