Reviewer's report
Title:Twenty years and still counting: including women as participants and
studying sex and gender in biomedical research
Version:1Date:6 April 2015
Reviewer: Cara Tannenbaum
Reviewer's report:
The authors present a timely and compelling debate on the state of current
science, policy and practice for integrating sex and gender into preclinical and
clinical research.
The chronology and description of progress to date are interesting and warrant
publication from both a historical and analytical point of view.
The following edits should be considered to improve the clarity and impact of the
manuscript.
Major Compulsory Revisions:
1 - Please add a brief section on the Methods/Sources of Data used to capture
the reports and publications referenced and included in the manuscript. This is
important to ensure comprehensiveness. For instance, was a PubMed search
conducted from 1990 - 2014 to identify the scientific studies on the inclusion of
sex and gender in health research? What keywords were used? Was an
environmental scan performed of the grey literature and certain government
organisation webistes (ORWH and FDA)? How was the CBS 60 minutes report
captured? Were reports identified but omitted from the manuscript (what were the
selection criteria used)? Were only US publications considered? A justification for
the strategic selection of the data is required.
2 - Would re-title the discussion section Results - since these are really the
results of the search for evidence on the topic of this debate.
Minor Essential Revisions:
1 - As presented, the discussion (i.e. the results of the analysis) is listed in
chronological order with only vague reference to the type of intervention that was
made. The authors are encouraged to sub-divide or categorize each salient
milestone in the chronology of their work into "scientific evidence" or "policy" or
"advocacy action" to assist the reader in understanding the critical components of
the movement to integrate sex and gender into preclinical and clinical research.
As presented, there is little interpretation/analysis of the efforts and evidence
base leading to progress in integrating sex and gender into health research. A
better understanding of the multisectorial strategy that is required to bring about
this culture shift would be achieved by dividing the results into types of actions,
as well as timelines. This could be best summarized in a table or figure.
2 - The logical rationale for including some of the reports (and omitting others) is
not always evident. For instance, I would encourage the authors to reconsider
the inclusion of the Henry J Kaiser Family Foundation Focus on Health Reform
Report. Should issues of economic coverage be included in the same debate as
inclusion of female animals and female participants in health research? The intro
should specify the exact topic that is being covered in this debate.
3 - Dividing the paper into decades (1990-2000, 2001-2010, and 2011 onwards)
may aid analysis and interpretation. The arbitrary cut-off of 2014 (now that we
are in 2015) does not make complete sense to me. Nor does the sentence in line
538 stating that the policy changes will be rolled out this fall (meaning fall 2014).
4. A table or figure listing the key players in bringing about progress would be a
nice addition to the paper. For instance: what role did individual scientists or
professional organisations play? The ORWH? The FDA? The media? Other
government or NGO organizations?
5. The discussion/conclusion would be enhanced by an analytic commentary on
the above factors.
Discretionary Revisions
1 - Tables 2 & 3 do not add anything to the debate in my opinion
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I declare that I have no competing interests.