Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations.

Manchanda, R; Burnell, M; Loggenberg, K; Desai, R; Wardle, J; Sanderson, SC; Gessler, S; Side, L; Balogun, N; Kumar, A; Dorkins, H; Wallis, Y; Chapman, C; Tomlinson, I; Taylor, R; Jacobs, C; Legood, R; Raikou, M; McGuire, A; Beller, U; Menon, U; Jacobs, I

Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations.

Manchanda, R Burnell, M Loggenberg, K Desai, R Wardle, J Sanderson, SC Gessler, S Side, L Balogun, N Kumar, A Dorkins, H Wallis, Y Chapman, C Tomlinson, I Taylor, R Jacobs, C

Legood, R Raikou, M McGuire, A Beller, U Menon, U Jacobs, I

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Publisher:: BMJ PUBLISHING GROUP
Publication Type:: Journal Article
Citation:: J Med Genet, 2016, 53, (7), pp. 472-480
Issue Date:: 2016-07

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Field	Value	Language
dc.contributor.author	Manchanda, R
dc.contributor.author	Burnell, M
dc.contributor.author	Loggenberg, K
dc.contributor.author	Desai, R
dc.contributor.author	Wardle, J
dc.contributor.author	Sanderson, SC
dc.contributor.author	Gessler, S
dc.contributor.author	Side, L
dc.contributor.author	Balogun, N
dc.contributor.author	Kumar, A
dc.contributor.author	Dorkins, H
dc.contributor.author	Wallis, Y
dc.contributor.author	Chapman, C
dc.contributor.author	Tomlinson, I
dc.contributor.author	Taylor, R
dc.contributor.author	Jacobs, C https://orcid.org/0000-0002-9557-9080
dc.contributor.author	Legood, R
dc.contributor.author	Raikou, M
dc.contributor.author	McGuire, A
dc.contributor.author	Beller, U
dc.contributor.author	Menon, U
dc.contributor.author	Jacobs, I
dc.date.accessioned	2022-04-18T23:38:35Z
dc.date.available	2016-02-21
dc.date.available	2022-04-18T23:38:35Z
dc.date.issued	2016-07
dc.identifier.citation	J Med Genet, 2016, 53, (7), pp. 472-480
dc.identifier.issn	0022-2593
dc.identifier.issn	1468-6244
dc.identifier.uri	http://hdl.handle.net/10453/156361
dc.description.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.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	BMJ PUBLISHING GROUP
dc.relation.ispartof	J Med Genet
dc.relation.isbasedon	10.1136/jmedgenet-2015-103740
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	06 Biological Sciences, 11 Medical and Health Sciences
dc.subject.classification	Genetics & Heredity
dc.subject.mesh	BRCA1 Protein
dc.subject.mesh	BRCA2 Protein
dc.subject.mesh	Female
dc.subject.mesh	Genetic Counseling
dc.subject.mesh	Genetic Testing
dc.subject.mesh	Humans
dc.subject.mesh	Jews
dc.subject.mesh	Male
dc.subject.mesh	Middle Aged
dc.subject.mesh	Mutation
dc.subject.mesh	Risk Assessment
dc.subject.mesh	Risk Factors
dc.subject.mesh	Humans
dc.subject.mesh	BRCA1 Protein
dc.subject.mesh	BRCA2 Protein
dc.subject.mesh	Risk Assessment
dc.subject.mesh	Risk Factors
dc.subject.mesh	Genetic Counseling
dc.subject.mesh	Mutation
dc.subject.mesh	Middle Aged
dc.subject.mesh	Jews
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Genetic Testing
dc.title	Cluster-randomised non-inferiority trial comparing DVD-assisted and traditional genetic counselling in systematic population testing for BRCA1/2 mutations.
dc.type	Journal Article
utslib.citation.volume	53
utslib.location.activity	England
utslib.for	06 Biological Sciences
utslib.for	11 Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health/GSH.Genetic Counselling
utslib.copyright.status	open_access	*
dc.date.updated	2022-04-18T23:38:33Z
pubs.issue	7
pubs.publication-status	Published
pubs.volume	53
utslib.citation.issue	7

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.

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