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. 2017 Mar 14;2017(3):CD006887. doi: 10.1002/14651858.CD006887.pub4

Sheridan 2011.

Study characteristics
Methods Randomised controlled trial, parallel group (1:1)
Participants Men and women aged 40‐79 years with no history of CVD or diabetes mellitus, at moderate or high‐risk based on Framingham risk score
Exclusion criteria: serious medical condition that limited life expectancy to less than 5 years, first clinic visit, no cholesterol level checked in 18 months, extreme risk factor levels (systolic blood pressure > 180 mmHg or total cholesterol > 300 mg/dL)
Total randomised at baseline: 160 participants (n = 81 to intervention group, n = 79 to comparison group)
Mean age: 63 years, 28% women, 86% white, 10% African American
Interventions Intervention group:
  • web‐based, computerised decision support tool to promote initiation of effective CHD prevention strategies prior to clinic visit that included provision of personalised CVD risk estimate

  • series of automated mailed tailored messages to promote adherence to medications at 2, 4, and 6 weeks


Comparison group: usual care
Outcomes Primary outcome: feasibility of subject recruitment, intervention delivery, and measurement of study outcomes
Secondary outcomes: self‐reported adherence, global CHD risk, blood pressure, serum total and HDL cholesterol levels, smoking status, aspirin use, intent to start CHD reducing medication, self‐efficacy for CHD risk reduction
Total analysed: 154 participants (n = 77 intervention group, n = 77 comparison group)
Follow‐up: 3 months
Study funding sources National Heart, Lung, and Blood Institute, USA; National Cancer Institute, USA; American Heart Association
Notes Feasibility study, no power calculation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method for sequence generation not reported. Baseline imbalances between intervention and control noted
Allocation concealment (selection bias) Unclear risk "Patients were randomised by study staff who accessed an online randomised schedule."
Blinding of participants and personnel (performance bias)
All outcomes High risk "Physicians were not blinded and saw patients in both the intervention and control group."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Method of outcome assessment not reported
Incomplete outcome data (attrition bias)
All outcomes Low risk "The study lost 6 patient participants during follow‐up, resulting in a 96% follow up rate."
Selective reporting (reporting bias) Low risk All outcomes reported in trial registration reported
Other bias High risk "[P]hysicians saw patients in both the intervention and control groups, which may have resulted in contamination between study groups."