A call for transparency, improved reporting, and interpretation of trials using surrogate end points in cardiac electrophysiology.

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Tác giả: Kenneth Bilchick, Chastity N Bradford, Sumeet S Chugh, Mina K Chung, Oriana Ciani, Kenneth A Ellenbogen, Jose F Huizar, Samir R Kapadia, Anthony Muchai Manyara, Sanjiv M Narayan, Pasquale Santangeli, Stephen Olufemi Sodeke, Rod S Taylor, Larisa G Tereshchenko, Marmar Vaseghi, Oussama Wazni

Ngôn ngữ: eng

Ký hiệu phân loại: 297.9386 Babism and Bahai Faith

Thông tin xuất bản: United States : Heart rhythm , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 692272

In this call for transparency, we aim to disseminate knowledge about recent CONSORT-Surrogate and SPIRIT-Surrogate checklists. SPIRIT-Surrogate is an extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist, developed as a consensus document and designed as a reporting guideline for randomized controlled trial (RCT) protocols using surrogate end points as the primary end points. CONSORT-Surrogate is an extension of the Consolidated Standards of Reporting Trials (CONSORT) checklist, a consensus-driven reporting guideline for RCTs using surrogate end points as the primary end points. We discuss the definition of surrogate and target/final end points in cardiac electrophysiology (EP) RCTs. We review historical examples of surrogate paradoxes in the cardiac EP field and consider the theoretical framework of a surrogate paradox. Furthermore, we consider the bioethics of transparent reporting of clinical trial protocols and results. A nonlethal cardiac arrhythmia and its burden (eg, atrial fibrillation, premature ventricular contractions, nonsustained ventricular tachycardia) is a surrogate end point unless justified otherwise. Therefore, clinical investigators in the cardiac EP field need to implement the SPIRIT-Surrogate and CONSORT-Surrogate extension checklists for transparent reporting.
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