Farooq 2011.

Methods	Randomized controlled trial
Participants	The study location was the psychiatry department of Lady Reading Hospital, Peshawar, Pakistan 55 participants were randomized to the intervention group and 55 participants were randomized to the control group The inclusion criteria were (a) aged 17 to 60 years; (b) a diagnosis of schizophrenia or schizoaffective disorder based on the ICD‐10 Research Diagnostic Criteria (RDC); and (c) residence in Peshawar district The exclusion criteria were evidence of organic disorder, ICD‐10 'mental retardation', and severe drug dependence requiring in‐patient treatment and/or detoxification
Interventions	Intervention: Supevised Treatment in Out‐patients for Schizophrenia (STOPS) Participants in the STOPS arm received usual care plus specific education given to a key care supervisor about the illness and the importance of adherence, medications were provided 1 month at a time free of charge Control: TAU Psychiatrists provided treatment as they would normally deliver in routine out‐patient settings. These included prescribing evidence‐based pharmacological treatments, out‐patient attendance in the psychiatry department as deemed appropriate by the consultant and brief counseling about the treatment and outcome. Participants who could not afford to buy medication had the option to seek free drug treatment from the social welfare department of the hospital
Outcomes	The measures of adherence were measurement by interview using a questionnaire with a 5‐point scale (where 1 is always and 5 is never). The assessments for adherence to treatment were done quarterly from baseline with the help of information provided by participants and relatives. All assessments were carried out by doctors with at least 2 years' training in psychiatry. These researchers were masked to participant group assignment and instructed not to enquire about a participant's treatment during interviews The patient outcomes were Global Assessment of Functioning (GAF) ratings and Positive and Negative Syndrome Scale (PANSS) for schizophrenia, taken at 3, 6 months, and 1 year by doctors with psychiatry training and researchers masked to participant group
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Author's note: to us there was low risk of bias as an epidemiologist was contacted for the same and she used random number tables for it. However, this was not explicitly mentioned in the article as is mentioned in 3.1.1
Allocation concealment (selection bias)	Low risk	Opaque, sealed, sequential envelopes. (pg 468) "Individuals who met inclusion criteria were randomly assigned to each treatment group. The random allocations of patients to each group were enclosed in opaque envelopes which were sealed and numbered sequentially. These allocations were placed away from the site of assessment. After assessment and satisfying the inclusion criteria, the staff which were not part of the study were asked to open the sealed envelope and reveal the treatment arm for each patient."
Selective reporting (reporting bias)	Unclear risk	Author's note: tablet counts are not reported in the article although this was stated in the protocol
Other bias	Unclear risk	Mention risk that not paying for control medications might skew results. (pg 471) "It can be argued that the provision of free drugs could have contributed to the better outcome in the STOPS group. The average cost of medication for a month using atypical drugs is about 900 rupees (£1 is equivalent to approximately 136 rupees), which can be quite costly for patients and families from lower socioeconomic backgrounds presenting in a public hospital such as Lady Reading Hospital. The DOTS is a complex intervention and free access to medication is an essential component of the DOTS programme as applied in tuberculosis control. The participants in the TAU group had the option of accessing free drugs from the social welfare department. Providing free medication as part of the trial would have grossly distorted the TAU condition in these settings. The evidence, however, suggests that even if drugs were free, non‐adherence persists. One recent study showed that even among people who have health plans with no cost‐sharing for medication, rates of non‐adherence were nearly 40%."
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ It states outcome assessors were masked. (pg 469) "The follow‐up assessments were done by researchers who were masked to participant group assignment and instructed not to enquire about a participant's treatment during interviews. To ensure this, the administration of STOPS was kept completely separate from the research team assessing adherence and administering questionnaires for the trial and they were not associated with clinical care of the participants in the trial. The participants and relatives were briefed not to discuss their treatment with the assessors."
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) GAF AND PANSS SCORES ‐ it states outcome assessors were blind. pg 469 "The same team of psychiatrists carried out all the follow‐up assessments. The follow‐up assessments were done by researchers who were masked to participant group assignment and instructed not to enquire about a participant's treatment during interviews. To ensure this, the administration of STOPS was kept completely separate from the research team assessing adherence and administering questionnaires for the trial and they were not associated with clinical care of the participants in the trial. The participants and relatives were briefed not to discuss their treatment with the assessors."
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No mention of patient blinding; questionnaire responses would be influenced by lack of blinding. Since patients were receiving free pills in the STOPS intervention, it is probably easy for the patients to figure out which group they belonged to
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) GAF AND PANSS SCORES ‐ Author's note: patients/participants were blinded
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Insufficient information to permit judgment of 'Low risk' or 'High risk'. No mention of study staff blinding or role in study
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) GAF AND PANSS SCORES ‐ Author's note: although not mentioned explicitly in the write up, there was "low risk of bias" as the blinding was maintained for all the staff used to assess the patients on various scales. Only the co‐ordinator was aware of the participants' respective group
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ Nearly equal dropouts across groups, reasons for dropouts seemingly unrelated to intervention
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) GAF AND PANSS SCORES ‐ Nearly equal dropouts across groups; reasons for dropouts seemingly unrelated to intervention