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. 2021 Aug 5;2021(8):CD009149. doi: 10.1002/14651858.CD009149.pub3

Tan 2005.

Study characteristics
Methods Study design: RCT  
Duration of study: May 2003 to June 2004  
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  
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
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 
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 
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