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Pearls and Pitfalls of Medical Publishing

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Pearls and Pitfalls of Medical Publishing Stephen L. Corson, M.D. Editor-in-Chief The Journal of Minimally Invasive Gynecology The Official Journal of the AAGL – PowerPoint PPT presentation

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Title: Pearls and Pitfalls of Medical Publishing


1
Pearls and Pitfalls of Medical Publishing
  • Stephen L. Corson, M.D.
  • Editor-in-Chief
  • The Journal of Minimally Invasive Gynecology
  • The Official Journal of the AAGL
  • Advancing Minimally Invasive Gynecology Worldwide
  • Published in partnership with Elsevier Inc.

2
Considerations
  • Have something meaningful to say
  • IRB approval if applicable
  • Consult a statistician first!!!!!
    If RCT, power analysis based on
    assumptions, necessary numbers in each arm, is
    protocol valid?
  • Adequate literature search

3
Manuscript Preparation
  • Follow instructions on website
  • Senior author must sign attestation form
  • All authors need to complete disclosure
  • Where appropriate supply abstract, precis and key
    words
  • Separate legend sheet for figures titles for
    tables
  • Consider a copy editor with English skills

4
Case Reports
  • Must be truly uniquepathology, diagnostic
    methods, management, complications.
  • Is the information clinically useful?
  • Limit on number of authors and references

5
Instruments and Techniques
  • Really new or a minor modification?
  • Are claims of increased efficacy/safety supported
    by data (statistically, if compared)?
  • Photo documentation and/or video is preferred
    limit of 4.5 minutes for video.
  • Industry Support? Full disclosure

6
Pilot Study
  • Deals with new instruments, diagnostic methods,
    new procedures with small patient numbers.
  • Statistics not an issue
  • No claims of safety or efficacy can be made.

7
Review Article
  • Data bases used Medline, Cochrane Review
  • Balanced approach to literature review
  • Unbiased presentation as much as possible
  • Does it fully encompass the current and older
    literature?

8
Type of Study Design
  • Case control Usually retrospective, matched.
  • Cohort prospective, not randomized, parallel
  • Crossover two groups or one group with placebo
  • Randomized Control Trial (RCT) is the gold
    standard of investigations

9
Canadian Task Force Classification of Level of
Evidence
  • I Properly designed randomized control trial
  • II-1 Properly designed controlled, not randomized
    trial
  • II-2 Well designed cohort case controlled study,
    usually multicentered, prospective or
    retrospective
  • II-3 Comparisons between times/places
    uncontrolled
  • Opinions can be published in Clinical Opinions
    Section

10
Original Research Papers
  • Title must reflect an accurate description of the
    content.
  • Keywords are important for citations in
    literature
  • Abstract must contain study objective, design
    classification, setting, patients, interventions,
    measurements, main results and conclusions. The
    abstract must be clear, concise and accurate
    without discrepancy with the text. It is the
    teaser.

11
Introduction
  • Rationale for the Study
  • Relevant references
  • State the question or the issue to be studied
  • Is there a hypothesis to be tested?

12
Materials and Methods
  • Study design
  • Ethical Review Board approval if applicable
  • Selection process how randomized? Inclusions and
    specific exclusions
  • Single or double blind? (pain/pathology/adhesion
    study data)
  • Sample size power analysis (gt80)
  • Method of data collection
  • Definitions of measurement norms and methods such
    as for EBL and histologic data

13
Materials and Methods (cont.)
  • Statistical Methods
  • If data are normally distributed, use mean,
    standard deviation, 95 confidence intervals.
  • If data are skewed, use median, range, and if
    desired quartiles.
  • Students t test may be used to compare means.
  • Wilcoxon, or Mann-Whitney analysis for ordered
    categories such as continence/pain studies
  • Contingency Tables (chi-square) for numbered data

14
Results
  • Population demographics and experimental data
  • Relationship between independent and dependent
    variables
  • Multivariable analysis where appropriate
  • Tables should be used to help the reader digest
    data, especially comparisons between groups or
    literature results. Do not repeat all the
    information given in the text. Tables need
    titles.
  • Figures should elucidate. Furnish legends on a
    separate legend/title page.
  • Photos must be of good quality arrows to depict
    points of interest or structures are helpful.
    Videos demonstrating anatomy/techniques are
    desired (4.5 minutes maximum)
  • Statistical significance of the results. Try to
    avoid use of trends.
  • Adequate follow-up interval, especially for onco
    and urogyn

15
Discussion
  • No new data from your study
  • The first sentence summarizes the results
  • Concise statement of findings
  • Was the question answered or the hypothesis
    proved?
  • Explain any unexpected results as best possible
  • Compare results with the literature giving both
    pro and con
  • Present limitations of the study
  • Comment are statistical differences relevant
    clinically?

16
Evolution of Data Reporting
  • Case Report
  • Pilot Study
  • Consecutive Series (prospective)
  • Matched case control (retrospective)
  • Randomized Controlled Trial

17
Consecutive Series
  • Useful in the early phases of study such as
    evaluating docking time, EBL and total operating
    time and hospital bed days for early experience
    with robotic surgery comparing first x cases with
    last x cases.
  • Problems include Intent to treat statistics and
    lost to follow-up representing a skewed
    population (of not satisfied patients).

18
Crossover Study
  • Limited usefulness because of carryover effect
    mostly for pharmacologicals
  • One group with A then B and one group with B then
    A (randomized).
  • Could also be one group with different treatments
    of bilateral structures (tubes)
  • Problems include patient assignment and
    sequencing, timing of measurements and dealing
    with dropouts.

19
Randomization
  • Not every other patient or every other day
  • Should be made from a computer generated list of
    random numbers.
  • Important to follow block randomization in
    multicenter studies

20
Statistical Tidbits Power Analysis
  • Ideally this should precede the study
  • The power analysis determines the sample size
    necessary to show either a difference or
    similarity between groups.
  • It depends on the assumption of the magnitude of
    the difference
  • Usually a value of gt80 is needed for validity
  • A power analysis has become almost mandatory for
    all RCTs

21
Statistical Tidbits p values
  • Used to express the degree of dissimilarity
  • Values show probability of results occurring by
    chance
  • Type 1 error falsely rejecting the null
    hypothesis
  • Type 2 error failure to accept the hypothesis
  • The p value is not a substitute for power
  • One sided-two sided analysis
  • Report data as decimal without zero (.02)
  • Usual criterion of lt.05

22
Statistical Tidbits Confidence Interval
  • Shows the extremes at which the true value lies
    95 of the time
  • Gives information not available from p values
  • The values are based on actual experimentally
    derived data

23
Contingency Tables
Ectopic Pregnancy
US Present (a) 90 Absent (b) 3
US - Present (c) 4 Absent (d) 50
a/(ac) sensitivity d/(bd) specificity
90/(904)96 50/(350)94
Positive predictive strength a/(ab) Negative
predictive strength d/(cd)
24
Evidence Based Screening
  • Screening test 95 accurate
  • False positive 1
  • Prevalence 0.5
  • 100 000 screened, 500 with disease and 475
    (.95X500) positive tests
  • Of 99,500 without disease, 1 positive (.01
    X 99,500) 995 false positives
  • Therefore with 1470 positive tests only 32 have
    the disease.

25
Advanced Statistics
  • Linear Regression
  • Multivariable Analysis
  • Life Table AnalysisSurvival Curves
  • Analysis of Variance (1 and 2 way)
  • Fishers Exact Test, Bonferroni Correction
  • Receiver Operating Curves
  • Markov Tree
  • Correlation Coefficient

26
Trends in Medical Publishing
  • Reduced hard copy increased electronic
  • Speed and economics
  • More video content
  • International multicenter studies with focus on
    gender and ethnic differences
  • Large central sources of journals such as medical
    school libraries
  • Readers such as Kindle and IPad

27
Conclusions
  • I am your advocate. My job is to help you present
    your data in the best possible format
  • The editor also has a responsibility to the
    readers
  • Language problems and poor writing usually can be
    fixed
  • Statistical issues and fatal protocols are often
    unfixable

28
The Journal of Minimally Invasive Gynecology
welcomes your submissions
  • Submit your manuscript at www.ees.elsevier.com\jmi
    g
  • For English-language editing services, please
    consult http//webshop.elsevier.com/languageediti
    ng/

Thank you for your attention.
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