Staring 2010.

Methods	Randomized controlled trial
Participants	The study location was the Netherlands 54 participants were randomized to the intervention group and 55 participants were randomized to the control group The inclusion criteria were a DSM–IV diagnosis of schizophrenia or schizoaffective disorder; receiving out‐patient treatment; mastery of the Dutch language; at least some problems with service engagement, as defined by an average item‐score of 1.25 or higher on at least 2 subscales of the Service Engagement Scale (SES). Individuals were referred when the clinician believed them to meet the criteria. In order to classify individuals according to DSM–IV, they were interviewed using the lifetime Composite International Diagnostic Interview, version 2.1.The SES was used to determine whether an individual met the 4th criterion
Interventions	Intervention: TREATMENT ADHERENCE THERAPY Initial sessions assess individual determinants of non‐adherence. According to the clusters of determinants detected, therapists fill out a decision form and chose from the 3 modules available for the subsequent patient appoints. Modules are motivational interviewing, medication optimization, and behavioral training. If more than one cluster of problems was present in an individual, the modules were completed in order. The duration and number of sessions varied per patient, in general taking no more than 6 months. Most of the therapists were psychiatric nurses who were not the patients own mental health professionals. All sessions were recorded and used in supervision Control: TREATMENT AS USUAL Treatment as usual generally consisted of sessions with a psychiatric nurse and a psychiatrist when indicated. The sessions varied in frequency and duration, but mostly consisted of 1 or 2 sessions per month. The contents reflected overall problems the participant might encounter such as symptoms, social participation, work, daily activities, and medication issues. Some participants received psychoeducation individually or in group sessions. This was recorded
Outcomes	The measures of adherence were a composite of the adherence subscale of the Service Engagement Scale (SES) and the results of a semi‐structured interview with the participant. The SES was completed by the clinician most familiar with the participant. The interview was conducted by an independent rater who normalized non‐adherence and the reasons for it, stressing that the obtained information would not be passed on to the participant's clinician. The interviewed inquired about the number of missed doses in the past days and weeks. These 2 measures were standardized, summed, and reversed, thereby creating a compiled measure of adherence in which null scores indicated the average adherence in our study and high scores indicated good adherence. Adherence measures were collected at baseline, after the 6‐month treatment period, and 6 months after treatment ended The patient outcomes were admissions, symptoms, and quality of life. Admissions documented, at the time the study was conducted, if participants had been readmitted to a psychiatric hospital, and, if so, whether this had been voluntary or involuntary. Symptoms were measured with the PANSS25, a 30‐item rating scale that is completed by trained raters. It has 3 subscales: positive, negative, and general psychopathology. Quality of life was measured with the self report EQ–5D, which has been validated in people with schizophrenia. All measured were obtained at baseline, after 6 months of treatment, and 6 months after treatment ended
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomized according to a lottery system, executed by the main researcher. "Participants were randomly assigned to one of the treatment conditions. This was done according to a lottery system, executed by the main researcher." (pg 449)
Allocation concealment (selection bias)	Unclear risk	No information was provided about how allocation was handled
Selective reporting (reporting bias)	Low risk	The protocol is available in the Dutch Trial Registry: NTR1159. All outcomes are accounted for
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) SERVICE ENGAGEMENT SCALE ‐ Clinician ratings ‐ clinicians were aware of the patient's group membership and this might have biased their responses
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) ADMISSIONS ‐ The author notes that they had close contact with the patients and health professionals, and access to their psychiatric institute files. It was very easy to collect data on whether the patients were admitted to a psychiatric inpatient clinic or not, how many days this was, and whether it was voluntary or not
Blinding of participants (performance bias) Adherence measure	Low risk	(PRIMARY) SERVICE ENGAGEMENT SCALE ‐ Ratings were done by the clinician, not the patient
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) ADMISSIONS ‐ Patients were not involved in the collection of this measure
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SERVICE ENGAGEMENT SCALE ‐ it is unclear how the data were combined from the interview with the other results ‐ possible introduction of bias?
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) ADMISSIONS ‐ 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	Low risk	(PRIMARY) SERVICE ENGAGEMENT SCALE ‐ Small number of dropouts
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) ADMISSIONS ‐ Few dropouts