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 |
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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 |
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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 |
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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 |