Patient-Reported Outcome Measures used in Randomized Controlled Trials Following Surgical Intervention for Endometriosis

Endometriosis, a chronic inflammatory condition, affects up to 10% of reproductive-age people1. The annual cost-of-illness burden attributed to medications, treatment, and time away from work for endometriosis has been estimated to be approximately $15,000 per affected person in the United States2 and $20,000 per affected person in Australia. 3 Although rarely life-threatening, endometriosis can significantly affect patients’ quality of life (QoL). Bothersome to debilitating symptoms such as pelvic pain, dyspareunia, dysuria, dyschezia and infertility indicate treatment of affected patients. The goal in endometriosis treatment, therefore, is to provide relief of patients’ pain symptoms and improvement of QoL according to patient-reported treatment goals and outcomes. Outcomes, assessed systematically using patient-reported outcome measure (PROM) instruments, allow clinicians and investigators to measure symptoms and determine treatment outcomes that matter to patients.

PROMs are instruments that collect information directly from patients about how they feel or function without interpretation by healthcare or other professionals. 4 The use of PROMs provides valuable information regarding the impact of the disease and chosen treatment on patients’ health and QoL. Such instruments can identify specific areas of a patient's life that are most affected by endometriosis. When uniformly used across studies, these tools may facilitate the comparison of results, draw meaningful conclusions, and advance our understanding of the disease and treatment effectiveness.

Standardization of reporting of surgical outcomes after endometriosis surgery has been proposed. 5 Furthermore, a core outcomes set has been developed for outcome selection, collection and reporting for randomized controlled trials (RCTs) and systematic reviews that evaluate treatments for endometriosis. 6 Despite these, there is no consensus on which specific PROMs to use in research and clinical settings to measure endometriosis-related patient outcomes. 7-9 The primary objective of this structured review from the AAGL Practice Guideline group was to evaluate and synthesize the existing evidence on the PROMs used by high-quality randomized controlled trials (RCTs) that assessed and report patient outcomes after surgical interventions for endometriosis. Findings from this review can provide an interim list of outcome measure tools for investigators until a consensus can be obtained from an expert panel in a separate rigorous process.

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