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 |
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Interventions | Intervention group:
Comparison group: usual care |
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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 |
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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." |