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Informed Decision Making During Pregnancy: Risk Consideration in Clinical Practice and Research

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Informed Decision Making During Pregnancy: Risk Consideration in Clinical Practice and Research Western University Scholarship@Western Electronic Thesis and Dissertation Repository 3-22-2016 12:00 AM Informed Decision Making During Pregnancy: Risk Consideration in Clinical Practice and Research Kyoko Wada The University of Western Ontario Supervisor Marilyn Evans The University of Western Ontario Joint Supervisor Jeff Nisker The University of Western Ontario Graduate Program in Health and Rehabilitation Sciences A thesis submitted in partial fulfillment of the equirr ements for the degree in Doctor of Philosophy © Kyoko Wada 2016 Follow this and additional works at: https://ir.lib.uwo.ca/etd Part of the Medical Education Commons Recommended Citation Wada, Kyoko, "Informed Decision Making During Pregnancy: Risk Consideration in Clinical Practice and Research" (2016). Electronic Thesis and Dissertation Repository. 3636. https://ir.lib.uwo.ca/etd/3636 This Dissertation/Thesis is brought to you for free and open access by Scholarship@Western. It has been accepted for inclusion in Electronic Thesis and Dissertation Repository by an authorized administrator of Scholarship@Western. For more information, please contact [email protected]. Abstract This thesis addressed a cluster of issues related to risk and the pregnant woman’s decision making in clinical practice and research. In terms of clinical practice, the minimal risk concept - a low risk standard codified in research ethics regulations - was applied to clinicians’ information provision to the patient. As clinicians must discuss a variety of health risks, minimal risk standards may be useful as a threshold to demarcate risks that clinicians should discuss with the patient. Application of minimal risk standards to risk factors in pregnancy showed the usefulness and limitations of these standards. In terms of pregnant women’s clinical research participation, analyses of national and international research ethics regulations suggested that regulations could potentially be overprotective. A grounded theory study revealed that pregnant women were protective of themselves and their fetus in considering clinical research participation. In determining whether a clinical research project involving pregnant women would be acceptable, obstetric healthcare providers emphasized the adherence to regulatory requirements while researchers in reproduction areas focused on scrutinizing the scientific quality and interpretation of prerequisite studies. These three populations shared safety concerns. While minimal risk standards may be useful in identifying risks to be discussed with the patient, determining permissible risk during pregnancy may be more complex, including consideration on the risk benefit ratio in the pregnant woman’s context. This thesis has implications on risk communication in clinical practice and research, policies on clinical research with pregnant women, and education for healthcare providers, clinical investigators, and the general public. Keywords pregnant women, clinical research, research ethics guideline, minimal risk, risk benefit ratio, patient participation, informed consent, information provision ii Co-Authorship Statement I, Kyoko Wada, acknowledge that this thesis includes four integrated manuscripts that evolved as a result of collaborative endeavors. In the four manuscripts, the primary intellectual contributions were made by the first author in terms of the methodology, study design, ethics application, conducting literature review, collecting data, transcribing the interview record, coding and analyzing the data, and writing the manuscript. The contribution of the co-authors, Dr. Jeff Nisker, Dr. Marilyn Evans, Dr, Barbra deVrijer, and Dr. Barbara Hales was primarily providing guidance, supervision from their expertise, and intellectual and editorial support in writing the manuscripts. iii Acknowledgments I was privileged to work with a team of unique scholars with academic and clinical backgrounds. I am very grateful to the co-supervisors, Dr. Jeff Nisker and Dr. Marilyn Evans as well as Dr. Barbra deVrijer on the thesis committee. Dr. Nisker has guided me throughout the course of the PhD program and has always encouraged me to write. He often said: "We research as we write." This is one of the most important things I have learned from him as a researcher. Dr. Evans, with abundant experience in qualitative research with pregnant women as well as other populations, has had a tremendous influence on me - a novice qualitative researcher - in collecting and analyzing the data as well as writing up the research findings. As a thesis committee member, Dr. Barbra deVrijer, a maternal fetal medicine specialist, has always been ready to give advice from her clinical expertise with pregnant women. She has also been very supportive in introducing me to clinicians and researchers as well as her patients to participate in the interview for the empirical research. I would also like to express my thanks to Dr. Barbara Hales at McGill University for being on board for a manuscript integrated into this thesis. As a distinguished basic scientist in maternal and fetal toxicology, she has much contributed to the scientific aspects of in utero exposure to potential harm. Importantly, this research was not possible without participants who volunteered to spend their time to be interviewed. I am so grateful to their kindness, generosity, and enthusiasm for sharing their views. For recruiting pregnant women, I had support from the London Health Science Centre, Victoria Hospital and London-Middlesex Health Unit. Also, I would also like to express my gratitude to the expertise and generosity of the scholars on the examining committee. Finally, I would like to thank for the financial support of the Canadian Institutes for Health Research (CIHR) Training Program in Reproductive, Early Development and the Impact on Health (REDIH); CIHR grants (Institute for Human Development, Child and Youth Health (IHDCYH)), RHF100625 and RHF100626; Faculty of Health Sciences, Western University; iv and Department of Obstetrics and Gynaecology, Schulich School of Medicine and Dentistry, Western University. v Table of Contents Abstract ............................................................................................................................... ii Co-Authorship Statement................................................................................................... iii Acknowledgments.............................................................................................................. iv Table of Contents ............................................................................................................... vi List of Tables .................................................................................................................... xii List of Figures .................................................................................................................. xiii List of Appendices ........................................................................................................... xiv Chapter 1 ............................................................................................................................. 1 1 Introduction .................................................................................................................... 1 1.1 Background ............................................................................................................. 2 1.1.1 Importance of maternal and fetal health and a paucity of evidence for prenatal and preconception care .................................................................. 2 1.1.2 Informed decision making in clinical care and research ............................. 2 1.1.3 Complexity of information for pregnant women’s decision making about health ........................................................................................................... 3 1.2 Purpose of this thesis .............................................................................................. 5 1.3 Research questions .................................................................................................. 5 1.4 Thesis overview ...................................................................................................... 5 References (Chapter 1) ................................................................................................... 8 Chapter 2 ........................................................................................................................... 13 2 Risk concept by Hansson and Lupton .......................................................................... 13 2.1 Introduction ........................................................................................................... 13 2.2 Hansson, S.O. ........................................................................................................ 13 2.2.1 Roles of philosophy in risk studies ........................................................... 13 2.2.2 Risk and ethics .......................................................................................... 15 vi 2.2.3 Risk and public health policy .................................................................... 18 2.3 Lupton, D. ............................................................................................................. 20 2.3.1 Theorizing risk in social sciences ............................................................. 20 2.3.2 Pregnancy and the risk discourse .............................................................
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