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Sex-Specific Reporting of Scientific Research A Workshop Summary (2012) / Chapter Skim
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IMPLICATIONS FOR JOURNALS OF SEX-SPECIFICREPORTING POLICIES OF JOURNALS
Pages 26-35

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From page 26...
... Legato suggested that editors put out a request for papers that directly address sex differences, perhaps for publication in a supplemental issue. Robert Golub, deputy editor of JAMA, said that his journal publishes theme issues on topics that are of immediate relevance, and sex differences could be considered as one of those topics.
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From page 27...
... Interdisciplinary Science Journals Katrina Kelner, editor of the new journal Science Translational Medicine and former deputy editor for biology at Science, said that the issue of sex-specific reporting "is not on the radar screen" of the interdisciplinary journals (such as Proceedings of the National Academy of Sciences, Science, and Nature)
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From page 28...
... Medical Journals Study Design, Analysis, and Reporting Golub shared the results of his informal audit of the 50 most recent randomized controlled trials published in JAMA. Of the 50, 21 reported single-sex results (on sex-specific topics)
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From page 29...
... Gregory Curfman, executive editor the New England Journal of Medicine, concurred that the real challenge in reporting clinical-trial results separately for males and females is whether there is adequate statistical power for subgroup analysis. The rationale for reporting data by sex is indisputable, he said, but if a clinical trial has not been adequately powered to look at males and females separately, the conclusions are not going to be statistically sound.
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From page 30...
... Berlin added that appropriate study design and use of common definitions would improve the ability to conduct meta-analyses of such archived data. Current NIH policy on the participation of women in clinical trials has not achieved the desired effect of having enough women enrolled in all studies for sufficient statistical power, Golub said.
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From page 31...
... Parekh explained that FDA guidance documents for preclinical animal studies recommend studying both male and female animals. Phase 1 clinical studies look for safety and pharmacokinetic differences among subpopulations of healthy volunteers, including women and men.
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From page 32...
... Golub noted that there is a difference between a prespecified secondary analysis and a post hoc exploratory analysis. Sex Subgroups Sex hormones influence virtually all cells, and stage of reproductive life and development should be considered in designing and reporting studies, Blaustein said.
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From page 33...
... Questions about what can be accomplished by editors and publishers through setting standards for authors, whether these be recommendations or mandates, versus the role of federal agencies and other funders in shaping research culture to embrace consideration of sex differences as part of sound study design, were raised in a number of comments by participants. As discussed earlier, the ICMJE policy is specific to medical journals.
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From page 34...
... Annals of Internal Medicine does not have a specific policy on sex-specific reporting but follows the ICMJE policy, Laine said, and encourages authors to follow reporting guidelines, including CONSORT and STROBE. She added that for many years, Annals has indicated in the title and abstract when a study includes only men or only women and indicates in the limitations of the study if data are insufficient to examine potentially relevant sex differences or racial or ethnic differences.
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From page 35...
... that "the International Committee of Medical Journal Editors and other editors of relevant journals should adopt a guideline that all papers reporting the outcomes of clinical trials report on men and women separately unless a trial is of a sex-specific condition" (IOM, 2010, p.
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Key Terms

  • study design
  • clinical trials
  • subgroup analysis
  • editorial policies
  • health research

  • subgroup analyses
  • reporting results
  • science translational
  • exploratory analyses
  • icmje policy

  • observational studies
  • translational medicine
  • adequate power
  • clinical trial
  • valid subgroup

  • specific reporting
  • reporting guidelines
  • bayesian statistical
  • medical journals
  • females separately

  • journal editors
  • statistical power
  • adequately powered
  • deputy editor
  • estrous cycle

  • discussed earlier
  • disclosure forms
  • default choice
  • animal studies
  • berlin added


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