Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/29100
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dc.contributor.authorGrant, Aileenen_UK
dc.contributor.authorDean, Sarahen_UK
dc.contributor.authorHay-Smith, Jeanen_UK
dc.contributor.authorHagen, Suzanneen_UK
dc.contributor.authorMcClurg, Doreenen_UK
dc.contributor.authorTaylor, Anneen_UK
dc.contributor.authorKovandzic, Marijaen_UK
dc.contributor.authorBugge, Carolen_UK
dc.date.accessioned2019-03-26T01:00:59Z-
dc.date.available2019-03-26T01:00:59Z-
dc.date.issued2019-02en_UK
dc.identifier.othere024152en_UK
dc.identifier.urihttp://hdl.handle.net/1893/29100-
dc.description.abstractIntroduction Female urinary incontinence (UI) is common affecting up to 45% of women. Pelvic floor muscle training (PFMT) is the first-line treatment but there is uncertainty whether intensive PFMT is better than basic PFMT for long-term symptomatic improvement. It is also unclear which factors influence women’s ability to perform PFMT long term and whether this has impacts on long-term outcomes. OPAL (optimising PFMT to achieve long-term benefits) trial examines the effectiveness and cost-effectiveness of basic PFMT versus biofeedback-mediated PFMT and this evaluation explores women’s experiences of treatment and the factors which influence effectiveness. This will provide data aiding interpretation of the trial findings; make recommendations for optimising the treatment protocol; support implementation in practice; and address gaps in the literature around long-term adherence to PFMT for women with stress or mixed UI. Methods and analysis This evaluation comprises a longitudinal qualitative case study and process evaluation (PE). The case study aims to explore women’s experiences of treatment and adherence and the PE will explore factors influencing intervention effectiveness. The case study has a two-tailed design and will recruit 40 women, 20 from each trial group; they will be interviewed four times over 2 years. Process data will be collected from women through questionnaires at four time-points, from health professionals through checklists and interviews and by sampling 100 audio recordings of appointments. Qualitative analysis will use case study methodology (qualitative study) and the framework technique (PE) and will interrogate for similarities and differences between the trial groups regarding barriers and facilitators to adherence. Process data analyses will examine fidelity, engagement and mediating factors using descriptive and interpretative statistics. Ethics and dissemination Approval from West of Scotland Research Ethics Committee 4 (16/LO/0990). Findings will be published in journals, disseminated at conferences and through the final report. Trial registration number ISRCTN57746448.en_UK
dc.language.isoenen_UK
dc.publisherBMJ Publishing Groupen_UK
dc.relationGrant A, Dean S, Hay-Smith J, Hagen S, McClurg D, Taylor A, Kovandzic M & Bugge C (2019) Effectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: Protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluation. BMJ Open, 9, Art. No.: e024152. https://doi.org/10.1136/bmjopen-2018-024152en_UK
dc.rightsThis is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.en_UK
dc.titleEffectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: Protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluationen_UK
dc.typeJournal Articleen_UK
dc.identifier.doi10.1136/bmjopen-2018-024152en_UK
dc.identifier.pmid30782894en_UK
dc.citation.jtitleBMJ Openen_UK
dc.citation.issn2044-6055en_UK
dc.citation.volume9en_UK
dc.citation.publicationstatusPublisheden_UK
dc.citation.peerreviewedRefereeden_UK
dc.type.statusVoR - Version of Recorden_UK
dc.contributor.funderNational Institute for Health Researchen_UK
dc.citation.date08/02/2019en_UK
dc.contributor.affiliationRobert Gordon Universityen_UK
dc.contributor.affiliationUniversity of Exeteren_UK
dc.contributor.affiliationUniversity of Otagoen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationGlasgow Caledonian Universityen_UK
dc.contributor.affiliationHealth Sciences Stirlingen_UK
dc.contributor.affiliationHealth Sciences Stirlingen_UK
dc.contributor.affiliationHealth Sciences Stirlingen_UK
dc.identifier.isiWOS:000471124600116en_UK
dc.identifier.scopusid2-s2.0-85061306923en_UK
dc.identifier.wtid1235490en_UK
dc.contributor.orcid0000-0002-0644-5233en_UK
dc.contributor.orcid0000-0002-4071-0803en_UK
dc.date.accepted2018-11-23en_UK
dc.description.refREF Eligible with Permitted Exceptionen_UK
dc.date.filedepositdate2019-02-28en_UK
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