Perspectives on Contraceptive Research for Individuals with Increased Thrombosis Risk: A Qualitative Exploration of Patients and Clinicians.

OBJECTIVES: Although most progestin-only contraceptives are generally considered safe for most patients at increased risk of arterial and venous thrombosis, patients and clinicians may be wary of their use based on limited studies. Large prospective contraceptive studies with primary data collection would improve the evidence base for people at increased thrombosis risk. We therefore aimed to find solutions for recruitment and long-term retention of representative participants in large prospective studies of contraceptives for patients at increased risk of thrombosis, identify patient- and clinician-prioritized outcomes, and determine patients' and clinicians' preferred dissemination methods for study results.

METHODS: In this formative qualitative study, we conducted semistructured interviews with reproductive-age patients at increased thrombosis risk and clinicians in related fields in New Mexico via telephone and Zoom. Interviews were transcribed and coded deductively using Dedoose qualitative coding software. We categorized emerging themes based on our study aims.

RESULTS: We interviewed 16 patients and 11 clinicians from June 2020 to June 2022. Most of the patients (60%) had more than one of the following conditions: hypertension, antiphospholipid antibody syndrome, history of cerebral vascular accident, deep vein thrombosis, pulmonary embolism or myocardial infarction, systemic lupus erythematosus, or a thrombophilia. Clinician specialties included hematology, rheumatology, pulmonology, pharmacy, and women's health. The majority of respondents participated to help others. Although participants highlighted discomfort with reproductive health as a potential barrier to participation, others indicated that they wanted to share their difficult experiences to bring awareness to the topic. Virtual participation in interviews overcame several participation barriers such as scheduling concerns, transportation, and finding childcare. Patients and clinicians both cited effectiveness, safety, side effects, and developing more contraceptive method options as priority research outcomes. All of the participants were interested in receiving the results of the study in which they participated. Clinicians recommended constructing research teams reflecting participant demographics.

CONCLUSIONS: Altruism may be a strong motivator for contraceptive research participation among medically complex patients. Both patients and clinicians desire new efficacious, safe, low side effect contraceptives for patients at increased thrombosis risk. Virtual participation options address common participant recruitment and, likely, retention barriers. Clinicians anticipate that research teams that reflect participant demographics may lead to better representation of at-risk populations in contraceptive research.