The Journal of Pediatrics

Manuscript Writing: Thriving in the "Publish or Perish" World of Academic Pediatrics

William Balistreri, MD Denise M. Goodman, MD, MS Raye-Ann deRegnier, MD Sarah L. Long, MD Stephen R. Daniels, MD, PhD Robin H. Steinhorn, MD Paul G. Fisher, MD Thomas R. Welch, MD

Successful manuscript writing

 Goal: To contribute to medical knowledge through the publication of valid scientific work

 Objectives:  To describe the processes that scientific journals use to optimize exposure of valid new information and guard against exposure of unreliable, false, or redundant information  To hone skills to write a manuscript clearly and concisely, knowing each section’s purpose, inclusions, flow, and exclusions  To plan the strategy for responses to reviewers’ and editors’ comments and decisions, knowing when/how to optimize a revision versus when to disengage and regroup Outline

 Introduction to the editorial process  Manuscript preparation and submission  Peer review and editorial decisions  Publication ethics  Innovations in peer review  Exercises, examples, discussion Manuscript Writing Workshop: Introduction to the Editorial Process William F. Balistreri, M.D. Editor Outline

► Why Write Manuscripts? ► Ethics in Scientific Publication ► Editors Obligations/Priorities ► Keys to Good Writing ► What happens to a submitted MS? Why Write Manuscripts?

► Improve the care of children ► Share important observations that advance science and practice ► Foster evidence-based medicine ► Fame and Fortune (motivation beyond academics) ► Academic advancement ►Quantity vs. Quality Scientific writing is a long and difficult journey How to Write Manuscripts

What are the “rules of the game”? HOW - Huth’s Rules

1. Decide on message  Importance of the work?  What is novel? 2. Search the literature 3. Decide on target audience 4. Decide on target Journal 5. Decide on authorship 6. Assemble the “tools” “Bill’s” Rules: Keys to Good Writing “Bill’s” Rules: Keys to Good Writing Get Organized Revise, revise, revise Simplify, simplify, simplify Use excellent graphics Focus Spell correctly Shorten “Typical” length targets

5 page published article equals 9-10 manuscript text pages

 Introduction - 1 page  Methods - 2-3 pages  Results - 2-3 pages  Discussion - 3-5 pages  Graphics ≤4 tables + figures  References ≤30 “Reverse Rules”: Editors Obligations/Priorities 1. To Public: Act as gatekeeper for accurate literature Seek information that advances science and clinical practice Provide readable material that they can trust and will use Establish guidelines & policies “Reverse Rules”: Editors Obligations/Priorities

2. To Authors: Establish guidelines & policies Prompt, fair review Timely decision “Reverse Rules”: Editors Obligations/Priorities

3. To Reviewers: Ask for reviews in areas of expertise Keep them informed about fate of manuscript What happens to a submitted manuscript? The Editor – A Vital Role

“with great power comes great responsibility”  Create an end product which a respected brand endorses implicitly  Pledge ongoing monitoring Filtering Selection Refinement Finalization

The Old Days! Electronic Publication – The New Frontier

 Electronic submissions

 Electronic reviews

 Electronic publishing (without redacting)

 Electronic access to papers http://www.jpeds.com Components of the Editorial Process

Editor  Associate Editors Editorial Office  Managing Editor  Editorial Assistants Editorial Board Reviewers Journal Publishers Readers http://www.jpeds.com Odyssey of a Manuscript

MS Received Step 1: Editorial Assistant

Reviews MS for completeness & compliance with instructions Flags potential concerns: Conflicts of interest Duplicate publications Copyright problems Poor figures ? return non-compliant MS to Au Odyssey of a Manuscript MS Received

Incomplete send back Odyssey of a Manuscript MS Received

Incomplete send back -Assign to Editor -Initial triage Step 2: Editor-in-Chief

Reviews content of MS Does it fit? Screens Assigns to an Associate Editor Step 3: Associate Editor

Assesses for quality/content Is it true? (validity) Is it new? (novelty) Who cares? (what is the audience) What next? (what are implications)  Checks adherence to reporting guidelines, registration, etc Reporting Guidelines

Different for different study types: CONSORT PRIMSA STROBE SQUIRE etc.  Review at the time of study design Will remind you of important methodologic considerations

www.equator-network.org Guidelines for reporting various types of studies www.equator-network.org Clinical Trial Registration

The registration of all clinical trials is a scientific, ethical and moral responsibility Clinical Trial Registration

ICMJE initiative requiring prior entry of clinical trials in a public registry as a condition for publication Any intervention study must be registered before patients are enrolled www.clincaltrials.gov ClinicalTrials.gov facilitates registration of trials in accordance with ICMJE Applicable Clinical Trials

Interventional study of FDA-regulated drug, biologic product, or device Meets one of the following conditions: One or more sites in the US Conducted under FDA investigational NDA or investigational device exemption Manufactured in the US or its territories and exported for research Clinical Trial Registration

Ensures trial integrity (consistency of endpoints and analytic plan) Maintains commitment to patients Address selective publication and selective reporting Check journal policy Step 3: Associate Editor

Incomplete send back -Assign to Editor -Initial triage

Edit Reject Send to Reviewers Typical Reasons for “Editorial Rejection”

Subject matter is not appropriate for the readers of The Journal Format does not fit The Journal Fatal ethical issues – informed consent/IRB, trial registration, COI Obviously unsound science Fatal methodologic flaw (validity) Main point of paper is not novel Writing is unintelligible Odyssey of a Manuscript MS Received

Incomplete send back -Assign to Editor -Initial triage

Edit Reject Send to Reviewers Step 4: Reviewer

Reads manuscript carefully Advises editors about: Acceptability (science, relevance, novelty) Readability Length Importance Potential ethical issues Step 4 (cont): Reviewer

Provides useful and specific comments to the authors and editor re: Unclear areas Tables / Figures (“don’t work”) Typographical errors Back to Editor Odyssey of a Manuscript MS Received

Incomplete send back -Assign to Editor -Initial triage

Edit Reject Send to Reviewers

Editor Step 5: Associate Editor’s Decision

 Review comments from reviewers  Reassess the manuscript  Make preliminary decision:  Reject  Revise  Accept

Reviewers advise; Editor’s decide! Special Situations

Significant disagreements between reviewers Referral for “consultation” (e.g. statistical) Detection of ethical issues or similar concerns Referral to Editorial Board member for assistance Odyssey of a Manuscript MS Received

Incomplete send back -Assign to Editor -Initial triage

Edit Reject Send to Reviewers

Editor

Reject Revise Odyssey of a Manuscript

Revision received

- Triage - Back to Editor Odyssey of a Manuscript

Revision received

- Triage Back to - Back to Editor Reviewers

Editor decision Odyssey of a Manuscript

Revision received

- Triage Back to - Back to Editor Reviewers

Editor decision

Repeat Accept process Revise Odyssey of a Manuscript

Revision received

- Triage Back to - Back to Editor Reviewers

Editor decision

To Editors’ Repeat Accept process Revise Meeting Step 6: Presentation at Editors Conference Call

Associate Editor presents a summary of the manuscript and reviewers’ comments to the rest of the Editors

Final acceptance occurs only after a group discussion Odyssey of a Manuscript

Revision received

Final - Triage Back to Accept - Back to Editor Reviewers

Editing, finalizing MS for submission to Editor decision publisher

To Editors’ Repeat Accept process Revise Meeting Step 7: Submission to Publisher Step 7: Submission to Publisher

At this point, editorial staff relinquishes active involvement “Ownership” is transferred Authors must work carefully with publisher to assure quality of the “finished product” Editors become re-involved if major changes made in proofs Post-acceptance

Embargo: results cannot be released until journal does so Check Guide for Authors re: policy (example: posting the paper on your web page) Post-publication peer review: letter to the editor & authors’ response PubPeer (https://pubpeer.com/) Post-acceptance

Additional media: Podcasts Social media promotion of published article (by journal and/or author), etc. Pet Peeves

 Children with asthma…NOT…asthmatic children  Sex vs. gender  Bulleted text  Too much background in Objectives  Rambling Discussions  Did I mention poor proofreading and grammar? Resources

publicationethics.org

www.icmje.org

www.wame.org councilscienceeditors.org Resources

AMA Manual of Style 10th Edition, 2007 www.amamanalofstyle.com

Chicago Manual of Style www.chicagomanualofstyle.org Manuscript Preparation And Submission Objective

To help you write a manuscript that highlights what is new and important about your study, shows the rigor of your processes and explains your findings clearly and succinctly to maximize your chances of journal acceptance and impact.  Determining your article type  Assessing authorship  Preparing your manuscript

 Selecting a journal

 Following reporting guidelines

 Write a clear and concise manuscript Categories of Articles

 Case reports (“Insights and Images,” ”Rediscovering the Physical Examination”)  Review articles (“Medical Progress”)  Editorials and Commentaries  Original articles Case Reports Insights and Images, Rediscovering the Physical Examination

Should provide novel insights into genetics, pathophysiology, diagnosis, or treatment Avoid presenting cases of coincidences (two rare diseases in same patient) & extremes (worst presentation or bad medical care) unless there is a novel insight Review Articles, Commentaries, & Editorials

 These article types are generally approved in advance (Review Articles/Commentaries) or solicited by the editorial staff.  Unsolicited papers may not be considered so check with the journal first before submitting These article types require a focused theme, updated information or a new perspective Editorials are usually solicited by journal editors as a companion to an original article.  Typically editorialists are experts on the topic  Reviewers of the paper sometimes offer to write an editorial Original Articles

All should be novel, compelling, complete  Case series  Observational studies  Meta-analyses & systematic reviews  Clinical trials Note: clinical trials should be registered prior to enrollment of the first patient on an approved trial registry Abstract

 Common to skim abstracts and review tables/figures so these are very important  Structured abstract formats provided in journal instructions  Not all components listed below are used by all journals & header names may differ  Background or Introduction (why)  Study question (what)  Methods/Study design (how)  Results (what happened)  Conclusions

 A concise statement bringing it all together WHO is an author?

Drafting the work or revising it Substantial contributions to critically for important the conception or design of intellectual content the work; or the acquisition, analysis, or interpretation of data for the work Agreement to be accountable for all aspects of the work in ensuring that questions related to the Final approval of the accuracy or integrity of any part version to be published of the work are appropriately investigated and resolved Deciding Authorship

 Determine and agree on authorship as early as possible  Review journal authorship guidelines  Know and understand the ICMJE criteria for authorship Selecting a Journal Preparing your Manuscript

Selecting a journal

 In the past, articles of interest were identified by reading journals in print  It was easy to determine what types of articles were in specific journals  Electronic searching of topics has made it difficult to assess the “personality” of the journal  May be difficult to assess what type of journal may be best for your manuscript http://jane.biosemantics.org

 Add title of your article or a keyword  Click “Find Journals”  Jane will search for journals that have articles most similar to your input Output from jane.biosemantics.org

 Confidence score is based on specific articles on the topic published in the journal. More articles on the topic give greater confidence.

 Article influence indicates how often articles are cited in first five years after publication, weighted for overall journal influence.

 Show articles brings up a list of other articles on this topic published in the journal.

 Colored bars next to journal names include some information about specific journals (open access, medline-indexed, PMC) Prestige of a Journal

 How are journals ranked?  To whom is rank important?

The tradeoff Is the risk of delay in publication resulting from an initial rejection worth the benefit of publication in a “better ranked” journal?

-- General medical > subspecialty (NEJM > J Pediatr > Pediatr Nephrol)

-- General science > specialized science (Science > J Biol Chem) Preparing your Manuscript

Strategies

 Consider your audience  Look at journal websites for table of contents  Read instructions for authors Instructions for Authors

Review these carefully when starting work on the paper Article types Specific instructions for clinical trial reporting Page/word limits Formatting instructions Reference style Reporting Guidelines

 Reporting guidelines provide systematic approaches to manuscript preparation  Promotes quality, uniformity, accuracy and transparency  Equator-network.org site provides reporting guidelines for many types of studies Observational (STROBE) Randomized trials (CONSORT) Systematic reviews (PRISMA) Case reports (CARE)  Journals want you to use these guidelines! CONSORT 2010 checklist of information to include when reporting a randomised trial*

Item Reported Section/Topic No Checklist item on page No Title and abstract 1a Identification as a randomised trial in the title 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) Introduction Background and 2a Scientific background and explanation of rationale objectives 2b Specific objectives or hypotheses

Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 4b Settings and locations where the data were collected Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisation: Sequence 8a Method used to generate the random allocation sequence generation 8b Type of randomisation; details of any restriction (such as blocking and block size) Allocation 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), concealment describing any steps taken to conceal the sequence until interventions were assigned mechanism Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those

CONSORT 2010 checklist Page 1

Basic Layout

 Title Page  Abstract  Methods  Results  Conclusions  References  Tables  Figure Legends  Figures Title

 The title should be a succinct, but accurate description  “Randomized trial” should be in title if that’s the case  Draws interest to your paper  Does not sensationalize, not “cute”  You may need to provide a shorter title or running title Abstract

 Common to skim abstracts and review tables/figures so these are very important  Structured abstract formats provided in journal instructions  Background or Introduction (why)  Study question (what)  Methods/Study design (how)  Results (what happened)  Conclusions

 A concise statement bringing it all together Introduction

 One page/3 paragraphs  Overview & importance of general problem  Infants with congenital heart disease are at increased risk for neuromotor impairments in follow-up….. (lead into…) The specific causes of these impairments are not well understood.  Overview of your specific question  Why might low cerebral oximetry be associated with neuromotor outcomes? Provide some data on this topic  Hypothesis/study question or purpose  The purpose of this study was to evaluate … (be specific) We predicted that … (be specific) Methods

 IRB/informed consent language  Sequence (use reporting guidelines)  Participants (inclusion/exclusion)/Study design  Interventions or outcomes evaluated  Data collection-define sources and terms  Analysis (sample size calculations, data reduction, statistical analysis)  Another researcher should be able to repeat your study using your methods section Results

 Condense results so they easily lead to the conclusion  Include precise p-values for results  Use tables and figures to summarize details  Do not duplicate detailed results in text, tables, and figures  Do not interpret findings in the results, just describe them exactly  Summarize negative findings succinctly Parallel Style

 Makes the manuscript easier to follow  Try to use the same tense throughout the study  Use the same ordering system for abstract, methods, results  Example: study with three study groups-report groups in same order in abstract, methods, results  This makes it easy for your readers to anticipate what will come next Discussion

 Summarize key results with reference to study objectives  Put the results into perspective of the other literature  Discuss why your study is important (not necessarily because it is the 1st or largest-think of how it may change understanding or guide practice)  Discuss interesting/important aspects of study design  Discuss strengths and limitations of the study. Limitations do not equal a bad study  Don’t make conclusions beyond the data, state if you are speculating Discussion

An example of paragraph structure for the discussion 1. Integrated interpretation of results 2. General context from literature 3. Specific comments relative to previous studies 4. Major strengths of study 5. Weaknesses, cautions, limitations 6. Implications/future directions/why important References

 Follow journal instructions for reference style  Make sure references are current or classic, target to points made in manuscript  Reference book chapters or review articles sparingly  Do not reference abstracts  Do not need to provide an exhaustive list of references Tables

 Journals may have limits on published tables/figures  Online presentation of extra material  “Long, detailed tables are lethal”  Tables (or results section) should include  Number of participants (report missing data)  Complete summary measures (e.g., mean + SD)  Unadjusted and adjusted estimates and precision (e.g., 95% CI)  Precise p-values Figures

 Figures will have legends on a separate page  Make figures high contrast/easy to see  Likely will have to pay for color figures  Ask yourself if your figure would be a good slide? If so, it would be good for the paper. General Hints

 Organize/focus your thoughts before you write  If struggling, write the methods and results first  Go back to your original IRB or grant application  Revise, revise, revise  Ask others to read your manuscript for clarity and content  Members of your study team, your mentors  Native English speaker  Professional editor  Be direct-don’t make the reader guess anything! Good Writing is Important!

“Vigorous writing is concise. A sentence should contain no unnecessary words, a paragraph no unnecessary sentences, for the same reason that a drawing should have no unnecessary lines and a machine no unnecessary parts.

Elements of Style, Strunk & White, 3rd edition Be Specific

 Very important in your abstract and results, you can generalize a bit more in the discussion, if justified by the data. Low cerebral oximetry was associated with poor outcomes What is low? What is a poor outcome?

 Use consistent terminology throughout the manuscript If using you have defined a poor outcome in a specific way, use this terminology throughout the paper. For example if motor delay is defined a test score >2 SD below the mean, always use the term “motor delay” if you are talking about this outcome. Don’t also call it a motor impairment or motor difficulties etc. This can confuse readers who may wonder if they missed something. Comparisons

Treatment A was better.  Need to specify what about treatment A was better than what? Treatment A lowered blood pressure better than Treatment B. Avoid Wordiness

 The fact was that intraventricular hemorrhage and/or hypoxia- ischemia may have occurred prior to birth of the newborn infant.  Try leaving words out and see if the meaning of the sentence changes!  Intraventricular hemorrhage or hypoxia-ischemia may have occurred prior to birth.  Don’t cut down on words by using a lot of abbreviations!  Too many abbreviations will make your paper hard to read  Stick with common abbreviations Manuscript Review and Revision How are Reviewers Chosen?

 Authors’ suggestions

 Recognized experts in the field

 Database of reviewers

 Reference list of the manuscript

 Literature search by editors

 Recommendations of Editorial Board Good or Bad Choice of Reviewers? By Specialty and Institution

“Effect of zinc supplementation on interleukin 6 levels and outcome of neonatal sepsis” Andy Author, PhD Children’s Hospital, Seattle WA Suggested Reviewers Good Bad Ronald Reviewer, PhD Microbiology U Washington * Rosie Reviewer, PhD Outcomes research U Wisconsin * Rita Reviewer, RN, MS Nutrition U Melbourne ? Reginald Reviewer, MD Neonatology Ketchikan, AK * Richard Reviewer, MD Neonatology Baylor Coll Med * Robert Reviewer, PhD Innate immunity Duke U * Randolph Reviewer, MD Gen Pediatrics Portland * Rudolph Reviewer, MD Ped Inf Diseases U Colorado * Audrey Author, MD Psychiatry Swedish Hosp * Good or Bad Choice of Reviewers? By Content Expertise and Institution

“Effect of zinc supplementation on interleukin 6 levels and outcome of neonatal sepsis” Andy Author, PhD Children’s Hospital, Seattle WA

Suggested Reviewers Good Bad Ronald Reviewer Excellent neonatologist [email protected] ? Rosie Reviewer Expert zinc & infection [email protected] * Rita Reviewer Expert zinc & malaria [email protected] ? Reginald Reviewer Content expert [email protected] ? Richard Reviewer Interest antibiotics NICU [email protected] * Robert Reviewer Neonatal cytokines(Ref) [email protected] * Randolph Reviewer Lead on sepsis guidelines [email protected] ? Rudolph Reviewer Former mentor, retired [email protected] * Bill Balistreri Famous GI doctor [email protected] * Choosing Good Reviewers It’s All About Content Expertise

“Intestinal parasites and psychological problems in int’l adoptees in Finland” Inf Dis Psych Int’l adoption Rita Reviewer, MD Richard Reviewer, PhD Rebecca Reviewer, MD Dept Ped, Vanderbilt U. Dept Psych, Med U So Carolina Dir, Adoption Clinic NYC PID expert on parasites (Ref) Behav problems adoptees AAP recs evaluation int’ls (Ref) [email protected] [email protected] [email protected] “Part-time practice: Preparation, effects on Pediatrics and personal career advancement”

Physician workforce Medical education Part-time practice Academics

“Prenatal maternal DHA supplementation and infant morbidity in the first year of life” Nutrition/Diet Maternal & child health Epidemiologic methods Nutritional immunology

“Gentamicin exposure and sensorineural hearing loss in preterm infants”

Neo pharmacologist Safety gentamicin neonates Neurodev outcomes prematurity Reviewers Convey Subject Knowledge

Don’t Choose Reviewers: From any author’s own institution >1 from same outside institution All from same city Consider Offer to Exclude: Co-author of former publication Exclusion 1 reviewer (<5%) Former mentor unless only expert Exclusion >1 reviewer (<1%) Friends Relatives (explain non-related same name) Famous, esp w/o content expertise

Do Choose Reviewers: Content experts (Ref # _ on list) Content colleagues > personal colleagues List reviewer’s title, dept, institution, specific content expertise, email Choose full number of reviewers requested Guidelines for Reviewers

 Reviewers make comments and recommendations to editor  Reviewers comment, query methods/data/results/interpretation, and make suggestions to authors  Comments and suggestions to authors may not reflect the reviewers’ complete opinions Reviews are In! The Editors May… Accept “We are happy to accept provisionally” — Rare for the initial submission

x Reject “We are sorry to inform …will not publish — We do not want to see a revision

x Revise Neutral “We will review a revised version…” — Major problems, you might be able to address If you can, we are willing to assess revision Will go back for re-review x Revise Neg “…not accepted…requires substantial” — Major problems, not likely that you can address Only if you can, we are willing to assess revision Will go back for re-review

x Revise Pos “…very interested in a revised version” — Major questions we hope that you can address We like it Likely will go back for targeted review/reviewer Keep in Mind

 The editor usually sees more than the author (comments to editors) and has reviewers’ overall scores  The reviewers may have disparate opinions or priorities about importance of the study  The editor has an opinion about the completeness, fairness, and astuteness of each review Preparing a Revised Manuscript

 Revise if given the opportunity and you can answer major questions  Read the decision letter very carefully  It should provide clues to the aspects of the revision that the editor thinks are most important  It also should highlight and resolve conflicting recommendations by reviewers  Adhere strictly to any length suggestions Preparing a Revised Manuscript

 Read the reviewers’ comments carefully  Read the reviewers’ comments carefully  Re-read the editor’s letter carefully  Remember that comments to the authors may be somewhat different from those sent to the editors Preparing a Revised Manuscript

 Make a list of the important points made by the reviewers before beginning revision  Resist the temptation to be defensive about the paper rather than to change it  Change the text; don’t just answer the reviewer/editor  Write a summary letter to the editor including a (cut-and-paste) point-by-point response to the comments of the reviewers, keyed to the appropriate page of the revision/change in manuscript Addressing Reviewers’ Comments

Reviewer #1: Methods “You do not indicate how many discharge codes were used to define LRTI” Thank you. We now explicitly describe our approach (naming both primary and secondary diagnosis codes) and refer to several recent studies that used this standard approach (Methods: page 5, last paragraph)

“It would be more meaningful to break down regions studied beyond census tracts, such as by tribal regions or states. I believe that your present grouping ignores significant potential socioeconomic and exposure differences.” We agree that this level of analysis would be ideal, however, data bank and sample design restrictions precluded our ability to estimate rates at more granular levels. We added a reference regarding the databank, and addressed the issue in methods and limitations. (Methods:page 5, para 1; Discussion:page…)

Reviewer #2: Results “You should calculate the relative risks for specific durations of breastfeeding - 0,3,6 mos” We calculated the ORs and IRRs as suggested. Thank you. The previously identified trend now shows statistical significance. Tables 2 and 3 have been revised to show these intervals and analyses. Preparing a Revised Manuscript, con’t.

If you absolutely disagree with a point made by a reviewer, send a rebuttal to the editor but remember:  Be polite  Be clear  Remember that the editor chose the reviewer  Indicate succinctly why you cannot do something requested by the reviewer Responding to Editorial Decisions

Title, Results and Conclusions Reviewers’ Key Points Appeal? What Grounds? “The geographic distribution of Small sample size, not “U.S.” No condition x in the U.S.” Child’s condition x is based Not a misunderstanding on parents’ report online. Criticism of major aspect R: Prevalence of x is increasing. Condition x frequently is of study design. 5 zip codes had high incidence, confused with conditions Conclusion could be valid 2 had low incidence. y and z by parents. if from large unbiased sample C: Should seek reasons for high risk.

“Weight-for-length trajectories over Scores: Low Possible IF: the first 3 years in children born Overwhelming “statistical Simplify stats. to mothers with eating disorders” speak”. “My assessment is Still have a valid conclusion. that there is vanishing Can clarify valid diagnostic R/C: Children of mothers with binge little impact.” methods. eating and anorexia nervosa had Methods for diagnoses of Can provide context of lower W-f-L trajectories various EDs not clear. importance of findings. Little novel; 6 prior pubs Be: smart, respectful, on infant outcomes appreciative on rev’s help Additional Resources

 International Committee of Medical Journal Editors http://www.icmje.org/  Committee on Publication Ethics http://publicationethics.org  Office of Research Integrity http://ori.dhhs.gov/  ORI’s tool for avoiding research misconduct in the lab http://ori.hhs.gov/TheLab/  Retraction Watch http://retractionwatch.wordpress.com/  Elsevier’s Publishing Ethics Resource Kit https://www.elsevier.com/editors/perk Additional Resources

 Elsevier’s Research Academy https://researcheracademy.elsevier.com/  Equator Network (reporting guidelines, including clinical trials) http://www.equator-network.org/  ClinicalTrials.gov Ethics of Scientific Publication William F. Balistreri, M.D. Editor “Publish or Perish”

Published manuscripts are the currency of the academic world: Promotion Funding

“…fierce competition in scientific disciplines and the increasing necessity to publish may lead authors to engage in questionable behavior” Errami, Nucleic Acids Research, 37:D921, 2009 “The purpose of authorship has shifted” Martinson, NATURE, 550:303, 2017

“Once - Primary role = share knowledge; now it is to get a publication”

“Authorship has become a valuable commodity; as with all commodities, it is bought, sold, traded and stolen” Ushma Neill (editor) JCI 118:2368, 2008 http://national-academies.org “The research enterprise is not broken, but it faces significant challenges in creating conditions needed to foster & sustain the highest standards of integrity”

Robert M. Nerem, Chair of the Report National Academy of Sciences, Engineering and Medicine Why misconduct?

Desire to distribute the findings Lack of accountability Lack of accountability Don’t understand the harm Don’t understand the rules (?) Guidelines vague/overwhelming Academic pressure Ethical Issues in Scientific Publication

1.Research Misconduct 2.Conflicts of Interest 3.Plagiarism 4.Duplicate Publication and Least Publishable Unit 5.Authorship 6.Predatory Publishers Research Misconduct Defined

Unethical treatment of research subjects (human or animal) Fabrication in proposing, performing, Falsification reviewing, or Plagiarism reporting research “The role of ethics in research extends through the moral obligation to report that research and to do so in an honest, transparent, and timely manner”

Summerskill, et al THE LANCET 373:992, 2009 Martinson, Anderson, de Vries Nature 435:737, 2005 http://www.iom.edu Conflicts of Interest…

“…exist when a participant in the peer review process (author, reviewer, and editor)… …has financial or personal relationships…that inappropriately influence (bias) his or her action…” ICMJE Uniform Requirements (October 2008) Financial or other conflicts of interest

Need not prevent a researcher from doing a study; nor bias the resulting report However, they must be declared at submission; to withhold is to disguise biases

Rennie, et al: JAMA 266: 266,1991 Impact

“Any error is everlasting….once an error gets into print it will live on in libraries carefully catalogued, scrupulously indexed…deceiving researchers through the ages, all of whom will make new errors on the strength of the original errors, and so on into an exponential explosion of errata”

John McPhee, Checkpoints, The New Yorker, February 9 & 16, p. 56, 2009 Failure to Disclose Impact is far reaching

“As editors of general medical journals, we recognize that the publication of clinical-research findings in peer- reviewed journals is the ultimate basis for most treatment decisions”

Davidoff, THE LANCET 358:856, 2001 JAMA. 2006;296:220-221 Fontanarosa, JAMA 304:1496, 2010 What Is Plagiarism?

“Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit”

Office of Research Integrity http://ori.hhs.gov/policies Accessed April 14, 2009 Plagiarism—examples

 Taking credit for others’ text/ideas  Lack of proper attribution  No citation for summarizing and paraphrasing ideas  Lack of quotation marks for: exact words phrases sentences Laine, Ann Intern Med. 166:148, 2017 Pathogenesis:

Caused by…  Human error?  Cultural differences?  Academic dishonesty?  Academic laziness? “it’s easier” (cut & paste) A Problem Because... Injects bias/misunderstanding into medical evidence: Duplicate publication Wastes time, energy, resources for authors, reviewers, readers Violates copyrights laws May be unknown to other authors Impact on perpetuator (FRAUD) SCIENCE 348:18, 2015 A tale of two citations Errami & Garner NATURE 451:397, 2008

“the advent of new computational text-searching algorithms, electronic indexes/ full-text manuscripts, makes it easier to detect unethical publications” http://jane.biosemantics.org http://jane.biosemantics.org

These articles are most similar to your input: Duplicate Publication definition:

“substantially duplicates another article without acknowledgement”

 Serious breach of ethics; publishing same findings in more than one journal  Might be spotted (reviewers, editors, or readers)  With proliferation of sub-sub-specialty journals duplicate publication is easy to attempt and hard to prevent Least Publishable Unit (LPU)

 Academic advancement process offers incentives to “max out” research into greatest number of publications possible  LPU = submitting separate papers on each significant finding, no matter how small or related to the other findings STUDY 1c

STUDY 1b

STUDY 1a

“salami slicing” Credit and accountability

 Editors are most concerned about accountability  Authors are most interested in the credit

Smith, J R Soc Med 99:115, 2006 “I encourage you to openly discuss from the start who is to be an author”

How to write a scientific masterpiece Neill, J. Clin. Invest. 117:3599, 2007

…and the order! (WFB) Authorship

Criteria for what merits authorship International Committee of Medical Journal Editors (ICMJE)  sign an authorship attestation before publication (www.icmje.org) Required Authorship Criteria: 1. Contributed to conception/design; AND/OR acquire/analyze/interpret data 2. Drafted/revised the MS 3. Approved final version of MS 4. Agreed to be accountable for all aspects of the work

www.icmje.org What does not constitute authorship?

Funding acquisition Data collection Statistical analysis General supervision of research group Writing/Editing Department Chair “Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure”

PLoS Medicine February 2009:6;e1000023 Predatory Journals: The Problem Some clearly written by individuals struggling with functional illiteracy Predatory Journals Barraged by a deluge of emails actively soliciting your manuscript…or inviting you to serve on an Editorial Board  Promises made: rapid decision expeditious publication NO mention of a fee  Seems unbelievable – AND IT IS !!! Butler, NATURE 495:433, 2013 Open Access Journals

 A way to increase visibility  However, open access has brought some unforeseen consequences  Predatory journals take advantage of OA model “Journals that exploit the author-pays model damage scholarly publishing…” “…dishonest,Beall, NATURE lack 489:179, transparency” 2012

Beall, NATURE 489:179, 2012 Predatory Journals

Threaten science, scientists & effective communication of science  Publish ANYTHING

Beall, NATURE 489:179, 2012 What can be done to avoid predators? ? “White list” http://thinkchecksubmit.org Shamseer, BMC Medicine 15:28, 2017 Impact of Transgressions

• On science • On the individual • On the “economy” • On clinical practice Fiscal Impact

“On more than one occasion..., publication of an article in the Journal has been the direct cause of sharp fluctuations in stock prices” Arnold Relman, NEJM 310: 1182, 1984 Failure to Disclose

Scientific articles that endorse or criticize a product are news; widely publicized  Direct impact on product sales  ? Clinical consequences Alleged Measles Vaccine Autism Connection

Dr Andrew Wakefield Innovations in scholarly publishing

Persistent identifiers ORCID Data sharing Preprints Altmetrics

https://xkcd.com/1945/ ORCID

 Unique identifier to avoid name disambiguation  Free to register (https://orcid.org/)  User controls privacy/visibility  Once ORCID record is established, as long as the iD is used during the submission process, the ORCID record will automatically update! This includes publications, funding, grants, and more.

orcid.org/0000-0003-3497-4105 Data sharing

 Data can be deposited to a repository and is given a DOI that can be linked to published articles  Data statements: provides information about the data presented in an article and provides a reason if data is not available to access  Benefits

 Increased transparency

 Compliance with data policies

 It’s good scientific practice!

https://www.elsevier.com/authors/author-services/research-data Preprints

Are they that new? Check journal author guidelines before uploading your research to a preprint server! What’s next for preprints? Altmetrics

 Article-level metrics to measure research impact 46%  Post-publication article promotion

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