The Safety of Outpatient Health Care : Review of Electronic Health Records.

BACKGROUND: Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. OBJECTIVE: To measure AEs in the outpatient setting. DESIGN: Retrospective review of the electronic health record (EHR). SETTING: 11 outpatient sites in Massachusetts in 2018. PATIENTS: 3103 patients who received outpatient care. MEASUREMENTS: Using a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites. RESULTS: The 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care-associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, -0.05 [CI, -0.09 to -0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially. LIMITATION: Retrospective EHR review may miss AEs. CONCLUSION: Outpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed. PRIMARY FUNDING SOURCE: Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.

Outcomes of Isolated Tricuspid Valve Surgery: A Society of Thoracic Surgeons Analysis and Risk Model.

BACKGROUND: To provide patients and surgeons with clinically relevant information, the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD) was queried to develop a risk model for isolated tricuspid valve (TV) operations. METHODS: All patients in the STS-ACSD undergoing isolated TV repair or replacement (N=13,587; age 48.3±18.4 years) were identified (7/2017-6/2023). Multivariable logistic regression accounting for TV replacement versus repair was used to model eight operative outcomes: mortality, morbidity and/or mortality, stroke, renal failure, reoperation, prolonged ventilation, short and prolonged hospital stay. Model discrimination (C-statistic) and calibration were assessed using 9-fold cross-validation. RESULTS: The isolated TV study population included 41.1% repairs (N=5,583; age 52.6±18.1 years) and 58.9% replacements (N=8,004; age 45.3±18.0 years). Overall predicted risk of operative mortality was 5.6%, similar in repairs and replacements (5.5% and 5.7%, respectively); as was the predicted risk of composite morbidity and mortality (28.2% and 26.8%). Replacements were generally younger patients with a higher endocarditis prevalence than repairs (45.7% vs. 21.1%). The model yielded a C-statistic of 0.81 for mortality and 0.76 for the composite of morbidity and mortality, with excellent observed-to-expected calibration that was comparable in all sub-cohorts and predicted risk decile groups. CONCLUSIONS: A new STS risk model has been developed for isolated TV surgery. The current mortality of isolated TV operations is lower than previously observed. This risk prediction model and these contemporary outcomes provide a new benchmark for current and future isolated TV interventions.

Association Between Past and Present Operative Mortality in Congenital Heart Surgery: An Analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

BACKGROUND: Mortality after congenital heart surgery is an important metric across benchmarking, quality, and reporting initiatives. All rely on estimates from prior years, and how well these reflect current outcomes is unclear. METHODS: Index operations from The Society of Thoracic Surgeons Congenital Database (2014-2019) were included. Adjusted operative mortality in "past" 4-year and 1-year intervals vs the most recent year ("present") was evaluated using Bayesian hierarchical logistic regression with results presented as odds ratios and 95% credible intervals (CrI). RESULTS: Among 115,699 operations (106 hospitals), overall present observed mortality was 2.5%. Regression to the mean was evident, and individual hospital's present vs past adjusted mortality were only weakly correlated (-0.11 vs past 1-year data, 0.22 vs past 4-year data). A significant relationship was found between past and present mortality only for the group of hospitals in the highest mortality quartile, most prominent for past 4-year data (adjusted odds ratio vs lowest mortality quartile, 2.04; 95% CrI, 1.44-2.80). The proportion of present hospital mortality variation explained by past mortality quartile was 52% (95% CrI, 20%-90%) using past 4-year data and only 27% (95% CrI, 92%-83%) using past 1-year data. Overall 66% of hospitals changed mortality quartiles from past to present (30% by ≥2 quartiles). CONCLUSIONS: Past mortality relates to present primarily for groups of hospitals at the extremes, with past 4-year data more informative than past 1-year data. For individual hospitals, past may differ from present, regression to the mean is common, and many change quartiles. Past mortality should be used thoughtfully and not as the sole factor informing present decision making.

Long-Term Sustainability and Adaptation of I-PASS Handovers.

BACKGROUND: Inadequate communication during transitions of care is a major health care quality and safety vulnerability. In 2013 Massachusetts General Hospital (MGH) embarked on a comprehensive training program using a standardized handover system (I-PASS) that had been shown to reduce adverse events by 30% even when not completely executed on each patient. In this cross-sectional study, the authors sought to characterize handover practices six years later. METHODS: Using a standardized interview tool, the researchers evaluated handovers between responding clinicians in 10 departments and then validated these findings through direct observations, allowing for flexibility and customization in the I-PASS elements. The study qualitatively compared I-PASS element use in verbal handovers to MGH early postintervention data, as well as verbal and written handovers with the I-PASS Study Group's postintervention results. RESULTS: The authors observed 156 verbal and reviewed 182 written patient handovers. Ninety percent of departments adhered at least partially to the I-PASS system. Average handover duration ranged from 0.6 to 2.1 minutes per established patient. The service with best I-PASS adherence also consistently included the most information per unit of time. Acknowledging substantial differences in study technique, MGH adherence was, on average, comparable or better on all I-PASS elements in verbal handovers and on three of four elements of written handovers compared with the I-PASS Study Group's postintervention results. CONCLUSION: Although uptake has varied across services, six years after hospitalwide implementation of I-PASS, the majority of services are performing structured and sequenced handovers, most of which include some elements of the I-PASS system. Those services with the best I-PASS adherence conducted the most efficient handovers.

Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US.

Importance: Professional societies and the Centers for Medicare & Medicaid Services suggest volume thresholds to ensure quality in transcatheter aortic valve implantation (TAVI). Objective: To model the association of volume thresholds vs spoke-and-hub implementation of outcome thresholds with TAVI outcomes and geographic access. Design, Setting, and Participants: This cohort study included patients who enrolled in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Site volume and outcomes were determined from a baseline cohort of adults undergoing TAVI between July 1, 2017, and June 30, 2020. Exposures: Within each hospital referral region, TAVI sites were categorized by volume (<50 or ≥50 TAVIs per year) and separately by risk-adjusted outcome on the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy 30-day TAVI composite during the baseline period (July 2017 to June 2020). Outcomes of patients undergoing TAVIs from July 1, 2020, to March 31, 2022, were then modeled as though the patients had been treated at (1) the nearest higher volume (≥50 TAVIs per year) or (2) the best outcome site within the hospital referral region. Main Outcomes and Measures: The primary outcome was the absolute difference in events between the adjusted observed and modeled 30-day composite of death, stroke, major bleeding, stage III acute kidney injury, and paravalvular leak. Data are presented as the number of events reduced under the above scenarios with 95% bayesian credible intervals (CrIs) and median (IQR) driving distance. Results: The overall cohort included 166 248 patients with a mean (SD) age of 79.5 (8.6) years; 74 699 (47.3%) were female and 6657 (4.2%) were Black; 158 025 (95%) were treated in higher-volume sites (≥50 TAVIs) and 75 088 (45%) were treated in best-outcome sites. Modeling a volume threshold, there was no significant reduction in estimated adverse events (-34; 95% CrI, -75 to 8), while the median (IQR) driving time from the existing site to the alternate site was 22 (15-66) minutes. Transitioning care to the best outcome site in a hospital referral region resulted in an estimated 1261 fewer adverse outcomes (95% CrI, 1013-1500), while the median (IQR) driving time from the original site to the best site was 23 (15-41) minutes. Directionally similar findings were observed for Black individuals, Hispanic individuals, and individuals from rural areas. Conclusions and Relevance: In this study, compared with the current system of care, a modeled outcome-based spoke-and-hub paradigm of TAVI care improved national outcomes to a greater extent than a simulated volume threshold, at the cost of increased driving time. To improve quality while maintaining geographic access, efforts should focus on reducing site variation in outcomes.

Risk of Surgical Mitral Valve Repair for Primary Mitral Regurgitation.

BACKGROUND: Risk estimation for surgical intervention is an essential component of heart team shared decision-making. However, current mitral valve (MV) surgery risk models used in practice lack etiologic or procedural specificity. OBJECTIVES: The purpose of this study was to establish a comprehensive method for assessment of operative risk of MV repair of primary mitral regurgitation (MR). METHODS: A novel etiology and procedure-specific algorithm identified 53,462 consecutive (July 2014 to June 2020) intention-to-treat MV repair patients with primary MR from The Society of Thoracic Surgeons Adult Cardiac Surgery Database. Risk models were fit for 30-day operative mortality, mortality and/or major morbidity, and conversion-to-replacement (CONV). As-treated mortality and morbidity models were derived separately. RESULTS: Event rates for mortality (n = 619; 1.16%), mortality plus morbidity (n = 4,746; 8.88%), and CONV (n = 3,399; 6.36%) were low. Mortality was higher in CONV patients vs repair (3.18% vs 1.02%). All event rates were lower with increasing program volumes. The mortality risk model had excellent discrimination (AUC: 0.807) and calibration and confirmed very low mortality risk for isolated MV repair for primary MR, with mean mortality risk of 1.16% and median of 0.55% (IQR: 0.30%-1.17%) with 90th and 95th percentiles 2.48% and 3.99%, respectively. The mortality risk was <0.5% in patients <65 years of age, with 97% of the total population across age groups having a risk of <3%. Only 1 in 4 patients age 75 or older had >3% estimated risk of mortality. CONCLUSIONS: This etiologic and procedure-specific risk model establishes that the contemporary mortality risk of MV repair for primary MR is <1% for the vast majority of patients.

Risk of Surgical Mitral Valve Repair for Primary Mitral Regurgitation.

BACKGROUND: Risk estimation for surgical intervention is an essential component of heart team shared decision-making. However, current mitral valve (MV) surgery risk models used in practice lack etiologic or procedural specificity. The purpose of this study was to establish a comprehensive method for assessment of operative risk of MV repair of primary mitral regurgitation (MR). METHODS: A novel etiology and procedure-specific algorithm identified 53,462 consecutive (July 2014 to June 2020) intention-to-treat MV repair patients with primary MR from The Society of Thoracic Surgeons Adult Cardiac Surgery Database. Risk models were fit for 30-day operative mortality, mortality and/or major morbidity, and conversion-to-replacement (CONV). As-treated mortality and morbidity models were derived separately. RESULTS: Event rates for mortality (n = 619; 1.16%), mortality plus morbidity (n = 4746; 8.88%), and CONV (n = 3399; 6.36%) were low. Mortality was higher in CONV patients vs repair (3.18% vs 1.02%). All event rates were lower with increasing program volumes. The mortality risk model had excellent discrimination (AUC: 0.807) and calibration and confirmed very low mortality risk for isolated MV repair for primary MR, with mean mortality risk of 1.16% and median of 0.55% (interquartile range: 0.30%-1.17%) with 90th and 95th percentiles 2.48% and 3.99%, respectively. The mortality risk was <0.5% in patients <65 years of age, with 97% of the total population across age groups having a risk of <3%. Only 1 in 4 patients age 75 or older had >3% estimated risk of mortality. CONCLUSIONS: This etiologic and procedure-specific risk model establishes that the contemporary mortality risk of MV repair for primary MR is <1% for the vast majority of patients.

The Safety of Inpatient Health Care.

BACKGROUND: Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. METHODS: We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. RESULTS: In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). CONCLUSIONS: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Development of a Novel Society of Thoracic Surgeons Adult Congenital Mortality Risk Model.

BACKGROUND: Operative mortality risk models for adults with congenital heart disease (ACHD) undergoing cardiac operations are essential, given the growing population of these patients, yet they are currently unavailable. Existing adult Society of Thoracic Surgeons (STS) models exclude congenital procedures, whereas existing congenital models exclude operations for acquired disease. We aimed to develop an STS mortality risk model for ACHD patients undergoing cardiac operations. METHODS: Leveraging a comprehensive list of diagnostic and procedure codes, ACHD patients who underwent cardiac operations were identified from the STS Adult Cardiac Surgery Database (versions: v2.73, v2.81, and v2.9) between 2011 and 2019. The model was developed and validated in the ACHD population using a 60/40 development/validation split. Univariate analyses and clinical expertise informed the addition of ACHD-relevant procedure and diagnosis variables to existing STS adult risk model variables. Model performance was assessed overall and in 38 subgroups based on patient demographics, procedures, and diagnoses. RESULTS: Forty-seven procedure and diagnosis variables relevant to ACHD were added to existing STS adult risk model variables. The derived ACHD model for operative mortality was well calibrated within demographic, procedural, and diagnosis subgroups and the overall ACHD population, and discrimination in the validation cohort was excellent (C statistic, 0.815) compared with the model using only existing STS adult risk model variables (C statistic, 0.79; P < .0001). CONCLUSIONS: A novel, high-performing STS ACHD mortality risk model has been developed on the basis of contemporary patient data. The ACHD risk model represents an important expansion of the STS portfolio. Implementation with an online risk calculator is planned.

Volume-Outcome Relationship of Resternotomy Coronary Artery Bypass Grafting.

BACKGROUND: We assessed volume-outcome relationships of resternotomy coronary artery bypass grafting (CABG). METHODS: We studied 1,362,218 first-time CABG and 93,985 resternotomy CABG patients reported to The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2010 and 2019. Primary outcomes were in-hospital mortality and mortality and morbidity (M&M) rates calculated per hospital and per surgeon. Outcomes were compared across 6 total cardiac surgery volume categories. Multivariable generalized linear mixed-effects models were used considering continuous case volume as the main exposure, adjusting for patient characteristics and within-surgeon and hospital variation. RESULTS: We observed a decline in resternotomy CABG unadjusted mortality and M&M from the lowest to the highest case-volume categories (hospital-level mortality, 3.9% ± 0.6% to 3.3% ± 0.1%; M&M, 18.5% ± 1.1% to 15.7% ± 0.4%, P < .001; surgeon-level mortality, 4.1% ± 0.3% to 4.1% ± 1.3%; M&M, 18.5% ± 0.6% to 14.5% ± 2.2%, P < .001). Looking at outcomes vs continuous volume showed that beyond a minimum annual volume (hospital 200-300 cases; surgeon 100-150 cases, approximately), mortality and M&M rates did not further improve. Using individual-level data and adjusting for patient characteristics and clustering within surgeon and hospital, we found higher procedural volume was associated with improved surgeon-level outcomes (mortality adjusted odds ratio, 0.39/100 procedures; 95% CI, 0.24-0.61; M&M adjusted odds ratio, 0.37/100 procedures; 95% CI, 0.28-0.48; P < .001 for both). Hospital-level adjusted volume-outcomes associations were not statistically significant. CONCLUSIONS: We observed an inverse relationship between total cardiac case volume and resternotomy CABG outcomes at the surgeon level only, indicating that individual surgeon's experience, rather than institutional volume, is the key determinant.

Resternotomy Coronary Artery Bypass 1999-2018: Insights From The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: We sought to quantify the risk trend of resternotomy coronary artery bypass grafting (CABG) over the past 2 decades. METHODS: We compared the outcomes of 194 804 consecutive resternotomy CABG patients and 1 445 894 randomly selected first-time CABG patients (50% of total) reported to The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 1999 and 2018. Primary outcomes were in-hospital mortality and overall morbidity. Using multiple logistic regression for each outcome for each year, we computed the annual trends of risk-adjusted odds ratios for the primary outcomes in the entire cohort and in 194 776 propensity-matched pairs. RESULTS: The annual resternotomy CABG case volume from participating centers declined by 68%, from a median of 25 (range, 14-44) to a median of 8 (range, 4-15). Compared with first-time CABG, resternotomy CABG patients were consistently older, with higher proportions of comorbidities. After propensity matching, primary outcomes of resternotomy and first-time CABG were similar (mortality: 3.5% vs 2.3%, standardized difference [SDiff], 7.5%; morbidity: 40.7% vs 40.3%, SDiff, 0.9%). Mortality of resternotomy CABG performed after prior CABG was higher than that after prior non-CABG (4.3% vs 2.4%; SDiff, 10.8). Morbidity was similar between these subgroups (41.0% vs 39.1%; SDiff, 2.9). The adjusted odds ratio for mortality after resternotomy CABG declined from 1.93 (95% CI, 1.73-2.16) to 1.22 (95% CI, 0.92-1.62), and that of morbidity declined from 1.13 (95% CI, 1.08-1.18) to 0.91 (95% CI, 0.87-0.95), P < .001 for both. CONCLUSIONS: The risk of resternotomy CABG has decreased substantially over time. Resternotomy CABG performed after a prior CABG is higher risk compared with that performed after a non-CABG operation.

Variation in Case-Mix Across Hospitals: Analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

BACKGROUND: The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database was queried to document variation of patient characteristics, procedure types, and programmatic case-mix. METHODS: All index cardiac operations in patients less than 18 years of age in the STS Congenital Heart Surgery Database (July 2016 to June 2020) were eligible for inclusion except patients weighing ≤2.5 kg undergoing isolated patent ductus arteriosus closure. At the hospital level, we describe variations in patient and procedural characteristics known from previous analyses to be associated with outcomes. We also report variations across hospitals of programmatic case-mix. RESULTS: Data were analyzed from 117 sites (90 322 total operations, 87 296 total index cardiac operations eligible for STAT [STS-European Association for Cardio-Thoracic Surgery] 2020 Mortality Score). The median annual total index cardiac operations eligible for STAT 2020 Mortality Score per hospital was 157 (interquartile range [IQR], 94-276). Wide variability was documented in total annual index cardiac operations eligible for STAT 2020 Mortality Score per hospital (ratio 90th/10th percentile = 9.01), operations in neonates weighing <2.5 kg (ratio 90th/10th percentile = 4.09), operations in patients with noncardiac anatomic abnormalities (ratio 90th/10th percentile = 3.46), and operations in patients with preoperative mechanical ventilation (ratio 90th/10th percentile = 3.97). At the hospital level, the median percentage of all index cardiac operations in STAT 2020 Mortality Category 5 was 3.7% (IQR, 1.7%-4.9%), the median percentage of all index cardiac operations in STAT 2020 Mortality Category 4 or 5 was 24.4% (IQR, 19.0%-28.4%), the median hospital-specific mean STAT Mortality Category was 2.39 (IQR, 2.20-2.47), and the median hospital-specific mean STAT Mortality Score was 0.86 (IQR, 0.73-0.91). CONCLUSIONS: Substantial variation of patient characteristics, procedure types, and case-mix exists across pediatric and congenital cardiac surgical programs. Knowledge about programmatic case-mix augments data about indirectly standardized programmatic observed-to-expected (O/E) mortality. Indirectly standardized O/E ratios do not provide a complete description of a given pediatric and congenital cardiac surgical program. The indirectly standardized programmatic O/E ratios associated with a given program apply only to its specific case-mix of patients and may represent a quite different case-mix than that of another program.

Comparing Consumer-Directed Hospital Rankings With STS Adult Cardiac Surgery Database Outcomes.

BACKGROUND: Public interest in stratifying hospital performance has led to the proliferation of commercial, consumer-oriented hospital rankings. In cardiac surgery, little is known about how these rankings correlate with clinical registry quality ratings. METHODS: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was queried for isolated coronary artery bypass grafting or coronary artery bypass grafting/valve patients at hospitals among the top 100 U.S. News & World Report (USNWR) Cardiology & Heart Surgery rankings from 2016 to 2020. Hospitals were grouped into deciles by risk-adjusted observed/expected (O/E) ratios for morbidity and mortality using the STS 2018 risk models. Agreement between STS Adult Cardiac Surgery Database and USNWR ranked deciles was calculated by Bowker symmetry test. The association between each center's annual change in STS O/E ratio and change in USNWR ranking was modeled in repeated measures regression analysis. RESULTS: Inclusion criteria were met by 524 393 patients from 149 hospitals that ranked in USNWR top 100 at least once during the study period. There was no agreement between USNWR ranking and STS major morbidity and mortality O/E ratio (P > .50 for all years). Analysis of patients undergoing surgery at the 65 hospitals that were consistently ranked in the top 100 during the study period demonstrated no association between annual change in hospital ranking and change in O/E ratio (P all > .3). CONCLUSIONS: There was no agreement between annual USNWR hospital ranking and corresponding risk-adjusted STS morbidity or mortality. Furthermore, annual changes in USNWR rankings could not be accounted for using clinical outcomes. These findings suggest that factors unrelated to key surgical outcomes may be driving consumer-directed rankings.

The National Cardiovascular Data Registry Data Quality Program 2020: JACC State-of-the-Art Review.

The National Cardiovascular Data Registry is a group of registries maintained by the American College of Cardiology Foundation. These registries are used by a diverse constituency to improve the quality and outcomes of cardiovascular care, to assess the safety and effectiveness of new therapies, and for research. To achieve these goals, registry data must be complete and reliable. In this article, we review the process of National Cardiovascular Data Registry data collection, assess data completeness and integrity, and report on the current state of the data. Registry data are complete. Accuracy is very good but variable, and there is room for improvement. Knowledge of the quality of data is essential to ensuring its appropriate use.