Systematic reviews (SRs) have the potential to contribute uniquely to the evaluation of sex and gender differences (termed “sex effects”). This article describes the reporting of sex effects by SRs on interventions for depression, type 2 diabetes mellitus, and chronic pain conditions (chronic low back pain, knee osteoarthritis, and fibromyalgia). It includes SRs published since 1 October 2009 that evaluate medications, behavioral interventions, exercise, quality improvement, and some condition-specific treatments. The reporting of sex effects by primary randomized, controlled trials is also examined. Of 313 eligible SRs (86 for depression, 159 for type 2 diabetes mellitus, and 68 for chronic pain), few (n = 29) reported sex effects. Most SRs reporting sex effects used metaregression, whereas 9 SRs used subgroup analysis or individual-patient data meta-analysis. The proportion of SRs reporting the sex distribution of primary studies varied from a low of 31% (n = 8) for low back pain to a high of 68% (n = 23) for fibromyalgia. Primary randomized, controlled trials also infrequently reported sex effects, and most lacked an adequate sample size to examine them. Therefore, all SRs should report the proportion of women enrolled in primary studies and evaluate sex effects using appropriate methods whenever power is adequate.
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Author, Article and Disclosure Information
Affiliations:
From Durham Veterans Affairs Medical Center and Duke University School of Medicine, Durham, North Carolina; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.
Acknowledgment: The authors thank Megan Van Noord for help with the literature search and retrieval and Liz Wing for editorial assistance.
Grant Support: By the Veterans Affairs Office of Academic Affiliations (fellowship support TPM 21-022; Dr. Duan-Porter) and the Veterans Health Administration Health Services Research & Development (Career Development Award 13-263; Dr. Goldstein).
Disclosures: Dr. Duan-Porter reports grants from the U.S. Department of Veterans Affairs during the conduct of the study. Dr. Goldstein reports grants from U.S. Department of Veterans Affairs and Veterans Affairs Health Services Research & Development Service during the conduct of the study. Dr. Clowse reports other support (funding from the U.S. Department of Veterans Affairs to members of the author group) during the conduct of the study and personal fees (UCB Pharma) and grants (Pfizer and Janssen) outside the submitted work. Dr. Allen LaPointe reports other support (Center for Health Services Research in Primary Care [CIN 13-410] on Veterans Affairs-funded project ESP 09-010) during the conduct of the study. Dr. Williams reports grants from Veterans Affairs Health Services Research & Development Service during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2877.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol and data set: Available at www.hsrd.research.va.gov/publications/esp. Statistical code: Not relevant.
Corresponding Author: Wei Duan-Porter, MD, PhD, Durham Veterans Affairs Medical Center Health Administration Health Services Research & Development, 411 West Chapel Hill Street, Suite 600, NC 27701; e-mail, wei.
Current Author Addresses: Drs. Duan-Porter and McDuffie, Ms. Masilamani, and Mr. Nagi: Durham Veterans Affairs Medical Center, Health Services Research & Development, 411 West Chapel Hill Street, Suite 600, NC 27701.
Drs. Goldstein and Gierisch: Durham Veterans Affairs Medical Center, Health Services Research & Development, 508 Fulton Street, Durham, NC 27705.
Ms. Hughes: University of North Carolina at Chapel Hill, Campus Box 7200, Chapel Hill, NC 27599.
Dr. Clowse: Duke University School of Medicine, 200 Trent Drive, 7 Baker House, Durham, NC 27710.
Dr. Klap: Veterans Affairs West Los Angeles Medical Center, 11301 Wilshire Boulevard, Building 206, Room 231, Los Angeles, CA 90073.
Dr. Allen LaPointe: Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27715.
Dr. Williams: Durham Veterans Affairs Medical Center, Health Services Research & Development, 411 West Chapel Hill Street, Suite 500, Durham, NC 27701.
Author Contributions: Conception and design: W. Duan-Porter, J.R. McDuffie, R.S. Klap, N.M. Allen LaPointe, J.M. Gierisch, J.W. Williams.
Analysis and interpretation of the data: W. Duan-Porter, K.M. Goldstein, J.M. Hughes, M.E.B. Clowse, R.S. Klap, N.M. Allen LaPointe, J.M. Gierisch, J.W. Williams.
Drafting of the article: W. Duan-Porter, J.R. McDuffie, K.M. Goldstein.
Critical revision of the article for important intellectual content: W. Duan-Porter, K.M. Goldstein, J.R. McDuffie, M.E.B. Clowse, J.W. Williams.
Final approval of the article: W. Duan-Porter, K.M. Goldstein, J.R. McDuffie, M.E.B. Clowse, R.S. Klap, N.M. Allen LaPointe, J.M. Gierisch, J.W. Williams.
Statistical expertise: J.W. Williams.
Obtaining of funding: R.S. Klap, J.M. Gierisch, J.W. Williams.
Administrative, technical, or logistic support: J.R. McDuffie, N.M. Allen LaPointe, A. Nagi, J.M. Gierisch.
Collection and assembly of data: W. Duan-Porter, K.M. Goldstein, J.R. McDuffie, J.M. Hughes, M.E.B. Clowse, R.S. Klap, V. Masilamani, N.M. Allen LaPointe.
This article was published at www.annals.org on 26 April 2016.
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