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) |
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| 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 |
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| 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 |
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| Outcomes | Antihypertensive drug Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Hypertension control |
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| 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. |