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

Huffman 2011.

Methods Study design: Randomised controlled trial
Participants Setting: Specialist, primary care
Diagnosis: Clinical depression defined as a PHQ‐9 score greater than or equal to 10, with 5 or more symptoms (including either depressed mood or anhedonia) present more than half the days for at least the preceding 2 weeks
Inclusion criteria:  Hospitalised cardiac patients. Eligible patients were admitted to 1 of 3 inpatient cardiac units at an urban academic medical centre for acute cardiac disease, defined as admission for myocardial infarction, unstable angina, decompensated heart failure, or arrhythmia
Exclusion criteria:  Bipolar disorder, psychotic symptoms, active substance abuse, active suicidal ideation, unable to speak English or unable to provide informed consent due to cognitive problems or the severity of their current medical illness
Age: Mean 62.4 years
Gender: 49% female
Ethnicity: 92% white
Country: United States
Sample size (randomised): Total participants 175, intervention 90, control 85
Interventions Intervention: Collaborative care
Contains the four elements of collaborative care:
1) a multi‐professional approach to patient care: Primary medical physician including cardiologist (PCP), social worker (CM), psychiatrist (MH specialist)
2) a structured management plan: In hospital interventions: CM provided written and verbal education about depression and its impact on cardiac disease, helped the patient to schedule pleasurable activities after discharge, and described treatment options (pharmacotherapy or psychotherapy referral). CM then consulted with MH specialist, who developed individualised depression treatment recommendations based on previous/current treatment and preference including SSRI and/or referral for therapy. CM worked to co‐ordinate these recommendations with inpatient and outpatient medical care providers. Post‐discharge interventions: Post‐discharge interventions lasted 12 weeks. For patients with clinical depression at any follow‐up, a multi‐component intervention (similar to the in‐hospital intervention) was undertaken. CM discussed the case with the MH specialist, written treatment recommendations were generated (e.g., increase AD, therapy referral). These were discussed with the patient and the PCP (and faxed to the PCP), and the CM worked to coordinate implementation
3) scheduled patient follow‐ups: Inpatient = unclear, post‐discharge = 3 telephone calls in 12 weeks
4) enhanced inter‐professional communication: Treatment recommendations discussed with and faxed to PCP. CM and MH specialists held weekly team meetings
Control: Treatment as usual enhanced as CM informed the inpatient treatment team of the patient's depression and recommended that the patient receive treatment. If patients met criteria for clinical depression at follow‐up, the PCP was informed via written communication that the patient had ongoing depression and would benefit from treatment
Outcomes Depression (PHQ‐9): 6, 12 months
Medication use: 6 weeks
Quality of Life (mental and physical health): 6 weeks, 3, 6 months
Satisfaction: 6 months
Notes CM: case manager; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number generator
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 (PHQ‐9 50% decrease) was: overall 37/175 (21%), 19/90 (21%) intervention and 18/85 (21%) control. Reasons for loss to follow‐up not reported by group. Intention‐to‐treat analysis reported using random‐effects regression models 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