Tan 2005.
Study characteristics | ||
Methods |
Study design: RCT Duration of study: May 2003 to June 2004 |
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Participants |
Country: China Income classification: lower‐middle income Geographical scope: rural Healthcare setting: community health service centre and participants’ homes Mental health condition: schizophrenia Population 1. Age: 24 to 63 years 2. Gender: both 3. Socioeconomic background: not specified 4. Inclusion criteria a. Patients who met criteria for schizophrenia who received care in a community area in Enshi City between 2003 and 2005 and between 2004 and 2006 5. Exclusion criteria a. Severe debility b. Comorbid physical illness |
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Interventions |
Stated purpose: to study the impact of community management and economic factors on efficacy of treatment for patients with schizophrenia and the burden on their families INTERVENTION (n = 80) Name: community observational group Delivered by: PHP (community doctor) Title/name of PW and number: community doctors ‐ number not specified 1. Selection: from community health service centre 2. Educational background: medical degree 3. Training (contents, duration, by whom): not specified 4. Supervision: not specified Intervention details: collaborative involving mental health professionals (psychiatrists and therapists), community doctor, and caregiver 1. Duration/frequency: 12 months/monthly follow‐up 2. Content of intervention (by types of health workers and per patients/carers): community doctors ensured that participants’ rehabilitation plans were followed and solved routine problems as they arose. Mental health professionals developed care plan including pharmacological treatment using convenient and effective therapies such as depot or oral antipsychotics, with medication dosages equivalent to chlorpromazine at 238 mg ± 9.67mg/d, gave monthly educational seminars, and individualised family therapy; they were on hand for guidance and questions CONTROL (n = 80) Participants went to hospital for treatment when their disease became active, where they received medications (dosages equivalent to chlorpromazine 242 mg ± 10.53 mg/d) CO‐INTERVENTIONS: both groups received similar types and dosages of medications |
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Outcomes |
Patients 1. BPRS 2. SDSS 3. Medication compliance (#) 4. Relapse Carers Nil Process/health workers Nil Economic outcomes 1. Healthcare costs of prevention and treatment of schizophrenia 2. Economic losses caused by missed work (patients and family members reported separately) due to health (Table 2) (asterisk for study's primary outcomes; star: outcomes that we have not reported in this review) Time point: 0 months |
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Notes | Article in Chinese Source of funding: National Science Program of Hebei Department of Education Notes on validation of instruments (screening and outcomes): validated Additional information: declarations of interest ‐ none Handling the data (e.g. imputed values/other calculations we have made): nil Prospective trial registration number: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding in the paper |
Blinding of outcome assessment (detection bias) all outcomes | High risk | No mention of blinding in the paper |
Baseline outcome measurements similar | Low risk | 2 groups had similar baseline BPRS scores, SDSS scores, and medication compliance rates |
Baseline characteristics similar? | Low risk | 2 groups were similar in gender distribution, age, and duration of disease |
Incomplete outcome data (attrition bias) Efficacy data | Low risk | No attrition |
Incomplete outcome data (attrition bias) Safety data (e.g. adverse events) | Low risk | No attrition |
Protection against contamination | Low risk | No risk of contamination between groups (different setting) |
Selective reporting (reporting bias) | Unclear risk | No clinical trial protocol available; all outcomes described in methods section reported in results section |
Other bias | Low risk | No comments |