Reporting of sex and gender in clinical trials of opioids and rehabilitation in military and Veterans with chronic pain

Abstract

Introduction: This study assesses the extent to which published research on pain management in Veterans has considered sex and gender differences in the design and reporting of results. Methods: The study identified randomized clinical trials (RCTs) that included active duty military or Veterans with non-cancer pain who were treated with rehabilitation and/or opioid(s) interventions (vs. any control group) published from January 2000 to February 2021. Authors extracted data on the inclusion of sex/gender in design and reporting using the Sex and Gender Equity in Research guidelines (SAGER) and Sex and Gender Methods Review guidelines to assess sex and gender reporting in the included RCTs. Results: The study included 21 RCTs. Reporting of sex and/or gender according to SAGER guidelines indicated all 21 RCTs did not specify any sex and/or gender information in the title/abstract, introduction, methods, results, or discussion. The reporting of sex and/or gender according to Sex and Gender Methods Review guidelines indicated 21 of 21 RCTs did not analyze to identify sex and/or gender differences in the literature review, research question(s), study design, analysis, or interpretation sections. Discussion: Despite expectations of important sex or gender differences in the effects of opioid or rehabilitation interventions for chronic pain in active duty military personnel or Veterans, no identified RCTs published over a 21-year period adequately reported or analyzed data in accordance with current standards for considering sex and gender. Failure to consider sex and gender in design, analysis, and reporting limits advancement of understanding sex/gender differences in pain management through research.