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 (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 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.
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Introduction and hypothesis
Qualitative research has an increasing role in the development of core outcome sets (COS) adding patient perspectives to the considerations of core outcomes. We aimed to identify priorities of women with experience of chronic pelvic pain (CPP).
Methods
The search strategy was a systematic review of qualitative studies identified from Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, MEDLINE and PsycInfo databases. Selection criteria were qualitative studies exploring the experience of women with CPP. Two independent researchers extracted data and summarized findings using thematic analysis. A CERQual assessment was performed to assess the confidence of review findings.
Results
We identified pertinent issues affecting women with CPP including the lack of holistic care, influence of psychosocial factors and the impact of pain on quality of life. Five meta-themes central to delivering a patient-centred approach were highlighted: acceptance of pain, quality of life, management of CPP, communication and support. Management of CPP was the most commonly reported meta-theme across seven studies and half of studies reported quality of life, management, communication and support. Quality appraisal of included studies identified only a single study that met all CASP (Critical Appraisal Skills Programme) criteria. There was high confidence in the evidence for acceptance of pain, quality of life and communication meta-themes.
Conclusion
Meta-themes revealed by this review should be considered as a priority and reflected in outcomes reported by future studies evaluating interventions for CPP. In addition, these themes should be considered by clinicians managing women with CPP.
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