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Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change.

ABSTRACT: Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid-19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid-19 trials (119/165; 72%), especially those investigating therapies with a prior safety record in pregnancy (139/164; 85%). The main perceived barriers to inclusion identified were unwillingness of pregnant patients to participate and of treating teams to offer participation, the burden of regulatory approval, and a general "culture of exclusion" of pregnant women from trials. We describe why some physicians may be reluctant to include pregnant individuals in trials, and we identify barriers to the appropriate participation of pregnant people in clinical research.

SUBMITTER: Trahan MJ

PROVIDER: S-EPMC8652879 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change.

Trahan Marie-Julie MJ Cumyn Annabelle A Cheng Matthew P MP McDonald Emily G EG Lapinsky Stephen E SE Daneman Nick N Abenhaim Haim A HA Malhamé Isabelle I

Ethics & human research 20211026 6

Excluding pregnant people from Covid-19 clinical trials may lead to unintended harmful consequences. For this study, an online questionnaire was sent to physicians belonging to Canadian professional medical associations in order to evaluate their perspectives on the participation of pregnant women in Covid-19 clinical trials. The majority of respondents expressed support for including pregnant women in Covid-19 trials (119/165; 72%), especially those investigating therapies with a prior safety r ...[more]

PMID: 34699138

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Project description:Physician hesitancy is said to occur when physicians do not recommend COVID-19 vaccination, and it is a contributing factor for the low vaccination rate for COVID-19 in pregnant women. Physician hesitancy has become a major, unaddressed problem with regard to the quality and safety of obstetrical care. We identify 3 root causes of physician hesitancy and describe how professional ethics in obstetrics should guide in reversing these root causes. They are clinical misapplications of key components of professionally responsible obstetrical practice: therapeutic nihilism, shared decision-making, and respect for patient autonomy. Therapeutic nihilism directs the obstetrician to avoid any clinical interventions during pregnancy to prevent teratogenic effects that might be unknown. Therapeutic nihilism is misapplied when there is a documented net clinical benefit with no evidence of clinical harm. Shared decision directs the obstetrician to only offer but not recommend clinical management. Shared decision-making plays a major role when there is uncertainty in clinical judgment but is misapplied when it becomes a universal model. It does not apply when there is a net clinical benefit. When there is a net clinical benefit, clinical management should be recommended, not simply offered. The ethical principle of respect for patient autonomy plays an indispensable role in decision-making with patients. It is misapplied when it is assumed that respect for autonomy requires physicians not to make recommendations and to defer to and implement patients' decisions without exception. There is evidence that the obstetrician's recommendations about the management of pregnancy are the most important factor in a pregnant woman's decision-making. Simply deferring to the patient's decisions makes for misapplied respect for patient autonomy. Obstetricians must end physician hesitancy about COVID-19 vaccination of pregnant women by reversing these 3 root causes of physician hesitancy. Reversing the root causes of physician hesitancy is an urgent matter of patient safety. The longer physician hesitancy continues and the longer the low vaccine acceptance rate of pregnant women lasts, preventable serious diseases, deaths of pregnant women, intensive care unit admissions, stillbirths, and other maternal and fetal complications of unvaccinated women will continue to occur. Physician hesitancy should not be permitted to influence the response to future pandemics.

Dataset Information

Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change.

Publications

Physician Perspectives on Including Pregnant Women in Covid-19 Clinical Trials: Time for a Paradigm Change.

Similar Datasets

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