| Methods |
Random allocation by means of a table of random numbers |
| Participants |
Patients between the ages of 18 and 65 who were admitted to hospital with acute psychosis over 8 months. Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised (DSM III‐R) diagnoses of subjects included schizophrenia, severe affective disorders, schizophreniform, schizoaffective disorder, delusional disorders, and psychotic disorder not otherwise classified. Non‐English speakers and subjects with low IQ scores, deafness, or organic brain disease were excluded |
| Interventions |
Control group treatment consisted of 4 to 6 supportive counseling sessions with the same therapist. Therapists listened to patient concerns but declined to discuss treatment. Experimental intervention treatment consisted of 4 to 6 sessions of "compliance therapy" ‐ a strategy that borrows from motivational interviewing. During session 1 and session 2, patients reviewed their illness and conceptualized the problem. In the next 2 sessions, patients focused on symptoms and the side effects of treatment. In the last 2 sessions, the stigma of drug treatment was addressed |
| Outcomes |
Adherence scores were measured using a 7‐point scale (1 = complete refusal to 7 = active participation and ready acceptance). Measures were obtained preintervention, postintervention, at 3‐month follow‐up and at 6‐month follow‐up. Outcome measures included ratings on a brief psychiatric rating scale, global functioning assessment, and dose of antipsychotic drug |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Used random number table. (pg 346) "Patients were randomly assigned by means of a table of random numbers to compliance therapy or control treatment." |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of allocation concealment. (pg 346) "Patients were randomly assigned by means of a table of random numbers to compliance therapy or control treatment." |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
Unclear risk |
The author note the following: (pg 348) "compliance rating at three months were made by a research psychiatrist (RK), who was not blind to intervention" |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) SELF REPORTED SCALE ‐ (pg 346) "Initial compliance was rated blind to intervention by the patients' primary nurses on a seven point rating scale." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) PSYCHIATRIC SYMPTOMS ‐ (pg 346) "6 month evaluation was conducted by an independent investigator blinded to intervention" "Initial compliance was rated blind to intervention by the patients' primary nurses on a seven point rating scale." |
| Blinding of participants (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORTED SCALE ‐ Control group were given non‐specific counseling ‐ same duration as intervention. No other effort to ensure blinding is not mentioned |
| Blinding of participants (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) PSYCHIATRIC SYMPTOMS ‐ Control group were given non‐specific counseling ‐ same duration as intervention. No other effort to ensure blinding is mentioned, therefore marked uncertain |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORTED SCALE ‐ Blinding of personnel other than data collectors not mentioned |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) PSYCHIATRIC SYMPTOMS ‐ Blinding of personnel other than data collectors not mentioned |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORTED SCALE ‐ Missing data uniform in 2 groups. Missing data for each outcome measure at different time points not included in the postintervention analysis. For example, compliance data were measured at 6 months in the control group for 18/22 (19%) subjects and 22/25 (12%) subjects. Not known whether this could have changed the results |
| Incomplete outcome data (attrition bias)
Patient outcome |
Low risk |
(PRIMARY) PSYCHIATRIC SYMPTOMS ‐ Psychiatric rating scale data for 4 subjects (19%) from control group missing and 3 (12%) from intervention group. Reasons for dropouts provided and dropouts were low |
