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

MacMahon Tone 2009.

Study characteristics
Methods An intensive nurse‐led, multi‐interventional clinic is more successful in achieving vascular risk reduction targets than standard diabetes care
RCT (NA clusters and NA providers), conducted in 1) Outpatient department and diabetes centre of Beaumont Hospital in Dublin, Ireland, 2) Patients randomised to intensive care were seen by the vascular intervention nurse every 2–3 months and continued to receive annual review in the diabetes clinic in Ireland
2 arms: 1. Control group (standard care) (control arm) and 2. Intervention (intensive nurse‐led care) (intervention arm)
Participants Control arm N: 99
Intervention arm N: 101, NA, NA
Diabetes type: 2
Mean age: 61.65 ± 10.6
% Male: 54.26
Longest follow‐up: 12 months
Interventions Control arm: (standard care)
1) Case management
2) Team change
3) Patient education
Intervention arm: (intensive nurse‐led care)
1) Case management
2) Team change
3) Patient education
Outcomes Anti‐platelet drugs
Lipid‐lowering drugs
Antihypertensive drug
Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
Hypertension control
Smoking status
Funding source This research was support by a research grant from Bristol Myer Squibb (Ireland) and Pfizer Healthcare Ireland
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were randomised to either intensive (n = 101) or standard (n = 99) groups by the use of standard randomisation tables, in order to eliminate bias. Using these tables, patients were randomised on the basis of the date of presentation for their first visit and the last digit of their hospital number.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk P values stated as not significant.
Patient's baseline outcomes (selection bias) Unclear risk More patients were on diuretics in the standard group (35.9%) at the beginning of the study, as opposed to the intensive group (20.2%) (P = 0.022).
Incomplete outcome data (attrition bias) Low risk Loss of 5 from standard group (99 to 94) after randomisation (~5%). Loss of 7 from intervention group (101 to 94) after randomisation (~7%). Balanced and less than 10%. Reasons for loss provided.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Objective measure for HbA1c, SBP, DBP, LDL Htn‐C. Subjective for ASA, statin, antihypertensives, smoking.
Selective reporting (reporting bias) Unclear risk No protocol registered. Methods match outcomes.
Risk of contamination (other bias) Unclear risk Both groups seen by vascular intervention nurse.
Other bias Low risk None identified.