Lobello 2010.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: Primary diagnosis of major depressive disorder assessed using a modified Mini‐International Neuropsychiatric Interview (MINI), and a diagnosis of major depressive disorder, single or recurrent episode without psychotic features, was confirmed according to Diagnostic and Statistical Manual of Mental Disorders(DSM‐IV) criteria. Patients were required to have a minimum Hamilton Rating Scale for Depression (HAM‐D17) score of 14. Inclusion criteria: Male and female outpatients aged 18 years or older.  Sexually active women of child bearing potential were required to use medically acceptable contraception. Exclusion criteria: Current treatment with venlafaxine or previously failed venlafaxine treatment at adequate dose and duration; significant risk of suicide based on clinical judgment; pregnancy or breastfeeding; introduction or change in cognitive behavioural therapy, interpersonal therapy, or other psychotherapy within 3 months before randomisation; and concomitant use of other psychopharmacologic drugs. Age: Mean 44.5 years Gender: 73% female Ethnicity: 87% white Country: United States Sample size (randomised): Total participants 537, intervention 268, control 269
Interventions	Intervention: Venlafaxine ER plus Dialogues programme Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care physician (PCP), nurse (CM) 2) a structured management plan: The Dialogues programme included a welcome kit that included the first issue of the Dialogues Magazine, a Straight Talk booklet (on side effects), and a tip sheet (points to discuss with PCP). Over a 4‐month period, patients also received a comprehensive resource guide, 2 additional issues of the Dialogues Magazine, and 3 additional Straight Talk booklets (progress, managing stress, long‐term therapy) 3) scheduled patient follow‐ups: 3 planned periodic calls (weeks 1, 5 and 13) and access to a 12‐hour daily help line. 4) enhanced inter‐professional communication: After each telephone call a contact report was sent to the PCP Control: The venlafaxine ER group received venlafaxine ER as part of the standard practice of care for the treatment of major depression
Outcomes	Depression (HAM‐D): 14, 45, 112, 135, 180 days Medication use: 14, 45, 112, 135, 180 days Quality of Life (mental and physical health): 14, 45, 112, 135, 180 days Satisfaction: 14, 45, 112, 135, 180 days
Notes	CM: case manager; HAM‐D: Hamilton Depression Rating Scale; MH: mental health; PCP: primary care provider
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information available to assess
Allocation concealment (selection bias)	Unclear risk	Insufficient information available to assess
Incomplete outcome data (attrition bias) All outcomes	Low risk	Short‐term loss to follow‐up based on primary depression outcome (HAMD remission total score ≤ 7) was: overall 45/537 (8%), 29/268 (11%) intervention and 16/269 (6%) control. Reasons for loss to follow‐up provided, with similar reasons across groups. 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	Unclear risk	Insufficient information available to assess