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      Independent Housing and Support for non-homeless individuals with severe mental illness: randomised controlled trial vs. observational study – study protocol

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          Abstract

          Background

          Social inclusion is essential for an adequate rehabilitation process for people with serious mental illness (SMI). Various supported housing settings aim to promote housing competencies and social inclusion in service users. Nevertheless, there is a strong preference in service users for independent living. We aim to evaluate the effectiveness and efficiency of Independent Housing and Support (IHS) compared to institutionalised residential care settings and other treatment as usual conditions (RCS/TAU) in two cities in Switzerland.

          Methods

          This is a prospective multi-centre, four-arm, non-inferiority cohort study investigating the effectiveness and efficiency of IHS and RCS/TAU for people with SMI. Effectiveness will be measured by a standardised measure of social inclusion as primary outcome as well as by measures of functioning and well-being. Efficiency will be analysed on the basis of service usage and costs associated with the different housing settings. Participants will be consecutively recruited and subsequently enrolled between April 2019 and December 2020 and assessed at baseline and after six, twelve and after 24 months. At one study site, 56 participants will be randomly assigned to one of the conditions; the other study site will be conducted as an observational study investigating 112 admitted participants.

          Discussion

          While the UN Convention of the Rights of People with Disabilities aims to promote the opportunity to choose one’s place of residence, the limited supply of alternative forms of housing does not guarantee genuine freedom of choice. Increased diversification and flexibility of housing support is essential. If IHS shows non-inferiority in terms of their effectiveness and efficiency, users should be allowed to choose their kind of housing support.

          Trial registration

          ClinicalTrials.gov: NCT03815604, December 04, 2019. 

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          Most cited references55

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          Global assessment of functioning. A modified scale.

          The modified Global Assessment of Functioning (GAF) scale has more detailed criteria and a more structured scoring system than the original GAF. The two scales were compared for reliability and validity. Raters who had different training levels assigned hospital admission and discharge GAF scores from patient charts. Intraclass correlation coefficients for admission GAF scores were higher for raters who used the modified GAF (0.81), compared with raters who used the original GAF (0.62). Validity studies showed a high correlation (0.80) between the two sets of scores. The modified GAF also correlated well with Zung Depression scores (-0.73). The modified GAF may be particularly useful when interrater reliability needs to be maximum and/or when persons with varying skills and employment backgrounds--and without much GAF training--must rate patients. Because of the increased structure, the modified GAF may also be more resistant to rater bias.
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            Statistical Criteria for Selecting the Optimal Number of Untreated Subjects Matched to Each Treated Subject When Using Many-to-One Matching on the Propensity Score

            Propensity-score matching is increasingly being used to estimate the effects of treatments using observational data. In many-to-one (M:1) matching on the propensity score, M untreated subjects are matched to each treated subject using the propensity score. The authors used Monte Carlo simulations to examine the effect of the choice of M on the statistical performance of matched estimators. They considered matching 1–5 untreated subjects to each treated subject using both nearest-neighbor matching and caliper matching in 96 different scenarios. Increasing the number of untreated subjects matched to each treated subject tended to increase the bias in the estimated treatment effect; conversely, increasing the number of untreated subjects matched to each treated subject decreased the sampling variability of the estimated treatment effect. Using nearest-neighbor matching, the mean squared error of the estimated treatment effect was minimized in 67.7% of the scenarios when 1:1 matching was used. Using nearest-neighbor matching or caliper matching, the mean squared error was minimized in approximately 84% of the scenarios when, at most, 2 untreated subjects were matched to each treated subject. The authors recommend that, in most settings, researchers match either 1 or 2 untreated subjects to each treated subject when using propensity-score matching.
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              Health of the Nation Outcome Scales (HoNOS). Research and development.

              An instrument was required to quantify and thus potentially measure progress towards a Health of the Nation target, set by the Department of Health, "to improve significantly the health and social functioning of mentally ill people". A first draft was created in consultation with experts and on the basis of literature review. This version was improved during four stages of testing: two preliminary stages, a large field trial involving 2706 patients (rated by 492 clinicians) and tests of the final Health of the Nation Outcome Scales (HoNOS), which included an independent study (n = 197) of reliability and relationship to other instruments. The resulting 12-item instrument is simple to use, covers clinical problems and social functioning with reasonable adequacy, has been generally acceptable to clinicians who have used it, is sensitive to change or the lack of it, showed good reliability in independent trials and compared reasonably well with equivalent items in the Brief Psychiatric Rating Scales and Role Functioning Scales. The key test for HoNOS is that clinicians should want to use it for their own purposes. In general, it has passed that test. A further possibility, that HoNOS data collected routinely as part of a minimum data set, for example for the Care Programme Approach, could also be useful in anonymized and aggregated form for public health purposes, is therefore testable but has not yet been tested.
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                Author and article information

                Contributors
                christine.adamus@upd.unibe.ch
                Journal
                BMC Psychiatry
                BMC Psychiatry
                BMC Psychiatry
                BioMed Central (London )
                1471-244X
                19 June 2020
                19 June 2020
                2020
                : 20
                : 319
                Affiliations
                [1 ]GRID grid.412559.e, ISNI 0000 0001 0694 3235, Center for Psychiatric Rehabilitation, , Universitäre Psychiatrische Dienste Bern (UPD), ; Murtenstrasse 46, CH-3008 Bern, Switzerland
                [2 ]GRID grid.5734.5, ISNI 0000 0001 0726 5157, University Hospital of Psychiatry and Psychotherapy, , University of Bern, ; Bern, Switzerland
                [3 ]GRID grid.412004.3, ISNI 0000 0004 0478 9977, Department of Psychiatry, Psychotherapy and Psychosomatics, , University Hospital of Psychiatry Zurich, ; Zurich, Switzerland
                [4 ]GRID grid.483003.c, Psychiatrie Baselland, ; Liestal, Switzerland
                [5 ]GRID grid.424060.4, ISNI 0000 0001 0688 6779, Departement of Health Professions, , Bern University of Applied Sciences, ; Bern, Switzerland
                Author information
                http://orcid.org/0000-0002-5215-4226
                Article
                2712
                10.1186/s12888-020-02712-y
                7304176
                32560681
                07666e71-b23a-4261-9d68-59a8dff2f51d
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 29 April 2020
                : 1 June 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001711, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung;
                Award ID: 10531C_179451
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2020

                Clinical Psychology & Psychiatry
                residential rehabilitation,supported housing,non-homeless people,serious mental illness,randomised controlled trial,observational study design,non-inferiority

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