Non-surgical interventions for pelvic organ prolapse in women: a component network meta-analysis and cost-effectiveness analysis - Protocol (version 1.1)

Abstract

Background: Pelvic organ prolapse (POP) is the descent of a woman's womb, bladder or rectum into the vagina. Up to 1 in 10 women have POP, which can be caused by childbirth, obesity, surgical removal of the womb or ageing. Women with POP have emphasised that the condition is life-altering due to symptoms, such as incontinence, that affect daily activities, quality of life, body image and mental health. Surgery for POP is twice as common as incontinence surgery, costing the NHS £45 million per year. The National Institute for Health and Care Excellence (NICE) recommends women try non-surgical treatments for POP (e.g. pelvic floor exercises or pessaries) before surgery. However, in our two patient and public involvement workshops women with POP told us that after clinical guidance they remain unsure what non-surgical treatments are available, and which work best. As the number of people with POP is predicted to increase due to an ageing population, it is important to know which non-surgical treatments work and are value for money. This will allow women to make informed choices about their care and the NHS can make best use of its resources. We are applying for funding to carry out this research. Methods: In a workshop, women with POP from different ethnic and socioeconomic backgrounds discussed what research questions were most relevant to them. They wanted to know what available treatments (from the NHS and elsewhere) were most effective. A statistical method called 'component network meta-analysis' will bring together data from all relevant existing clinical studies to compare treatments and find out how well they work (e.g. do they reduce the severity of prolapse and improve quality of life?). We will use these data to see which non-surgical treatments make best use of NHS resources. This means we will have the best available evidence to inform women, clinicians and policy makers about which non-surgical treatments are best. Patient and public involvement: Patient and public involvement has been central to developing the proposed work. We openly advertised for and recruited two patient co-applicants to help control and influence decision making during the development of this proposed research project. We also involved women with lived experiences of POP, including our patient co-applicants, in a survey and two workshops that have significantly shaped our aims, objectives and helped identify our key outcomes. If funded, we will recruit up to 10 women to an advisory group to provide different perspectives that will help shape the research whilst it is being planned and undertaken. We will provide contributors with training in key methods (e.g. systematic review) designed for lay audiences, so they are better able to shape the work. We will engage the group in all aspects of the work, regularly meeting and sharing progress updates. We will work with the group to discuss their experience of care and how this should determine the health economic analyses. Group members will help us interpret findings and to develop key messages for dissemination that will maximise their public reach. How the findings will be shared: We will share our findings as journal articles and at academic conferences. As identified by workshop discussions, research findings will be shared on appropriate media platforms (e.g. BBC Radio). We will further explore best approaches to share research findings with our planned patient advisory group.