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Trial participant representativeness compared to ordinary service users in a work rehabilitation setting.

ABSTRACT: Background: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. Method:The AWaC trial was a multicenter RCT conducted at six different treatment centers (n = 1193). After the trial was over, the centers were upheld and run as ordinary services. At that time, we surveyed 80 ordinary service users with the same baseline questionnaire as used in the trial, and compared them with those who participated in the trial. Results:There were a higher proportion of people with the highest level of education (4 years or more at university/college) in the post-trial comparison sample. This sample also reported to be "dissatisfied" with their job more often, but rated their chances for return to work as "bad" less often than the ordinary trial participants. No further significant differences between the two samples in any of the other education categories, or for any of the other demographic, health or work related comparisons were found. Discussion:Participation bias is likely to depend on study context, but in the setting of a trial to help improve work participation among people who struggle with common mental disorders, the trial participants were overall very similar to those who sought the same services as ordinary practice.

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]

PMID: 29736442

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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.

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.

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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Trial participant representativeness compared to ordinary service users in a work rehabilitation setting.

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Trial participant representativeness compared to ordinary service users in a work rehabilitation setting.

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