Erratum: The statistical design and analysis of pandemic platform trials: Implications for the future - CORRIGENDUM.

[This corrects the article DOI: 10.1017/cts.2024.

Resource Use in the Randomized Master Protocol for Immune Modulators for Treating COVID-19 (ACTIV-1 IM): A Secondary Data Analysis.

Background: Coronavirus disease 2019 (COVID-19) pneumonia requires considerable healthcare resources.

Research Objective: Examine if a single dose of infliximab or abatacept, in addition to remdesivir and steroids, decreased resource utilization among participants hospitalized with COVID-19 pneumonia.

Study Design And Methods: Accelerating COVID-19 Therapeutic Interventions and Vaccines Immunomodulator (ACTIV-1 IM) master protocol was a randomized, placebo-controlled trial examining the potential benefit in time to recovery and mortality of immunomodulators infliximab, abatacept, and cenicriviroc.

Engaging communities in therapeutics clinical research during pandemics: Experiences and lessons from the ACTIV COVID-19 therapeutics research initiative.

This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials.

The statistical design and analysis of pandemic platform trials: Implications for the future.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group gathered lessons learned from statisticians responsible for the design and analysis of the 11 ACTIV therapeutic master protocols to inform contemporary trial design as well as preparation for a future pandemic. The ACTIV master protocols were designed to rapidly assess what treatments might save lives, keep people out of the hospital, and help them feel better faster. Study teams initially worked without knowledge of the natural history of disease and thus without key information for design decisions.

Artificial Intelligence in Cardiovascular Clinical Trials.

Randomized clinical trials are the gold standard for establishing the efficacy and safety of cardiovascular therapies. However, current pivotal trials are expensive, lengthy, and insufficiently diverse. Emerging artificial intelligence (AI) technologies can potentially automate and streamline clinical trial operations.

ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.

Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally.

SEPSIGN: early identification of sepsis signs in emergency department.

Because 20-30% of patients with sepsis deteriorate to critical illness, biomarkers that provide accurate early prognosis may identify which patients need more intensive treatment versus safe early discharge. The objective was to test the performance of sVEGFR2, suPAR and PCT, alone or combined with clinical signs and symptoms, for the prediction of clinical deterioration. This prospective observational study enrolled patients with suspected infection who met SIRS criteria without organ dysfunction (delta SOFA <2 from baseline) from 16 emergency departments.

Predicting Complications in Head and Neck Surgery: Comparing Calculators to Surgeons.

Surgical outcomes determine national ranking, reputation, and funding, and are often assessed with objective surgical risk calculators (SRCs). Surgeons' assessments are not considered. This study aims to determine if surgeons or SRCs are more accurate in predicting outcomes.

A Randomized Controlled Comparison of Guardian-Perceived Cosmetic Outcome of Simple Lacerations Repaired With Either Dermabond, Steri-Strips, or Absorbable Sutures.

Objectives: The aim of this study was to compare the guardian-perceived 3-month cosmetic outcome for pediatric lacerations repaired with absorbable sutures, Dermabond, or Steri-Strips. Secondarily, pain and satisfaction with the procedure from both guardian and provider perspectives were compared.

Methods: In this randomized controlled trial, we enrolled a convenience sample of children aged 0 to <18 years who presented with simple linear lacerations (≤5 cm in length, ≤0.

Out-of-Hospital Intranasal Ketamine as an Adjunct to Fentanyl for the Treatment of Acute Traumatic Pain: A Randomized Clinical Trial.

Study Objective: To evaluate if out-of-hospital administration of fentanyl and intranasal ketamine, compared to fentanyl alone, improves early pain control after injury.

Methods: We conducted an out-of-hospital randomized, placebo-controlled, blinded, parallel group clinical trial from October 2017 to December 2021. Participants were male, aged 18 to 65 years, receiving fentanyl to treat acute traumatic pain prior to hospital arrival, treated by an urban fire-based emergency medical services agency, and transported to the region's only adult Level I trauma center.

Upstrapping to determine futility: predicting future outcomes nonparametrically from past data.

Background: Clinical trials often involve some form of interim monitoring to determine futility before planned trial completion. While many options for interim monitoring exist (e.g.

Abatacept Pharmacokinetics and Exposure Response in Patients Hospitalized With COVID-19: A Secondary Analysis of the ACTIV-1 IM Randomized Clinical Trial.

Importance: The pharmacokinetics of abatacept and the association between abatacept exposure and outcomes in patients with severe COVID-19 are unknown.

Objective: To characterize abatacept pharmacokinetics, relate drug exposure with clinical outcomes, and evaluate the need for dosage adjustments.

Design, Setting, And Participants: This study is a secondary analysis of data from the ACTIV-1 (Accelerating COVID-19 Therapeutic Interventions and Vaccines) Immune Modulator (IM) randomized clinical trial conducted between October 16, 2020, and December 31, 2021.

Trends in use of composite endpoints in clinical trials: A comparison between acute heart failure trials and COVID-19 trials.

Composite endpoints can encode multiple pieces of information and are increasingly adopted in clinical trials. Advocacy for using composite endpoints began decades ago in cardiovascular trials, leading to incorporation of patient-oriented outcomes and consideration of a hierarchical ranking system. The use of composite endpoints in coronavirus disease (COVID-19) trials has evolved similarly.

Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure.

Background: The primary goals during acute heart failure (AHF) hospitalization are decongestion and guideline-directed medical therapy (GDMT) optimization. Unlike diuretics or other GDMT, early dapagliflozin initiation could achieve both AHF goals.

Objectives: The authors aimed to assess the diuretic efficacy and safety of early dapagliflozin initiation in AHF.

Association between weight-for-length percentile and ICU length of stay in patients with a single ventricle undergoing bidirectional Glenn repair: A retrospective cohort study.

Background: Poor weight gain has been identified as an independent risk factor for increased surgical morbidity and mortality for patients with single-ventricle physiology undergoing staged surgical palliation. Conversely, excessive weight gain has also emerged as an independent risk factor predicting increased morbidity and mortality in a single-center study. Given this novel single-center concept, we investigated the impact of excessive weight on patients with single-ventricle physiology undergoing bidirectional Glenn palliation in a multicenter study model.

Effect of a Co-Located Bridging Recovery Initiative on Hospital Length of Stay Among Patients With Opioid Use Disorder: The BRIDGE Randomized Clinical Trial.

Importance: Co-located bridge clinics aim to facilitate a timely transition to outpatient care for inpatients with opioid use disorder (OUD); however, their effect on hospital length of stay (LOS) and postdischarge outcomes remains unclear.

Objective: To evaluate the effect of a co-located bridge clinic on hospital LOS among inpatients with OUD.

Design, Setting, And Participants: This parallel-group randomized clinical trial recruited 335 adult inpatients with OUD seen by an addiction consultation service and without an existing outpatient clinician to provide medication for OUD (MOUD) between November 25, 2019, and September 28, 2021, at a tertiary care hospital affiliated with a large academic medical center and its bridge clinic.

Peer review of clinical and translational research manuscripts: Perspectives from statistical collaborators.

Research articles in the clinical and translational science literature commonly use quantitative data to inform evaluation of interventions, learn about the etiology of disease, or develop methods for diagnostic testing or risk prediction of future events. The peer review process must evaluate the methodology used therein, including use of quantitative statistical methods. In this manuscript, we provide guidance for peer reviewers tasked with assessing quantitative methodology, intended to complement guidelines and recommendations that exist for manuscript authors.