Katon 2010.
Study characteristics | ||
Methods |
Collaborative care for patients with depression and chronic illnesses Patient RCT, conducted in 14 primary care clinics (within a Group Health Cooperative) in Washington State, USA Two arms: 1. Usual care group (control arm) and 2. Intervention group (intervention arm) |
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Participants | Control arm N: 108 Intervention arm N: 106 Diabetes type: unclear/not reported Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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Interventions |
Control arm: 1) Facilitated relay of clinical information Intervention arm: 1) Case management 2) Team changes 3) Electronic patient registry 4) Patient education 5) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.0 (1.9), post 7.8 (1.9) Intervention arm: pre 8.1 (2.0), post 7.3 (1.2) 2) SBP, mean mmHg (SD) Control arm: pre 132.0 (17.2), post 132.3 (17.4) Intervention arm: pre 136.0 (18.4), post 131.0 (18.2) 3) LDL, mean mg/dL (SD) Control arm: pre 109.0 (36.5), post 101.4 (36.6) Intervention arm: pre 106.5 (35.3), post 91.9 (36.7) |
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Funding source | Supported by grants (MH041739 and MH069741) from the Services Division of the National Institute of Mental Health (to Dr. Katon) and by institutional support from Group Health Cooperative | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: " …use of a permuted‐block design, with randomly selected block sizes of 4, 6, and 8 patients" but how they generated this list is not reported. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Patient's baseline characteristics (selection bias) | Unclear risk | Mentioned in text, but not in table. |
Patient's baseline outcomes (selection bias) | Low risk | Quote: "The characteristics of the patients in the intervention group and the usual‐care group were similar at baseline." |
Incomplete outcome data (attrition bias) | High risk | Numbers and reasons for loss to follow‐up not provided; they only provide the percentage who completed 6 months and 12 months follow‐up. Baseline based on those randomised, however seems like a per‐protocol analysis was done. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcomes: laboratory methods not described, however they state that research assistants who carried out the study protocol were blinded; assume they were the outcome assessors. However, physicians were not blinded, had both intervention and comparator as patients, and could have influenced the treatment. |
Selective reporting (reporting bias) | Low risk | Checked protocol and everything proposed was completed. |
Risk of contamination (other bias) | High risk | Quote: "Spillover of the intervention is possible, since primary care physicians cared for patients in both the intervention and control groups." |
Other bias | Low risk | Information not available. |