Abstract

BACKGROUND: A core outcome set (COS) is required to address inconsistencies in outcome reporting in chronic pelvic pain (CPP) trials. OBJECTIVES: Evaluation of reported outcomes and selected outcome measures in CPP trials by producing a comprehensive inventory to inform a COS. SEARCH STRATEGY: Systematic review of RCT identified from Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and MEDLINE databases. SELECTION CRITERIA: RCT assessing efficacy and safety of medical, surgical and psychological interventions for women with idiopathic CPP. DATA COLLECTION AND ANALYSIS: Two independent researchers extracted outcomes and outcome measures. Similar outcomes were grouped and classified into domains to produce a structured inventory. MAIN RESULTS: Twenty-four trials were identified including 136 reported outcomes and outcome measures. Rates of reporting outcomes varied (4-100%), pelvic pain was the most frequently reported outcome (100%). All trials reported the pain domain however, only half reported quality of life, clinical effectiveness and adverse events. No differences in outcome reporting were observed in five high-quality trials (21%). Univariate analysis demonstrated an association between quality of outcome reporting and methodological quality of studies (rs =0.407, p = 0.048). CONCLUSION: There is wide variation in reported outcomes and applied outcome measures in CPP trials. While a COS is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain. These include: pain (pelvic pain, dyspareunia, dysmenorrhoea), life impact (quality of life, emotional functioning, physical functioning), clinical effectiveness (efficacy, satisfaction, cost effectiveness, return to daily activities) and adverse events (surgical, perioperative observations, non-surgical).