| Methods |
Random allocation of consenting patients to compliance therapy or control groups using odd and even digits from a standard random numbers table. The researcher obtaining outcome measures was blinded to the intervention |
| Participants |
54 of 96 consecutive people with psychosis, who had been admitted to St. John of God Hospital, Dublin, agreed to join the study. Patients aged 18 to 65 years, an IQ greater then 80, fluent in English, with no evidence of organic disturbance and diagnosed with schizophrenia. Each person who signed for informed consent took part in a structured clinical interview to determine their diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders |
| Interventions |
The control group received non‐specific counseling compromising of 5 sessions lasting 30 to 60 minutes. The experimental group received 5 sessions of compliance therapy, each session lasting 30 to 60 minutes. The sessions covered a review of the patient's illness history, understanding of the illness and his or her ambivalence to treatment, maintenance medication, and stigma. Compliance therapy is a cognitive behavior intervention with techniques adapted from motivational interviewing, other cognitive therapies, and psychoeducation |
| Outcomes |
A structured clinical interview was used to assess compliance 1 month before the intervention and 1 year post‐intervention. Patient outcome measures included attitude towards medication, symptomatology, insight, functioning, quality of life, and psychiatric hospital bed occupancy. The following scales were used: DAI ‐ Drug attitude inventory; PANSS ‐ positive and negative symptom scale; SAI ‐ Schedule for assessment of insight; GAF ‐ global assessment of function; QLS‐ Heinrich's quality of life scale |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number table was used to generate sequence. "We randomly allocated consenting patients to compliance therapy or control groups using odd and even digits from a standard table of random numbers." (pg 2) |
| 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 |
Unclear risk |
The authors note that they may have overestimated compliance. "Like Kemp et al, we relied on the reports of patients and their relatives and healthcare professionals for our measure of compliance. This is not ideal and, like pill counts and serum drug levels, probably overestimates compliance. Electronic measurement is methodologically superior but is expensive, is not foolproof, and can be difficult to use.We have no reason to believe that using a self report method led to a systematic bias." (pg 3) |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) STRUCTURED CLINICAL INTERVIEW ‐ "One year after the intervention a researcher who was blind to the type of intervention delivered repeated the assessments of participants' compliance, attitudes to treatment, insight, symptomatology, overall functioning, and quality of life" (pg 2) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) SYMPTOMATOLOGY (PANSS) ‐ "One year after the intervention a researcher who was blind to the type of intervention delivered repeated the assessments of participants' compliance, attitudes to treatment, insight, symptomatology, overall functioning, and quality of life." (pg 2) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) INSIGHT (SAI) ‐ "One year after the intervention a researcher who was blind to the type of intervention delivered repeated the assessments of participants' compliance, attitudes to treatment, insight, symptomatology, overall functioning, and quality of life." (pg 2) |
| Blinding of participants (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) STRUCTURED CLINICAL INTERVIEW ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) SYMPTOMATOLOGY (PANSS) ‐ This is a subjective measure; there is no information on blinding |
| Blinding of participants (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) INSIGHT (SAI) ‐ This is a subjective measure; there is no information on blinding |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) STRUCTURED CLINICAL INTERVIEW ‐ 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) SYMPTOMATOLOGY (PANSS) ‐ 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) INSIGHT (SAI) ‐ 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 |
Unclear risk |
(PRIMARY) STRUCTURED CLINICAL INTERVIEW ‐ "Six patients were lost to follow up: two dropped out during therapy (both controls); three (two controls, one compliance therapy) refused follow up, and one (compliance therapy) died in the follow up period. More than 80% follow up reported in both groups" (pg 2). It is not known whether the missing data could have changed the result |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) INSIGHT (SAI) ‐ "Six patients were lost to follow up: two dropped out during therapy (both controls); three (two controls, one compliance therapy) refused follow up, and one (compliance therapy) died in the follow up period. More than 80% follow up reported in both groups". It is not known whether the missing data could have changed the result |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) SYMPTOMATOLOGY (PANSS) ‐ "Six patients were lost to follow up: two dropped out during therapy (both controls); three (two controls, one compliance therapy) refused follow up, and one (compliance therapy) died in the follow up period. More than 80% follow up reported in both groups" (pg 2). Not known whether the missing data could have changed the result |
