| Methods |
Patients were randomly assigned to 2 groups of 28 patients each. No statement concerning concealment of randomization |
| Participants |
Patients were included if they had an ICD‐10 diagnosis of functional psychosis, were clinically stable, living in the community, and receiving antipsychotic medication for at least 6 months. Patients were excluded if they were prescribed clozapine or were hospital in‐patients. 60 patients were approached. 56 patients agreed to participate |
| Interventions |
The study group participated in a discussion about the risks and benefits of neuroleptic medications based on individual semi‐structured educational sessions with reference to a standardized information sheet modified from Kleinman et al (1989). The patients were asked whether they had heard of tardive dyskinesia (TD). The common movements of TD were modeled and the patients were asked whether they thought they had the condition or had seen others with it. They were informed that they were receiving an antipsychotic drug and were given information about extrapyramidal symptoms and TD, its risk factors, prevalence, treatment, potential irreversibility and the 1% risk of TD in non‐antipsychotic‐treated patients. They were told that gradual discontinuation of antipsychotic medication was the best way to prevent the condition but if done abruptly carries a high risk of relapse and of precipitating TD. It was stated that the optimum maintenance treatment, taking into account its risks and benefits, was to use the lowest dose of antipsychotic drug that would keep them well. Most importantly, they were asked not to make any changes to their treatment without discussion with their psychiatrist. Finally, they were given the opportunity to ask questions in an informal interactive session lasting 30 minutes, and were given an information sheet for reference. The control group received usual care |
| Outcomes |
1. Relapse, defined as a period of hospitalization, evidence of clear clinical deterioration in the case notes or in discussion with the keyworker, or evidence of deterioration at follow‐up interview. 2. Increase in antipsychotic dose of > 200 mg chlorpromazine equivalents. 3. If the patient missed more than 2 weeks of their antipsychotic medication they were considered non‐compliant |
| Notes |
In this study, the intent was not to increase compliance, rather to test whether information about benefits and adverse effects of the treatment would decrease compliance |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random number sequence generation not described. (pg 79) "Those who agreed to be interviewed were randomly assigned to two groups, each of 28 patients." |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation not described |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available |
| Other bias |
High risk |
Authors note in discussion that control participants might have inquired and received education. Potential Hawthorne effect noted (pg 3). In the community teams and control patients, there was surprisingly little opposition to the study. All consultant psychiatrists gave agreement for a researcher to recruit patients but some team members declined permission. It was essential to brief the teams about the nature of the study and how previous work had shown good clinical outcome, because key workers or psychiatrists were likely to be asked by patients or their relatives to explain about tardive dyskinesia. The modest gain in knowledge by the control patients could have resulted from the community teams' awareness of the study (the Hawthorne effect) or enquiry about tardive dyskinesia after exposure to the questionnaire |
| Blinding of outcome assessment (detection bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ (pg 80) "The researcher was not blind to the study and control groups." |
| Blinding of outcome assessment (detection bias)
Patient outcome |
High risk |
(PRIMARY) RELAPSE ‐ (pg 80) "The researcher was not blind to the study and control groups." |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No blinding; subjective outcome |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) RELAPSE ‐ it is unlikely that this measure could be influenced by patient's knowledge of their group membership |
| Blinding of personnel (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ (pg 80) "The researcher was not blind to the study and control groups." |
| Blinding of personnel (performance bias)
Patient outcome |
High risk |
(PRIMARY) RELAPSE ‐ (pg 80) "The researcher was not blind to the study and control groups." |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ Insufficient reporting of details regarding missing data |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) RELAPSE ‐ Insufficient missing data information |
