PROPEL: implementation of an evidence based pelvic floor muscle training intervention for women with pelvic organ prolapse: a realist evaluation and outcomes study protocol

Abstract

BackgroundPelvic Organ Prolapse (POP) is estimated to affect 41%–50% of women aged over 40. Findings from the multi-centre randomised controlled “Pelvic Organ Prolapse PhysiotherapY” (POPPY) trial showed that individualised pelvic floor muscle training (PFMT) was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. However, provision of PFMT for prolapse continues to vary across the UK, with limited numbers of women’s health physiotherapists specialising in its delivery. Implementation of this robust evidence from the POPPY trial will require attention to different models of delivery (e.g. staff skill mix) to fit with differing care environments.MethodsA Realist Evaluation (RE) of implementation and outcomes of PFMT delivery in contrasting NHS settings will be conducted using multiple case study sites. Involving substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT and how these lead to service change. The RE will track how implementation is working; identify what influences outcomes; and, guided by the RE-AIM framework, will collect robust outcomes data. This will require mixed methods data collection and analysis.Qualitative data will be collected at four time-points across each site to understand local contexts and decisions regarding options for intervention delivery and to monitor implementation, uptake, adherence and outcomes. Patient outcome data will be collected at baseline, six months and one year follow-up for 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). An economic evaluation will assess the costs and benefits associated with 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.DiscussionStudy of the implementation of varying models of service delivery of PFMT across contrasting sites combined with outcomes data and a cost effectiveness analysis will provide insight into the implementation and value of different models of PFMT service delivery and the cost benefits to the NHS in the longer term.

Implementing pelvic floor muscle training for women with pelvic organ prolapse: a realist evaluation of different delivery models

“…PROPEL project aimed to maximise the delivery of PFMT to women with prolapse. The precise format and setting of PFMT delivery was expected to be determined locally by individual sites during the service planning stage [8]. The sites were asked to develop their bespoke models of service delivery through local stakeholder engagement i.e.…”

“…These 'mesh implants' are now known to be associated with significant complications such as pain and erosion [3,5], resulting in their use being suspended in Scotland in 2014 [3] and in the rest of the UK in 2018. However, awareness of POP and conservative treatment options is poor among women [6] and healthcare professionals [7,8].…”

“…With these gaps in knowledge, the PROPEL project was designed to maximise the delivery of effective PFMT for women with prolapse through the study of its implementation in five diverse real-world settings [8]. This involved developing different service delivery models, such as using different staff skill mixes to deliver PFMT, with the format and setting of delivery being determined by local clinical and managerial teams.…”

“…It was overseen by an independent steering committee comprised of specialist physiotherapists, nurses and women with POP. We conducted a realist, outcome and economic evaluation of the implementation of PFMT using different delivery models (see Maxwell et al 2017 [ 8 ] for full methods). No changes or deviations were made from the published protocol.…”

An International Classification of Function, Disability and Health (ICF)-based investigation of movement impairment in women with pelvic organ prolapse

“…Despite the interactive role of the PFM in the motor control and core stability system, studies have isolated their investigations mainly to the strength aspect of the PFM during training and its association with pathology, without further definition of the movement impairment and how it fits into a holistic approach (Maxwell et al 2017). Although associations have been found between activation of the PFM and the abdominal muscles, further investigation into the specific muscle roles and interactions have not been done (Sapsford et al 2001).…”