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MacArthur C, Bick D, Salmon V, et al. Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT. Southampton (UK): National Institute for Health and Care Research; 2024 Nov. (Programme Grants for Applied Research, No. 12.09.)

Cover of Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT

Midwifery-led antenatal pelvic floor muscle exercise intervention to reduce postnatal urinary incontinence: APPEAL research programme including a feasibility and pilot cluster RCT.

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Contributions of authors

Christine MacArthur (https://orcid.org/0000-0003-0434-2158) (Professor of Maternal and Child Epidemiology) was chief investigator and, with the help of other co-applicants, conceived the programme. She supervised the Birmingham-based research team and took overall responsibility for the programme. She led the writing of this final report.

Debra Bick (https://orcid.org/0000-0002-8557-7276) (Professor of Evidence Based Midwifery) was midwife lead involved in conceiving the programme, chief investigator for the pilot and feasibility trial in WP4.2 and contributed to the writing of this final report.

Victoria Salmon (https://orcid.org/0000-0002-1536-4750) (Research Fellow) was involved in the research in WP1, WP3 and WP4.3, led the design of the training intervention and resources for midwives and women and assisted in the preparation of this final report.

Ellie Jones (https://orcid.org/0000-0003-2552-8322) (Research Midwife/Fellow) was involved in conducting the pilot and feasibility cluster trial in WP4.2 trial, training intervention midwives, supporting Trust research midwives and assisted in the preparation of this final report.

Jean Hay-Smith (https://orcid.org/0000-0002-9009-2812) (Professor in Rehabilitation and Professor in Women’s Health, University of Otago, New Zealand) was involved in conceiving the programme, contributed across the programme, attended the National Stakeholder event, contributed the mobile phone app review in the APPEAL resources for women and commented on the draft report.

Jon Bishop (https://orcid.org/0000-0003-1789-5886) (Trial Statistician) undertook the analyses in WP4.1, supervised the analyses of the pilot and feasibility cluster trial in WP4.2 and contributed to the writing of this final report.

Eleni Gkini (https://orcid.org/0000-0001-8083-2947) (Trainee Trial Statistician) undertook the pilot and feasibility trial analysis in WP4.2 supervised by the other statisticians, was involved in preparing the report of WP 4.2 and commented on the draft report.

Karla Hemming (https://orcid.org/0000-0002-2226-6550) (Professor of Biostatistics) was co-applicant and senior statistician with specific expertise in cluster trial analysis; was responsible for this methodology and commented on the draft report.

Sara Webb (https://orcid.org/0000-0002-4924-3017) (Head of Research at Royal College of Midwives) was research midwife in the earlier parts of the programme, was lead for WP4.1 and commented on the draft report.

Mark Pearson (https://orcid.org/0000-0001-7628-7421) (Reader in Implementation Science) was lead for WP1.1, gave expert implementation science input across the programme and commented on the draft report.

Tim Coleman (https://orcid.org/0000-0002-7303-4805) (Professor of Primary Care) gave expert support of behaviour change and trial methodology and general support across the programme and commented on the draft report.

Rohini Terry (https://orcid.org/0000-0003-4188-8504) (Research Fellow) was involved in the research in WP1.2, supported the intervention development and practice training event (WP3), was involved with interviews in WP4.3 and assisted in the preparation of this final report.

Libby Edwards (https://orcid.org/0000-0001-9380-7732) (Research Midwife) was involved in training the intervention midwives in WP4.2, assisted with interviews in WP4.3 and supporting Trust research midwife work and commented on the draft report.

Helena Frawley (https://orcid.org/0000-0002-7126-6979) (Associate Professor, Women’s Health Physiotherapy, University of Melbourne, Australia) contributed expert advice on intervention development and delivery, attended the National Stakeholder event, contributed to the APPEAL video resources for women and commented on the draft report.

Eivor Oborn (https://orcid.org/0000-0003-0566-4327) (Professor of Implementation Science) gave expert implementation science support across the work of the programme and commented on the draft report.

Sarah Dean (https://orcid.org/0000-0002-3682-5149) (Professor of Psychology Applied to Rehabilitation and Health) was involved in conceiving the programme, led the Exeter-based research in WP1, WP3 and WP4.3, supported the research in WP2 and WP4.2 and co-ordinated the international team involvement. In addition, she is senior author of this final report.

Acknowledgements

We would like to thank all the midwives who took part in the intervention, all the women who returned the questionnaires and all other participants and Trusts who supported the programme in various ways.

The study team acknowledges the study delivery support given by Birmingham Clinical Trials Unit, in particular William McKinnon and Mary Nulty.

We also acknowledge the work undertaken by early-phase researchers Lucy Hope, Rachael Jarvie and Chidubem Okeke Ogwulu and by students on supervised research placements with the University of Exeter team: Lauren Chandler, Alex Sherrell, Saskia Chapman, Clodagh Smith and Rohan May.

We acknowledge the support by the NIHR Applied Research Collaborations in the West Midlands, Southwest Peninsula, and South London.

Patient and Public Advisory Group members

Thanks to the APPEAL public advisory group for their ongoing valuable contribution and commitment to this project. Thanks to the PenARC Public Involvement Team, researchers Kate Boddy and Emma Cockcroft, for their support recruiting PPI members, setting up and running the PPI advisory group meetings.

Programme Steering Committee members

Professor Nadine Foster (Chair) Professor Suzanne Hagen, Professor Helen Cheyne, Ms Sarah Skinner.

National Stakeholder Group members

We would like to thank the women, healthcare professionals and the following organisations for their contribution to the national stakeholder consultation event: Birmingham Women’s and Children’s NHS Foundation Trust (Grete Drewett, Sue Smithson); Camden Clinical Commissioning Group; Chartered Society of Physiotherapy; Gusset Grippers (Elaine Miller); Mumsnet; Mumsnet guest blogger (Sarah Haselwood); National Childbirth Trust; NHS Education for Scotland (Helene Marshall); NHS England, Head of Maternity, Children and Young People (Jacqueline Dunkley-Bent); NHS England Maternity team (Clare Capito); Pelvic, Obstetric and Gynaecological Physiotherapy; Royal College of Midwives President (Kathryn Gutteridge); Royal College of Midwives professional adviser for education (Gail Johnson); Royal College of Obstetricians and Gynaecologists (RCOG); RCOG Women’s Voices; Sandwell and West Birmingham NHS Trust; University Hospitals Birmingham; Virgincare/University College London (Health visitor).

We would also like to acknowledge Professor Jane Daniels, Professor Tracy Roberts, Professor Doug Tincello, Dr Clare Davenport and Ms Joanne Kidd-Chadwick who were involved as co-applicants in the first stage of the programme but did not continue into the second stage of the work.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

Ethics statement

Ethics statements have been included in the WP to which they are relevant.

Information governance statement

The University of Birmingham and The University of Exeter are joint data controllers and are committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679.

Under the Data Protection Legislation The University of Birmingham is the Data Processor and the Data Controller for information relating to midwife participants’ data and we process personal data in accordance with their instructions. The University of Birmingham is the Data Controller and Data Processor for information relating to outcomes of pregnant participants’ data. The University of Exeter is the Data Processor and the Data Controller for information relating to midwife participants’ data including audio files/transcripts arising from the telephone interviews. Birmingham Women’s and Children’s NHS Foundation Trust is also a Data Processor for information relating to outcomes of pregnant participants’ data.

You can find out more about how The University of Birmingham handle personal data, including how to exercise your individual rights, by contacting The University of Birmingham’s Data Protection Officer by e-mail: ku.ca.mahb.stcatnoc@noitcetorpatad and about how The University of Exeter handle personal data, including how to exercise your individual rights, by contacting The University of Exeter’s Data Protection Officer by e-mail: ku.ca.retexe@noitcetorpatad

Disclosure of interests

Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/TJDH7946.

Primary conflicts of interest: Christine MacArthur was a member of the NIHR Policy Research Units Commissioning Panel 2017–8 and 2022–3 and declares NIHR funding grants (NIHR202869, NIHR129182 and NIHR200165). Sarah Dean is on the NIHR Programme Grant for Applied Research funding Panel Committee and The Stroke Association Funding Panel and declares NIHR funding grants (NIHR151938, NIHR204099, NIHR202020, NIHR201038, NIHR201070 and NIHR 200428). Debra Bick was a HS&DR Researcher-Led Panel Member (1 April 2020–30 April 2023) and is Chair of Trustees of MASIC charity and declares NIHR funding grants (NIHR202172, NIHR206660, NIHR202165, NIHR134298, NIHR150979, NIHR131250, NIHR131352, NIHR128721, NIHR16/77/02 and NIHR131161). Victoria Salmon has received funding from the Academic Health Science Network South-West to develop video resources related to APPEAL Grant. Ellie Jones has received a NIHR Advanced Fellowship (NIHR1906817). Rohini Terry declares NIHR funding grants (NIHR204030, NIHR151938, NIHR856766 and NIHR200428). Mark Pearson is a member of the NIHR HS&DR Funding Committee and declares NIHR funding grants (NIHR 131606, NIHR132931, NIHR135128, NIHR206122, NIHR203682, NIHR158758, NIHR203123, NIHR204349, NIHR204312 and NIHR206252). Karla Hemming declares NIHR funding grants (NIHR204156, NIHR202826 and NIHR203062). Tim Coleman is on the NIHR HTA Clinical Evaluation and Trials Committee (2015–9), Programmes for Applied Health Research Committee (2022 to date) and NIHR Research for Patient Benefit Committee (2022 to date) and declares NIHR funding grants (NIHR129210, NIHR206513, RP-PG-0109-10020 and RP-PG-0615-20003).

Publications

Salmon V, Hay-Smith J, Jarvie R, Dean S, Oborn E, Bayliss S, et al.; APPEAL study. Opportunities, challenges and concerns for the implementation and uptake of pelvic floor muscle assessment and exercises during the childbearing years: protocol for a critical interpretive synthesis. Syst Rev 2017;6:18. https://doi.org/10.1186/s13643-017-0420-z

Salmon VE, Hay-Smith J, Jarvie R, Dean S, Oborn E, Bayliss SE, et al. Opportunities, challenges and concerns for implementing pelvic floor muscle assessment and training during childbearing years: a critical interpretive synthesis. ICS conference, Florence Sept 2017. Neurourol Urodyn 2017;36:S280–1. https://doi.org/10.1186/s13643-017-0420-z. Won best scientific abstract prize for health services research.

Hay-Smith J PL, Farmery D, Dean S, Grainger R. Apps-olutely fabulous? – the quality of PFMT smartphone app content and design rated using the Mobile App Rating Scale, behaviour change taxonomy, and guidance for exercise prescription. ICS 2019 Gothenburg Scientific Programme. Neurourol Urodyn 2019;38:S1–532. https://doi.org/10.1002/nau.24118

Terry R, Jarvie R, Hay-Smith J, Salmon V, Pearson M, Boddy K, Salmon V, Pearson M, MacArthur C, Dean S. Are you doing your pelvic floors? An ethnographic exploration of discussions between health professionals and pregnant women about pelvic floor muscle exercise during pregnancy. International Continence Society (ICS) Conference 2019, Gothenburg. Neurourol Urodyn 2019;38:S1–532 https://doi.org/10.1002/nau.24118.

Terry R, Jarvie R, Hay-Smith J, et al. ‘Are you doing your pelvic floor?’ An ethnographic exploration of the interaction between women and midwives about pelvic floor muscle exercises (PFME) during pregnancy. Midwifery 2020;83:102647. https://doi.org/10.1016/j.midw.2020.102647

Salmon V, Hay-Smith EJ, Jarvie R, Dean S, Terry R, Frawley H, et al. Implementing pelvic floor muscle training in women’s childbearing years: a critical interpretive synthesis of individual, professional, and service issues. Neurol Urodyn 2020;39(2):863–70. https://doi.org/10.1002/nau.24256

Bick D, Bishop J, Coleman T, Dean S, Edwards E, Frawley H, et al. Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): protocol for a feasibility and pilot cluster randomised controlled trial. Pilot Feas Stud 2022;8:231. https://doi.org/10.1186/s40814-022-01185-y

Dean S, Salmon V, Terry R, Hay-Smith J, Frawley H, Chapman S, et al.; on behalf of the Research Programme Team. Teaching effective pelvic floor muscle exercises in antenatal care: design and development of a training package for community midwives in the UK. ICS Conference 2022, Vienna. Won Best in Category prize. Continence 2022;2:100204. https://doi.org/10.1016/j.cont.2022.100204

Smith C, Salmon V, Jones, E, Edwards L, Hay-Smith J, Frawley H, et al.; on behalf of the APPEAL Programme Team. Training for midwives to support women to do their exercises during pregnancy. A mixed method evaluation of the midwife training during a feasibility and pilot randomised controlled trial. ICS Conference 2022, Vienna. Continence 2022;2:100206. https://doi.org/10.1016/j.cont.2022.100206

Disclaimers

This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, PGfAR or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the PGfAR programme or the Department of Health and Social Care.

Copyright © 2024 MacArthur et al.

This work was produced by MacArthur et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.

Bookshelf ID: NBK609148

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