| Methods |
Random allocation, not otherwise specified |
| Participants |
63 DSM‐III‐R Chinese schizophrenic patients living with family members |
| Interventions |
Standard care (medication prescription at hospital discharge plus laissez faire follow‐up on patient's or family's initiative) versus a family‐based intervention that included monthly 45‐minute counseling sessions focused on the management of social and occupational problems, medication management, family education, family group meetings, and crisis intervention |
| Outcomes |
Medication usage was assessed by family member reports. Time for which the patient took more than 50% of prescribed dosage was the measure for comparison of groups. Psychiatric outcomes were assessed at 6, 12, and 18 months following hospital discharge by observers who were trained clinical researchers, blinded to study group allocation |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization was not described in detail. "...they were randomly assigned to family intervention (experimental) or the standard care (control) group." (pg 240) |
| 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) SELF REPORT (BY FAMILY MEMBER) ‐ Assessors were blind. At 6‐month intervals after discharge 2 experienced clinical researchers who were blind to patients' treatment status conducted home interviews with patients and family members to assess patients' clinical and social functioning over the previous 6 months |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) BRIEF PSYCHIATRIC RATING SCALE (BPRS) ‐ Assessors were blind. At 6‐month intervals after discharge 2 experienced clinical researchers who were blind to patients' treatment status conducted home interviews with patients and family members to assess patients' clinical and social functioning over the previous 6 months |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) SCALE OF ASSESSMENT (SANS) OF NEGATIVE SYMPTOMS ‐ Assessors were blind. At 6‐month intervals after discharge 2 experienced clinical researchers who were blind to patients' treatment status conducted home interviews with patients and family members to assess patients' clinical and social functioning over the previous 6 months |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) SCALE FOR ASSESSMENT OF POSITIVE SYMPTOMS (SAPS) ‐ Assessors were blind. At 6‐month intervals after discharge 2 experienced clinical researchers who were blind to patients' treatment status conducted home interviews with patients and family members to assess patients' clinical and social functioning over the previous 6 months |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT (BY FAMILY MEMBER) ‐ Family members reported adherence; therefore, a subjective measure. No mention of blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) BRIEF PSYCHIATRIC RATING SCALE (BPRS) ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) SCALE OF ASSESSMENT (SANS) OF NEGATIVE SYMPTOMS ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) SCALE FOR ASSESSMENT OF POSITIVE SYMPTOMS (SAPS) ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT (BY FAMILY MEMBER) ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) SCALE OF ASSESSMENT (SANS) OF NEGATIVE SYMPTOMS ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) SCALE FOR ASSESSMENT OF POSITIVE SYMPTOMS (SAPS) ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) BRIEF PSYCHIATRIC RATING SCALE (BPRS) ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Incomplete outcome data (attrition bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT (BY FAMILY MEMBER) ‐ Unclear number of dropouts/losses to follow‐up. As treated analysis was performed even though rate of compliance was low. The statistical plan was not described. 32% non‐attendance rate in the intervention group. The rates of noncompliance with the individual family sessions in patients and family members were 23% and 27% |
| Incomplete outcome data (attrition bias)
Patient outcome |
High risk |
(PRIMARY) SCALE OF ASSESSMENT (SANS) OF NEGATIVE SYMPTOMS ‐ As treated analysis was performed even though rate of compliance was low. The statistical plan was not described. 32% non‐attendance rate in the intervention group. The rates of non‐compliance with the individual family sessions in patients and family members were 23% and 27% |
| Incomplete outcome data (attrition bias)
Patient outcome |
High risk |
(PRIMARY) BRIEF PSYCHIATRIC RATING SCALE (BPRS) ‐ As treated analysis performed even though rate of compliance was low. Statistical plan was not described. 32% non‐attendance rate in the intervention group. The rates of noncompliance with the individual family sessions in patients and family members were 23% and 27%. Likely to be high risk of bias |
| Incomplete outcome data (attrition bias)
Patient outcome |
High risk |
(PRIMARY) SCALE FOR ASSESSMENT OF POSITIVE SYMPTOMS (SAPS) ‐ As treated analysis was performed even though rate of compliance was low. The statistical plan was not described. 32% non‐attendance rate in the intervention group. The rates of noncompliance with the individual family sessions in patients and family members were 23% and 27% |
