Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules.

BACKGROUND: Concern persists that extended shifts in medical residency programs may adversely affect patient safety. METHODS: We conducted a cluster-randomized noninferiority trial in 63 internal-medicine residency programs during the 2015-2016 academic year. Programs underwent randomization to a group with standard duty hours, as adopted by the Accreditation Council for Graduate Medical Education (ACGME) in July 2011, or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts. The primary outcome for each program was the change in unadjusted 30-day mortality from the pretrial year to the trial year, as ascertained from Medicare claims. We hypothesized that the change in 30-day mortality in the flexible programs would not be worse than the change in the standard programs (difference-in-difference analysis) by more than 1 percentage point (noninferiority margin). Secondary outcomes were changes in five other patient safety measures and risk-adjusted outcomes for all measures. RESULTS: The change in 30-day mortality (primary outcome) among the patients in the flexible programs (12.5% in the trial year vs. 12.6% in the pretrial year) was noninferior to that in the standard programs (12.2% in the trial year vs. 12.7% in the pretrial year). The test for noninferiority was significant (P = 0.03), with an estimate of the upper limit of the one-sided 95% confidence interval (0.93%) for a between-group difference in the change in mortality that was less than the prespecified noninferiority margin of 1 percentage point. Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also below 1 percentage point; the noninferiority criterion was not met for 30-day readmissions or prolonged length of hospital stay. Risk-adjusted measures generally showed similar findings. CONCLUSIONS: Allowing program directors flexibility in adjusting duty-hour schedules for trainees did not adversely affect 30-day mortality or several other measured outcomes of patient safety. (Funded by the National Heart, Lung, and Blood Institute and Accreditation Council for Graduate Medical Education; iCOMPARE ClinicalTrials.gov number, NCT02274818.).

A National Comparison of Operative Outcomes of New and Experienced Surgeons.

OBJECTIVE: To determine whether outcomes achieved by new surgeons are attributable to inexperience or to differences in the context in which care is delivered and patient complexity. BACKGROUND: Although prior studies suggest that new surgeon outcomes are worse than those of experienced surgeons, factors that underlie these phenomena are poorly understood. METHODS: A nationwide observational tapered matching study of outcomes of Medicare patients treated by new and experienced surgeons in 1221 US hospitals (2009-2013). The primary outcome studied is 30-day mortality. Secondary outcomes were examined. RESULTS: In total, 694,165 patients treated by 8503 experienced surgeons were matched to 68,036 patients treated by 2119 new surgeons working in the same hospitals. New surgeons' patients were older (25.8% aged ≥85 vs 16.3%,P<0.0001) with more emergency admissions (53.9% vs 25.8%,P<0.0001) than experienced surgeons' patients. Patients of new surgeons had a significantly higher baseline 30-day mortality rate compared with patients of experienced surgeons (6.2% vs 4.5%,P<0.0001;OR 1.42 (1.33, 1.52)). The difference remained significant after matching the types of operations performed (6.2% vs 5.1%, P<0.0001; OR 1.24 (1.16, 1.32)) and after further matching on a combination of operation type and emergency admission status (6.2% vs 5.6%, P=0.0007; OR 1.12 (1.05, 1.19)). After matching on operation type, emergency admission status, and patient complexity, the difference between new and experienced surgeons' patients' 30-day mortality became indistinguishable (6.2% vs 5.9%,P=0.2391;OR 1.06 (0.97, 1.16)). CONCLUSIONS: Among Medicare beneficiaries, the majority of the differences in outcomes between new and experienced surgeons are related to the context in which care is delivered and patient complexity rather than new surgeon inexperience.

Evaluating the Costs and Outcomes of Hospital Nursing Resources: a Matched Cohort Study of Patients with Common Medical Conditions.

BACKGROUND: Nursing resources, such as staffing ratios and skill mix, vary across hospitals. Better nursing resources have been linked to better patient outcomes but are assumed to increase costs. The value of investments in nursing resources, in terms of clinical benefits relative to costs, is unclear. OBJECTIVE: To determine whether there are differential clinical outcomes, costs, and value among medical patients at hospitals characterized by better or worse nursing resources. DESIGN: Matched cohort study of patients in 306 acute care hospitals. PATIENTS: A total of 74,045 matched pairs of fee-for-service Medicare beneficiaries admitted for common medical conditions (25,446 sepsis pairs; 16,332 congestive heart failure pairs; 12,811 pneumonia pairs; 10,598 stroke pairs; 8858 acute myocardial infarction pairs). Patients were also matched on hospital size, technology, and teaching status. MAIN MEASURES: Better (n = 76) and worse (n = 230) nursing resourced hospitals were defined by patient-to-nurse ratios, skill mix, proportions of bachelors-degree nurses, and nurse work environments. Outcomes included 30-day mortality, readmission, and resource utilization-based costs. KEY RESULTS: Patients in hospitals with better nursing resources had significantly lower 30-day mortality (16.1% vs 17.1%, p < 0.0001) and fewer readmissions (32.3% vs 33.6%, p < 0.0001) yet costs were not significantly different ($18,848 vs 18,671, p = 0.133). The greatest outcomes and cost advantage of better nursing resourced hospitals were in patients with sepsis who had lower mortality (25.3% vs 27.6%, p < 0.0001). Overall, patients with the highest risk of mortality on admission experienced the greatest reductions in mortality and readmission from better nursing at no difference in cost. CONCLUSIONS: Medicare beneficiaries with common medical conditions admitted to hospitals with better nursing resources experienced more favorable outcomes at almost no difference in cost.

Outcomes among pediatric patients with cancer who are treated on trial versus off trial: A matched cohort study.

BACKGROUND: Approximately 50% of children with cancer in the United States who are aged <15 years receive primary treatment on a therapeutic clinical trial. To the authors' knowledge, it remains unknown whether trial enrollment has a clinical benefit compared with the best alternative standard therapy and/or off trial (ie, clinical trial effect). The authors conducted a retrospective matched cohort study to compare the morbidity and mortality of pediatric patients with cancer who are treated on a phase 3 clinical trial compared with those receiving standard therapy and/or off trial. METHODS: Subjects were aged birth to 19 years; were diagnosed between 2000 and 2010 with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), rhabdomyosarcoma, or neuroblastoma; and had received initial treatment at the Children's Hospital of Philadelphia. On-trial and off-trial subjects were matched based on age, race, ethnicity, a diagnosis of Down syndrome (for patients with ALL or AML), prognostic risk level, date of diagnosis, and tumor type. RESULTS: A total of 428 participants were matched in 214 pairs (152 pairs for ALL, 24 pairs for AML, 32 pairs for rhabdomyosarcoma, and 6 pairs for neuroblastoma). The 5-year survival rate did not differ between those treated on trial versus those treated with standard therapy and/or off trial (86.9% vs 82.2%; P = .093). On-trial patients had a 32% lower odds of having worse (higher) mortality-morbidity composite scores, although this did not reach statistical significance (odds ratio, 0.68; 95% confidence interval, 0.45-1.03 [P = .070]). CONCLUSIONS: There was no statistically significant difference in outcomes noted between those patients treated on trial and those treated with standard therapy and/or off trial. However, in partial support of the clinical trial effect, the results of the current study indicate a trend toward more favorable outcomes in children treated on trial compared with those treated with standard therapy and/or off trial. These findings can support decision making regarding enrollment in pediatric phase 3 clinical trials.

Comparing Outcomes and Costs of Surgical Patients Treated at Major Teaching and Nonteaching Hospitals: A National Matched Analysis.

OBJECTIVE: To compare outcomes and costs between major teaching and nonteaching hospitals on a national scale by closely matching on patient procedures and characteristics. BACKGROUND: Teaching hospitals have been shown to often have better quality than nonteaching hospitals, but cost and value associated with teaching hospitals remains unclear. METHODS: A study of Medicare patients at 340 teaching hospitals (resident-to-bed ratios ≥ 0.25) and matched patient controls from 2444 nonteaching hospitals (resident-to-bed ratios < 0.05).We studied 86,751 pairs admitted for general surgery (GS), 214,302 pairs of patients admitted for orthopedic surgery, and 52,025 pairs of patients admitted for vascular surgery. RESULTS: In GS, mortality was 4.62% in teaching hospitals versus 5.57%, (a difference of -0.95%, <0.0001), and overall paired cost difference = $915 (P < 0.0001). For the GS quintile of pairs with highest risk on admission, mortality differences were larger (15.94% versus 18.18%, difference = -2.24%, P < 0.0001), and paired cost difference = $3773 (P < 0.0001), yielding $1682 per 1% mortality improvement at 30 days. Patterns for vascular surgery outcomes resembled general surgery; however, orthopedics outcomes did not show significant differences in mortality across teaching and nonteaching environments, though costs were higher at teaching hospitals. CONCLUSIONS: Among Medicare patients, as admission risk of mortality increased, the absolute mortality benefit of treatment at teaching hospitals also increased, though accompanied by marginally higher cost. Major teaching hospitals appear to return good value for the extra resources used in general surgery, and to some extent vascular surgery, but this was not apparent in orthopedic surgery.

Duty Hour Reform and the Outcomes of Patients Treated by New Surgeons.

OBJECTIVE: The aim of the study was to address the controversy surrounding the effects of duty hour reform on new surgeon performance, we analyzed patients treated by new surgeons following the transition to independent practice. SUMMARY BACKGROUND DATA: In 2003, duty hour reform affected all US surgical training programs. Its impact on the performance of new surgeons remains unstudied. METHODS: We studied 30-day mortality among 1,483,074 Medicare beneficiaries undergoing general and orthopedic operations between 1999 and 2003 ("traditional" era) and 2009 and 2013 ("modern" era). The operations were performed by 2762 new surgeons trained before the reform, 2119 new surgeons trained following reform and 15,041 experienced surgeons. We used a difference-in-differences analysis comparing outcomes in matched patients treated by new versus experienced surgeons within each era, controlling for the hospital, operation, and patient risk factors. RESULTS: Traditional era odds of 30-day mortality among matched patients treated by new versus experienced surgeons were significantly elevated [odds ratio (OR) 1.13; 95% confidence interval (CI) (1.05, 1.22), P < 0.001). The modern era elevated odds of mortality were not significant [OR 1.06; 95% CI (0.97-1.16), P = 0.239]. Relative performance of new and experienced surgeons with respect to 30-day mortality did not appear to change from the traditional era to the modern era [OR 0.93; 95% CI (0.83-1.05), P = 0.233]. There were statistically significant adverse changes over time in relative performance to experienced surgeons in prolonged length of stay [OR 1.08; 95% CI (1.02-1.15), P = 0.015], anesthesia time [9 min; 95% CI (8-10), P < 0.001], and costs [255USD; 95% CI (2-508), P = 0.049]. CONCLUSIONS: Duty hour reform showed no significant effect on 30-day mortality achieved by new surgeons compared to their more experienced colleagues. Patients of new surgeons, however, trained after duty hour reform displayed some increases in the resources needed for their care.

Comparing Outcomes and Costs of Medical Patients Treated at Major Teaching and Non-teaching Hospitals: A National Matched Analysis.

BACKGROUND: Teaching hospitals typically pioneer investment in new technology and cultivate workforce characteristics generally associated with better quality, but the value of this extra investment is unclear. OBJECTIVE: Compare outcomes and costs between major teaching and non-teaching hospitals by closely matching on patient characteristics. DESIGN: Medicare patients at 339 major teaching hospitals (resident-to-bed (RTB) ratios ≥ 0.25); matched patient controls from 2439 non-teaching hospitals (RTB ratios < 0.05). PARTICIPANTS: Forty-three thousand nine hundred ninety pairs of patients (one from a major teaching hospital and one from a non-teaching hospital) admitted for acute myocardial infarction (AMI), 84,985 pairs admitted for heart failure (HF), and 74,947 pairs admitted for pneumonia (PNA). EXPOSURE: Treatment at major teaching hospitals versus non-teaching hospitals. MAIN MEASURES: Thirty-day all-cause mortality, readmissions, ICU utilization, costs, payments, and value expressed as extra cost for a 1% improvement in survival. KEY RESULTS: Thirty-day mortality was lower in teaching than non-teaching hospitals (10.7% versus 12.0%, difference = - 1.3%, P < 0.0001). The paired cost difference (teaching - non-teaching) was $273 (P < 0.0001), yielding $211 per 1% mortality improvement. For the quintile of pairs with highest risk on admission, mortality differences were larger (24.6% versus 27.6%, difference = - 3.0%, P < 0.0001), and paired cost difference = $1289 (P < 0.0001), yielding $427 per 1% mortality improvement at 30 days. Readmissions and ICU utilization were lower in teaching hospitals (both P < 0.0001), but length of stay was longer (5.5 versus 5.1 days, P < 0.0001). Finally, individual results for AMI, HF, and PNA showed similar findings as in the combined results. CONCLUSIONS AND RELEVANCE: Among Medicare patients admitted for common medical conditions, as admission risk of mortality increased, the absolute mortality benefit of treatment at teaching hospitals also increased, though accompanied by marginally higher cost. Major teaching hospitals appear to return good value for the extra resources used.

Comparing Resource Use in Medical Admissions of Children With Complex Chronic Conditions.

BACKGROUND: Children with complex chronic conditions (CCCs) utilize a disproportionate share of hospital resources. OBJECTIVE: We asked whether some hospitals display a significantly different pattern of resource utilization than others when caring for similar children with CCCs admitted for medical diagnoses. RESEARCH DESIGN: Using Pediatric Health Information System data from 2009 to 2013, we constructed an inpatient Template of 300 children with CCCs, matching these to 300 patients at each hospital, thereby performing a type of direct standardization. SUBJECTS: Children with CCCs were drawn from a list of the 40 most common medical principal diagnoses, then matched to patients across 40 Children's Hospitals. MEASURES: Rate of intensive care unit admission, length of stay, resource cost. RESULTS: For the Template-matched patients, when comparing resource use at the lower 12.5-percentile and upper 87.5-percentile of hospitals, we found: intensive care unit utilization was 111% higher (6.6% vs. 13.9%, P<0.001); hospital length of stay was 25% higher (2.4 vs. 3.0 d/admission, P<0.001); and finally, total cost per patient varied by 47% ($6856 vs. $10,047, P<0.001). Furthermore, some hospitals, compared with their peers, were more efficient with low-risk patients and less efficient with high-risk patients, whereas other hospitals displayed the opposite pattern. CONCLUSIONS: Hospitals treating similar patients with CCCs admitted for similar medical diagnoses, varied greatly in resource utilization. Template Matching can aid chief quality officers benchmarking their hospitals to peer institutions and can help determine types of their patients having the most aberrant outcomes, facilitating quality initiatives to target these patients.

Defining Multimorbidity in Older Surgical Patients.

BACKGROUND: There are numerous definitions of multimorbidity (MM). None systematically examines specific comorbidity combinations accounting for multiple testing when exploring large datasets. OBJECTIVES: Develop and validate a list of all single, double, and triple comorbidity combinations, with each individual qualifying comorbidity set (QCS) more than doubling the odds of mortality versus its reference population. Patients with at least 1 QCS were defined as having MM. RESEARCH DESIGN: Cohort-based study with a matching validation study. SUBJECTS: All fee-for-service Medicare patients between age 65 and 85 without dementia or metastatic solid tumors undergoing general surgery in 2009-2010, and an additional 2011-2013 dataset. MEASURES: 30-day all-location mortality. RESULTS: There were 576 QCSs (2 singles, 63 doubles, and 511 triples), each set more than doubling the odds of dying. In 2011, 36% of eligible patients had MM. As a group, multimorbid patients (mortality rate=7.0%) had a mortality Mantel-Haenszel odds ratio=1.90 (1.77-2.04) versus a reference that included both multimorbid and nonmultimorbid patients (mortality rate=3.3%), and Mantel-Haenszel odds ratio=3.72 (3.51-3.94) versus only nonmultimorbid patients (mortality rate=1.6%). When matching 3151 pairs of multimorbid patients from low-volume hospitals to similar patients in high-volume hospitals, the mortality rates were 6.7% versus 5.2%, respectively (P=0.006). CONCLUSIONS: A list of QCSs identified a third of older patients undergoing general surgery that had greatly elevated mortality. These sets can be used to identify vulnerable patients and the specific combinations of comorbidities that make them susceptible to poor outcomes.

Disparities in Breast Cancer Survival by Socioeconomic Status Despite Medicare and Medicaid Insurance.

Policy Points Patients with low socioeconomic status (SES) experience poorer survival rates after diagnosis of breast cancer, even when enrolled in Medicare and Medicaid. Most of the difference in survival is due to more advanced cancer on presentation and the general poor health of lower SES patients, while only a very small fraction of the SES disparity is due to differences in cancer treatment. Even when comparing only low- versus not-low-SES whites (without confounding by race) the survival disparity between disparate white SES populations is very large and is associated with lower use of preventive care, despite having insurance. CONTEXT: Disparities in breast cancer survival by socioeconomic status (SES) exist despite the "safety net" programs Medicare and Medicaid. What is less clear is the extent to which SES disparities affect various racial and ethnic groups and whether causes differ across populations. METHODS: We conducted a tapered matching study comparing 1,890 low-SES (LSES) non-Hispanic white, 1,824 black, and 723 Hispanic white women to 60,307 not-low-SES (NLSES) non-Hispanic white women, all in Medicare and diagnosed with invasive breast cancer between 1992 and 2010 in 17 US Surveillance, Epidemiology, and End Results (SEER) regions. LSES Medicare patients were Medicaid dual-eligible and resided in neighborhoods with both high poverty and low education. NLSES Medicare patients had none of these factors. MEASUREMENTS: 5-year and median survival. FINDINGS: LSES non-Hispanic white patients were diagnosed with more stage IV disease (6.6% vs 3.6%; p < 0.0001), larger tumors (24.6 mm vs 20.2 mm; p < 0.0001), and more chronic diseases such as diabetes (37.8% vs 19.0%; p < 0.0001) than NLSES non-Hispanic white patients. Disparity in 5-year survival (NLSES - LSES) was 13.7% (p < 0.0001) when matched for age, year, and SEER site (a 42-month difference in median survival). Additionally, matching 55 presentation factors, including stage, reduced the disparity to 4.9% (p = 0.0012), but further matching on treatments yielded little further change in disparity: 4.6% (p = 0.0014). Survival disparities among LSES blacks and Hispanics, also versus NLSES whites, were significantly associated with presentation factors, though black patients also displayed disparities related to initial treatment. Before being diagnosed, all LSES populations used significantly less preventive care services than matched NLSES controls. CONCLUSIONS: In Medicare, SES disparities in breast cancer survival were large (even among non-Hispanic whites) and predominantly related to differences of presentation characteristics at diagnosis rather than differences in treatment. Preventive care was less frequent in LSES patients, which may help explain disparities at presentation.

Valuing hospital investments in nursing: multistate matched-cohort study of surgical patients.

BACKGROUND: There are known clinical benefits associated with investments in nursing. Less is known about their value. AIMS: To compare surgical patient outcomes and costs in hospitals with better versus worse nursing resources and to determine if value differs across these hospitals for patients with different mortality risks. METHODS: Retrospective matched-cohort design of patient outcomes at hospitals with better versus worse nursing resources, defined by patient-to-nurse ratios, skill mix, proportions of bachelors-degree nurses and nurse work environments. The sample included 62 715 pairs of surgical patients in 76 better nursing resourced hospitals and 230 worse nursing resourced hospitals from 2013 to 2015. Patients were exactly matched on principal procedures and their hospital's size category, teaching and technology status, and were closely matched on comorbidities and other risk factors. RESULTS: Patients in hospitals with better nursing resources had lower 30-day mortality: 2.7% vs 3.1% (p<0.001), lower failure-to-rescue: 5.4% vs 6.2% (p<0.001), lower readmissions: 12.6% vs 13.5% (p<0.001), shorter lengths of stay: 4.70 days vs 4.76 days (p<0.001), more intensive care unit admissions: 17.2% vs 15.4% (p<0.001) and marginally higher nurse-adjusted costs (which account for the costs of better nursing resources): $20 096 vs $19 358 (p<0.001), as compared with patients in worse nursing resourced hospitals. The nurse-adjusted cost associated with a 1% improvement in mortality at better nursing hospitals was $2035. Patients with the highest mortality risk realised the greatest value from nursing resources. CONCLUSION: Hospitals with better nursing resources provided better clinical outcomes for surgical patients at a small additional cost. Generally, the sicker the patient, the greater the value at better nursing resourced hospitals.

Impact of Dependent Coverage Provision of the Affordable Care Act on Insurance Continuity for Adolescents and Young Adults With Cancer.

PURPOSE: The 2010 Dependent Coverage Provision (DCP) of the Affordable Care Act (ACA) allowed enrollees to remain on their parents' health insurance until 26 years of age. We compared rates of insurance disenrollment among patients with cancer who were DCP-eligible at age 19 to those who were not eligible at age 19. METHODS: Using OptumLabs Data Warehouse, which contains longitudinal, real-world, de-identified administrative claims for commercial enrollees, we examined patients born between 1982 and 1993 and diagnosed with cancer between 2000 and 2015. In the recent cohort, patients who turned 19 in 2010-2012 (DCP-eligible to stay on parents' insurance) were matched to patients who turned 19 in 2007-2009 (not DCP-eligible when turning 19). In an earlier control cohort, patients who turned 19 between 2004 and 2006 (not DCP-eligible) were matched to patients who turned 19 between 2001 and 2003 (not DCP-eligible). Patients were matched on cancer type, diagnosis date, demographics, and treatment characteristics. The time to loss of coverage was estimated using Cox models. Difference-in-difference between the recent and earlier cohorts was also evaluated. RESULTS: A total of 2,829 patients who turned 19 years of age in 2010-2012 were matched to patients who turned 19 in 2007-2009. Median time to disenrollment was 26 months for younger patients versus 22 months for older patients (hazard ratio [HR], 0.85; 95% CI, 0.80 to 0.90; P = .001). In 8,978 patients who turned 19 between 2001 and 2006, median time to disenrollment was 20 months among both younger and older patients (HR, 0.99; 95% CI, 0.94 to 1.03; P = .59). The difference between the recent cohort and the earlier control cohort was a 15% greater reduction in coverage loss (P < .0001), favoring those turning 19 after the DCP went into effect. CONCLUSION: In the vulnerable population of adolescent and young adult cancer survivors, the ACA may have lowered the insurance dropout rate.

Using Appendicitis to Improve Estimates of Childhood Medicaid Participation Rates.

OBJECTIVE: Administrative data are often used to estimate state Medicaid/Children's Health Insurance Program duration of enrollment and insurance continuity, but they are generally not used to estimate participation (the fraction of eligible children enrolled) because administrative data do not include reasons for disenrollment and cannot observe eligible never-enrolled children, causing estimates of eligible unenrolled to be inaccurate. Analysts are therefore forced to either utilize survey information that is not generally linkable to administrative claims or rely on duration and continuity measures derived from administrative data and forgo estimating claims-based participation. We introduce appendectomy-based participation (ABP) to estimate statewide participation rates using claims by taking advantage of a natural experiment around statewide appendicitis admissions to improve the accuracy of participation rate estimates. METHODS: We used Medicaid Analytic eXtract (MAX) for 2008-2010; and the American Community Survey for 2008-2010 from 43 states to calculate ABP, continuity ratio, duration, and participation based on the American Community Survey (ACS). RESULTS: In the validation study, median participation rate using ABP was 86% versus 87% for ACS-based participation estimates using logical edits and 84% without logical edits. Correlations between ABP and ACS with or without logical edits was 0.86 (P < .0001). Using regression analysis, ABP alone was a significant predictor of ACS (P < .0001) with or without logical edits, and adding duration and/or the continuity ratio did not significantly improve the model. CONCLUSION: Using the ABP rate derived from administrative claims (MAX) is a valid method to estimate statewide public insurance participation rates in children.