Evidence map›Paper›PMID 41015071›Full record

Trial reportAmerican heart journal2026

A Bayesian re-analysis of the STRESS trial.

Kevin D Hill, Jake Koerner, Hwanhee Hong, Jennifer S Li, Christoph Hornik, Prince J Kannankeril, Jeffrey P Jacobs, H Scott Baldwin, Marshall L Jacobs, Eric M Graham and 16 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American heart journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03229538 (STeroids to REduce Systemic Inflammation After Infant Heart Surgery), which is not on this 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.

NCT03229538 phase3completednot on this map

STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)

TypeinterventionalSponsorKevin HillRan2017 to 2022Enrolled1,263ConditionsCongenital Heart Disease in Children, Inflammatory ResponseArmsMethylprednisolone, Isotonic saline
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

26 authors.

Kevin D HillDuke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: kevin.hill@duke.edu.
Jake KoernerDuke University Pediatric and Congenital Heart Center, Durham, NC.
Hwanhee HongDuke University Pediatric and Congenital Heart Center, Durham, NC.
Jennifer S LiDuke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
Christoph HornikDuke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
Prince J KannankerilVanderbilt University Medical Center, Nashville, TN.
Jeffrey P JacobsUniversity of Florida Congenital Heart Center, Gainesville, FL.
H Scott BaldwinVanderbilt University Medical Center, Nashville, TN.
Marshall L JacobsJohns Hopkins University School of Medicine, Baltimore, MD.
Eric M GrahamMedical University of South Carolina, Charleston, SC.
Brian BlasioleUPMC Children's Hospital of Pittsburgh, Pittsburgh, PA.
David F VenerDepartment of Anesthesiology, Baylor College of Medicine, Pediatric Cardiac Anesthesiology, Texas Children's Hospital, Houston, TX.
Adil S HusainUniversity of Utah/Primary Children's Hospital, Salt Lake City, UT.
S Ram KumarCriss Heart Center, Children's Nebraska and University of Nebraska Medical Center, Omaha, NE.
Alexis BenscoterCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH.
Eric WaldAnn & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL.
Tara KaramlouAkron Children's and Cincinnati Children's Hospital, Akron, OH.
Andrew H Van BergenAdvocate Children's Heart Institute, Division of Pediatric Cardiac Critical Care, Advocate Children's Hospital, Oak Lawn, IL.
David OvermanDivision of Cardiovascular Surgery, Children's Minnesota, Minneapolis, MN.
Pirooz EghtesadySection of Pediatric Cardiothoracic Surgery, Washington University School of Medicine, St Louis, MO.
Ryan ButtsDepartment of Pediatrics, Division of Cardiology, University of Texas Southwestern, Dallas, TX.
John S KimDepartment of Pediatrics, Heart Institute, Division of Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.
John P ScottChildren's Wisconsin, Medical College of Wisconsin, Milwaukee, WI.
Brett R AndersonMount Sinai Children's Heart Center, New York, NY.
Michael F SwartzUniversity of Rochester Medical Center, Rochester, NY.
Sean M O'BrienDuke Clinical Research Institute, Durham, NC.

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., HERNANDEZ, ADRIAN · 2016 to 2022
$177.0M
Leveraging existing registry resources to facilitate clinical trialsU01TR001803 · NCATS · DUKE UNIVERSITY · PI BALDWIN, H SCOTT, JACOBS, JEFFREY PHILLIP · 2016 to 2020
$5.5M
Integrated Biostatistical Training for CVD ResearchT32HL079896 · NHLBI · NORTH CAROLINA STATE UNIVERSITY RALEIGH · PI Sean M O'Brien, Ana-Maria Staicu · 2006 to 2026
$4.1M
FDA HHS U18 FD006298NCATS NIH HHS L40 TR002124NCATS NIH HHS U01 TR001803NCATS NIH HHS U24 TR001608NHLBI NIH HHS T32 HL079896NICHD NIH HHS HHSN267200700051C
6 · The paper itself

Abstract

backgroundProphylactic steroids are often used to reduce the systemic inflammatory response to cardiopulmonary bypass in infants undergoing heart surgery. The STRESS trial found that the odds of a worse outcome did not differ between infants randomized to methylprednisolone (n = 599) versus placebo (n = 601) (adjusted odds ratio [OR], 0.86; P = .14). However, secondary analyses showed possible benefits with methylprednisolone. To investigate further using a different probabilistic approach, we re-analyzed the STRESS trial using Bayesian analytics.

methodsWe used a covariate-adjusted proportional odds model using the original STRESS trial primary endpoint, a ranked composite of death, transplant, major complication and post op length of stay. We performed Markov Chain Monte Carlo simulations to assess the probability of benefit (OR < 1) versus harm (OR > 1). Primary analysis assumed a neutral probability of benefit versus harm with weak prior belief strength (nearly noninformative prior distribution). To illustrate magnitude of effect, we calculated predicted risk of death, transplant or major complications for methylprednisolone and placebo. Sensitivity analyses evaluated pessimistic (5%-30% prior likelihood of benefit), neutral and optimistic (70%-95%) prior beliefs, and controlled strength of prior belief as weak (30% variance), moderate (15%) and strong (5%). A secondary analysis derived empirical priors using data from four previous steroid trials.

resultsThe posterior probability of any benefit from methylprednisolone was 92% and probability of harm was 8%. Composite death or major complication occurred in 18.8% of subjects with an absolute risk difference of -2% (95% CI -3%, +1%) for methylprednisolone. Each of 9 sensitivity analyses demonstrated greater probability of benefit than harm in the methylprednisolone group with 8 of 9 demonstrating >80% probability of benefit and ≥1% absolute difference in risk of death, transplant or major complications. In secondary analysis deriving priors from previous steroid trials, results were consistent with a 95% posterior probability of benefit.

conclusionOur Bayesian re-analysis of the STRESS trial, using a range of prior beliefs, demonstrated a high probability that perioperative methylprednisolone reduces the risk of death or major complications in infants undergoing cardiopulmonary bypass compared with placebo. This more in-depth analysis expands the initial clinical evaluation of methylprednisolone provided by the STRESS trial.

trial registrationClinicaltrials.gov: NCT03229538 (https://clinicaltrials.gov/study/NCT03229538).

Indexed as

Cardiac Surgical ProceduresCardiopulmonary BypassMethylprednisolonePostoperative ComplicationsBayes TheoremFemaleGlucocorticoidsHumansInfantMaleGlucocorticoidsMethylprednisolone

Identifiers

PMID41015071
PMCPMC12527032

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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.