title: Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations.
abstract: 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.
  
  
  
  A cluster-randomised non-inferiority trial in the London Ashkenazi Jewish population.
  
  
  
  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.
  
  
  
  relevance, satisfaction, adequacy, emotional impact and improved understanding with the DVD; cost-minimisation analysis for TC and DVD-C approaches.
  
  
  
  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).
  
  
  
  DVD-C is an effective, acceptable, non-inferior, time-saving and cost-efficient alternative to TC.
  
  
  
  ISRCTN 73338115.
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK Department of Gynaecological Oncology, Bartshealth NHS Trust, Royal London Hospital, London, UK Barts Cancer Institute, Queen Mary University of London, London, UK.
authors.forename: Ranjit
authors.identifier: 0000-0003-3381-5057
authors.initials: R
authors.lastname: Manchanda
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Burnell
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
authors.forename: Kelly
authors.initials: K
authors.lastname: Loggenberg
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
authors.forename: Rakshit
authors.initials: R
authors.lastname: Desai
authors.affiliation: Behavioural Sciences Unit, Department of Epidemiology and Public Health, University College London, London, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Wardle
authors.affiliation: Mt Sinai University, New York, USA.
authors.forename: Saskia C
authors.initials: SC
authors.lastname: Sanderson
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Gessler
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Side
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
authors.forename: Nyala
authors.initials: N
authors.lastname: Balogun
authors.affiliation: Department of Clinical Genetics, North East Thames Regional Genetics Unit, Great Ormond Street Hospital, London, UK.
authors.forename: Ajith
authors.initials: A
authors.lastname: Kumar
authors.affiliation: Department of Clinical Genetics, North West Thames Regional Genetics Unit, Northwick Park Hospital, London, UK.
authors.forename: Huw
authors.initials: H
authors.lastname: Dorkins
authors.affiliation: West Midlands Regional Genetics Laboratory, Birmingham Women's NHS Foundation Trust, Birmingham, UK.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Wallis
authors.affiliation: Depatment of Clinical Genetics, West Midlands Regional Genetics, Birmingham Women's NHS Foundation Trust, Birmingham, UK.
authors.forename: Cyril
authors.initials: C
authors.lastname: Chapman
authors.affiliation: London Research Institute, Cancer Research UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Tomlinson
authors.affiliation: South West Thames Molecular Genetics Diagnostic Laboratory, St George's Hospital, London, UK.
authors.forename: Rohan
authors.initials: R
authors.lastname: Taylor
authors.affiliation: Department of Clinical Genetics, Guy's Hospital, London, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Jacobs
authors.affiliation: Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Rosa
authors.initials: R
authors.lastname: Legood
authors.affiliation: Department of Health Economics, London School of Economics, London, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Raikou
authors.affiliation: Department of Health Economics, London School of Economics, London, UK.
authors.forename: Alistair
authors.initials: A
authors.lastname: McGuire
authors.affiliation: Department of Gynaecology, Shaare Zedek Medical Centre, Jerusalem, Israel.
authors.forename: Uziel
authors.initials: U
authors.lastname: Beller
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
authors.forename: Usha
authors.initials: U
authors.lastname: Menon
authors.affiliation: Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK University of New South Wales, Sydney, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Jacobs
mesh_terms: D019313:BRCA1 Protein / Q000235:genetics*; D024682:BRCA2 Protein / Q000235:genetics*; D005260:Female; D005817:Genetic Counseling / Q000379:methods; D005820:Genetic Testing / Q000379:methods; D006801:Humans; D007585:Jews / Q000235:genetics; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics*; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D019313:BRCA1 Protein; C492913:BRCA1 protein, human; D024682:BRCA2 Protein; C551750:BRCA2 protein, human
keywords: BRCA1, BRCA2; Cluster Randomised trial; Genetic screening/counselling; Population based testing; genetic testing