Trial participant representativeness compared to ordinary service users in a work rehabilitation setting.
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ABSTRACT:
SUBMITTER: Overland S
PROVIDER: S-EPMC5935858 | biostudies-literature | 2016 Apr
REPOSITORIES: biostudies-literature
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Trial participant representativeness compared to ordinary service users in a work rehabilitation setting.
Øverland Simon S Grasdal Astrid A Reme Silje Endresen SE
Contemporary clinical trials communications 20151217
<h4>Background</h4>Study representativeness is a major concern for generalizations from trials. The extent of the problem varies with study design and context. There is a strong emphasis on developing interventions to help people remain in the work force despite mental illness. We need to know if results from upcoming trials in this area are valid for those that later might receive the services.<h4>Method</h4>The AWaC trial was a multicenter RCT conducted at six different treatment centers (n = ...[more]
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Project description:BackgroundDesign of rehabilitation environments is usually "expert" driven with little consideration given to the perceptions of service users, especially patients and informal carers. There is a need to engage with consumers of services to gain their insights into what design aspects are required to facilitate optimum physical activity, social interaction and psychological responses when they are attempting to overcome their limitations and regain function.Research designQualitative exploratory study.MethodInterviews were conducted with patients (n = 54) and informal carers (n = 23), and focus groups with rehabilitation staff (n = 90), from the three metropolitan South Australia rehabilitation health services, comprising different building and environmental configurations. Thematic analysis was assisted by the use of NVivo 11 qualitative software, with pooled data from all interviews and focus groups undergoing open, axial and finally selective coding.ResultsFour major themes were identified as follows: (a) choice can be an Illusion in a rehabilitation ward; (b) access to outside areas is a priority and affects well-being; (c) socialization can be facilitated by the environment; and (d) ward configuration should align with the model of care.Discussion and conclusionParticipants who encountered the most restrictive environments accepted their situation until probed to consider alternatives; those who enjoyed the most choice and access to facilities showed the greatest enthusiasm for these affordances. Future architectural designers should therefore consider the perceptions of a wide range of consumers with varying experiences to ensure they understand the complex requirements of patients and that the ward design facilitates the optimum rehabilitation model of care.
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Project description:[Purpose] We investigated the relationship of quality of life (QOL) with cognitive function, physical function, and activity ability, and aimed to identify functions related to QOL improvement, among elderly people who use day-care rehabilitation. [Participants and Methods] The participants were 37 elderly rehabilitation users, whose QOL was assessed using the Health Organization QOL26 (WHOQOL26), which consists of a 26-item self-report questionnaire. Cognitive function was assessed using the Mini-Mental State Examination, while physical function was assessed with seated forward bending, knee extension, grip, 30-second chair stand test, timed up and go test, and gait speed. Activity ability was assessed using the Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG index). [Results] A positive correlation was found between five WHOQOL26 categories (psychological QOL, social QOL, environmental QOL, total QOL, and QOL average) and social role in the TMIG index. There was also a positive correlation between four WHOQOL26 categories (psychological QOL, social QOL, environmental QOL, and QOL average) and instrumental activity of daily living in the TMIG index. To identify factors influencing the QOL score, association with TMIG index was investigated. Social role in the TMIG index was a positive factor in psychological and social QOL. [Conclusion] Enhancing social role is important to improve QOL of elderly rehabilitation users.
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Project description:Background: Community Care Units (CCUs) are a model of community-based residential rehabilitation support available in Australia that assists people affected by severe and persistent mental illness to enhance their independent living skills and community involvement. These services have been subject to limited evaluation, and available descriptions of consumer cohorts lack relevance to the understanding of their rehabilitation needs. Method: A clinical assessment battery covering a broad range of relevant domains was completed with consumers commencing at three CCUs in Queensland, Australia, between December 2014 and December 2017 (N = 145). The cohort was described based on demographic, diagnostic, treatment-related variables, and the assessment battery. The comparability of included sites was assessed. This contemporary cohort was also compared to the pooled cohort of Australian community-based residential rehabilitation services emerging from a previous systematic review. Additionally, cluster analysis (CA) was completed in two stages based on the clinician-rated assessments: hierarchical CA (Wards method) to identify the optimal number of clusters, followed by K-means clustering. Results: Dominant features of the cohort were male sex and the primary diagnoses of schizophrenia spectrum disorders. The average consumer age was 31.4 years. Most consumers were referred from the community, had been living with family, and were not subject to involuntary treatment orders. No site-based differences were observed on demographic, diagnostic and treatment-related variables. However, some site-based variation in levels of symptoms and functional impairment emerged. Overall, the cohort was comparable with the Transitional Residential Rehabilitation (TRR) cohort defined in a previous systematic review. Through CA, a three-cluster solution emerged: Cluster 1 (15%) was characterised by higher levels of substance use comorbidity; Cluster 2 (39%) was characterised by higher levels of disability and symptoms; and Cluster 3 (46%) was distinguished by lower levels of general psychiatric symptoms. Conclusions: The cohort was generally comparable to the TRR cohort. Site-based variability in the characteristics of admitted consumers was minimal. The CA solution suggested that three different sub-groups of consumers are admitted to CCUs, which have implications for adapting the approach to rehabilitation. Recommendations include ensuring early availability of interventions to address co-morbidities and pacing rehabilitation expectations to consumers stage of recovery.
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Project description:BackgroundA telemedicine service enabling remote surgical consultation had shown promising results. When the service was to be scaled up, it was unclear how contextual variations among different clinical sites could affect the clinical outcomes and implementation of the service. It is generally recognized that contextual factors and work system complexities affect the implementation and outcomes of telemedicine. However, it is methodologically challenging to account for context in complex health care settings. We conducted a work domain analysis (WDA), an engineering method for modeling and analyzing complex work environments, to investigate and represent contextual influences when a telemedicine service was to be scaled up to multiple hospitals.ObjectiveWe wanted to systematically characterize the implementation contexts at the clinics participating in the scale-up process. Conducting a WDA would allow us to identify, in a systematic manner, the functional constraints that shape clinical work at the implementation sites and set the sites apart. The findings could then be valuable for informed implementation and assessment of the telemedicine service.MethodsWe conducted observations and semistructured interviews with a variety of stakeholders. Thematic analysis was guided by concepts derived from the WDA framework. We identified objects, functions, priorities, and values that shape clinical procedures. An iterative "discovery and modeling" approach allowed us to first focus on one clinic and then readjust the scope as our understanding of the work systems deepened.ResultsWe characterized three sets of constraints (ie, facets) in the domain: the treatment facet, administrative facet (providing resources for procedures), and development facet (training, quality improvement, and research). The constraints included medical equipment affecting treatment options; administrative processes affecting access to staff and facilities; values and priorities affecting assessments during endoscopic retrograde cholangiopancreatography; and resources for conducting the procedure.ConclusionsThe surgical work system is embedded in multiple sets of constraints that can be modeled as facets of the system. We found variations between the implementation sites that might interact negatively with the telemedicine service. However, there may be enough motivation and resources to overcome these initial disruptions given that values and priorities are shared across the sites. Contrasting the development facets at different sites highlighted the differences in resources for training and research. In some cases, this could indicate a risk that organizational demands for efficiency and effectiveness might be prioritized over the long-term outcomes provided by the telemedicine service, or a reduced willingness or ability to accept a service that is not yet fully developed or adapted. WDA proved effective in representing and analyzing these complex clinical contexts in the face of technological change. The models serve as examples of how to analyze and represent a complex sociotechnical context during telemedicine design, implementation, and assessment.
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Project description:BackgroundWork problems are common in people with inflammatory arthritis. Up to 50% stop work within 10 years due to their condition and up to 67% report presenteeism (i.e. reduced work productivity), even amongst those with low disease activity. Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations. This aims to create a better match between the person's abilities and their job demands. The objectives of the Workwell trial are to test the overall effectiveness and cost-effectiveness of JRVR (WORKWELL) provided by additionally trained National Health Service (NHS) occupational therapists compared to a control group who receive self-help information both in addition to usual care.MethodsBased on the learning from a feasibility trial (the WORK-IA trial: ISRCTN76777720 ), the WORKWELL trial is a multi-centre, pragmatic, individually-randomised parallel group superiority trial, including economic evaluation, contextual factors analysis and process evaluation. Two hundred forty employed adults with rheumatoid arthritis, undifferentiated inflammatory arthritis or psoriatic arthritis (in secondary care), aged 18 years or older with work instability will be randomised to one of two groups: a self-help written work advice pack plus usual care (control intervention); or WORKWELL JRVR plus a self-help written work advice pack and usual care. WORKWELL will be delivered by occupational therapists provided with additional JRVR training from the research team. The primary outcome is presenteeism as measured using the Work Limitations Questionnaire-25. A comprehensive range of secondary outcomes of work, health, contextual factors and health resource use are included. Outcomes are measured at 6- and 12- months (with 12-months as the primary end-point). A multi-perspective within-trial cost-effectiveness analyses will also be conducted.DiscussionThis trial will contribute to the evidence base for provision of JRVR to people with inflammatory arthritis. If JRVR is found to be effective in enabling people to keep working, the findings will support decision-making about provision of JRVR by rheumatology teams, therapy services and healthcare commissioners, and providing evidence of the effectiveness of JRVR and the economic impact of its implementation.Trial registrationClinical Trials.Gov: NCT03942783 . Registered 08/05/2019 ( https://clinicaltrials.gov/ct2/show/NCT03942783 ); ISRCTN Registry: ISRCTN61762297 . Registered:13/05/2019 ( http://www.isrctn.com/ISRCTN61762297 ). Retrospectively registered.
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Project description:ImportanceWhile effective, cardiovascular rehabilitation (CR) as traditionally delivered is not well implemented in lower-resource settings.ObjectiveTo test the noninferiority of hybrid CR compared with traditional CR in terms of cardiovascular events.Design, setting, and participantsThis pragmatic, multicenter, parallel arm, open-label randomized clinical trial (the Hybrid Cardiac Rehabilitation Trial [HYCARET]) with blinded outcome assessment was conducted at 6 referral centers in Chile. Adults aged 18 years or older who had a cardiovascular event or procedure, no contraindications to exercise, and access to a mobile telephone were eligible and recruited between April 1, 2019, and March 15, 2020, with follow-up until July 29, 2021.InterventionsParticipants were randomized 1:1 in permuted blocks to the experimental arm, which received 10 center-based supervised exercise sessions plus counseling in 4 to 6 weeks and then were supported at home via telephone calls and text messages through weeks 8 to 12, or the control arm, which received the standard CR of 18 to 22 sessions with exercises and education in 8 to 12 weeks.Main outcomes and measuresThe primary outcome was cardiovascular events or mortality. Secondary outcomes were quality of life, return to work, and lifestyle behaviors measured with validated questionnaires; muscle strength and functional capacity, measured through physical tests; and program adherence and exercise-related adverse events, assessed using checklists.ResultsA total of 191 participants were included (mean [SD] age, 58.74 [9.80] years; 145 [75.92%] male); 93 were assigned to hybrid CR and 98 to standard CR. At 1 year, events had occurred in 5 unique participants in the hybrid CR group (5.38%) and 9 in the standard CR group (9.18%). In the intention-to-treat analysis, the hybrid CR group had 3.80% (95% CI, -11.13% to 3.52%) fewer cardiovascular events than the standard CR group, and relative risk was 0.59 (95% CI, 0.20-1.68) for the primary outcome. In the per-protocol analysis at different levels of adherence to the intervention, all 95% CIs crossed the noninferiority boundary (eg, 20% adherence: absolute risk difference, -0.35% [95% CI, -7.56% to 6.85%]; 80% adherence: absolute risk difference, 3.30% [95% CI, -3.70% to 10.31%]). No between-group differences were found for secondary outcomes except adherence to supervised CR sessions (79.14% [736 of 930 supervised sessions] in the hybrid CR group vs 61.46% [1201 of 1954 sessions] in the standard CR group).Conclusions and relevanceThe results suggest that a hybrid CR program is noninferior to standard center-based CR in a low-resource setting, primarily in terms of recurrent cardiovascular events and potentially in terms of intermediate outcomes. Hybrid CR may induce superior adherence to supervised exercise. Clinical factors and patient preferences should inform CR model allocation.Trial registrationClinicalTrials.gov Identifier: NCT03881150.
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Project description:The assessment of work-related functioning is a key process in vocational rehabilitation to identify specific domains of disability that can be considered within return to work strategies. The Work Rehabilitation Questionnaire (WORQ) was developed to evaluate work-related functioning based on the International Classification of Functioning, Disability, and Health (ICF) framework and is available in different languages. The aim of this study was to assess the French version of the WORQ using item response theory to further validate the scale. Rasch analysis of WORQ and the WORQ-BRIEF (a brief version of the WORQ) was performed using a calibration sample of 221 persons with musculoskeletal injuries. A four-testlet solution indicated the unidimensionality of WORQ, with no differential item functioning for age, education, physical job demands, and injury severity. Reliability was 0.969 and 0.918 for WORQ and WORQ-BRIEF, respectively. The minimal detectable change was calculated to be 4.2% of its operational range for WORQ and 8.5% for WORQ-BRIEF. Consequently, the French version of WORQ can be considered a good measure of work-related functioning in musculoskeletal conditions. WORQ can be used in rehabilitation practice to comprehensively identify the disability and guide clinical decision making and intervention planning. Further studies are needed to evaluate the psychometric properties of WORQ in other health conditions.
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Project description:BackgroundRetraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the "WORKout-app" which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity.ObjectiveThe aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes).MethodsWe conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes.ResultsThis study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022).ConclusionsThe findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation.International registered report identifier (irrid)DERR1-10.2196/50200.
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Project description:IntroductionWork is integral to the occupations of human beings and accounts for up to a third of time spent in an average adult life. Occupational therapists play a role in vocational rehabilitation of mental health service users (MHSUs) with the aim of optimising their work participation. It is advisable that occupational therapists providing vocational rehabilitation to MHSUs with chronic mental illness in mental healthcare settings are guided by a practice framework developed for that particular context. This scoping review aims to summarise existing evidence on vocational rehabilitation for MHSUs in low-income to upper-middle-income countries. The findings will inform subsequent phases of research undertaken to formulate a vocational rehabilitation practice framework for MHSUs in Namibia.Methods and analysisThe scoping review will employ the five stage methodological framework proposed by Arksey and O'Malley. This will be used in conjunction with the Preferred Reporting Items for Systematic Reviews extension for Scoping Reviews (PRISM-ScR) and Joanna Briggs scoping review guidelines. MESH terms, Boolean operators and truncation strategies will be employed for a comprehensive article search in electronic scholarly databases. These databases will include PsycINFO, EBSCOhost, HINARI, Google scholar, Medline, CINAHL, PubMed, Cochrane Library, Scopus, Science Direct and Wiley Online Library. Mendeley and Rayyan, both open source platforms, will be used for title, abstract and full-text screening, as well as data extraction. Data will be sifted and sorted by key categories and themes using a data charting form.Ethics and disseminationThe scoping review findings will be published in a peer-reviewed journal and presented at local and international conferences. Ethical clearance for this study will not be required as secondary data will be utilised and there are no patients involved.
| S-EPMC8287089 | biostudies-literature
Project description:ObjectiveTo synthesise research published on vocational rehabilitation (VR) interventions offered in institutions, by occupational therapists, to mental health service users (MHSUs) with chronic mental illness, in low-income to upper-middle-income countries (L-UMIC).DesignThis scoping review used Arksey and O'Malley's methodological framework, the Preferred Reporting Items for Systematic Reviews extension for Scoping Reviews and Joanna Briggs scoping review guidelines.Data sourcesWe searched PsycInfo, EBSCOhost, HINARI, Google Scholar, Medline, CINAHL, PubMed, Cochrane Library, Scopus, Science Direct and Wiley online library between 15 July and 31 August 2021.Eligibility criteriaSources, published in English between 2011 and 2021, on institution-based VR in occupational therapy for MHSUs who had chronic mental illness in L-UMIC were included. We included primary studies of any design.Data extraction and synthesisThree reviewers used Mendeley to manage identified references, Rayyan for abstract and full-text screening and Microsoft Excel for data extraction. Data were sifted and sorted by key categories and themes.Results895 sources were identified, and their title and abstracts reviewed. 207 sources were included for full-text screening. 12 articles from 4 countries (South Africa, India, Brazil and Kenya) were finally included. Types of VR intervention included supported employment, case management and prevocational skills training. Client centeredness, support and empowerment were the key VR principles identified. Teaching of illness self-management, job analysis and matching, job coaching, trial placement, and vocational guidance and counselling were the main intervention strategies reported.ConclusionsVR intervention in institutions for MHSUs in L-UMIC revealed the multidimensional uniqueness of individual MHSU's vocational ability, needs and contexts. The interventions allowed client-centred approaches that offer support and empowerment beyond the boundaries of the institutions. Occupational therapists offering VR need to expand their interventions beyond their institutions to contexts where MHSUs are working or intending to work.
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