Understanding the biases to sepsis surveillance and quality assurance caused by inaccurate coding in administrative health data.

PURPOSE: Timely and accurate data on the epidemiology of sepsis are essential to inform policy decisions and research priorities. We aimed to investigate the validity of inpatient administrative health data (IAHD) for surveillance and quality assurance of sepsis care. METHODS: We conducted a retrospective validation study in a disproportional stratified random sample of 10,334 inpatient cases of age ≥ 15 years treated in 2015-2017 in ten German hospitals. The accuracy of coding of sepsis and risk factors for mortality in IAHD was assessed compared to reference standard diagnoses obtained by a chart review. Hospital-level risk-adjusted mortality of sepsis as calculated from IAHD information was compared to mortality calculated from chart review information. RESULTS: ICD-coding of sepsis in IAHD showed high positive predictive value (76.9-85.7% depending on sepsis definition), but low sensitivity (26.8-38%), which led to an underestimation of sepsis incidence (1.4% vs. 3.3% for severe sepsis-1). Not naming sepsis in the chart was strongly associated with under-coding of sepsis. The frequency of correctly naming sepsis and ICD-coding of sepsis varied strongly between hospitals (range of sensitivity of naming: 29-71.7%, of ICD-diagnosis: 10.7-58.5%). Risk-adjusted mortality of sepsis per hospital calculated from coding in IAHD showed no substantial correlation to reference standard risk-adjusted mortality (r = 0.09). CONCLUSION: Due to the under-coding of sepsis in IAHD, previous epidemiological studies underestimated the burden of sepsis in Germany. There is a large variability between hospitals in accuracy of diagnosing and coding of sepsis. Therefore, IAHD alone is not suited to assess quality of sepsis care.

Ethnoracial Disparities in Rates of Non-Natural Causes of Death After the 2020 COVID-19 Outbreak in New York State.

Introduction: COVID-19 was associated with increases in non-natural cause mortality in the U.S., including deaths due to drug overdose, homicide, and motor vehicle crashes. Initial reports indicated higher rates of non-natural mortality among ethnoracial minority groups. This report aims to clarify these disparities by documenting trends in non-natural mortality across ethnoracial groups during the 2020 COVID-19 surge in New York State. Methods: We report monthly trends in non-natural cause mortality (overall and stratified by ethnoracial status) in New York State from January 2019 through December 2020, which included the COVID-19 onset in March 2020. Results: Total mean monthly unintentional overdose rates per 100,000 increased from 17.45 (before surge: January 2019-February 2020) to 23.19 (after surge: March 2020-December 2020) (mean difference=5.73, 95% CI=3.82, 7.65; p<0.001). Mean monthly homicide death rates increased from 2.34 before surge to 3.55 after surge (mean difference=1.20, 95% CI=0.60, 1.81; p<0.001), with the increase seen primarily in the non-Latinx Black population. Although increasing unintentional overdose death rates before surge equally affected non-Latinx White, Latinx, and non-Latinx Black persons, they remained high for non-Latinx Black persons but dropped for the other 2 groups after the pandemic onset. None of the ethnoracial subgroups showed significant increases in suicide or motor vehicle crash death rates. Conclusions: Non-Latinx Black persons showed disproportionately high and sustained increased rates of unintentional overdose and homicide death rates after the 2020 COVID-19 surge in New York State. Fatality review and death scene investigation research is needed to better understand these disparities.

Estimating Sepsis Incidence Using Administrative Data and Clinical Medical Record Review.

Importance: Despite the large health burden, reliable data on sepsis epidemiology are lacking; studies using International Statistical Classification of Diseases and Related Health Problems (ICD)-coded hospital discharge diagnosis for sepsis identification suffer from limited sensitivity. Also, ICD data do not allow investigation of underlying pathogens and antimicrobial resistance. Objectives: To generate reliable epidemiological estimates by linking data from a population-based database to a reference standard of clinical medical record review. Design, Setting, and Participants: This was a retrospective, observational cohort study using a population-based administrative database including all acute care hospitals of the Scania region in Sweden in 2019 and 2020 to identify hospital-treated sepsis cases by ICD codes. From this database, clinical medical records were also selected for review within 6 strata defined by ICD discharge diagnosis (both with and without sepsis diagnosis). Data were analyzed from April to October 2022. Main outcomes and measures: Hospital and population incidences of sepsis, case fatality, antimicrobial resistance, and temporal dynamics due to COVID-19 were assessed, as well as validity of ICD-10 case identification methods compared with the reference standard of clinical medical record review. Results: Out of 295 531 hospitalizations in 2019 in the Scania region of Sweden, 997 patient medical records were reviewed, among which 457 had sepsis according to clinical criteria. Of the patients with clinical sepsis, 232 (51%) were female, and 357 (78%) had at least 1 comorbidity. The median (IQR) age of the cohort was 76 (67-85) years. The incidence of sepsis in hospitalized patients according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria in 2019 was 4.1% (95% CI, 3.6-4.5) by medical record review. This corresponds to an annual incidence rate of 747 (95% CI, 663-832) patients with sepsis per 100 000 population. No significant increase in sepsis during the COVID-19 pandemic nor a decrease in sepsis incidence when excluding COVID-19 sepsis was observed. Few sepsis cases caused by pathogens with antimicrobial resistance were found. The validity of ICD-10-based case identification in administrative data was low. Conclusions and Relevance: In this cohort study of sepsis epidemiology, sepsis was a considerable burden to public health in Sweden. Supplying administrative data with information from clinical medical records can help to generate reliable data on sepsis epidemiology.

The German Quality Network Sepsis: Evaluation of a Quality Collaborative on Decreasing Sepsis-Related Mortality in a Controlled Interrupted Time Series Analysis.

Background: Sepsis is one of the leading causes of preventable deaths in hospitals. This study presents the evaluation of a quality collaborative, which aimed to decrease sepsis-related hospital mortality. Methods: The German Quality Network Sepsis (GQNS) offers quality reporting based on claims data, peer reviews, and support for establishing continuous quality management and staff education. This study evaluates the effects of participating in the GQNS during the intervention period (April 2016-June 2018) in comparison to a retrospective baseline (January 2014-March 2016). The primary outcome was all-cause risk-adjusted hospital mortality among cases with sepsis. Sepsis was identified by International Classification of Diseases (ICD) codes in claims data. A controlled time series analysis was conducted to analyze changes from the baseline to the intervention period comparing GQNS hospitals with the population of all German hospitals assessed via the national diagnosis-related groups (DRGs)-statistics. Tests were conducted using piecewise hierarchical models. Implementation processes and barriers were assessed by surveys of local leaders of quality improvement teams. Results: Seventy-four hospitals participated, of which 17 were university hospitals and 18 were tertiary care facilities. Observed mortality was 43.5% during baseline period and 42.7% during intervention period. Interrupted time-series analyses did not show effects on course or level of risk-adjusted mortality of cases with sepsis compared to the national DRG-statistics after the beginning of the intervention period (p = 0.632 and p = 0.512, respectively). There was no significant mortality decrease in the subgroups of patients with septic shock or ventilation >24 h or predefined subgroups of hospitals. A standardized survey among 49 local quality improvement leaders in autumn of 2018 revealed that most hospitals did not succeed in implementing a continuous quality management program or relevant measures to improve early recognition and treatment of sepsis. Barriers perceived most commonly were lack of time (77.6%), staff shortage (59.2%), and lack of participation of relevant departments (38.8%). Conclusion: As long as hospital-wide sepsis quality improvement efforts will not become a high priority for the hospital leadership by assuring adequate resources and involvement of all pertinent stakeholders, voluntary initiatives to improve the quality of sepsis care will remain prone to failure.

The Association of Socioeconomic Factors With Percutaneous Coronary Intervention Outcomes.

BACKGROUND: Numerous studies have identified the association of socioeconomic factors with outcomes of cardiac surgical procedures. Most have focused on easily measured demographic factors or on socioeconomic characteristics of patients' 5-digit zip codes. The impact of socioeconomic information that is derived from smaller geographic regions has rarely been studied. METHODS: The association of the Area Deprivation Index (ADI) with short-term mortality and readmissions was tested for patients undergoing percutaneous coronary intervention (PCI) in New York while adjusting for numerous patient risk factors, including race, ethnicity, and payer. Changes in hospitals' risk-adjusted outcomes and outlier status with the addition of socioeconomic factors were examined. RESULTS: After adjustment, patients in the 2 most deprived ADI quintiles were more likely to experience in-hospital and 30-day mortality after PCI (adjusted odds ratios [95% confidence intervals] 1.39 [1.18-1.65] and 1.24 [1.03-1.49], respectively), than patients in the first quintile (least deprived). Also, patients in the second and fifth ADI quintiles had higher 30-day readmissions rates than patients in the first quintile (1.12 [1.01-1.25] and 1.17 [1.04-1.32], respectively). Medicare patients had higher mortality and readmission rates, Hispanics had lower mortality, and Medicaid patients had higher readmission rates. CONCLUSIONS: Patients with the most deprived ADIs are more likely to experience short-term mortality and readmissions after PCI. Ethnicity and payer are significantly associated with adverse outcomes even after adjusting for ADI. This information should be considered when identifying patients who are at the highest risk for adverse events after PCI and when risk-adjusting hospital outcomes and assessing quality of care.

The Association of Socioeconomic Factors With Outcomes for Coronary Artery Bypass Surgery.

BACKGROUND: Numerous studies have identified the associations of socioeconomic factors with outcomes of cardiac procedures. The majority have focused on easily measured factors like sex, race, and insurance status, or on socioeconomic characteristics of patients' 5-digit zip codes. The impact of more granular census-derived socioeconomic information on outcomes has rarely been studied. METHODS: The independent impact of the Area Deprivation Index (ADI) on short-term mortality and readmissions was tested on patients undergoing isolated coronary artery bypass grafting (CABG) surgery in New York by using it in logistic regression models in conjunction with patient risk factors and typical disparities measures (race, ethnicity, payer). Changes in hospitals' risk-adjusted outcomes and outlier status with the addition of socioeconomic measures were also tested. RESULTS: After adjusting for numerous patient characteristics, patients in the fourth and fifth highest ADI quintiles (most deprived) were more likely to experience in-hospital/30-day mortality after CABG surgery (adjusted odds ratio [AOR] 1.54, 95% confidence interval [CI] 1.08, 2.20; and AOR 1.50, 95% CI 1.02, 2.21), respectively. ADI was not associated with readmissions, but African Americans (AOR 1.49, 95% CI 1.18, 1.87), Hispanics (AOR 1.33, 95% CI 1.06, 1.65) and Medicaid patients (AOR 1.34, 95% CI 1.09, 1.64) were more likely to be readmitted. CONCLUSIONS: Patients with high ADIs are more likely to experience short-term mortality after CABG surgery. African Americans, Hispanics, and Medicaid patients are more likely to experience 30-day readmissions. This information should be taken into account when monitoring patients to reduce adverse events following surgery, and more studies related to ADI are needed to fully understand its implications.

The Influence of the Gender Asterisk ("Gendersternchen") on Comprehensibility and Interest.

Recently, the gender asterisk ("Gendersternchen") has become more widespread in grammatical gender languages in order to represent all genders. Such gender-fair language is intended to help better address women and other genders and make their interests and achievements more visible. Critics often argue this would make the language less comprehensible and less aesthetically appealing. Two experiments examined the effects of the gender asterisk on text comprehensibility, aesthetic perception, and interest. N = 159 and N = 127 participants were randomly provided with a text in either masculine-only form or alternatively in gender-fair language with the gender asterisk. The results of the first experiment showed no impairment of comprehensibility and aesthetic evaluation of the texts by the gender asterisk and no effect on interest in the game, while the second experiment showed significant impairments of comprehensibility, aesthetic evaluation, and interest in the game by the gender asterisk. The proportion of singular forms is discussed as a possible explanation for the different results. Experiment 1 predominantly used plural forms like die Spieler*innen (∼"the fe*male players") and did not include forms such as der*die Spieler*in (∼"the*the fe*male player"), whereas Experiment 2 included many such more complex singular forms. We argue that this issue might be crucial, and that it deserves full attention in future studies.

Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction Before and During COVID in New York.

Little is known about regional differences in volume, treatment, and outcomes of STEMI patients undergoing PCI during the pandemic. The objectives of this study were to compare COVID-19 pandemic and prepandemic periods with respect to regional volumes, outcomes, and treatment of patients undergoing percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) between January 1, 2019 and March 14, 2020 (pre-COVID period) and between March 15, 2020 and April 4, 2020 (COVID period) in 51 New York State hospitals certified to perform PCI. The hospitals were classified as being in either high-density or low-density COVID-19 counties on the basis of deaths/10,000 population. There was a decrease of 43% in procedures/week in high-density COVID-19 counties (p <0.0001) and only 4% in low-density counties (p = 0.64). There was no difference in the change in risk-adjusted in-hospital mortality rates in either type of county, but STEMI PCI patients in high-density counties had longer times from symptom onset to hospital arrival and lower cardiac arrest rates in the pandemic period. In conclusion, the decrease in STEMI PCIs during the pandemic was mainly limited to counties with a high density of COVID-19 deaths. The decrease appears to be primarily related to patients not presenting to hospitals in high-density COVID regions, rather than PCI being avoided in STEMI patients or a reduction in the incidence of STEMI. Also, high-density COVID-19 counties experienced delayed admissions and less severely ill STEMI PCI patients during the pandemic. This information can serve to focus efforts on convincing STEMI patients to seek life-saving hospital care during the pandemic.

Racial And Ethnic Disparities In Care Following The New York State Sepsis Initiative.

After 2013, when New York State mandated that hospitals follow protocols to treat sepsis, completion of the protocols increased and mortality declined. Whether these encouraging trends have equitably benefited racial/ethnic minority populations is unknown. Although there were no significant racial/ethnic differences in rates of protocol completion at the onset of New York's Sepsis Initiative, over time white patients experienced a greater increase in protocol completion rates (14.0 percentage points) compared to black patients (5.3 percentage points). The emergence of this disparity was due to smaller performance improvements among hospitals with higher proportions of black patients, though white and black patients showed similar improvements when treated within the same hospital. Our study suggests an urgent need to understand why improvements in sepsis care lagged in hospitals in New York that care for higher proportions of minority patients. Policy makers should anticipate and monitor the effects of quality improvement initiatives on disparities to ensure that all racial/ethnic groups realize their benefits equitably.

Mortality Changes Associated with Mandated Public Reporting for Sepsis. The Results of the New York State Initiative.

RATIONALE: In 2013, the New York State Department of Health (NYSDOH) began a mandatory state-wide initiative to improve early recognition and treatment of severe sepsis and septic shock. OBJECTIVES: This study examines protocol initiation, 3-hour and 6-hour sepsis bundle completion, and risk-adjusted hospital mortality among adult patients with severe sepsis and septic shock. METHODS: Cohort analysis included all patients from all 185 hospitals in New York State reported to the NYSDOH from April 1, 2014, to June 30, 2016. A total of 113,380 cases were submitted to NYSDOH, of which 91,357 hospitalizations from 183 hospitals met study inclusion criteria. NYSDOH required all hospitals to submit and follow evidence-informed protocols (including elements of 3-h and 6-h sepsis bundles: lactate measurement, early blood cultures and antibiotic administration, fluids, and vasopressors) for early identification and treatment of severe sepsis or septic shock. MEASUREMENTS AND MAIN RESULTS: Compliance with elements of the sepsis bundles and risk-adjusted mortality were studied. Of 91,357 patients, 74,293 (81.3%) had the sepsis protocol initiated. Among these individuals, 3-hour bundle compliance increased from 53.4% to 64.7% during the study period (P < 0.001), whereas among those eligible for the 6-hour bundle (n = 35,307) compliance increased from 23.9% to 30.8% (P < 0.001). Risk-adjusted mortality decreased from 28.8% to 24.4% (P < 0.001) in patients among whom a sepsis protocol was initiated. Greater hospital compliance with 3-hour and 6-hour bundles was associated with shorter length of stay and lower risk and reliability-adjusted mortality. CONCLUSIONS: New York's statewide initiative increased compliance with sepsis-performance measures. Risk-adjusted sepsis mortality decreased during the initiative and was associated with increased hospital-level compliance.

Association Between the New York Sepsis Care Mandate and In-Hospital Mortality for Pediatric Sepsis.

Importance: The death of a pediatric patient with sepsis motivated New York to mandate statewide sepsis treatment in 2013. The mandate included a 1-hour bundle of blood cultures, broad-spectrum antibiotics, and a 20-mL/kg intravenous fluid bolus. Whether completing the bundle elements within 1 hour improves outcomes is unclear. Objective: To determine the risk-adjusted association between completing the 1-hour pediatric sepsis bundle and individual bundle elements with in-hospital mortality. Design, Settings, and Participants: Statewide cohort study conducted from April 1, 2014, to December 31, 2016, in emergency departments, inpatient units, and intensive care units across New York State. A total of 1179 patients aged 18 years and younger with sepsis and septic shock reported to the New York State Department of Health who had a sepsis protocol initiated were included. Exposures: Completion of a 1-hour sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour. Main Outcomes and Measures: Risk-adjusted in-hospital mortality. Results: Of 1179 patients with sepsis reported at 54 hospitals (mean [SD] age, 7.2 [6.2] years; male, 54.2%; previously healthy, 44.5%; diagnosed as having shock, 68.8%), 139 (11.8%) died. The entire sepsis bundle was completed in 1 hour in 294 patients (24.9%). Antibiotics were administered to 798 patients (67.7%), blood cultures were obtained in 740 patients (62.8%), and the fluid bolus was completed in 548 patients (46.5%) within 1 hour. Completion of the entire bundle within 1 hour was associated with lower risk-adjusted odds of in-hospital mortality (odds ratio [OR], 0.59 [95% CI, 0.38 to 0.93], P = .02; predicted risk difference [RD], 4.0% [95% CI, 0.9% to 7.0%]). However, completion of each individual bundle element within 1 hour was not significantly associated with lower risk-adjusted mortality (blood culture: OR, 0.73 [95% CI, 0.51 to 1.06], P = .10; RD, 2.6% [95% CI, -0.5% to 5.7%]; antibiotics: OR, 0.78 [95% CI, 0.55 to 1.12], P = .18; RD, 2.1% [95% CI, -1.1% to 5.2%], and fluid bolus: OR, 0.88 [95% CI, 0.56 to 1.37], P = .56; RD, 1.1% [95% CI, -2.6% to 4.8%]). Conclusions and Relevance: In New York State following a mandate for sepsis care, completion of a sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour was associated with lower risk-adjusted in-hospital mortality among patients with pediatric sepsis and septic shock.

Reporting of Sepsis Cases for Performance Measurement Versus for Reimbursement in New York State.

OBJECTIVES: Under "Rory's Regulations," New York State Article 28 acute care hospitals were mandated to implement sepsis protocols and report patient-level data. This study sought to determine how well cases reported under state mandate align with discharge records in a statewide administrative database. DESIGN: Observational cohort study. SETTING: First 27 months of mandated sepsis reporting (April 1, 2014, to June 30, 2016). PATIENTS: Hospitalizations with sepsis at New York State Article 28 acute care hospitals. INTERVENTION: Sepsis regulations with mandated reporting. MEASUREMENTS AND MAIN RESULTS: We compared cases reported to the New York State Department of Health Sepsis Clinical Database with discharge records in the Statewide Planning and Research Cooperative System database. We classified discharges as 1) "coded sepsis discharges"-a diagnosis code for severe sepsis or septic shock and 2) "possible sepsis discharges," using Dombrovskiy and Angus criteria. Of 111,816 sepsis cases reported to the New York State Department of Health Sepsis Clinical Database, 105,722 (94.5%) were matched to discharge records in Statewide Planning and Research Cooperative System. The percentage of coded sepsis discharges reported increased from 67.5% in the first quarter to 81.3% in the final quarter of the study period (mean, 77.7%). Accounting for unmatched cases, as many as 82.7% of coded sepsis discharges were potentially reported, whereas at least 17.3% were unreported. Compared with unreported discharges, reported discharges had higher rates of acute organ dysfunction (e.g., cardiovascular dysfunction 63.0% vs 51.8%; p < 0.001) and higher in-hospital mortality (30.2% vs 26.1%; p < 0.001). Hospital characteristics (e.g., number of beds, teaching status, volume of sepsis cases) were similar between hospitals with a higher versus lower percent of discharges reported, p values greater than 0.05 for all. Hospitals' percent of discharges reported was not correlated with risk-adjusted mortality of their submitted cases (Pearson correlation coefficient 0.11; p = 0.17). CONCLUSIONS: Approximately four of five discharges with a diagnosis code of severe sepsis or septic shock in the Statewide Planning and Research Cooperative System data were reported in the New York State Department of Health Sepsis Clinical Database. Incomplete reporting appears to be driven more by underrecognition than attempts to game the system, with minimal bias to risk-adjusted hospital performance measurement.

Time to Treatment and Mortality during Mandated Emergency Care for Sepsis.

BACKGROUND: In 2013, New York began requiring hospitals to follow protocols for the early identification and treatment of sepsis. However, there is controversy about whether more rapid treatment of sepsis improves outcomes in patients. METHODS: We studied data from patients with sepsis and septic shock that were reported to the New York State Department of Health from April 1, 2014, to June 30, 2016. Patients had a sepsis protocol initiated within 6 hours after arrival in the emergency department and had all items in a 3-hour bundle of care for patients with sepsis (i.e., blood cultures, broad-spectrum antibiotic agents, and lactate measurement) completed within 12 hours. Multilevel models were used to assess the associations between the time until completion of the 3-hour bundle and risk-adjusted mortality. We also examined the times to the administration of antibiotics and to the completion of an initial bolus of intravenous fluid. RESULTS: Among 49,331 patients at 149 hospitals, 40,696 (82.5%) had the 3-hour bundle completed within 3 hours. The median time to completion of the 3-hour bundle was 1.30 hours (interquartile range, 0.65 to 2.35), the median time to the administration of antibiotics was 0.95 hours (interquartile range, 0.35 to 1.95), and the median time to completion of the fluid bolus was 2.56 hours (interquartile range, 1.33 to 4.20). Among patients who had the 3-hour bundle completed within 12 hours, a longer time to the completion of the bundle was associated with higher risk-adjusted in-hospital mortality (odds ratio, 1.04 per hour; 95% confidence interval [CI], 1.02 to 1.05; P<0.001), as was a longer time to the administration of antibiotics (odds ratio, 1.04 per hour; 95% CI, 1.03 to 1.06; P<0.001) but not a longer time to the completion of a bolus of intravenous fluids (odds ratio, 1.01 per hour; 95% CI, 0.99 to 1.02; P=0.21). CONCLUSIONS: More rapid completion of a 3-hour bundle of sepsis care and rapid administration of antibiotics, but not rapid completion of an initial bolus of intravenous fluids, were associated with lower risk-adjusted in-hospital mortality. (Funded by the National Institutes of Health and others.).

The Impact of Excluding Shock Patients on Hospital and Physician Risk-Adjusted Mortality Rates for Percutaneous Coronary Interventions: The Implications for Public Reporting.

OBJECTIVES: The authors examined the impact of including shock patients in public reporting of percutaneous coronary intervention (PCI) risk-adjusted mortality. BACKGROUND: There is concern that an unintended consequence of statewide public reporting of medical outcomes is the avoidance of appropriate interventions for high-risk patients. METHODS: New York State's PCI registry was used to compare hospital and physician risk-adjusted mortality rates and outliers from New York's public report models with rates and outliers based on statistical models that include refractory shock patients and exclude both refractory shock and other shock patients. RESULTS: Correlations between the public report model and each of the other 2 models were above 0.92 for hospital risk-adjusted rates and were 0.99 for all physician risk-adjusted rates (p < 0.0001). There were 11 physicians with lower than expected mortality rates (low outliers) and 41 physicians with higher than expected mortality rates (high outliers) across the 3 time periods in the public report, compared with 10 low outliers and 40 high outliers if all shock patients had been excluded. There was considerable overlap among outliers identified by the 3 models. Findings were similar for hospital outliers. CONCLUSIONS: Risk-adjusted hospital and physician mortality rates are highly correlated regardless of whether shock patients are included in public reporting. The numbers of outliers are similar, and outlier changes are minimal, although 10% to 15% of cardiologists who were outliers in either exclusion rule were not outliers in the other one. This information can form a basis for subsequent discussions regarding the exclusion of high-risk patients from public reporting.