When women are PIs: A story foretold on the vascular frontlines

“Multifactorial” issues persist in gender representation in vascular leadership and trial enrollment, leading women vascular surgeons tell Vascular Specialist. 

“We would have fewer untoward side effects, fewer drugs removed from the market by the FDA [Food and Drug Administration], and, ultimately, better outcomes in women,” states Melina R. Kibbe, MD, dean at the University of Virginia School of Medicine, Charlottesville, Virgina, as she reflects on two decades of missed opportunities, the underrepresentation of women as clinical principal investigators (PIs), and women’s under-enrollment as participants in vascular trials. Her statement is far from isolated—underpinned by a growing body of research which addresses key gender inequities in study leadership and participation. Vascular Specialist spoke to prominent names across the global vascular space on their experiences as a PI, meditations on the barriers to access, and the vital work needed to improve diversity across the board. 

Mounting data from recent research has spurred widespread review of women’s progression in the vascular field to date. In particular, focus has been placed on how the gender of PIs has affected the balance of male and female participants enrolled in trials. Conducted in April this year, Kibbe et al evaluated 1,427 clinical trials published in the Journal of the American Medical Association (JAMA), The Lancet, and the New England Journal of Medicine (NEJM), from January 1, 2015, to December 31, 2019, to determine if women’s enrollment in research correlated with the gender of first and/or senior authors. Their results showed a positive correlation between female enrollees and female first and senior authors (51.7% vs. 48.3%, p≤0.0001)—an association which endured in subset analyses by funding source, phase, randomization for study participants, drug and/or device trial, and geographic location. 

Kibbe et al’s results uncover a deficit in both leadership and enrollment which poses crucial challenges to obtaining accurate research outcomes for women and underrepresented minorities (URMs). Adding detail to this, Kathleen Ozsvath, MD, president-elect of the Eastern Vascular Society (EVS), from St Peters Health Partners in Albany, New York, tells Vascular Specialist of the fundamental anatomical differences, presentation to care, and symptom manifestation—such as acute myocardial infarction, she adds— that differ between women and men in vascular treatment. Ozsvath notes that “these differences are yet to be better understood,” a statement echoed by Caitlin Hicks, MD, associate fellowship program director at Johns Hopkins in Baltimore, Maryland, who says that gender-based differences have “only just” begun to gain attention in vascular surgical outcomes, “despite being present for decades.” 

Considering the results of her review, “no,” is Kibbe’s resounding response when reflecting on whether current journal and society efforts are sufficient in promoting diversity and inclusion. Hicks observes the SVS’ “concerted effort over the last few years to improve equity in a wide range of vascular-related initiatives,” but there remains, she adds, a “persistent gender gap in clinical trial PIs,” despite how “critically important” rectification of enrollment inequities is. Moreover, Palma Shaw, MD, professor of surgery at the State University of New York in Albany, New York, and president-elect of the International Society for Endovascular Specialists (ISEVS), delineates that “opportunities for women’s advancement differs in each society, but regional vascular societies have been more progressive”—although when looking nationally, progression is “much slower.” Shaw continues: “Some journals have made an intentional effort to increase the number of female and underrepresented minorities as reviewers and editors. The #Medbikini movement triggered a much-needed change.” 

A watershed dressed in a bikini 

In 2020, #Medbikini marked a watershed, exposing the deepening inequities that have been slow to change. The hashtag arose after an abstract, entitled “Prevalence of unprofessional social media content among young vascular surgeons,” published in the Journal of Vascular Surgery (JVS), was shared online. Labeling bikinis “inappropriate attire,” the study warned that posting pictures wearing one could be viewed as “potentially unprofessional.” This ignited a viral response on Twitter and Instagram under the hashtag #Medbikini, seeing women and men across specialties post themselves in bikinis or casual attire in shared criticism of biased targeting of women in vascular surgery. 

The virality of the movement undoubtedly reflected back an uncomfortable truth for vascular societies and institutions, which began installing strategies to support women and URMs seeking equal opportunities in research and clinical progression. In 2019, Kim Hodgson, MD, then SVS president, established the SVS Diversity, Equity and Inclusion (DEI) Task Force. Late in 2020, as the Task Force was morphing into a committee, leaders asked members to complete a census to survey demographics and member priorities. 

In a review of the dedicated DEI session named Building Diversity and Equitable Systems in Vascular Surgery at the 2022 Vascular Annual Meeting (VAM) given by Imani E. McElroy, MD, from Harvard University, in Cambridge, Massachusetts and Carla C. Moreira, MD, from Brown University in Providence, Rhode Island, “shockingly low attendance” by both members and leaders was reported, leaving the few attendees feeling as if they had “witnessed a fumble at a one-yard line.” The subsequent social media backlash drew a brief statement from the SVS committing to continued prioritization of DEI principles to address shortcomings. 

This year, at VAM 2023, the E. Stanley Crawford Critical Issues Forum raised continued concerns over workforce maldistribution relating to the SVS’ DEI declaration, which states support of “a diverse workforce with equal opportunities.” Addressing the panel, Rana Afifi, MD, associate professor of vascular surgery at McGovern Medical School, University of Texas Health Houston in Houston, Texas, maintained how data presented by former SVS president Michel S. Makaroun, MD, from the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania—whose talk concerned insufficient numbers in the workforce pipeline—do not represent her. 

After graduating from her residency-fellowship outside of the U.S., Afifi was told after “PGY-11 years” to repeat her residency when seeking a path toward U.S. Board certification, she related from the VAM floor. Afifi asserted that others too must be “struggling,” and “are broken because they feel inadequate,” highlighting key “problems” in the handling of DEI matters relating to the vascular workforce. 

Slow progress to seniority 

“Times are changing with an interest and awareness of DEI,” Ozsvath asserts, punctuating her optimism with the fact that women are still “a fraction of the membership within vascular societies” today. This detail sits amid an international rise in the number of women in the vascular field, yet runs parallel to a wealth of new research which reports how this increase does not translate to equitable gender distribution in roles of high-level seniority or decision-making in both academia and clinical care. 

A retrospective review conducted in 2021 by Misty D. Humphries, MD, of UC Davis Health in Sacramento, California, et al—including Julie A. Freischlag, MD, the first and still only ever woman SVS president, and CEO of Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina—found that between 1999–2009 and 2010–2019, the mean percentage of women who presented abstracts at five U.S. regional and national societies “increased significantly” from 10.9% to 20.6%. However, increases in the number of women as senior authors and committee chairs remained statistically insignificant throughout both early and late periods. Humphries et al commented that efforts to recruit women into the field of vascular surgery, and support for their professional development, are “facilitated” by women in leadership roles. Speaking to Vascular Specialist, Freischlag emphasizes that the progression of women and people of color to these positions is “key” to more accurate enrollment and results in clinical research. 

In Europe too, the unequal representation of women pervades. “It’s a male community,” Marianne Brodmann, MD, head of clinical research in the division of angiography at Medical University of Graz in Graz, Austria, tells Vascular Specialist, “especially in the endovascular and [vascular] surgical [space].” Weighing in, Janet Powell, MD, professor of vascular biology and medicine at Imperial College in London, England, and co-investigator in the widely endorsed WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial, says that Europe’s advancement in this arena is “further behind” that of the U.S., which boasts the likes of Linda M. Harris, MD, who, to Powell, represents a “leading light in making life easier for women [in clinical research].” Harris set up the Women’s Vascular Summit, an annual meeting dedicated to reviewing how vascular disease presents and is treated in women. 

However, for Powell, “better representation” of women only gained significant ground around nine months ago, while the inclusion of people from minorities and lower socioeconomic groups has not yet been addressed, she adds. In particular, Powell raises concerns over the underenrollment of women and URM groups in the recent BASIL-2 and BEST-CLI trials for the management of chronic limb-threatening ischemia (CLTI). Women made up just 28% and 19% of participants in the trials, respectively, while 72% and 91% of enrollees were white. In Powell’s words, this reveals how contemporary enrollment disparities are perhaps “worse in Europe” currently, but shows a global need to urgently re-evaluate enrollment processes. 

Industry responsibility and stimulating change 

For Harris, who is a professor of vascular surgery at the University at Buffalo in Buffalo, New York, and a past president of the EVS, slow progression of diversity in PI positions and leadership roles in the vascular field is “multifactorial.” 

“Some of it is seniority, but much of it is relationships cultivated with industry in a previously more nepotistic system,” she tells Vascular Specialist. “Breaking in as a PI, especially for women, is the hard part. Once established, it is much easier to continue work with industry, and sponsorship helps immensely—or having partners from the same or different institutions.” 

However, cultivating these relationships with limited experience of the process may be “hard,” Hicks opines, and “initiative typically falls on the woman,” rather than on the industry partner’s outreach efforts. “Our industry partners need to play a role in this— many vascular trials are industry sponsored and, therefore, medical device companies need to recognize and acknowledge the lack of women PIs included in prior trials, and make a conscious effort to include women moving forward,” Hicks says. 

The rise in research concerning gender equity within vascular specialties in recent years has created a wealth of visible evidence. Hopes abound that industry and institutions will now do more. However, in a male-dominated field, fears exist that research of this nature could spark a backlash and/or result in researchers being ostracized. A study carried out by Matthew R. Smeds, MD, et al, titled “Gender disparity and sexual harassment in vascular surgical practices,” found—through an anonymous survey sent to vascular surgery faculty members at 52 training sites in the U.S. — that 32% of respondents believed that harassment most commonly occurred in surgical specialties that are historically male-dominated due to purposeful ignorance of hierarchy/ power dynamics in the field. Of the study’s conclusions, perceptions of workplace gender disparities “differed significantly” between the genders. 

Better strategies are needed 

Research such as this makes clear that alignment on gender inequities among vascular professionals must be present to affect change—in Ozsvath’s words “awareness of this deficit will encourage industry to find more diverse PIs” and support DEI initiatives more broadly. Positively, initiatives are being taken up by more institutions to improve gender disparities, such as the Athena Swan Charter—a framework used globally to support the advancement of women in higher education and research. “The initiative is taken very seriously and is supported by annual Athena Swan lectures,” Powell notes of her institution in the UK. 

For women in the vascular field, deciding to pursue academic progression can be “complex,” Harris explains, as, for women beginning down this career path, most are “also at an age when they often have young children.” Although this “does not preclude them from running studies or being academic surgeons, the work-life balance issues are still different and more complex for women than for men based on assessments of division of labor for home obligations,” she states. Yet, Harris believes that this is “starting to change” as the younger generations “[embrace] more of a work-life balance for all.” 

When speaking to Vascular Specialist, all interviewees coalesced around the idea that women’s representation in academic and clinical leadership, as well as in research enrollment, must be addressed collectively to accelerate progression to gender equity. Most vitally, through better representation, Powell says, women who have previously been “underrepresented and underserved” in clinical research can be more accurately assessed and treated with improved knowledge of their crucial vascular variations. 

For Shaw, the positioning of women in these roles and the targeted enrollment of women need to be “deliberate and established at the time of the proposal for the trial.” This approach must include women from “diverse backgrounds,” Ozsvath says, “so we can better understand how these patient populations differ in presentation and what best treatment options exist specific to them.” By measuring the impact of women’s vascular differences, including “size, biologic responsiveness, hormonal issues, social determinants and trust issues,” Harris finishes, “we will be successful in moving the needle in our understanding and care of women vascular patients.” 



Please enter your comment!
Please enter your name here