Patient-Reported Outcome Measures Used in Randomized Controlled Trials Following Surgical Intervention for...

Area of Science:

• Gynecology
• Surgical Innovation
• Patient-Reported Outcomes

Background:

• There is no consensus on patient-reported outcome measure (PROM) instruments for endometriosis surgery.
• Randomized controlled trials (RCTs) evaluating surgical endometriosis treatments utilize various PROMs.

Approach:

• A structured review identified RCTs using PROMs for quality of life, pain, and sexual, bowel, or bladder function.
• Searches were conducted in Ovid MEDLINE, Embase, and Cochrane Library from 2000 to July 2022.
• Nineteen studies involving 2089 participants and 16 distinct PROMs were analyzed.

Key Points:

• Quality of life was assessed using Endometriosis Health Profile-30/5, SF-36/12, and EQ-5D.
• Bowel function PROMs included Knowles-Eccersley-Scott-Symptom Questionnaire and Cleveland Clinic Fecal Incontinence Severity Scoring System.
• Bladder function PROMs comprised Bristol Female Lower Urinary Tract Symptoms and International Prostate Symptom Score.
• Sexual function was evaluated by Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire and Sexual Activity Questionnaire.
• Visual analog scale was the primary PROM for pain assessment.
• Use of multiple PROMs per study increased after 2015.

Conclusions:

• A wide array of PROMs are employed in surgical endometriosis RCTs.
• High-quality trials demonstrate specific PROM preferences for different health domains.
• Standardization of PROM selection remains an area for future consensus.