Evidence map›Paper›PMID 40021073›Full record

ReviewHeart rhythm2025

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

Larisa G Tereshchenko, Anthony Muchai Manyara, Oriana Ciani, Stephen Olufemi Sodeke, Chastity N Bradford, Pasquale Santangeli, Samir R Kapadia, Oussama Wazni, Sanjiv M Narayan, Sumeet S Chugh and 6 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Heart rhythm, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Larisa G TereshchenkoQuantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio; Heart, Vascular & Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: tereshl@ccf.org.
Anthony Muchai ManyaraSchool of Health and Well Being, University of Glasgow, Glasgow, UK University of Glasgow, Glasgow, United Kingdom; Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Oriana CianiCentre for Research on Health and Social Care Management, SDA Bocconi School of Management, Milan, Italy.
Stephen Olufemi SodekeTuskegee University, Tuskegee, Alabama.
Chastity N BradfordTuskegee University, Tuskegee, Alabama.
Pasquale SantangeliHeart, Vascular & Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
Samir R KapadiaHeart, Vascular & Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
Oussama WazniHeart, Vascular & Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
Sanjiv M NarayanStanford University, Palo Alto, California.
Sumeet S ChughCedars-Sinai Health System, Los Angeles, California.
Kenneth BilchickUniversity of Virginia, Charlottesville, Virginia.
Jose F HuizarVirginia Commonwealth University, Richmond, Virginia.
Marmar VaseghiUniversity of California Los Angeles, Los Angeles, California.
Mina K ChungHeart, Vascular & Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
Kenneth A EllenbogenVirginia Commonwealth University, Richmond, Virginia.
Rod S TaylorSchool of Health and Well Being, University of Glasgow, Glasgow, UK University of Glasgow, Glasgow, United Kingdom.

Funding

Project 3 Genes to Omics-Informed Drugs: Drug Repositioning and Testing to Prevent AF ProgressionsP01HL158502 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI Robert Alden Koeth · 2022 to 2026
$16.9M
The Dynamics of Human Atrial FibrillationR01HL083359 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Sanjiv M Narayan · 2008 to 2026
$7.9M
Machine Learning in Atrial FibrillationR01HL149134 · NHLBI · STANFORD UNIVERSITY · PI NARAYAN, SANJIV M · 2020 to 2024
$3.8M
RADIOMIC APPROACHES TO IMPROVE TARGETING FOR ATRIAL FIBRILLATION CATHETER ABLATIONR01HL158071 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI BARNARD, JOHN, CHUNG, MINA KAY · 2021 to 2024
$2.9M
Machine Learning for Ventricular ArrhythmiasR01HL162260 · NHLBI · STANFORD UNIVERSITY · PI Sanjiv M Narayan · 2023 to 2026
$2.5M
Sex differences in cardiac autonomic remodeling after myocardial infarctionR01HL170626 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Crystal May Ripplinger, Marmar Vaseghi · 2024 to 2026
$2.1M
Novel ECG Measures and Risk of Sudden Cardiac DeathR01HL118277 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI TERESHCHENKO, LARISA GENNADIEVNA · 2013 to 2016
$1.5M
Novel ECG measures and risk of sudden cardiac deathR56HL118277 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI TERESHCHENKO, LARISA GENNADIEVNA · 2018 to 2018
$396k
American Heart Association-American Stroke Association 23IPA1054947American Heart Association-American Stroke Association 23TPA1141088BLRD VA IK6 BX006185NHLBI NIH HHS P01 HL158502NHLBI NIH HHS R01 HL083359NHLBI NIH HHS R01 HL118277NHLBI NIH HHS R01 HL149134NHLBI NIH HHS R01 HL158071NHLBI NIH HHS R01 HL162260NHLBI NIH HHS R01 HL170626NHLBI NIH HHS R56 HL118277
6 · The paper itself

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.

Indexed as

Arrhythmias, CardiacCardiac ElectrophysiologyElectrophysiologic Techniques, CardiacEndpoint DeterminationRandomized Controlled Trials as TopicChecklistHumansResearch DesignBiomarkerChecklistClinical trialOutcomeRandomized controlled trialResearch designStandardsSurrogate end pointSurrogate marker

Identifiers

PMID40021073
PMCPMC12317828

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.