Vagholkar 2014.
Study characteristics | ||
Methods | Cluster‐randomised trial, parallel group (1:1) | |
Participants | People aged 45‐69 years without CVD, recruited from 34 general practices in urban Sydney, Australia Unit of randomisation: practice Exclusion criteria: insufficient English skills, cognitively impaired, Aboriginal or Torres Strait Islander, diagnosed or treated CVD Total randomised: 34 clusters of 1074 participants (n = 18 practices with 567 participants in the intervention group, n = 16 practice with 507 participants in the comparison group) Mean age: 56 years, 58% women, 56% Anglo‐Celtic, 12% diabetes mellitus |
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Interventions | Intervention group: physicians received training on the importance of absolute risk assessment and use of a CVD risk calculator; participants received a 20‐30 min consultation that involved calculating cardiovascular risk and providing appropriate management based on risk level and current guidelines Comparison group: general health check |
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Outcomes | Primary outcome: antihypertensive medication prescription, lipid‐lowering medication prescription at 12 months Secondary outcomes: changes in blood pressure and blood lipids; self‐reported smoking; self‐reported physical activity levels; diet consumption Total analysed: 34 clusters of 906 participants (n = 18 practices with 475 participants in the intervention group; n = 15 practices with 431 participants in the comparison group) Follow‐up: 12 months |
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Study funding sources | National Health and Medical Research Council of Australia | |
Notes | Only 685/1074 (64%) had values available for risk assessment | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A person (U.J.) independent of the intervention and data collection conducted the allocation using a computer randomization program." |
Allocation concealment (selection bias) | Low risk | See above |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Personnel not blinded to intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Research staff collecting practice data were blinded to group allocation, as were patients." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Large amount of missing data. Only 64% of participants had values available for risk assessment |
Selective reporting (reporting bias) | High risk | Several outcomes (such as health‐related quality of life) mentioned in trial registry and protocol were not reported in this report |
Other bias | Low risk | Other sources of bias not identified |