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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

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)
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
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
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)
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.