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

Denver 2003.

Study characteristics
Methods Management of uncontrolled hypertension in a nurse‐led clinic compared with conventional care for patients with type 2 diabetes
RCT (NA clusters and NA providers), conducted in 1) The study was organized from Whittington Hospital, which serves an inner‐city community of 154,000 adults in North Islington, London. Outpatient nurse‐led hypertension clinic. 2) Hypertension nurse, attending physicians. In United Kingdom.
2 arms: 1. Control (conventional primary care) (control arm) and 2. Intervention (nurse‐led hypertension clinic) (intervention arm)
Participants Control arm N: 60
Intervention arm N: 60, NA, NA
Diabetes type: 2
Mean age: 60.25 ± 5.5
% Male: 63.34
Longest follow‐up: 6 months
Interventions Control arm: (conventional primary care)
1) Clinician education
2) Facilitated relay of clinical information
Intervention arm: (nurse‐led hypertension clinic)
1) Case management
2) Team change
3) Promotion of self‐management
Outcomes Antihypertensive drug
Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Hypertension control
Funding source Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Each of the 3 investigators independently assessed and randomly referred eligible patients from their clinics. Patients were then allocated to conventional primary care (CPC) or the nurse‐led hypertension clinic group on an alternate basis. This scheme prevented individual physicians from predicting the treatment patients would receive, thereby eliminating referral bias and generating equally sized groups.
Allocation concealment (selection bias) Unclear risk Each of the 3 investigators independently assessed and randomly referred eligible patients from their clinics. Patients were then allocated to conventional primary care (CPC) or the nurse‐led hypertension clinic group on an alternate basis. This scheme prevented individual physicians from predicting the treatment patients would receive, thereby eliminating referral bias and generating equally sized groups.
Patient's baseline characteristics (selection bias) Low risk Table 1. P values provided, above 0.05.
Patient's baseline outcomes (selection bias) Low risk Table 1. P values provided, above 0.05.
Incomplete outcome data (attrition bias) Low risk The study was completed by 56 (93%) and 59 (98%) patients in the CPC and NLC groups, respectively. Three patients failed to attend the final visit, and one patient died in the CPC group. One patient from the NLC group refused to continue in the study.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measure of HbA1c, BP, Htn‐C, medication prescription.
Selective reporting (reporting bias) Unclear risk No registered protocol, methods match outcomes.
Risk of contamination (other bias) Low risk This scheme prevented individual physicians from predicting the treatment patients would receive, thereby eliminating referral bias and generating equally sized groups. Unlikely that control patients received intervention from hypertension nurse.
Other bias Low risk None identified.