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

Adair 2013.

Study characteristics
Methods Improving chronic disease care by adding laypersons to the primary care team. A parallel randomized trial.
Patient RCT, conducted in 6 primary care clinics in Minnesota, USA
Two arms: 1) Usual care (control arm) and 2) Care guide (intervention arm)
Participants Control arm N: 706
Intervention arm N: 1429
Diabetes type: unclear/not reported
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 12 months
Interventions Control arm:
1) Electronic patient registry
2) Clinician reminders
3) Patient education
Intervention arm:
1) Case management
2) Team changes
3) Electronic patient registry
4) Clinician reminders
5) Patient education
6) Promotion of self‐management
7) Patient reminders
Outcomes 1) Anti‐hypertensives (ACE inhibitor or angiotensin II receptor blockers)
2) Retinopathy screening (eye exam)
3) Renal screening (albumin)
4) Glycated haemoglobin
5) Systolic blood pressure
6) Diastolic blood pressure
7) Low‐density lipoprotein
8a) Hypertension control (DBP < 81 mmHg)
8b) Hypertension control (SBP < 141 mmHg)
9) Smoking cessation
Funding source Financial support: by the Robina Foundation
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…prepared sealed opaque envelopes containing either a purple card (assignment to a care guide) or a gold card (assignment to usual care)… each clinic's envelope were shuffled before delivery and daily thereafter."
Allocation concealment (selection bias) Low risk Quote: "…prepared sealed opaque envelopes containing either a purple card (assignment to a care guide) or a gold card (assignment to usual care)… each clinic's envelope were shuffled before delivery and daily thereafter."
Patient's baseline characteristics (selection bias) Low risk Characteristics relatively balanced between groups.
Patient's baseline outcomes (selection bias) Low risk Outcomes relatively balanced between groups.
Incomplete outcome data (attrition bias) Low risk < 10% losses in each, reasons balanced.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) High risk For blood pressure control, they do not state how this was assessed. In addition, outcome assessors were not blinded.
Selective reporting (reporting bias) Low risk Outcomes matched protocol.
Risk of contamination (other bias) High risk Quote: "…the usual care delivered by providers may have been influenced by contact with care guides about other patients."
Other bias High risk Hawthorne effect. Quote: "…improvement in usual care patients could be related to their knowledge that they were study participants."