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The objective of the current study was to use a biomarker-based approach to investigate the influence of atrazine exposure on American toad ( Anaxyrus americanus ) and grey tree frog ( Hyla versicolor ) tadpoles. Atrazine is one of the most frequently detected herbicides in environmental matrices throughout the United States. In surface waters, it has been found at concentrations from 0.04–2859 μg/L and thus presents a likely exposure scenario for non-target species such as amphibians. Studies have examined the effect of atrazine on the metamorphic parameters of amphibians, however, the data are often contradictory. Gosner stage 22–24 tadpoles were exposed to 0 (control), 10, 50, 250 or 1250 μg/L of atrazine for 48 h. Endogenous polar metabolites were extracted and analyzed using gas chromatography coupled with mass spectrometry. Statistical analyses of the acquired spectra with machine learning classification models demonstrated identifiable changes in the metabolomic profiles between exposed and control tadpoles. Support vector machine models with recursive feature elimination created a more efficient, non-parametric data analysis and increased interpretability of metabolomic profiles. Biochemical fluxes observed in the exposed groups of both A. americanus and H. versicolor displayed perturbations in a number of classes of biological macromolecules including fatty acids, amino acids, purine nucleosides, pyrimidines, and mono- and di-saccharides. Metabolomic pathway analyses are consistent with findings of other studies demonstrating disruption of amino acid and energy metabolism from atrazine exposure to non-target species. [ABSTRACT FROM AUTHOR]

Background Irritable bowel syndrome (IBS) is a serious health problem that affects an estimated 10-15% of people worldwide and has economic consequences in the United States of over $30 billion annually. In the US, IBS affects all races and both sexes, with more females than males (2 : 1) reporting symptoms consistent with IBS. Although the etiology of this functional gastrointestinal disorder is unknown, literature suggests that a subclinical inflammatory component has a role in the etiologic mechanisms underlying IBS. The aim of this study was to evaluate the gene expression of inflammatory biomarkers in patients with and without IBS and among different IBS phenotypes. Methods Irritable bowel syndrome patients ( n = 12) that met Rome III Criteria for IBS longer than 6 months were compared with healthy matched controls ( n = 12). Peripheral whole blood from fasting participants was collected and RNA was extracted. The expression of 96 inflammatory genes was then analyzed using a custom quantitative real-time PCR array. Key Results CCL-16 gene expression was upregulated by 7.46-fold in IBS patients when compared with controls. CCL-16 was overexpressed by over 130-fold in IBS-constipation patients when compared with both controls and IBS-diarrhea patients. Conclusions & Inferences These results further suggest a subclinical inflammatory component underlying IBS. To better understand the phenotypic differences in IBS it is important to broaden the study of these inflammatory and other biomarkers. [ABSTRACT FROM AUTHOR]

Objective To determine whether radical nephrectomy causes less morbidity, less mortality and is associated with a shorter hospital stay than is partial nephrectomy. Patients and methods A total of 1885 nephrectomies (1373 radical and 512 partial) conducted between 1991 and 1998 in the Department of Veterans Affairs (VA) National Surgical Quality Improvement Program were evaluated. Using multivariate analyses, outcomes were risk-adjusted based on 45 preoperative variables to compare mortality and morbidity rates. Results The unadjusted 30-day mortality was 2.0% for radical and 1.6% for partial nephrectomy (P = 0.58). Risk-adjusting the two groups did not result in a statistically significant difference in mortality. The 30-day overall morbidity rate was 15% for radical and 16.2% for partial nephrectomy (P = 0.52); risk-adjusted morbidity rates were not statistically different. There were no statistically significant differences in the rates of postoperative progressive renal failure, acute renal failure, urinary tract infection, prolonged ileus, transfusion requirement, deep wound infection, or extended length of stay. Conclusions Partial nephrectomy carried out in the VA program has low morbidity and mortality rates, comparable with the complication rates after radical nephrectomy. [ABSTRACT FROM AUTHOR]

Context: Computerized systems to remind physicians to provide appropriate care have not been widely evaluated in large numbers of patients in multiple clinical settings.Objective: To examine whether a computerized reminder system operating in multiple Veterans Affairs (VA) ambulatory care clinics improves resident physician compliance with standards of ambulatory care.Design, Setting, and Participants: A total of 275 resident physicians at 12 VA medical centers were randomly assigned in firms or half-day clinic blocks to either a reminder group (n = 132) or a control group (n = 143). During a 17-month study period (January 31, 1995-June 30, 1996), the residents cared for 12,989 unique patients for whom at least 1 of the studied standards of care (SOC) was applicable.Main Outcome Measures: Compliance with 13 SOC, tracked using hospital databases and encounter forms completed by residents, compared between residents in the reminder group vs those in the control group.Results: Measuring compliance as the proportion of patients in compliance with all applicable SOC by their last visit during the study period, the reminder group had statistically significantly higher rates of compliance than the control group for all standards combined (58.8% vs 53.5%; odds ratio [OR], 1.24; 95% confidence interval [CI], 1.08-1.42; P =.002) and for 5 of the 13 standards examined individually. Measuring compliance as the proportion of all visits for which care was indicated in which residents provided proper care, the reminder group also had statistically significantly higher rates of compliance than the control group for all standards combined (17.9% vs 12.2%; OR, 1.57; 95% CI, 1.45-1.71; P<.001) and for 9 of the 13 standards examined individually. The benefit of reminders, however, declined throughout the course of the study, even though the reminders remained active.Conclusions: Our data indicate that reminder systems installed at multiple sites can improve residents' compliance to multiple SOC. The benefits of such systems, however, appear to deteriorate over time. Future research needs to explore methods to better sustain the benefits of reminders. JAMA. 2000;284:1411-1416. [ABSTRACT FROM AUTHOR]

This study evaluates the impact of military service during the Vietnam era (1965 to 1975) on posttraumatic stress disorder using a sample of 2092 male-male, monozygotic, veteran twin pairs. Data were collected in 1987 using mail and telephone interviews. In 715 monozygotic twin pairs who were discordant for military service in southeast Asia (SEA), posttraumatic stress disorder was found to be strongly associated with military service in SEA. The prevalence of posttraumatic stress disorder was 16.8% in twins who served in SEA compared with 5.0% in co-twins who did not serve in SEA. There was a ninefold increase in the prevalence of posttraumatic stress disorder (95% confidence interval, 4.8 to 17.6), comparing twins who experienced high levels of combat with their co-twin who did not serve in SEA. Our results demonstrate that nearly 15 years following the end of the Vietnam War, there remains a substantially increased prevalence of posttraumatic stress disorder among veterans who served in SEA. [ABSTRACT FROM AUTHOR]

The article presents information on the health of Gulf War veterans. Veterans of the 1991 Gulf War reported various physical and mental symptoms. They sometimes reported symptoms that were poorly defined or were not limited to any one organ in the body. These included fatigue, joint and muscle pains, night sweats, rashes, headaches, diarrhea, and problems with thinking clearly or with memory. The researchers identified all 693,826 troops who were deployed to the Persian Gulf area in 1991. They also identified about half of the non deployed troops who were in military service between September 1990 and May 1991.

To study spray drift contributions to non-targeted habitats, pesticide concentrations in stemflow (water flowing down the trunk of a tree during a rain event), throughfall (water from tree canopy only), and surface water in an agriculturally impacted wetland area near Tifton, Georgia, USA were measured (2015–2016). Agricultural fields and sampling locations were on the University of Georgia's Gibbs Research Farm, Tifton, GA. Samples were screened for more than 160 pesticides, and cumulatively, 32 different pesticides were detected across matrices. Data indicate that herbicides and fungicides were present in all types of environmental samples analyzed while insecticides were only detected in surface water samples. The highest pesticide concentration observed was 10.50 μg/L of metolachlor in an August 2015 surface water sample. Metolachlor, tebuconazole, and fipronil were the most frequently detected herbicide, fungicide, and insecticide, respectively, regardless of sample origin. The most frequently detected pesticide in surface water and stemflow samples was metolachlor (0.09–10.5 μg/L), however, the most commonly detected pesticide in throughfall samples was biphenyl (0.02–0.07 μg/L). These data help determine the importance of indirect chemical exposures to non-targeted habitats by assessing inputs from stemflow and throughfall into surface waters. [ABSTRACT FROM AUTHOR]

Importance: To our knowledge, this study reports on the largest cohort of long-term survivors (LTSs) (≥10 years) following a diagnosis of pancreatic ductal adenocarcinoma (PADC) and identifies the characteristics associated with LTS., Objective: To determine patient, tumor, surgical, and sociodemographic characteristics associated with LTS., Design, Setting, and Participants: A nationwide retrospective cohort study of patients with invasive PADC (International Classification of Diseases for Oncology, Third Edition codes 8140/3, 8500/3, 8021/3, and 8035/3) was conducted using data collected in the National Cancer Database (NCDB). A multivariable logistic regression model of factors significantly associated with LTS was developed and used to generate a nomogram predicting the likelihood of surviving at least 10 years from initial diagnosis. Data collected from more than 1500 academic centers and community hospitals in the United States and Puerto Rico were assessed. Patients included were those with histologically proven PADC who underwent pancreatic surgical resection aimed at removal of the primary tumor between January 1, 1998, and December 31, 2002 (n = 11,917). The initial cohort (n = 70,915) excluded noninvasive tumors or tumors with unknown histology (n = 11,696) and was limited to patients who underwent surgical resection (n = 47,302 excluded). Analysis was conducted from January 1, 1998, to December 31, 2011., Exposures: Pancreatic ductal adenocarcinoma., Main Outcomes and Measures: Long-term survival, defined as surviving at least 10 years from initial diagnosis., Results: Of the 11,081 patients with complete survival information, 431 individuals (3.9%) were LTSs. Significant predictors of LTS included (determined using odds ratio [OR]; 95% CI), in order of importance, lymph node positivity ratio (0%: 4.6; 3.4-6.4), adjuvant chemotherapy (2.4; 2.0-3.0), pathologic T stage (T1: 3.1; 1.8-5.6), patient age (50-60 years: 3.4; 1.8-6.7), tumor grade (well differentiated: 2.2; 1.5-3.0), surgical margin (negative: 1.9; 1.4-2.6), pathologic M stage (M = X: 5.6; 2.1-22.8), tumor size (<2 cm: 1.7; 1.2-2.5), educational level (>86% high school graduates: 1.7; 1.2-2.4), and insurance status according to the patient's zip code (private: 2.0; 95% CI, 0.9-5.1). The model C index was 0.768. Based on our nomogram, patients with the most favorable characteristics had an 18.1% chance of LTS. Furthermore, survival curves demonstrated that the probability of dying following initial diagnosis of PADC reached a plateau of approximately 10% per year after 7 years of survival., Conclusions and Relevance: Although PADC remains a deadly disease, long-term survival is possible, even beyond the 10-year mark. Our adjusted analysis identified lymph node ratio, administration of adjuvant chemotherapy, and pathologic T stage as being the top 3 variables associated with LTS of PADC. In addition, our easy-to-use nomogram may be able to identify potential LTS among patients with resected PADC.

Background: Surgical care is delivered around the clock. Elective cases within the Veterans Affairs health system starting after 4 pm appear to have an elevated risk of morbidity, but not mortality, compared with earlier cases. The relationship between operation start time and patient outcomes is not described in private-sector patients or for emergency cases., Study Design: We performed a retrospective cohort study of 56,920 general and vascular surgical procedures performed from October 2001 through September 2004, and entered into the National Surgical Quality Improvement Program database. Operation start time was the independent variable of interest. Random effects, hierarchical logistic regression models adjusted for patient, operative, and facility characteristics. Two independent models determined associations between start time and morbidity or mortality. Subset analysis was performed for emergency and nonemergency cases., Results: After adjustment for patient and procedure characteristics, mortality had a moderately strong association with start time, but only for nonemergency cases starting 9:30 pm to 7:30 am (odds ratio = 1.752; p = 0.028; reference 7:30 am to 9:30 am). As for morbidity, after adjustment, operations starting 9:30 am to 1:30 pm and 5:30 pm to 9:30 pm were associated with a weakly elevated risk of morbidity, but those starting 9:30 pm to 7:30 am demonstrated a strong effect on morbidity (odds ratio = 1.32; p < 0.0001). Subgroup analysis showed this effect was largely a result of elevated risk of morbidity in emergency cases from this overnight time period (odds ratio = 1.48; p = 0.001)., Conclusions: Surgical start times are associated with risk-adjusted patient outcomes. In terms of facility operations management and resource allocation, consideration should be given to the capacity to accommodate cases with differences in risk during different time periods.

Under the guidance of the American College of Surgeons (ACS) and in partnership with the US Department of Veterans Affairs (VA), the National Surgical Quality Improvement Program (NSQIP) has been developed to improve the quality of surgical care in adults on a national level. Its purpose is to provide reliable, risk-adjusted outcomes data so that surgical quality can be assessed and compared between institutions. Data analysis consists of reporting observed to expected ratios (O/E) for 30-day postoperative mortality and morbidity measurements. A surgical clinical nurse reviewer is assigned at each medical center to collect information on 97 variables, including preoperative, operative, and postoperative factors for patients undergoing major operations in the specialties of general and vascular surgery. Eligible operations are entered into the database on a structured 8-day cycle to ensure representative sampling of cases. Since the introduction of the program into the VA system, there has been a 47% reduction in 30-day postoperative mortality and a 42% reduction in 30-day postoperative morbidity. Over 160 institutions have enrolled with the ACS in its adult NSQIP. In 2005, a planning committee was formed by the ACS and the American Pediatric Surgical Association to explore the development of a children's surgery NSQIP module. In conjunction with the Colorado Health Outcomes Program at the University of Colorado, a program potentially applicable to all children's surgical specialties has been designed. This manuscript describes the development of that Children's ACS-NSQIP module.

Background: Prophylactic antibiotic (PA) administration 1 to 2 hours before surgical incision (SIP-1) is a publicly reported process measure proposed for performance pay. We performed an analysis of patients undergoing major surgical operations to determine if SIP-1 was associated with surgical site infection (SSI) rates in Department of Veterans Affairs (VA) hospitals., Study Design: Patients with External Peer Review Program Surgical Care Improvement Project (SCIP)-1 data with matched National Surgical Quality Improvement Program data were included in the study. Patient and facility level analyses comparing SCIP-1 and SSI were performed. We adjusted for clustering effects within hospitals, validated SSI risk score, and procedure type (percentage of colon, vascular, orthopaedic) using generalized estimating equations and linear modeling., Results: The study population included 9,195 elective procedures (5,981 orthopaedic, 1,966 colon, and 1,248 vascular) performed in 95 VA hospitals. Timely PA occurred in 86.4% of patients. Untimely PA was associated with a rate of SSI of 5.8%, compared with 4.6% in the timely group (odds ratio = 1.29, 95% CI 0.99, 1.67) in bivariable unadjusted analysis. Patient level risk-adjusted multivariable generalized estimating equation modeling found the SSI risk score was predictive of SSI (p < 0.001); SIP-1 was not associated with SSI. Hospital level multivariable generalized linear modeling found procedure mix (p < 0.0001), but not SIP-1 rate or facility volume, to be associated with facility SSI rate. The study had 80% power to detect a 1.75% difference for patient level SSI rates., Conclusions: Timely PA did not markedly contribute to overall patient or facility SSI rates. These data are important for the ongoing discourse on how to measure and pay for quality of surgical care.

Objectives: We analyzed the Veterans Affairs (VA) National Surgical Quality Improvement Program (NSQIP), a large clinical database, to investigate which factors, other than technical, were associated with a higher incidence of early graft failure in infrainguinal bypass., Methods: Data are prospectively collected in NSQIP from 123 participating VA Medical Centers. All patients from 1995 to 2003 in the NSQIP database who underwent infrainguinal arterial bypass were identified by Current Procedural Terminology (CPT) codes (CPT is a registered trademark of the American Medical Association, Chicago, Ill, Copyright 2007). Data for 30-day graft failure were evaluated by univariate analysis, and multivariate logistic regression was used to control for possible confounders., Results: The NSQIP database identified 14,788 patients who underwent infrainguinal lower extremity arterial bypasses during the study period, and 723 acute graft failures (4.9%) occurred. On multivariate analysis, compared with patients aged >70 years, patient ages of <50 and 51 to 60 years were significantly associated with early graft failure (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.6-3.0; P < .001; OR, 1.4; 95% CI, 1.2-1.6, P < .001; respectively); age range of 61 to 70 years was not significantly associated with early graft failure. African American race was also associated with early graft failure, and diabetes mellitus had a negative association with early graft failure (OR, 1.4; 95% CI, 1.3-1.5; P < .001; OR, 0.72; 95% CI, 0.58-0.89; P = .002; respectively). Although smoking was a significant factor for acute graft failure on univariate analysis, it was not significant on multivariate analysis. Multivariate analysis of the type of procedure performed revealed that femoral to popliteal bypass with vein or prosthetic graft was associated with better early graft patency than any of the tibial vessel bypass procedures except for popliteal to tibial bypass with autogenous vein., Conclusion: These data suggest that factors other than technique have an effect on the 30-day graft failure rates of infrainguinal bypasses. These results help the vascular surgeon to predict more accurately early bypass failure rates while planning the procedure and counseling patients about its prognosis.

Background: Most reports on postoperative (OP) morbidity and mortality following breast cancer surgery (BCS) are limited by relatively small sample size resulting in a lack of national benchmarks for quality of care. This paper reports the 30-day morbidity and mortality following BCS in women using a large prospective multi-institutional database., Methods: The National Surgical Quality Improvement Program Patient Safety in Surgery, prospectively collected inpatient and outpatient 30 day postoperative morbidity and mortality data on patients undergoing surgery at 14 university and 4 community centers. Using the procedure CPT code, the database was queried for all women undergoing mastectomy (MT) or lumpectomy with an axillary procedure (L-ANP). Morbidity and mortality were categorized as mortality, wound, cardiac, renal, pulmonary, and central nervous system. Logistic regression models for the prediction of wound complications were developed. Preoperative variables having bivariate relationships with postoperative wound complications with P < or = 0.20 were submitted for consideration., Results: We identified 1660 and 1447 women who underwent MT and l-ANP, respectively. The mean age was 55.9 years. The majority of procedures were under general anesthesia. The 30-day postoperative mortality for MT and l-ALNP were 0.24% and 0%, respectively. The most frequent morbid complication was wound infection, more commonly occurring in the mastectomy (4.34%) group versus the lumpectomy group (1.97%). Cardiac and pulmonary complications occurred infrequently in the mastectomy group (cardiac: MT, 0.12%; and pulmonary: MT, 0.66%). There were no cardiac or pulmonary complications in the lumpectomy group. CNS morbidities were rare in both surgical groups (MT, 0.12%; and l-ALNP, 0.07%). Development of a UTI was more common in women who underwent a mastectomy (0.66%) when compared with women that had a lumpectomy (0.14%). The only significant predictors of a wound complication were morbid obesity (BMI >30), having had a MT, low preoperative albumin and hematocrit greater than 45%., Conclusion: Morbidity and mortality rates following BCS in women are low, limiting their value in assessing quality of care. Mastectomy carries higher complication rate than l-ANP with wound infection being the most common.

Background: The Office of the Medical Inspector of the Department of Veterans Affairs (VA) studied the reliability of data collected by the VA's National Surgical Quality Improvement Program (NSQIP). The study focused on case selection bias, accuracy of reports on patients who died, and interrater reliability measurements of patient risk variables and outcomes., Study Design: Surgical data from a sample of 15 VA medical centers were analyzed. For case selection bias, reviewers applied NSQIP criteria to include or exclude 2,460 patients from the database, comparing their results with those of NSQIP staff. For accurate reporting of patients who died, reviewers compared Social Security numbers of 10,444 NSQIP records with those found in the VA Beneficiary Identification and Records Locator Subsystem, VA Patient Treatment Files, and Social Security Administration death files. For measurement of interrater reliability, reviewers reabstracted 59 variables in each of 550 patient medical records that also were recorded in the NSQIP database., Results: On case selection bias, the reviewers agreed with NSQIP decisions on 2,418 (98%) of the 2,460 cases. Computer record matching identified 4 more deaths than the NSQIP total of 198, a difference of about 2%. For 52 of the categorical variables, agreement, uncorrected for chance, was 96%. For 48 of 52 categorical variables, kappas ranged from 0.61 to 1.0 (substantial to almost perfect agreement); none of the variables had kappas of less than 0.20 (slight to poor agreement)., Conclusions: This sample of medical centers shows adherence to criteria in selecting cases for the NSQIP database, for reporting deaths, and for collecting patient risk variables.

Objective: The VA National Surgical Quality Improvement Program (NSQIP) formula for risk factors was applied to the University of Texas Health Science Center at San Antonio (UTHSCSA)/University Hospital (UH) database. Its applicability to a civilian organization was established. Logistic regression analysis of the UH database revealed that operative complexity was significantly related to mortality only at high complexity levels. Patient risk factors were the major determinants of operative mortality for most civilian surgical cases., Summary Background Data: Since 1994, the NSQIP has collected preoperative risk factors, intraoperative data, 30-day morbidity, and mortality within the VA health system. The VA formula to predict 30-day postoperative mortality was applied to our UH patients (N = 8593). The c-index of .907, a statistical measure of accuracy, compared favorably to the VA patient c-index of .89. The UH database did not include a surrogate for operative complexity. We were elated by the predictive accuracy but had concern that operative complexity needed further evaluation., Methods: Operative complexity was ascribed to each of the 8593 UH cases, and logistic regression analyses were compared with and without operative complexity. Operative complexity was graded on a scale of 1 to 5; 5 was the most complex., Results: Without operative complexity, a c-index was .915. With operative complexity: an even higher c-index of .941 was reached. The large volume of level 2-3 operative cases obscured to a degree the effect of operative difficulty on mortality., Conclusion: Operative complexity played a major role in risk estimation, but only at the extreme. The dominance of cases of midlevel complexity masked the effect of higher complexity cases on mortality. In any individual case, operative complexity must be added to estimate operative mortality accurately. Patient risk factors alone accounted for operative mortality for operations less than level 4 (95% of patients).

Background: Comparison of institutional health care outcomes requires risk adjustment. Risk-adjustment methodology may influence the results of such comparisons., Methods: We compared 3 risk-adjustment methodologies used to assess the quality of surgical care. Nurse reviewers abstracted data from a continuous sample of 2,167 surgical patients at 3 academic institutions. One risk adjustor was based on medical record data (National Surgical Quality Improvement Program [NSQIP]) whereas the other 2, the DxCG and Charlson Comorbidity Index (CCI), primarily used International Classification of Disease-9 (ICD-9) codes. Risk-assessment scores from the 3 systems were compared with each other and with mortality., Results: Substantial disagreement was found in the risk assessment calculated by the 3 methodologies. Although there was a weak association between the CCI and DxCG, neither correlated well with the NSQIP. The NSQIP was best able to predict mortality, followed by the DxCG and CCI., Conclusion: In surgical patients, different risk-adjustment methodologies afford divergent estimates of mortality risk.

The recently concluded Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) was a randomized clinical trial of percutaneous coronary intervention versus coronary bypass graft surgery among patients with medically refractory ischemia who were at high risk for coronary bypass graft surgery because of > or =1 risk factors that included severely reduced left ventricular (LV) function, defined as LV ejection fraction <35%. This study reports the outcome of patients with LV ejection fraction <35% in the randomized clinical trial and the physician-directed and patient choice registries of the AWESOME study.

Objectives: Uvulopalatopharyngoplasty (UPPP) is the most common surgical treatment for obstructive sleep apnea (OSA). Anatomic and physiologic abnormalities associated with OSA can make perioperative management difficult. Only single-site case series provide current estimates of the incidence of perioperative complications, with a pooled crude serious complication rate of 3.5% and a crude mortality rate of 0.4%. The primary objective of this study was to calculate the incidence of perioperative morbidity and mortality in a large, multisite cohort of UPPP patients., Study Design: Prospective cohort study of adults undergoing inpatient UPPP with or without other concurrent procedures, Methods: The serious complication and 30-day mortality rates were calculated from the Department of Veterans Affairs (VA) National Surgical Quality Improvement Program database of prospectively collected outcomes of all VA inpatient surgeries nationally 1991 to 2001. Serious complications were defined by 15 specific life-threatening complications. Deaths were captured whether the patient was in the hospital or discharged., Results: Veteran patients (n = 3130) had a mean age of 50 years and were predominantly male (97%). The serious nonfatal complication rate was 1.5% (47/3,130) (95% confidence interval [CI] 1.1%, 1.9%). The 30-day mortality rate was 0.2% (7/3130) (95% CI 0.1%, 0.4%). There was no significant effect of year of surgery or patient age on the risk of serious complication or death., Conclusion: The incidence of serious nonfatal complications and 30-day mortality after UPPP are 1.5% and 0.2%, respectively, in a large cohort of UPPP patients at veteran hospitals.

Background: This article describes the development and implementation of a randomized clinical trial designed to answer the question: Is watchful waiting an acceptable alternative to operation for men with asymptomatic or minimally symptomatic inguinal hernias?, Study Design: A clinical trial has been designed to compare watchful waiting and operation for men with an asymptomatic or a relatively asymptomatic inguinal hernia. Men are randomized to watchful waiting or a standard open operation, the Lichtenstein tension-free hernia repair, and are followed for a minimum of 2 years. The target sample size of 753 patients was chosen so that the trial would have power sufficiently high to detect a clinically meaningful difference between treatment groups in either of the two primary outcomes as measured at 2 years: pain or discomfort interfering with normal activities and the physical component summary score of the SF-36 health-related quality-of-life survey. The study was begun in five centers located in both community and academic environments. At 18 months, a sixth site was added and at 28 months, after enrollment of 145 patients, one of the centers was terminated for reasons related to inadequate followup; all data from this center were deleted. As a routine measure, an independent experienced trial manager audited all clinical sites., Results: Enrollment of patients began in January 2000 and will end on December 31, 2002. As of November 1, 2002, 637 patients had been randomized, 85% of the target enrollment. An additional 2,115 patients were screened but not randomized, yielding a recruitment rate of 23.1%. Analysis and publication of the results of the study will take place on completion of the minimum 2-year followup period for all patients., Conclusions: A trial to compare the outcomes of watchful waiting and operation for management of inguinal hernias in men is needed to provide data to surgeons and to patients that can aid in choice of treatment. A description of the design of such a trial is presented.

Background and Purpose: Most quality improvement methods implicitly assume that facilities with high complication rates are likely to have substandard processes of care, a stable characteristic that, in the absence of intervention, will persist over time. We assessed the extent to which this holds true for carotid endarterectomy., Methods: Using data from the Department of Veterans Affairs National Surgical Quality Improvement Project, we classified facilities on the basis of 30-day complications of carotid endarterectomy (stroke, myocardial infarction, death) during 1994 to 1995 (period 1, n=3389) and then compared these groups of facilities for complication rates during 1996 to 1997 (period 2, n=4453)., Results: Despite wide variation in facility-specific complication rates, the correlation between rates in periods 1 and 2 was low (Spearman correlation coefficient, 0.04; P=0.01) Facility-specific rates did not show greater correlation when we examined only facilities with higher volumes patients in different clinical categories (asymptomatic, transient ischemic attack, stroke). Comorbid illness profiles were similar between the 2 time periods., Conclusions: Most of the facility-specific differences in complication rates in period 1 were not maintained into period 2. Many apparent quality improvement problems may not be as large as they first appear, especially when based on few complications per facility. The inability, in practice, to estimate complication rates at a high degree of precision is a fundamental difficulty for clinical policy making regarding procedures with complication rates such as carotid endarterectomy.

Objectives: To determine if race/ethnicity is independently associated with an increased risk for nontraumatic lower extremity amputation versus lower extremity bypass revascularization among patients with peripheral arterial disease (PAD)., Methods: Data were analyzed from the National VA Surgical Quality Improvement Program (NSQIP) and from the Veterans Affairs Patient Treatment File (PTF). Race/ethnicity was defined as non-Hispanic white, black, or Hispanic. Variables that were univariately associated (P < or = 0.05) with the outcome of amputation were placed into a multiple logistic regression model to determine independent predictors for the dependent variable, lower extremity amputation versus lower extremity bypass revascularization., Results: Three thousand eighty-five lower extremity amputations and 8409 lower extremity bypass operations were identified. Among all cases included, there were 416 Hispanic patients (3.6%), 2337 black patients (20.3%), and 8741 non-Hispanic white patients (76.1%). Among all variables within the model, Hispanic and black race were each associated with a greater risk for amputation than a history of rest pain/gangrene (Hispanic race 1.4, 95% CI 1.1, 1.9; black race 1.5, 95% CI 1.4, 1.7; rest pain/gangrene 1.1, 95% CI 1.0, 1.3). The final model had a c statistic of 0.83., Conclusion: Hispanic race and black race were independent risk factors for lower extremity amputation in patients with PAD. Although the burden of certain atherosclerotic risk factors (eg, diabetes and hypertension) is higher in minority patients, the impact of this burden does not account for the increased risk for the outcome of lower extremity amputation in these two populations. Further research is needed to better understand the reason(s) why race/ethnicity is independently associated with poor outcomes in PAD.

Purpose: Racial variation in health care outcomes is an important topic. Risk-adjustment models have not been developed for elective abdominal aortic aneurysm repair (AAA), lower extremity bypass revascularization (LEB), or lower extremity amputation (AMP). Earlier studies examining racial variation in mortality and morbidity from AAA, LEB, or AMP were limited to administrative data. This study determined risk factors for mortality after surgery for vascular disease and determined whether race is an important risk factor., Methods: Data in this prospective observational study were obtained from the Department of Veterans Affairs (VA) National Surgical Quality Improvement Program. Detailed demographic and clinical data were collected prospectively from patients' medical records by trained nurse reviewers. Eligible patients were those 18 years and older who underwent elective AAA, LEB, or AMP at one of 44 VA medical centers performing both vascular and cardiac surgery (phase I; October 1991 to December 1993) and at one of these 44 or 79 additional VA medical centers performing vascular but not cardiac surgery (phase II; January 1994 to August 1995). The independent association of several preoperative factors with the 30-day postoperative mortality rate was examined with stepwise logistic regression analysis for AAA, LEB, and AMP. Models were developed in the combined 44 VA medical centers and validated in the 79 VA medical centers. The independent association of race with the 30-day postoperative mortality rate was examined after controlling for important preoperative risk factors for each operation., Results: More than 10,000 surgical operations were examined, and 5, 3, and 10 independent preoperative predictors of 30-day mortality rate were identified for AAA, LEB, and AMP, respectively. The observed mortality rate for patients undergoing AAA was higher (7.2% vs 3.2%; P =.02) in African American patients than in white patients in the 44 VA medical centers, although the differences were not significant in LEB and AMP or at the additional 79 hospitals. After important preoperative risk factors were controlled, there was no difference in 30-day mortality rates between African American patients and white patients., Conclusion: We identified several important preoperative risk factors for 30-day mortality rate in three vascular operations. From the results of this study, race was determined not to be an independent predictor of mortality.

Purpose: A noncardiac surgery risk model was used as a means of analyzing variations in postoperative mortality and amputation-free survival for older veterans undergoing femorodistal bypass grafting surgery., Methods: A prospective cohort study was undertaken in 105 Veterans Affairs (VA) hospitals at the time of index operation from 1991 to 1995. Each patient was linked to subsequent hospitalizations, major amputation surgery, and survival through 1999. Logistic regression and proportional hazards models were used as a means of developing risk indices on the basis of risk factors from the VA National Surgical Quality Improvement Program. A total of 4288 male veterans 40 years or older underwent artificial, vein, or in situ bypass grafting surgery at the femoral to tibial level. The main outcome measures were 30-day postoperative mortality and amputation-free survival., Results: Approximately half of all patients had undergone an earlier revascularization or amputation at any level for vascular disease. The 30-day postoperative mortality rate was 2.1% and varied greatly between mortality risk index quartiles (0.6%-5.2%). In a median 44.3 months of follow-up, surviving patients had 17,694 subsequent VA hospitalizations, 1147 patients (26.7%) underwent subsequent major amputation, and 1913 patients (44.6%) died. The overall survival probability was 88% at 1 year and 63% at 5 years; 1- and 5-year (any sided) limb salvage rates were 87% and 74%, respectively, for patients who underwent a femoropopliteal bypass grafting procedure, compared with 77% and 63%, respectively, for patients who underwent a tibial bypass grafting procedure. When amputation and death were combined as end points, amputation-free survival probability rates at 1, 3, and 7.5 years were 74%, 56%, and 29%, respectively. Patients with the best 20% survival risk scores had observed mean survival probability rates 30% higher than patients in the poorest 20% of survival risk., Conclusion: Risk indices derived from the preoperative workup may be of use to clinicians in assessing and communicating risk and prognosis. Risk-adjustment of outcomes is critical for evaluating future disease management initiatives for patients with advanced peripheral arterial disease.

Corporate integrity agreements (CIAs) imposed by the Office of Inspector General (OIG) of HHS have increased dramatically in the past five years. Healthcare organizations that enter into a CIA face burdensome monitoring and reporting requirements. However, it may be possible to lessen these burdens by negotiating modifications to the CIA's requirements. Organizations that have compliance programs in place can negotiate with the OIG to integrate elements of their existing compliance programs into the CIA. The organization also should attempt to negotiate limiting the scope of the monitoring to include only the area that was originally investigated. In addition, it may be valuable to negotiate insertion of a clause in the CIA allowing the organization to request renegotiation of the terms and duration of certain elements of the agreement after the first year, if conditions are met. An organized CIA negotiation process may be valuable in obtaining a reduced scope of the procedures required by the CIA and preparing the organization to meet its obligations.

Background: A surgical risk model is used to analyze postoperative mortality and late survival for older veterans who underwent above- or below-knee amputations in 119 Veterans Affairs (VA) hospitals from 1991 to 1995., Methods: Preoperative medical conditions and laboratory values abstracted by the VA National Surgical Quality Improvement Program were linked to subsequent hospitalization and survival through 1999. Logistic regression and proportional hazards models were used to develop risk indexes for postoperative mortality and long-term survival., Results: Thirty-day postoperative mortality was 6.3% for 1909 below-knee and 13.3% for 2152 above-knee amputees. Mortality varied greatly between the lowest-highest risk index quartiles (0.8%-18.4% for below-knee amputation and 2.3%-31.1% for above-knee amputation). Surviving patients had 10,827 subsequent VA hospitalizations during a median 32-month follow-up. Survival probabilities for below- and above-knee amputees were 77% and 59% at 1 year, 57% and 39% at 3 years, and 28% and 20% at 7.5 years. The lowest quartile of survival risk had a 61% five-year survival compared with 14% for the highest-risk quartile., Conclusion: A generic surgical risk model can be of use in stratifying prognosis after major amputation. The heavy burden of hospital use by these patients suggests the need for better disease management for this high-risk, high-cost patient population.

Objective: The primary purpose of this study was to validate risk-adjusted surgical outcomes as indicators of the quality of surgical care at US Department of Veterans Affairs (VA) hospitals. The secondary purpose was to validate the risk-adjustment models for screening cases for quality review., Design: We compared quality of care, determined by structured implicit chart review, for patients from hospitals with higher and lower than expected operative mortality and morbidity (hospital-level tests) and between patients with high and low predicted risk of mortality and morbidity who died or developed complications (patient-level tests)., Subjects: 739 general, peripheral vascular and orthopedic surgery cases sampled from the 44 VA hospitals participating in the National VA Surgical Risk Study., Main Outcome Measures: A global rating of quality of care based on chart review., Results: Ratings of overall quality of care did not differ significantly between patients from hospitals with higher and lower than expected mortality and morbidity. On some of the secondary measures, patient care was rated higher for hospitals with lower than expected operative mortality. At the patient level of analysis, those who died or developed complications and had a high predicted risk of mortality or morbidity were rated higher on quality of care than those with a low predicted risk of adverse outcome., Conclusions: The absence of a relationship between most of our measures of process of care and risk-adjusted outcomes may be due to an insensitivity of chart reviews to hospital-level differences in quality of care. Site visits to National VA Surgical Risk Study hospitals with high and low risk-adjusted mortality and morbidity have detected differences on a number of dimensions of quality. The patient-level findings suggest that the risk-adjustment models are useful for screening adverse outcome cases for quality of care review.

Although well-designed randomized controlled trials (RCT) provide the strongest evidence regarding causation, only relatively recently have they been used by health services researchers to study the organization, delivery, quality, and outcomes of care. More recent yet is the extension of multisite RCTs to health services research. Such studies offer numerous methodological advantages over single-site trials: (1) enhanced external validity; (2) greater statistical power when studying conditions with a low incidence or prevalence, small event rate in the outcome (eg, mortality), and/or large variance in the outcome (eg, health care costs); and (3) rapid recruitment to provide health care organizations and policy makers with timely results. This paper begins by outlining the advantages of multisite RCTs over single-site trials. It then discusses both scientific challenges (ie, standardizing eligibility criteria, defining and standardizing the intervention, defining usual care, standardizing the data collection protocol, blinded outcome assessment, data management and analysis, measuring health care costs) and operational issues (ie, site selection, randomization procedures, patient accrual, maintaining enthusiasm, oversight) posed by multisite RCTs in health services research. Recommendations are offered to health services researchers interested in conducting such studies.

Measures of risk-adjusted outcome are particularly suited for the assessment of the quality of surgical care. The reliability of measures of quality that use surgical outcomes is enhanced by prospective data acquisition and should be adjusted for the preoperative severity of illness. Such measures should be based only on reliable and validated data, and they should apply state-of-the-art analytical methods. The risk-adjusted postoperative mortality rate is useful as a quality measure only in specialties and operations expected to have a high rate of postoperative deaths. Risk-adjusted complications are more common but are limited as a comparative measure of quality by a lack of uniform definitions and data collection mechanisms. In specialties in which the expected postoperative mortality is low, risk-adjusted functional outcomes are promising measures for the assessment of the quality of surgical care. Measures of cost and patient satisfaction should also be incorporated in systems designed to measure the quality and cost-effectiveness of surgical care.

Context: Although home-based health care has grown over the past decade, its effectiveness remains controversial. A prior trial of Veterans Affairs (VA) Team-Managed Home-Based Primary Care (TM/HBPC) found favorable outcomes, but the replicability of the model and generalizability of the findings are unknown., Objectives: To assess the impact of TM/HBPC on functional status, health-related quality of life (HR-QoL), satisfaction with care, and cost of care., Design and Setting: Multisite randomized controlled trial conducted from October 1994 to September 1998 in 16 VA medical centers with HBPC programs., Participants: A total of 1966 patients with a mean age of 70 years who had 2 or more activities of daily living impairments or a terminal illness, congestive heart failure (CHF), or chronic obstructive pulmonary disease (COPD). Intervention Home-based primary care (n=981), including a primary care manager, 24-hour contact for patients, prior approval of hospital readmissions, and HBPC team participation in discharge planning, vs customary VA and private sector care (n=985)., Main Outcome Measures: Patient functional status, patient and caregiver HR-QoL and satisfaction, caregiver burden, hospital readmissions, and costs over 12 months., Results: Functional status as assessed by the Barthel Index did not differ for terminal (P=.40) or nonterminal (those with severe disability or who had CHF or COPD) (P=.17) patients by treatment group. Significant improvements were seen in terminal TM/HBPC patients in HR-QoL scales of emotional role function, social function, bodily pain, mental health, vitality, and general health. Team-Managed HBPC nonterminal patients had significant increases of 5 to 10 points in 5 of 6 satisfaction with care scales. The caregivers of terminal patients in the TM/HBPC group improved significantly in HR-QoL measures except for vitality and general health. Caregivers of nonterminal patients improved significantly in QoL measures and reported reduced caregiver burden (P=.008). Team-Managed HBPC patients with severe disability experienced a 22% relative decrease (0.7 readmissions/patient for TM/HBPC group vs 0.9 readmissions/patient for control group) in hospital readmissions (P=.03) at 6 months that was not sustained at 12 months. Total mean per person costs were 6.8% higher in the TM/HBPC group at 6 months ($19190 vs $17971) and 12.1% higher at 12 months ($31401 vs $28008)., Conclusions: The TM/HBPC intervention improved most HR-QoL measures among terminally ill patients and satisfaction among non-terminally ill patients. It improved caregiver HR-QoL, satisfaction with care, and caregiver burden and reduced hospital readmissions at 6 months, but it did not substitute for other forms of care. The higher costs of TM/HBPC should be weighed against these benefits.

Objective: To determine clinical and patient-centered factors predicting non-elective hospital readmissions., Design: Secondary analysis from a randomized clinical trial., Clinical Setting: Nine VA medical centers., Participants: Patients discharged from the medical service with diabetes mellitus, congestive heart failure, and/or chronic obstructive pulmonary disease (COPD)., Main Outcome Measurement: Non-elective readmission within 90 days., Results: Of 1378 patients discharged, 23.3% were readmitted. After controlling for hospital and intervention status, risk of readmission was increased if the patient had more hospitalizations and emergency room visits in the prior 6 months, higher blood urea nitrogen, lower mental health function, a diagnosis of COPD, and increased satisfaction with access to emergency care assessed on the index hospitalization., Conclusions: Both clinical and patient-centered factors identifiable at discharge are related to non-elective readmission. These factors identify high-risk patients and provide guidance for future interventions. The relationship of patient satisfaction measures to readmission deserves further study.

Objectives: The goal of this study was to compare long-term survival and valve-related complications between bioprosthetic and mechanical heart valves., Background: Different heart valves may have different patient outcomes., Methods: Five hundred seventy-five patients undergoing single aortic valve replacement (AVR) or mitral valve replacement (MVR) at 13 VA medical centers were randomized to receive a bioprosthetic or mechanical valve., Results: By survival analysis at 15 years, all-cause mortality after AVR was lower with the mechanical valve versus bioprosthesis (66% vs. 79%, p = 0.02) but not after MVR. Primary valve failure occurred mainly in patients <65 years of age (bioprosthesis vs. mechanical, 26% vs. 0%, p < 0.001 for AVR and 44% vs. 4%, p = 0.0001 for MVR), and in patients > or =65 years after AVR, primary valve failure in bioprosthesis versus mechanical valve was 9 +/- 6% versus 0%, p = 0.16. Reoperation was significantly higher for bioprosthetic AVR (p = 0.004). Bleeding occurred more frequently in patients with mechanical valve. There were no statistically significant differences for other complications, including thromboembolism and all valve-related complications between the two randomized groups., Conclusions: At 15 years, patients undergoing AVR had a better survival with a mechanical valve than with a bioprosthetic valve, largely because primary valve failure was virtually absent with mechanical valve. Primary valve failure was greater with bioprosthesis, both for AVR and MVR, and occurred at a much higher rate in those aged <65 years; in those aged > or =65 years, primary valve failure after AVR was not significantly different between bioprosthesis and mechanical valve. Reoperation was more common for AVR with bioprosthesis. Thromboembolism rates were similar in the two valve prostheses, but bleeding was more common with a mechanical valve.

Purpose: Comorbid conditions affect the risk of adverse outcomes after surgery, but the magnitude of risk has not previously been quantified using multivariate statistical methods and prospectively collected data. Identifying factors that predict results of surgical procedures would be valuable in assessing the quality of surgical care. This study was performed to define risk factors that predict adverse events after colectomy for cancer in Department of Veterans Affairs Medical Centers., Methods: The National Veterans Affairs Surgical Quality Improvement Program contains prospectively collected and extensively validated data on more than 415,000 surgical operations. All patients undergoing colectomy for colon cancer from 1991 to 1995 who were registered in the National Veterans Affairs Surgical Quality Improvement Program database were selected for study. Independent variables examined included 68 preoperative and 12 intraoperative clinical risk factors; dependent variables were 21 specific adverse outcomes. Stepwise logistic regression analysis was used to construct models predicting the 30-day mortality rate and 30-day morbidity rates for each of the ten most frequent complications., Results: A total of 5,853 patients were identified; 4,711 (80 percent) underwent resection and primary anastomosis. One or more complications were observed in 1,639 of 5,853 (28 percent) patients. Prolonged ileus (439/5,853; 7.5 percent), pneumonia (364/5,853; 6.2 percent), failure to wean from the ventilator (334/5,853; 5.7 percent), and urinary tract infection (292/5,853; 5 percent) were the most frequent complications. The 30-day mortality rate was 5.7 percent (335/5,853). For most complications, 30-day in-hospital mortality rates were significantly higher for patients with a complication than for those without. Thirty-day mortality rates exceeded 50 percent if postoperative coma, cardiac arrest, a pre-existing vascular graft prosthesis that failed after colectomy, renal failure, pulmonary embolism, or progressive renal insufficiency occurred. Preoperative factors that predicted a high risk of 30-day mortality included ascites, serum sodium >145 mg/dl, "do not resuscitate" status before surgery, American Society of Anesthesiologists classes III and IV OR V, and low serum albumin., Conclusions: Mortality rates after colectomy in Veterans Affairs hospitals are comparable with those reported in other large studies. Ascites, hypernatremia, do not resuscitate status before surgery, and American Society of Anesthesiologists classes III and IV OR V were strongly predictive of perioperative death. Clinical trials to decrease the complication rate after colectomy for colon cancer should focus on these risk factors.

Objective: To determine whether enhanced access to primary care affects the diagnostic evaluation, pharmacologic management, or health outcomes of patients hospitalized with congestive heart failure (CHF)., Design: Multisite randomized, controlled trial., Setting: Nine Veterans Affairs medical centers., Patients: 443 patients who were hospitalized with a diagnosis of CHF., Intervention: Enhanced access to primary care, including assignment of a primary care nurse and physician, increased telephone contact, additional outpatient visits, and patient education., Main Outcome Measures: Diagnostic evaluation, pharmacologic management, health-related quality of life, and hospital readmission rates., Results: About 80% of patients who had enhanced access to care and patients receiving usual care underwent recommended evaluation of left ventricular ejection fraction. Among the subset of patients for whom an angiotensin-converting enzyme (ACE) inhibitor was recommended (i.e., ejection fraction < 40%), three quarters of the patients in both the enhanced access and usual care groups received the drug (75% vs. 73%; P > 0.2). Enhanced access to primary care did not improve quality of life and increased hospital readmissions, with an average of 1.5 +/- SD 2.0 readmissions per 6 months of follow-up for patients who had enhanced access compared with 1.1 +/- SD 1.8 for those who received usual care (P = 0.02)., Conclusions: Compliance with recommended CHF testing and treatment guidelines was equally high in both study groups. Enhanced access to primary care did not improve patients' self-reported health status and was associated with more frequent hospitalizations.

This article describes the design of an ongoing randomized trial intended to test whether patients who require elective vascular surgery would benefit from preoperative coronary artery revascularization prior to the vascular procedure. The primary objective is to determine whether coronary artery revascularization reduces long-term mortality (mean 3.5 years) in patients undergoing vascular surgery. The study design calls for 620 patients to be randomized and followed for a mean of 3.5 years following vascular surgery. Secondary endpoints include measures of quality of life and cost-effectiveness. Patients with coronary artery disease in need of an elective vascular operation are considered candidates for the study. Anatomic exclusion criteria include ejection fraction <20%, severe aortic stenosis (valve area <1.0 cm2), left main stenosis > or =50%, nonobstructive coronary artery disease (stenosis <70%), and coronary arteries that are not amenable to revascularization. Prior to the vascular surgery, the trial randomizes eligible patients to coronary artery revascularization (either bypass surgery or angioplasty) versus medical therapy. The trial stratifies the randomization by hospital and type of vascular surgery (intraabdominal versus infrainguinal) because of differences in long-term prognosis in those patients. A 1-year feasibility trial involving five Veterans Affairs (VA) medical centers of variable vascular surgical loads has been completed. The results showed that over 90% of expected patients could be randomized. As a result, a larger VA Cooperative Study involving 18 centers will begin recruitment of patients. The findings should help determine the best strategy for managing patients with coronary artery disease in need of elective vascular surgery.

Background: While studies have found racial differences in the rates of use of established invasive cardiac and cerebrovascular procedures, no study has evaluated racial variation in the rates of adoption of new surgical procedures. For patients undergoing laparoscopic cholecystectomy, the procedure represents a new and safe option that shortens the duration of postoperative hospitalization by almost one week. In this study, we evaluated whether, in the equal access Veterans Affairs (VA) medical system, the rate of adoption of this procedure and improvements in the duration of postoperative hospitalization differed between African-American and Caucasian patients., Study Design: Data were obtained from two sources-administrative claims files and prospectively compiled dinical data from medical records and patient interviews. In both data sets, frequency of use, length of stay, and outcomes for African-American and Caucasian patients undergoing minimally invasive and open gallbladder surgery were analyzed for the first four years of use of the procedure in the VA system (1992 to 1995)., Results: Analyses based on claims files indicated that, after adjustment for potentially confounding variables, African-American patients who underwent cholecystectomy in VA medical centers were 25% less likely to undergo a minimally invasive cholecystectomy during the first 4 years of use of the new procedure (adjusted odds ratio, 0.74; 95% confidence interval, 0.66-0.83). Shortening of the average postoperative length of stay from 9 days or more in the prelaparoscopic era to less than 4.5 days for patients undergoing the laparoscopic procedure occurred in the first year for Caucasian patients, but did not occur until the fourth year for African-American patients (p<0.001). The overall difference in postoperative length of stay between African-American and Caucasian patients more than doubled from 1.7 days before introduction of laparoscopic cholecystectomy to 3.8 days in the fourth year. In comparison, analyses based on nurse-compiled clinical data indicated that, after adjustment for relevant clinical factors, racial variations in the rate of laparoscopic surgery were even larger (adjusted odds ratio for laparoscopic versus open cholecystectomy for African-American versus Caucasian veterans, 0.68; 95% confidence interval, 0.55-0.84)., Conclusions: Compared to Caucasian patients, African-American patients who underwent cholecystectomy in VA medical centers had an approximately 25% to 32% lower likelihood of undergoing minimally invasive cholecystectomy procedures. The differences in rates of adoption of laparoscopic surgery did not appear to be from more comorbid illnesses among African-American patients. African-American and Caucasian veterans may differ in their preference for new surgical procedures like laparoscopic cholecystectomy. Conversely, VA physicians may have been less likely to recommend laparoscopic cholecystectomies to African-American patients.

Background: A part of the prospective, multi-institutional National Veterans Affairs Surgical Quality Improvement Program was developed to predict 30-day mortality and morbidity for patients undergoing a major pulmonary resection., Methods: Perioperative data were acquired from 194,319 noncardiac surgical operations at 123 Veterans Affairs Medical Centers between October 1, 1991, and August 31, 1995. Current Procedural Terminology code-based analysis was undertaken for major pulmonary resections (lobectomy and pneumonectomy). Preoperative, intraoperative, and outcome variables were collected. The 30-day mortality and morbidity models were developed by means of multivariable stepwise logistic regression with the preoperative and intraoperative variables used as independent predictors of outcome., Results: A total of 3516 patients (mean age 64 9 years) underwent either lobectomy (n = 2949) or pneumonectomy (n = 567). Thirty-day mortality was 4.0% for lobectomy (119/2949) and 11.5% for pneumonectomy (65/567). The preoperative predictors of 30-day mortality were albumin, do not resuscitate status, transfusion of more than 4 units, age, disseminated cancer, impaired sensorium, prothrombin time more than 12 seconds, type of operation, and dyspnea. When the intraoperative variables were considered, intraoperative blood loss was added to the preoperative model. In the presence of these intraoperative variables in the model, do not resuscitate status and prothrombin time more than 12 seconds were only marginally significant. Thirty-day morbidity, defined as the presence of 1 or more of the 21 predefined complications, was 23.8% for lobectomy (703/2949) and 25.7% for pneumonectomy (146/567). In multivariable models, independent preoperative predictors (P <.05) of 30-day morbidity were age, weight loss greater than 10% in the 6 months before surgery, history of chronic obstructive pulmonary disease, transfusion of more than 4 units, albumin, hemiplegia, smoking, and dyspnea. When intraoperative variables were added to the preoperative model, the duration of operation time and intraoperative transfusions were included in the model and albumin became marginally significant., Conclusions: This analysis identifies independent patient risk factors that are associated with 30-day mortality and morbidity for patients undergoing a major pulmonary resection. This series provides an initial risk-adjustment model for major pulmonary resections. Future refinements will allow comparative assessment of surgical outcomes and quality of care at many institutions.

Context: Health-related quality of life has not been evaluated as a predictor of mortality following coronary artery bypass graft (CABG) surgery. Evaluation of health status as a mortality predictor may be useful for preoperative risk stratification., Objective: To determine whether the Physical and Mental Component Summary scores from the preoperative Short-Form 36 (SF-36) health status survey predict mortality following CABG surgery after adjustment for known clinical risk variables., Design: Prospective cohort study conducted between September 1992 and December 1996., Setting: Fourteen Veterans Affairs hospitals., Patients: Of the 3956 patients undergoing CABG surgery only and who were enrolled in the Processes, Structures, and Outcomes of Care in Cardiac Surgery study, the 2480 who completed a preoperative SF-36., Main Outcome Measure: All-cause mortality within 180 days after surgery., Results: A total of 117 deaths (4.7%) occurred within 180 days of CABG surgery. The Physical Component Summary of the preoperative SF-36 was a statistically significant risk factor for 6-month mortality after adjustment for known clinical risk factors for mortality following CABG surgery. In multivariate analysis, a 10-point lower SF-36 Physical Component Summary score had an odds ratio (OR) of 1.39 (95% confidence interval [CI], 1.11-1.77; P=.006) for predicting mortality. The SF-36 Mental Component Summary score was not associated with 6-month mortality in multivariate analyses (OR, 1.09; 95% CI, 0.92-1.29; P=.31)., Conclusions: The Physical Component Summary score from the preoperative SF-36 is an independent risk factor for mortality following CABG surgery. The baseline Mental Component Summary score does not appear to be predictive of mortality. Preoperative patient self-report of the physical component of health status may be helpful for risk stratification and clinical decision making for patients undergoing CABG surgery.

Objectives: The interest in the economic impact of new health care interventions has increased dramatically over recent years; however, the results can be highly variable depending upon the economic assumptions made and the approaches taken in collecting the data and in conducting the analyses. This paper describes experiences from the VA Cooperative Studies Program in measuring health care utilization and costs for studies that evaluate clinical interventions., Methods: Experiences from two multisite randomized clinical trials (RCTs) are highlighted to illustrate strategies used to measure costs by directly measuring health care utilization and economic data within the context of the trials., Conclusions: Despite the substantial resources required to gather evidence about the cost of care for health care innovations, future VA multisite studies should include accepted health economic approaches to make important contributions to health planning and health policy within and outside the VA health care system.

Background: More than 600,000 coronary artery bypass graft (CABG) procedures are done annually in the United States. Some data indicate that 10 to 20% of patients who are undergoing a CABG procedure have a serum creatinine of more than 1.5 mg/dl. There are few data on the impact of a mild increase in serum creatinine concentration on CABG outcome., Methods: We analyzed a Veterans Affairs database obtained prospectively from 1992 through 1996 at 14 of 43 centers performing heart surgery. We compared the outcome after CABG in patients with a baseline serum creatinine of less than 1.5 mg/dl (median 1.1 mg/dl, N = 3271) to patients with a baseline serum creatinine of 1.5 to 3.0 mg/dl (median 1.7, N = 631)., Results: Univariate analysis revealed that patients with a serum creatinine of 1.5 to 3.0 mg/dl had a higher 30-day mortality (7% vs. 3%, P < 0.001) requirement for prolonged mechanical ventilation (15% vs. 8%, P = 0.001), stroke (7% vs. 2%, P < 0.001), renal failure requiring dialysis at discharge (3% vs. 1%, P < 0.001), and bleeding complications (8% vs. 3%, P < 0.001) than patients with a baseline serum creatinine of less than 1.5 mg/dl. Multiple logistic regression analyses found that patients with a baseline serum creatinine of less than 1.5 mg/dl had significantly lower (P < 0.02) 30-day mortality and postoperative bleeding and ventilatory complications than patients with a serum creatinine of 1.5 to 3.0 mg/dl when controlling for all other variables., Conclusion: These results demonstrate that mild renal failure is an independent risk factor for adverse outcome after CABG.

Objective: To test the hypothesis that surgical services combining relatively high levels of feedback and programming approaches to the coordination of surgical staff would have better quality of care than surgical services using low levels of both coordination approaches as well as those surgical service using low levels of either coordination approach., Study Setting: A study sample of 44 academically affiliated surgical services that are part of the Department of Veterans Affairs., Study Design: In a cross-sectional analysis, surgical services were assigned to one of three groups based on their scores on feedback and programming coordination measures: high on both measures; high on one measure, low on the other; and low on both. Univariate and multivariate analyses were used to assess differences among these groups with respect to three quality indicators: risk-adjusted mortality, risk-adjusted morbidity, and staff perceptions of quality., Data Collection/extraction Methods: Risk-adjusted mortality and morbidity came from an outcomes reporting program within the Department of Veterans Affairs that entails the prospective collection of clinical data from patient charts. Data on coordination practices and perceived quality came from a survey of surgical staff at each of the 44 participating surgical services., Principal Findings: The group of surgical services using high feedback and high programming had the best perceived quality. This group also had the lowest morbidity, but the difference was statistically significant with respect to only one of the two other groups: the group with low feedback and low programming. No significant group differences were found for mortality., Conclusions: Study results provide partial support for the hypothesis that high levels of feedback and programming should be combined for optimal quality of care. Study results also suggest that staff coordination is more important for improving morbidity than mortality in surgical services.

Objective: To define risk factors that predict adverse outcomes after proctectomy for cancer in Department of Veterans Affairs Medical Centers., Summary Background Data: Accurate presurgical assessment of the risk of perioperative complications and death is important in planning surgical therapy., Methods: The National VA Surgical Quality Improvement Program contains prospectively collected and extensively validated data on >287,000 patients. All patients undergoing proctectomy for rectal cancer from 1991 to 1995 who were registered in this data base were selected for study. Independent variables examined included 68 presurgical and 12 intraoperative clinical risk factors; dependent variables were 21 specific adverse outcomes. Stepwise logistic regression analysis was used to construct models predicting 30-day morbidity rates for each of the 10 most common complications and the 30-day mortality rate., Results: Five hundred ninety-one patients were identified; 467 (79%) underwent abdominoperineal resection and 124 (21%) were treated with sphincter-saving procedures. Thirty percent of patients had one or more complications after proctectomy. Prolonged ileus, urinary tract infection, pneumonia, and deep wound infection were the most frequently reported complications. The 30-day mortality rate was 3.2% (19 deaths). For most complications, 30-day mortality rates were significantly higher for patients with complications than for those without. Thirty-day mortality rates for several complications exceeded 50%: cardiac arrest requiring cardiopulmonary resuscitation, deep venous thrombosis or thrombophlebitis, coma lasting >24 hours, acute renal failure, cerebrovascular accident, and pulmonary embolism. Four presurgical factors predicted a high risk of 30-day mortality in the logistic regression analysis: elevated blood urea nitrogen level, impaired sensorium, low serum albumin concentration, and partial thromboplastin time < or =25 seconds., Conclusions: Mortality rates after proctectomy in VA hospitals are comparable to those reported in other large series. Most postsurgical complications are associated with an increased 30-day mortality rate. Elevated presurgical blood urea nitrogen level, impaired sensorium, low serum albumin concentration, and partial thromboplastin time < or =25 seconds predict a high risk of 30-day mortality.

The co-twin control design has been widely used in studying the effects of environmental factors on the development of diseases. For binary outcomes that arise from co-twin control studies, the conditional likelihood method is commonly used. This approach, however, does not readily extend to ordinal response data because the standard conditional likelihood does not exist for cumulative logit or proportional odds models. In this paper, we investigate the applicability of the random-effects and GEE approaches in analysing ordinal response data from co-twin control studies. Using both approaches, we re-analyse data from a co-twin control study of the impact of military services during the Vietnam era on post-traumatic stress disorders (PTSD). The ordinal models have considerably increased power in detecting the effects of exposure when compared to the analyses using a dichotomized response. We discuss the interpretation of the estimates from GEE and random-effect models in the context of the twin data.

The Department of Veterans Affairs, through its Cooperative Studies Program, has a long history of conducting large-scale, multihospital biomedical clinical trials. The agency's Health Services Research and Development Service, although newer, has a distinguished record of mainly single-site research into the organization, delivery, and financing of health services. In 1990, a joint program was initiated to conduct multicenter studies in health services research. This article describes the studies developed in the new program and the research design issues encountered in planning them. Identification of the patient population, specification and measurement of the intervention, and description of the control group, as well as attention to the unit of randomization and analysis, outcome variables and choice of effect size, data quality, and ethical considerations are among the important issues related to the design of these studies and future studies in health services.

Objective: The Veterans Affairs Cooperative Study in Type 2 Diabetes Mellitus was conducted in NIDDM patients to determine if a significant difference in HbA1c could be achieved between groups receiving standard and intensive treatment. We observed differences in the response to exogenous insulin between African-Americans and other intensively treated patients. Therefore, we assessed the variations of response and correlated factors that might explain such differences., Research Design and Methods: One hundred fifty-three men aged 40-69 years with NIDDM for < or = 15 years were randomized to either the standard therapy (n = 78) or the intensive therapy (n = 75) arm. Of the 75 patients in the intensive therapy group, 57 completed the study on insulin therapy alone. Of these, 18 were African-Americans and 39 were non-African-Americans. We conducted an analysis of the data collected to determine differences in baseline characteristics, glycemic response, insulin requirement, body weight, exercise, and basal C-peptide level, factors that may explain a difference in response to insulin therapy., Results: Glycemic control improved in all patients with intensive insulin therapy. African-Americans achieved a greater improvement in HbA1c compared with non-African-Americans with a similar increment in insulin. This difference could not be explained by differences in body weight, activity, concomitant use of other medicines, or insulin-secretory capacity of the pancreas., Conclusions: We conclude that ethnic differences may exist in the response to insulin therapy. A knowledge of such differences may aid in achieving good glycemic control, especially since minorities have a greater prevalence of and burden from the microvascular complications of diabetes.

Background: Risk-adjusted mortality and morbidity rates are often used as measures of the quality of surgical care. This study was conducted to determine the validity of risk-adjusted surgical morbidity and mortality rates as measures of quality of care by assessing the process and structure of care in surgical services with higher-than-expected and lower-than-expected risk-adjusted 30-day mortality and morbidity rates., Study Design: A structural survey of 44 Veterans Affairs Medical Center surgical services and site visits to 20 surgical services with higher-than-expected and lower-than-expected risk-adjusted outcomes were conducted. Main outcome measures included assessment of technology and equipment, technical competence of staff, leadership, relationship with other services, monitoring of quality of care, coordination of work, relationship with affiliated institutions, and overall quality of care., Results: Surgical services with lower-than-expected risk-adjusted surgical morbidity and mortality rates had significantly more equipment available in surgical intensive care units than did services with higher-than-expected outcomes (4.3 versus 2.9, p < 0.05). Site-visitor ratings of overall quality of care were significantly higher for surgical services with lower-than-expected morbidity and mortality rates (6.1 versus 4.5 for high outliers, p < 0.05); technology and equipment were rated significantly better among low-outlier services (7.1 versus 4.8 for high outliers, p < 0.001). Masked site-visit teams correctly predicted the outlier status (high versus low) of 17 of the 20 surgical services visited (p < 0.001)., Conclusions: Significant differences in several dimensions of process and structure of the delivery of surgical care are associated with differences in risk-adjusted surgical morbidity and mortality rates among 44 Veterans Affairs Medical Centers.

Background: The National Veterans Affairs Surgical Risk Study was designed to collect reliable, valid data on patient risk and outcomes for major surgery in the Veterans Health Administration and to report comparative risk-adjusted postoperative mortality and morbidity rates for surgical services in the Veterans Health Administration., Study Design: This was a cohort study conducted at 44 Veterans Affairs Medical Centers closely affiliated with university medical centers. Included were 87,078 major noncardiac operations performed under general, spinal, or epidural anesthesia between October 1, 1991, and December 31, 1993. The main outcomes measures in this report are 21 postoperative adverse events (morbidities) occurring within 30 days after the index procedure. Multivariable logistic regression risk-adjustment models for all operations and for eight surgical subspecialties were developed., Results: Patient risk factors predictive of postoperative morbidity included serum albumin level, American Society of Anesthesia class, the complexity of the operation, and 17 other preoperative risk variables. Wide variation in the unadjusted rates of one or more postoperative morbidities for all operations was observed across the 44 hospitals (7.4-28.4%). Risk-adjusted observed-to-expected ratios ranged from 0.49 to 1.46. The Spearman rank order correlation between the ranking of the hospitals based on unadjusted morbidity rates and risk-adjusted observed-to-expected ratios for all operations was 0.87. There was little or no correlation between the rank order of the hospitals by risk-adjusted morbidity and risk-adjusted mortality., Conclusions: The Department of Veterans Affairs has successfully implemented a system for the prospective collection and comparative reporting of postoperative mortality and morbidity rates after major noncardiac operations. Risk adjustment had only a modest effect on the rank order of the hospitals.