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

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 randomised controlled trials (RCTs) identified from Cochrane Central Register of Controlled Trials (CENTRAL), Embase and MEDLINE databases. Selection criteria RCTs 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%) 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). Conclusion 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). Tweetable abstract There is significant variation in outcome reporting in CPP trials. Our systematic review forms the basis for the development of a core outcome set.

Automated summary

There is significant variation in outcome reporting in chronic pelvic pain trials. The systematic review provides basis for the development of a core outcome set. It is recommended to use commonly reported outcomes in the domains of pain, life impact, clinical effectiveness, and adverse events while the core outcome set is being developed.