Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial

Hill, Kevin D.; Baldwin, H. Scott; Bichel, David P.; Chamberlain, Reid C.; Ellis, Alicia M.; Graham, Eric M.; Hickerson, Jesse; Hornik, Christoph P.; Jacobs, Jeffrey P.; Jacobs, Marshall L.; Jaquiss, Robert D. B.; Kannankeril, Prince J.; O’Brien, Sean M.; Török, Rachel D.; Turek, Joseph W.; Li, Jennifer S.; Bergen, Andrew H. Van; Wald, Eric; Resheidat, Ashraf; Vener, David F.; Jaggers, James; Kumar, S. Ram; Louis, James St.; Hammel, Jim; Overman, David M.; Blasiole, Brian; Scott, J. Paul; Benscoter, Alexis; Karamlou, Tara; Ravekes, William; Ofori-Amanfo, George; Buckley, Jason R.; Zyblewski, Sinai C.; McConnell, Patrick I.; Anderson, Brett R.; Santana-Acosta, Darlene; Eghtesady, Pirooz; Bleiweis, Mark S.; Swartz, Michael F.; Butts, Ryan J.; Husain, S. Adil; Lambert, Linda M.; Amula, Venugopal; Eckhauser, Rusty; Griffiths, Eric; Williams, Richard L.; Witte, Madolin K.; Minich, L. LuAnn

doi:10.1016/j.ahj.2019.11.016

Cited by 36 publications

(21 citation statements)

References 42 publications

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“…Because no published standards exist regarding the amount of time it takes to collect and manage research data, estimates of time were obtained through a series of semi-structured interviews with investigators, research coordinators, data managers from 18 academic institutions, programmers from four registry-based investigations, [15][16][17][18] and statisticians and project managers at HealthCore (formerly The New England Research Institutes), a contract research organisation with expertise in all aspects of trial implementation, including trial design, project management, data coordination and integration, research analytics, and quality assurance (www.healthcore.com). Amongst others, HealthCore coordinates trial activities for the National Heart Lung and Blood Institute-sponsored Pediatric Heart Network, which has led over 30 paediatric cardiovascular multi-centre investigations over the past 17 years (see Appendix 1 and Supplemental Figure 3).…”

Section: Data Sourcesmentioning

confidence: 99%

“…Centralised data accessaccessing data from the central repositoryis typically the most straightforward. 16,17 It also offers the benefit of including the greatest number of sites and assures uniform data linkage and cleaning. When the costs of accessing centralised data are high, or when registries place significant barriers to access, some investigators may prefer to use locally held data by soliciting cooperation from individual sites.…”

Section: Standard Clinical Trialmentioning

confidence: 99%

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Registry-based trials: a potential model for cost savings?

et al. 2020

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Background/Aims:Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.Methods:We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.Results:Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.Conclusions:Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.

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Section: Data Sourcesmentioning

confidence: 99%

Section: Standard Clinical Trialmentioning

confidence: 99%

Registry-based trials: a potential model for cost savings?

et al. 2020

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“…The NIH Challenge Grant laid the groundwork for the current STRESS trial. 17 Our NIH Challenge Grant confirmed that we could answer important questions looking at a linked database that could not be answered by a single database in isolation. In fact, one of the aims of the NIH Challenge Grant was to identify important questions for future research.…”

Section: Diseases Figuring Out What Your Endpoint Is Becomes Very DImentioning

confidence: 85%

“…[8][9][10][11][12][13][14][15][16] More recently we have a study utilizing the Society of Thoracic Surgeons Congenital Heart Database called the Steroids to Reduce Systemic Inflammation after Infant Heart Surgery (STRESS) trial. 17 In this study, we are randomizing infants to steroids or placebo during cardiac surgery. It is a trial within a registry, which is somewhat novel since we are collecting our clinical trial data through the Society of Thoracic Surgeons Congenital Heart Database.…”

Section: Diseases Figuring Out What Your Endpoint Is Becomes Very DImentioning

confidence: 99%

Global Leadership in Paediatric and Congenital Cardiac Care: “Using data to improve outcomes – an interview with Jennifer S. Li, MD, MHS”

Tretter

Jacobs

2020

Cardiol Young

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Dr. Jennifer Li is the focus of our second in a planned series of interviews in Cardiology in the Young entitled, “Global Leadership in Paediatric and Congenital Cardiac Care”. Dr. Li was born in Boston, Massachusetts, United States of America, and moved to Indianapolis, Indiana where she completed her secondary education. She then attended Stanford University, majoring in Chemistry and English and graduating with distinction in 1983. Dr. Li then attended Duke University School of Medicine, graduating in 1987. She then completed her internship at Children’s Hospital of Philadelphia in 1987–1989, returning to Duke University Medical Center to complete both her residency in general paediatrics in 1989–1990 followed by her fellowship in paediatric cardiology in 1990–1993. She would later complete her Master’s Degree in Health Sciences at Duke University in 2005. Dr. Li has spent her entire career as a paediatric cardiologist at Duke University Medical Center, where she was appointed a Professor of Pediatrics and Professor of Medicine in 2008 and has held the position as Beverly C. Morgan Endowed Professor of Pediatrics since 2012. She has served as the Chief of Paediatric Cardiology at Duke University Medical Center since 2006. She also was the Director of Paediatric Research at Duke Clinical Research Institute from 2001-2015. Dr. Li has played an instrumental role in evaluating the safety and efficacy of drugs in children, as well as in analysing and linking large multicentric databases to evaluate the outcomes, quality, and cost of paediatric and congenital cardiac care. Dr. Li has received funding from the National Institute of Health of the United States of America, as well as from industry and foundation grants. This article presents our interview with Dr. Li, an interview that covers her experience collaborating with governmental organizations and industry in the pursuit of common interests to design clinical drug trials, link and analyse large, multicentric databases, and improve paediatric health care.

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“…The study by Elzein failed to meet its primary end point (fluid balance) but nonetheless yielded interesting data on a potential myocardial protective effect which most clinicians would agree to be of significant importance particularly in the staged single ventricle population with its elevated lifelong risk of heart failure. 19,20 Given the complexity of our patient population, it is unlikely that single trial end points will be applicable across interventions studied and between subpopulations. Tools such as composite or global rank end points may be of value in addressing this issue but are unlikely to replace a careful consideration of prior trial end points, known or presumed pathophysiologic differences between populations and interventions studied when choosing the essential primary end point of a trial.…”

mentioning

confidence: 99%