Labor epidurals improve outcomes for babies of mothers at high risk for unscheduled cesarean section.

CONTEXT: Epidural placement for labor in the general population of laboring women is associated with increased incidence of operative deliveries, prolongation of labor, and may be associated with an increased cesarean section rate. The risks and benefits associated with epidural placement for labor in the subpopulation of mothers at high risk for cesarean section have not been studied. OBJECTIVE: To determine if a population of mothers and babies at high risk for cesarean section will have improved outcomes with labor epidural placement. DESIGN: A decision and cost analysis examining epidural placement for labor on a population of women who are at high risk for unscheduled cesarean section and may benefit from scheduled cesarean section as determined by threshold analysis was performed. Outcomes and probabilities were determined through analysis of the Department of Defense's 1996 National Quality Management Program (NQMP) Birth Product Line data set containing more than 7000 deliveries. Outcomes were defined using variables comprised of all documented conditions that occurred during the peripartum and neonatal hospitalizations. The 1997 NQMP data set was used to validate the results. SETTING: Military Treatment Facilities throughout the United States and abroad and civilian facilities in the United States providing care to military dependents. PATIENT POPULATION: Active duty and dependent pregnant women and babies. RESULTS: About 8% of mothers in this patient population were found to be at high risk for cesarean section. The decision and cost analyses showed that babies of the high risk mothers who received epidurals for labor had better clinical outcomes (p<0.05) and the procedure was cost neutral (p=0.23). The procedure did not increase the frequency of cesarean section, and there was no effect on maternal outcomes scores. These results were confirmed by the validation study. CONCLUSIONS: There is a sizable subpopulation of women at high risk for cesarean section whose babies may have better outcomes with epidural placement with no sacrifice in maternal outcomes or costs.

A method for correcting for the variability of inhibitory effects of soluble human interleukin 1 receptor II measured by different ELISAS.

Seven ELISAs were developed by using several combinations of anti-human IL-1beta antibodies for detecting interleukin 1beta (IL-1beta) in cell culture supernatants. These ELISAs have different sensitivities in detecting standard preparations of recombinant human IL-1beta (WHO reference standard) compared with conventional preparations of IL-1beta produced by stimulated human peripheral blood mononuclear cells. The observed differences were attributed to differences in epitope specificity of the various monoclonal antibodies used and the heterogeneity of IL-1beta secreted into culture supernatants. The presence of soluble IL-1 receptor type I did not alter the levels of IL-1beta detected by these ELISAs. However, soluble IL-1 receptor type II interfered with the detection of IL-1beta to different degrees in these ELISAs. A method involving standarization by means of separate measurement of the amount of receptor and its inhibitory effect in the IL-1beta ELISA, yields consistent estimates of the correct IL-1beta levels.

Validity of the Department of Defense Standard Inpatient Data Record for quality management and health services research.

OBJECTIVE: To assess the validity of the Department of Defense's Standard Inpatient Data Record (SIDR) for health services research and quality measurement. SUBJECTS: Patients whose inpatient charts were abstracted through the Civilian External Peer Review Program's studies of acute myocardial infarction (N = 1,432) and 1993 review of the birth product line (N = 9,705). METHODS: Separate databases of professionally abstracted (the clinical data set) and hospital-reported (the administrative SIDR data set) diagnoses and procedures were compared for each patient, and the sensitivity and specificity of the SIDR for elements in the Civilian External Peer Review Program's clinical "gold standard" data set were calculated. Agreement beyond chance was examined with kappa statistics. RESULTS: The clinical data set's principal procedure was found as a SIDR principal or secondary procedure in 92.5% of cases. Sensitivities of the SIDR data for common diagnoses in the clinical data ranged from 64% (viral infection) to 97% (diabetes), with kappa statistics ranging from 0.55 to 0.96. Procedural sensitivities ranged from 77% (echocardiography) to 99% (cesarean section), with kappa statistics ranging from 0.7 to 1.0. CONCLUSIONS: Our analyses indicate that the Department of Defense's SIDR is a reliable source of administrative data that compares favorably with traditional civilian quality management and health services research data sources, such as those from the Health Care Financing Administration and large insurers.

'Best clinical practice': assessment of processes of care and of outcomes in the US Military Health Services System.

The National Quality Management Program of the Military Health Services System of the United States has undertaken a series of projects whose objective is the active, on-going monitoring and improvement of the effectiveness and efficiency of the care provided to a broad population that encompasses troops on active duty, retirees and dependents. The analytic activities consist of (1) identification by clinical panels of conditions and procedures of interest; (2) collection of data from electronic repositories and from charts to characterize the patients, how they are managed, the clinical outcomes they experience, the resource costs their care entails, and, from questionnaires, their functional status and level of satisfaction, and (3) generation of 'report cards' that inform organizational units down to the level of the hospital of the characteristics of their patients, their practices, and the risk-adjusted outcomes they achieve. The patterns of care employed by the hospitals that obtain the best risk-adjusted outcomes and resource utilization ('best clinical practice') are identified and made known. In addition, (4) a systematic process of developing outcomes-based practice guidelines has been devised. It intent is to serve as a decision-support tool for clinicians. Initial estimates have been obtained of the probable consequences of the application of this tool to operative interventions in childbirth. Use of the tool would result in a higher occurrence of elective Caesarean sections, a reduced rate of emergency Caesarean sections and much lower use of forceps, with an overall improvement in outcomes and lower resource costs. This program is currently in the early phases of implementation. The two principal requirements for the immediate future are (1) education of the clinical and administrative communities in the use of the data and the decision-support tools and (2) evaluation of the consequences of the use of the data by the clinical and administrative communities.

The relationship of the value of outcome comparisons to the number of patients per provider.

PURPOSE: Monte Carlo methods were used to assess how the value of outcome comparisons depends on the number of patients per provider. METHODS: We simulated two patient data sets that have been used for well-known studies of outcome comparisons: mortality rates for coronary artery bypass surgeons from New York and Pennsylvania, and 30-day hospital mortality rates of Medicare patient from a national data set. In the simulated data sets, each surgeon or hospital provider was assigned a true or underlying probability of mortality. RESULTS: For the simulated CABG surgery data set, the underlying probability of mortality explained 30% of the variation in the observed mortality rate when there were 100 patients per physician, and 63% when there were 400 patients. The positive predictive value of using an observed mortality rate in the bottom 10% to identify a surgeon whose underlying probability of mortality was in the bottom 10% was 31% for 100 patients and 59% for 400 patients. The relationship between underlying and observed rates was weaker in the simulated Medicare data set with the same number of patients per provider. For a given data set, the amount of random variation in the observed rates of adverse outcomes among providers can be estimated with a simple equation. CONCLUSION: The results show that the assessment of provider outcomes may be greatly affected by random variation. An indication of the amount of random variation in a given data set can be obtained from the examples in this study and an equation for estimating random variation.

Competency in health care management: a training model in epidemiologic methods for assessing and improving the quality of clinical practice through evidence-based decision making.

This article describes a training model that focuses on health care management by applying epidemiologic methods to assess and improve the quality of clinical practice. The model's uniqueness is its focus on integrating clinical evidence-based decision making with fundamental principles of resource management to achieve attainable, cost-effective, high-quality health outcomes. The target students are current and prospective clinical and administrative executives who must optimize decision making at the clinical and managerial levels of health care organizations.

Gastroenterology workforce modeling.

OBJECTIVE: To examine the current supply and distribution of gastroenterologists and project future supply under various scenarios to provide a paradigm for workforce reform. DESIGN: An analysis of current practices and distribution of gastroenterologists and a demographic model, using the 1992 gastroenterology workforce as a baseline. MAIN OUTCOME MEASURE: Comparison of current supply, distribution, and practice profiles with past data and future projections, using analyses of data from the 1993 Area Resource File, 1992 Medicare Part B file, age- and sex-specific death and retirement rates from the Bureau of Health Professions, managed care staffing patterns, the National Survey of Internal Medicine Manpower, and the Bureau of the Census. RESULTS: Rapid growth in the number of US gastroenterologists has resulted in a gastroenterologist-to-population ratio double that used on average by health maintenance organizations. In addition, the work profile of gastroenterologists is shared significantly by primary care physicians and other specialists, with the exception of a few specific and uncommon procedures. CONCLUSIONS: Empirical evidence suggests that, even in the absence of detailed models to describe the desired supply/need balance for gastroenterology, the US health care system and clinicians may benefit from a reduction in gastroenterology training programs. The Gastroenterology Leadership Council endorsed a goal of 25% to 50% reduction in trainee numbers over 5 years, and recent National Resident Matching Program data indicate that a voluntary downsizing process is in full force. This study illustrates a paradigm for workforce planning that could be useful for other medical specialties.

Physician impact on hospital admission and on mortality rates in the Medicare population.

OBJECTIVE: We assess the effect of variations in the supply and specialty distribution of physicians on admission rates for ambulatory care-sensitive conditions (ACS) and for all causes, and on mortality rates among Medicare beneficiaries of various health care service areas (HCSA). DATA SOURCES: For the Medicare beneficiaries, sources were the Health Care Financing Administration's 1992 enrollment and impatient (Part A) files for a 5 percent sample of that population; for the overall populations and for the medical resources of the HCSAs, the Area Resource File. STUDY DESIGN: This observational, cross-sectional study employed multiple linear regression to assess the influence of population characteristics and of the supply of physicians on hospital admissions, and Poisson regression in the analysis of the factors that affect mortality. PRINCIPAL FINDINGS: Physician supply levels vary nearly fourfold or more when comparing the top and bottom deciles of the HCSAs, Medicare admissions for ACS conditions vary about threefold, and admission rates for all causes and mortality rates vary about 1.5-fold. Physician supply levels and distributions have very little influence on ACS admission rates, and even less on the admissions for all causes and on mortality, except in HCSAs with very low physician supply levels (one-fourth the national average or less). However, these HCSAs account for only about 1 percent of the U.S. population. CONCLUSIONS: Physician supply levels and the proportions of specialists and generalists have negligible effects on health status as measured by mortality rates and by rates of admission for all causes and for conditions presumed to be sensitive to the adequacy of ambulatory care. Reductions in admissions for such conditions are not likely to be achieved through broadening of insurance to levels that exist under Medicare, nor through increases in the supply of physicians, nor, conversely, through a reduction in any presumed oversupply of physicians.

The relationship of clinical outcomes to status as a Medicare-approved heart transplant center.

This study reports the evaluation of the validity and utility of the Medicare heart transplant center selection process, as outlined in its 1986 Heart Coverage Regulations. A total of 9401 heart transplants performed in the U.S. between 1986 and 1991 were analyzed. The outcomes assessed were mortality and the occurrence of infection during the hospital stay. Outcomes experienced by centers with and without Medicare approval were compared directly and following adjustment for patient risk factors. Patients at centers that satisfied the Medicare criteria experienced lower mortality. The risk-adjusted hazard ratio for death over the five years of observation was 0.874 (P = 0.005). The probability of death following a transplant at a Medicare-approved center was 7.0 +/- 0.4% at 30 days and 16.2 +/- 0.6% at one year, and 9.2 +/- 0.4% and 19.2 +/- 0.6%, respectively, at centers without Medicare approval (P = 0.001). The difference appeared to be principally associated with death within 30 days of admission due to nonspecific graft failure. The posttransplant infection rate at Medicare-approved centers was 0.743 (P < 0.001) but this result is strongly confounded with differences in reporting patterns of the two types of centers. Criteria used by HCFA identify medical centers where outcomes of heart transplantation, as measured by mortality, are superior. This difference is established early, persists over time, and is not attributable to the numerous risk factors considered in our models. Overall, the results of the present study suggest that "centers of excellence" can be identified through the evaluation of center characteristics and outcomes, and that this approach chosen by HCFA may have broad health care systems applications.

The systematic assessment of variations in medical practices and their outcomes.

The Health Care Financing Administration of the Department of Health and Human Services has carried out for several years the systematic assessment of variations over time and among geographic locales in patterns of care and patterns of outcomes experienced by Medicare beneficiaries. This routine monitoring focuses principally on hospitalizations and their outcomes (death and readmission) and is based on the Medicare enrollment file and the claims file for inpatient care. The period 1985-88 has been marked by declining adjusted post-admission risks for mortality (down 4 percent) and readmission (down 6 percent) for Medicare beneficiaries. The downward trend in mortality risks is most evident following hospitalizations for acute myocardial infarction (down 8 percent) and stroke (down 12 percent). Hospital admission and population mortality rates, adjusted for differences in demographic and socioeconomic characteristics of the populations, vary substantially among areas as large as States and Metropolitan Statistical Areas, as do risk-adjusted post admission probabilities of death among those areas and among hospitals. Thus, if overall admission and mortality rates in the upper three quartiles of Metropolitan Statistical Areas were brought down to the average of the lowest quartile, there would be 20 percent fewer admissions and 12 percent fewer deaths within 180 days of admission for hospitalized patients. Although favorable trends in the effectiveness of the hospital care received by Medicare beneficiaries appear discernible, the existence of substantial variations suggests that further improvement may be possible.

Serum levels of tumor necrosis factor-alpha, interleukin-1, and interleukin-6 in hemorrhagic fever with renal syndrome.

Hemorrhagic fever with renal syndrome is an acute viral disease caused by hantavirus. On the basis of clinical observation, the illness is divided into five sequential stages: febrile, hypotensive, oliguric, diuretic, and convalescent. Because interleukin-1 (IL-1), tumor necrosis factor-alpha (TNF-alpha), and interleukin-6 (IL-6) are mediators responsible for fever, septic shock, and acute phase protein induction, we examined, using ELISA, the presence of these three cytokines in 276 sera collected during the Korean Conflict from 110 patients. Detectable levels (> 20 pg/ml) of TNF-alpha, IL-1 beta, and IL-6 occurred in 14, 14, and 33% of these samples, respectively. There was a significant correlation between serum levels of IL-1 beta and TNF-alpha (r = 0.66, p < 0.001), IL-1 beta and IL-6 (r = 0.59, p < 0.001), and IL-6 and TNF-alpha (r = 0.71, p < 0.001). The pathophysiologic processes of HFRS do not have clear or consistent correlations with alterations in the levels of the cytokines studied.

The relationship of hospital ownership and teaching status to 30- and 180-day adjusted mortality rates.

Hospital characteristics have been shown previously to be associated with variations in the probability of death within 30 days of admission. In the current study, the authors extend the examination of the relationship between hospital type to both short-term and long-term adjusted mortality. Observed and predicted 1988 hospital mortality rates were obtained from the Health Care Financing Administration (HCFA). A total of 3,782 acute care hospitals were divided into six mutually exclusive groups on the basis of their status as osteopathic, private for-profit, public teaching, public nonteaching, private teaching, and private nonteaching hospitals. After adjusting for the HCFA predicted mortality, Medicaid admissions, and emergency visits, 30-day and 30-to-180-day patient mortality rates were compared for these hospital types. Separate comparisons also were performed after stratifying hospitals into three groups defined by community size. The risk-adjusted 30-day mortality per 1,000 patients was 91.5, ranging from 85.4 for private teaching hospitals to 95.3 for nonteaching public hospitals, and 97.4 for osteopathic hospitals. The adjusted 30-to-180-day mortality was 84.7, ranging from 82.6 for nonteaching public hospitals to 87.4 and 88.2, respectively for public teaching and osteopathic hospitals. Differences among hospital types were minimal for small communities and increased with community size. In the large communities, the types of hospitals with high 30-day mortality also had higher mortality after 30 days. There was a strong association of hospital type with adjusted 30-day mortality, which should depend on the quality of hospital care, and a much weaker association with post-30-day mortality, which may be more dependent on patient risk. There was no evidence that types of hospitals with low 30-day mortality were postponing rather than preventing mortality.

The impact of HLA mismatches on the survival of first cadaveric kidney transplants.

BACKGROUND: The benefits of HLA-A, B, and DR matching of cadaveric kidney grafts and recipients remain controversial when viewed from the perspective of social equity and graft survival. METHODS: We estimated graft survival using proportional-hazards techniques, adjusting for patient and donor characteristics, for a series of 30,564 Medicare patients receiving a first cadaveric kidney transplant between 1984 and 1990. The effects of minimal achievable HLA mismatches and maximal matching on graft survival were estimated by simulated allocation of a sample of organs to a sample of 20,000 candidates for transplantation. RESULTS: The adjusted one-year graft survival was 84.3 percent for grafts with no mismatches and 77.0 percent for grafts with four mismatches. National rationing of donor organs to achieve minimal mismatching and maximal matching could potentially decrease the average number of HLA mismatches from 3.6 to 1.2, with a corresponding increase in the number of matches. As a consequence, projected five-year graft survival could potentially increase from 58.5 percent to 62.9 percent. This would be associated with a decrease in the proportion of kidneys allocated to black recipients from 22.2 to 15.0 percent. CONCLUSIONS: Under ideal circumstances, a policy of maximal matching of cadaveric renal transplants would increase five-year graft survival by a comparatively small 4.4 percentage points, but the actual benefit is likely to be smaller.

Severity of illness measures derived from the Uniform Clinical Data Set (UCDSS).

The Health Care Financing Administration (HCFA) plans to use the Uniform Clinical Data Set System (UCDSS) to collect data on hospitalized Medicare patients. This study examined the value of UCDSS data for creating severity of illness measures. UCDSS data were obtained from a study hospital and from a national data set for patients with pneumonia (n = 528) and stroke (n = 565). Models to predict length of stay or an adverse event were derived for each condition using HCFA claims data alone, UCDSS data alone, and UCDSS data supplemented with additional information also abstracted from charts. The models were derived from one set of patients and validated on another. The R2 for predicting length of stay in the validation data for the UCDSS model was 0.29 for pneumonia and 0.19 for stroke compared to R2 values from the claims model of 0.09 for stroke and 0.06 for pneumonia. UCDSS models also were better than claims models for predicting adverse events. The best UCDSS models included International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes and other information requiring clinical judgment, and were improved by adding more information on patient functional status. Some findings were more strongly associated with outcome for the study hospital than for the national data. These results suggest that UCDSS models will predict outcome much better than the claims based models currently used by HCFA for the analysis of hospitalization-related mortality; more functional status information should be added to UCDSS; and despite an extensive objective database, the most predictive UCDSS models require clinician-assigned diagnostic codes.