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

Landis 2007.

Methods Study design: Randomised controlled trial
Participants Setting: Primary care
Diagnosis: Significant depression determined by a score of 10 or more on the PHQ‐9.  The primary care physician verified the presence of major depression by clinical exam
Inclusion criteria: Willing to begin or continue antidepressant medication
Exclusion criteria: Bipolar disorder, psychotic symptoms, active suicidal ideation requiring psychiatric admission
Age: Mean 39.7 (SD 10.7) years
Gender: 96% female
Ethnicity: 62% white
Country: United States
Sample size (randomised): Total participants 45, intervention 22, control 23
Interventions Intervention: Care management
Contains the four elements of collaborative care:
1) a multi‐professional approach to patient care: Primary care physician (PCP), mental health graduate (CM), psychiatrist (MH specialist)
2) a structured management plan: CMs provided patient education about depression and instruction in self‐management skills and goals and monitored adherence and side effects.
3) scheduled patient follow‐ups: Acute: telephone or in‐person every 2 weeks for up‐to 12 weeks, maintenance: every 4 weeks until 6 months post‐initial session
4) enhanced inter‐professional communication: CMs coordinated with the PCP and received bi‐weekly telephone supervision from MH specialist
Control: Treatment as usual enhanced as PCP was informed of diagnosis
Outcomes Depression (PHQ‐9): 3, 6 months
Medication use: 3, 6 months
Quality of Life (mental and physical health): 3, 6 months
Satisfaction: 3, 6 months
Notes CM: case manager; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire‐9
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random assignment of 200 study numbers pre‐trial. Stratified by newly diagnosed and already treated with AD medication
Allocation concealment (selection bias) Low risk Sealed envelope
Incomplete outcome data (attrition bias) 
 All outcomes High risk Short‐term loss to follow‐up based on primary depression outcome (PHQ‐9) was: overall 11/45 (24%), 5/22 (23%) intervention and 6/23 (26%) control. Reasons for loss to follow‐up not provided. 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