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Background: Confounding by indication is a serious threat to comparative studies using real world data. We assessed the utility of automated data-adaptive analytic approach for confounding adjustment when both claims and clinical registry data are available., Methods: We used a comparative study example of carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) in 2005-2008 when CAS was only indicated for patients with high surgical risk. We included Medicare beneficiaries linked to the Society for Vascular Surgery's Vascular Registry >65 years old undergoing CAS/CEA. We compared hazard ratios (HRs) for death while adjusting for confounding by combining various 1) Propensity score (PS) modeling strategies (investigator-specified [IS-PS] vs. automated data-adaptive [ada-PS]); 2) data sources (claims-only, registry-only and claims-plus-registry); and 3) PS adjustment approaches (matching vs. quintiles-adjustment with/without trimming). An HR of 1.0 was used as a benchmark effect estimate based on CREST trial., Results: The cohort included 1,999 CAS and 3,255 CEA patients (mean age 76). CAS patients were more likely symptomatic and at high surgical risk, and experienced higher mortality (crude HR = 1.82 for CAS vs. CEA). HRs from PS-quintile adjustment without trimming were 1.48 and 1.52 for claims-only IS-PS and ada-PS, 1.51 and 1.42 for registry-only IS-PS and ada-PS, and 1.34 and 1.23 for claims-plus-registry IS-PS and ada-PS, respectively. Estimates from other PS adjustment approaches showed similar patterns., Conclusions: In a comparative effectiveness study of CAS vs. CEA with strong confounding by indication, ada-PS performed better than IS-PS in general, but both claims and registry data were needed to adequately control for bias., Competing Interests: HK and HM are affiliated with the department of Healthcare Quality Assessment, University of Tokyo, which is a social collaboration department supported by the National Clinical Database, Johnson & Johnson KK, and Nipro Corporation. HK has received lecture fees from Chugai Pharmaceutical Co., Ltd., Johnson & Johnson KK, and consultancy fees from Mitsubishi Tanabe Pharm and EP Croit Co., Ltd. JJJ is a full-time employee of Regeneron Pharmaceuticals. This study was conducted prior to her employment at the company. SS has served as a member of the US FDA advisory committee and as a consultant for Pfizer Inc., Medtronic, and Merck. SS has also received research funding from the National Institutes of Health, the Cystic Fibrosis Foundation, Pfizer Inc., and Bristol-Myers Squibb. All other authors have no conflicts to declare. The above do not alter our adherence to Plos One policies on sharing data and materials.

Background: International collaboration has an interest in health care quality evaluation. We compared characteristics and surgical outcomes between Asian patients in the United States and Japanese patients who undergo adult cardiac surgery., Methods: Using the Japan Adult Cardiovascular Surgery Database (JCVSD) and The Society of Thoracic Surgeons (STS) National Database, we compared Asian patients undergoing isolated coronary artery bypass graft surgery between 2013 and 2016 in Japan and the United States. The STS had 16,903 Asian patients among 573,823 patients of all races undergoing isolated coronary artery bypass graft surgery (2.95%); the JCVSD had 55,570 patients, almost all of whom are Japanese. Descriptive statistics were analyzed independently, then the data were aggregated for comparison., Results: The JCVSD patients were older (69 vs 65 years) with a smaller body surface area (1.65 m 2 vs 1.81 m 2 ) and body mass index (24 kg/m 2 vs 26 kg/m 2 ). The proportion of males (79% vs 78%), prevalence of chronic lung disease (82% vs 86%), and diabetes mellitus (54% vs 60%) were similar. The JCVSD had higher prevalence of renal disease requiring dialysis (11% vs 6%). The numbers of anastomoses were similar (3.1 vs 3.3); off-pump procedures and the usage of right internal mammary artery were more prevalent (60% vs 15% and 38% vs 7%, respectively) in the JCVSD. The unadjusted operative mortality was 2.7% in the JCVSD and 2.1% in the STS database., Conclusions: Comparisons of coronary artery bypass graft surgery characteristics and outcomes were conducted between the STS National Database and the JCVSD to illustrate the value of international collaboration on adult cardiac surgery databases., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Stratifying patient risk for acute kidney injury (AKI) prior to percutaneous coronary intervention (PCI) can enable clinicians to tailor their approach to minimize AKI. The National Cardiovascular Data Registry (NCDR) CathPCI Registry recently developed 2 prediction models: for AKI and AKI requiring dialysis (AKI-D)., Objectives: This study sought to externally validate the NCDR AKI and AKI-D models in a Japanese population. Determining the generalizability of the U.S. model could support quality improvement efforts in Japan., Methods: The NCDR prediction models were applied to 11,041 consecutive patients in the Japanese multicenter PCI registry. AKI was defined as an absolute increase ≥ 0.3 mg/dl or a relative increase of 50% in serum creatinine, in accordance with the definition of AKI Network criteria; AKI-D was defined as initiation of dialysis after PCI. Discrimination and calibration of the NCDR models were tested in the Japanese cohort. If the model was perfectly calibrated, the slope and intercept would equal 1.0 and 0.0, respectively., Results: In the Japanese PCI cohort, AKI and AKI-D occurred in 10.5% and 1.5% of patients, respectively. The NCDR AKI prediction model showed good discrimination (c-statistic = 0.76) and calibration (slope = 0.93 and intercept = -0.10) in both acute and nonacute PCI. The AKI-D prediction model had good discrimination (c-statistic = 0.92), but while the calibration slope was good (1.04), the intercept was significantly underestimated (0.96). However, this was corrected with recalibration (slope = 1.04 and intercept = -0.087)., Conclusions: In a Japanese population, the NCDR AKI models validly predict post-procedural AKI and, with recalibration, AKI-D. Prospective use of these models to inform clinical decision making should be tested as a means of reducing AKI after PCI in Japan. (Japan Cardiovascular Database, Percutaneous Coronary Intervention Registry; UMIN R000004736)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

International collaboration is important in healthcare quality evaluation; however, few international comparisons of general surgery outcomes have been accomplished. Furthermore, predictive model application for risk stratification has not been internationally evaluated. The National Clinical Database (NCD) in Japan was developed in collaboration with the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), with a goal of creating a standardized surgery database for quality improvement. The study aimed to compare the consistency and impact of risk factors of 3 major gastroenterological surgical procedures in Japan and the United States (US) using web-based prospective data entry systems: right hemicolectomy (RH), low anterior resection (LAR), and pancreaticoduodenectomy (PD).Data from NCD and ACS-NSQIP, collected over 2 years, were examined. Logistic regression models were used for predicting 30-day mortality for both countries. Models were exchanged and evaluated to determine whether the models built for one population were accurate for the other population.We obtained data for 113,980 patients; 50,501 (Japan: 34,638; US: 15,863), 42,770 (Japan: 35,445; US: 7325), and 20,709 (Japan: 15,527; US: 5182) underwent RH, LAR, and, PD, respectively. Thirty-day mortality rates for RH were 0.76% (Japan) and 1.88% (US); rates for LAR were 0.43% versus 1.08%; and rates for PD were 1.35% versus 2.57%. Patient background, comorbidities, and practice style were different between Japan and the US. In the models, the odds ratio for each variable was similar between NCD and ACS-NSQIP. Local risk models could predict mortality using local data, but could not accurately predict mortality using data from other countries.We demonstrated the feasibility and efficacy of the international collaborative research between Japan and the US, but found that local risk models remain essential for quality improvement., Competing Interests: disclosures: The authors report no conflicting financial interests.

Background: Details on Japanese patients undergoing percutaneous coronary intervention (PCI) and how they compare to US patients remain unclear. Furthermore, the application of US risk models has not been evaluated internationally., Methods: The JCD-KiCS, a multicenter registry of consecutive PCI patients, was launched in 2008, with variables defined in accordance with the US NCDR. Patient and procedural characteristics from patients enrolled from 2008 to 2010 in the JCD-KiCS database (n = 9,941) and those in the NCDR (n = 732,345) were compared. The primary outcomes of this analysis were the hospital-level all-cause mortality and bleeding complications. The NCDR risk models for these 2 outcomes were evaluated in the Japanese data set; from the expected mortality and bleeding rates, the observed/expected ratios were calculated., Results: The Japanese patients were older, with a higher proportion of men, diabetes, and smoking than the US patients. The Japanese patients also had a higher rate of complex lesions (26.1 vs 12.7% for bifurcation and 6.2% vs 3.2% for chronic total occlusions, all P < .001), longer procedure time (29.7 ± 21.5 vs 14.4 ± 11.5 minutes, P < .001), and higher mortality (1.6% vs 0.9%, P < .001) and bleeding rates (2.9% vs 1.8%, P < .001) compared with US patients. The observed/expected ratios for mortality and bleeding were 0.921 and 0.467, respectively, in Japanese patients, and 1.002 and 0.981, respectively, for US patients., Conclusions: The characteristics of patients undergoing PCI in clinical practice in Japan and the US differ substantially. The NCDR risk models applied well in Japanese patients for prediction of mortality, but not for bleeding, which tended to underestimate the risk., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Appropriateness use criteria (AUC) are widely used to assess quality of care. American professional organizations and Japanese experts have both developed original AUC for percutaneous coronary intervention (PCI). However, rating discrepancies have not been investigated., Methods: Patients registered in the Japanese multicenter PCI registry were analyzed. We assessed the appropriateness of PCI based on both the US and Japanese criteria and compared the ratings. A logistic regression analysis was performed to identify clinical predictors of inappropriate ratings under both standards., Results: From a total of 4,950 nonacute, consecutive PCIs, 1,982 and 2,077 procedures could be successfully rated using the US and Japanese criteria, respectively. The major difference between the 2 criteria was the rating of "asymptomatic, low- or intermediate-risk patients, no lesion in the proximal left anterior descending coronary artery (PLAD)"; this scenario was deemed appropriate in the Japanese but not in the US criteria. As a consequence, the rate of inappropriate PCI using the Japanese criteria (5.2%) was substantially lower when compared with the rating using the US criteria (15%). Common clinical variables associated with "inappropriate" PCI were male, multivessel diseases, and lesions in the non-PLAD. Suboptimal antianginal medication was also a significant predictor of inappropriate PCI under the US but not under the Japanese criteria., Conclusions: Significant and clinically relevant rating discrepancies were observed between the US and Japanese criteria-based assessments, owing largely to the ratings of asymptomatic, non-PLAD-related, low- or intermediate-risk cases., (Copyright © 2014 Elsevier Inc. All rights reserved.)