Ranjit Manchanda1, Matthew Burnell2, Kelly Loggenberg2, Rakshit Desai2, Jane Wardle3, Saskia C Sanderson4, Sue Gessler2, Lucy Side2, Nyala Balogun2, Ajith Kumar5, Huw Dorkins6, Yvonne Wallis7, Cyril Chapman8, Ian Tomlinson9, Rohan Taylor10, Chris Jacobs11, Rosa Legood12, Maria Raikou13, Alistair McGuire13, Uziel Beller14, Usha Menon2, Ian Jacobs15. 1. 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. 2. Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK. 3. Behavioural Sciences Unit, Department of Epidemiology and Public Health, University College London, London, UK. 4. Mt Sinai University, New York, USA. 5. Department of Clinical Genetics, North East Thames Regional Genetics Unit, Great Ormond Street Hospital, London, UK. 6. Department of Clinical Genetics, North West Thames Regional Genetics Unit, Northwick Park Hospital, London, UK. 7. West Midlands Regional Genetics Laboratory, Birmingham Women's NHS Foundation Trust, Birmingham, UK. 8. Depatment of Clinical Genetics, West Midlands Regional Genetics, Birmingham Women's NHS Foundation Trust, Birmingham, UK. 9. London Research Institute, Cancer Research UK. 10. South West Thames Molecular Genetics Diagnostic Laboratory, St George's Hospital, London, UK. 11. Department of Clinical Genetics, Guy's Hospital, London, UK. 12. Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK. 13. Department of Health Economics, London School of Economics, London, UK. 14. Department of Gynaecology, Shaare Zedek Medical Centre, Jerusalem, Israel. 15. Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK University of New South Wales, Sydney, Australia.
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 underwentpre-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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Entities:
Keywords:
BRCA1, BRCA2; Cluster Randomised trial; Genetic screening/counselling; Population based testing; genetic testing
Authors: Janet Jull; Sascha Köpke; Maureen Smith; Meg Carley; Jeanette Finderup; Anne C Rahn; Laura Boland; Sandra Dunn; Andrew A Dwyer; Jürgen Kasper; Simone Maria Kienlin; France Légaré; Krystina B Lewis; Anne Lyddiatt; Claudia Rutherford; Junqiang Zhao; Tamara Rader; Ian D Graham; Dawn Stacey Journal: Cochrane Database Syst Rev Date: 2021-11-08
Authors: Ranjit Manchanda; Li Sun; Shreeya Patel; Olivia Evans; Janneke Wilschut; Ana Carolina De Freitas Lopes; Faiza Gaba; Adam Brentnall; Stephen Duffy; Bin Cui; Patricia Coelho De Soarez; Zakir Husain; John Hopper; Zia Sadique; Asima Mukhopadhyay; Li Yang; Johannes Berkhof; Rosa Legood Journal: Cancers (Basel) Date: 2020-07-17 Impact factor: 6.639
Authors: Jeanna M McCuaig; Susan Randall Armel; Melanie Care; Alexandra Volenik; Raymond H Kim; Kelly A Metcalfe Journal: Cancers (Basel) Date: 2018-11-13 Impact factor: 6.639
Authors: Li Sun; Adam Brentnall; Shreeya Patel; Diana S M Buist; Erin J A Bowles; D Gareth R Evans; Diana Eccles; John Hopper; Shuai Li; Melissa Southey; Stephen Duffy; Jack Cuzick; Isabel Dos Santos Silva; Alec Miners; Zia Sadique; Li Yang; Rosa Legood; Ranjit Manchanda Journal: JAMA Oncol Date: 2019-10-03 Impact factor: 31.777