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      Organising Support for Carers of Stroke Survivors (OSCARSS): a cluster randomised controlled trial with economic evaluation

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          Abstract

          Objective

          Investigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors.

          Design

          Pragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation.

          Setting

          Clusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers.

          Participants

          Adult carers in participating clusters were referred to the study by cluster staff following initial support contact.

          Interventions

          Intervention was the Carer Support Needs Assessment Tool for Stroke: a staff-facilitated, carer-led approach to help identify, prioritise and address the specific support needs of carers. It required at least one face-to-face support contact dedicated to carers, with reviews as required. Control was usual care, which included carer support (unstructured and variable).

          Outcome measures

          Participants provided study entry and self-reported outcome data by postal questionnaires, 3 and 6 months after first contact by cluster staff. Primary outcome: 3-month caregiver strain (Family Appraisal of Caregiving Questionnaire, FACQ). Secondary outcomes: FACQ subscales of caregiver distress and positive appraisals of caregiving, mood (Hospital Anxiety and Depression Scale) and satisfaction with stroke services (Pound). The economic evaluation included self-reported healthcare utilisation, intervention costs and EQ-5D-5L.

          Randomisation and masking

          Clusters were recruited before randomisation to intervention or control, with stratification for size of service. Cluster staff could not be masked as training was required for participation. Carer research participants provided self-reported outcome data unaware of allocation; they consented to follow-up data collection only.

          Results

          Between 1 February 2017 and 31 July 2018, 35 randomised clusters (18 intervention; 17 control) recruited 414 cRCT carers (208 intervention; 206 control). Study entry characteristics were well balanced. Primary outcome measure: intention-to-treat analysis for 84% retained participants (175 intervention; 174 control) found mean (SD) FACQ carer strain at 3 months to be 3.11 (0.87) in the control group compared with 3.03 (0.90) in the intervention group, adjusted mean difference of −0.04 (95% CI −0.20 to 0.13). Secondary outcomes had similarly small differences and tight CIs. Sensitivity analyses suggested robust findings. Intervention fidelity was not achieved. Intervention-related group costs were marginally higher with no additional health benefit observed on EQ-5D-5L. No adverse events were related to the intervention.

          Conclusions

          The intervention was not fully implemented in this pragmatic trial. As delivered, it conferred no clinical benefits and is unlikely to be cost-effective compared with usual care from a stroke specialist provider organisation. It remains unclear how best to support carers of stroke survivors. To overcome the implementation challenges of person-centred care in carers’ research and service development, staff training and organisational support would need to be enhanced.

          Trial registration number

          ISRCTN58414120.

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          Most cited references26

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          The Hospital Anxiety and Depression Scale

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            Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

            Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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              Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

              Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2021
                12 January 2021
                : 11
                : 1
                : e038777
                Affiliations
                [1 ]departmentDivision of Neuroscience and Experimental Psychology , The University of Manchester, Manchester Academic Health Sciences Centre (MAHSC) , Manchester, UK
                [2 ]National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Greater Manchester (NIHR CLAHRC GM) , Manchester, UK
                [3 ]departmentCentre for Biostatistics, Division of Population Health, Health Services Research & Primary Care , The University of Manchester , Manchester, UK
                [4 ]departmentManchester Centre for Health Economics, Division of Population Health, Health Services Research & Primary Care, School of Health Sciences , The University of Manchester , Manchester, UK
                [5 ]departmentAlliance Manchester Business School , The University of Manchester , Manchester, UK
                [6 ]departmentCentre for Reviews and Dissemination , University of York , York, UK
                [7 ]departmentDivision of Nursing Midwifery and Social Work, School of Health Sciences , The University of Manchester, Manchester Academic Health Sciences Centre (MAHSC) , Manchester, UK
                [8 ]departmentCentre for Family Research , University of Cambridge , Cambridge, UK
                Author notes
                [Correspondence to ] Professor Audrey Bowen; audrey.bowen@ 123456manchester.ac.uk
                Author information
                http://orcid.org/0000-0002-4198-5761
                http://orcid.org/0000-0001-9574-7710
                http://orcid.org/0000-0001-5420-6774
                http://orcid.org/0000-0003-2200-1680
                http://orcid.org/0000-0001-9547-7247
                http://orcid.org/0000-0003-4075-1215
                Article
                bmjopen-2020-038777
                10.1136/bmjopen-2020-038777
                7805348
                33436463
                447d5515-43f7-46a2-b62f-ff8c07c9e699
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 23 March 2020
                : 10 December 2020
                : 14 December 2020
                Categories
                Patient-Centred Medicine
                1506
                1722
                Original research
                Custom metadata
                unlocked

                Medicine
                stroke,health economics,education & training (see medical education & training),mental health,primary care

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