David M Shahian

Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States

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Publications (211)

  • [Show abstract] [Hide abstract] ABSTRACT: The Society of Thoracic Surgeons Adult Cardiac Database (ACSD) is an international voluntary effort that is the foundation of our specialty's efforts in clinical performance assessment and quality improvement. Containing nearly 6,000,000 patient records, the ACSD is a robust resource for clinical research. Seven major original publications and four review articles were generated from the ACSD in 2015. The risk-adjusted outcome analyses and quality measures reported in these studies have made substantial contributions to inform daily clinical practice. This report summarizes the ACSD-based research efforts published in 2015.
    Article · Jun 2016 · The Annals of thoracic surgery
  • Fred H. Edwards · Victor A. Ferraris · Paul A. Kurlansky · [...] · David M. Shahian
    [Show abstract] [Hide abstract] ABSTRACT: Background: Failure to rescue (FTR) is increasingly recognized as an important quality indicator in surgery. The Society of Thoracic Surgeons National Database was used to develop FTR metrics and a predictive FTR model for coronary artery bypass grafting (CABG). Methods: The study included 604,154 patients undergoing isolated CABG at 1,105 centers from January 2010 to January 2014. FTR was defined as death after four complications: stroke, renal failure, reoperation, and prolonged ventilation. FTR was determined for each complication and a composite of the four complications. A statistical model to predict FTR was developed. Results: FTR rates were 22.3% for renal failure, 16.4% for stroke, 12.4% for reoperation, 12.1% for prolonged ventilation, and 10.5% for the composite. Mortality increased with multiple complications and with specific combinations of complications. The multivariate risk model for prediction of FTR demonstrated a C index of 0.792 and was well calibrated, with a 1.0% average difference between observed/expected (O/E) FTR rates. With centers grouped into mortality terciles, complication rates increased modestly (11.4% to 15.7%), but FTR rates more than doubled (6.8% to 13.9%) from the lowest to highest terciles. Centers in the lowest complication rate tercile had an FTR O/E of 1.14, whereas centers in the highest complication rate tercile had an FTR O/E of 0.91. Conclusions: CABG mortality rates vary directly with FTR, but complication rates have little relation to death. FTR rates derived from The Society of Thoracic Surgeons data can serve as national benchmarks. Predicted FTR rates may facilitate patient counseling, and FTR O/E ratios have promise as valuable quality metrics.
    Article · Jun 2016 · The Annals of thoracic surgery
  • [Show abstract] [Hide abstract] ABSTRACT: Importance Prediction of operative risk is a critical step in decision making for cardiac surgery. Existing risk models may be improved by integrating a measure of frailty, such as 5-m gait speed, to better capture the heterogeneity of the older adult population. Objective To determine the association of 5-m gait speed with operative mortality and morbidity in older adults undergoing cardiac surgery. Design, Setting, and Participants A prospective cohort study was conducted from July 1, 2011, to March 31, 2014, at 109 centers participating in the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The 5-m gait speed test was performed in 15 171 patients aged 60 years or older undergoing coronary artery bypass graft, aortic valve surgery, mitral valve surgery, or combined procedures. Main Outcomes and Measures All-cause mortality during the first 30 days after surgery; secondarily, a composite outcome of mortality or major morbidity during the index hospitalization. Results Among the cohort of 15 171 patients undergoing cardiac surgery, the median age was 71 years and 4622 were female (30.5%). Compared with patients in the fastest gait speed tertile (>1.00 m/s), operative mortality was increased for those in the middle tertile (0.83-1.00 m/s; odds ratio [OR], 1.77; 95% CI, 1.34-2.34) and slowest tertile (<0.83 m/s; OR, 3.16; 95% CI, 2.31-4.33). After adjusting for the Society of Thoracic Surgeons predicted risk of mortality and the surgical procedure, gait speed remained independently predictive of operative mortality (OR, 1.11 per 0.1-m/s decrease in gait speed; 95% CI, 1.07-1.16). Gait speed was also predictive of the composite outcome of mortality or major morbidity (OR, 1.03 per 0.1-m/s decrease in gait speed; 95% CI, 1.00-1.05). Addition of gait speed to the Society of Thoracic Surgeons predicted risk resulted in a C statistic change of 0.005 and integrated discrimination improvement of 0.003. Conclusions and Relevance Gait speed is an independent predictor of adverse outcomes after cardiac surgery, with each 0.1-m/s decrease conferring an 11% relative increase in mortality. Gait speed can be used to refine estimates of operative risk, to support decision-making and, since incremental value is modest when used as a sole criterion for frailty, to screen older adults who could benefit from further assessment.
    Article · May 2016 · JAMA Cardiology
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    Full-text Dataset · Mar 2016
  • [Show abstract] [Hide abstract] ABSTRACT: Importance Patient selection for transcatheter aortic valve replacement (TAVR) should include assessment of the risks of TAVR compared with surgical aortic valve replacement (SAVR). Existing SAVR risk models accurately predict the risks for the population undergoing SAVR, but comparable models to predict risk for patients undergoing TAVR are currently not available and should be derived from a population that underwent TAVR.Objective To use a national population of patients undergoing TAVR to develop a statistical model that will predict in-hospital mortality after TAVR.Design, Setting, and Participants Patient data were obtained from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry. The model was developed from 13 718 consecutive US patients undergoing TAVR in centers participating in the STS/ACC TVT Registry from November 1, 2011, to February 28, 2014. Validation was conducted using 6868 records of consecutive patients undergoing TAVR from March 1 to October 8, 2014. Covariates were selected through a process of expert opinion and statistical analysis. The association between in-hospital mortality and baseline covariates was estimated using logistic regression. The final set of predictors was selected via stepwise variable selection. Data were collected and analyzed from November 1, 2011, to February 28, 2014.Main Outcomes and Measures In-hospital TAVR mortality.Results The development sample included 13 718 patient records from 265 participant sites (of 13 672 with data available, 6680 men [48.9%]; 6992 women [51.1%]; mean [SD] age, 82.1 [8.3] years). The final validation cohort included 6868 patients from 314 participating centers (3554 men [51.7%]; 3314 women [48.3%]; mean [SD] age, 81.6 [8.8] years). In-hospital mortality occurred in 730 patients (5.3%). The C statistic for discrimination was 0.67 (95% CI, 0.65-0.69) in the development group and 0.66 (95% CI, 0.62-0.69) in the validation group. The final model covariates (reported as odds ratios; 95% CIs) were age (1.13; 1.06-1.20), glomerular filtration rate per 5-U increments (0.93; 0.91-0.95), hemodialysis (3.25; 2.42-4.37), New York Heart Association functional class IV (1.25; 1.03-1.52), severe chronic lung disease (1.67; 1.35-2.05), nonfemoral access site (1.96; 1.65- 2.33), and procedural acuity categories 2 (1.57; 1.20-2.05), 3 (2.70; 2.05-3.55), and 4 (3.34; 1.59-7.02). Calibration analysis demonstrated no significant difference between the model (predicted vs observed) calibration line (−0.18 and 0.97 for intercept and slope, respectively) compared with the ideal calibration line.Conclusions and Relevance Data from the STS/ACC TVT Registry have been used to develop a predictive model of in-hospital mortality for patients undergoing TAVR. Validation based on a population of patient records not used in model development demonstrates discrimination and calibration indices that are more favorable than other models used in populations with TAVR. This model should be a valuable adjunct for patient counseling, local quality improvement, and national monitoring for appropriateness of selection of patients for TAVR.
    Article · Mar 2016 · JAMA Cardiology
  • Jeffrey Bruckel · Xiu Liu · Samuel F Hohmann · [...] · David M Shahian
    [Show abstract] [Hide abstract] ABSTRACT: Background: National Hospital Quality Measures (NHQM) should accurately reflect quality of care, as they increasingly impact reimbursement and reputation. However, similar to risk adjustment of outcomes measures, NHQM process measures pose unique methodological concerns, including lack of representativeness of the final denominator population after exclusions. This study determines population size and characteristics for each acute myocardial infarction (AMI) measure, reasons for exclusion from the measures, and variation in exclusion rates among hospitals. Methods and results: 163 144 discharges from 172 University HealthSystem Consortium hospitals between 2008-Q4 and 2013-Q3 were examined, including characteristics and propensity scores of included and excluded groups. Measure exclusions ranged from 17.8% (discharge aspirin) to 90.1% (percutaneous coronary intervention, PCI, within 90 min), with substantial variation across hospitals. Median annual denominator size (IQR) for PCI within 90 min was 28 (20, 44) at major teaching hospitals, versus 10 (0, 25) at non-teaching hospitals. Patients most likely to be excluded (in the 10th vs 1st propensity decile) were older (mean age (SD) of 78.1 (10.8) vs 50.3 (8.6) years), more likely to have Medicare (90.5% vs 0.9%), had more documented comorbidities (15.6 (4.6) vs 6.2 (2.5) hierarchical clinical condition categories) and higher admission mortality risk (Major or Extreme 80.9% vs 7.3%, respectively), and experienced higher inpatient mortality (10.0% vs 1.6%). Conclusions: Exclusion from AMI measures varied substantially among hospitals, sample sizes were very small for some measures (PCI and ACE inhibitor measures) and measures often excluded high-risk populations. This has implications for the representativeness and comparability of the measures and provides insight for future measure development.
    Article · Mar 2016 · BMJ quality & safety
  • David M. Shahian
    [Show abstract] [Hide abstract] ABSTRACT: Although widely regarded as the leader in clinical registries, quality measurement, and public reporting to advance patient care, the STS is committed to a robust strategic vision that assures this leadership position for years to come, and which strives to provide even more functionality to its participants.
    Article · Mar 2016 · The Annals of thoracic surgery
  • [Show abstract] [Hide abstract] ABSTRACT: The Society of Thoracic Surgeons Congenital Heart Surgery Database is the largest congenital and pediatric cardiac surgical clinical data registry in the world. It is the platform for all activities of The Society of Thoracic Surgeons related to the analysis of outcomes and the improvement of quality in this subspecialty. This article summarizes current aggregate national outcomes in congenital and pediatric cardiac surgery and reviews related activities in the areas of quality measurement, performance improvement, and transparency. The reported data about aggregate national outcomes are exemplified by an analysis of 10 benchmark operations performed from January 2011 to December 2014 and documenting overall discharge mortality (interquartile range among programs with more than 9 cases): off-bypass coarctation, 1.0% (0.0% to 0.9%); ventricular septal defect repair, 0.7% (0.0% to 1.1%); tetralogy of Fallot repair, 1.0% (0.0% to 1.7%); complete atrioventricular canal repair, 3.2% (0.0% to 6.5%); arterial switch operation, 2.7% (0.0% to 5.6%); arterial switch operation plus ventricular septal defect, 5.3% (0.0% to 6.7%); Glenn/hemiFontan, 2.1% (0.0% to 3.8%); Fontan operation, 1.4% (0.0% to 2.4%); truncus arteriosus repair, 9.6% (0.0 % to 11.8%); and Norwood procedure, 15.6% (10.0% to 21.4%).
    Article · Mar 2016 · The Annals of thoracic surgery
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    [Show abstract] [Hide abstract] ABSTRACT: Background: -Surgical risk scores do not include frailty assessments (e.g., gait speed), which are of particular importance for severe aortic stenosis patients considering transcatheter aortic valve replacement (TAVR). Methods and results: -We assessed the association of 5-meter gait speed with outcomes in a cohort of 8039 patients who underwent TAVR (11/2011-06/2014) and were registered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry™ (STS/ACC TVT Registry). We evaluated the association between continuous and categorical gait speed and 30-day all-cause mortality before and after adjustment for STS-predicted risk of mortality score and key variables. Secondary outcomes included in-hospital mortality, bleeding, acute kidney injury, and stroke. The median gait speed was 0.63 m/s (0.47-0.79), with the slowest walkers (<0.5 m/s) constituting 28%, slow walkers (0.5 to 0.83 m/s) 48%, and normal walkers (>0.83 m/s) 24% of the population. Thirty-day all-cause mortality rates were 8.4%, 6.6%, and 5.4% for slowest, slow, and normal walkers, respectively (p<0.001). Each 0.2 m/s decrease in gait speed corresponded to an 11% increase in 30-day mortality (adjusted odds ratio 1.11, 95% confidence interval 1.01-1.22). The slowest walkers had 35% higher 30-day mortality than normal walkers (adjusted odds ratio 1.35, 95% confidence interval 1.01-1.80), significantly longer hospital stays, and a lower probability of being discharged to home. Conclusions: -Gait speed is independently associated with 30-day mortality following TAVR. Identification of frail patients with the slowest gait speeds facilitates pre-procedural evaluation and anticipation of a higher level of post-procedural care. Clinical Trial Registration Information-ClinicalTrials.gov. Identifier: NCT01737528.
    Full-text Article · Feb 2016 · Circulation
  • [Show abstract] [Hide abstract] ABSTRACT: BACKGROUND: The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease.
    Article · Feb 2016
  • [Show abstract] [Hide abstract] ABSTRACT: Background: The Society of Thoracic Surgeons (STS) has developed multidimensional composite quality measures for common cardiac surgery procedures. This first composite measure for general thoracic surgery evaluates STS participant performance for lobectomy in lung cancer patients. Methods: The STS lobectomy composite score is composed of two outcomes: risk-adjusted mortality; and any-or-none, risk-adjusted major complications. General Thoracic Surgery Database data were included from 2011 to 2014 to provide adequate sample size, and 95% Bayesian credible intervals were used to determine "star ratings." The STS participants were also compared with national benchmarks (including non-STS participants) using the National Inpatient Sample. Comparisons of discharge mortality, postoperative length of stay, and percent of stage I lung cancers resected using minimally invasive approaches are not included in star ratings but will be reported to participants in STS feedback reports. Results: The study population included 20,657 lobectomy patients from 231 participating centers. Operative mortality was 1.5%, major complication rate was 9.6%, and median postoperative length of stay was 4 days. Risk-adjusted mortality and major complication rates varied threefold from highest performing (three-star) to lowest performing (one-star) programs. Approximately 5% of participants were one-star, 7% were three-star, and 88% were two-star programs. Conclusions: The STS has developed the first general thoracic surgery quality composite measure to compare programs performing lobectomy for lung cancer. This measure will be used for quality assessment and provider feedback, and will be made available for voluntary public reporting.
    Article · Jan 2016 · The Annals of thoracic surgery
  • David M Shahian · Sharon-Lise T Normand · Mark W Friedberg · [...] · Peter J Pronovost
    Article · Jan 2016 · Annals of surgery
  • David M. Shahian
    Article · Dec 2015 · The Annals of thoracic surgery
  • Vinay Badhwar · J. Scott Rankin · Xia He · [...] · David M. Shahian
    [Show abstract] [Hide abstract] ABSTRACT: Background: The Society of Thoracic Surgeons (STS) Quality Measurement Task Force is developing a portfolio of composite performance measures for the most commonly performed procedures in adult cardiac surgery. We now describe the fourth in this series, the STS composite measure for mitral valve repair/replacement (MVRR). Methods: We examined all patients undergoing isolated MVRR, with or without concomitant performance of tricuspid valve repair, surgical arrhythmia ablation, or repair of atrial septal defect, between July 1, 2011, and June 30, 2014. In this two-domain model, risk-adjusted mortality and any-or-none major morbidity were combined into a composite score using 3 years of STS data and 95% Bayesian credible intervals to estimate composite scores and star ratings. Results: There were 61,201 MVRR patients studied at 867 participant sites. Mitral valve repair was performed in 57.4% (35,114 of 61,201) and mitral valve replacement in 42.6% (26,087 of 61,201). Mortality was 2.9% (1,773 of 61,201), and occurrence of any major morbidity was 17.0% (10,381 of 61,201). The median composite score was 93.2% (interquartile range, 92.3% to 94.2%). Star rating classifications included 23 of 867 (2.6%) 1-star programs (lower-than-expected performance), 795 of 867 (91.7%) 2-star programs (as-expected or average performance), and 49 of 867 (5.7%) 3-star programs (higher-than-expected performance). Conclusions: STS has developed an MVRR composite performance measure that will be used for participant feedback, quality performance assessment and improvement, and voluntary public reporting.
    Article · Dec 2015 · The Annals of thoracic surgery
  • Rajendra H. Mehta · David M. Shahian · Shubin Sheng · [...] · Eric D. Peterson
    [Show abstract] [Hide abstract] ABSTRACT: Background: -Prior studies have reported that blacks undergoing coronary artery bypass surgery (CABG) had worse outcomes than white patients, even after accounting for patient factors. The degree to which clinician-, hospital- and care-factors account for these outcome differences remains unclear. Methods and results: -We evaluated procedural outcomes in 11697 blacks and 136,362 whites undergoing isolated CABG at 663 STS Database participating sites (1/1/2010-6/30/2011) adjusted for patients' clinical and socioeconomic features, hospital and surgeon effects and care processes (internal mammary artery [IMA] graft and perioperative medications use). Relative to whites, blacks undergoing CABG were younger, yet had higher comorbidities and more adverse presenting features. Blacks were also more likely to be treated at hospitals with higher risk-adjusted mortality. The use of IMA was marginally lower in blacks than whites (93.3% vs. 92.2%, p<0.0001). Unadjusted mortality and major morbidity rates were higher in blacks than whites (1.8% vs. 2.5%, p<0.0001) and (13.6% vs. 19.4%, p <0.0001), respectively. These racial differences in outcomes narrowed but still persisted after adjusting for surgeon, hospital and care processes in addition to patient and socioeconomic factors (OR 1.17 [1.00-1.36] and OR 1.26 [1.19-1.34], respectively). Conclusions: -The risks of procedural mortality and morbidity after CABG were higher among black compared with white patients. These differences were in part accounted for by patient comorbidities, socioeconomic status, as well as surgeon, hospital, and care factors as suggested by reduction in the strength of the race-outcomes association. However, black race remained an independent predictor of outcomes even after accounting for these differences.
    Article · Nov 2015 · Circulation
  • Jeffrey P Jacobs · David M Shahian · Xia He · [...] · Frederick L Grover
    [Show abstract] [Hide abstract] ABSTRACT: Background: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) has been successfully linked to the Centers for Medicare and Medicaid (CMS) Medicare database, thereby facilitating comparative effectiveness research and providing information about long-term follow-up and cost. The present study uses this link to determine contemporary completeness, penetration, and representativeness of the STS ACSD. Methods: Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft (CABG) surgery hospitalizations discharged between 2000 and 2012, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. Results: Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number of CMS CABG sites) increased from 45% in 2000 to 90% in 2012. In 2012, 973 of 1,081 CMS CABG sites (90%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% in 2000 to 94% in 2012. In 2012, 71,634 of 76,072 CMS CABG hospitalizations (94%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. Conclusions: Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data facilitates studying long-term outcomes and costs of cardiothoracic surgery.
    Article · Nov 2015 · The Annals of thoracic surgery
  • Richard S. D’Agostino · Jeffrey P. Jacobs · Vinay Badhwar · [...] · David M. Shahian
    [Show abstract] [Hide abstract] ABSTRACT: The Society of Thoracic Surgeons Adult Cardiac Database is one of the longest-standing, largest, and most highly regarded clinical data registries in health care. It serves as the foundation for all quality measurement and improvement activities of The Society of Thoracic Surgeons. This report summarizes current aggregate national outcomes in adult cardiac surgery and reviews database-related activities in the areas of quality measurement and performance improvement.
    Article · Nov 2015 · The Annals of thoracic surgery
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    [Show abstract] [Hide abstract] ABSTRACT: Background: The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. Objectives: This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. Methods: The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Results: Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. Conclusions: The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.
    Full-text Article · Nov 2015 · Journal of the American College of Cardiology
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    [Show abstract] [Hide abstract] ABSTRACT: Background-Risk prediction is a critical step in patient selection for aortic valve replacement (AVR), yet existing risk scores incorporate very few echocardiographic parameters. We sought to evaluate the incremental predictive value of a complete echocardiogram to identify high-risk surgical candidates before AVR. Methods and Results-A cohort of patients with severe aortic stenosis undergoing surgical AVR with or without coronary bypass was assembled at 2 tertiary centers. Preoperative echocardiograms were reviewed by independent observers to quantify chamber size/function and valve function. Patient databases were queried to extract clinical data. The cohort consisted of 432 patients with a mean age of 73.5 years and 38.7% females. Multivariable logistic regression revealed 3 echocardiographic predictors of in-hospital mortality or major morbidity: E/e' ratio reflective of elevated left ventricular (LV) filling pressure; myocardial performance index reflective of right ventricular (RV) dysfunction; and small LV end-diastolic cavity size. Addition of these echocardiographic parameters to the STS risk score led to an integrated discrimination improvement of 4.1% (P<0.0001). After a median follow-up of 2 years, Cox regression revealed 5 echocardiographic predictors of all-cause mortality: small LV end-diastolic cavity size; LV mass index; mitral regurgitation grade; right atrial area index; and mean aortic gradient <40 mm Hg. Conclusions-Echocardiographic measures of LV diastolic dysfunction and RV performance add incremental value to the STS risk score and should be integrated in prediction when evaluating the risk of AVR. In addition, findings of small hypertrophied LV cavities and/or low mean aortic gradients confer a higher risk of 2-year mortality.
    Full-text Article · Oct 2015 · Journal of the American Heart Association
  • Deepak L Bhatt · Joseph P Drozda · David M Shahian · [...] · Karl F Welke
    [Show abstract] [Hide abstract] ABSTRACT: The futures of registries and performance measurement are intertwined. Theworldwide role of registries as tools to capture and analyze data will increase, and the parallel demand for performance measures will result in preferential use of these data because they are more credible and widely accepted than other sources and can be more fully risk adjusted. The nexus of clinical registries and performance measures will become even more important as risk-adjusted outcomes data are used for high-stakes applications, such as public report cards, preferred provider networks, and reimbursement. When feasible, limitations of clinical registries, such as their data collection burden, must be mitigated by automatic extraction of some data elements from EHRs. This will be possible only for those variables for which the integrity of clinical registry content will not be compromised by automatic EHR data extraction. Similarly, the value of clinical registries, the data of which historically have been limited to short-term outcomes, will be enhanced through linkages with other data sources, such as claims data. Sources such as claims data can provide information on long-term outcomes, resource use, rehospitalizations, and reinterventions. These linkages will require methods for identifying patients across data sources. Also needed is clarification by the federal government of Common Rule and Health Insurance Portability and Accountability Act regulations, because lack of clarity in these rules sometimes dissuades providers from submitting data. By measuring and reporting registry performance to clinicians, individual sites, and integrated healthcare networks, as well as publicly reporting when appropriate, registries will be able to influence care profoundly. This will include iterative changes occurring as a result of routine, nationally benchmarked feedback reports, as well as randomized clinical trials embedded into ongoing registries, such as the TASTE (Thrombus Aspiration in ST-Elevation myocardial infarction) trial, which was performed in the Swedish Coronary Angiography and Angioplasty Registry (31,32), and the SAFE PCI for Women (Study of Access Site for Enhancement of PCI for Women) study, which used the NCDR's CathPCI Registry (114). Measuring and reporting registry performance data would facilitate the empirical determination of specific process-improvement strategies that result in improved patient-centered outcomes. As clinical registries cover progressively more of the healthcare landscape and are supplemented by additional data from EHRs, claims databases, and other data sources (e.g., industry databases, patient-reported information from personal health records and websites ["big data"]), we will benefit from insights into real-world practice that have not yet been possible, ultimately improving healthcare delivery and patient outcomes.
    Article · Oct 2015 · Journal of the American College of Cardiology

Publication Stats

9k Citations


  • 2013
    • Children's Hospitals and Clinics of Minnesota
      Minneapolis, Minnesota, United States
  • 2010
    • FACC Aerostructures Engines & Nacelles Interiors
      Neuhofen, Lower Austria, Austria
  • 2001-2009
    • Massachusetts General Hospital
      • • Department of Surgery
      • • Division of Cardiac Surgery
      Boston, Massachusetts, United States
  • 2007
    • Harvard University
      Cambridge, Massachusetts, United States
  • 2004
    • University of Alabama at Birmingham
      Birmingham, Alabama, United States
  • 1987-2001
    • Lahey Hospital and Medical Center
      Burlington, Massachusetts, United States
  • 1984-1986
    • Harvard Medical School
      Boston, Massachusetts, United States