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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 Fellows who do not publish during fellowship will often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The number of unpublished studies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/understand


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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.pdf


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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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