Inadequacies in Reporting and Representation of Sex and Gender in Randomized Clinical Trials of Chronic Pain Interventions: an ACTTION COPASETIQ Review

The concepts of sex and gender are often incorrectly used in health research. Sex is a biological construct while gender is a social construct, but both may have differential effects on the outcome of pain treatments. To better understand how chronic pain trials collect, report, and analyze data regarding sex and gender we conducted a targeted systematic review of randomized clinical trials of pharmacological and non-pharmacological treatments for various chronic pain conditions. Across 6 pain specialty journals, 2,883 abstracts from papers published 2016-2021 were screened, and 73 manuscripts ultimately reviewed for reporting and analysis of sex and gender. All 73 studies collected information on sex, yet only 16 papers (21.9%) reported how they collected this information (e.g., self-report, medical record review). No studies collected information on gender, and 30 papers (41.1%) used the terms sex and gender interchangeably. Across studies, the average distribution of females and males was 62% and 38%, respectively. None of the papers reported study outcomes disaggregated by sex (e.g., subgroup analysis), and only 21 studies (28.8%) included sex as a covariate in their analyses. These findings indicate inadequate reporting, poor distinction of sex and gender, poor representation of different genders, and a lack of exploration of or accounting for potential sex differences in outcomes. Given that this timespan (2016-2021) may not reflect growing awareness of the distinction between sex and gender and updated reporting recommendations (e.g., SAGER), we are currently expanding our review to include papers published through 2023.