The WISDOM study: a new approach to screening can and should be tested

Esserman, Laura J.; Eklund, Martin; Veer, Laura van’t; Shieh, Yiwey; Tice, Jeffrey A.; Ziv, Elad; Blanco, Amie; Kaplan, Celia P.; Hiatt, Robert A.; Fiscalini, Allison Stover; Yau, Christina; Scheuner, Maren T.; Naeim, Arash; Wenger, Neil S.; Lee, Vivian; Heditsian, Diane; Brain, Susie; Parker, Barbara A.; LaCroix, Andrea Z.; Madlensky, Lisa; Hogarth, Michael; Borowsky, Alexander D.; Anton‐Culver, Hoda; Kaster, Andrea; Olopade, Olufunmilayo I.; Sheth, Deepa; Garcia, Augustin; Lancaster, Rachael; Plaza, Michael J.

doi:10.1007/s10549-021-06346-w

Cited by 22 publications

(19 citation statements)

References 32 publications

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“…These algorithms allow tailored prevention and early detection for women at higher risk[ 6 ] and possibly reduced screening for women at lower risk [ 7 ]. With no randomised controlled trial (RCT) evidence to date[ 8 ], the effectiveness of risk-stratified screening at preventing the development of higher-stage breast cancers is being tested internationally in the WISDOM and MyPeBS trials[ 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

Healthcare professionals’ views following implementation of risk stratification into a national breast cancer screening programme

et al. 2022

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Background It is crucial to determine feasibility of risk-stratified screening to facilitate successful implementation. We introduced risk-stratification (BC-Predict) into the NHS Breast Screening Programme (NHSBSP) at three screening sites in north-west England from 2019 to 2021. The present study investigated the views of healthcare professionals (HCPs) on acceptability, barriers, and facilitators of the BC-Predict intervention and on the wider implementation of risk-based screening after BC-Predict was implemented in their screening site. Methods Fourteen semi-structured interviews were conducted with HCPs working across the breast screening pathway at three NHSBSP sites that implemented BC-Predict. Thematic analysis interpreted the data. Results Three pre-decided themes were produced. (1) Acceptability of risk-based screening: risk-stratification was perceived as a beneficial step for both services and women. HCPs across the pathway reported low burden of running the BC-Predict trial on routine tasks, but with some residual concerns; (2) Barriers to implementation: comprised capacity constraints of services including the inadequacy of current IT systems to manage women with different risk profiles and, (3) Facilitators to implementation: included the continuation of stakeholder consultation across the pathway to inform implementation and need for dedicated risk screening admin staff, a push for mammography staff recruitment and guidance for screening services. Telephone helplines, integrating primary care, and supporting access for all language needs was emphasised. Conclusion Risk-stratified breast screening was viewed as a progressive step providing it does not worsen inequalities for women. Implementation of risk-stratified breast screening requires staff to be reassured that there will be systems in place to support implementation and that it will not further burden their workload. Next steps require a comprehensive assessment of the resource needed for risk-stratification versus current resource availability, upgrades to screening IT and building screening infrastructure. The role of primary care needs to be determined. Simplification and clarification of risk-based screening pathways is needed to support HCPs agency and facilitate implementation. Forthcoming evidence from ongoing randomised controlled trials assessing effectiveness of breast cancer risk-stratification will also determine implementation.

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Section: Introductionmentioning

confidence: 99%

Healthcare professionals’ views following implementation of risk stratification into a national breast cancer screening programme

et al. 2022

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“…13 Independent Cancer Patients' Voice, London, UK. 14 Unicancer, Paris, France. 15 Paris Est Creteil University, Créteil, France.…”

Section: Appendixmentioning

confidence: 99%

“…Internationally, there are several ongoing trials analysing these outcomes under risk-stratified screening in comparison to routine breast cancer screening. These include the BC-Predict project in the UK [12], Perspective in Canada [13], and two controlled randomised trial: the Wisdom study in the US [14], and the MyPeBS study ("My Personal Breast Screening") in Europe and Israel.…”

Section: Introductionmentioning

confidence: 99%

Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the “My Personal Breast Screening” (MyPeBS) randomised clinical trial

et al. 2022

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Background The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women’s reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. Methods At inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants’ acceptability and comprehension of the trial, and their experience of risk assessment. Discussion Beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. Trial registration Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). Clinicaltrials.gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

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“…This incorporates cost versus benefit with the goal of not missing a malignant diagnosis that could alter life expectancy. We look forward to the results of trials such as WISDOM 10 (Women Informed to Screen Depending on Measures of Risk), which may provide us some of the guidance needed.…”

Section: Personalized Screeningmentioning

confidence: 99%

Screening MRI in Patients with High-Risk Breast Lesions: More May Not Necessarily be More

Paramo

Rao

2022

Ann Surg Oncol

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The WISDOM study: a new approach to screening can and should be tested

Cited by 22 publications

References 32 publications

Healthcare professionals’ views following implementation of risk stratification into a national breast cancer screening programme

Healthcare professionals’ views following implementation of risk stratification into a national breast cancer screening programme

Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the “My Personal Breast Screening” (MyPeBS) randomised clinical trial

Screening MRI in Patients with High-Risk Breast Lesions: More May Not Necessarily be More

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