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

Ell 2007.

Methods Study design: Randomised controlled trial
Participants Setting: Community
Diagnosis: Screened positive for clinically significant depression
Inclusion criteria: Home care, 65 and older
Exclusion criteria: significant cognitive impairment, participation in another depression study
Age:  =Mean 78.1 years
Gender: 73% female
Ethnicity: 72% white
Country: United States
Sample size (randomised): Total participants 311, intervention 155, control 156
Interventions Treatment: Stepped care decision support
Contains the four elements of collaborative care:
1) a multi‐professional approach to patient care: Primary care physician (PCP), existing staff ‐ nurses, social workers, psychiatric nurses, a telephone case manager and a psychologist (CM), existing staff ‐ psychiatrist, nurses, social workers (MH specialist)
2) a structured management plan: A stepped care algorithm (based on IMPACT) in which patients were offered a choice of PST or ADs prescribed by PCP, or combined treatment if indicated. Step 1 (8‐10 weeks) choice of AD or PST. Patients with full response go to maintenance treatment. Step 2 (4‐8 weeks): if AD in step 1 and partial response give different AD type or augment AD, if no response PST. If PST in step 1 and partial response add AD or different AD type, if no response give AD. CMs monitored medication and delivered structured PST
3) scheduled patient follow‐ups: PST = 6‐12 sessions, medication = as per stepped care algorithm
4) enhanced inter‐professional communication: CM communicated with PCP about medication or if a patient did not improve. Usual supervisory staff had the responsibility of monitoring and supportive supervision
Control: Treatment as usual was enhanced by routine depression screening and staff training in depression care management for older adults. Patients PCP informed if a patient screened positive for probable major or minor depression
Outcomes Depression (PHQ‐9): 4, 8, 12 months
Medication use: during study period
Quality of Life (mental and physical health): 4, 8, 12 months
Notes AD: antidepressant; CM: case manager; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire–9; PST: problem solving therapy
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 Unclear risk Short‐term loss to follow‐up based on primary depression outcome (PHQ‐9 50% reduction) was: overall 113/311 (36%), 58/156 (37%) intervention and 55/155 (35%) control. Reasons for loss to follow‐up not provided across groups. Intention‐to‐treat analysis reported using observed data
Selective reporting (reporting bias) Unclear risk Insufficient information available to assess
Other bias Unclear risk Insufficient information available to assess
Implementation Integrity Low risk Attempts were made to assess implementation integrity (e.g. direct observation or rating of tapes)
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