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

Manchanda, Ranjit; Burnell, Matthew; Loggenberg, K; Desai, Roopal; Wardle, Jane; Sanderson, Saskia C.; Gessler, Sue; Side, Lucy; Balogun, Nyaladzi; Kumar, Ajith; Dorkins, Huw; Wallis, Yvonne; Chapman, Cyril; Tomlinson, Ian; Taylor, Rohan; Jacobs, Chris; Legood, Rosa; Raikou, Maria; McGuire, Alistair; Beller, Uziel; Menon, Usha; Jacobs, Ian

doi:10.1136/jmedgenet-2015-103740

Cited by 50 publications

(83 citation statements)

References 41 publications

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“…The Israeli/Canadian studies provided only post‐test counselling to mutation carriers or those with a strong family history (FH) of cancer. High satisfaction rates have been reported in all three studies . A population‐based approach identifies >50% additional BRCA ‐carriers compared with clinical criteria/FH‐based testing, does not detrimentally affect psychological well‐being or quality‐of‐life on a population basis, and has been found to be extremely cost‐effective .…”

Section: Introductionmentioning

confidence: 78%

“…Nevertheless, both ‘pre‐test’ and ‘post‐test only’ counselling approaches explored in all three population studies report similar and extremely high levels of overall satisfaction (91–95%) with the testing process. Earlier randomised trials found standard face‐to‐face pre‐test counselling comparable with pre‐test telephone, DVD‐based, and tele‐genetic counselling . The changing landscape, increasing awareness, and expanding applicability enabling large‐scale high‐volume genetic testing has resulted in exploration of novel approaches with a move away from traditional face‐to‐face counselling.…”

Section: Discussionmentioning

confidence: 99%

“…Pre‐test counselling was undertaken through six high‐street/community‐based centres in London . Recruitment clinics (clusters) were randomised to traditional face‐to‐face and DVD‐counselling approaches between 2009 and 2010, the outcomes of which have been reported earlier . We report on data from individuals who underwent pre‐test counselling in recruitment clinic clusters.…”

Section: Methodsmentioning

confidence: 99%

“…The GCaPPS trial offered pre‐test counselling outside a hospital in a high‐street/community‐based setting. Traditional face‐to‐face and DVD‐based approaches were compared and found to be equivalent . The Israeli/Canadian studies provided only post‐test counselling to mutation carriers or those with a strong family history (FH) of cancer.…”

Section: Introductionmentioning

confidence: 99%

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Attitude towards and factors affecting uptake of population‐basedBRCAtesting in the Ashkenazi Jewish population: a cohort study

Manchanda

Burnell

Gaba

et al. 2019

BJOG

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Objective To evaluate factors affecting unselected population‐based BRCA testing in Ashkenazi Jews (AJ). Design Cohort‐study set within recruitment to the GCaPPS trial (ISRCTN73338115). Setting North London AJ population. Population or sample Ashkenazi Jews women/men >18 years, recruited through self‐referral. Methods Ashkenazi Jews women/men underwent pre‐test counselling for BRCA testing through recruitment clinics (clusters). Consenting individuals provided blood samples for BRCA testing. Data were collected on socio‐demographic/family history/knowledge/psychological well‐being along with benefits/risks/cultural influences (18‐item questionnaire measuring ‘attitude’). Four‐item Likert‐scales analysed initial ‘interest’ and ‘intention‐to‐test’ pre‐counselling. Uni‐ and multivariable logistic regression models evaluated factors affecting uptake/interest/intention to undergo BRCA testing. Statistical inference was based on cluster robust standard errors and joint Wald tests for significance. Item‐Response Theory and graded‐response models modelled responses to 18‐item questionnaire. Main outcome measures Interest, intention, uptake, attitude towards BRCA testing. Results A total of 935 individuals (women = 67%/men = 33%; mean age = 53.8 (SD = 15.02) years) underwent pre‐test genetic‐counselling. During the pre‐counselling, 96% expressed interest in and 60% indicated a clear intention to undergo BRCA testing. Subsequently, 88% opted for BRCA testing. BRCA‐related knowledge (P = 0.013) and degree‐level education (P = 0.01) were positively and negatively (respectively) associated with intention‐to‐test. Being married/cohabiting had four‐fold higher odds for BRCA testing uptake (P = 0.009). Perceived benefits were associated with higher pre‐counselling odds for interest in and intention to undergo BRCA testing. Reduced uncertainty/reassurance were the most important factors contributing to decision‐making. Increased importance/concern towards risks/limitations (confidentiality/insurance/emotional impact/inability to prevent cancer/marriage ability/ethnic focus/stigmatisation) were significantly associated with lower odds of uptake of BRCA testing, and discriminated between acceptors and decliners. Male gender/degree‐level education (P = 0.001) had weaker correlations, whereas having children showed stronger (P = 0.005) associations with attitudes towards BRCA testing. Conclusions BRCA testing in the AJ population has high acceptability. Pre‐test counselling increases awareness of disadvantages/limitations of BRCA testing, influencing final cost‐benefit perception and decision‐making on undergoing testing. Tweetable abstract BRCA testing in Ashkenazi Jews has high acceptability and uptake. Pre‐test counselling facilitates informed decision‐making.

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Section: Introductionmentioning

confidence: 78%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Attitude towards and factors affecting uptake of population‐basedBRCAtesting in the Ashkenazi Jewish population: a cohort study

Manchanda

Burnell

Gaba

et al. 2019

BJOG

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show abstract

“…For population testing to be feasible, newer approaches for delivering pre‐test information are needed to facilitate informed decision‐making. An Ashkenazi Jewish UK non‐inferiority cluster‐randomised trial, found that DVD‐based pre‐test counselling for population BRCA testing was non‐inferior with respect to knowledge gained, satisfaction and risk perception, and equivalent for testing uptake as well as being time‐saving and cost‐efficient compared with standard/1:1 face‐to‐face genetic counselling . Data from randomised controlled trials show that telephone counselling is also non‐inferior to traditional genetic counselling.…”

Section: Population Testing In the Jewish Populationmentioning

confidence: 99%

A commentary on population genetic testing for primary prevention: changing landscape and the need to change paradigm

Manchanda

Gaba

2019

BJOG

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A Cost-effectiveness Analysis of Multigene Testing for All Patients With Breast Cancer

et al. 2019

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IMPORTANCE Moving to multigene testing for all women with breast cancer (BC) could identify many more mutation carriers who can benefit from precision prevention. However, the cost-effectiveness of this approach remains unaddressed. OBJECTIVE To estimate incremental lifetime effects, costs, and cost-effectiveness of multigene testing of all patients with BC compared with the current practice of genetic testing (BRCA) based on family history (FH) or clinical criteria. DESIGN, SETTING, AND PARTICIPANTS This cost-effectiveness microsimulation modeling study compared lifetime costs and effects of high-risk BRCA1/BRCA2/PALB2 (multigene) testing of all unselected patients with BC (strategy A) with BRCA1/BRCA2 testing based on FH or clinical criteria (strategy B) in United Kingdom (UK) and US populations. Data were obtained from 11 836 patients in population-based BC cohorts (regardless of FH) recruited to 4 large research studies. Data were collected and analyzed from January 1, 2018, through June 8, 2019. The time horizon is lifetime. Payer and societal perspectives are presented. Probabilistic and 1-way sensitivity analyses evaluate model uncertainty. INTERVENTIONS In strategy A, all women with BC underwent BRCA1/BRCA2/PALB2 testing. In strategy B, only women with BC fulfilling FH or clinical criteria underwent BRCA testing. Affected BRCA/PALB2 carriers could undertake contralateral preventive mastectomy; BRCA carriers could choose risk-reducing salpingo-oophorectomy (RRSO). Relatives of mutation carriers underwent cascade testing. Unaffected relative carriers could undergo magnetic resonance imaging or mammography screening, chemoprevention, or risk-reducing mastectomy for BC risk and RRSO for ovarian cancer (OC) risk. MAIN OUTCOMES AND MEASURES Incremental cost-effectiveness ratio (ICER) was calculated as incremental cost per quality-adjusted life-year (QALY) gained and compared with standard £30 000/QALY and $100 000/QALY UK and US thresholds, respectively. Incidence of OC, BC, excess deaths due to heart disease, and the overall population effects were estimated. RESULTS BRCA1/BRCA2/PALB2 multigene testing for all patients detected with BC annually would cost £10 464/QALY

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

Abstract: ISRCTN 73338115.

Cited by 50 publications

References 41 publications

Attitude towards and factors affecting uptake of population‐basedBRCAtesting in the Ashkenazi Jewish population: a cohort study

Attitude towards and factors affecting uptake of population‐basedBRCAtesting in the Ashkenazi Jewish population: a cohort study

A commentary on population genetic testing for primary prevention: changing landscape and the need to change paradigm

A Cost-effectiveness Analysis of Multigene Testing for All Patients With Breast Cancer

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