Hassiotis 2001.
Methods | Study design: parallel RCT Types of interventions: Multidisciplinary team + Continuity of care |
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Participants | Clinical problem: Patients with severe psychotic illness with mild intellectual disability (IQ range 51‐70) or borderline IQ (IQ range 71‐85) Setting: London and Manchester, England Sample size (N): I: 50; C: 54 Gender (male): 65% (for entire sample) Age (median): 36.5 years |
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Interventions | C: Standard mainstream case management: Case manager is trained mental health professional responsible for direct care and coordinating health and social inputs outside of hospital; member of multidisciplinary team (1 case manager: 30‐35 clients). I: Intensive mainstream case management. Same as C but smaller case load (1 case manager: 10‐15 clients). |
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Outcomes | Mean number of days in hospital for psychiatric reasons Quality of life: Lancashire quality of life profile Burden measures NR |
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Notes | Results are from larger study including persons without low IQ score. 95% confidence intervals show effect of intervention in persons with lower IQ. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation done by an independent statistical centre. |
Allocation concealment (selection bias) | Low risk | A centralised randomisation scheme was used. |
Baseline measurement? | Low risk | Baseline measurements were collected and were similar in both groups. Analyses were performed adjusting for baseline levels. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up < 90% for objective outcomes; missing data between 2% and 32% for subjective outcomes. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Main outcomes for this sub‐study were objective (costs and days in hospital). Participants and personnel not blinded to allocation. |
Proctection against contamination? | Unclear risk | No description of protection again contamination provided in paper. |
Selective reporting (reporting bias) | Low risk | Main outcomes prespecified by the protocol included in the final report (hospital admission and length of stay; met and unmet needs; patient satisfaction; contact with case managers, cost‐effectiveness; referral and service utilisation). Medication compliance and added cost‐effectiveness not reported. |
Other bias | Unclear risk | No other biases were reported in the paper. |