Résumés
Résumé
L’implantation d’une nouvelle technologie est une étape de la translation d’une découverte vers une application clinique. De nombreux modèles ont été proposés pour étudier une telle translation ; celui de Goering, Holland et Kelley met de l’avant des priorités qui résonnent avec la bioéthique. Nous proposons l’application d’un outil issu des sciences de l’implantation, le Consolidated Framework for Implementation Research (CFIR), pour identifier les enjeux éthiques d’une nouvelle technologie. Cet outil est conçu pour identifier les barrières et facilitateurs de l’implantation d’une technologie, et par le fait même s’inscrit dans le modèle de la recherche translationnelle. Nous prenons en exemple le test génomique prénatal non invasif (TGPNI). Ce test est offert dans certaines provinces du Canada en deuxième intention pour les personnes enceintes ayant une haute probabilité d’avoir un foetus avec une aneuploïdie. Des innovations potentielles du TGPNI sont de l’offrir comme test de première intention et d’étendre le nombre de conditions génétiques dépistées. Nous proposons donc d’utiliser le CFIR pour identifier les enjeux éthiques qui découlent des barrières et facilitateurs de ces innovations du TGPNI. En identifiant les barrières et facilitateurs de l’implantation d’une technologie, cet outil permet aux bioéthiciens de recourir à un outil éprouvé d’une autre discipline pour étudier des enjeux éthiques. Les bioéthiciens peuvent alors se tourner vers leurs outils traditionnels pour identifier les enjeux éthiques que soulèvent ces éléments. Notre proposition est un exemple parmi d’autres possibles de ce que cette approche peut accomplir : identifier d’une manière innovatrice des enjeux éthiques d’une nouvelle technologie.
Mots-clés :
- dépistage prénatal,
- recherche translationnelle,
- science de l’implantation,
- bioéthique,
- dépistage prénatal non invasif
Abstract
The implementation of a new technology is one step in the translation of a discovery into a clinical application. Numerous models have been proposed to study such translation; Goering, Holland and Kelley’s model puts forward priorities that resonate with bioethics. We propose the application of a tool from the implementation sciences, the Consolidated Framework for Implementation Research (CFIR), to identify the ethical issues of a new technology. This tool is designed to identify the barriers and facilitators to the implementation of a technology and is therefore part of the translational research model. An example is the non-invasive prenatal genomic test (NIPGT). This test is offered in some provinces in Canada as a second-line test for pregnant persons with a high probability of having a fetus with aneuploidy. Potential innovations of NIPGT are to offer it as a first-line test and to expand the number of genetic conditions screened. We thus propose to use CFIR to identify the ethical issues that arise from the barriers and facilitators to these innovations in NIPGT. By identifying barriers and facilitators to the implementation of a technology, this tool allows bioethicists to use a proven tool from another discipline to study ethical issues. Bioethicists can then turn to their traditional tools to identify the ethical issues raised by these elements. Our proposal is just one example of what this approach can accomplish: identifying ethical issues in a new technology in an innovative way.
Keywords:
- prenatal screening,
- translational research,
- implantation science,
- bioethics,
- non-invasive prenatal screening
Veuillez télécharger l’article en PDF pour le lire.
Télécharger
Parties annexes
Remerciements / Acknowledgements
Les auteurs aimeraient remercier l’équipe Pégase de l’Université de Montréal qui a participé aux échanges et aux réflexions : Marie-Christine Roy, Marie-François Malo, Stanislav Birko, Hortense Gallois, Charles Selva-Rivero, Cynthia Henriksen, Marie-Ève Lemoine, Jessica Leclerc-Blain, Stéphanie Cloutier.
The authors would like to thank the Pegasus team from the University of Montreal who participated in the discussions and reflections: Marie-Christine Roy, Marie-François Malo, Stanislav Birko, Hortense Gallois, Charles Selva-Rivero, Cynthia Henriksen, Marie-Ève Lemoine, Jessica Leclerc-Blain, Stéphanie Cloutier.
Bibliographie
- 1. van El C, Henneman L. Cell-free DNA-based noninvasive prenatal testing and society. Dans: Page-Christiaens L, Klein H-G. Noninvasive Prenatal Testing (NIPT): Elsevier; 2018. p. 235-49.
- 2. Bayefsky MJ, Berkman BE. Implementing expanded prenatal genetic testing: should parents have access to any and all fetal genetic information? American Journal of Bioethics. 2022;22(2):4-22.
- 3. Society for Maternal-Fetal Medicine. Practice Bulletin No. 163 Summary: Screening for Fetal Aneuploidy. Obstetrics and Gynecology. 2016;127(5):e123-37.
- 4. Ravitsky V. The shifting landscape of prenatal testing: between reproductive autonomy and public health. Hastings Center Report. 2017;47(suppl 3):S34-40.
- 5. Nshimyumukiza L, Beaumont JA, Rousseau F, Reinharz D. Introducing cell-free DNA noninvasive testing in a Down syndrome public health screening program: a budget impact analysis. Cost Effectiveness and Resource Allocation. 2020;18:49.
- 6. Murdoch B, Ravitsky V, Ogbogu U, et al. Non-invasive prenatal testing and the unveiling of an impaired translation process. Journal of Obstetrics and Gynaecology Canada. 2017;39(1):10-7.
- 7. Gekas J, Langlois S, Ravitsky V, et al. Non-invasive prenatal testing for fetal chromosome abnormalities: review of clinical and ethical issues. The Application of Clinical Genetics. 2016;9:15-26.
- 8. Birko S, Lemoine M-E, Nguyen MT, Ravitsky V. Moving towards routine non-invasive prenatal testing (NIPT): challenges related to women’s autonomy. OBM Genetics 2018;2(2).
- 9. van der Laan AL, Boenink M. Beyond bench and bedside: disentangling the concept of translational research. Health Care Analysis. 2015;23(1):32-49.
- 10. Khoury MJ, Gwinn M, Yoon PW, Dowling N, Moore CA, Bradley L. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention? Genetics in Medicine. 2007;9(10):665-74.
- 11. Caballero FE. L’évaluation des tests génétiques: considérations normatives et contextuelles. Maitrise en Administration des services de santé, Université de Montréal; 2013.
- 12. Goering S, Holland S, Edwards K. Making good on the promise of genetics: justice in translational science. Dans: Burke W, Edwards K, Goering S, Holland S, Trinidad SB, rédacteurs. Achieving Justice in Genomic Translation: Re-Thinking the Pathway to Benefit. Oxford: Oxford University Press; 2011. p. 1-21.
- 13. Kelley M, Edwards K, Starks H, et al. Values in translation: how asking the right questions can move translational science toward greater health impact. Clinical and Translational Science. 2012;5(6):445-51.
- 14. Lo YD, Corbetta N, Chamberlain PF, et al. Presence of fetal DNA in maternal plasma and serum. The Lancet. 1997;350(9076):485-7.
- 15. Chiu RW, Lo YD. Non-invasive prenatal diagnosis by fetal nucleic acid analysis in maternal plasma: the coming of age. Seminars in Fetal and Neonatal Medicine. 2011;16(2):88-93.
- 16. Allyse M, Minear MA, Berson E, et al. Non-invasive prenatal testing: a review of international implementation and challenges. International Journal of Women’s Health. 2015;7:113-26.
- 17. Chan WV, Johnson J-A, Wilson RD, Metcalfe A. Obstetrical provider knowledge and attitudes towards cell–free DNA screening: results of a cross-sectional national survey. BMC Pregnancy and Childbirth. 2018;18(1):40.
- 18. Bellai‐Dussault K, Meng L, Huang T, et al. A 2‐year review of publicly funded cell‐free DNA screening in Ontario: utilization and adherence to funding criteria. Prenatal Diagnosis. 2020;40(2):164-72.
- 19. Rogowski WH, Grosse SD, Khoury MJ. Challenges of translating genetic tests into clinical and public health practice. Nature Reviews Genetics. 2009;10(7):489-95.
- 20. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Administration and Policy in Mental Health. 2009;36(1):24-34.
- 21. Roberts MC, Mensah GA, Khoury MJ. Leveraging implementation science to address health disparities in genomic medicine: examples from the field. Ethnicity & Disease. 2019;29(Suppl 1):187-92.
- 22. Williams JK, Feero WG, Leonard DG, Coleman B. Implementation science, genomic precision medicine, and improved health: A new path forward? Nursing Outlook. 2017;65(1):36-40.
- 23. Chambers DA, Feero WG, Khoury MJ. Convergence of implementation science, precision medicine, and the learning health care system: a new model for biomedical research. JAMA. 2016;315(18):1941-2.
- 24. Nilsen P. Making sense of implementation theories, models and frameworks. Implementation Science. 2015;10(1):53.
- 25. Kamenova K, Ravitsky V, McMullin S, Caulfield T. Media portrayal of non-invasive prenatal testing: a missing ethical dimension. JCOM. 2016;15(2):A03.
- 26. Haidar H, Vanstone M, Laberge A-M, Bibeau G, Ghulmiyyah L, Ravitsky V. Cross-cultural perspectives on decision making regarding noninvasive prenatal testing: A comparative study of Lebanon and Quebec. AJOB Empirical Bioethics. 2018;9(2):99-111.
- 27. Haidar H, Dupras C, Ravitsky V. Non-invasive prenatal testing: review of ethical, legal and social implications. BioéthiqueOnline. 2016;5:6.
- 28. Mozersky J, Ravitsky V, Rapp R, Michie M, Chandrasekharan S, Allyse M. Toward an ethically sensitive implementation of noninvasive prenatal screening in the global context. Hastings Center Report. 2017;47(2):41-9.
- 29. Bauer MS, Damschroder L, Hagedorn H, Smith J, Kilbourne AM. An introduction to implementation science for the non-specialist. BMC Psychology. 2015;3(1):32.
- 30. Burke W, Korngiebel DM. Closing the gap between knowledge and clinical application: challenges for genomic translation. PLoS genetics. 2015;11(2):e1004978.
- 31. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation Science. 2009;4:50.
- 32. Cole AM, Esplin A, Baldwin L-M. Adaptation of an evidence-based colorectal cancer screening program using the Consolidated Framework for Implementation Research. Preventing Chronic Disease. 2015;12:E213.
- 33. Martinez RG, Lewis CC, Weiner BJ. Instrumentation issues in implementation science. Implementation Science. 2014;9:118.
- 34. Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for Implementation Research. Implementation Science. 2016;11:72.
- 35. DeSisto CL, Kroelinger CD, Estrich C, et al. Application of an implementation science framework to policies on immediate postpartum long-acting reversible contraception. Public Health Reports. 2019;134(2):189-96.
- 36. Orlando LA, Sperber NR, Voils C, et al. Developing a common framework for evaluating the implementation of genomic medicine interventions in clinical care: the IGNITE Network’s Common Measures Working Group. Genetics in Medicine. 2018;20(6):655-63.
- 37. Horowitz CR, Orlando LA, Slavotinek AM, et al. The genomic medicine integrative research framework: a conceptual framework for conducting genomic medicine research. American Journal of Human Genetics. 2019;104(6):1088-96.
- 38. Robins LS, Jackson JE, Green BB, Korngiebel D, Force RW, Baldwin L-M. Barriers and facilitators to evidence-based blood pressure control in community practice. Journal of the American Board of Family Medicine. 2013;26(5):539-57.
- 39. Gilmer TP, Katz ML, Stefancic A, Palinkas LA. Variation in the implementation of California’s Full Service Partnerships for persons with serious mental illness. Health Services Research. 2013;48(6 Pt 2):2245-67.