Evaluating registry-based trial economics: Results from the STRESS clinical trial.

Background: Registry-based trials have the potential to reduce randomized clinical trial (RCT) costs. However, observed cost differences also may be achieved through pragmatic trial designs. A systematic comparison of trial costs across different designs has not been previously performed. Methods: We conducted a study to compare the current Steroids to Reduce Systemic inflammation after infant heart surgery (STRESS) registry-based RCT vs. two established designs: pragmatic RCT and explanatory RCT. The primary outcome was total RCT design costs. Secondary outcomes included: RCT duration and personnel hours. Costs were estimated using the Duke Clinical Research Institute's pricing model. Results: The Registry-Based RCT estimated duration was 31.9 weeks greater than the other designs (259.5 vs. 227.6 weeks). This delay was caused by the Registry-Based design's periodic data harvesting that delayed site closing and statistical reporting. Total personnel hours were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design (52,488 vs 29,763 vs. 24,480 h, respectively). Total costs were greatest for the Explanatory design followed by the Pragmatic design and the Registry-Based design ($10,140,263 vs. $4,164,863 vs. $3,268,504, respectively). Thus, Registry-Based total costs were 32 % of the Explanatory and 78 % of the Pragmatic design. Conclusion: Total costs for the STRESS RCT with a registry-based design were less than those for a pragmatic design and much less than an explanatory design. Cost savings reflect design elements and leveraging of registry resources to improve cost efficiency, but delays to trial completion should be considered.

Long-Term Health Care Utilization After Cardiac Surgery in Children Covered Under Medicaid.

BACKGROUND: Understanding the longitudinal burden of health care expenditures and utilization after pediatric cardiac surgery is needed to counsel families, improve care, and reduce outcome inequities. OBJECTIVES: The purpose of this study was to describe and identify predictors of health care expenditures and utilization for Medicaid-insured pediatric cardiac surgical patients. METHODS: All Medicaid enrolled children age <18 years undergoing cardiac surgery in the New York State CHS-COLOUR database, from 2006 to 2019, were followed in Medicaid claims data through 2019. A matched cohort of children without cardiac surgical disease was identified as comparators. Expenditures and inpatient, primary care, subspecialist, and emergency department utilization were modeled using log-linear and Poisson regression models to assess associations between patient characteristics and outcomes. RESULTS: In 5,241 New York Medicaid-enrolled children, longitudinal health care expenditures and utilization for cardiac surgical patients exceeded noncardiac surgical comparators (cardiac surgical children: $15,500 ± $62,000 per month in year 1 and $1,600 ± $9,100 per month in year 5 vs noncardiac surgical children: $700 ± $6,600 per month in year 1 and $300 ± $2,200 per month in year 5). Children after cardiac surgery spent 52.9 days in hospitals and doctors' offices in the first postoperative year and 90.5 days over 5 years. Being Hispanic, compared with non-Hispanic White, was associated with having more emergency department visits, inpatient admissions, and subspecialist visits in years 2 to 5, but fewer primary care visits and greater 5-year mortality. CONCLUSIONS: Children after cardiac surgery have significant longitudinal health care needs, even among those with less severe cardiac disease. Health care utilization differed by race/ethnicity, although mechanisms driving disparities should be investigated further.

Evolving Cost-Quality Relationship in Pediatric Heart Surgery.

BACKGROUND: For the more than 40,000 children in the United States undergoing congenital heart surgery annually, the relationship between hospital quality and costs remains unclear. Prior studies report conflicting results and clinical outcomes have continued to improve over time. We examined a large contemporary cohort, aiming to better inform ongoing initiatives seeking to optimize health care value in this population. METHODS: Clinical information (The Society of Thoracic Surgeons Congenital Database) was merged with standardized cost data (Pediatric Health Information Systems) for children undergoing heart surgery from 2010 to 2015. In-hospital cost variability was analyzed using Bayesian hierarchical models adjusted for case-mix. Quality metrics examined included in-hospital mortality, postoperative complications, postoperative length of stay (PLOS), and a composite. RESULTS: Overall, 32 hospitals (n = 45,315 patients) were included. Median adjusted cost per case varied across hospitals from $67,700 to $51,200 in the high vs low cost tertile (ratio 1.32; 95% credible interval, 1.29 to 1.35), and all quality metrics also varied across hospitals. Across cost tertiles, there were no significant differences in the quality metrics examined, with the exception of PLOS. The PLOS findings were driven by high-risk The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery categories 4 and 5 cases (adjusted median length of stay 16.8 vs 14.9 days in high vs low cost tertile [ratio 1.13, 1.05 to 1.24]), and intensive care unit PLOS. CONCLUSIONS: Contemporary congenital heart surgery costs vary across hospitals but were not associated with most quality metrics examined, highlighting that performance in one area does not necessarily convey to others. Cost variability was associated with PLOS, particularly related to intensive care unit PLOS and high-risk cases. Care processes influencing PLOS may provide targets for value-based initiatives in this population.

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

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.

Estimating Resource Utilization in Congenital Heart Surgery.

BACKGROUND: Optimal methods to assess resource utilization in congenital heart surgery remain unclear. We compared traditional cost-to-charge ratio methods with newer standardized cost methods that aim to more directly assess resources consumed. METHODS: Clinical data from The Society of Thoracic Surgeons Database were linked with resource use data from the Pediatric Health Information Systems Database (2010 to 2015). Standardized cost methods specific to the congenital heart surgery population were developed and compared with cost-to-charge ratio methods. Resource use in the overall population and variability across hospitals were described using hierarchical mixed effect models adjusting for case-mix. RESULTS: Overall, 43 hospitals (65,331 patients) were included. There were minimal population-level differences in the distribution of resource use as estimated by the two methods. At the hospital level, there was less apparent variability in resource use across centers with the standardized cost vs cost-to-charge ratio method, overall (coefficient of variation 20% vs 25%) and across complexity (The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery [STAT]) categories. When hospitals were categorized into tertiles by resource use, 33% changed classification depending on which resource use method was used (26% by one tertile and 7% by two tertiles). CONCLUSIONS: In this first evaluation of standardized cost methodology in the congenital heart population, we found minimal differences vs traditional methods at the population level. At the hospital level, the magnitude of variation in resource use was less with standardized cost methods, and approximately one third of centers changed resource use categories depending on the methodology used. Because of these differences, care should be taken in future studies and in benchmarking and reporting efforts in selecting optimal methodology.

Biomarkers associated with 30-day readmission and mortality after pediatric congenital heart surgery.

OBJECTIVES: Novel cardiac biomarkers serum (suppression of tumorigenicity [ST2]) and Galectin-3 may be associated with an increased likelihood of important events after cardiac surgery. Our objective was to explore the association between pre- and postoperative serum biomarker levels and 30-day readmission or mortality for pediatric patients. METHODS: We prospectively enrolled pediatric patients <18 years of age who underwent at least one cardiac surgical operation at Johns Hopkins Children's Center from 2010 to 2014 (N = 162). Blood samples were collected immediately before surgery and at the end of bypass. We evaluated the association between pre- and postoperative Galectin-3 and ST2 with 30-day readmission or mortality, using backward stepwise logistic regression, adjusting for covariates based on the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Mortality Risk Model. RESULTS: In our cohort, 21 (12.9%) patients experienced readmission or mortality 30-days from discharge. Before adjustment, preoperative ST2 terciles demonstrated a strong association with readmission and/or mortality after surgery (OR: 2.58; 95% CI: 1.17-3.66 and OR: 4.37; 95% CI: 1.31-14.57). After adjustment for covariates based on the STS congenital risk model, Galectin-3 postoperative mid-tercile was significantly associated with 30-day readmission or mortality (OR: 6.17; 95% CI: 1.50-0.43) as was the highest tercile of postoperative ST2 (OR: 4.98; 95% CI: 1.06-23.32). CONCLUSIONS: Elevated pre-and postoperative levels of ST2 and Galectin-3 are associated with increased risk of readmission or mortality after pediatric heart surgery. These clinically available biomarkers can be used for improved risk stratification and may guide improved patient care management.

Self-reported functional health status following interrupted aortic arch repair: A Congenital Heart Surgeons' Society Study.

OBJECTIVES: Improved survival after congenital heart surgery has led to interest in functional health status. We sought to identify factors associated with self-reported functional health status in adolescents and young adults with repaired interrupted aortic arch. METHODS: Follow-up of survivors (aged 13-24 years) from a 1987 to 1997 inception cohort of neonates included completion of functional health status questionnaires (Child Health Questionnaire-CF87 [age <18 years, n = 51] or the Short Form [SF]-36 [age ≥18 years, n = 66]) and another about 22q11 deletion syndrome (22q11DS) features (n = 141). Factors associated with functional health status domains were determined using multivariable linear regression analysis. RESULTS: Domain scores of respondents were significantly greater than norms in 2 of 9 Child Health Questionnaire-CF87 and 4 of 10 SF-36 domains and only lower in the physical functioning domain of the SF-36. Factors most commonly associated with lower scores included those suggestive of 22q11DS (low calcium levels, recurrent childhood infections, genetic testing/diagnosis, abnormal facial features, hearing deficits), the presence of self-reported behavioral and mental health problems, and a greater number of procedures. Factors explained between 10% and 70% of domain score variability (R2 = 0.10-0.70, adj-R2 = 0.09-0.66). Of note, morphology and repair type had a minor contribution. CONCLUSIONS: Morbidities associated with 22q11DS, psychosocial issues, and recurrent medical issues affect functional health status more than initial morphology and repair in this population. Nonetheless, these patients largely perceive themselves as better than their peers. This demonstrates the chronic nature of interrupted aortic arch and suggests the need for strategies to decrease reinterventions and for evaluation of mental health and genetic issues to manage associated deteriorations.

Congenital Heart Surgery Case Mix Across North American Centers and Impact on Performance Assessment.

BACKGROUND: Performance assessment in congenital heart surgery is challenging due to the wide heterogeneity of disease. We describe current case mix across centers, evaluate methodology inclusive of all cardiac operations versus the more homogeneous subset of Society of Thoracic Surgeons benchmark operations, and describe implications regarding performance assessment. METHODS: Centers (n = 119) participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2010 through 2014) were included. Index operation type and frequency across centers were described. Center performance (risk-adjusted operative mortality) was evaluated and classified when including the benchmark versus all eligible operations. RESULTS: Overall, 207 types of operations were performed during the study period (112,140 total cases). Few operations were performed across all centers; only 25% were performed at least once by 75% or more of centers. There was 7.9-fold variation across centers in the proportion of total cases comprising high-complexity cases (STAT 5). In contrast, the benchmark operations made up 36% of cases, and all but 2 were performed by at least 90% of centers. When evaluating performance based on benchmark versus all operations, 15% of centers changed performance classification; 85% remained unchanged. Benchmark versus all operation methodology was associated with lower power, with 35% versus 78% of centers meeting sample size thresholds. CONCLUSIONS: There is wide variation in congenital heart surgery case mix across centers. Metrics based on benchmark versus all operations are associated with strengths (less heterogeneity) and weaknesses (lower power), and lead to differing performance classification for some centers. These findings have implications for ongoing efforts to optimize performance assessment, including choice of target population and appropriate interpretation of reported metrics.

Impact of Patient Characteristics on Hospital-Level Outcomes Assessment in Congenital Heart Surgery.

BACKGROUND: Accurate hospital outcome measures in congenital heart surgery are important to multiple initiatives. While methods have been developed to account for differences in procedural case-mix, characteristics patients bring into the operation that may also vary across hospitals and influence outcome have received less attention. We evaluated the impact of these characteristics in a large cohort. METHODS: Patients undergoing congenital heart surgery at centers participating in The Society of Thoracic Surgeons Congenital Heart Surgery Database (2010 to 2013) with adequate data quality were included. Variation across hospitals in important patient characteristics was examined, and hospital operative mortality rates were compared with and without adjustment for patient characteristics. RESULTS: Overall, 86 centers (52,224 patients) were included. There was greater than twofold variation across hospitals for nearly all patient characteristics examined. For example, the proportion of a center's surgical population comprised of neonates ranged from 12.8% to 26.6% across hospitals; the proportion with a non-cardiac anomaly ranged from 0.7% to 5.0%. When hospital mortality rankings were evaluated based on "standard" (adjustment for differences in procedural case-mix alone) versus "full" models (adjustment for both differences in procedural case-mix and patient characteristics), 14.0% changed their ranking for mortality by 20 or greater positions, 34.9% of centers changed which mortality quartile they were classified in, and 14.0% changed their statistical classification (statistically higher, lower, or same-as-expected mortality). CONCLUSIONS: Characteristics of patients undergoing congenital heart surgery vary across centers and impact hospital outcomes assessment. Methods to assess outcomes and relative performance should account for these characteristics.

Quality-Cost Relationship in Congenital Heart Surgery.

BACKGROUND: There is an increasing focus on optimizing health care quality and reducing costs. The care of children undergoing heart surgery requires significant investment of resources, and it remains unclear how costs of care relate to quality. We evaluated this relationship across a multicenter cohort. METHODS: Clinical data from The Society of Thoracic Surgeons Database were merged with cost data from the Pediatric Health Information Systems Database for children undergoing heart surgery (2006 to 2010). Hospital-level costs were modeled using Bayesian hierarchical methods adjusting for case-mix, and hospitals were categorized into cost tertiles. The primary quality metric evaluated was in-hospital mortality. RESULTS: Overall, 27 hospitals (30,670 patients) were included. Median adjusted cost per case was $82,360 and varied fivefold across hospitals, while median adjusted mortality was 3.4% and ranged from 2.4% to 5.0% across hospitals. Overall, hospitals in the lowest cost tertile had significantly lower adjusted mortality rates compared with the middle and high cost tertiles (2.5% vs 3.8% and 3.5%, respectively, both p < 0.001). When assessed at the individual hospital level, most (75%) but not all hospitals in the lowest cost tertile were also in the lowest mortality tertile. Similar relationships were seen across the spectrum of surgical complexity. Lower cost hospitals also had shorter length of stay and trends toward fewer major complications. CONCLUSIONS: Lowest cost hospitals generally deliver the highest quality care for children undergoing heart surgery, although there is some variation in this relationship. This information is important in the design of initiatives aiming to optimize health care value in this population.

Stage 1 hybrid palliation for hypoplastic left heart syndrome--assessment of contemporary patterns of use: an analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

OBJECTIVE: Hybrid palliation is an alternative to Norwood stage 1 for the initial management of hypoplastic left heart syndrome. Contemporary multicenter hybrid use and institutional/patient factors associated with hybrid use relative to the Norwood have not been evaluated. We describe hybrid use in relation to institutional volume, patient factors, and short-term outcomes. METHODS: Infants aged 60 days or less listed in The Society of Thoracic Surgeons Congenital Heart Surgery Database (2010-2012) undergoing initial palliation of hypoplastic left heart syndrome were included. Annual institutional hybrid use rates were calculated: [hybrid procedures/(Norwood + hybrid + transplant procedures)]. In-hospital outcomes for primary hybrid and primary Norwood were compared and stratified by high (defined as ≥50%) versus low (defined as ≤10%) institutional hybrid use. RESULTS: Of 1728 patients (100 centers), most (n = 1496, 87%) underwent an index Norwood; 232 patients (13%) underwent an index hybrid procedure. Preoperative patient risk factors were more prevalent in patients undergoing the hybrid procedure. Only 13 of 100 institutions were high hybrid users, and these tended to have lower annual hypoplastic left heart syndrome index case volume. Unadjusted in-hospital mortality was higher for the hybrid compared with the Norwood procedure (30% vs 16%; P < .001). In-hospital mortality for the hybrid procedure was not associated with hybrid use (26% among institutions with low use vs 28% among institutions with high use). However, centers with high hybrid use had higher mortality after the Norwood (43%) compared with centers with low hybrid use (16%). CONCLUSIONS: Few centers currently select the hybrid procedure for most infants with hypoplastic left heart syndrome. Although unadjusted in-hospital hybrid mortality is higher than Norwood mortality, potential risk factors are more prevalent among hybrid cases. Institutions with higher hybrid use have lower hypoplastic left heart syndrome case volume and higher Norwood mortality.

Excess costs associated with complications and prolonged length of stay after congenital heart surgery.

BACKGROUND: While there is an increasing emphasis on both optimizing quality of care and reducing health care costs, there are limited data regarding how to best achieve these goals for common and resource-intense conditions such as congenital heart disease. We evaluated excess costs associated with complications and prolonged length of stay (LOS) after congenital heart surgery in a large multicenter cohort. METHODS: Clinical data from The Society of Thoracic Surgeons Database were linked to estimated costs from the Pediatric Health Information Systems Database (2006 to 2010). Excess cost per case associated with complications and prolonged LOS was modeled for 9 operations of varying complexity adjusting for patient baseline characteristics. RESULTS: Of 12,718 included operations (27 centers), average excess cost per case in those with any complication (versus none) was $56,584 (+$132,483 for major complications). The 5 highest cost complications were tracheostomy, mechanical circulatory support, respiratory complications, renal failure, and unplanned reoperation or reintervention (ranging from $57,137 to $179,350). Patients with an additional day of LOS above the median had an average excess cost per case of $19,273 (+$40,688 for LOS 4 to 7 days above median). Potential cost savings in the study cohort achievable through reducing major complications (by 10%) and LOS (by 1 to 3 days) were greatest for the Norwood operation ($7,944,128 and $3,929,351, respectively) and several other commonly performed operations of more moderate complexity. CONCLUSIONS: Complications and prolonged LOS after congenital heart surgery are associated with significant costs. Initiatives able to achieve even modest reductions in these morbidities may lead to both improved outcomes and cost savings across both moderate and high complexity operations.

Congenital heart operations performed in the first year of life: does geographic variation exist?

BACKGROUND: Geographic variations associated with surgical intervention for congenital heart disease are ill defined. This study uses a large clinical registry to assess frequency of surgical intervention for various infant congenital heart diseases overall and across US geographic regions. METHODS: Patients younger than 1 year of age in the Society of Thoracic Surgeons Congenital Heart Surgery Database (January 2010 through June 2012) were included. Index operations were classified on the basis of seven major diagnostic groups and 10 specific diagnoses and were compared across geographic regions using a χ(2) test. Region was defined by patient residence. RESULTS: The study included 23,379 patients (94 centers). Septal defects (26.2%) were the most frequently reported diagnostic group, and tetralogy of Fallot (10.6%) was the most frequent specific diagnosis. Significant geographic variation was noted for all seven major diagnostic groups. The proportion of patients undergoing surgery for septal defects varied from 23.9% to 30.2% (p = 0.001); pulmonary venous anomalies, 2.8% to 4.5% (p = 0.03); right heart lesions, 15.7% to 21.4% (p < 0.0001); left heart lesions, 22.7% to 30.4% (p = 0.0002); single-ventricle lesions, 7.3% to 11.4% (p < 0.0001); transposition of the great arteries and double-outlet right ventricle, 9.0% to 15.3% (p < 0.0001); and coronary artery anomalies, 0.4% to 1.4% (p = 0.04). Significant regional variation was also observed for 7 of the 10 specific diagnoses examined. CONCLUSIONS: These data demonstrate significant variation in congenital heart disease diagnostic groups requiring surgery before 1 year of age across US geographic regions.

The Impact of Differential Case Ascertainment in Clinical Registry Versus Administrative Data on Assessment of Resource Utilization in Pediatric Heart Surgery.

BACKGROUND: Resource utilization in congenital heart surgery is typically assessed using administrative data sets. Recent analyses have called into question the accuracy of coding of cases in administrative data; however, it is unclear whether miscoding impacts assessment of associated resource use. METHODS: We merged data coded within both an administrative data set and clinical registry on children undergoing heart surgery (2004-2010) at 33 hospitals. The impact of differences in coding of operations between data sets on reporting of postoperative length of stay (PLOS) and total hospital costs associated with these operations was assessed. RESULTS: For each of the eight operations of varying complexity evaluated (total n = 57,797), there were differences in coding between data sets, which translated into differences in the reporting of associated resource utilization for the cases coded in either data set. There were statistically significant differences in PLOS and cost for seven of the eight operations, although most PLOS differences were relatively small with the exception of the Norwood operation and truncus repair (differences of two days, P < .001). For cost, there was a >5% difference for three of the eight operations and >10% difference for truncus repair (US$10,570; P < .01). Grouping of operations into categories of similar risk appeared to mitigate many of these differences. CONCLUSION: Differences in coding of cases in administrative versus clinical registry data can translate into differences in assessment of associated PLOS and cost for certain operations. This may be minimized through evaluating larger groups of operations when using administrative data or using clinical registry data to accurately identify operations of interest.

Survey of nongovernmental organizations providing pediatric cardiovascular care in low- and middle-income countries.

BACKGROUND: Nearly 90% of the children with heart disease in low- and middle-income countries (LMICs) cannot access cardiovascular (CV) services. Limitations include inadequate financial, human, and infrastructure resources. Nongovernmental organizations (NGOs) have played crucial roles in providing clinical services and infrastructure supports to LMICs CV programs; however, these outreach efforts are dispersed, inadequate, and lack coordination. METHODS: A survey was sent to members of the World Society for Pediatric and Congenital Heart Society and PediHeart. RESULTS: A clearinghouse was created to provide information on NGO structures, geographic reach, and scope of services. The survey identified 80 NGOs supporting CV programs in 92 LMICs. The largest outreach efforts were in South and Central America (42%), followed by Africa (18%), Europe (17%), Asia (17%), and Asia-Western Pacific (6%). Most NGOs (51%) supported two to five outreach missions per year. The majority (87%) of NGOs provided education, diagnostics, and surgical or catheter-based interventions. Working jointly with LMIC partners, 59% of the NGOs performed operations in children and infants; 41% performed nonbypass neonatal operations. Approximately a quarter (26%) reported that partner sites do not perform interventions in between missions. CONCLUSIONS: Disparity and inadequacy in pediatric CV services remain an important problem for LMICs. A global consensus and coordinated efforts are needed to guide strategies on the development of regional centers of excellence, a global outcome database, and a CV program registry. Future efforts should be held accountable for impacts such as growth in the number of independent LMIC programs as well as reduction in mortality and patient waiting lists.

Variation in congenital heart surgery costs across hospitals.

BACKGROUND: A better understanding of costs associated with common and resource-intense conditions such as congenital heart disease has become increasingly important as children's hospitals face growing pressure to both improve quality and reduce costs. We linked clinical information from a large registry with resource utilization data from an administrative data set to describe costs for common congenital cardiac operations and assess variation across hospitals. METHODS: Using linked data from The Society of Thoracic Surgeons and Pediatric Health Information Systems Databases (2006-2010), estimated costs/case for 9 operations of varying complexity were calculated. Between-hospital variation in cost and associated factors were assessed by using Bayesian methods, adjusting for important patient characteristics. RESULTS: Of 12,718 operations (27 hospitals) included, median cost/case increased with operation complexity (atrial septal defect repair, [$25,499] to Norwood operation, [$165,168]). Significant between-hospital variation (up to ninefold) in adjusted cost was observed across operations. Differences in length of stay (LOS) and complication rates explained an average of 28% of between-hospital cost variation. For the Norwood operation, high versus low cost hospitals had an average LOS of 50.8 vs. 31.8 days and a major complication rate of 50% vs. 25.3%. High volume hospitals had lower costs for the most complex operations. CONCLUSIONS: This study establishes benchmarks for hospital costs for common congenital heart operations and demonstrates wide variability across hospitals related in part to differences in LOS and complication rates. These data may be useful in designing initiatives aimed at both improving quality of care and reducing cost.

Differential case ascertainment in clinical registry versus administrative data and impact on outcomes assessment for pediatric cardiac operations.

BACKGROUND: Administrative datasets are often used to assess outcomes and quality of pediatric cardiac programs; however their accuracy regarding case ascertainment is unclear. We linked patient data (2004-2010) from the Society of Thoracic Surgeons Congenital Heart Surgery (STS-CHS) Database (clinical registry) and the Pediatric Health Information Systems (PHIS) database (administrative database) from hospitals participating in both to evaluate differential coding/classification of operations between datasets and subsequent impact on outcomes assessment. METHODS: Eight individual benchmark operations and the Risk Adjustment in Congenital Heart Surgery, version 1 (RACHS-1) categories were evaluated. The primary outcome was in-hospital mortality. RESULTS: The cohort included 59,820 patients from 33 centers. There was a greater than 10% difference in the number of cases identified between data sources for half of the benchmark operations. The negative predictive value (NPV) of the administrative (versus clinical) data was high (98.8%-99.9%); the positive predictive value (PPV) was lower (56.7%-88.0%). Overall agreement between data sources in RACHS-1 category assignment was 68.4%. These differences translated into significant differences in outcomes assessment, ranging from an underestimation of mortality associated with truncus arteriosus repair by 25.7% in the administrative versus clinical data (7.01% versus 9.43%; p = 0.001) to an overestimation of mortality associated with ventricular septal defect (VSD) repair by 31.0% (0.78% versus 0.60%; p = 0.1). For the RACHS-1 categories, these ranged from an underestimation of category 5 mortality by 40.5% to an overestimation of category 2 mortality by 12.1%; these differences were not statistically significant. CONCLUSIONS: This study demonstrates differences in case ascertainment between administrative and clinical registry data for children undergoing cardiac operations, which translated into important differences in outcomes assessment.

Centre variation in cost and outcomes for congenital heart surgery.

Although overall outcomes for children undergoing heart surgery have improved, there is a significant variation in outcomes across hospitals. This review discusses the variation in cost and outcomes across centres performing congenital heart surgery, potential underlying mechanisms, and efforts to reduce variation and improve outcome.

Stratification of complexity improves the utility and accuracy of outcomes analysis in a Multi-Institutional Congenital Heart Surgery Database: Application of the Risk Adjustment in Congenital Heart Surgery (RACHS-1) and Aristotle Systems in the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database.

Quality-of-care evaluation must take into account variations in "ase mix."This study reviewed the application of two case-mix complexity-adjustment tools in the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database: the Aristotle Basic Complexity (ABC) score and the Risk Adjustment in Congenital Heart Surgery (RACHS-1) method. The 2006 STS Congenital Heart Surgery Database Report, the first STS report to incorporate both methods, included 45,635 operations from 47 centers. Each operation was assigned an ABC score in a range from 1.5 (lowest complexity) to 15 (highest complexity), an ABC level in a range from 1 (lowest complexity) to 4 (highest complexity), and a RACHS-1 category in a range from 1 (lowest risk) to 6 (highest risk). The overall discharge mortality was 3.9% (1,222/31,719 eligible cardiac index operations). Of the eligible cardiac index operations, 85.8% (27,202/31,719) were eligible for analysis by the RACHS-1 method, and 94.0% (29,813/31,719) were eligible for analysis by the ABC approach. With both RACHS-1 and ABC, as complexity increases, discharge mortality also ncreases. The ABC approach allows classification of more operations, whereas the RACHS-1 discriminates better at the higher end of complexity. Complexity stratification is a useful method for analyzing the impact of case mix on pediatric cardiac surgical outcomes. Both the RACHS-1 and ABC methods facilitate complexity stratification in the STS database.