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

Li 2002.

Study characteristics
Methods Study design: RCT 
Duration of study; 9 months. Recruitment between June 1999 and March 2001. Intervention lasted 50 to 51 days. Follow‐up assessments 6 months post intervention   
Participants Country: China 
Income classification: lower‐middle income between 1999 and 2002  
Geographical scope: rural 
Healthcare setting: home and community 
Mental health condition: schizophrenia (specifically late‐onset) 
Population (mention if patient, carer, or dyad) 
1. Age: 50 years and older 
2. Gender: both 
3. Socioeconomic background: over 80% were farmers 
4. Inclusion criteria 
a. Met Chinese Classification of Mental Disorder (CCMD)‐2‐R criteria for schizophrenia
b. Age 50 and above
c. First episode of illness 
5. Exclusion criteria: nil 
Interventions Stated purpose: to determine the efficacy of community rehabilitation for patients with late‐onset schizophrenia 
INTERVENTION (n = 38) 
Name: community rehabilitation 
Delivered by: PHP
Title/name of PW and number: village and street‐level doctors ‐ number not specified  
1. Selection: existing infrastructure 
2. Educational background: medical degree 
3. Training (contents, duration, by whom): briefed by a hospital community medicine doctor regarding general mental health prevention and treatment and specific issues to take note of   
4. Supervision: hospital community medicine doctor in charge of patient 
Intervention details: home visits and telephone enquiries 
1. Duration/frequency: duration 50.12 ± 28.19 days, frequency of home visits at least weekly, telephone enquiries as needed  
2. Content of intervention (by types of health workers and per patients/carers): medication following specific guidelines (see below), counselling, requested work, social activities 
CONTROL (n = 38)
Specialist care ‐ inpatient care; doctors in charge were psychiatrists, treated mainly with medication according to guidelines (same as intervention group), supplemented by occupational therapy and psychotherapy. Duration 51.03 ± 29.17 days 
CO‐INTERVENTIONS: medication guidelines were to begin with a low dose of a typical antipsychotic such as perphenazine, gradually increased as needed up to 29.05 ± 9.83 mg/d, to add on sulpiride up to 200mg/d for depressed mood, apathy, or withdrawal, and to add on alprazolam if there was obvious insomnia      
Outcomes Patients 
1. Recovery (BPRS reduced by ≥ 80%) 
2. BPRS 
3. SDSS 
4. Relapse (reappearance of symptoms or worsening of original symptoms requiring medication modification)
5. Disease much improved (BPRS reduced by ≥ 60%)#
6.Disease improved (BPRS reduced by ≥ 30%)# 
7. Disease showing no improvement (BPRS reduction <3 0%)# 
Carers 
Nil 
Process/health workers
Nil 
Economic outcomes 
Direct costs of treatment (page 2 of article (page 712 of journal), right column, paragraph numbered “4”) 
(asterisk for study's primary outcomes; star: outcomes that we have not reported in this review) 
Time points: 0 months, 6 months 
Notes Article in Chinese
Source of funding: none 
Notes on validation of instruments (screening and outcomes): validated 
Additional information: declarations of interest ‐ none
Handling the data: none 
Prospective trial registration number: none 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement comment: randomised based on sequence of admission to hospital
Allocation concealment (selection bias) High risk Judgement comment: no description of any efforts to conceal allocation
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No effort to blind participants was mentioned in the paper
Blinding of outcome assessment (detection bias)
all outcomes High risk No attempt at blinding researchers was mentioned in the paper
Baseline outcome measurements similar Low risk Baseline outcome measures (table 2 ‐ BPRS, table 3 ‐ SDSS) were similar in both groups
Baseline characteristics similar? Low risk Baseline characteristics (age, gender, occupation, education, marital status, family history) were similar in both arms
Incomplete outcome data (attrition bias)
Efficacy data Low risk There is no attrition in this study
Protection against contamination Low risk Judgement comment: groups were treated in different settings (hospital, community); therefore unlikely to contaminate each other
Selective reporting (reporting bias) Unclear risk All outcomes planned in materials and methods section were reported in results section. No clinical trial protocol is available 
Other bias Low risk No other sources of bias have been found