Abstract:Background
Evidence on the effectiveness of Independent Supported Housing (ISH) for non-homeless people with severe mental illness primarily comes from observational cohort studies, which have high risk of bias due to confounding by time-invariant sample characteristics. The present study proposes an alternative study design known from pharmacology to overcome this bias and strengthen evidence.
Methods
We conducted a retrospective mirror-image anal… Show more
“…In addition to the OS design, other quantitative study designs should be explored to complement existing evidence. For example, the self-controlled mirror-image design known from pharmacology has been shown to overcome the risk of confounding owing to time-invariant sample characteristics because every subject acts as its own control ( 60 , 61 ). This design allows for causal inference when time-variant confounding (i.e., regression toward the mean) is adequately addressed ( 60 ).…”
BackgroundNo randomised controlled study (RCT) on the effectiveness of Independent Supported Housing (ISH) vs. housing as usual (HAU) settings for non-homeless individuals with severe mental illness (SMI) has been conducted to date because of limited feasibility. Alternative designs, such as observational studies, might be suitable for providing adequate evidence if well conducted. To test this hypothesis, this article reports on a prospective, direct comparison of the designs of two parallel studies in this field.MethodsA two-centre, parallel-group non-inferiority effectiveness study was conducted at two locations in Switzerland using identical instruments and clinical hypotheses. One centre applied an RCT design and the other an observational study (OS) design with propensity score methods (ClinicalTrials.gov: NCT03815604). The comparability of the two study centres was investigated in terms of participants, procedures, and outcomes. The primary outcome was social inclusion and the secondary outcomes were quality of life and psychiatric symptoms.ResultsThe study included 141 participants (RCT: n = 58; OS: n = 83). Within one year, 27% study dropouts occurred (RCT: 34%; OS: 22%). A similar balance of sample characteristics was achieved in the RCT and the OS using propensity score methods (inverse probability of treatment weighting). After one year, ISH was non-inferior to the control condition regarding social inclusion (mean differences [95% CI]) in the RCT (6.28 [–0.08 to 13.35]) and the OS (2.24 [–2.30 to 6.77]) and showed no significant differences in quality of life (RCT: 0.12 [–0.52 to 0.75]; OS: 0.16 [–0.26 to 0.58]) and symptoms (RCT: –0.18 [–0.75 to 0.40]; OS: 0.21 [–0.17 to 0.60]) in both study centres. However, strong and persistent preferences for ISH in the RCT control group reduced participants’ willingness to participate. Because of several limitations in the RCT, the results of the RCT and the OS are not comparable.ConclusionParticipants were comparable in both study sites. However, there were significant problems in conducting the RCT because of strong preferences for ISH. The OS with propensity score methods provided results of more stable groups of participants and revealed balanced samples and valid outcome analysis. Our results do not support further investment in RCTs in this field.
“…In addition to the OS design, other quantitative study designs should be explored to complement existing evidence. For example, the self-controlled mirror-image design known from pharmacology has been shown to overcome the risk of confounding owing to time-invariant sample characteristics because every subject acts as its own control ( 60 , 61 ). This design allows for causal inference when time-variant confounding (i.e., regression toward the mean) is adequately addressed ( 60 ).…”
BackgroundNo randomised controlled study (RCT) on the effectiveness of Independent Supported Housing (ISH) vs. housing as usual (HAU) settings for non-homeless individuals with severe mental illness (SMI) has been conducted to date because of limited feasibility. Alternative designs, such as observational studies, might be suitable for providing adequate evidence if well conducted. To test this hypothesis, this article reports on a prospective, direct comparison of the designs of two parallel studies in this field.MethodsA two-centre, parallel-group non-inferiority effectiveness study was conducted at two locations in Switzerland using identical instruments and clinical hypotheses. One centre applied an RCT design and the other an observational study (OS) design with propensity score methods (ClinicalTrials.gov: NCT03815604). The comparability of the two study centres was investigated in terms of participants, procedures, and outcomes. The primary outcome was social inclusion and the secondary outcomes were quality of life and psychiatric symptoms.ResultsThe study included 141 participants (RCT: n = 58; OS: n = 83). Within one year, 27% study dropouts occurred (RCT: 34%; OS: 22%). A similar balance of sample characteristics was achieved in the RCT and the OS using propensity score methods (inverse probability of treatment weighting). After one year, ISH was non-inferior to the control condition regarding social inclusion (mean differences [95% CI]) in the RCT (6.28 [–0.08 to 13.35]) and the OS (2.24 [–2.30 to 6.77]) and showed no significant differences in quality of life (RCT: 0.12 [–0.52 to 0.75]; OS: 0.16 [–0.26 to 0.58]) and symptoms (RCT: –0.18 [–0.75 to 0.40]; OS: 0.21 [–0.17 to 0.60]) in both study centres. However, strong and persistent preferences for ISH in the RCT control group reduced participants’ willingness to participate. Because of several limitations in the RCT, the results of the RCT and the OS are not comparable.ConclusionParticipants were comparable in both study sites. However, there were significant problems in conducting the RCT because of strong preferences for ISH. The OS with propensity score methods provided results of more stable groups of participants and revealed balanced samples and valid outcome analysis. Our results do not support further investment in RCTs in this field.
“…According to the existing research literature, these instruments have been shown to reduce coercive admissions (de Jong et al, 2016). Residential support services have also been shown to have a preventive effect on admission to psychiatric hospitals (Adamus et al, 2022a, Adamus et al, 2022b. A consistent expansion of outpatient support services, even outside of crisis situations, could make a significant contribution to reducing inpatient stays.…”
Section: Dilemmas Of a Consistent Human Rights Implementation In Psyc...mentioning
The use of coercion in psychiatry has been controversial for decades. With the United Nations Convention on the Rights of Persons with Disabilities from 2006, the discussion about the legitimisation or abolition of measures against the will of the people affected has taken on new implications. From the perspective of the Convention, the use of coercion is a violation of human rights. This chapter traces the discussions and arguments that have arisen in connection with the human rights perspective against the use of coercion in psychiatry.
“…In addition, they generally include representative samples, testing objective outcome variables, such as the number of hospital admissions or emergency department visits. 19 , 21 , 22 However, evidence from mirror-image studies investigating LAIs in BD is scattered and has not been systematically evaluated so far. This would be helpful to clarify the possible role of LAIs for the maintenance treatment of BD from the relevant body of evidence accumulated in the last few years.…”
Clinical trials and real-world data have shown that long-acting injectable antipsychotics (LAIs) might be an effective therapeutic option also for people with bipolar disorder (BD). However, complementing evidence from mirror-image studies investigating LAIs in BD is scattered and has not been systematically evaluated so far. We thus performed a review of observational mirror-image studies testing the effectiveness of LAI treatment on clinical outcomes in people with BD. Embase, MEDLINE, and PsycInfo electronic databases were systematically searched (via Ovid) up to November 2022. We included six mirror-image studies that compared relevant clinical outcomes between the 12-months after (post-treatment period) and the 12-months before (pre-treatment period) the initiation of a LAI treatment in adults with BD. We found that LAI treatment is associated with a significant reduction in days spent in hospital and number of hospitalizations. Moreover, LAI treatment seems to be associated with a significant decrease in the proportion of individuals with at least one hospital admission, even though data on this outcome were reported by just two studies. In addition, studies consistently estimated a significant reduction of hypo-/manic relapses after LAI treatment initiation, while the effect of LAIs for depressive episodes is less clear. Finally, LAI treatment initiation was associated with a lower number of emergency department visits in the year after LAI initiation. The findings of this review seem to suggest that the use of LAIs is an effective strategy to improve major clinical outcomes in people with BD. Nonetheless, additional research, based on standardized assessments of prevalent polarity and relapses, is needed to identify the clinical characteristics of individuals with BD who are most likely to benefit from a LAI treatment.
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