| Methods |
Random allocation not otherwise specified |
| Participants |
Men discharged after their first admission to the hospital for schizophrenia. Schizophrenia was defined according to the Chinese Medical Association criteria. Inclusion criteria were no serious concurrent medical illnesses, living within commuting distance of the hospital, and willingness to attend regular family intervention sessions. Mean age for the 78 men who were followed was 24 years. Occupation was the only baseline characteristic that was not the same in each group |
| Interventions |
Men in both groups came to the outpatient department by their own choice; no regular appointments were made and there was no routine follow‐up. Medication was obtained at these visits. Families and patients in the family intervention group were assigned to one of 2 counselors for their ongoing care, were invited to come to a discharge session that focused on education about the management of the patient's treatment, asked to come to a family group counseling session with other families 3 months after discharge, and then attend 3‐monthly group sessions with other families with similar patient problems. Non‐attendance triggered a visit from study staff. Each family was contacted at least once during the 18‐month follow‐up. Control group patients received no family interventions |
| Outcomes |
All patients were seen every 3 months by staff physicians, blinded to the group assignment, where medication status and adherence were assessed. Adherence was defined as taking at least 33% of dose prescribed at the time of the index discharge for at least 6 days/week. Non‐adherence was anything else. Readmission to hospital, the mean hospital‐free period for those who were readmitted, and BPRS and GAS scores were the treatment outcomes assessed |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail |
| Allocation concealment (selection bias) |
Unclear risk |
No information was provided about how allocation was handled is given |
| 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 |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Staff were blinded but, blinding may have been broken as noted in the limitations section. "This is a source of bias that we were not able to completely eliminate from this study; it may have had some effect on the assessment of the severity of symptoms." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) BPRS AND GAS SURVEYS ‐ Staff were blinded but, blinding may have been broken as noted in the limitations section. "This is a source of bias that we were not able to completely eliminate from this study; it may have had some effect on the assessment of the severity of symptoms." |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) BPRS AND GAS SURVEYS ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No information provided regarding the blinding key members other than assessors. Psychiatrists seeing the patients at their regular visits may have be unblinded |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) BPRS AND GAS SURVEYS ‐ Status of other personnel not reported |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ They imply that there are no missing data for adherence measurement. It seems unlikely that all the patients were interviewed for adherence because all interviews were conducted together; however. Thus, the risk of bias is unclear |
| Incomplete outcome data (attrition bias)
Patient outcome |
High risk |
(PRIMARY) BPRS AND GAS SURVEYS ‐ There is a high rate of missing data for BPRS and GAF assessment. From tables 5 and 6, it is clear that 11/39 were not assessed |
