TY - JOUR T1 - Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations JF - Journal of Medical Genetics JO - J Med Genet DO - 10.1136/jmedgenet-2015-103740 SP - jmedgenet-2015-103740 AU - Ranjit Manchanda AU - Matthew Burnell AU - Kelly Loggenberg AU - Rakshit Desai AU - Jane Wardle AU - Saskia C Sanderson AU - Sue Gessler AU - Lucy Side AU - Nyala Balogun AU - Ajith Kumar AU - Huw Dorkins AU - Yvonne Wallis AU - Cyril Chapman AU - Ian Tomlinson AU - Rohan Taylor AU - Chris Jacobs AU - Rosa Legood AU - Maria Raikou AU - Alistair McGuire AU - Uziel Beller AU - Usha Menon AU - Ian Jacobs Y1 - 2016/03/18 UR - http://jmg.bmj.com/content/early/2016/03/18/jmedgenet-2015-103740.abstract N2 - Background Newer approaches to genetic counselling are required for population-based testing. We compare traditional face-to-face genetic counselling with a DVD-assisted approach for population-based BRCA1/2 testing.Methods A cluster-randomised non-inferiority trial in the London Ashkenazi Jewish population.Inclusion criteria Ashkenazi Jewish men/women >18 years; exclusion criteria: (a) known BRCA1/2 mutation, (b) previous BRCA1/2 testing and (c) first-degree relative of BRCA1/2 carrier. Ashkenazi Jewish men/women underwent pre-test genetic counselling prior to BRCA1/2 testing in the Genetic Cancer Prediction through Population Screening trial (ISRCTN73338115). Genetic counselling clinics (clusters) were randomised to traditional counselling (TC) and DVD-based counselling (DVD-C) approaches. DVD-C involved a DVD presentation followed by shorter face-to-face genetic counselling. Outcome measures included genetic testing uptake, cancer risk perception, increase in knowledge, counselling time and satisfaction (Genetic Counselling Satisfaction Scale). Random-effects models adjusted for covariates compared outcomes between TC and DVD-C groups. One-sided 97.5% CI was used to determine non-inferiority. Secondary outcomes: relevance, satisfaction, adequacy, emotional impact and improved understanding with the DVD; cost-minimisation analysis for TC and DVD-C approaches.Results 936 individuals (clusters=256, mean-size=3.6) were randomised to TC (n=527, clusters=134) and DVD-C (n=409, clusters=122) approaches. Groups were similar at baseline, mean age=53.9 (SD=15) years, women=66.8%, men=33.2%. DVD-C was non-inferior to TC for increase in knowledge (d=−0.07; lower 97.5% CI=−0.41), counselling satisfaction (d=−0.38, 97.5% CI=1.2) and risk perception (d=0.08; upper 97.5% CI=3.1). Group differences and CIs did not cross non-inferiority margins. DVD-C was equivalent to TC for uptake of genetic testing (d=−3%; lower/upper 97.5% CI −7.9%/1.7%) and superior for counselling time (20.4 (CI 18.7 to 22.2) min reduction (p<0.005)). 98% people found the DVD length and information satisfactory. 85–89% felt it improved their understanding of risks/benefits/implications/purpose of genetic testing. 95% would recommend it to others. The cost of genetic counselling for DVD-C=£7787 and TC=£17 307. DVD-C resulted in cost savings=£9520 (£14/volunteer).Conclusions DVD-C is an effective, acceptable, non-inferior, time-saving and cost-efficient alternative to TC.Trial registration number ISRCTN 73338115. ER -