Random variation drives a critical bias in the comparison of healthcare-associated infections.

OBJECTIVE: To evaluate random effects of volume (patient days or device days) on healthcare-associated infections (HAIs) and the standardized infection ratio (SIR) used to compare hospitals. DESIGN: A longitudinal comparison between publicly reported quarterly data (2014-2020) and volume-based random sampling using 4 HAI types: central-line-associated bloodstream infections, catheter-associated urinary tract infections, Clostridioides difficile infections, methicillin-resistant Staphylococcus aureus infections. METHODS: Using 4,268 hospitals with reported SIRs, we examined relationships of SIRs to volume and compared distributions of SIRs and numbers of reported HAIs to the outcomes of simulated random sampling. We included random expectations into SIR calculations to produce a standardized infection score (SIS). RESULTS: Among hospitals with volumes less than the median, 20%-33% had SIRs of 0, compared to 0.3%-5% for hospitals with volumes higher than the median. Distributions of SIRs were 86%-92% similar to those based on random sampling. Random expectations explained 54%-84% of variation in numbers of HAIs. The use of SIRs led hundreds of hospitals with more infections than either expected at random or predicted by risk-adjusted models to rank better than other hospitals. The SIS mitigated this effect and allowed hospitals of disparate volumes to achieve better scores while decreasing the number of hospitals tied for the best score. CONCLUSIONS: SIRs and numbers of HAIs are strongly influenced by random effects of volume. Mitigating these effects drastically alters rankings for HAI types and may further alter penalty assignments in programs that aim to reduce HAIs and improve quality of care.

Variation in the Reporting of Elective Surgeries and Its Influence on Patient Safety Indicators.

BACKGROUND: US hospital safety is routinely measured via Patient Safety Indicators (PSIs). Receiving a score for most PSIs requires a minimum number of qualifying cases to meet specific criteria; for example, whether an admission was elective. Because admission type is determined by hospitals' internal policies, the study team suspected that hospitals may be exempted from elective-based PSI scores as a result of their internal admission classification policies. METHODS: Multiple regression was combined with machine learning to analyze Medicare inpatient claims data reported by 3,484 hospitals during the 2015-2017 PSI measurement period. The researchers examined the average percentage of elective admissions across surgical diagnosis-related groups (DRGs) (average percent elective [APE]) in relation to hospital characteristics, surgical claims volumes, and numbers and types of surgical DRGs. This study asked whether hospitals with exceptionally low APE shared particular characteristics, reported claims for similar DRGs, or were disproportionately exempted from elective-based PSIs. RESULTS: Cross-validated multiple regression explained 73.9% of variation in APE among hospitals and identified surgical claims volume and 16 surgical DRGs as consistently important variables. However, the exceptionally low APE of 96 hospitals could not be explained by surgical claims volume, surgical DRGs among claims, or hospital characteristics. These outliers were disproportionately exempt from elective-based PSI scores. CONCLUSION: Some hospitals may have classified admissions in a way that exempted them from elective-based PSI scores. Transparency into admission classification policies is needed to ensure fair and reliable use of PSIs when ranking hospitals and adjusting payments. Alternatively, PSIs may need modifications to rely on externally validated criteria.

An interactive tool to forecast US hospital needs in the coronavirus 2019 pandemic.

OBJECTIVE: We developed an application (https://rush-covid19.herokuapp.com/) to aid US hospitals in planning their response to the ongoing Coronavirus Disease 2019 (COVID-19) pandemic. MATERIALS AND METHODS: Our application forecasts hospital visits, admits, discharges, and needs for hospital beds, ventilators, and personal protective equipment by coupling COVID-19 predictions to models of time lags, patient carry-over, and length-of-stay. Users can choose from 7 COVID-19 models, customize 23 parameters, examine trends in testing and hospitalization, and download forecast data. RESULTS: Our application accurately predicts the spread of COVID-19 across states and territories. Its hospital-level forecasts are in continuous use by our home institution and others. DISCUSSION: Our application is versatile, easy-to-use, and can help hospitals plan their response to the changing dynamics of COVID-19, while providing a platform for deeper study. CONCLUSION: Empowering healthcare responses to COVID-19 is as crucial as understanding the epidemiology of the disease. Our application will continue to evolve to meet this need.

The Substance Use Intervention Team: A Preliminary Analysis of a Population-level Strategy to Address the Opioid Crisis at an Academic Health Center.

OBJECTIVE: In 2017, an academic health center in Chicago launched the multidisciplinary Substance Use Intervention Team (SUIT) to address opioid misuse across 18 inpatient units and in a new outpatient addiction medicine clinic. This report assesses the first 5 months of implementation and associations with patient health and healthcare utilization. METHODS: Patient demographic and screening data were extracted from the administrative data warehouse of the electronic health record (EHR) infrastructure. Distribution of sample characteristics for positive initial screens for opioid misuse was tested against those of all patients screened using a 2-tailed test of proportions (P < 0.05). A second analysis compared length of stay and 30-day readmissions within a cohort of patients with a secondary diagnosis of substance use disorder. RESULTS: Between November, 2017 and March, 2018, 76% of 15,054 unique patients were screened, 578 had positive scores on the Alcohol Use Disorders Identification Test and Drug Abuse Screening Test, 131 had positive scores for opioid misuse, and 52 patients initiated medication treatment. Patients with a secondary diagnosis of substance use disorder who received a SUIT consult (n = 161), compared with those who did not (n = 612), had a shorter average length of stay (5.91 vs 6.73 days) and lower 30-day readmission rate (13.6% vs 15.7%). CONCLUSION: Leveraging the EHR to conduct standardized screenings and treatment has helped identify an at-risk population-disproportionately younger, black, and male-and treat new cases of opioid and substance misuse. The intervention indicates trends toward a shortened length of stay, reduced 30-day readmissions, and has linked patients to outpatient care.

Consumer Rankings and Health Care: Toward Validation and Transparency.

BACKGROUND: Differences between the Centers for Medicare & Medicaid Services (CMS)-measured rates of safety events for Rush University Medical Center (RUMC; Chicago) and the U. S. News & World Report (USNWR)-deter mined patient safety score were evaluated in an attempt to validate the USNWR patient safety score-based ranking. METHODS: The USNWR findings for Patient Safety Indicators (PSIs) were compared with findings derived from RUMC internal billing data, and sensitivity analyses were conducted using a simulated data set derived from the Healthcare Cost and Utilization Project (HCUP) state inpatient data sets. RESULTS: Discrepancies were found for PSIs 3 (Pressure Ulcer Rate), 9 (Perioperative Hemorrhage or Hematoma Rate), and 11 (Postoperative Respiratory Failure Rate)-an excess of 0.72, 0.63, and 0.26 cases/1,000 admissions, in USNWR versus RUMC, respectively). The sensitivity analysis, which included missing present on admission (POA) flags and dates, resulted in an increase of rates by 1.83 (95% confidence interval [CI] = 1.10-2.56) cases/1,000 hospital- izations, 2.72 (CI = 0.00-5.90) cases/1,000 hospitalizations, and 3.89 (CI = 1.60-6.20) cases/1,000 hospitalizations for PSI 3, 9, and 11, respectively. Regression modeling showed that each 1% increase in transfers was associated with an in- crease of 0.06 cases of PSI 3/1,000 admissions; each 1,000 increase in admissions was associated with an increase of 0.04 cases of PSI 9/1,000 admissions. CONCLUSION: The USNWR data set produced inaccurate PSI rates for RUMC, and false-positive event rates were more common among high-transfer and high-volume hos- pitals. More transparency and validation is needed for con- sumer-based benchmarking methods. In response to these findings and concerns raised by others, in 2016 USNWR made changes to its methodology and data sources and reported them in announcing its 2016-17 Best Hospitals.

Comparison of FOLFIRI with or without cetuximab in patients with resected stage III colon cancer; NCCTG (Alliance) intergroup trial N0147.

BACKGROUND: Two arms with FOLFIRI, with or without cetuximab, were initially included in the randomized phase III intergroup clinical trial NCCTG (North Central Cancer Treatment Group) N0147. When other contemporary trials demonstrated no benefit to using irinotecan as adjuvant therapy, the FOLFIRI-containing arms were discontinued. We report the clinical outcomes for patients randomized to FOLFIRI with or without cetuximab. PATIENTS AND METHODS: After resection, patients were randomized to 12 biweekly cycles of FOLFIRI, with or without cetuximab. KRAS (Kirsten rat sarcoma viral oncogene homolog) mutation status was retrospectively determined in a central lab. The primary end point was disease-free survival (DFS). Secondary end points included overall survival (OS) and toxicity. RESULTS: One hundred and six patients received FOLFIRI and 40 received FOLFIRI plus cetuximab. Median follow-up was 5.95 years (range, 0.1-7.0 years). The addition of cetuximab showed a trend toward improved DFS (hazard ratio [HR], 0.53; 95% CI, 0.26-1.1; P = .09) and OS (HR, 0.45; 95% CI, 0.17-1.16; P = .10) in the overall group, regardless of KRAS status, and in patients with wild type KRAS. Grade ≥ 3 nonhematologic adverse effects were significantly increased in the cetuximab versus FOLFIRI-alone arm (68% vs. 46%; P = .02). Adjuvant FOLFIRI resulted in a 3-year DFS less than that expected for FOLFOX. CONCLUSION: In this small randomized subset of patients with resected stage III colon cancer, the addition of cetuximab to FOLFIRI was associated with a nonsignificant trend toward improved DFS and OS. Nevertheless, considering the limitations of this analysis, FOLFOX without the addition of a biologic agent remains the standard of care for adjuvant therapy in resected stage III colon cancer.

Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial.

CONTEXT: Leucovorin, fluorouracil, and oxaliplatin (FOLFOX) is the standard adjuvant therapy for resected stage III colon cancer. Adding cetuximab to FOLFOX benefits patients with metastatic wild-type KRAS but not mutated KRAS colon cancer. OBJECTIVE: To assess the potential benefit of cetuximab added to the modified sixth version of the FOLFOX regimen (mFOLFOX6) in patients with resected stage III wild-type KRAS colon cancer. DESIGN, SETTING, AND PARTICIPANTS: A randomized trial of 2686 patients aged 18 years or older at multiple institutions across North America enrolled following resection and informed consent between February 10, 2004, and November 25, 2009. The primary randomized comparison was 12 biweekly cycles of mFOLFOX6 with and without cetuximab. KRAS mutation status was centrally determined. The trial was halted after a planned interim analysis of 48% of predicted events (246/515) occurring in 1863 (of 2070 planned) patients with tumors having wild-type KRAS. A total of 717 patients with mutated KRAS and 106 with indeterminate KRAS were accrued. The 2070 patients with wild-type KRAS provided 90% power to detect a hazard ratio (HR) of 1.33 (2-sided α = .05), with planned interim efficacy analyses after 25%, 50%, and 75% of expected relapses. MAIN OUTCOME MEASURES: Disease-free survival in patients with wild-type KRAS mutations. Secondary end points included overall survival and toxicity. RESULTS: Median (range) follow-up was 28 (0-68) months. The trial demonstrated no benefit when adding cetuximab. Three-year disease-free survival for mFOLFOX6 alone was 74.6% vs 71.5% with the addition of cetuximab (HR, 1.21; 95% CI, 0.98-1.49; P = .08) in patients with wild-type KRAS, and 67.1% vs 65.0% (HR, 1.12; 95% CI, 0.86-1.46; P = .38) in patients with mutated KRAS, with no significant benefit in any subgroups assessed. Among all patients, grade 3 or higher adverse events (72.5% vs 52.3%; odds ratio [OR], 2.4; 95% CI, 2.1-2.8; P < .001) and failure to complete 12 cycles (33% vs 23%; OR, 1.6; 95% CI, 1.4-1.9; P < .001) were significantly higher with cetuximab. Increased toxicity and greater detrimental differences in all outcomes were observed in patients aged 70 years or older. CONCLUSION: Among patients with stage III resected colon cancer, the use of cetuximab with adjuvant mFOLFOX6 compared with mFOLFOX6 alone did not result in improved disease-free survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00079274.