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. 2012 Oct 17;2012(10):CD006525. doi: 10.1002/14651858.CD006525.pub2

McCusker 2008.

Methods Study design: Pilot cluster‐randomised controlled trial
Participants Setting: Primary care
Diagnosis: A positive response to either of the PHQ‐2 screening questions, followed by a screen for major depression using a Structured Clinical Interview (SCID)
Inclusion criteria: Able to speak English or French well enough to be able to complete study questionnaires, aged 60 or over, reside in an area easily accessible for the depression care worker, with a maximum travel time of 45 minutes in each direction, see the participating family physician as their principal primary care physician
Exclusion criteria: In active treatment with a Psychiatrist or Psychologist, bipolar, psychosis, hearing impairment, and ability to provide consent (no or only minimal cognitive impairment)
Age: Mean 73.3 years
Gender: 67% female
Ethnicity: Not stated
Country: Canada
Sample size (randomised): Total participants 68, intervention 36, control 32
Interventions Intervention: Depression Care Practitioner
Contains the four elements of collaborative care:
1) a multi‐professional approach to patient care: Family physician (PCP), social worker/psychologist (CM), psychiatrist (MH specialist)
2) a structured management plan: Patients were provided with an educational brochure and a video prepared for the IMPACT study. CMs assessed and worked with each patient and PCP to develop a treatment plan that could include pharmacotherapy using an evidence‐based medication algorithm and 4 sessions of problem solving therapy (PST). During follow‐up CMs monitored the patient's progress
3) scheduled patient follow‐ups: Assessment plus 4 weekly sessions (telephone or face‐to‐face)
4) enhanced inter‐professional communication: CMs sent the PCP a copy of the assessment and all details of follow‐up sessions. CMs had weekly supervision with MH specialist. The MH specialist reviewed all medication recommendations proposed by PCP, was available for rapid verbal consultations with physicians and CMs, and offered an immediate consultation when needed
Control: Treatment as usual enhanced as PCPs were informed of patients diagnosis
Outcomes Depression (HSCL): 2 months
Medication use: 2 months
Satisfaction: 2 months
Notes 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) Unclear risk Physicians were randomised based on their preference and size and type of practice, in the patient randomised arm a prepared list of random numbers in blocks of 4 were used
Allocation concealment (selection bias) Unclear risk Standard block size. Allocation of patients conducted by study coordinator
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Short‐term loss to follow‐up based on primary depression outcome (HSCL) was: overall 2/34 (6%), 0/19 (0%) intervention and 2/15 (13%) control. Reasons for loss to follow‐up provided and only observed in control group. Intention‐to‐treat analysis not reported, no description of methods to manage missing data
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