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      A Tailored Occupational Therapist–Led Vocational Intervention for People With Stroke: Protocol for a Pilot Randomized Controlled Trial


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          Resuming work after stroke is a common goal of working-age adults, yet there are few vocational rehabilitation programs designed to address the unique challenges faced following stroke. The Work intervention was developed to address these gaps.


          This paper presents a protocol that outlines the steps that will be undertaken to pilot both the intervention and trial processes for the Work trial.


          The Work trial is a 2-arm, prospective, randomized, blinded-assessor study with intention-to-treat analysis. A total of 54 adults of working age who have experienced a stroke <4 months prior will be randomized 1:1 to either (1) an experimental group who will receive a 12-week early vocational intervention (Work intervention) plus usual clinical rehabilitation or (2) a control group who will receive only their usual clinical rehabilitation.


          Outcomes include study and intervention feasibility and intervention benefit. In addition to evaluating the feasibility of delivering vocational intervention early after stroke, benefit will be assessed by measuring rates of vocational participation and quality-of-life improvements at the 3- and 6-month follow-ups. Process evaluation using data collected during the study, as well as postintervention individual interviews with participants and surveys with trial therapists, will complement quantitative data.


          The results of the trial will provide details on the feasibility of delivering the Work intervention embedded within the clinical rehabilitation context and inform future trial processes. Pilot data will enable a future definitive trial to determine the clinical effectiveness of vocational rehabilitation when delivered in the early subacute phase of stroke recovery.

          Trial Registration

          Australian New Zealand Clinical Trials Registry ACTRN12619001164189; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378112&isReview=true

          International Registered Report Identifier (IRRID)


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          Most cited references25

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          The hospital anxiety and depression scale.

          A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
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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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              Design and analysis of pilot studies: recommendations for good practice.

              Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                October 2022
                31 October 2022
                : 11
                : 10
                : e40548
                [1 ] School of Allied Health, Human Services and Sport La Trobe University Melbourne Australia
                [2 ] Department of Occupational Therapy Monash University Frankston Australia
                [3 ] Nottingham University Nottingham United Kingdom
                [4 ] Institute of Clinical Trials Research University of Leeds Leeds United Kingdom
                [5 ] Centre for Ergonomics and Human Factors School of Psychology and Public Health La Trobe University Bundoora Australia
                [6 ] Department of Occupational Therapy Alfred Health Prahran Australia
                [7 ] Department of Neuroscience Monash University Melbourne Australia
                [8 ] Department of Neurology Alfred Health Prahran Australia
                [9 ] Living with Disability Research Centre School of Allied Health La Trobe University Bundoora Australia
                [10 ] School of Medical and Health Science Edith Cowan University Joondalup Australia
                [11 ] Alfred Health Prahran Australia
                Author notes
                Corresponding Author: Natasha A Lannin natasha.lannin@ 123456monash.edu
                Author information
                ©Sophie O'Keefe, Kathryn Radford, Amanda Farrin, Jodi Oakman, Serena Alves-Stein, Geoffrey Cloud, Jacinta Douglas, Mandy Stanley, Natasha A Lannin. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.10.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 27 June 2022
                : 8 July 2022
                : 14 August 2022
                : 18 August 2022
                Custom metadata
                This paper was peer reviewed by the Stroke Foundation (Melbourne, Australia).

                return to work,vocational rehabilitation,acquired brain injury,stroke,traumatic brain injury,neuroscience,rehabilitation,intervention,feasibility,stroke recovery,resume work


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