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.).

Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine.

BACKGROUND: A purpose of duty-hour regulations is to reduce sleep deprivation in medical trainees, but their effects on sleep, sleepiness, and alertness are largely unknown. METHODS: We randomly assigned 63 internal-medicine residency programs in the United States to follow either standard 2011 duty-hour policies or flexible policies that maintained an 80-hour workweek without limits on shift length or mandatory time off between shifts. Sleep duration and morning sleepiness and alertness were compared between the two groups by means of a noninferiority design, with outcome measures including sleep duration measured with actigraphy, the Karolinska Sleepiness Scale (with scores ranging from 1 [extremely alert] to 9 [extremely sleepy, fighting sleep]), and a brief computerized Psychomotor Vigilance Test (PVT-B), with long response times (lapses) indicating reduced alertness. RESULTS: Data were obtained over a period of 14 days for 205 interns at six flexible programs and 193 interns at six standard programs. The average sleep time per 24 hours was 6.85 hours (95% confidence interval [CI], 6.61 to 7.10) among those in flexible programs and 7.03 hours (95% CI, 6.78 to 7.27) among those in standard programs. Sleep duration in flexible programs was noninferior to that in standard programs (between-group difference, -0.17 hours per 24 hours; one-sided lower limit of the 95% confidence interval, -0.45 hours; noninferiority margin, -0.5 hours; P = 0.02 for noninferiority), as was the score on the Karolinska Sleepiness Scale (between-group difference, 0.12 points; one-sided upper limit of the 95% confidence interval, 0.31 points; noninferiority margin, 1 point; P<0.001). Noninferiority was not established for alertness according to the PVT-B (between-group difference, -0.3 lapses; one-sided upper limit of the 95% confidence interval, 1.6 lapses; noninferiority margin, 1 lapse; P = 0.10). CONCLUSIONS: This noninferiority trial showed no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. Noninferiority of the flexible group for alertness was not established. (Funded by the National Heart, Lung, and Blood Institute and American Council for Graduate Medical Education; ClinicalTrials.gov number, NCT02274818.).

Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine.

BACKGROUND: Concern persists that inflexible duty-hour rules in medical residency programs may adversely affect the training of physicians. METHODS: We randomly assigned 63 internal medicine residency programs in the United States to be governed by standard duty-hour policies of the 2011 Accreditation Council for Graduate Medical Education (ACGME) or by more flexible policies that did not specify limits on shift length or mandatory time off between shifts. Measures of educational experience included observations of the activities of interns (first-year residents), surveys of trainees (both interns and residents) and faculty, and intern examination scores. RESULTS: There were no significant between-group differences in the mean percentages of time that interns spent in direct patient care and education nor in trainees' perceptions of an appropriate balance between clinical demands and education (primary outcome for trainee satisfaction with education; response rate, 91%) or in the assessments by program directors and faculty of whether trainees' workload exceeded their capacity (primary outcome for faculty satisfaction with education; response rate, 90%). Another survey of interns (response rate, 49%) revealed that those in flexible programs were more likely to report dissatisfaction with multiple aspects of training, including educational quality (odds ratio, 1.67; 95% confidence interval [CI], 1.02 to 2.73) and overall well-being (odds ratio, 2.47; 95% CI, 1.67 to 3.65). In contrast, directors of flexible programs were less likely to report dissatisfaction with multiple educational processes, including time for bedside teaching (response rate, 98%; odds ratio, 0.13; 95% CI, 0.03 to 0.49). Average scores (percent correct answers) on in-training examinations were 68.9% in flexible programs and 69.4% in standard programs; the difference did not meet the noninferiority margin of 2 percentage points (difference, -0.43; 95% CI, -2.38 to 1.52; P=0.06 for noninferiority). od Institute and the ACGME; iCOMPARE ClinicalTrials.gov number, NCT02274818 .). CONCLUSIONS: There was no significant difference in the proportion of time that medical interns spent on direct patient care and education between programs with standard duty-hour policies and programs with more flexible policies. Interns in flexible programs were less satisfied with their educational experience than were their peers in standard programs, but program directors were more satisfied. (Funded by the National Heart, Lung, and Blo

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.

Practice Style Variation in Medicaid and Non-Medicaid Children With Complex Chronic Conditions Undergoing Surgery.

OBJECTIVES: With differential payment between Medicaid and Non-Medicaid services, we asked whether style-of-practice differs between similar Medicaid and Non-Medicaid children with complex chronic conditions (CCCs) undergoing surgery. SUMMARY OF BACKGROUND DATA: Surgery in children with CCCs accounts for a disproportionately large percentage of resource utilization at major children's hospitals. METHODS: A matched cohort design, studying 23,582 pairs of children with CCCs undergoing surgery (Medicaid matched to Non-Medicaid within the same hospital) from 2009 to 2013 in 41 Children's Hospitals. Patients were matched on age, sex, principal procedure, CCCs, and other characteristics. RESULTS: Median cost in Medicaid patients was $21,547 versus $20,527 in Non-Medicaid patients (5.0% higher, P < 0.001). Median paired difference in cost (Medicaid minus Non-Medicaid) was $320 [95% confidence interval (CI): $208, $445], (1.6% higher, P < 0.001). 90th percentile costs were $133,640 versus $127,523, (4.8% higher, P < 0.001). Mean paired difference in length of stay (LOS) was 0.50 days (95% CI: 0.36, 0.65), (P < 0.001). ICU utilization was 2.8% higher (36.7% vs 35.7%, P < 0.001). Finally, in-hospital mortality pooled across all pairs was higher in Medicaid patients (0.38% vs 0.22%, P = 0.002). After adjusting for multiple testing, no individual hospital displayed significant differences in cost between groups, only 1 hospital displayed significant differences in LOS and 1 in ICU utilization. CONCLUSIONS: Treatment style differences between Medicaid and Non-Medicaid children were small, suggesting little disparity with in-hospital surgical care for patients with CCCs operated on within Children's Hospitals. However, in-hospital mortality, although rare, was slightly higher in Medicaid patients and merits further investigation.

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.

Comparing Outcomes between Antibody Induction Therapies in Kidney Transplantation.

Kidney transplant recipients often receive antibody induction. Previous studies of induction therapy were often limited by short follow-up and/or absence of information about complications. After linking Organ Procurement and Transplantation Network data with Medicare claims, we compared outcomes between three induction therapies for kidney recipients. Using novel matching techniques developed on the basis of 15 clinical and demographic characteristics, we generated 1:1 pairs of alemtuzumab-rabbit antithymocyte globulin (rATG) (5330 pairs) and basiliximab-rATG (9378 pairs) recipients. We used paired Cox regression to analyze the primary outcomes of death and death or allograft failure. Secondary outcomes included death or sepsis, death or lymphoma, death or melanoma, and healthcare resource utilization within 1 year. Compared with rATG recipients, alemtuzumab recipients had higher risk of death (hazard ratio [HR], 1.14; 95% confidence interval [95% CI], 1.03 to 1.26; P<0.01) and death or allograft failure (HR, 1.18; 95% CI, 1.09 to 1.28; P<0.001). Results for death as well as death or allograft failure were generally consistent among elderly and nonelderly subgroups and among pairs receiving oral prednisone. Compared with rATG recipients, basiliximab recipients had higher risk of death (HR, 1.08; 95% CI, 1.01 to 1.16; P=0.03) and death or lymphoma (HR, 1.12; 95% CI, 1.01 to 1.23; P=0.03), although these differences were not confirmed in subgroup analyses. One-year resource utilization was slightly lower among alemtuzumab recipients than among rATG recipients, but did not differ between basiliximab and rATG recipients. This observational evidence indicates that, compared with alemtuzumab and basiliximab, rATG associates with lower risk of adverse outcomes, including mortality.

Examining Causes of Racial Disparities in General Surgical Mortality: Hospital Quality Versus Patient Risk.

BACKGROUND: Racial disparities in general surgical outcomes are known to exist but not well understood. OBJECTIVES: To determine if black-white disparities in general surgery mortality for Medicare patients are attributable to poorer health status among blacks on admission or differences in the quality of care provided by the admitting hospitals. RESEARCH DESIGN: Matched cohort study using Tapered Multivariate Matching. SUBJECTS: All black elderly Medicare general surgical patients (N=18,861) and white-matched controls within the same 6 states or within the same 838 hospitals. MEASURES: Thirty-day mortality (primary); others include in-hospital mortality, failure-to-rescue, complications, length of stay, and readmissions. RESULTS: Matching on age, sex, year, state, and the exact same procedure, blacks had higher 30-day mortality (4.0% vs. 3.5%, P<0.01), in-hospital mortality (3.9% vs. 2.9%, P<0.0001), in-hospital complications (64.3% vs. 56.8% P<0.0001), and failure-to-rescue rates (6.1% vs. 5.1%, P<0.001), longer length of stay (7.2 vs. 5.8 d, P<0.0001), and more 30-day readmissions (15.0% vs. 12.5%, P<0.0001). Adding preoperative risk factors to the above match, there was no significant difference in mortality or failure-to-rescue, and all other outcome differences were small. Blacks matched to whites in the same hospital displayed no significant differences in mortality, failure-to-rescue, or readmissions. CONCLUSIONS: Black and white Medicare patients undergoing the same procedures with closely matched risk factors displayed similar mortality, suggesting that racial disparities in general surgical mortality are not because of differences in hospital quality. To reduce the observed disparities in surgical outcomes, the poorer health of blacks on presentation for surgery must be addressed.

Racial disparities in colon cancer survival: a matched cohort study.

BACKGROUND: Differences in colon cancer survival by race are a recognized problem among Medicare beneficiaries. OBJECTIVE: To determine to what extent the racial disparity in survival is due to disparity in presentation characteristics at diagnosis or disparity in subsequent treatment. DESIGN: Black patients with colon cancer were matched with 3 groups of white patients: a "demographic characteristics" match controlling for age, sex, diagnosis year, and Survey, Epidemiology, and End Results (SEER) site; a "presentation" match controlling for demographic characteristics plus comorbid conditions and tumor characteristics, including stage and grade; and a "treatment" match, including presentation variables plus details of surgery, radiation, and chemotherapy. SETTING: 16 U.S. SEER sites. PATIENTS: 7677 black patients aged 65 years or older diagnosed between 1991 and 2005 in the SEER-Medicare database and 3 sets of 7677 matched white patients, followed until 31 December 2009. MEASUREMENTS: 5-year survival. RESULTS: The absolute difference in 5-year survival between black and white patients was 9.9% (95% CI, 8.3% to 11.4%; P<0.001) in the demographic characteristics match. This disparity remained unchanged between 1991 and 2005. After matching for presentation characteristics, the difference decreased to 4.9% (CI, 3.6% to 6.1%; P<0.001). After additional matching for treatment, this difference decreased to 4.3% (CI, 2.9% to 5.5%; P<0.001). The disparity in survival attributed to treatment differences made up only an absolute 0.6% of the overall 9.9% survival disparity. LIMITATION: An observational study limited to elderly Medicare fee-for-service beneficiaries living in selected geographic areas. CONCLUSION: Racial disparities in colon cancer survival did not decrease among patients diagnosed between 1991 and 2005. This persistent disparity seemed to be more related to presentation characteristics at diagnosis than to subsequent treatment differences. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality and National Science Foundation.

Association of the 2011 ACGME resident duty hour reforms with mortality and readmissions among hospitalized Medicare patients.

IMPORTANCE: Patient outcomes associated with the 2011 Accreditation Council for Graduate Medical Education (ACGME) duty hour reforms have not been evaluated at a national level. OBJECTIVE: To evaluate the association of the 2011 ACGME duty hour reforms with mortality and readmissions. DESIGN, SETTING, AND PARTICIPANTS: Observational study of Medicare patient admissions (6,384,273 admissions from 2,790,356 patients) to short-term, acute care, nonfederal hospitals (n = 3104) with principal medical diagnoses of acute myocardial infarction, stroke, gastrointestinal bleeding, or congestive heart failure or a Diagnosis Related Group classification of general, orthopedic, or vascular surgery. Of the hospitals, 96 (3.1%) were very major teaching, 138 (4.4%) major teaching, 442 (14.2%) minor teaching, 443 (14.3%) very minor teaching, and 1985 (64.0%) nonteaching. EXPOSURE: Resident-to-bed ratio as a continuous measure of hospital teaching intensity. MAIN OUTCOMES AND MEASURES: Change in 30-day all-location mortality and 30-day all-cause readmission, comparing patients in more intensive relative to less intensive teaching hospitals before (July 1, 2009-June 30, 2011) and after (July 1, 2011-June 30, 2012) duty hour reforms, adjusting for patient comorbidities, time trends, and hospital site. RESULTS: In the 2 years before duty hour reforms, there were 4,325,854 admissions with 288,422 deaths and 602,380 readmissions. In the first year after the reforms, accounting for teaching hospital intensity, there were 2,058,419 admissions with 133,547 deaths and 272,938 readmissions. There were no significant postreform differences in mortality accounting for teaching hospital intensity for combined medical conditions (odds ratio [OR], 1.00; 95% CI, 0.96-1.03), combined surgical categories (OR, 0.99; 95% CI, 0.94-1.04), or any of the individual medical conditions or surgical categories. There were no significant postreform differences in readmissions for combined medical conditions (OR, 1.00; 95% CI, 0.97-1.02) or combined surgical categories (OR, 1.00; 95% CI, 0.98-1.03). For the medical condition of stroke, there were higher odds of readmissions in the postreform period (OR, 1.06; 95% CI, 1.001-1.13). However, this finding was not supported by sensitivity analyses and there were no significant postreform differences for readmissions for any other individual medical condition or surgical category. CONCLUSIONS AND RELEVANCE: Among Medicare beneficiaries, there were no significant differences in the change in 30-day mortality rates or 30-day all-cause readmission rates for those hospitalized in more intensive relative to less intensive teaching hospitals in the year after implementation of the 2011 ACGME duty hour reforms compared with those hospitalized in the 2 years before implementation.

Acute kidney injury, renal function, and the elderly obese surgical patient: a matched case-control study.

OBJECTIVE: To investigate the association between obesity and perioperative acute kidney injury (AKI), controlling for preoperative kidney dysfunction. BACKGROUND: More than 30% of patients older than 60 years are obese and, therefore, at risk for kidney disease. Postoperative AKI is a significant problem. METHODS: We performed a matched case-control study of patients enrolled in the Obesity and Surgical Outcomes Study, using data of Medicare claims enriched with detailed chart review. Each AKI patient was matched with a non-AKI control similar in procedure type, age, sex, race, emergency status, transfer status, baseline estimated glomerular filtration rate, admission APACHE score, and the risk of death score with fine balance on hospitals. RESULTS: We identified 514 AKI cases and 694 control patients. Of the cases, 180 (35%) followed orthopedic procedures and 334 (65%) followed colon or thoracic surgery. After matching, obese patients undergoing a surgical procedure demonstrated a 65% increase in odds of AKI within 30 days from admission (odds ratio = 1.65, P < 0.005) when compared with the nonobese patients. After adjustment for potential confounders, the odds of postoperative AKI remained elevated in the elderly obese (odds ratio = 1.68, P = 0.01.) CONCLUSIONS: : Obesity is an independent risk factor for postoperative AKI in patients older than 65 years. Efforts to optimize kidney function preoperatively should be employed in this at-risk population along with keen monitoring and maintenance of intraoperative hemodynamics. When subtle reductions in urine output or a rising creatinine are observed postoperatively, timely clinical investigation is warranted to maximize renal recovery.

Teaching hospital five-year mortality trends in the wake of duty hour reforms.

BACKGROUND: The Accreditation Council for Graduate Medical Education (ACGME) implemented duty hour regulations for residents in 2003 and again in 2011. While previous studies showed no systematic impacts in the first 2 years post-reform, the impact on mortality in subsequent years has not been examined. OBJECTIVE: To determine whether duty hour regulations were associated with changes in mortality among Medicare patients in hospitals of different teaching intensity after the first 2 years post-reform. DESIGN: Observational study using interrupted time series analysis with data from July 1, 2000 to June 30, 2008. Logistic regression was used to examine the change in mortality for patients in more versus less teaching-intensive hospitals before (2000-2003) and after (2003-2008) duty hour reform, adjusting for patient comorbidities, time trends, and hospital site. PATIENTS: Medicare patients (n = 13,678,956) admitted to short-term acute care non-federal hospitals with principal diagnoses of acute myocardial infarction (AMI), gastrointestinal bleeding, or congestive heart failure (CHF); or a diagnosis-related group (DRG) classification of general, orthopedic, or vascular surgery. MAIN MEASURE: All-location mortality within 30 days of hospital admission. KEY RESULTS: In medical and surgical patients, there were no consistent changes in the odds of mortality at more vs. less teaching intensive hospitals in post-reform years 1-3. However, there were significant relative improvements in mortality for medical patients in the fourth and fifth years post-reform: Post4 (OR 0.88, 95 % CI [0.93-0.94]); Post5 (OR 0.87, [0.82-0.92]) and for surgical patients in the fifth year post-reform: Post5 (OR 0.91, [0.85-0.96]). CONCLUSIONS: Duty hour reform was associated with no significant change in mortality in the early years after implementation, and with a trend toward improved mortality among medical patients in the fourth and fifth years. It is unclear whether improvements in outcomes long after implementation can be attributed to the reform, but concerns about worsening outcomes seem unfounded.

Racial disparities in operative procedure time: the influence of obesity.

BACKGROUND: Using Pennsylvania Medicare claims from 1995 to 1996, the authors previously reported that anesthesia procedure length appears longer in blacks than whites. In a new study using a different and larger data set, the authors now examine whether body mass index (BMI), not available in Medicare claims, explains this difference. The authors also examine the relative contributions of surgical and anesthesia times. METHODS: The Obesity and Surgical Outcomes Study of 47 hospitals throughout Illinois, New York, and Texas abstracted chart information including BMI on elder Medicare patients (779 blacks and 14,596 whites) undergoing hip and knee replacement and repair, colectomy, and thoracotomy between 2002 and 2006. The authors matched all black Medicare patients to comparable whites and compared procedure lengths. RESULTS: Mean BMI in the black and white populations was 30.24 and 28.96 kg/m, respectively (P<0.0001). After matching on age, sex, procedure, comorbidities, hospital, and BMI, mean white BMI in the comparison group was 30.1 kg/m (P=0.94). The typical matched pair difference (black-white) in anesthesia (induction to recovery room) procedure time was 7.0 min (P=0.0019), of which 6 min reflected the surgical (cut-to-close) time difference (P=0.0032). Within matched pairs, where the difference in procedure times was greater than 30 min between patients, blacks more commonly had longer procedure times (Odds=1.39; P=0.0008). CONCLUSIONS: Controlling for patient characteristics, BMI, and hospital, elder black Medicare patients experienced slightly but significantly longer procedure length than their closely matched white controls. Procedure length difference was almost completely due to surgery, not anesthesia.

Characteristics associated with differences in survival among black and white women with breast cancer.

IMPORTANCE: Difference in breast cancer survival by race is a recognized problem among Medicare beneficiaries. OBJECTIVE: To determine if racial disparity in breast cancer survival is primarily attributable to differences in presentation characteristics at diagnosis or subsequent treatment. DESIGN, SETTING, AND PATIENTS: Comparison of 7375 black women 65 years and older diagnosed between 1991 to 2005 and 3 sets of 7375 matched white control patients selected from 99,898 white potential controls, using data for 16 US Surveillance, Epidemiology and End Results (SEER) sites in the SEER-Medicare database. All patients received follow-up through December 31, 2009, and the black case patients were matched to 3 white control populations on demographics (age, year of diagnosis, and SEER site), presentation (demographics variables plus patient comorbid conditions and tumor characteristics such as stage, size, grade, and estrogen receptor status), and treatment (presentation variables plus details of surgery, radiation therapy, and chemotherapy). MAIN OUTCOMES AND MEASURES: 5-Year survival. RESULTS: The absolute difference in 5-year survival (blacks, 55.9%; whites, 68.8%) was 12.9% (95% CI, 11.5%-14.5%; P < .001) in the demographics match. This difference remained unchanged between 1991 and 2005. After matching on presentation characteristics, the absolute difference in 5-year survival was 4.4% (95% CI, 2.8%-5.8%; P < .001) and was 3.6% (95% CI, 2.3%-4.9%; P < .001) lower for blacks than for whites matched also on treatment. In the presentation match, fewer blacks received treatment (87.4% vs 91.8%; P < .001), time from diagnosis to treatment was longer (29.2 vs 22.8 days; P < .001), use of anthracyclines and taxols was lower (3.7% vs 5.0%; P < .001), and breast-conserving surgery without other treatment was more frequent (8.2% vs 7.3%; P = .04). Nevertheless, differences in survival associated with treatment differences accounted for only 0.81% of the 12.9% survival difference. CONCLUSIONS AND RELEVANCE: In the SEER-Medicare database, differences in breast cancer survival between black and white women did not substantially change among women diagnosed between 1991 and 2005. These differences in survival appear primarily related to presentation characteristics at diagnosis rather than treatment differences.

Medical and financial risks associated with surgery in the elderly obese.

OBJECTIVE: To study the medical and financial outcomes associated with surgery in elderly obese patients and to ask if obesity itself influences outcomes above and beyond the effects from comorbidities that are known to be associated with obesity. BACKGROUND: Obesity is a surgical risk factor not present in Medicare's risk adjustment or payment algorithms, as BMI is not collected in administrative claims. METHODS: A total of 2045 severely or morbidly obese patients (BMI ≥ 35 kg/m, aged between 65 and 80 years) selected from 15,914 elderly patients in 47 hospitals undergoing hip and knee surgery, colectomy, and thoracotomy were matched to 2 sets of 2045 nonobese patients (BMI = 20-30 kg/m). A "limited match" controlled for age, sex, race, procedure, and hospital. A "complete match" also controlled for 30 additional factors such as diabetes and admission clinical data from chart abstraction. RESULTS: Mean BMI in the obese patients was 40 kg/m compared with 26 kg/m in the nonobese. In the complete match, obese patients displayed increased odds of wound infection: OR (odds ratio) = 1.64 (95% CI: 1.21, 2.21); renal dysfunction: OR = 2.05 (1.39, 3.05); urinary tract infection: OR = 1.55 (1.24, 1.94); hypotension: OR = 1.38 (1.07, 1.80); respiratory events: OR = 1.44 (1.19, 1.75); 30-day readmission: OR = 1.38 (1.08, 1.77); and a 12% longer length of stay (8%, 17%). Provider costs were 10% (7%, 12%) greater in obese than in nonobese patients, whereas Medicare payments increased only 3% (2%, 5%). Findings were similar in the limited match. CONCLUSIONS: Obesity increases the risks and costs of surgery. Better approaches are needed to reduce these risks. Furthermore, to avoid incentives to underserve this population, Medicare should consider incorporating incremental costs of caring for obese patients into payment policy and include obesity in severity adjustment models.

The impact of resident duty hour reform on hospital readmission rates among Medicare beneficiaries.

BACKGROUND: A key goal of resident duty hour reform by the Accreditation Council for Graduate Medical Education (ACGME) in 2003 was to improve patient outcomes. OBJECTIVE: To assess whether the reform led to a change in readmission rates. DESIGN: Observational study using multiple time series analysis with hospital discharge data from July 1, 2000 to June 30, 2005. Fixed effects logistic regression was used to examine the change in the odds of readmission in more versus less teaching-intensive hospitals before and after duty hour reform. PARTICIPANTS: All unique Medicare patients (n = 8,282,802) admitted to acute-care nonfederal hospitals with principal diagnoses of acute myocardial infarction, congestive heart failure, gastrointestinal bleeding, or stroke (combined medical group), or a DRG classification of general, orthopedic, or vascular surgery (combined surgical group). MAIN MEASURES: Primary outcome was 30-day all-cause readmission. Secondary outcomes were (1) readmission or death within 30 days of discharge, and (2) readmission, death during the index admission, or death within 30 days of discharge. KEY RESULTS: For the combined medical group, there was no evidence of a change in readmission rates in more versus less teaching-intensive hospitals [OR = 0.99 (95% CI 0.94, 1.03) in post-reform year 1 and OR = 0.99 (95% CI 0.95, 1.04) in post-reform year 2]. There was also no evidence of relative changes in readmission rates for the combined surgical group: OR = 1.03 (95% CI 0.98, 1.08) for post-reform year 1 and OR = 1.02 (95% CI 0.98, 1.07) for post-reform year 2. Findings for the secondary outcomes combining readmission and death were similar. CONCLUSIONS: Among Medicare beneficiaries, there were no changes in hospital readmission rates associated with resident duty hour reform.

Estimating anesthesia time using the medicare claim: a validation study.

INTRODUCTION: Procedure length is a fundamental variable associated with quality of care, though seldom studied on a large scale. The authors sought to estimate procedure length through information obtained in the anesthesia claim submitted to Medicare to validate this method for future studies. METHODS: The Obesity and Surgical Outcomes Study enlisted 47 hospitals located across New York, Texas, and Illinois to study patients undergoing hip, knee, colon, and thoracotomy procedures. A total of 15,914 charts were abstracted to determine body mass index and initial patient physiology. Included in this abstraction were induction, cut, close, and recovery room times. This chart information was merged to Medicare claims that included anesthesia Part B billing information. Correlations between chart times and claim times were analyzed, models developed, and median absolute differences in minutes calculated. RESULTS: Of the 15,914 eligible patients, there were 14,369 for whom both chart and claim times were available for analysis. For these 14,369, the Spearman correlation between chart and claim time was 0.94 (95% CI 0.94, 0.95), and the median absolute difference between chart and claim time was only 5 min (95% CI: 5.0, 5.5). The anesthesia claim can also be used to estimate surgical procedure length, with only a modest increase in error. CONCLUSION: The anesthesia bill found in Medicare claims provides an excellent source of information for studying surgery time on a vast scale throughout the United States. However, errors in both chart abstraction and anesthesia claims can occur. Care must be taken in the handling of outliers in these data.

Nonoperative care for hip fracture in the elderly: the influence of race, income, and comorbidities.

CONTEXT: Hip fracture occurs in 340,000 older adults each year. Operative repair is the standard of care, maximizing the chances of functional recovery. Not receiving operative care may condemn patients to a lifetime of pain and potential immobility. OBJECTIVE: To measure the incidence of nonoperative treatment for first-time hip fracture in a population-based cohort and to measure the odds of nonoperative treatment of hip fracture among patients of differing race and income. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of 165,861 Medicare beneficiaries admitted for hip fracture between March 31, 2002 and December 31, 2006 to hospitals in New York, Illinois, and Texas. MAIN OUTCOME MEASURES: Odds of nonoperative management of hip fracture, adjusted for fracture characteristics, comorbidities, source of admission, age, sex, race, income, and individual hospital effects. RESULTS: Nonoperative management occurred in 6.2% of patients (N = 10,283). After adjustment, black patients had a 79% increase in the odds of nonoperative management as compared with whites (OR 1.79, 95% CI 1.64-1.95). Low income itself was not associated with a change in the odds of nonoperative care. Among patients not receiving operative repair, blacks demonstrated lower mortality than whites at 7 days (7.96% vs. 20.17%, P < 0.0001) and 30 days (24.14% vs. 38.22%, P < 0.0001). CONCLUSIONS: Black race predicts an increased odds of nonoperative care for hip fracture. Among patients receiving nonoperative care, black patients demonstrated increased survival compared with whites. These results are consistent with differential selection of operative candidates by patient race.

Effects of resident duty hour reform on surgical and procedural patient safety indicators among hospitalized Veterans Health Administration and Medicare patients.

OBJECTIVE: Improving patient safety was a strong motivation behind duty hour regulations implemented by Accreditation Council for Graduate Medical Education on July 1, 2003. We investigated whether rates of patient safety indicators (PSIs) changed after these reforms. RESEARCH DESIGN: Observational study of patients admitted to Veterans Health Administration (VA) (N = 826,047) and Medicare (N = 13,367,273) acute-care hospitals from July 1, 2000 to June 30, 2005. We examined changes in patient safety events in more versus less teaching-intensive hospitals before (2000-2003) and after (2003-2005) duty hour reform, using conditional logistic regression, adjusting for patient age, gender, comorbidities, secular trends, baseline severity, and hospital site. MEASURES: Ten PSIs were aggregated into 3 composite measures based on factor analyses: "Continuity of Care," "Technical Care," and "Other" composites. RESULTS: Continuity of Care composite rates showed no significant changes postreform in hospitals of different teaching intensity in either VA or Medicare. In the VA, there were no significant changes postreform for the technical care composite. In Medicare, the odds of a Technical Care PSI event in more versus less teaching-intensive hospitals in postreform year 1 were 1.12 (95% CI; 1.01-1.25); there were no significant relative changes in postreform year 2. Other composite rates increased in VA in postreform year 2 in more versus less teaching-intensive hospitals (odds ratio, 1.63; 95% CI; 1.10-2.41), but not in Medicare in either postreform year. CONCLUSIONS: Duty hour reform had no systematic impact on PSI rates. In the few cases where there were statistically significant increases in the relative odds of developing a PSI, the magnitude of the absolute increases were too small to be clinically meaningful.

Prolonged hospital stay and the resident duty hour rules of 2003.

BACKGROUND: Resident duty hour reforms of 2003 had the potential to create a major impact on the delivery of inpatient care. OBJECTIVE: We examine whether the reforms influenced the probability of a patient experiencing a prolonged hospital length of stay (PLOS), a measure reflecting either inefficiency of care or the development of complications that may slow the rate of discharge. RESEARCH DESIGN: Conditional logistic models to compare PLOS in more versus less teaching-intensive hospitals before and after the reform, adjusting for patient comorbidities, common time trends, and hospital site. SUBJECTS: Medicare (N = 6,059,015) and Veterans Affairs (VA) (N = 210,276) patients admitted for medical conditions (acute myocardial infarction, heart failure, stroke, or gastrointestinal bleeding) or surgical procedures (general, orthopedic, and vascular) from July 2000 to June 2005. MEASURES: Prolonged length of stay. RESULTS: Modeling all medical conditions together, the odds of prolonged stay in the first year post reform at more versus less teaching intensive hospitals was 1.01 (95% CI: 0.97-1.05) for Medicare and 1.07 (0.94-1.20) for the VA. Results were similarly negative in the second year post reform. For "combined surgery" the post year 1 odds ratios were 1.04 (0.98-1.09) and 0.94 (0.78-1.14) for Medicare and the VA respectively, and similarly unchanged in post year 2. Isolated increases in the probability of prolonged stay did occur for some vascular surgery procedures. CONCLUSIONS: Hospitals generally found ways to cope with duty hour reform without increasing the prevalence of prolonged hospital stays, a marker of either inefficient care or complications.