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Research and Reporting Methods |

Reporting of Sex Effects by Systematic Reviews on Interventions for Depression, Diabetes, and Chronic PainReporting of Sex Effects by Systematic Reviews on Interventions

Wei Duan-Porter, MD, PhD; Karen M. Goldstein, MD, MSPH; Jennifer R. McDuffie, PhD, MPH; Jaime M. Hughes, MPH, MSW; Megan E.B. Clowse, MD, MPH; Ruth S. Klap, PhD; Varsha Masilamani, MBBS; Nancy M. Allen LaPointe, PharmD, MHS; Avishek Nagi, MS; Jennifer M. Gierisch, PhD, MPH; and John W. Williams Jr., MD, MHSc
[+] Article, Author, and Disclosure Information

This article was published at www.annals.org on 26 April 2016.


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.

Requests for Single Reprints: 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.duan-porter@duke.edu.

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.


Ann Intern Med. 2016;165(3):184-193. doi:10.7326/M15-2877
Text Size: A A A

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.

Figures

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Figure 1.

Summary of evidence search and selection.

* 114 of 159 eligible diabetes reviews were fully abstracted. The remaining 45 reviews received a keyword text search and were not further abstracted because of negative search results.

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Appendix Figure.

Primary studies included in the largest eligible SR for key interventions addressing conditions of interest.

SR = systematic review.

* Some reviews included studies with other depressive disorders.

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Figure 2.

Proportion of eligible SRs reporting sex effects for depression and diabetes.

In addition, 2 diabetes reviews reported sex effects for bariatric surgery; 1 depression review examined sex effects for combined medications and psychotherapy; 1 depression review reported on guided self-help; and 2 reviews on chronic low back pain looked at sex effects for medications and pain rehabilitation programs, respectively. No reviews on knee osteoarthritis or fibromyalgia reported sex effects. SR = systematic review.

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Figure 3.

Proportion of eligible SRs reporting sex effects for depression and diabetes from 2010 to 2014.

SR = systematic review.

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Sex effect of interventions in patients with type 2 diabetes mellitus
Posted on September 9, 2016
Tomoyuki Kawada
Nippon Medical School
Conflict of Interest: None Declared
Duan-Porter et al. evaluated sex effects by systematic reviews on interventions for depression, type 2 diabetes mellitus (T2DM), and chronic pain (1). Among them, the authors could analyze 13 reports on sex effects among 159 T2DM reports. Unfortunately, the authors failed to collect an adequate sample size to examine them. I have two concerns on their study

Kautzky-Willer et al. conducted a review on pathophysiology and complications of T2DM with special reference to sex effects (2). The authors recognized that T2DM attenuates the protective effect of the female sex in the development of cardio-vascular and kidney diseases, although endocrine and behavioral factors affect gender inequalities on some complications of T2DM. Krag et al. also assessed sex effect in morbidity and mortality by a follow-up study in patients with T2DM receiving structured personal care against routine care (3). In women, adjusted hazard ratios (HRs) (95% confidence intervals (CIs)) of structured personal care against routine care for any diabetes-related endpoint, diabetes-related death, all-cause mortality and stroke were 0.65 (0.48 - 0.87), 0.70 (0.50-0.96), 0.74 (0.57 -0.97) and 0.59 (0.36 - 0.97), respectively. In contrast, significant HR was not observed in men. On this point, Peters et al. reported meta-analysis for the effect of diabetes on stroke risk with special emphasis on sex effect (4), concluding that the risk of stroke associated with diabetes was predominant in women against men. Namely, the pooled HR (95% CI) of women against men for stroke was 1.27 (1.10 - 1.46). Krag et al. reported 41% reduction of stroke risk in women with diabetes by structured personal care, and this intervention would be useful for increased risk of women with diabetes against men for stroke.

Regensteiner et al. summarized that insulin resistance and abdominal adiposity were predictive of cardiovascular events in women with prediabetes, and the beneficial effects of lifestyle interventions would be more successful in women (5). As there are sex effects on the progress of prediabetes, and interventions in patients withT2DM should also be considered in early stage of T2DM.


Reference

1. Duan-Porter W, Goldstein KM, McDuffie JR, Hughes JM, Clowse ME, Klap RS, et al. Reporting of sex effects by systematic reviews on Interventions for depression, diabetes, and chronic pain. Ann Intern Med. 2016;165:184-93.

2. Kautzky-Willer A, Harreiter J, Pacini G. Sex and gender differences in risk, pathophysiology and complications of type 2 diabetes mellitus. Endocr Rev. 2016;37:278-316.

3. Krag MØ, Hasselbalch L, Siersma V, Nielsen AB, Reventlow S, Malterud K, et al. The impact of gender on the long-term morbidity and mortality of patients with type 2 diabetes receiving structured personal care: a 13 year follow-up study. Diabetologia. 2016;59:275-85.

4. Peters SA, Huxley RR, Woodward M. Diabetes as a risk factor for stroke in women compared with men: a systematic review and meta-analysis of 64 cohorts, including 775 385 individuals and 12 539 strokes. Lancet. 2014;383:1973-80.

5. Regensteiner JG, Golden S, Huebschmann AG, Barrett-Connor E, Chang AY, Chyun D, et al. Sex Differences in the Cardiovascular Consequences of Diabetes Mellitus: A Scientific Statement From the American Heart Association. Circulation. 2015;132:2424-47.
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