PASSReviewer 1· 95% conf
The trial design is rigorous with adequate randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation]
“we managed a simple randomisation with equal (1:1:1) allocation by using the Oracle DBMS_RANDOM package following screening results.”direct quote[Methods, Sample size]
“To achieve 80% power to detect differences in proportions as small as 10% (at a Bonferroni adjusted α level of 0.017 to permit all three possible pairwise comparisons) in the primary outcomes between the control arm and each of the intervention arms, we needed a sample of 373 women randomised to each arm (total n=1119).”direct quote[Methods, Participants]
“Women were excluded if they did not have dense breasts (BI-RADS density A (almost entirely fatty) and B (scattered areas of fibroglandular density)), were recalled with screen detected abnormalities, reported a breast symptom or a clinical concern was noted by the radiographer at their screening episode, had a personal history of breast cancer, needed an interpreter (self-report on screening booking information or identified by the screening service), were unable to consent to breast screening, or did not have an active mobile phone number or email address.”PASSReviewer 2· 95% conf
The trial design is rigorous with clear randomization, blinding, sample size calculation, and pre-specified inclusion/exclusion criteria.
Evidence
direct quote[Methods, Randomisation]
“we managed a simple randomisation with equal (1:1:1) allocation by using the Oracle DBMS_RANDOM package following screening results.”direct quote[Methods, Sample size]
“To achieve 80% power to detect differences in proportions as small as 10% (at a Bonferroni adjusted α level of 0.017 to permit all three possible pairwise comparisons) in the primary outcomes between the control arm and each of the intervention arms, we needed a sample of 373 women randomised to each arm (total n=1119).”direct quote[Methods, Participants]
“Women were excluded if they did not have dense breasts (BI-RADS density A (almost entirely fatty) and B (scattered areas of fibroglandular density)), were recalled with screen detected abnormalities, reported a breast symptom or a clinical concern was noted by the radiographer at their screening episode, had a personal history of breast cancer, needed an interpreter (self-report on screening booking information or identified by the screening service), were unable to consent to breast screening, or did not have an active mobile phone number or email address.”