Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation
Background: Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A multicentre randomised controlled trial of individualised pelvic floor muscle training found that pelvic floor muscle training was effective in reducing symptoms of prolapse, improved quality of life and s...
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Format: | Article |
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NIHR Journals Library
2020-12-01
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Series: | Health Services and Delivery Research |
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Online Access: | https://doi.org/10.3310/hsdr08470 |
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doaj-8273f6a0833e48d09c74d7769fb4e7fe |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Margaret Maxwell Karen Berry Sarah Wane Suzanne Hagen Doreen McClurg Edward Duncan Purva Abhyankar Andrew Elders Catherine Best Joyce Wilkinson Helen Mason Linda Fenocchi Eileen Calveley Karen Guerrero Douglas Tincello |
spellingShingle |
Margaret Maxwell Karen Berry Sarah Wane Suzanne Hagen Doreen McClurg Edward Duncan Purva Abhyankar Andrew Elders Catherine Best Joyce Wilkinson Helen Mason Linda Fenocchi Eileen Calveley Karen Guerrero Douglas Tincello Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation Health Services and Delivery Research realist evaluation economic evaluation pelvic organ prolapse pelvic floor muscle training implementation re-aim framework |
author_facet |
Margaret Maxwell Karen Berry Sarah Wane Suzanne Hagen Doreen McClurg Edward Duncan Purva Abhyankar Andrew Elders Catherine Best Joyce Wilkinson Helen Mason Linda Fenocchi Eileen Calveley Karen Guerrero Douglas Tincello |
author_sort |
Margaret Maxwell |
title |
Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation |
title_short |
Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation |
title_full |
Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation |
title_fullStr |
Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation |
title_full_unstemmed |
Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluation |
title_sort |
pelvic floor muscle training for women with pelvic organ prolapse: the propel realist evaluation |
publisher |
NIHR Journals Library |
series |
Health Services and Delivery Research |
issn |
2050-4349 2050-4357 |
publishDate |
2020-12-01 |
description |
Background: Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A multicentre randomised controlled trial of individualised pelvic floor muscle training found that pelvic floor muscle training was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. Provision of pelvic floor muscle training for prolapse has continued to vary across the UK, with limited availability of specialist physiotherapists to deliver it. Objectives: This project aimed to study the implementation and outcomes of different models of delivery to increase the service provision of pelvic floor muscle training, and to follow up treatment outcomes for the original trial participants. Design: A realist evaluation of pelvic floor muscle training implementation conducted within three full case study sites and two partial case study sites; an observational prospective cohort study comparing patient-reported outcomes pre and post intervention in all five sites; and a long-term follow-up study linking previous trial participants to routine NHS hospital data. Setting: The setting for the realist evaluation was pelvic floor muscle training service delivery models in three NHS sites. The setting for the patient-reported outcome measures study was pelvic floor muscle training services in five NHS sites. Methods: Realist evaluation qualitative data were collected at four time points in three case study sites to understand the implementation models, uptake, adherence and impact. Interviews involved service managers/leads, consultants, staff delivering pelvic floor muscle training and women receiving pelvic floor muscle training. Main outcomes measures: Patient-reported outcomes were collected at baseline and at 6 and 12 months across five sites, including the Pelvic Organ Prolapse Symptom Score, health-related quality of life (measured using the EuroQol-5 Dimensions, five-level version, questionnaire), prolapse severity (measured using the Pelvic Organ Prolapse Quantification System), urinary incontinence (measured using International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) and need for further treatment. Results: A total of 102 women were recruited to the patient-reported outcome measures cohort study (target, n = 120), and 65 women had matched baseline and 6-month Pelvic Organ Prolapse Symptom Scores. The mean Pelvic Organ Prolapse Symptom Score was 10.18 (standard deviation 5.63) at baseline and 6.98 (standard deviation 5.23) at 6 months, representing a statistically significant and clinically meaningful difference. There was no statistically significant difference between the outcomes obtained from delivery by specialist physiotherapists and the outcomes obtained from delivery by other health-care professionals (mean change in Pelvic Organ Prolapse Symptom Score: –3.95 vs. –2.81, respectively). Services delivered using higher-band physiotherapists only were more costly than services delivered using other staff mixes. The effect of the original pelvic floor muscle training intervention, over a post-intervention period of > 10 years, was a reduction in the odds of any treatment during follow-up (odds ratio 0.61, 95% confidence interval 0.37 to 0.99). The realist evaluation revealed stark differences in implementation. The site with a specialist physiotherapy service resisted change because of perceived threats to the specialist role and concerns about care quality. Pelvic floor muscle training delivery by other health-care staff was easier when there was a lack of any existing specialist service; staff had prior training and interest in pelvic health; staff had support, autonomy, time and resources to deliver pelvic floor muscle training as part of their core role; and surrounding services supported a flow of pelvic floor muscle training referrals. Limitations: The number of available matched pre and post outcomes for women and the lack of Pelvic Organ Prolapse Quantification System examinations were limitations of this study. Conclusions: It is possible to train different staff to effectively deliver pelvic floor muscle training to women. Women’s self-reported outcomes significantly improved across all service models. Training should be adequately tailored to differential skill mix needs. Future work: Future work should include further implementation of pelvic floor muscle training and should include pre- and post-outcome data collection using the Pelvic Organ Prolapse Symptom Score. Study registration: This study is registered as Research Registry 4919. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 47. See the NIHR Journals Library website for further project information. |
topic |
realist evaluation economic evaluation pelvic organ prolapse pelvic floor muscle training implementation re-aim framework |
url |
https://doi.org/10.3310/hsdr08470 |
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doaj-8273f6a0833e48d09c74d7769fb4e7fe2020-12-10T15:28:27ZengNIHR Journals LibraryHealth Services and Delivery Research2050-43492050-43572020-12-0184710.3310/hsdr0847014/04/02Pelvic floor muscle training for women with pelvic organ prolapse: the PROPEL realist evaluationMargaret Maxwell0Karen Berry1Sarah Wane2Suzanne Hagen3Doreen McClurg4Edward Duncan5Purva Abhyankar6Andrew Elders7Catherine Best8Joyce Wilkinson9Helen Mason10Linda Fenocchi11Eileen Calveley12Karen Guerrero13Douglas Tincello14Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UKNursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UKDepartment of Sport, Exercise and Rehabilitation, University of Northumbria, Newcastle upon Tyne, UKNursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UKNursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UKNursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UKDivision of Health Sciences, Faculty of Health Sciences and Sport, University of Stirling, Stirling, UKNursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UKNursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UKDivision of Health Sciences, Faculty of Health Sciences and Sport, University of Stirling, Stirling, UKYunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UKYunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow, UKNursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling, UKDepartment of Urogynaecology, Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UKDepartment of Health Sciences, Centre for Medicine, University of Leicester, Leicester, UKBackground: Pelvic organ prolapse is estimated to affect 41–50% of women aged > 40 years. A multicentre randomised controlled trial of individualised pelvic floor muscle training found that pelvic floor muscle training was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. Provision of pelvic floor muscle training for prolapse has continued to vary across the UK, with limited availability of specialist physiotherapists to deliver it. Objectives: This project aimed to study the implementation and outcomes of different models of delivery to increase the service provision of pelvic floor muscle training, and to follow up treatment outcomes for the original trial participants. Design: A realist evaluation of pelvic floor muscle training implementation conducted within three full case study sites and two partial case study sites; an observational prospective cohort study comparing patient-reported outcomes pre and post intervention in all five sites; and a long-term follow-up study linking previous trial participants to routine NHS hospital data. Setting: The setting for the realist evaluation was pelvic floor muscle training service delivery models in three NHS sites. The setting for the patient-reported outcome measures study was pelvic floor muscle training services in five NHS sites. Methods: Realist evaluation qualitative data were collected at four time points in three case study sites to understand the implementation models, uptake, adherence and impact. Interviews involved service managers/leads, consultants, staff delivering pelvic floor muscle training and women receiving pelvic floor muscle training. Main outcomes measures: Patient-reported outcomes were collected at baseline and at 6 and 12 months across five sites, including the Pelvic Organ Prolapse Symptom Score, health-related quality of life (measured using the EuroQol-5 Dimensions, five-level version, questionnaire), prolapse severity (measured using the Pelvic Organ Prolapse Quantification System), urinary incontinence (measured using International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) and need for further treatment. Results: A total of 102 women were recruited to the patient-reported outcome measures cohort study (target, n = 120), and 65 women had matched baseline and 6-month Pelvic Organ Prolapse Symptom Scores. The mean Pelvic Organ Prolapse Symptom Score was 10.18 (standard deviation 5.63) at baseline and 6.98 (standard deviation 5.23) at 6 months, representing a statistically significant and clinically meaningful difference. There was no statistically significant difference between the outcomes obtained from delivery by specialist physiotherapists and the outcomes obtained from delivery by other health-care professionals (mean change in Pelvic Organ Prolapse Symptom Score: –3.95 vs. –2.81, respectively). Services delivered using higher-band physiotherapists only were more costly than services delivered using other staff mixes. The effect of the original pelvic floor muscle training intervention, over a post-intervention period of > 10 years, was a reduction in the odds of any treatment during follow-up (odds ratio 0.61, 95% confidence interval 0.37 to 0.99). The realist evaluation revealed stark differences in implementation. The site with a specialist physiotherapy service resisted change because of perceived threats to the specialist role and concerns about care quality. Pelvic floor muscle training delivery by other health-care staff was easier when there was a lack of any existing specialist service; staff had prior training and interest in pelvic health; staff had support, autonomy, time and resources to deliver pelvic floor muscle training as part of their core role; and surrounding services supported a flow of pelvic floor muscle training referrals. Limitations: The number of available matched pre and post outcomes for women and the lack of Pelvic Organ Prolapse Quantification System examinations were limitations of this study. Conclusions: It is possible to train different staff to effectively deliver pelvic floor muscle training to women. Women’s self-reported outcomes significantly improved across all service models. Training should be adequately tailored to differential skill mix needs. Future work: Future work should include further implementation of pelvic floor muscle training and should include pre- and post-outcome data collection using the Pelvic Organ Prolapse Symptom Score. Study registration: This study is registered as Research Registry 4919. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 47. See the NIHR Journals Library website for further project information.https://doi.org/10.3310/hsdr08470realist evaluationeconomic evaluationpelvic organ prolapsepelvic floor muscle trainingimplementationre-aim framework |