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

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 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.

Evaluation of clinical practice guidelines (CPG) on the management of female chronic pelvic pain (CPP) using the AGREE II instrument

“…The detrimental impact of CPP on quality of life outcomes has been described and identified as a priority for women with CPP [18]. Despite this, quality of life assessment is only reported by half of RCTs evaluating treatments for CPP [5]. Our findings demonstrated that all guidelines referred to the measurement of quality of life; however, there was no recommendation regarding which measurement instrument to utilize.…”

“…The shortage of primary research supporting the management of women with CPP may prohibit the development of useful guidelines [18]. Furthermore, the quality of existing RCTs evaluating CPP interventions is variable with significant variability in outcome selection and reporting [5]. A working group within CHORUS is currently in the progress of establishing core outcome sets (COS) in CPP.…”

“…Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women [4]. Furthermore, the variation in outcome reporting of trials evaluating interventions has prevented the synthesis of data to identify effective treatments and draw clinically relevant conclusions in the context of guideline formation [5].…”

A meta-synthesis of qualitative literature on female chronic pelvic pain for the development of a core outcome set: a systematic review

“…Pertinent issues related to management of conditions may be overlooked and not reflective of patient priorities. For example, a systematic review of reported outcomes in therapeutic interventions in CPP demonstrated that quality of life was only reported by half of trials [23]. However, our study indicated that poor quality of life was a prevalent and reoccurring theme for women suffering with CPP.…”

A review of the Cochrane COVID-19 Study Register reveals inconsistency in the choice and measurement of SARS-CoV-2 infection outcomes in prevention trials

“…Dyspnoea/shortness of breath/ been reported in areas such as delirium, hearing loss, chronic pelvic pain, and breast reconstruction, with studies concluding the need for consensus on outcomes and their associated measures for use in future clinical trials in these disease areas. [19][20][21][22] To our knowledge, this is the first study to examine how SARS-CoV-2 infection outcomes are measured in registered COVID-19 prevention trials. However, there are some methodological limitations.…”