A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set.

Abstract

A core outcome set (COS) is required to address inconsistencies in outcome reporting in chronic pelvic pain (CPP) trials. Evaluation of reported outcomes and selected outcome measures in CPP trials by producing a comprehensive inventory to inform a COS. Systematic review of randomised controlled trials (RCTs) identified from Cochrane Central Register of Controlled Trials (CENTRAL), Embase and MEDLINE databases. RCTs assessing efficacy and safety of medical, surgical and psychological interventions for women with idiopathic CPP. Two independent researchers extracted outcomes and outcome measures. Similar outcomes were grouped and classified into domains to produce a structured inventory. Twenty-four trials were identified including 136 reported outcomes and outcome measures. Rates of reporting outcomes varied (4-100%) and 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 (r_s  = 0.407, P = 0.048). There is wide variation in reported outcomes and applied outcome measures in CPP trials. While a COS is being developed and implemented, we propose the interim use of commonly reported outcomes in each domain: 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, nonsurgical). There is significant variation in outcome reporting in CPP trials. Our systematic review forms the basis for the development of a core outcome set.