The Pediatric Heart Network Residual Lesion Score Study: Design and objectives

Nathan, Meena; Trachtenberg, Felicia; Rompay, Maria I. Van; Gaynor, William; Kanter, Kirk R.; Bacha, Emile A.; Tweddell, James S.; Minich, L. LuAnn; Mery, Carlos M.; Colan, Steven D.; Levine, Jami C.; Lambert, Linda M.; Pizarro, Christian; Dunbar‐Masterson, Carolyn; Anderson, Brett R.; Graham, Eric M.; Raghuveer, Geetha; Schamberger, Marcus S.; Kaltman, Jonathan R.; Goot, Benjamin H.; Sivanandam, Shanthi; Overman, David M.; Jacobs, Marshall L.; Jacobs, Jeffrey P.; Adachi, Iki; Madsen, Nicolas

doi:10.1016/j.jtcvs.2019.10.146

Cited by 35 publications

(20 citation statements)

References 19 publications

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“…Evaluating the full treatment pathway from preoperative factors to postoperative events is attractive, but conceptually challenging. The recently proposed notion of "residual lesion score" from the Pediatric Heart Network 3 , based on previous work on technical performance scores 16 is one such attempt, and could offer even more insight into the mechanisms of unplanned reinterventions.…”

Section: Discussionmentioning

confidence: 99%

“…Used judiciously, it could identify lapses in patient care, be it incomplete diagnosis, technical issues and residual defects or failed therapeutic plan. 3,4 On the other hand, uRE's are difficult to measure; we previously investigated early reoperations using UK National Congenital Heart Disease Audit (NCDHA) data, and found it impossible to retrospectively decide if a reintervention is "unplanned". 5 Nevertheless, the National Health Service in the UK has already adopted uRE as a metric of performance, 6 while a recent NCHDA report highlighted the limitations involved in collecting such data.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Factors associated with unplanned reinterventions and their relation to early mortality after pediatric cardiac surgery

Dorobantu

Ridout

Brown

et al. 2021

The Journal of Thoracic and Cardiovascular Surgery

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Factors associated with unplanned reinterventions and their relation to early mortality after pediatric cardiac surgery

Dorobantu

Ridout

Brown

et al. 2021

The Journal of Thoracic and Cardiovascular Surgery

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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%

“…In these cases, investigators work with collaborators at peer institutions, helping them to gather and share locally held data. This can be accomplished either via focused data queries at each site 15 or a more generic data harvest, with post hoc data manipulation. 25,26 We modelled each of these data acquisition strategies.…”

Section: Standard Clinical Trialmentioning

confidence: 99%

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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“…[2][3][4] The reliability of the modern CPB circuits has resulted in an important paradigm shift from speed to precision. [5][6][7][8][9] This has also permitted an expansion in the complexity of cases that can be undertaken given the safety of the CPB circuits.…”

Section: Introductionmentioning

confidence: 99%

Prevalence of Complications Following Unifocalization and Pulmonary Artery Reconstruction Procedures

Mainwaring

Patrick

Dixit

et al. 2020

World J Pediatr Congenit Heart Surg

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Background: Unifocalization and pulmonary artery reconstructions have been developed to treat complex disorders of pulmonary artery development. These procedures require extremely long periods of cardiopulmonary bypass (CPB) to facilitate surgical repair. The objective of this study was to document the prevalence of complications in patients undergoing unifocalization or pulmonary artery reconstructions associated with prolonged periods of CPB. Methods: This was a retrospective review of 100 consecutive patients who underwent unifocalization (n = 66) or pulmonary artery reconstructions (n = 34) with CPB times in excess of five hours. Thirty-eight of these operations were primary procedures, whereas 62 were reoperations. Results: The median age at surgery was 15 months, median duration of CPB was 473 minutes, median number of postoperative complications was 5, and the median length of hospital stay was 24 days. The most frequently encountered complications were low cardiac output (43%), open sternum (40%), reintubation (24%), arrhythmia (17%), and bronchoscopy (17%). There was a correlation between the total number of complications and overall length of hospital stay ( R 2 = 0.64). Major adverse cardiac events (MACE) occurred in 11 patients with one hospital mortality. Patients who experienced MACE had a median length of stay that was 35 days longer (56 vs 21 days) than patients who did not experience MACE. Conclusions: The data demonstrate that complications were relatively frequent in this cohort of patients and had a linear association with hospital length of stay. Major adverse cardiac events were encountered at a modest prevalence but had a profound impact on measures of outcome.

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The Pediatric Heart Network Residual Lesion Score Study: Design and objectives

Cited by 35 publications

References 19 publications

Factors associated with unplanned reinterventions and their relation to early mortality after pediatric cardiac surgery

Factors associated with unplanned reinterventions and their relation to early mortality after pediatric cardiac surgery

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

Prevalence of Complications Following Unifocalization and Pulmonary Artery Reconstruction Procedures

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