Helping the science speak for itself: lessons learned developing video summaries for a precision medicine and health disparities collaborative.

Skills to effectively communicate research findings are important to expand meaningful inclusion of the public in research, but attempts to summarize findings may be challenging given increasing reliance on succinct communications. Led by our Ethics Advisory Board and within the context of this work with the Precision Medicine and Health Disparities Collaborative, the authors decided to engage in the iterative process of developing video summaries. Our stakeholders taught us to incorporate novel strategies to engage broader audiences, leading to the production of two video summaries, a public summary toolbox and an adapted process for developing video summaries.

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease.

Background: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.

Methods: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis.

Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial.

Background: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed.

Main Text: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease.

Vocal fold botulinum toxin injection for refractory paradoxical vocal fold motion disorder.

Objective: Demonstrate efficacy of vocal fold botulinum toxin injection for treatment of refractory paradoxical vocal fold motion disorder (PVFMD).

Methods: A retrospective review was completed of patients diagnosed with PVFMD who underwent vocal fold botulinum toxin injection for dyspnea symptoms that persisted despite laryngeal control therapy, medical management, and biofeedback therapy. Outcomes measured included overall improvement and resolution of dyspnea symptoms, number of botulinum toxin injections and dose range, change in dyspnea severity index (DSI) scores, and adverse effects of injection therapy.

Recruiting for a pragmatic trial using the electronic health record and patient portal: successes and lessons learned.

Objective: Querying electronic health records (EHRs) to find patients meeting study criteria is an efficient method of identifying potential study participants. We aimed to measure the effectiveness of EHR-driven recruitment in the context of ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness)-a pragmatic trial aiming to recruit 15 000 patients.

Materials And Methods: We compared the participant yield of 4 recruitment methods: in-clinic recruitment by a research coordinator, letters, direct email, and patient portal messages.