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

Ciria de Pablo 2008.

Study characteristics
Methods Control of risk factor in diabetic patients in secondary prevention. MIRVAS Study
RCT (NA clusters and NA providers), conducted in 1) Multifactorial and intensive intervention done in a specific consultation clinic at La Princesa University Hospital, Madrid, Spain. 2) Intervention delivered by specialist/trained nurses and usual physicians. In Spain.
2 arms: 1) Control (conventional healthcare) (control arm) and 2) Intervention (multifactorial and intensive intervention) (intervention arm)
Participants Control arm N: 33
Intervention arm N: 38, NA, NA
Diabetes type: 2
Mean age: 65.91 ± NR
% Male: 74.6
Longest follow‐up: 12 months
Interventions Control arm: (conventional healthcare)
Intervention arm: (multifactorial and intensive intervention)
1) Case management
2) Clinician education
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 Only found information in the protocol. Sponsor type: Hospital/treatment centre. Funder name: La Princesa University Hospital (Hospital Universitario de La Princesa), Biomedical Research Foundation (Fundación de Investigación Biomédioca) (Spain).
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method to generate the sequence not reported. Quote: "Patients are randomly assigned to each group and by blocks (type of pathology: AMI or stroke)."
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Unclear risk Table 2. For the distribution of baseline cardiovascular episodes, CVRF, dyslipidaemia, vascular history and hypertension, groups are similar (P values = NS). For age and gender, they only compare diabetics with non‐diabetics, and not control vs intervention. Quote: "The mean age of both groups showed no significant differences (65.91 years in diabetics compared to 64.99 years in non‐diabetics). The gender distribution also does not differ significantly: 74.6% of diabetic males compared to 74.4% of non‐diabetic males."
Patient's baseline outcomes (selection bias) Unclear risk Table 2. They only report data for tobacco use at baseline, P value above 0.05. Quote: "The mean basal lipid values ​​(determined in the first 24 hours after admission) of the different subgroups (diabetics vs. non‐diabetics and diabetics assigned to intervention vs. diabetics assigned to control) showed no significant differences". Quote: "Baseline BP, Hba1c, weight and abdominal perimeter were not available."
Incomplete outcome data (attrition bias) Unclear risk No information on the number of patients lost in each group.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Unclear risk Method to collect drug prescribed is not reported. Tobacco use is likely self‐reported, so subjective outcome (Quote: "You are considered a smoker if you have used any type of tobacco in the previous six months"). HbA1c, LDL and blood pressure were objectively collected.
Selective reporting (reporting bias) High risk Retrospectively registered protocol not referred to in the paper. From the protocol, MIRVAS study was designed to last 3 years, and here they report the results after 1 year. Data reported in Table 4 (HbA1c, BP, LDL, etc.) were not planned to be reported at 1 year.
Risk of contamination (other bias) Unclear risk Patients randomised from a single clinic at La Princesa University Hospital. It is unclear if the same physicians were following patients in both groups. If so, the physicians might have applied the intensive treatment to control patients. Unlikely that control patients met with the nurses.
Other bias High risk Diabetic subgroup analysis was not the main objective of the study.