Development and evaluation of a decision aid for women eligible for organized breast cancer screening according to international standards: A multi-method study.

BACKGROUND: and purpose: In France, women lack information to make a shared decision to start breast cancer screening. Decision aids are useful to facilitate this discussion, yet few meet international standards. The objective of this project was to build, validate and measure the quality of a decision aid for organized breast screening in France, in line with international standards, intended for both women and healthcare professionals. MATERIALS AND METHODS: This mixed-methods study was conducted between January 2017 and June 2022. The prototype was developed from a qualitative study, systematic review and targeted literature review and alpha tested during two Delphi rounds. Readability was evaluated with the Flesch score and content with International Patient Decision Aid Standards Instrument (IPSASi). RESULTS: An online decision aid, accessible at www.Discutons-mammo.fr, written in French was developed. The content included eligibility, information about breast screening the advantages and disadvantages of screening, patient preferences and a patient-based discussion guide using text, infographics, and videos. The Flesch readability test score was 65.4 and the IPDASi construct quality score was 176 out of 188. CONCLUSIONS: This decision aid complies with IPDASi standards and could help women eligible for breast screening in France make a shared decision with a specialized healthcare professional about whether or not to participate in organized breast screening.

What do women and healthcare professionals expect of decision aids for breast cancer screening? A qualitative study in France.

OBJECTIVE: Breast cancer screening decision aids (DAs) are designed to help women decide whether or not to participate in mammography-based programmes. We aimed to explore women's and healthcare professionals' expectations of a breast cancer screening DA, as part of the French DEDICACES study. METHODS: This French qualitative study was based on semistructured, individual interviews with women from the general population, general practitioners (GPs), midwives, gynaecologists, radiologists and screening centre managers. Sampling was purposive and used diversification criteria. The inductive analysis was based on grounded theory. RESULTS: Between April 2018 and May 2019, we interviewed 40 people: 13 women, 14 GPs, 4 gynaecologists, 3 midwives, 3 radiologists and 3 screening centre managers. The women and the healthcare professionals considered that a DA could help to improve levels of knowledge, harmonise medical practice and provide reliable, comprehensive information. Overall, the interviewees wanted an easy-to-use, intuitive, graphic-rich, interactive, computer-based, patient-centred DA. Use of the DA might be limited by a lack of familiarity with shared decision-making (SDM), the risk of misuse and a preference for asymmetric positive information. CONCLUSION: The present results are likely to facilitate the development of the first validated tool for SDM support in French breast cancer screening programmes.

Partnering with patients in translational oncology research: ethical approach.

BACKGROUND: The research program CARPEM (cancer research and personalized medicine) brings together the expertise of researchers and hospital-based oncologists to develop translational research in the context of personalized or "precision" medicine for cancer. There is recognition that patient involvement can help to take into account their needs and priorities in the development of this emerging practice but there is currently no consensus about how this can be achieved. In this study, we developed an empirical ethical research action aiming to improve patient representatives' involvement in the development of the translational research program together with health professionals. The aim is to promote common understanding and sharing of knowledge between all parties and to establish a long-term partnership integrating patient's expectations. METHODS: Two distinct committees were settled in CARPEM: an "Expert Committee", gathering healthcare and research professionals, and a "Patient Committee", gathering patients and patient representatives. A multidisciplinary team trained in medical ethics research ensured communication between the two committees as well as analysis of discussions, minutes and outputs from all stakeholders. RESULTS: The results highlight the efficiency of the transfer of knowledge between interested parties. Patient representatives and professionals were able to identify new ethical challenges and co-elaborate new procedures to gather information and consent forms for adapting to practices and recommendations developed during the process. Moreover, included patient representatives became full partners and participated in the transfer of knowledge to the public via conferences and publications. CONCLUSIONS: Empirical ethical research based on a patient-centered approach could help in establishing a fair model for coordination and support actions during cancer research, striking a balance between the regulatory framework, researcher needs and patient expectations. Our approach addresses the concept of translational ethics as a way to handle the main remaining gap between combining care and research activities in the medical pathway and the existing framework.