Katon 1995a.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: Diagnosed by the primary care physician as meeting criteria for definite or probable major depression and who had agreed to antidepressant therapy.  A 20‐item Symptom Checklist (HSCL) depression screening score of 0.75 or greater Inclusion criteria: Aged between 18 and 80 years and willingness to take antidepressant medication Exclusion criteria: Current alcohol abuse, current psychotic symptoms, serious suicidal ideation or plan, dementia, pregnancy, terminal illness, limited command of English; and plan to disenroll from the insurance plan within the next 12 months Age: Mean 51.3 years Gender: 73% female Ethnicity: Not stated Country: United States Sample size (randomised: Minor depression): Total participants 126, intervention 59, control 67
Interventions	Intervention: Multifaceted intervention programme Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), psychiatrist (CM/MH specialist) 2) a structured management plan: Patients received a brief booklet on the biology of depression, the mechanism of action of ADs, a second booklet on simple CBT techniques and a videotape covering similar material. Patients were asked to write down any questions in preparation for their initial meeting. The CM educated the patient about depression and ADs and side‐effects and also reviewed stressful life events. Changes in ADs could be initiated by PCP or CM after verbal consultation. CM monitored automatic pharmacy data to assess adherence 3) scheduled patient follow‐ups: 2‐4 visits over 4 to 6 weeks interspersed with 2 scheduled visits with PCP 7‐10 days apart 4) enhanced inter‐professional communication: CMs and PCPs held monthly case conferences and case by case consultations. CMs helped PCPs choose alternative medication for patients. Change in ADs could be initiated by the PCP or CM after verbal consultation. PCPs received a typed psychiatric consultation note within one week. CMs notified PCPs when patients failed to refill AD prescriptions. Control: Treatment as usual
Outcomes	Depression (HSCL): 4 months Medication use: 1, 4 months Satisfaction: 4 months
Notes	CM: case manager; HSCL: Hopkins Sympton 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 in blocks of 8
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 50% improvement) was: overall 13/126 (10%), 6/59 (10%) intervention and 7/67 (10%) 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	High risk	Reported analysis not by randomised group but by participants with a) minor and b) major depression.
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