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

Abstract

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.

Keywords: Biomarker; Checklist; Clinical trial; Outcome; Randomized controlled trial; Research design; Standards; Surrogate end point; Surrogate marker.