Merinder 1999.
| Methods | Patients were block‐randomized, stratified for gender and for illness duration. The randomization was carried out by an independent institution. Due to the nature of the intervention, patients could not be blinded. Ratings of psychopathology and psychosocial function were performed by researchers who were not informed of treatment allocation. Relapse and compliance outcomes were assessed by researchers blind to the allocation of the patients | |
| Participants | Patients aged 18 to 49 years and a clinical ICD‐10 diagnosis of schizophrenia and in treatment at the time of recruitment were included. Patients were included based on a clinical diagnosis, validated by the use of operational criteria checklist for psychotic and affective illness (OPCRIT) on case records | |
| Interventions | The control group received usual treatment provided in community psychiatry. The experimental group received an 8‐session intervention using a mainly didactic interactive method. The program was standardized with a manual for group leaders, overhead presentations, and a booklet for participants. Patient and relative interventions were conducted separately, with group sizes in both patient and relative groups of 5 to 8 participants. The program was the same for both patients and relatives, and sessions were conducted weekly | |
| Outcomes | Compliance measurements: compliance measures were made at baseline and at follow‐up (12 months after start of intervention). A non‐compliance episode was rated if the case notes indicated that the patient did not receive medication for a period of 14 days Measurement of clinical health outcomes: patient outcome measures included knowledge, relapse, psychosocial function, insight and satisfaction. The following scales were used: OPCRIT ‐ operational criteria checklist for psychotic illness; BPRS‐ brief psychiatric rating scale; GAF ‐ global assessment of function; IS ‐ insight scale; VSS ‐ Vern service satisfaction scale. Also, knowledge of schizophrenia was evaluated |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The authors note that the randomization was carried out by an independent institution (Department of Biostatistics at the University of Aarhus, Denmark) |
| Allocation concealment (selection bias) | Low risk | The authors note that the randomization was carried out by an independent institution (Department of Biostatistics at the University of Aarhus, Denmark) |
| 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 | Unclear risk | Authors note in the discussion that the study used mainly validated and reliable instruments, tested inter‐rater reliability, and included control of medication dose. However, a blind assessment of psychopathology (BPRS) and psychosocial function (GAF) was not attained. The use of a non‐validated ad hoc instrument to measure knowledge and a compliance measure based on case records, which did not include urine testing or pill count, to some extent also limits the validity of findings. Furthermore, the power of the study and the generalizability of the findings are limited by the low eligibility of patients to the study and the resulting small sample size. The represent activity analysis indicated that the sample was skewed in the direction of more self destructive behavior diagnoses, fewer substance abuse diagnoses and towards shorter illness duration (pg 291) |
| Blinding of outcome assessment (detection bias) Adherence measure | Low risk | (PRIMARY) NON COMPLIANCE EPISODES ‐ The methods state these data were obtained from case records and the researchers were blinded. "Case records were used at baseline to obtain information on OPCRIT diagnosis and at baseline and at the end of FU to obtain information on relapse, compliance and medication before and after the intervention. The rating was done by researchers blind to the allocation of the patients. A non‐compliance episode was rated if case notes indicated that the patient did not receive medication for a period of 14 days. This ``unit'' of non‐compliance enabled a comparison of compliance between patients receiving depot medication and those taking daily oral medication, and was the basis of the analysis of the effectiveness of the programme on non‐compliance reduction. The comparison of baseline medication in allocation groups was based on transformation of medication data to DDD." (pg 289) |
| Blinding of outcome assessment (detection bias) Patient outcome | High risk | (PRIMARY) PSYCHOPATHOLOGY AND PSYCHOSOCIAL FUNCTION RATINGS ‐ The authors indicate blinding was broken: however, it was not possible to maintain blindness to the treatment allocation. After the PI and FU interviews, the raters guessed the allocation of the patients and guessed wrong in only 17% of the cases |
| Blinding of participants (performance bias) Adherence measure | Low risk | (PRIMARY) NON COMPLIANCE EPISODES ‐ The patients would have been aware of their own group membership, but it would not have influenced their case records. This is an objective measure of outcome |
| Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) PSYCHOPATHOLOGY AND PSYCHOSOCIAL FUNCTION RATINGS ‐ Patients likely to be unblinded due to the nature of the intervention |
| Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) NON COMPLIANCE EPISODES ‐ The author notes that these data were collected from records so unlikely to be influenced by knowledge of study group |
| Blinding of personnel (performance bias) Patient outcome | Unclear risk | (PRIMARY) PSYCHOPATHOLOGY AND PSYCHOSOCIAL FUNCTION RATINGS ‐ The ratings of psychopathology and psychosocial function were performed by researchers not involved in the intervention and not informed of the treatment allocation of the patient. However, it was not possible to maintain blindness to the treatment allocation. After the PI and FU interviews, the raters guessed the allocation of the patients and guessed wrong in only 17% of the cases |
| Incomplete outcome data (attrition bias) Adherence measure | Unclear risk | (PRIMARY) NON COMPLIANCE EPISODES ‐ Not enough information given on the reasons for drop out or which groups the patients were in pg 288. 8 patients (17.4%; 4 intervention and 4 control patients) were partly lost to follow‐up of compliance or relapse data, as they were referred to private practitioners for further treatment (n = 5) or moved to another county (n = 2). 1 patient in the control group committed suicide during the follow‐up period |
| Incomplete outcome data (attrition bias) Patient outcome | Unclear risk | (PRIMARY) PSYCHOPATHOLOGY AND PSYCHOSOCIAL FUNCTION RATINGS ‐ Dropout reasons are not given for the specific groups; not enough information to judge |