; Professor and Vice-Chair of Obstetrics and Gynecology; Gillette Professorship of Obstetrics and Gynecology; and Chief of Maternal-Fetal Medicine at 

Catherine Y. Spong, MD

New variants of coronavirus disease 2019 (COVID-19) and slow vaccination rates are prolonging the quarantine, and there is no certain end in sight. Without a clear path to a semblance of normalcy for our careers, families, and communities, it should be no surprise that our well-being is in jeopardy.

From private practice to academic medicine, strategies to proactively address physician wellness are urgently needed. Results from a survey of 1122 academic faculty across the nation reported that individuals feeling very or extremely stressed more than doubled from 2019 (32%) to 2020 (70%), and almost 3 times as many had increased anger (12% vs 35%).

During the same time frame, more than 12,000 physicians surveyed reported their rate of being “somewhat” or “very” happy declined from 82% to 58%,with a similar decline reported for ob/gyn physicians (81% to 57%).

 Female faculty members reported a dramatic increase in feeling stressed, from 34% to 75%, and they experienced stress at higher rates than men, 75% to 59%.

Since May 2020, 40% of women reported symptoms of anxiety or depression (

), which is almost 4 times higher than the 11% reported in 2019.

Figure. Anxiety and Depression in Women and Men: 2020-2021

Given the predominance of female ob/gyns—83% of residents are women—these statistics really hit home. The shift to remote learning and limited child care options have affected these colleagues, as women disproportionally shouldered the burden.

 For women, the dual role of being the family’s primary caregiver and practicing medicine has made the balancing act untenable for many, affecting both their mental health and career.

Many accept—often request—night and/or weekend shifts to maximize time at home to assist with child care and remote learning. In return, they have no down time, time to accomplish academic goals, or opportunity to recharge. Remote working has resulted in busier schedules and often longer hours for many, with fewer breaks as virtual meetings are stacked one on top of another. As eloquently stated in a recent Womxn’s Health Collaborative online post, the effort “comes at the expense of our own health and well-being.”

Solutions are not obvious, especially for ob/gyns. Early responses have been to encourage us to take care of ourselves, but when can we do this? Others have recommended taking time off; this burdens our colleagues and often results in insurmountable amounts of catch-up when we return.

 Physician burnout as a critical topic predates the pandemic. 

The National Academy of Medicine launched a resource repository on clinical burnout and well-being in 2018.

 There is a wealth of information on causes, effects, and solutions for clinical burnout available. Solutions include organizational and individual strategies, such as fostering communication, cultivating teamwork, and practicing mindfulness; however, data demonstrating their effectiveness are limited. Ultimately, system changes to address the inequity are needed to adjust metrics and support women in all roles: career, family, and community.

Physician burnout and the need for wellness will not be resolved once the pandemic is behind us. The American College of Obstetricians and Gynecologists has 5 warning signs of burnout: dread, increased complaining, irritability, lapses in confidentiality, and loosening boundaries.

For ourselves and our colleagues, let’s keep these in mind and work with each other to identify and address burnout proactively. A first step, although clearly not a solution, is having someone to talk to, someone to share the realities of life with. This can help us to address our burnout and provide an outlet. 

Although we cannot eliminate the current emphasis on virtual working, remote learning, and limited child care, we can enhance our support for each other. 

1. On the verge of burnout: COVID-19’s impact on faculty well-being and career plans. Chronicle of Higher Education

https://connect.chronicle.com/rs/931-EKA-218/images/Covid%26FacultyCareerPaths_Fidelity_ResearchBrief_v3%20%281%29.pdf

2. Martin KL. Medscape physician lifestyle & happiness report 2021. January 15, 2021. Accessed March 22, 2021. 

http://www.medscape.com/slideshow/2021-lifestyle-happiness-6013446

3. Martin KL. Medscape obstetrician & gynecologist lifestyle, happiness & burnout report 2021. February 19, 2021. Accessed March 22, 2021. 

http://www.medscape.com/slideshow/2021-lifestyle-obgyn-6013515

4. Anxiety and depression: Household Pulse Survey. Centers for Disease Control and Prevention. Updated March 10, 2021. Accessed March 22, 2021. 

http://www.cdc.gov/nchs/covid19/pulse/mental-health.htm

5.Sevilla A, Smith S.Baby steps: the gender division of childcare during the COVID-19 pandemic. 

. 2020;36(suppl 1):S169-S186. doi:10.1093/oxrep/graa027

6. Johnson C, Thornton H. Bracing for impact. Womxns Health Collaborative. Accessed March 22, 2021. 

https://womxnshealth.medium.com/bracing-for-impact-894b9f13db84

7. Sharing knowledge to combat clinician burnout. Clinician Well-Being Knowledge Hub. Accessed March 22, 2021. 

8. At risk for burnout? Check these 5 warning signs. The American College of Obstetricians and Gynecologists. January 28, 2019. Accessed March 22, 2021. 

http://www.acog.org/news/news-articles/2019/01/at-risk-for-burnout-check-these-5-warning-signs

Articles

Rarely a day goes by without a post, article, or email about physician burnout. 

Smoldering

As is clear from publications (and even my daughter's eighth grade science project, “COVID-19 Vaccine: Effectiveness Limited by Inclusion?”), neither group was included in therapeutic product or vaccine development for COVID-19.

As one who is passionate on the topic, I am disheartened by the lack of progress. Of many recommendations by experts, I see some opportunities that are surmountable and some that are critical, but difficult, to address.

First, an inclusion mandate should be required for pregnant and lactating people in research. At present, pregnant people are excluded from research by default. Those governing, funding, and/or mandating trials should require an explanation of why pregnant and lactating people are excluded. In 1993, with the passage of the National Institutes of Health (NIH) Revitalization Act, NIH-funded investigators were required to include women in human subject research

The 2000 U.S. Government Accountability Office Report on Women’s Health found significant progress in representation of women in clinical trials because of the requirement of assessment of their inclusion as part of the scientific merit of the research grant

. In the past several decades this has expanded and now all NIH grant applications include a section on inclusion on the basis of sex/gender, race, ethnicity, and age in clinical research

. Further expansion to include pregnant and lactating people is an attainable short-term goal that will focus the inclusion by default.

Second, recommendations for pregnant and lactating people should be more clear and not phrased in language that has a negative connotation. The phrasing of recommendations, especially for pregnant and lactating people, is critical; and when written in a confusing or negative framing, raise alarm. 

For example, although not included in the clinical trials, both the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention were permissive for pregnant and lactating people to receive the vaccine. Our professional organizations, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), worked with the experts to devise guidance in the absence of data. However, in an attempt to be unfailingly cautious, the verbiage for pregnant women is negative – “should not be withheld,” rather than positive – “should be offered,” as is the case for nonpregnant and lactating people 

Table 1. Professional Guidance for COVID-19 Vaccine for Pregnant and Lactating Women

Similarly, the NIH’s Coronavirus Disease 2019 (COVID-19) Treatment Guidelines include a section on pregnancy, which I take as a positive step to be included in the considerations; however, the language is negative, “The COVID-19 Treatment Guidelines Panel…recommends that potentially effective treatment for COVID-19 should not be withheld from pregnant women because of theoretical concerns related to the safety of therapeutic agents in pregnancy.

Furthermore, at times guidance was unclear and misguided, as noted by the World Health Organization’s statement on January 26, 2021, that pregnant women should not receive the Moderna vaccine, then rescinding that statement days later—but the damage was done. With these missteps, additional education and clarification are needed, and opportunities for vaccination are lost.

As is often said, the elephant in the room for inclusion is that of liability, intertwined with litigation. Until progress is made to mitigate liability, implement targeted incentive programs, and/or strengthen the authority of the FDA to require clinically relevant data on pregnant and lactating people, real progress on inclusion of pregnant people in development of therapeutic products or vaccines is not possible. 

Understandably, pharmaceutical companies are not interested in testing novel therapeutics in pregnant and lactating people given the potential of teratogenicity – further complicated by the complex physiology and metabolism. This seemingly insurmountable task has been discussed ad infinitum by experts. 

With no entity charged or overseeing the task, there is no clear path forward. A champion is urgently needed to motivate, legislate, and/or creatively innovate a path forward.

Clearly the COVID-19 pandemic has further highlighted the disparity for pregnant and lactating people. Without data, education and communication are key for the discussion of COVID-19 vaccination and therapies in our patients. One thing is certain—death crosses the placenta, and we all have seen or heard of fatal cases of COVID-19 in pregnancy. 

Preventing severe and critical COVID-19 illness in our pregnant and lactating patients is of highest priority. Creating the evidence base through research for our pregnant and lactating patients is essential, with a default of inclusion not exclusion. 

1. National Institutes of Health (NIH). Title 42—The Public Health and Welfare. § 289a–2. Accessed February 19, 2021. https://www.govinfo.gov/content/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapIII-partH-sec289a-2.pdf

2. U.S. Government Accountability Office. Women’s Health: NIH Has Increased Its Efforts to Include Women in Research. HEHS-00-96: Published: May 2, 2000. Publicly Released: May 2, 2000. Accessed February 19, 2021. https://www.gao.gov/products/HEHS-00-96

3. National Institutes of Health. Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity, and Age in Clinical Research. Updated March 18, 2019. Accessed February 19, 2021.https://grants.nih.gov/grants/peer/guidelines_general/Review_Human_Subjects_Inclusion.pdf

4. National Institutes of Health (NIH). COVID-19 Treatment Guidelines. Special considerations in pregnancy. Updated August 27, 2020. Accessed February 19, 2021. https://www.covid19treatmentguidelines.nih.gov/special-populations/pregnancy/

A major missed opportunity. Decades of effort including the development of guidance and implementation by individuals, groups, professional organizations, even the United States Congress, to address and facilitate inclusion of pregnant and lactating people in research and trials held no sway in the studies addressing the coronavirus disease 2019 (COVID-2019) pandemic.

A Missed Opportunity

“Even though they were not included in the studies, both the FDA and the CDC’s advisory committees left open the door to allow pregnant and lactating women access to the vaccine,” Spong said. “The American College of Obstetrics and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) have been advocating that pregnant women should have access to the vaccine. It’s important to consider what is the risk to the woman of COVID-19. In an area where there is active transmission, and she is in a high-risk group, she should certainly have access to the vaccine.”

for a peer-reviewed article by Emily Adhikari, MD, based on findings from

Pregnancy Outcomes Among Women With and Without Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Contemporary OB/GYN’s Editor in Chief, Catherine Y. Spong, MD, recently joined Howard Bauchner, MD, Editor in Chief of the Journal of the American Medical Association (JAMA) and Denise J. Jamieson, MD, MPH for a Q&A session to discuss COVID vaccination in pregnant and breastfeeding women. 

Contemporary OB/GYN and JAMA: COVID Vaccination in Pregnant and Breastfeeding Individuals

 series features Editor in Chief, Catherine Y. Spong, MD. 

We talked with her about what compelled her to join 

, become an MFM, and begin the Human Placenta Project at the National Institute of Child Health and Human Development. 

Videos

Get to know the members of our editorial advisory board with Contemporary OB/GYN's 'Meet the Board.'

Catherine Y. Spong, MD

Articles

Smoldering

A Missed Opportunity

Contemporary OB/GYN and JAMA: COVID Vaccination in Pregnant and Breastfeeding Individuals

Meet the Board: Catherine Y. Spong, MD