A Patient-reported outcome measure for PRolApse, Incontinence and meSh complication surgEry: The APPRAISE study

Research Question: Is a new patient-reported outcome measure (PROM) to assess surgical interventions for pelvic organ prolapse (POP), stress urinary incontinence (SUI) and mesh complications reliable, valid, responsive and acceptable for use in clinical trials and other evaluation studies? Background: Different surgical interventions are available to treat POP and SUI. Some use polypropylene mesh which has led to complications requiring further corrective surgery and adversely affected women’s quality of life and experiences of using urogynaecology services. A surgical intervention specific PROM, which captures experience post-surgery for POP, SUI and mesh complications is lacking. Aim and objectives: To develop a psychometrically validated PROM to compare outcomes for the different surgical approaches to treat POP, SUI and mesh complications that captures the full range of effects on quality of life, including patient experience, and long-term complications, which can also be used in economic evaluations. Barriers and facilitators to its implementation in clinical effectiveness studies will also be assessed. Sample: Women aged 16 years and older who have undergone surgical intervention for POP or SUI with or without mesh, and women with mesh complications seeking its removal. Recruitment will take place across NHS secondary care urogynaecology services with diverse populations (urban, inner city, coastal, rural) and Mesh Removal Centres. Methods: A mixed-method design across seven work packages, using established frameworks for PROM development and co-developed with patient expertise throughout. We will 1. review the literature, undertake a secondary data analysis of a subset of 25 highly relevant interview data generated in the PURSUE Study (NIHR202450), and interview up to a further 30 women to inform the framework and content of the PROM. The first version will then be created on paper and electronically, giving women a choice about which mode they would like to complete; 2. conduct a cognitive interviewing exercise with 30 women and translatability exercise with 12 women to ensure the PROM is acceptable and has cross-cultural applicability; 3. administer the PROM in two patient surveys to establish its psychometric properties in the context of short-term surgical outcomes; 4. administer the PROM in two further surveys to establish its psychometric properties in the context of long-term surgical outcomes and a clinical trial; 5. develop a preference-based version enabling the calculation of quality adjusted life years (QALYs); 6. gather qualitative evidence to understand what may inhibit or facilitate its use in clinical effectiveness studies; 7. pilot test the PROM on the Outcome and Registries Platform hosted by NHS England to ensure this web-based version is psychometrically robust and to identify any barriers and facilitators to its use, prior to the PROMs wider implementation across the NHS. Timelines for delivery: Three years Anticipated impact and dissemination: In the short-term a psychometrically robust PROM will be produced in paper and electronic formats, using plain English language. It will be freely available for use by patients and healthcare professionals to assess the short- and long-term outcomes and experiences of surgery for SUI, POP and mesh complications. The preference-based version will support policymakers to identify optimal treatments. Findings will be shared across social and mainstream media, at healthcare conferences, in high-quality journals and to third sector parties. A YouTube video and visual aids will facilitate dissemination to patients and the public, and a user manual for healthcare professionals will encourage use in clinical effectiveness studies. In the longer-term, NHS Digital will adopt our PROM and it can be easily translated into other languages increasing its reach and impact.