Biomedical Publication: Top Ten Pearls and Pitfalls

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Biomedical Publication Top Ten Pearls and
Pitfalls

• Phil B. Fontanarosa, MD, MBA
• Executive Deputy Editor, JAMA
• Adjunct Professor
• Feinberg School of Medicine
• Northwestern University

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10. Make a Commitment to Publish Your Research

• Riddle If a tree falls in the forest but
  nobody is around to hear it, does it make a
  sound?
• Symbolizes the ineffectiveness of unheard
  opinions/thoughts
• Riddle If medical research is conducted but
  not published, how will it advance medical
  science ?

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Importance of Scientific Publication

• Disseminate scientific research findings
• Promote new ideas, foster debate
• Academic advancement
• Personal accomplishment
• Expectation of supervisors, funding bodies
• Duty and responsibility to research
  participants

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9. Determine Authorship Roles and
Responsibilities

• Decide prospectively
• Agree on order of authors
• First author principal investigator
• Ensure authorship is justified
• Responsibility of deans, department chairs,
  research directors to have standards in place to
  ensure authorship is earned and is appropriate

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Authorship - Implications

• Accountability and Responsibility
• Appropriate recognition
• Credit (and Blame) where due
• Hwang WS, et al. (25 AUTHORS). "Patient-specific
  embryonic stem cells derived from human SCNT
  blastocysts". Science. 2005 308 (5729) 1777-83
  
• Second paper in which data were fabricated

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Author Contributions

• Study Conception
• Study Design
• Data Collection
• Data Analysis
• Data Interpretation
• Draft the manuscript

• Revise the manuscript
• Obtain Funding
• Administrative or Technical Support
• Supervision
• Other

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Authorship Criteria (ICMJE)

• Take public responsibility for the work
• Substantial Contributions to
• 1. Conception and design, or acquisition of
  data, or analysis and interpretation of the
  data and,
• 2. Drafting the manuscript or revising it
  critically for important intellectual content
  and,
• 3. Final approval of the version to be published
  
• Authors should fulfill all three criteria

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Simply Having Authorship Criteria is Not
Sufficient

• Honorary Authors - naming as an author an
  individual who does not meet authorship criteria
• Ghost Authors failure to name as an author an
  individual who made contributions that merit
  authorship

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Research on Authorship

• Survey - 809 corresponding authors from NEJM,
  JAMA, Ann IM, Am J Med Am J Ob/Gyn Am J Card
• Flanagin et al JAMA. 1998
• Honorary authors 156 papers (19)
• Ghost authors 93 papers (11)
• Survey 362 corresponding authors of Cochrane
  reviews
• Mowat et al. JAMA. 2002
• Honorary authors 141 reviews (39 )
• Ghost authors 32 reviews (9 )

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Authors vs Contributors

• Approach for reporting contributions
• Particularly useful with increased numbers of
  investigators and collaborations
• Possible advantages Allocate credit and
  responsibility Fairness in recognition May
  discourage fraud

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8. Develop a Strategy for Scientific Writing

• Writing is easy. All you have to do is sit and
  stare at the blank sheet of paper until the drops
  of blood form on your forehead.
• Gene Fowler
• Just get it down on paper, then well see what
  to do with it.
• Max Perkins

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Approach to Scientific Writing

• Know subject thoroughly
• Dont procrastinate
• Find peak creative time
• Focus on one task at a time
• Establish reasonable, achievable deadlines
• Expect multiple drafts
• Ask colleagues for honest feedback

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7. Decide on Article Format and Identify Target
Journal

• Original research paper
• Review article
• Case report, case series
• Opinion piece (commentary, editorial)
• Book review
• Letter to the editor (Research Letter)

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Biomedical Journals - 2007

• 15,000 published worldwide
• 5,200 indexed in Medline
• gt 10,500 citations added weekly
• gt 500,000 citations added annually
• More than 15 million citations in Medline
• Countless more articles released on-line

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Journal Selection

• Who - is involved / needs the information
• What reason for the paper
• Where best place for the information
• Why importance / suitability
• How- should message be communicated
• When - optimal timing, urgency

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Journal Selection

• Match focus / message of paper with journal
• Consider readership / target audience
• Recent articles on similar topics / issues
• Compare methods (eg, RCTs, MAs)
• Compare scope (eg, sample size, multi-center)
• Potential fit with specific journal section
• Contact editorial office

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6. Follow Journal Instructions for Authors
Carefully

• The best way to hide something must be to put it
  in the instructions for authors, because nobody
  reads them or at least it seems that way.
• Follow guidelines for manuscript preparation
• Abstract format manuscript length
• Provide additional materials as indicated
• Related papers Authorship forms
• Conflict of interest declarations

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Instructions for Authors and Manuscript
Submission

• Provide detailed cover letter (1 page)
• - Personal letter to Editor
• Explain why paper is suitable
• Suggest possible section
• Identify special issues (eg, conflicts, timing)
• Provide detailed contact information
• Multiple, complete, back-up

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Electronic Manuscript Submission

• Follow instructions carefully
• Keep copies of everything
• Acknowledgment of receipt by journal
• Assignment to individual editor
• Requests for additional information
• Follow-up if no reply from journal

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5. Avoid Common Problems and Mistakes

• Lack of attention to detail
• Carelessness, typos, missing elements
• Incorrect format (abstract)
• Internal inconsistencies
• Submission of small increments of information
  slices (the LPU)

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Common Problems and Mistakes

• Old data
• Delay from study completion to submission
• Low response rates or follow-up rates
• Incorrect interpretation (ie, causal inferences
  in observational studies)
• Overly enthusiastic, non-objective interpretation
• Excessively long papers

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4. Understand the Editorial Process
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Editorial Process - Principles

• Prompt assessment
• Rigorous evaluation
• Fair and objective
• Confidential
• Clear, straightforward communication

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Manuscript Evaluation ProcessFour test
questions

• Is it new ?
• Novelty, newness, timeliness
• Is it true ?
• Quality, methodological rigor, validity
• So what ?
• Clinical, research, or public health implications
• Who cares
• Importance for clinicians, researchers, public

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Fundamental Elements of Quality Manuscripts

• Original, good ideas
• Rigorous, solid studies
• Relevant, timely information
• Single, clear, focused message
• Scientific integrity
• Ethical conduct of research

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3. Respect the Peer Review Process

• The lynch pin of science
• Ask experts How good and how important is this
  paper ?
• Reviewers are consultants, not decision-makers
• Reviewer input extremely useful to authors,
  editors, and ultimately, readers

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Selection of Peer Reviewers

• Reviewer database
• Literature search, Reference lists
• Specific purposes or questions
• Statistics, genetics, etc
• Author suggestions
• Expect constructive, objective, professional
  comments (Golden Rule of Peer Review)

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Types of Reviewer Comments Authors Hope Not to
See

• Your words leap across rivers and mountains, but
  your thoughts are still only six inches
  long.
  E.B. White

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Types of Reviewer Comments Editors Hope Not to
See

• This manuscript is both good and original but
  the parts that are good are not original, and the
  parts that are original are not good.
  Samuel Johnson

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Peer Review and Editorial Decision Making at JAMA

• Highest priority for potentially practice
  changing major clinical trials
• New findings or first reports that will be of
  interest for a general medical audience
• Cutting edge scientific advances
• Papers with public health urgency or immediate
  importance (EXPRESS)
• Merits / message vs other papers

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JAMA Data - 2007

• Manuscripts received 5551
• External peer review 38
• Overall Acceptance rate 8
• Receipt to Rejection 7 days
• Submission to Acceptance 69 days
• Acceptance to Publication 37 days
• Receipt to Publication 113 days

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2. Respond Promptly and Professionally to
Editorial Decisions

• Reject (with or without review)
• Revise and reconsider
• Accept if suitably revised
• Accept as is

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Rejection Decisions

• Disappointing experience, but not personal
• Understand reasons for rejection
• Learn from experience and carefully consider the
  comments from the editors and reviewers
• Dont let rejection lead to inaction

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Appeals of Rejection Decisions

• Provide objective, evidence-based rationale for
  appeal
• Simply responding to reviewers comments is not
  sufficient
• Most effective if
• Can present convincing argument (eg, reviewer
  error)
• Have new methods, new analysis, or new data
• Overall, usually a low yield strategy

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Invitation to Submit a Revised Manuscript

• Respond promptly
• Professional and polite tone
• Address each comment in detail
• Indicate how manuscript was revised
• Clearly state position and rationale for any
  disagreement
• Express willingness to negotiate
• Contact editor if questions, discrepancies

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1. Fulfill Post-Acceptance Responsibilities

• Respond to remaining queries
• From editor, copy-editor, graphics
• Provide any missing details
• eg, author forms, new references requested
• Prompt turnaround on page proofs
• No new data no major rewriting no changes in
  authorship
• Cooperative, collaborative approach

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Post-Publication Responsibilities

• Communicating research information to the public
  (media attention)
• Scholarly, professional, prompt responses to
  letters to the editor (post-publication peer
  review)
• Express appreciation to colleagues who provided
  assistance / support funding sources and family
• Start to plan next research study

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Medical Research

• The important thing in science is not so much
  to obtain new facts as to discover new ways of
  thinking about them.  William Lawrence Bragg
• Medicine is the only profession that labors
  incessantly to destroy the reason for its own
  existence.  James Bryce