Successful Linking of The Society of Thoracic Surgeons Adult Cardiac Surgery Database to Centers for Medicare and Medicaid Services Medicare Data

Jacobs, Jeffrey P.; Edwards, Fred H.; Shahian, David M.; Haan, Constance K.; Puskas, John D.; Morales, David L.S.; Gammie, James S.; Sánchez, Juan A.; Brennan, James M.; O’Brien, Sean M.; Dokholyan, Rachel S.; Hammill, Bradley G.; Curtis, Lesley H.; Peterson, Eric D.; Badhwar, Vinay; George, Kristopher M.; Mayer, John E.; Chitwood, W. Randolph; Murray, Gordon F.; Grover, Frederick L.

doi:10.1016/j.athoracsur.2010.05.042

Cited by 149 publications

(110 citation statements)

References 8 publications

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“…Although new national and international registries of patients who are at risk for or experience AKI would be ideal to construct, the cost and time needed are probably prohibitive for providing short-term insights needed for current trial planning. Multiple data sources could be leveraged to inform clinical trial planning for selected AKI prevention and treatment populations (Table 2) (19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34). Depending on the data source, insights into the likely proportion of eligible patients as well as preliminary outcome rates at different follow-up times would be available to assist in sample size and power calculations.…”

Section: Power and Sample Size Issuesmentioning

confidence: 99%

Design of Clinical Trials in Acute Kidney Injury

Palevsky

Molitoris²,

Okusa³

et al. 2012

Clinical Journal of the American Society of Nephrology

132

121

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SummaryAcute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration, masking of therapeutic benefit by adverse events, and inadequate sample size. To address issues of clinical trial design, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a workshop titled "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" in December 2010. Workshop participants included representatives from academia, industry, and government agencies whose areas of expertise spanned basic science, clinical nephrology, critical care medicine, biostatistics, pharmacology, and drug development. This document summarizes the discussions of collaborative workgroups that addressed issues related to patient selection, study endpoints, the role of novel biomarkers, sample size and power calculations, and adverse events and pilot/feasibility studies in prevention and treatment of AKI. Companion articles outline the discussions of workgroups for model trials related to prevention or treatment of established AKI in different clinical settings, such as in patients with sepsis.

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Section: Power and Sample Size Issuesmentioning

confidence: 99%

Design of Clinical Trials in Acute Kidney Injury

Palevsky

Molitoris²,

Okusa³

et al. 2012

Clinical Journal of the American Society of Nephrology

132

121

View full text Add to dashboard Cite

show abstract

“…However, it has still been important to quantify the completeness of the STS database as representative of cardiac surgery care in the US. To that end, the STS linked successfully with the Centers for Medicare and Medicaid Services (CMS) Medicare database and demonstrated high and increasing penetration and completeness of the STS database [75]. In addition, this linkage should facilitate studying long-term outcomes of cardiothoracic surgery.…”

Section: Linkage Of Databasesmentioning

confidence: 99%

Risk Prediction and Outcome Analysis

Haan¹

2012

Current Concepts in General Thoracic Surgery

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“…Similarly, models using European databases focus on predictors of short-term events such as in-hospital mortality (11,12). Recent work by Fernandez and colleagues (7) linked the GTSD to Centers for Medicare and Medicaid Services data (22) to allow longitudinal follow up of over 37,000 lung cancer operations performed on patients age 65 years and older in the United States between 2002 and 2012. The authors report the median survival following resection for patients with pathologic stage I disease was 6.7 years.…”

Section: Editorialmentioning

confidence: 99%