Simon 2000b.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: Depression. Based on antidepressant prescription and also used a 20 item depression scale from the Hopkins symptom checklist Inclusion criteria: Patients at participating clinics who had received new prescriptions for antidepressants, with “new” defined as no antidepressant use in the previous 120 days Exclusion criteria: Not been diagnosed with depression at any visit (non­depression indication for prescription); had been diagnosed with bipolar disorder or psychotic disorder in the previous two years; had been diagnosed with alcohol or other substance misuse in the previous 90 days; or had visited a psychiatrist in the previous 90 days Age: Mean 46.7 years Gender: 71% female Ethnicity: Not stated Country: United States Sample size (randomised): Total participants 417, intervention 196, control 221
Interventions	Intervention: Care management Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), nurse (CM), psychiatrist (MH specialist) 2) a structured management plan: CMs assessed current use of ADs, side effects, and severity of depression. CMs supported PCPs by communicating urgent recommendations, assisting with arranging follow up visits, telephoning patients who had discontinued treatment, and helping with referrals. Telephone contacts sometimes included general support and encouragement but did not include any specific psychotherapeutic content. CMs helped with medication management but were not expected to make prescribing decisions but did recommend dosage changes or changes to different AD 3) scheduled patient follow‐ups: 3 telephone calls at beginning, 8 and 16 weeks 4) enhanced inter‐professional communication: After each telephone assessment PCPs received a feedback report including computerised data, assessment data, and sophisticated algorithm based recommendations. CMs received weekly supervision from MH specialist Control: Feedback only. PCPs received a detailed report on each patient eight and 16 weeks after the initial prescription. These included computerised data (AD dosage and repeat prescriptions, number of follow up visits, and arranged visits) and treatment recommendations on the basis of a computerised algorithm
Outcomes	Depression (HSCL‐20): 3, 6 months Medication use: 6 months
Notes	AD: antidepressant; CM: case manager; HSCL: Hopkins Symptom Checklist; MH: mental health; PCP: primary care provider
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated
Allocation concealment (selection bias)	Unclear risk	Insufficient information available to assess
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Short‐term loss to follow‐up based on primary depression outcome (HSCL‐20 50% decrease) was: overall 21/392 (5%), 10/196 (5%) intervention and 11/221 (5%) control. Reasons for loss to follow‐up not provided. Used intention‐to‐treat analysis
Selective reporting (reporting bias)	Unclear risk	Insufficient information available to assess
Other bias	Unclear risk	Insufficient information available to assess
Implementation Integrity	Unclear risk	Insufficient information available to assess
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessor was not aware of treatment allocation