Evans 2010.
| Study characteristics | ||
| Methods | RCT Unit of randomisation: participant |
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| Participants | Place of recruitment: primary care medical clinic Numbers randomised: total: 176 (8 stroke/TIA); I: 88 (4 stroke/TIA); C: 88 (4 stroke/TIA) % Completing final follow‐up: 89% Inclusion criteria: Framingham risk score ≥ 15% or coronary artery disease risk equivalent (coronary artery disease, peripheral artery disease, cerebrovascular disease, diabetes mellitus) Exclusion criteria: severe psychiatric conditions or demential symptomatic heart failure; terminal illness Type of stroke (%): not stated Mean age (SD): 62.5 (10.5) Gender (% men): 87.5% Ethnicity: not reported Socio‐economic or socio‐demographic status: not reported |
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| Interventions | Intervention details (components, length, frequency): pharmacist‐delivered secondary prevention program involving cardiovascular risk stratification, monitoring of cardiovascular risk factors and drug adherence support; participants were contacted approximately every 8 weeks for minimum of 6 months (telephone call, appointment, mailed letters); mean duration of follow‐up was 380 days; participants and their primary care physicians were informed if risk factors were uncontrolled Location: primary care medical clinic Mode of delivery: primary care appointment Personnel responsible for delivery: pharmacist (intervention designed for non‐specialist pharmacists to facilitate collaborative partnerships without the need for advanced training) Timing post‐stroke: unknown Usual care (I and C): general counselling about cardiovascular disease (1 hour pharmacist appointment) |
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| Outcomes | 12 months: SBP; DBP; total cholesterol; LDL; HDL; triglycerides; HbA1C; 10 year Framingham risk score | |
| General Information | Funding: funding through a Canadian Institute of Health Research (CIHR) Clinical Research Initiative Fellowship and funding for salary support award from the Alberta Heritage Foundation for Medical Research Country of origin: Canada Publication language: English |
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| Notes | Analysis method: stated intention‐to‐treat Risk of bias: low |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomisation lists were stratified by each physician and were created by using a table of random numbers in permuted blocks of four" |
| Allocation concealment (selection bias) | Low risk | "Randomisation codes were kept in individually sealed envelopes and opened by the study pharmacist at the end of the initial visit" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data reported by group Attrition: I: 11/88 (9 laboratory data not available; 1 moved; 1 died); C: 9/88 (8 laboratory data not available; 1 withdrew due to unrelated illness) Judgement: reasons for missing data reported and review authors judge that they are unlikely to be related to study outcomes |
| Selective reporting (reporting bias) | Low risk | Protocol available and outcomes reported in the pre‐specified way |
| Other bias | Low risk | The study appears to be free of other sources of bias |