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Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry.

ABSTRACT: Clinical databases in congenital and paediatric cardiac care provide a foundation for quality improvement, research, policy evaluations and public reporting. Structured audits verifying data integrity allow database users to be confident in these endeavours. We report on the initial audit of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry. Materials and methods Participants reviewed the entire registry to determine key fields for audit, and defined major and minor discrepancies for the audited variables. In-person audits at the eight initial participating centres were conducted during a 12-month period. The data coordinating centre randomly selected intensive care encounters for review at each site. The audit consisted of source data verification and blinded chart abstraction, comparing findings by the auditors with those entered in the database. We also assessed completeness and timeliness of case submission. Quantitative evaluation of completeness, accuracy, and timeliness of case submission is reported.We audited 434 encounters and 29,476 data fields. The aggregate overall accuracy was 99.1%, and the major discrepancy rate was 0.62%. Across hospitals, the overall accuracy ranged from 96.3 to 99.5%, and the major discrepancy rate ranged from 0.3 to 0.9%; seven of the eight hospitals submitted >90% of cases within 1 month of hospital discharge. There was no evidence for selective case omission.Based on a rigorous audit process, data submitted to the PC4 clinical registry appear complete, accurate, and timely. The collaborative will maintain ongoing efforts to verify the integrity of the data to promote science that advances quality improvement efforts.

SUBMITTER: Gaies M

PROVIDER: S-EPMC4788573 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry.

Gaies Michael M Donohue Janet E JE Willis Gina M GM Kennedy Andrea T AT Butcher John J Scheurer Mark A MA Alten Jeffrey A JA William Gaynor J J Schuette Jennifer J JJ Cooper David S DS Jacobs Jeffrey P JP Pasquali Sara K SK Tabbutt Sarah S

Cardiology in the young 20150911 6

<h4>Background</h4>Clinical databases in congenital and paediatric cardiac care provide a foundation for quality improvement, research, policy evaluations and public reporting. Structured audits verifying data integrity allow database users to be confident in these endeavours. We report on the initial audit of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry. Materials and methods Participants reviewed the entire registry to determine key fields for audit, and defined major ...[more]

PMID: 26358157

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Project description:To describe the clinical epidemiology of extubation failure in a multicenter cohort of patients treated in pediatric cardiac ICUs.Retrospective cohort study using prospectively collected clinical registry data.Pediatric Cardiac Critical Care Consortium registry.All patients admitted to the CICU at Pediatric Cardiac Critical Care Consortium hospitals.None.Analysis of all mechanical ventilation episodes in the registry from October 1, 2013, to July 31, 2014. The primary outcome of extubation failure was reintubation less than 48 hours after planned extubation. Repeated-measures analysis using generalized estimating equations to account for within patient and center correlation was performed to identify risk factors for extubation failure. Adjusted extubation failure rates for each hospital were calculated using logistic regression controlling for patient factors. Of 1,734 mechanical ventilation episodes (1,478 patients at eight hospitals) ending in a planned extubation, there were 100 extubation failures (5.8%). In multivariable analysis, only longer duration of mechanical ventilation was significantly associated with extubation failure (p = 0.01); the failure rate was 4% when ventilated less than 24 hours, 9% after 24 hours, and 13% after 7 days. For 503 patients intubated and extubated in the cardiac operating room, 15 patients (3%) failed extubation within 48 hours (12 within 24 hr). Case-mix-adjusted extubation failure rates ranged from 1.1% to 9.8% across hospitals. Patients failing extubation had greater median cardiac ICU length of stay (15 vs 3 d; p < 0.001) and in-hospital mortality (7.9 vs 1.2%; p < 0.001).Though extubation failure is uncommon overall, there may be opportunities to improve extubation readiness assessment in patients ventilated more than 24 hours. These data suggest that extubation in the operating room after cardiac surgery can be done with a low failure rate. We observed variation in extubation failure rates across hospitals, and future investigation must elucidate the optimal strategies of high-performing centers to reduce ventilation time while limiting extubation failures.

Project description:ObjectivesCardiopulmonary failure in children with cardiac disease differs from the general pediatric critical care population, yet the epidemiology of extracorporeal membrane oxygenation support in cardiac ICUs has not been described. We aimed to characterize extracorporeal membrane oxygenation utilization and outcomes across surgical and medical patients in pediatric cardiac ICUs.DesignRetrospective analysis of the Pediatric Cardiac Critical Care Consortium registry to describe extracorporeal membrane oxygenation frequency and outcomes. Within strata of medical and surgical hospitalizations, we identified risk factors associated with extracorporeal membrane oxygenation use through multivariate logistic regression.SettingTertiary-care children's hospitals.PatientsNeonates through adults with cardiac disease.InterventionsNone.Measurements and main resultsThere were 14,526 eligible hospitalizations from August 1, 2014, to June 30, 2016; 449 (3.1%) included at least one extracorporeal membrane oxygenation run. Extracorporeal membrane oxygenation was used in 329 surgical (3.5%) and 120 medical (2.4%) hospitalizations. Systemic circulatory failure and extracorporeal cardiopulmonary resuscitation were the most common extracorporeal membrane oxygenation indications. In the surgical group, risk factors associated with postoperative extracorporeal membrane oxygenation use included younger age, extracardiac anomalies, preoperative comorbidity, higher Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery category, bypass time, postoperative mechanical ventilation, and arrhythmias (all p < 0.05). Bleeding requiring reoperation (25%) was the most common extracorporeal membrane oxygenation complication in the surgical group. In the medical group, risk factors associated with extracorporeal membrane oxygenation use included acute heart failure and higher Vasoactive Inotropic Score at cardiac ICU admission (both p < 0.0001). Stroke (15%) and renal failure (15%) were the most common extracorporeal membrane oxygenation complications in the medical group. Hospital mortality was 49% in the surgical group and 63% in the medical group; mortality rates for hospitalizations including extracorporeal cardiopulmonary resuscitation were 50% and 83%, respectively.ConclusionsThis is the first multicenter study describing extracorporeal membrane oxygenation use and outcomes specific to the cardiac ICU and inclusive of surgical and medical cardiac disease. Mortality remains high, highlighting the importance of identifying levers to improve care. These data provide benchmarks for hospitals to assess their outcomes in extracorporeal membrane oxygenation patients and identify unique high-risk subgroups to target for quality initiatives.

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Project description:Importance:Tetralogy of Fallot (TOF) is a surgically repairable form of cyanotic congenital heart disease. Multicenter data for long-term survival following repair are sparse. Objective:To evaluate the long-term transplant-free survival of TOF by surgical strategy adjusted for era and patient characteristics. Design, Setting, and Participants:Retrospective cohort study enriched with data from the National Death Index and the Organ Procurement and Transplantation Network through 2014. Multicenter cohort from the Pediatric Cardiac Care Consortium (PCCC), a large, US-based clinical registry for interventions for congenital heart disease. The cohort included patients with adequate identifiers for linkage with the National Death Index and the Organ Procurement and Transplantation Network who were enrolled in the PCCC registry between 1982 and 2003 and survived surgical repair of simple TOF. Data were analyzed between September 2015 and April 2018. Exposures:We examined patient-associated and surgery-associated risk factors affecting survival. Main Outcomes and Measures:We analyzed the transplant-free survival during early (<6 years) and late (≥6 years) phase after TOF surgical repair. Results:Of the 3283 patients who survived repair for simple TOF and met the study's inclusion criteria, 56.4% were male and 43.6% were female. Twenty-five-year survival following TOF repair was 94.5%. Multivariable analysis demonstrated increased risk of early mortality with staged repair (HR, 2.68; 95% CI, 1.59-4.49) and non-valve-sparing operation (HR, 3.76; 95% CI, 1.53-9.19). Presence of a genetic abnormality was associated with increased risk of death both in the early (HR, 3.64; 95% CI, 2.05-6.47) and late postoperative phase (HR, 4.41; 95% CI, 2.62-7.44). Conclusions and Relevance:Long-term survival after simple TOF repair is excellent. Staged repair and non-valve-sparing operations were negatively associated with survival in the early postrepair phase but not the late postrepair phase. These data are important for patients with repaired TOF and their caretakers and may guide surgical strategies for optimizing the long-term outcomes of this population.

Dataset Information

Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry.

Publications

Data integrity of the Pediatric Cardiac Critical Care Consortium (PC4) clinical registry.

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