| Methods |
The selected patients were randomly assigned to the study group (n = 80), which received the culturally modified family therapy (CMFT), or control group (n = 86), which received the behavioral family therapy (BFT). Allocation was unblinded for treating psychiatrist and patient; outcome assessments were done by independent, blinded psychiatrists |
| Participants |
Recently discharged patients from the University Hospital with the diagnosis of schizophrenia (DSM‐IV). Inclusion criteria included: at least 2 previous psychiatric admissions (including the latest admission), aged between 17 to 55 years, staying with a responsible relative who is willing to be involved in the study, stabilized for at least 4 weeks (stabilization was defined as rating of 4 or less on the Brief Psychiatric Rating Scale (BPRS) psychotic items). Exclusion criteria not specified |
| Interventions |
The CMFT consists of a sociocultural approach of family education, drug intervention program and problem‐solving skills. The sociocultural approaches to family education include explanations of the concept of schizophrenia from a cultural perspective and an attempt to correct negative attitudes toward modern treatment. The family education and drug intervention was delivered as a package. The drug intervention program includes drug counseling [from Table 1] clear instruction about dose, frequency and possible side effects, the role of carers in supervision of medication at home, and close monitoring of compliance by a drug intake check‐list presented in every follow‐up visit. Both groups of patients received routine prescription of medication. It should be noted that 1 psychiatrist treated the intervention group throughout the study, and a 2nd psychiatrist treated the control group throughout the study. Patients in each group were followed up on the same schedule; monthly for the first 3 months and then every 6 weeks in the next 9 months |
| Outcomes |
Measurement of compliance: measured at the end of 6 months and 1 year after initiation of the intervention. Medication compliance was assessed through a semi‐structured interview with the carer and examination of the amount of unused medication. A home visit was made to assess unused medication "in doubtful cases". Drug compliance was measured globally as a percentage of the total prescribed drug dosage actually taken during the previous 6 months. The compliance was reported on a 6‐point ordinal scale, with 1 indicating non‐compliant, 2: 25% compliant, 3: 50% compliant, 4: 75% compliant, 5: 90% compliant and 6: 100% compliant. 90% compliance was considered to be an ideal level
Measurement of clinical health outcomes: measured at the end of 6 months and 1 year after initiation of the intervention. Frequency of symptoms exacerbation, psychosocial functioning and behavioral difficulties were measured. Symptomatic exacerbation was determined by BPRS ratings. A rating of 5 or above in one or more of the psychoticism scales indicated an exacerbation. Overall psychosocial function was rated using the Global Assessment of Function (GAF) of DSM‐IV, while the Social Behavior Schedule (SBS) measured the behavioral difficulties |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail. "The selected patients were randomly assigned to the study or control group" (pg 284) |
| Allocation concealment (selection bias) |
Unclear risk |
No information was provided about how allocation was handled |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
Low risk |
The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SEMI‐STRUCTURED INTERVIEW WITH CARER ‐ "Two independent psychiatrists (UAK and MS) who were blind to the treatment assignment carried out the assessments" (pg 285) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) EXACERBATIONS, PSYCHOSOCIAL FUNCTIONING AND BEHAVIORAL DIFFICULTIES ‐ "Two independent psychiatrists (UAK and MS) who were blind to the treatment assignment carried out the assessments" (pg 285) |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SEMI‐STRUCTURED INTERVIEW WITH CARER ‐ Patients could not be blinded; this is a subjective measure |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) EXACERBATIONS, PSYCHOSOCIAL FUNCTIONING AND BEHAVIORAL DIFFICULTIES ‐ This is a subjective measure |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SEMI‐STRUCTURED INTERVIEW WITH CARER ‐ Therapists were not blind to groups. "The two research psychiatrists treated the patients separately. The same psychiatrist throughout the study treated each group of patients. They were followed‐up on the same schedule; monthly for the first 3 months and then every 6 weeks in the next 9 months. SMR dealt with the study group while CIH treated the control group" (pg 285) |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) EXACERBATIONS, PSYCHOSOCIAL FUNCTIONING AND BEHAVIORAL DIFFICULTIES ‐ Therapists were not blind to groups. "The two research psychiatrists treated the patients separately. The same psychiatrist throughout the study treated each group of patients. They were followed‐up on the same schedule; monthly for the first 3 months and then every 6 weeks in the next 9 months. SMR dealt with the study group while CIH treated the control group" (pg 285) |
| Incomplete outcome data (attrition bias)
Adherence measure |
High risk |
(PRIMARY) SEMI‐STRUCTURED INTERVIEW WITH CARER ‐ There is a greater dropout rate in the control group. Authors address this in the discussion. "It could be argued that the significantly greater number of drop‐outs in the control group would bias the results but the bias would probably be to produce worse outcomes in the study group. The most likely reason for a drop out is a poor outcome" (pg 287) |
| Incomplete outcome data (attrition bias)
Patient outcome |
High risk |
(PRIMARY) EXACERBATIONS, PSYCHOSOCIAL FUNCTIONING AND BEHAVIORAL DIFFICULTIES ‐ There is a greater dropout rate in control group. The authors address this in the discussion. "It could be argued that the significantly greater number of drop‐outs in the control group would bias the results but the bias would probably be to produce worse outcomes in the study group. The most likely reason for a drop out is a poor outcome" (pg 287) |
