Implementing Publicly Funded Noninvasive Prenatal Testing for Fetal Aneuploidy in Ontario,Canada: Clinician Experiences With a Disruptive Technology

Abstract

The last decade has experienced unprecedented uptake of noninvasive prenatal testing (NIPT), creating significant changes in the way prenatal clinicians provide services. Through the lens of social shaping of technology, we examine the effects of the introduction of this technology on the health care system in Ontario, Canada. Using a qualitative descriptive approach, we conducted a cross-sectional study investigating clinicians’ perspectives of NIPT in 2014, 2016, and 2018. Through in-depth interviews (n = 37), we explored their perspectives on the impact of NIPT on their referral practices, workload, coordination of testing modalities, education and counseling, and elicited their views on recent expansions of the test. Findings suggest that the introduction of NIPT has created unintended consequences with respect to clinician workload and wellness, clinician education, equity of access, and public system resources. Responsiveness from decision makers is key to ensuring the responsible use of NIPT in the health care system.

Keywords

noninvasive prenatal testing social shaping of technology clinicians qualitative description Ontario Canada

Get full access to this article

View all access options for this article.

References

Aiken

L. H.

Clarke

S. P.

Sloane

D. M.

Sochalski

Silber

J. H.

(2005). Hospital nurse staffing and patient mortality, emotional exhaustion, and job dissatisfaction. Clinical Nurse Specialist, 19(5), 252–254. https://doi.org/10.1097/00002800-200509000-00008.

Allyse

Minear

M. A.

Berson

Sridhar

Rote

Hung

Chandrasekharan

(2015). Non-invasive prenatal testing: A review of international implementation and challenges. International Journal of Women’s Health, 7, 113–126. https://doi.org/10.2147/IJWH.S67124

Audibert

De Bie

Johnson

J.-A.

Okun

Wilson

R. D.

Armour

. . . Kim

(2017). No. 348-joint SOGC-CCMG guideline: Update on prenatal screening for fetal aneuploidy, fetal anomalies, and adverse pregnancy outcomes. Journal of Obstetrics and Gynaecology Canada, 39(9), 805–817. https://doi.org/10.1016/J.JOGC.2017.01.032

Bacchi

(2012). Introducing the “what’s the problem represented to be?”Approach. In Bletsas

Beasley

(Eds.), Engaging with Carol Bacchi: Strategic interventions and exchanges (pp. 21–24). University of Adelaide Press.

Beauchamp

T. L.

Childress

J. F.

(2001). Principles of biomedical ethics (7th ed.). Oxford University Press.

Bianchi

D. W.

Van Mieghem

Shaffer

L. G.

Faas

B. H. W.

Chitty

L. S.

Ghidini

Deprest

(2014). In case you missed it: The Prenatal Diagnosis section editors bring you the most significant advances of 2013. Prenatal Diagnosis, 34(1), 1–5. https://doi.org/10.1002/pd.4288

Bijker

W. E.

(2009). How is technology made?-That is the question! Cambridge Journal of Economics, 34(1), 63–76. https://doi.org/10.1093/cje/bep068

Blumer

(1954). What is wrong with social theory? American Sociological Review, 19(1), 3–10. https://doi.org/10.2307/2088165

Bonebright

D. A.

(2010). 40 years of storming: A historical review of Tuckman’s model of small group development. Human Resource Development International, 13(1), 111–120. https://doi.org/10.1080/13678861003589099

10.

Bowen

G. A.

(2006). Grounded theory and sensitizing concepts. International Journal of Qualitative Methods, 5(3), 12–23. https://doi.org/10.1177/160940690600500304

11.

Calman

Brunton

Molassiotis

(2013). Developing longitudinal qualitative designs: Lessons learned and recommendations for health services research. BMC Medical Research Methodology, 13(1), 1–10. https://doi.org/10.1186/1471-2288-13-14

12.

Cernat

Freitas

De Majid

Trivedi

Higgins

Vanstone

(2019). Facilitating informed choice about non-invasive prenatal testing (NIPT): A systematic review and qualitative meta-synthesis of women’s experiences. BMC Pregnancy and Childbirth 19, Article 27.

13.

Charmaz

(2003). Grounded theory: Objectivist and constructivist methods. In N. K. Denzin, & Y. Lincoln (Eds.), Strategies for qualitative inquiry (2nd ed., pp. 249–291). Sage.

14.

Charmaz

(2006). Constructing grounded theory: A practical guide through qualitative analysis. Sage.

15.

Chitty

L. S.

Bianchi

D. W.

(2013). Noninvasive prenatal testing: The paradigm is shifting rapidly. Prenatal Diagnosis, 33(6), 511–513. https://doi.org/10.1002/pd.4136

16.

Chitty

L. S.

Hudgins

Norton

M. E.

(2018). Current controversies in prenatal diagnosis 2: Cell-free DNA prenatal screening should be used to identify all chromosome abnormalities. Prenatal Diagnosis, 38(3), 160–165. https://doi.org/10.1002/pd.5216

17.

Collingridge

(1980). The social control of technology. Frances Pinter.

18.

Corbin

J. M.

(2008). Basics of qualitative research: Techniques and procedures for developing grounded theory (3rd ed.). Sage.

19.

Cummings. (2017). Cross-sectional design. In M

Allen

(Ed.), The SAGE encyclopedia of communication research methods. Sage. https://doi.org/10.4135/9781483381411

20.

de Jong

Dondorp

W. J.

de Die-Smulders

C. E. M.

Frints

S. G. M.

de Wert

G. M. W. R

. (2010). Non-invasive prenatal testing: Ethical issues explored. European Journal of Human Genetics, 18(3), 272–277. https://doi.org/10.1038/ejhg.2009.203

21.

Demers-Payette

Lehoux

Daudelin

(2016). Responsible research and innovation: A productive model for the future of medical innovation. Journal of Responsible Innovation, 3(3), 188–208. https://doi.org/10.1080/23299460.2016.1256659

22.

Dondorp

de Wert

Bombard

Bianchi

D. W.

Bergmann

Borry

. . . Cornel

M. C.

(2015). Non-invasive prenatal testing for aneuploidy and beyond: Challenges of responsible innovation in prenatal screening. European Journal of Human Genetics, 23(11), 1438–1450. https://doi.org/10.1038/ejhg.2015.57

23.

Farrimond

H. R.

Kelly

S. E.

(2013). Public viewpoints on new non-invasive prenatal genetic tests. Public Understanding of Science, 22(6), 730–744. https://doi.org/10.1177/0963662511424359

24.

Fixsen

D. L.

Blasé

K. A.

Timbers

G. D.

Wolf

M. M.

(2007). In search of program implementation: 792 replications of the Teaching-Family Model. The Behavior Analyst Today, 8(1), 96–110. https://doi.org/10.1037/h0100104

25.

Government of the United Kingdom. (2015). The NHS Constitution for England. https://www.gov.uk/government/publications/the-nhs-constitution-for-england/the-nhs-constitution-for-england

26.

Haidar

Dupras

Ravitsky

(2016). Non-invasive prenatal testing: Review of ethical, legal and social implications. BioethiqueOnline, 5. https://doi.org/10.7202/1044264ar

27.

Haidar

Vanstone

Laberge

A. M.

Bibeau

Ghulmiyyah

Ravitsky

(2018). Cross-cultural perspectives on decision making regarding noninvasive prenatal testing: A comparative study of Lebanon and Quebec. AJOB Empirical Bioethics, 9(2), 99–111. https://doi.org/10.1080/23294515.2018.1469551

28.

Haidar

Vanstone

Laberge

A. M.

Bibeau

Ghulmiyyah

Ravitsky

(2020). Implementation challenges for an ethical introduction of noninvasive prenatal testing: A qualitative study of healthcare professionals’ views from Lebanon and Quebec. BMC Medical Ethics, 21(1), Article 15. https://doi.org/10.1186/s12910-020-0455-x

29.

Health Canada. (2018). Canada Health Act: Annual Report 2017-18. https://www.canada.ca/en/health-canada/services/publications/health-system-services/canada-health-act-annual-report-2017-2018.html#s4

30.

Health Quality Ontario. (2019). Noninvasive prenatal testing for trisomies 21, 18, and 13, sex chromosome aneuploidies, and microdeletions: Health Quality Ontario Recommendation (Vol. 19). Queen’s Printer for Ontario. https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/noninvasive-prenatal-testing-for-trisomies-21-18-and-13-sex-chromosome-aneuploidies-and-microdeletions

31.

IsHak

Nikravesh

Lederer

Perry

Ogunyemi

Bernstein

(2013). Burnout in medical students: A systematic review. The Clinical Teacher, 10(4), 242–245. https://doi.org/10.1111/tct.12014

32.

Kibel

Vanstone

(2017). Reconciling ethical and economic conceptions of value in health policy using the capabilities approach: A qualitative investigation of Non-Invasive Prenatal Testing. Social Science & Medicine, 195, 97–104. https://doi.org/10.1016/j.socscimed.2017.11.024

33.

Lehoux

Roncarolo

Rocha Oliveira

Pacifico Silva

(2016). Medical innovation and the sustainability of health systems: A historical perspective on technological change in health. Health Services Management Research, 29(4), 115–123. https://doi.org/10.1177/0951484816670192

34.

Lewis

Silcock

Chitty

L. S.

(2013). Non-invasive prenatal testing for down’s syndrome: Pregnant women’s views and likely uptake. Public Health Genomics, 16(5), 223–232. https://doi.org/10.1159/000353523

35.

Long

Goldblatt

(2014). Noninvasive prenatal testing (NIPT) in Western Australia; Considerations in clinical practice. Australian and New Zealand Journal of Obstetrics and Gynaecology, 54(5), 487–489. https://doi.org/10.1111/ajo.12232

36.

Löwy

(2014). How genetics came to the unborn: 1960-2000. Studies in History and Philosophy of Biological and Biomedical Sciences, 47, 154–162. https://doi.org/10.1016/j.shpsc.2014.05.015

37.

MacKenzie

Wajcman

(1999). Introductory essay: The social shaping of technology In The social shaping of technology (2nd ed., pp. 2–27). Open University Press. https://doi.org/10.3987/Contents-03-61-01

38.

Mackie

Hemming

Allen

Morris

Kilby

(2017). The accuracy of cell-free fetal DNA-based non-invasive prenatal testing in singleton pregnancies: A systematic review and bivariate meta-analysis. BJOG: An International Journal of Obstetrics & Gynaecology, 124(1), 32–46.

39.

Martin

Iyengar

Kalyan

Lan

Simon

A. L.

Stosic

. . . Benn

(2018). Clinical experience with a single-nucleotide polymorphism-based non-invasive prenatal test for five clinically significant microdeletions. Clinical Genetics, 93(2), 293–300. https://doi.org/10.1111/cge.13098

40.

May

Finch

(2009). Implementing, embedding, and integrating practices: An outline of normalization process theory. Sociology, 43(3), 535–554. https://doi.org/10.1177/0038038509103208

41.

Metz

Bartley

(2012). Active implementation frameworks for program success: How to use implementation science to improve outcomes for children. Zero to Three, 32(4), 11–18.

42.

Minear

M. A.

Lewis

Pradhan

Chandrasekharan

(2015). Global perspectives on clinical adoption of NIPT. Prenatal Diagnosis, 35(10), 959–967.

43.

Ministry of Health and Long-Term Care. (2019). Schedule of benefits for physician services under the Health Insurance Act. http://www.health.gov.on.ca/en/pro/programs/ohip/sob/physserv/sob_master20160401.pdf

44.

Ministry of Health Welfare and Sport. (2018). Health Care in the Netherlands. Government of the Netherlands.

45.

Morse

J. M.

(1995). The significance of saturation. Qualitative Health Research, 5(2), 147–149. https://doi.org/10.1177/104973239500500201

46.

Parens

Asch

(2000). Prenatal testing and disability rights. Georgetown University Press. https://books.google.com/books?id=RnDA0EKcMaEC

47.

QSR International. (2015). NVivo 11 qualitative data analysis software.

48.

Ravitsky

(2017). The shifting landscape of prenatal testing: Between reproductive autonomy and public health. Hastings Center Report, 47(Suppl. 3), S34–S40. https://doi.org/10.1002/hast.793

49.

Rogers

E. M.

(2003). Diffusion of innovations (5th ed.). Free Press.

50.

Rotenstein

L. S.

Ramos

M. A.

Torre

Bradley Segal

Peluso

M. J.

Guille

. . . Mata

D. A.

(2016). Prevalence of depression, depressive symptoms, and suicidal ideation among medical students a systematic review and meta-analysis. Journal of the American Medical Association, 316(21), 2214–2236. https://doi.org/10.1001/jama.2016.17324

51.

Rothman

B. K.

(1993). The tentative pregnancy: How amniocentesis changes the experience of motherhood. W. W. Norton.

52.

Russell

Williams

(2002). Social shaping of technology: Frameworks, findings and implications for policy with glossary of social shaping concepts. In K. Sorenson, & R. Williams (Eds.), Shaping technology, guiding policy: Concepts, spaces and tools (pp. 37–132).

53.

Sandelowski

(2010). What’s in a name? Qualitative description revisited. Research in Nursing & Health, 33(1), 77–84. https://doi.org/10.1002/nur.20362

54.

Silva

H. P.

Lehoux

Miller

F. A.

Denis

J. L.

(2018). Introducing responsible innovation in health: A policy-oriented framework. Health Research Policy and Systems, 16(1), Article 90. https://doi.org/10.1186/s12961-018-0362-5

55.

Skirton

Goldsmith

Jackson

Lewis

Chitty

(2014). Offering prenatal diagnostic tests: European guidelines for clinical practice. European Journal of Human Genetics, 22(5), 580–586. https://doi.org/10.1038/ejhg.2013.205

56.

Statistics Canada. (n.d.). Table 17-10-0009-01 Population estimates, quarterly. https://doi.org/https://doi.org/10.25318/1710000901-eng

57.

Taylor

J. S.

(2008). The public life of the fetal sonogram: Technology, consumption, and the politics of reproduction. Rutgers University Press.

58.

ter Meulen

R. H. J

. (2005). The ethical basis of the precautionary principle in health care decision making. In Toxicology and applied pharmacology (Vol. 207, pp. 663–667). Academic Press. https://doi.org/10.1016/j.taap.2004.11.032

59.

Tuckman

B. W.

(1965). Developmental sequence in small groups. Psychological Bulletin, 63(6), 384–399. https://doi.org/10.1037/h0022100

60.

Vanstone

Cernat

Nisker

Schwartz

(2018). Women’s perspectives on the ethical implications of non-invasive prenatal testing: A qualitative analysis to inform health policy decisions. BMC Medical Ethics, 19, Article 27. https://doi.org/10.1186/s12910-018-0267-4

61.

Vanstone

King

de Vrijer

Nisker

(2014). Non-invasive prenatal testing: Ethics and policy considerations. Journal of Obstetrics and Gynaecology Canada, 36(6), 515–526. https://doi.org/10.1016/S1701-2163(15)30568-5

62.

Vanstone

Kinsella

E. A.

Nisker

(2012). Information-sharing to promote informed choice in prenatal screening in the spirit of the SOGC clinical practice guideline: A proposal for an alternative model. Journal of Obstetrics and Gynaecology Canada, 34(3), 269–275. https://doi.org/10.1016/S1701-2163(16)35188-X

63.

Vanstone

Yacoub

GIacomini

Hulan

McDonald

(2015a). Women’s experiences of publicly funded non-invasive prenatal testing in Ontario, Canada: Considerations for health technology policy-making. Qualitative Health Research, 25(8), 1069–1084. https://doi.org/10.1177/1049732315589745

64.

Vanstone

Yacoub

Winsor

Giacomini

Nisker

(2015b). What Is “NIPT”? Divergent characterizations of noninvasive prenatal testing strategies. AJOB Empirical Bioethics, 6(1), 54–67. https://doi.org/10.1080/23294515.2014.993102

65.

Wajcman

MacKenzie

D. A.

(1988). The social shaping of technology: How the refrigerator got its hum. Open University Press.

66.

Wasson

Cook

Helzlsouer

(2006). Direct-to-consumer online genetic testing and the four principles: An analysis of the ethical issues. Ethics & Medicine, 22(2), 83–91.

67.

Williams

(1997). The social shaping of information communication technologies. In Kubicek

Dutton

Williams

(Eds.), The social shaping of information superhighways: European and American roads to the information society (pp. 299–338). St. Martin’s Press.

68.

Williams

Edge

(1996). The social shaping of technology. Research Policy, 25, 865–899. https://doi.org/10.1016/0048-7333(96)00885-2

69.

Wilson

K. L.

Czerwinski

J. L.

Hoskovec

J. M.

Noblin

S. J.

Sullivan

C. M.

Harbison

. . . Singletary

C. N.

(2013). NSGC practice guideline: Prenatal screening and diagnostic testing options for chromosome aneuploidy. Journal of Genetic Counseling, 22(1), 4–15. https://doi.org/10.1007/s10897-012-9545-3

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.02 MB