{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T01:37:58Z","timestamp":1778636278917,"version":"3.51.4"},"reference-count":27,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2022,3,14]],"date-time":"2022-03-14T00:00:00Z","timestamp":1647216000000},"content-version":"unspecified","delay-in-days":13,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["15\/130\/11"],"award-info":[{"award-number":["15\/130\/11"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,1,30]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants and outcome measures<\/jats:title>\n                    <jats:p>Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists\u2019 attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Approval obtained through the East Midlands\u2014Nottingham 2 Research Ethics Committee (Ref: 18\/EM\/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"ISRCTN12464275\">ISRCTN12464275<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-053111","type":"journal-article","created":{"date-parts":[[2022,3,15]],"date-time":"2022-03-15T12:35:20Z","timestamp":1647347720000},"page":"e053111","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6246-3180","authenticated-orcid":false,"given":"Kathryn A","family":"Radford","sequence":"first","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"McKevitt","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences, School of Population Health and Environmental Sciences, King's College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5919-4282","authenticated-orcid":false,"given":"Sara","family":"Clarke","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katie","family":"Powers","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie","family":"Phillips","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristelle","family":"Craven","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Watkins","sequence":"additional","affiliation":[{"name":"Faculty of Health and Care, University of Central Lancashire, Preston, Lancashire, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Farrin","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jain","family":"Holmes","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel","family":"Cripps","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences, School of Population Health and Environmental Sciences, King's College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicki","family":"McLellan","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracey","family":"Sach","sequence":"additional","affiliation":[{"name":"Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, Norfolk, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Brindle","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ivana","family":"Holloway","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suzanne","family":"Hartley","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit (CTRU), University of Leeds, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4075-1215","authenticated-orcid":false,"given":"Audrey","family":"Bowen","sequence":"additional","affiliation":[{"name":"Division of Neuroscience and Experimental Psychology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rory J","family":"O'Connor","sequence":"additional","affiliation":[{"name":"Academic Department of Rehabilitation Medicine, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judith","family":"Stevens","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marion","family":"Walker","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Murray","sequence":"additional","affiliation":[{"name":"Centre for Rehabilitation and Ageing Research, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Shone","sequence":"additional","affiliation":[{"name":"Research and Innovation, University of Nottingham, Nottingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6279-1192","authenticated-orcid":false,"given":"David","family":"Clarke","sequence":"additional","affiliation":[{"name":"Academic Unit for Ageing and Stroke Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,3,15]]},"reference":[{"key":"2025121515203800000_12.3.e053111.1","unstructured":"Stroke Association . State of the nation: stroke statistics. stroke association, 2018. Available: https:\/\/www.stroke.org.uk\/resources\/state-nation-stroke-statistics [Accessed 27 Apr 2021]."},{"key":"2025121515203800000_12.3.e053111.2","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.108.534487"},{"key":"2025121515203800000_12.3.e053111.3","doi-asserted-by":"publisher","DOI":"10.3109\/09638288.2013.793410"},{"key":"2025121515203800000_12.3.e053111.4","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1177\/030802260306600502","article-title":"Returning to work after a stroke: an important but neglected area","volume":"66","author":"Corr","year":"2003","journal-title":"Br J Occup Ther"},{"key":"2025121515203800000_12.3.e053111.5","doi-asserted-by":"crossref","first-page":"126","DOI":"10.12968\/ijtr.2006.13.3.21364","article-title":"Vocational rehabilitation in the UK: opportunities for health-care professionals","volume":"13","author":"Frank","year":"2006","journal-title":"Int J Ther Rehabil"},{"key":"2025121515203800000_12.3.e053111.6","doi-asserted-by":"publisher","DOI":"10.2340\/16501977-0423"},{"key":"2025121515203800000_12.3.e053111.7","doi-asserted-by":"crossref","first-page":"382","DOI":"10.1111\/ane.13067","article-title":"Work-related predictors for return to work after stroke","volume":"139","author":"Palstam","year":"2019","journal-title":"Acta Neurol Scand"},{"key":"2025121515203800000_12.3.e053111.8","unstructured":"Waddell G , Burton AK , Kendall NA . Vocational rehabilitation\u2013what works, for whom, and when? (report for the vocational rehabilitation task group. London: TSO, 2008."},{"key":"2025121515203800000_12.3.e053111.9","doi-asserted-by":"publisher","DOI":"10.1007\/s10926-011-9292-6"},{"key":"2025121515203800000_12.3.e053111.10","doi-asserted-by":"publisher","DOI":"10.1177\/0269215514554241"},{"key":"2025121515203800000_12.3.e053111.11","doi-asserted-by":"crossref","first-page":"440","DOI":"10.1097\/HTR.0b013e3181d41139","article-title":"Prospective randomized controlled trial of resource facilitation on community participation and vocational outcome following brain injury","volume":"25","author":"Trexler","year":"2010","journal-title":"J Head Trauma Rehabil"},{"key":"2025121515203800000_12.3.e053111.12","doi-asserted-by":"crossref","unstructured":"Radford KA , Craven K , McLellan V , et al . An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work after stroKE (RETAKE) trial. Trials 2020;21.doi:10.1186\/s13063-020-04883-1","DOI":"10.1186\/s13063-020-04883-1"},{"key":"2025121515203800000_12.3.e053111.13","doi-asserted-by":"crossref","first-page":"457","DOI":"10.4276\/030802214X14098207541072","article-title":"Return to work after stroke: recording, measuring, and describing occupational therapy intervention","volume":"77","author":"Grant","year":"2014","journal-title":"Br J Occup Ther"},{"key":"2025121515203800000_12.3.e053111.14","doi-asserted-by":"crossref","first-page":"751","DOI":"10.1177\/1545968318777844","article-title":"Implementation-The missing link in the research translation pipeline: is it any wonder no one ever implements evidence-based practice?","volume":"32","author":"Lynch","year":"2018","journal-title":"Neurorehabil Neural Repair"},{"key":"2025121515203800000_12.3.e053111.15","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)30946-1"},{"key":"2025121515203800000_12.3.e053111.16","doi-asserted-by":"crossref","first-page":"472","DOI":"10.1177\/1747493017711815","article-title":"Improving the development, monitoring and reporting of stroke rehabilitation research: consensus-based core recommendations from the stroke recovery and rehabilitation roundtable","volume":"12","author":"Walker","year":"2017","journal-title":"Int J Stroke"},{"key":"2025121515203800000_12.3.e053111.17","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h1258"},{"key":"2025121515203800000_12.3.e053111.18","doi-asserted-by":"publisher","DOI":"10.1177\/109019818501200311"},{"key":"2025121515203800000_12.3.e053111.19","doi-asserted-by":"publisher","DOI":"10.1093\/her\/18.2.237"},{"key":"2025121515203800000_12.3.e053111.20","first-page":"3","volume-title":"The promise and challenges of dissemination and implementation research dissemination and implementation research in health: translating science to practice","volume":"Vol 24","author":"Colditz","year":"2012"},{"key":"2025121515203800000_12.3.e053111.21","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2753.2006.00660.x"},{"key":"2025121515203800000_12.3.e053111.22","doi-asserted-by":"crossref","DOI":"10.1186\/s12913-016-1807-6","article-title":"A knowledge translation intervention to enhance clinical application of a virtual reality system in stroke rehabilitation","volume":"16","author":"Levac","year":"2016","journal-title":"BMC Health Serv Res"},{"key":"2025121515203800000_12.3.e053111.23","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62227-8"},{"key":"2025121515203800000_12.3.e053111.24","unstructured":"et al May C , Murray E , Finch T . Normalization process theory online users\u2019 manual and toolkit. NPT: Normalization Process Theory, 2010. Available: http:\/\/www.normalizationprocess.org\/ [Accessed 27 Apr 2021]."},{"key":"2025121515203800000_12.3.e053111.25","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1186\/1748-5908-2-40","article-title":"A conceptual framework for implementation fidelity","volume":"2","author":"Carroll","year":"2007","journal-title":"Implementation Sci"},{"key":"2025121515203800000_12.3.e053111.26","doi-asserted-by":"crossref","unstructured":"Ciesielska M , Bostr\u00f6m KW , \u00d6hlander M . Observational methods. In: Qualitative methodologies in organization studies volume II: methods and possibilities. Cham, Switzerland: Springer, 2018: 33\u201352.","DOI":"10.1007\/978-3-319-65442-3_2"},{"key":"2025121515203800000_12.3.e053111.27","doi-asserted-by":"publisher","DOI":"10.1191\/1478088706qp063oa"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-053111","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T23:20:52Z","timestamp":1765840852000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-053111"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3]]},"references-count":27,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2022,3,15]]},"published-print":{"date-parts":[[2022,3]]}},"alternative-id":["10.1136\/bmjopen-2021-053111"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-053111","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3]]}}}