Mayo Clinic proceedings
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Mayo Clinic proceedings · Aug 2021
Readability of Participant Informed Consent Forms and Informational Documents: From Phase 3 COVID-19 Vaccine Clinical Trials in the United States.
To assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States. ⋯ Owing to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase 3 COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.
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Mayo Clinic proceedings · Aug 2021
Outcomes and Echocardiographic Follow-up After Surgical Management of Tricuspid Regurgitation in Patients With Transvenous Right Ventricular Leads.
To evaluate outcomes of elective surgical management of tricuspid regurgitation (TR) in patients with transvenous right ventricular leads, and compare results between non-lead-induced and lead-induced TR patients. ⋯ Lead-induced TR did not affect long-term survival after elective tricuspid valve surgery. In patients with lead-induced TR, tricuspid valve re-intervention was more common. Improvement in TR was achieved in both groups after surgery; however, severity of TR tended to increase over follow-up after tricuspid valve repair.