To the best of our knowledge, no randomised practice-based studies have yet explored how real patients' real-life decisions are influenced by different risk formats.
*Based on data for all randomised practices.
Of the 49 randomised practices, 36 recruited study participants.
The data set will consist of all included patients from randomised practices.
However, 38 practices in England verbally agreed to take part, 34 of these returned a practice agreement and were randomised, and 25 of the randomised practices recruited participants.
We aim to minimise attrition by maintaining regular contact and providing encouragement to all randomised practices, and will monitor and report on the attrition of clusters.
Among randomised practices, 271 (68%) in the intervention arm (198 114 men) and 302 (78%) in the control arm (221 929 men) consented to participate, meeting pre-specified power requirements.
To account for clustering effects from randomised practices, with a moderate intra-cluster correlation (ICC) of 0.05, this is inflated to 1104 with 24 practices recruiting 46 patients each.
To account for clustering effects from randomised practices, with a moderate intracluster correlation coefficient of 0.05, this was inflated to 1104 patients, with 24 practices recruiting 46 patients each.
Eligible for inclusion are all patients listed at the randomised practices who receive a PSA test within the study period, unless subject to one of the following exclusion criteria: age over 80 years; elevated PSA level (>4 ng/ml) concurrently or within previous 2 years; prostate or bladder disease; and PCa.
This cluster-randomised practice-based study has been implemented among GPs (single-handed or partnership practices) in the Region of Southern Denmark and their candidate patients for primary CVD prevention with statins.
