van Minnen 1997.
Methods | Study design: parallel RCT Types of interventions: Multidisciplinary team + Changes to the setting/site of service delivery + Continuity of care |
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Participants | Clinical problem: Persons with mild or borderline intellectual disability and serious mental illness (i.e. require in‐patient hospitalisation) Setting: Netherlands Sample size (N): I: 25; C: 25 Gender (male): 76% (for entire sample) Age (M, SD): I: 31.4 years (12.6); C: 31.0 (10.8) |
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Interventions | C: Standard hospital treatment: 48‐bed facility specialising in treatment of people with dual diagnosis. Interventions include: psychopharmacological medication, behavioural therapy, social skills training, education, structured daily activities.
(Patient contact 24 hours/day). I: Outreach treatment team: One member of team visits patient in home environment; works with care givers involved in daily life. Other interventions similar to C. (Interventions average 1 hour per week per patient). |
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Outcomes | Psychiatric symptoms: Psychopathology Inventory for Mentally Retarded Adults Subject Response (PIMRA‐SR); Psychopathology Inventory for Mentally Retarded Adults Informant response (PIMRA‐I); Reiss Screen for Maladaptive Behaviour Quality of life measure NR Care giver burden: Nijmegen Child‐Rearing Situation Questionnaire (NCSQ) |
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Notes | Differences in baseline measurement between groups adjusted using ANCOVA Authors also conducted equivalence testing |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of random sequence generation in the paper |
Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment in the paper. |
Baseline measurement? | Low risk | Baseline measurements were collected and were similar in both groups (Table 1) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “60 patients were randomized (30 patients to hospital treatment and 30 patients to outreach treatment). Ten patients (five in each group) dropped out before entering the study” (pg. 516) The final group of 50 patients were retained throughout the study |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Main outcomes were not objective. No description of blinding of outcome assessment described in paper. Participants and personnel not blinded to allocation. |
Proctection against contamination? | Low risk | "The outreach treatment group received treatment in their home environment, i.e., at home with their parents (n = 8), in sheltered accomodation (n = 7), in group homes or institutions for the care of mentally retarded people (n = 8), or in some other form of accomodation (n = 2)." (page 517). Unlikely that control group received treatment. No description of protection against contamination in the paper |
Selective reporting (reporting bias) | High risk | “The NCSQ was administered to both groups at baseline, and after 14 and 28 weeks only to the outreach treatment group. No 14‐ and 28‐week measurements were obtained in the hospital group because most of the patients had been relocated from an institution to the hospital and were no longer in contact with the carers from their original institution.” (pg. 518) |
Other bias | Unclear risk | "Equivalence testing (26, 27) was used to compare outreach and hospital treatment” (pg. 518) |
Characteristics of findings tables:
C: Control group conditions;
I: Intervention group conditions.
ID: intellectual disability.
ITS: interrupted time series.
RCT: randomised controlled trial.
CBA: controlled before and after study.
NR: not reported.
NS: not significant.
SD: standard deviation.
CI 95% confidence interval. * primary outcome was either identified by original study author or identified by review authors as best reflecting intervention