V Ghai1,2, V Subramanian1, H Jan1, V Pergialiotis3, R Thakar4, S K Doumouchtsis1,2,3,5. 1. Department of Obstetrics and Gynaecology, Epsom & St Helier University Hospitals NHS Trust, London, UK. 2. St George's University of London, London, UK. 3. Laboratory of Experimental Surgery and Surgical Research N.S. Christeas, Athens University Medical School, Athens, Greece. 4. Department of Urogynaecology, Croydon University Hospital NHS Trust, London, UK. 5. American University of the Caribbean, School of Medicine, Pembroke Pines, FL, USA.
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.
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.
Authors: Michael P Rimmer; Ruth A Howie; Richard A Anderson; Christopher L R Barratt; Kurt T Barnhart; Yusuf Beebeejaun; Ricardo Pimenta Bertolla; Siladitya Bhattacharya; Lars Björndahl; Pietro Bortoletto; Robert E Brannigan; Astrid E P Cantineau; Ettore Caroppo; Barbara L Collura; Kevin Coward; Michael L Eisenberg; Christian De Geyter; Dimitrios G Goulis; Ralf R Henkel; Vu N A Ho; Alayman F Hussein; Carin Huyser; Jozef H Kadijk; Mohan S Kamath; Shadi Khashaba; Yoshitomo Kobori; Julia Kopeika; Tansu Kucuk; Saturnino Luján; Thabo Christopher Matsaseng; Raj S Mathur; Kevin McEleny; Rod T Mitchell; Ben W Mol; Alfred M Murage; Ernest H Y Ng; Allan Pacey; Antti H Perheentupa; Stefan Du Plessis; Nathalie Rives; Ippokratis Sarris; Peter N Schlegel; Majid Shabbir; Maciej Śmiechowski; Venkatesh Subramanian; Sesh K Sunkara; Basil C Tarlarzis; Frank Tüttelmann; Andy Vail; Madelon van Wely; Mónica H Vazquez-Levin; Lan N Vuong; Alex Y Wang; Rui Wang; Armand Zini; Cindy M Farquhar; Craig Niederberger; James M N Duffy Journal: Hum Reprod Open Date: 2022-03-16