Dataset Information

Under-representation of Women as Proceduralists and Patients in TAVR and TMVr Procedures: Data, Implications and Proposed Solutions.

ABSTRACT: Women are under-represented among transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVr) operators. This review assesses the representation of women as patients and as proceduralists and trial authors in major structural interventions. Women are under-represented as proceduralists in structural interventions: only 2% of TAVR operators and 1% of TMVr operators are women. Only 1.5% of authors in landmark clinical TAVR and TMVr trials are interventional cardiologists who are women (4/260). Significant under-representation and under-enrolment of women in landmark TAVR trials is evident: the calculated participation-to-prevalence ratio (PPR) is 0.73, and in TMVr trials, the PPR is 0.69. Under-representation of women is also evident in registry data (PPR = 0.84 for TAVR registries and for TMVr registries). In structural interventional cardiology, women are under-represented as proceduralists, trial participants and patients. This under-representation has the potential to affect the recruitment of women to randomised trials, subsequent guideline recommendations, selection for treatment, patient outcomes and sex-specific data analysis.

SUBMITTER: Burgess S

PROVIDER: S-EPMC9947929 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Under-representation of Women as Proceduralists and Patients in TAVR and TMVr Procedures: Data, Implications and Proposed Solutions.

Burgess Sonya S Cader F Aaysha FA Shaw Elizabeth E Banerjee Shrilla S Stehli Julia J Krishnamorthy Roopa R Khor Lynn L Forotan Homa H Bastiany Alexandra A Rao Sarita S Chandrasekhar Jaya J Zaman Sarah S Alasnag Mirvat M Chieffo Alaide A Coylewright Megan M

European cardiology 20220201

Women are under-represented among transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVr) operators. This review assesses the representation of women as patients and as proceduralists and trial authors in major structural interventions. Women are under-represented as proceduralists in structural interventions: only 2% of TAVR operators and 1% of TMVr operators are women. Only 1.5% of authors in landmark clinical TAVR and TMVr trials are interventional cardiolog ...[more]

PMID: 36845217

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Project description:BackgroundPatient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research. The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.MethodsThis prospective, multicenter survey consisted in the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research (pre or post marketing, sponsored by an academic institution or pharmaceutical company). Logistic regression was used to determine factors contributing to "trust" versus "distrust" group membership and willingness to participate in each category of research.ResultsOne thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study. 48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female (p = 0.042), inactive in the employment market(p = 0.007), and not-knowing the name of one's disease(p = 0.010) are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.ConclusionDistrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials.

Dataset Information

Under-representation of Women as Proceduralists and Patients in TAVR and TMVr Procedures: Data, Implications and Proposed Solutions.

Publications

Under-representation of Women as Proceduralists and Patients in TAVR and TMVr Procedures: Data, Implications and Proposed Solutions.

Similar Datasets

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