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. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4

Anderson 2010.

Methods Randomized controlled trial
Participants The study location was a community mental health center in the southeast of the USA
12 participants were randomized to the intervention group and 14 participants were randomized to the control group
The inclusion criteria were male and female patients aged over 18 years with a diagnosis of schizophrenia or schizoaffective disorder, and were able to read and understand English
The exclusion criteria were (i) a comorbid axis I diagnosis of moderate or severe learning disability or organic brain disorder; (ii) a comorbid axis I diagnosis of drug or alcohol dependence; (iii) inpatient status at the start of the study; and (iv) suicidal or homicidal ideation at the start of the study
Interventions Intervention: ADHERENCE TREATMENT
 The intervention was 'adherence therapy' a manualized, patient centric approach that seeks to address a broad range of factors known to affect adherence. This individual therapy focuses on the needs, concerns, fears, values, goals, and experiences of the individual with the aim of encouraging people to take their medications. It was delivered by 4 therapists with Master's degree in social work. There were 8 one to one sessions of between 20 to 60 minutes, over 8 weeks. Follow‐up was conducted after the completion of the therapy. All intervention patients also received treatment as usual
Control: TREATMENT AS USUAL
 TAU included day treatment, case management, employment placement, medication monitoring, and individual counseling. During the trial, AT participants did not see their own therapist for therapy sessions, but continued their other treatment activities
Outcomes The measures of adherence were the Personal Evaluation of Transitions in Treatment (PETiT; Voruganti & Awad 2002), a 30‐item, self rated measure of patients' subjective evaluation of treatment with 6 questions specifically addressing medication adherence. The 30 items are rated on a 3‐point scale, with higher scores indicating greater satisfaction and adherence. Voruganti and Awad (2002) report high internal consistency, with a Cronbach's alpha of 0.96 and good split‐half reliability; they describe the scale as an indicator of medication adherence.The follow‐up was conducted after therapy completion (8 weeks)
The patient outcomes were severity of schizophrenia symptoms, measured with PANSS (Positive and negative syndrome scale), administered at baseline and completion of the 8‐week therapy by a researcher who was trained to administer the measure
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization by an independent randomization service(pg 342)
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias. "Written, informed consent was obtained from patients prior to randomization. Randomization was performed by an independent randomization service."
Selective reporting (reporting bias) Unclear risk Protocol unavailable
Other bias Unclear risk Follow‐up period is not clearly defined in the article; it says after completion of therapy only(pg 348). Several factors during this pilot study had the potential to influence the study results negatively. They included: (i) the small sample size, making the study underpowered and increasing the risk of type II errors; (ii) the possibility of outliers in a sample this size might have skewed the data; (iii) selection bias, considering the high rate of refusal to participate and a possibility of those who agreed already were more medication adherent; (iv) time constraints, as follow‐up was conducted only 6 to 8 weeks after the beginning of the intervention and within 1 to 2 days of the last counseling session; and (v) therapists' knowledge level of psychotropic medication could mean that cues from patients might have been missed
Blinding of outcome assessment (detection bias) 
 Adherence measure Low risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a single masked trial (pg 340). "Ratings were conducted masked" (pg 346)
Blinding of outcome assessment (detection bias) 
 Patient outcome Low risk (PRIMARY) POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) ‐ This is a single masked trial (pg 340). "The PANSS structured clinical interview rating was completed by a researcher (SF) who was trained to administer the measure." (pg 343). "Ratings were conducted masked" (pg 346)
Blinding of participants (performance bias) 
 Adherence measure High risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Patients not blind due to the nature of the intervention
Blinding of participants (performance bias) 
 Patient outcome High risk (PRIMARY) POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) ‐ Patients not blind due to the nature of the intervention
Blinding of personnel (performance bias) 
 Adherence measure Unclear risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk' of bias
Blinding of personnel (performance bias) 
 Patient outcome Unclear risk (PRIMARY) POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) ‐ Insufficient information to determine if study personnel were blinded
Incomplete outcome data (attrition bias) 
 Adherence measure Unclear risk (PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Missing data not balanced; dissimilar reasons but difficult to determine what impact this would have on the study
Incomplete outcome data (attrition bias) 
 Patient outcome Unclear risk (PRIMARY) POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) ‐ Missing data not balanced; dissimilar reasons but difficult to determine what impact this would have on the study