Title: Implementation of an evidence based pelvic floor muscle training intervention for women with pelvic organ prolapse (PROlapse and PFMT: implementing Evidence Locally - PROPEL)
Funder: Chief Scientist Office, Scotland

Abstract: Pelvic Organ Prolapse (POP) is estimated to affect 41%-50% of women aged over 40(1-2). The Pelvic Organ Prolapse Physiotherapy (POPPY) trial was a multi-centre randomised controlled trial of the effectiveness and cost-effectiveness of individualised pelvic floor muscle training (PFMT) compared to a lifestyle advice leaflet in newly-diagnosed women with stages I- III POP (3). Individualised PFMT was effective in reducing symptoms of prolapse, provided improvements in quality of life and showed clear potential to be cost-effective. Despite this evidence, provision of PFMT for POP continues to vary across the UK, and may not be helped by the limited numbers of physiotherapists with specialist training in pelvic floor dysfunction/women’s health (4-5). Implementation of this robust evidence which will be of benefit to large numbers of women will require attention to different models of delivery to fit with differing care environments. Research is required to support the implementation of PFMT as a first line treatment for POP. The opportunity also exists to examine the longer term treatment outcomes of original trial participants. This project aims to study implementation and outcomes of different models of delivery to increase service provision of PFMT across contrasting NHS sites; and to use linked healthcare data for longer term follow up of treatment outcomes for original POPPY trial participants. Design: Realist Evaluation based on multiple case studies of implementation and outcomes of PFMT delivery in 3 contrasting NHS settings. A Realist Evaluation (RE) (6) with substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT (e.g. using different skills mixes and numbers of appointments) and how these lead to service change. The RE will track how implementation is working; understand what influences outcomes; and guided by the RE-AIM (7) framework will collect robust outcomes data. This will require mixed methods data collection and analysis. Setting: Specialist women's health services in three sites: Glasgow (large university hospital, POPPY trial centre), Leicester (large university hospital, non-POPPY centre) and Caithness/Inverness (rural, non-POPPY centre). Methods: Qualitative data will be collected at 4 time-points across each site to establish an understanding of local contexts and decisions regarding options for delivery of PFMT and to monitor implementation, up-take, adherence and outcomes. Round 1 and Round 2 will track local decisions on 'how to implement PFMT services', and elicit their 'theories of change'. Qualitative data will be collected at meetings (n=3 per site) and from interviews (8-10 per site per round) with managers/service leads/consultants/staff with potential to deliver PFMT. Training to deliver PFMT will be given to identified staff. Round 3 (Implementation: How is it working?) and Round 4 (Post-implementation: Did it work?) will involve meetings (n=2) and interviews with managers/service leads/consultants, staff delivering PFMT/women receiving PFMT (n=8-10 staff and 8 women per site per round). Outcomes: Patient outcomes used in the POPPY trial(3) will be collected at baseline, six months and up to one year follow-up for up to 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS)(8). Secondary outcome measures are: quality of life EQ-5D-5L(9); prolapse severity (POP-Q)(10); need for further treatment. An economic evaluation will assess the costs and benefits associated with the different delivery models taking account of further health care resource use by the women. Cost data will be combined with the primary outcome in a cost effectiveness analysis and the EQ-5D 5L data in a cost utility analysis for each of the different models of delivery. Longer term follow-up of the original POPPY trial participants will be undertaken using record linkage of hospital and outpatient datasets. 1. Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. American Journal of Obstetrics & Gynecology 2002; 186(6):1160-1166. 2. Swift SE. The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. American Journal of Obstetrics & Gynecology 2000; 183(2):277-285. 3. Hagen S, Stark, Glazener C, Dickson S, Barry , Elders A, et al. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. The Lancet 2014, Volume 383, Issue 9919, pp796 – 806. 4. Hagen S, Stark D, Cattermole D. A United Kingdom-wide survey of physiotherapy practice in the treatment of pelvic organ prolapse. Physiotherapy 2004 Mar;90(1):19-26. 5. Hagen S. A survey of prolapse practice in UK women’s health physiotherapists: what has changed in the last decade? (unpublished report of 2 surveys conducted in 2002 and 2013). 6. Pawson R, Tilley N. (1997) Realistic evaluation. Sage: London. 7. Glasgow RE, Vogt TM, Boles SM. (1999) Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. 8. Hagen S, Glazener C, Sinclair L, Stark D, Bugge C. Psychometric properties of the Pelvic Organ Prolapse Symptom Score (POP-SS). BJOG: an International Journal of Obstetrics and Gynaecology. 2009a; 116: 25-31. 9. EQ-5D-3L User Guide Version 5.0 October 2013 10. C Persu, CR Chapple, V Cauni, S Gutue, and P Geavlete Pelvic Organ Prolapse Quantification System (POP–Q) – a new era in pelvic prolapse staging. J Med Life. Feb 15, 2011; 4(1): 75–81

Lay abstract: Pelvic Organ Prolapse (POP) can affect up to half the female population aged over 40. Surgery has been the main treatment option for most women but many women end up with an additional prolapse and around 30% of women have repeat surgery. A recent large scale trial has shown that pelvic floor muscle training (PFMT) is an effective and potentially cost effective treatment and should be recommended as the first treatment option. It showed that using PFMT improved prolapse symptoms and also that women who used PFMT had less further treatment. We know that running a trial can be different from real life practice. We also know that having evidence that something works does not always mean that it is put into practice. There can be many reasons for this within the NHS. PFMT is currently not widely available across the NHS and there are a limited number of physiotherapists specialising in women’s health and prolapse. To provide PFMT to the large numbers of women who would benefit from it we need to try out other ways of delivering it. This could involve training other healthcare professionals to deliver PFMT; and seeing how many sessions a woman needs with a PFMT specialist to be able to do it properly by herself. We want to understand how PFMT can be provided in the real world of the NHS and in the context of local services. Different sites will have access to different resources and their care pathways may be different. We need to allow local NHS sites to determine how they can best deliver PFMT. We will suggest using different types of staff and different numbers of sessions for women but they may have other ideas that can help give PFMT to the women who need it. We can learn important lessons from sites that are trying out different ways to deliver PFMT to lots more women and we can share this knowledge across the NHS - to let other areas know ‘what works’. We will work with 3 NHS sites in the UK to increase their provision of PFMT for women with prolapse. Sites will determine how they want to achieve this and we will provide training to new groups of staff to deliver PFMT. We will study their decisions, monitor how their new services are working and any problems that arise, and help services make changes if needed. We will study what the benefits (outcomes) are for the service, and most importantly for the women receiving PFMT. This will involve observing meetings and doing interviews with staff, NHS managers, and women who are referred to PFMT. We want to be sure that however local services decide to deliver PFMT does not affect the outcomes for women that we would expect. We hope to recruit around 120 women who will receive PFMT across our 3 study sites (Glasgow, Leicester and Caithness/Inverness) and to follow their progress and outcomes. We will use the same outcome measures that were used in the original trial so that we can know whether these new ways of delivering the PFMT still lead to improvements in symptoms for women. We will measure women's perceptions of their prolapse symptoms and how it affects their quality of life before and after PFMT; whether the severity of their prolapse has changed; and whether they need further prolapse treatment. We will assess the costs and benefits of different delivery methods. Finally, we will follow up original trial participants (through existing NHS datasets)to see if they have had further treatment, or if PFMT has indeed prevented surgery in the longer term.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH