Invasive Physiological Measurements in Patients with Peripheral Artery Disease: Willingness and Barriers to Participation

Abstract

Invasive physiological measurements such as microneurography, arterial and venous catheterization, and central neuraxial anesthesia are necessary to investigate mechanisms of cardiovascular control in humans. To date, these procedures have not been utilized in patients with peripheral artery disease (PAD). The purpose of this project was to quantify the willingness, motivating factors, and barriers to participating in invasive physiological experiments in adults with and without PAD. Data were gathered through focus groups (n = 19 participants age 55–79) and questionnaires (n = 2543 mailed, 438 adults age 18–85 responded). Of the people who returned the questionnaire, 90% were willing to participate in ultrasound assessment of vascular function and 76% were willing to undergo a venous blood draw, whereas only 40% were willing to participate in microneurography, 30% were willing to undergo arterial or venous drug infusions, 12% were willing to receive spinal or epidural anesthesia, and 14% were willing to undergo a muscle biopsy. PAD patients (n=45) were more willing than those without PAD (n=360) to participate in drug infusion studies (48% vs 18%, P<0.001) and trials of investigational drugs (44% vs 21%, P<0.001). The participants also provided feedback on our recruitment materials and made suggestions to increase enrollment in our ongoing randomized controlled trial. In the past three years, some of these strategies have been implemented. Based on our focus groups and questionnaire data, we speculate that engaging PAD patients in all aspects of the research process will lead to better recruitment and retention as compared to the “standard of care” (i.e., spending large amounts of money on radio and television advertising, printed brochures, searching electronic medical records, and direct mailing). However, this remains to be directly tested in future studies.Support or Funding InformationThis project was supported by NIH R21 AG054940 (to Dr. Proctor). This project was also supported, in part, by National Center for Advancing Translational Sciences Grants UL1 TR002014, UL1 TR‐000127 and KL2 TR‐000126 and also under a grant with the Pennsylvania Department of Health using Tobacco CURE funds (to Dr. Muller).