Hamann 2007.

Methods	Randomized controlled trial
Participants	The study location was 12 acute psychiatric wards of 2 German state hospitals (Bezirkskrankenhaus Haar, Klinikum Agatharied) 54 participants were randomized to the intervention group and 59 participants were randomized to the control group The inclusion criteria were all men and women aged 18 to 65 years who had an ICD‐10 diagnosis of schizophrenia or schizophreniform disorder (F20/F23) The exclusion criteria were (i) severe mental retardation, (ii) lack of fluency in German, and (iii) refusal to give written informed consent
Interventions	Intervention: SHARED DECISION MAKING (SDM) The intervention was designed to inform patients about their treatment options and to prepare them for a planning talk with their physicians. A printed 16‐page booklet covering the pros and cons of oral versus depot formulation, first versus second generation antipsychotics, psychoeducation, and type of socio‐therapeutic intervention was presented to the patients through the head nurse of the ward as soon as the psychiatrist in charge considered them able to co‐operate. Trained nurses assisted the patient to work trough the booklet. Within the decision aid, patients were asked to write down their experiences with previous antipsychotic medication and to indicate their preferences regarding the different options on each topic. Nurses were advised to answer any questions of the patients and to encourage them to state any point of view contrary to that of the doctor. They were also instructed to postpone the participation of patients in the study if serious thought disturbances or delusional misinterpretations were detected while working through the booklet. The average time for working through the booklet was 30 to 60 minutes. Patients met their physicians within 24 hours after having worked through the decision aid with their nurse. The aim of these meetings (planning talks) was to reach an agreement between patient and psychiatrist on the further treatment according to the preferences indicated by the patient in the booklet. Like nurses, physicians were also trained about the SDM and required communication skills Control: USUAL CARE "Patients in the control group were treated "as usual", thus they did not receive the decision aid and there was no arrangement for an extra planning talk
Outcomes	The measures of adherence were the Medication Adherence Rating Scale (MARS) adherence questionnaire and a measurement of plasma levels. Patients were followed‐up at 6 and 18 months. To rate compliance with medication, patients were requested to fill in a questionnaire on their compliance (MARS). MARS is a previously validated 10‐item questionnaire derived from the Drug Attitude Inventory (DAI) and the MAQ (Medical Adherence Questionnaire). Physicians were requested to rate compliance of their patients on a 4‐point scale ranging from "poor compliance" to "very good compliance". MARS rating below the median score of 8 were considered to indicate poor compliance; rating of 8 or above were considered to indicate good compliance. Physicians were requested to rate compliance of their patients on a 4‐point scale ranging from "poor compliance" to "very good compliance". Physicians were requested to make unannounced measurements of plasma levels of the prescribed antipsychotics at 6 months and 18 months after discharge. The estimates of compliance by patients and physicians as well as results of the plasma levels were dichotomized into good and poor compliance. A "conservative" algorithm was applied in order to obtain an overall measure of compliance for every patient and point in time. Overall compliance was considered "good" if patients and physicians agreed in their (positive) estimates. In all other cases (incongruence of ratings, both rating poor compliance), compliance was rated as "poor". Results were corrected in the direction toward the results of the plasma evaluation if plasma levels indicated compliance or noncompliance difference from that derived from self rating/physicians' rating (in 2 cases) The patient outcome was rehospitalization due to schizophrenia, which was recorded for the periods of 0 to 6 and 6 to 18 months after discharge from the hospital. Rehospitalization within 18 months after discharge was defined as the main outcome measure. The variable was dichotomized into scores of 1 (rehospitalization occurred with in 18 months after discharge) and 0 (no rehospitalization occurred within 18 months after discharge). At 6 and 18 months after discharge, patients' global functioning (Global Assessment of Functioning Score) and severity of illness (Clinical Global Impression scale) were assessed
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention of randomization method. (pg. 993) "... were randomly included in a decision aid program or received usual care"
Allocation concealment (selection bias)	Unclear risk	No mention of allocation concealment. (pg. 993) "... were randomly included in a decision aid program or received usual care"
Selective reporting (reporting bias)	Low risk	No protocol available, refers to another study (ref 11) for details on the intervention but that does not appear to be a protocol for this study
Other bias	High risk	The authors note several limitations to their study: "There are certainly limitation to our study, including the relatively low sample size, a considerable proportion of patients dropping out of the study because they were lost to follow‐up, a one time intervention without iteration or "booster sessions" and the well‐known difficulty of measuring compliance of outpatients." (pg 996) "Limitations and strengths of the study... Since we placed emphasis on studying the topic under real‐world conditions (state hospitals) and tried to avoid a study with highly selected patients, many of the limitations from the one point of view (internal validity) are thus strengths from another point of view (external validity): • We abstained from individual randomization to avoid contamination of the verum and control conditions and to avoid the situation that the same physician had to practice SDM and routine care at the same time. We believe, however, that our study does not suffer from the limitations of classical cluster trials (e.g. selection bias), since individual patients were 'randomly' sent to that ward of a pair that had free beds available and were not selected according to any patient characteristics. • We used broad inclusion criteria, which resulted in many patients being included who were afterward considered incapable of making reasonable decisions, but which shed light on the percentage of patients that can successfully be reached with this intervention. • This trial was not performed in a university setting but in state hospitals, which led on the one hand to a higher amount of lacking (selfreport) values and which limited the amount of questionnaires that could be administered (e.g. an objective measure of the decision making capacity), but which on the other hand now enables us to argue that the intervention is feasible in normal patient care and with 'normal', non‐selected patients. • The intervention took place as 'soon as possible'. An intervention shortly before discharge might have more adequately addressed the needs of the patients in regard to long‐term care. On the other hand, many decisions concerning maintenance therapy (e.g. drug choice) are made early during hospitalization." (pg 271 (supplement))
Blinding of outcome assessment (detection bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of blinding of outcome assessors
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) REHOSPITALIZATIONS ‐ No mention of blinding of outcome assessors but an objective outcome
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of blinding of patients and subjective outcome
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) REHOSPITALIZATIONS ‐ No mention of blinding of patients but an objective outcome
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of blinding of study staff
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) REHOSPITALIZATIONS ‐ No mention of blinding of study staff but an objective outcome
Incomplete outcome data (attrition bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Reasons for incomplete data unclear and high losses to follow‐up by 18 months
Incomplete outcome data (attrition bias) Patient outcome	High risk	(PRIMARY) REHOSPITALIZATIONS ‐ Reasons for dropouts unclear; large number of dropouts