Evidence Map: Reporting of Results by Sex or Gender in Randomized, Controlled Trials with Women Veteran Participants (2008 to 2018)

Elisheva R. Danan, Kristen Ullman, Ruth S. Klap, Elizabeth M. Yano, Erin E Krebs

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Background: Higher participation of women in randomized, controlled trials (RCTs) has not led to significantly improved reporting of sex-stratified results. A recent evidence map of research on women veterans revealed that many studies did not report results by sex or gender. This study's objectives were to compare characteristics of RCTs with women veteran participants that did or did not report results by sex or gender and to assess how sex and gender are addressed in research with women veterans. Methods: We extended the prior evidence map with a systematic search for RCTs with women veterans, published between 2008 and 2018. We compared the characteristics of RCTs that reported results by sex or gender with those of RCTs that did not, and reviewed methodology and reporting of sex/gender analyses. Results: In addition to 11 studies from the prior evidence map, we assessed 1,820 abstracts for relevance and ultimately included 45 unique RCTs. Five trials included only women and 40 included both men and women (median, 14.3% women). Ten studies reported results by sex or gender. These trials were larger (median study size of n = 343.5 vs. n = 125.5) and included a higher median proportion of women participants (16.8% vs. 11.2%) than studies without sex/gender results. Ten of 11 trials that tested pharmacologic or device interventions did not report results by sex or gender. Conclusions: Reporting of results by sex or gender remains low in veteran research, but may improve with larger studies and increased recruitment of women veterans into trials. Trials of pharmacologic or device interventions may be targets for future reporting requirements. Standardization could improve attention to sex and gender in methodology and reporting.

Original languageEnglish (US)
Pages (from-to)S112-S120
JournalWomen's Health Issues
Volume29
DOIs
StatePublished - Jun 25 2019

Bibliographical note

Funding Information:
This study was supported by resources of the Department of Veterans Affairs, Veterans Health Administration (VHA) and was based, in part, on prior research conducted by the Evidence-based Synthesis Program (ESP) site located at the Minneapolis VA Healthcare System, Minneapolis, Minnesota, funded by the VHA Office of Research and Development, Quality Enhancement Research Initiative (VA ESP Project #09-009). Dr. Yano's effort was supported by a VA HSR&D Senior Research Career Scientist Award (Project #RCS 05-195). Dr. Klap's effort was covered by the VA Women's Health Research Network (Project #SDR-10-012). The views expressed in this article are those of the authors and do not represent the views of the VA or the U.S. Government. This study was supported by resources of the Department of Veterans Affairs, Veterans Health Administration (VHA) and was based, in part, on prior research conducted by the Evidence-based Synthesis Program (ESP) site located at the Minneapolis VA Healthcare System, Minneapolis, Minnesota, funded by the VHA Office of Research and Development, Quality Enhancement Research Initiative (VA ESP Project #09-009). Dr. Yano's effort was supported by a VA HSR&D Senior Research Career Scientist Award (Project #RCS 05-195). Dr. Klap's effort was covered by the VA Women's Health Research Network (Project #SDR-10-012). The views expressed in this article are those of the authors and do not represent the views of the VA or the U.S. Government. The authors gratefully acknowledge the assistance of Nancy Greer, PhD, ESP Program Manager for the Minneapolis VA Medical Center. Dr. Danan had full access to all the data in the study and takes full responsibility for the integrity of the data and the accuracy of the data analysis. This study was supported by resources of the Department of Veterans Affairs, Veterans Health Administration (VHA) and was based, in part, on prior research conducted by the Evidence-based Synthesis Program (ESP) site located at the Minneapolis VA Healthcare System, Minneapolis, Minnesota, funded by the VHA Office of Research and Development, Quality Enhancement Research Initiative (VA ESP Project #09-009). Dr. Yano's effort was supported by a VA HSR&D Senior Research Career Scientist Award (Project #RCS 05-195). Dr. Klap's effort was covered by the VA Women's Health Research Network (Project #SDR-10-012). The views expressed in this article are those of the authors and do not represent the views of the VA or the U.S. Government.

Funding Information:
Supported by resources of the Department of Veterans Affairs , Veterans Health Administration (VHA) and was based, in part, on prior research conducted by the Evidence-based Synthesis Program (ESP) site located at the Minneapolis VA Healthcare System, Minneapolis, Minnesota, funded by the VHA Office of Research and Development , Quality Enhancement Research Initiative (VA ESP Project #09-009). Dr. Yano's effort was supported by a VA HSR&D Senior Research Career Scientist Award (Project #RCS 05-195). Dr. Klap's effort was covered by the VA Women's Health Research Network (Project #SDR-10-012). The views expressed in this article are those of the authors and do not represent the views of the VA or the U.S. Government.

Funding Information:
Supported by resources of the Department of Veterans Affairs, Veterans Health Administration (VHA) and was based, in part, on prior research conducted by the Evidence-based Synthesis Program (ESP) site located at the Minneapolis VA Healthcare System, Minneapolis, Minnesota, funded by the VHA Office of Research and Development, Quality Enhancement Research Initiative (VA ESP Project #09-009). Dr. Yano's effort was supported by a VA HSR&D Senior Research Career Scientist Award (Project #RCS 05-195). Dr. Klap's effort was covered by the VA Women's Health Research Network (Project #SDR-10-012). The views expressed in this article are those of the authors and do not represent the views of the VA or the U.S. Government. Supported by resources of the Department of Veterans Affairs, Veterans Health Administration (VHA) and was based, in part, on prior research conducted by the Evidence-based Synthesis Program (ESP) site located at the Minneapolis VA Healthcare System, Minneapolis, Minnesota, funded by the VHA Office of Research and Development, Quality Enhancement Research Initiative (VA ESP Project #09-009). Dr. Yano's effort was supported by a VA HSR&D Senior Research Career Scientist Award (Project #RCS 05-195). Dr. Klap's effort was covered by the VA Women's Health Research Network (Project #SDR-10-012). The views expressed in this article are those of the authors and do not represent the views of the VA or the U.S. Government. The authors gratefully acknowledge the assistance of Nancy Greer, PhD, ESP Program Manager for the Minneapolis VA Medical Center. Dr. Danan had full access to all the data in the study and takes full responsibility for the integrity of the data and the accuracy of the data analysis. Supported by resources of the Department of Veterans Affairs, Veterans Health Administration (VHA) and was based, in part, on prior research conducted by the Evidence-based Synthesis Program (ESP) site located at the Minneapolis VA Healthcare System, Minneapolis, Minnesota, funded by the VHA Office of Research and Development, Quality Enhancement Research Initiative (VA ESP Project #09-009). Dr. Yano's effort was supported by a VA HSR&D Senior Research Career Scientist Award (Project #RCS 05-195). Dr. Klap's effort was covered by the VA Women's Health Research Network (Project #SDR-10-012). The views expressed in this article are those of the authors and do not represent the views of the VA or the U.S. Government.

Publisher Copyright:
© 2019

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