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Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations
  1. Ranjit Manchanda1,2,3,
  2. Matthew Burnell1,
  3. Kelly Loggenberg1,
  4. Rakshit Desai1,
  5. Jane Wardle4,
  6. Saskia C Sanderson5,
  7. Sue Gessler1,
  8. Lucy Side1,
  9. Nyala Balogun1,
  10. Ajith Kumar6,
  11. Huw Dorkins7,
  12. Yvonne Wallis8,
  13. Cyril Chapman9,
  14. Ian Tomlinson10,
  15. Rohan Taylor11,
  16. Chris Jacobs12,
  17. Rosa Legood13,
  18. Maria Raikou14,
  19. Alistair McGuire14,
  20. Uziel Beller15,
  21. Usha Menon1,
  22. Ian Jacobs1,16
  1. 1Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK
  2. 2Department of Gynaecological Oncology, Bartshealth NHS Trust, Royal London Hospital, London, UK
  3. 3Barts Cancer Institute, Queen Mary University of London, London, UK
  4. 4Behavioural Sciences Unit, Department of Epidemiology and Public Health, University College London, London, UK
  5. 5Mt Sinai University, New York, USA
  6. 6Department of Clinical Genetics, North East Thames Regional Genetics Unit, Great Ormond Street Hospital, London, UK
  7. 7Department of Clinical Genetics, North West Thames Regional Genetics Unit, Northwick Park Hospital, London, UK
  8. 8West Midlands Regional Genetics Laboratory, Birmingham Women's NHS Foundation Trust, Birmingham, UK
  9. 9Depatment of Clinical Genetics, West Midlands Regional Genetics, Birmingham Women's NHS Foundation Trust, Birmingham, UK
  10. 10London Research Institute, Cancer Research UK,
  11. 11South West Thames Molecular Genetics Diagnostic Laboratory, St George's Hospital, London, UK
  12. 12Department of Clinical Genetics, Guy's Hospital, London, UK
  13. 13Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK
  14. 14Department of Health Economics, London School of Economics, London, UK
  15. 15Department of Gynaecology, Shaare Zedek Medical Centre, Jerusalem, Israel
  16. 16University of New South Wales, Sydney, Australia
  1. Correspondence to Dr Ranjit Manchanda, Consultant Gynaecological Oncologist, Clinical Senior Lecturer, Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London EC1M 6BQ, UK; r.manchanda{at}ucl.ac.uk

Abstract

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.

  • BRCA1, BRCA2
  • Cluster Randomised trial
  • Population based testing
  • Genetic screening/counselling
  • genetic testing

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