| Methods |
Random allocation, not otherwise specified |
| Participants |
Recently discharged patients with Present State Examination/CATEGO diagnoses of schizophrenia who were living with at least 1 parent, who exhibited high 'expressed emotion' on the Camberwell Family Interview |
| Interventions |
All patients had scheduled therapy and monthly medication appointments. Patients were allocated to family therapy or individual support sessions. All patients received oral neuroleptic medication (usually chlorpromazine) |
| Outcomes |
All patients were seen monthly by the prescribing psychiatrist, blinded to the group assignment, where medication status and adherence were assessed. Medication was adjusted based on mental status, side effects, and blood plasma levels. Patients with poor compliance for oral medications were given fluphenazine decanoate injections. Adherence was defined in 6 ways: number of missed appointments with psychiatrist; number of patients change to intramuscular depot medication; tablet‐taking compliance (pill counts, self reports by patient or family, and blood plasma levels); variability in plasma levels; mean and modal doses prescribed for each treatment group; mean plasma level in each group. Relapse was the treatment outcome (no information on how measured) |
| 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 |
| Selective reporting (reporting bias) |
High risk |
6 measures of compliance were reported in the method section; only a selected few were reported in the results section |
| Other bias |
Unclear risk |
Discussion notes results were confounded by pharmacotherapy, otherwise unclear |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) NUMBER OF MISSED APPOINTMENTS WITH PSYCHIATRIST ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk' |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) PLASMA LEVEL/PRESCRIBED DOSE RATIO ‐ No description of how the outcome was measured/calculated |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) NUMBER OF MISSED APPOINTMENTS WITH PSYCHIATRIST ‐ No mention of blinding of participants; although it should be very clear to the participants receiving a family therapy session. This may affect the number of appointments attended |
| Blinding of participants (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) PLASMA LEVEL/PRESCRIBED DOSE RATIO ‐ No description of how the outcome was measured/calculated |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) NUMBER OF MISSED APPOINTMENTS WITH PSYCHIATRIST ‐ Prescribing psychiatrist was blinded. "The prescribing psychiatrist, who was blind to the therapy assignment adjusted medication monthly on the basis of assessments of mental status..." (pg 88) |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) PLASMA LEVEL/PRESCRIBED DOSE RATIO ‐ No description of how the outcome was measured/calculated |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) NUMBER OF MISSED APPOINTMENTS WITH PSYCHIATRIST ‐ No incomplete outcome data were identified |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) PLASMA LEVEL/PRESCRIBED DOSE RATIO ‐ No description of how the outcome was measured/calculated |
