Ethics and methods in surgical trials.

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.

Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer.

PURPOSE: To examine variation in men's long-term regret of treatment decisions, ie, surgical versus chemical castration, for metastatic prostate cancer and its associations with quality of life. METHODS: Survey of previously treated patients to assess treatment decisions and quality of life, supplemented with focus groups. Two items addressing whether a patient wished he could change his mind and the belief that he would have been better off with the treatment not chosen were combined in classifying survey respondents as either satisfied or regretful. Chi(2) and t tests were used to test associations between regret and treatment history, complications, and quality of life. RESULTS: Survey respondents included 201 men aged 45 to 93 years (median, 71 years), who had begun treatment (71% chemical castration, 29% orchiectomy) a median of 2 years previously. Most reported complications: hot flashes (70%), nausea (34%), and erectile dysfunction (81%). Most were satisfied with the treatment decision, but 23% expressed regret. Regretful men more frequently reported surgical (43%) versus chemical (36%) castration (P: = .030) and nausea in the past week (54% v 32%; P: = .010) but less frequently reported erectile dysfunction (56% v 72%; P: = .048). Regretful men indicated poorer scores on every measure of generic and prostate cancer-related quality of life. Qualitative analyses revealed substantial uncertainty about the progress of their disease and the quality of the decisions in which patients participated. CONCLUSION: Regret was substantial and associated with treatment choice and quality of life. It may derive from underlying psychosocial distress and problematic communication with physicians when decisions are being reached and over subsequent years.

Postoperative delirium. A review of 80 primary data-collection studies.

We conducted an on-line search and manual searches for 1966 through 1992 to determine the incidence, diagnosis, risk factors, and treatment of postoperative delirium. Of the 374 citations found, 277 articles were excluded after criteria of relevance were applied. After methodologic criteria for validity were applied to the remaining 80 articles, 26 studies were retained for the final information synthesis. The incidence of postoperative delirium was 36.8% (range, 0% to 73.5%). Primary reasons for this disparity were insufficient sample size and inconsistent application of numerous diagnostic tools. One study provided statistically significant data that demonstrated that postoperative delirium is underdiagnosed by physicians and nurses. Four of the articles that met the established criteria provided risk factor data. Although age, preoperative cognitive impairment, and the use of anticholinergic drugs were significantly associated with postoperative delirium, gender, type and route of anesthesia, and sleep deprivation were not. Two studies demonstrated a decreased incidence of postoperative delirium when patients underwent preoperative psychiatric counseling or participated in a structured perioperative program. These findings indicate a need for (1) accurate incidence data with further definition of risk factors and (2) studies that address the diagnosis and treatment of this common postoperative problem.

Predicting non-elective hospital readmissions: a multi-site study. Department of Veterans Affairs Cooperative Study Group on Primary Care and Readmissions.

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.

The incidence of perioperative myocardial infarction with transurethral resection of the prostate.

We performed a prospective study of 250 men undergoing transurethral resection of the prostate to determine the incidence of perioperative myocardial infarction. The prevalence of coronary artery disease in the study group was 27%. Patients had measurement of total creatine kinase and its MB isoenzyme and electrocardiography preoperatively and on the first three postoperative days. Only one myocardial infarction was diagnosed, an incidence rate of 0.4%. The overall rate of serious post-operative complications was 3.6%. No deaths occurred during the operative hospitalization. We conclude that with transurethral resection perioperative myocardial infarction is a rare event despite the high prevalence of coronary artery disease in this surgical population. Routine postoperative surveillance with electrocardiograms and creatine kinase determinations in asymptomatic patients is not warranted.

The frequency and significance of ECG changes after transurethral prostate resection.

Although many clinicians routinely recommend a base-line preoperative electrocardiogram (ECG) and obtain frequent postoperative ECGs to screen for myocardial infarction or ischemia, the diagnostic utility of screening perioperative ECGs is unknown. The present analysis evaluates the sensitivity and specificity of the perioperative ECG and examines its value as a predictor of early postoperative cardiac events and outcomes during the postoperative year. ECGs obtained preoperatively and on the first 3 postoperative days in 206 men undergoing transurethral prostate resection were analyzed using the Minnesota Code. The occurrence of cardiac events during the operative stay was assessed by measurement of the cardiospecific MB creatine kinase isoenzyme on the first 3 postoperative days and review of the entire clinical course. Twenty-one percent of patients developed postoperative ECG changes, mostly involving the T wave; none had cardiac symptoms or sustained creatine kinase MB elevation. Changes were not significantly more common in men known to have coronary disease. The single patient who had a perioperative myocardial infarction confirmed by enzymes had no codable ECG changes. The specificity of any ECG change for perioperative infarction was 78%; of ST segment changes only, 95%. Only one of the patients (2%) who had postoperative ECG changes had a cardiac event in the year after surgery. Routine perioperative ECGs is of little diagnostic/predictive utility in situations in which the incidence of perioperative myocardial infarction is low.

In-patient workload in medical specialties: 2. Profiles of individual diagnoses from linked statistics.

We analysed hospital use for 58 common clinical conditions in the medical specialties, using data from the two districts covered by the Oxford record linkage study 1968-1986. Episode rates, person rates, and ratios of multiple admissions per person were computed. In young adults, poisoning was the most common reason for admission. In older adults, the most common clinical conditions included atherosclerotic diseases and smoking-related lung diseases. Comparing the first and last time periods studied, admission rates increased by 10% or more in 37 of the 58 conditions, including 7 of the 10 conditions with the highest overall hospitalization rates. Conditions in which admissions increased by 10% or more included myocardial infarction, other ischaemic heart disease, chronic obstructive lung disease, asthma, pneumonia, diabetes, poisoning, dementia, prostate cancer and breast cancer among others. Workload declined by 10% or more in 13 conditions, including stroke, subarachnoid haemorrhage, hypertension, thyrotoxicosis, acquired hypothyroidism, and tuberculosis. Secular trends in hospital use are generally attributable either to changes in disease frequency in the population or to changes in clinic- or hospital-based technology and practice.

Identifying complications and low provider adherence to normative practices using administrative data.

OBJECTIVE: This study investigated whether unexpected length of stay (LOS) could be used as an indicator to identify hospital patients who experienced complications or whose care exhibited low adherence to normative practices. DATA SOURCES AND STUDY SETTING: We analyzed 1,477 cases admitted for one of three medical conditions. All cases were discharged from one of nine participating Department of Veterans Affairs (VA) hospitals from October 1987 through September 1989. Analyses used administrative data and information abstracted through chart reviews that included severity of illness indicators, complications, and explicit process of care criteria reflecting adherence to normative practices. STUDY DESIGN: We developed separate multiple linear regression models for each disease using LOS as the dependent measure and variables that could be assumed present at the time of admission as explanatory variables. Unexpectedly long LOS (i.e., discharges with high residuals) was used to target complications and unexpectedly short LOS was used to target cases whose care might have exhibited low adherence to normative practices. Information gleaned from chart reviews served as the gold standard for determining actual complications and low adherence. PRINCIPAL FINDINGS: Analyses of administrative data showed that unexpectedly long LOS identified complications with sensitivities ranging from 40 through 62 percent across the three conditions. Positive predictive values all were at greater than chance levels (p < .05). This represented substantial improvement over identification of complications using ICD-9-CM codes contained in the administrative database where sensitivities were from 26 through 39 percent. Unexpectedly short LOS identified low provider adherence with sensitivities ranging from 33 through 45 percent with positive predictive values all above chance levels (p < .05). The addition to the LOS models of chart-based severity of illness information helped explain LOS, but failed to facilitate identification of complications or low adherence beyond what was accomplished using administrative data. CONCLUSIONS: Administrative data can be used to target cases when seeking to identify complications or low provider adherence to normative practices. Targeting can be accomplished through the creation of indirect measures based on unexpected LOS. Future efforts should be devoted to validating unexpected LOS as a hospital-level quality indicator. RELEVANCE/IMPACT: Scrutiny of unexpected LOS holds promise for enhancing the usefulness of administrative data as a resource for quality initiatives.

The hospital multistay rate as an indicator of quality of care.

OBJECTIVES: To evaluate the hospital multistay rate to determine if it has the attributes necessary for a performance indicator that can be applied to administrative databases. DATA SOURCES/STUDY SETTING: The fiscal year 1994 Veterans Affairs Patient Treatment File (PTF), which contains discharge data on all VA inpatients. STUDY DESIGN: Using a retrospective study design, we assessed cross-hospital variation in (a) the multistay rate and (b) the standardized multistay ratio. A hospital's multistay rate is the observed average number of hospitalizations for patients with one or more hospital stays. A hospital's standardized multistay ratio is the ratio of the geometric mean of the observed number of hospitalizations per patient to the geometric mean of the expected number of hospitalizations per patient, conditional on the types of patients admitted to that hospital. DATA COLLECTION/EXTRACTION METHODS: Discharge data were extracted for the 135,434 VA patients who had one or more admissions in one of seven disease groups. PRINCIPAL FINDINGS: We found that 17.3 percent (28,300) of the admissions in the seven disease categories were readmissions. The average number of stays per person (multistay rate) for an average of seven months of follow-up ranged from 1.15 to 1.45 across the disease categories. The maximum standardized multistay ratio ranged from 1.12 to 1.39. CONCLUSIONS: This study has shown that the hospital multistay rate offers sufficient ease of measurement, frequency, and variation to potentially serve as a performance indicator.

"Invisible" doctors: making a case for involving medical residents in hospital quality improvement programs.

The author maintains that residents should be as actively engaged in the evaluation and improvement of the inpatient and ambulatory care they deliver as staff physicians are, and that to exclude them from their departments' formal quality assessment and assurance program wastes valuable opportunities to train them and to improve patient care. For example, residents can benefit from process-of-care reviews, which help teach them the standards of adequate medical care and motivate them to improve the care they give. Residents can also benefit from participating in the quality assessment process itself; this will help develop their clinical and analytic skills, hone their skills in searching and critiquing the medical literature, and help them understand the links between the processes and outcomes of care. In addition, systematic, criteria-based reviews of residents' clinical competence in the diagnosis and treatment of common medical conditions can help attending physicians and residency directors evaluate the residents' abilities. And finally, hospitals benefit from the involvement of housestaff in the quality improvement program, since housestaff often have more insight than staff physicians or administrators into aspects of the physical plant or organizational structure that impair clinicians' ability to provide good care. The author gives examples for each of the preceding statements, and concludes by saying that when residents are treated as if they are "invisible" in quality assessment programs, the program staff is in some measure abdicating its responsibility for the residents' education and for the well-being of the program's current and the residents' future patients.

A conceptual framework for the study of early readmission as an indicator of quality of care.

Despite the perennial popularity of readmission as an indicator of the quality of hospital care, the empiric evidence linking it to process-of-care problems during the prior hospitalization is inconsistent. We devised a conceptual model for the use of unscheduled readmission within 31 days as an indicator of the quality of medical-surgical inpatient care for adults, and then conducted a systematic review of the readmission literature to determine the extent to which the evidence supports the proposed relationships. A fairly complex web of relationships influences the association between the process of inpatient care and early readmission. From the evidence to date, it is impossible to say with confidence that early readmission is or is not a valid and useful quality indicator. In most negative studies, the absence of an association appears to be explainable on the basis of improper study design, omission of important variables, or mis-specification of variables. Variables intervening between or confounding the relationship of the process of inpatient care to early readmission have received inadequate attention in past work. Investigators can use the proposed model and literature review to ensure their work advances the field and puts the hypothesis that early readmission is a valid quality indicator to a rigorous test. This matter has a certain urgency in view of the vast amount of resources that providers and payers devote to monitoring readmission rates and reviewing readmissions.

Using administrative databases to evaluate the quality of medical care: a conceptual framework.

Health care is consuming an ever larger share of national resources in the United States. Measures to contain costs and evidence of unexplained variation in patient outcomes have led to concern about inadequacy in the quality of health care. As a measure of quality, the evaluation of hospitals through analysis of their discharge databases has been suggested because of the scope and economy offered by this methodology. However, the value of the information obtained through these analyses has been questioned because of the inadequacy of the clinical data contained in administrative databases and the resultant inability to control accurately for patient variation. We suggest, however, that the major shortcoming of prior attempts to use large databases to perform across-facility evaluation has resulted from the lack of a conceptual framework to guide the analysis. We propose a framework which identifies component areas and clarifies the underlying assumptions of the analytic process. For each area, criteria are identified which will maximize the validity of the results. Hospitals identified as having unexpectedly high unfavorable outcomes when our framework is applied will be those where poor quality will most likely be found by primary review of the process of care.(ABSTRACT TRUNCATED AT 250 WORDS)

A psychometric analysis of the measurement level of the rating scale, time trade-off, and standard gamble.

A fundamental assumption of utility-based analyses is that patient utilities for health states can be measured on an equal-interval scale. This assumption, however, has not been widely examined. The objective of this study was to assess whether the rating scale (RS), standard gamble (SG), and time trade-off (TTO) utility elicitation methods function as equal-interval level scales. We wrote descriptions of eight prostate-cancer-related health states. In interviews with patients who had newly diagnosed, advanced prostate cancer, utilities for the health states were elicited using the RS, SG, and TTO methods. At the time of the study, 77 initial and 73 follow-up interviews had. been conducted with a consecutive sample of 77 participants. Using a Rasch model, the boundaries (Thurstone Thresholds) between four equal score sub-ranges of the raw utilities were mapped onto an equal-interval logit scale. The distance between adjacent thresholds in logit units was calculated to determine whether the raw utilities were equal-interval. None of the utility scales functioned as interval-level scales in our sample. Therefore, since interval-level estimates are assumed in utility-based analyses, doubt is raised regarding the validity of findings from previous analyses based on these scales. Our findings need to be replicated in other contexts, and the practical impact of non-interval measurement on utility-based analyses should be explored. If cost-effectiveness analyses are not found to be robust to violations of the assumption that utilities are interval, serious doubt will be cast upon findings from utility-based analyses and upon the wisdom of expending millions in research dollars on utility-based studies.

Perioperative myocardial infarction with noncardiac surgery.

The incidence of perioperative myocardial infarction with noncardiac surgery varies by the type of procedure and the prevalence of coronary atherosclerosis in the study population. Incidence is < or = 1% with minor procedures and may exceed 10% with vascular operations. The case fatality rate continues to be 30% to 50%. Pathogenesis is not understood completely. Diagnosis is sometimes problematic, because less than 50% of patients complain of chest pain. In addition, a high frequency of notable but apparently innocent postoperative electrocardiograph changes limits the diagnostic use of the electrocardiogram. Fortunately, the creatine kinase MB isoenzyme retains its sensitivity and specificity for acute infarction in perioperative patients. Different approaches to preoperative risk assessment have been developed, including a summative cardiac risk index and a stratification system based on the likelihood that the most powerful risk factor (coronary artery disease) is present. Although many interventions have been recommended to lower perceived risk, none has been tested in a randomized controlled trial, and their comparative efficacy and safety is unknown.

Rates of health services utilization and survival in patients with heart failure in the Department of Veterans Affairs medical care system.

The objective of this study was to describe patterns of hospital and clinic use and survival for a large nationwide cohort of patients with heart failure. A retrospective cohort study of patients treated in the Veterans Affairs medical care system was conducted using linked administrative databases as data sources. In 1996, the average heart failure cohort member had 1-2 hospitalizations, 14 inpatient days, 6-7 visits with the primary physician, 15 other visits for consultations or tests, and 1-2 urgent care visits per 12 months. The overall risk-adjusted 5-year survival rate was 36%. Hospital use rates in the cohort fell dramatically between 1992 and 1996. One-year survival rates increased slightly over the period. Patients with heart failure are heavy users of services and have a very poor prognosis. Utilization and outcome data indicate the need for major efforts to assure quality of care and to devise innovative ways of delivering comprehensive services.

Chart review. A need for reappraisal.

Imperfections of chart review as a data collection method are detailed, with particular emphasis on the issue of reliability. The authors identify 125 journal articles published between 1991 and 1992 in which the authors' conclusions were based principally on chart review findings and were either clinical or health care epidemiology studies, or quality assessment studies. Eight percent of epidemiology studies and 56% of quality assessment studies presented data on interrater reliability. Forty-four percent of epidemiology studies and 20% of quality assessment studies did not describe the number of chart reviewers involved. Forty-three percent of epidemiology studies and 28% of quality assessment studies used supplementary data sources. The authors conclude that the validity and utility of studies based on chart review would be enhanced by attention to interrater reliability and the use of supplementary data sources.

The health status of veterans using mobile clinics in rural areas.

Between 1992 and 1994, the Department of Veterans Affairs (VA) experimented with mobile clinics to provide health care for rural veterans. The objective was to assess the health status of rural mobile clinics' patients and compare this with patients receiving care in VA hospital-based clinics. This study hypothesized that hospital-based clinic patients would be more ill (i.e., have a greater reduction in health status). The Medical Outcomes Study (MOS) Short Form was used to evaluate patients' health status. Most patients sought care for the management of chronic disease. Patients in both groups had similar types of diseases. Mobile clinic patients were as ill as hospital-based patients (i.e., similar health status scores). This study shows that rural veterans have a case mix and a reduction in health status similar to that of VA hospital-based patients. Planners should account for this health reduction when planning the kinds of facilities and services needed in rural areas.

Incentives for vertical integration in healthcare: the effect of reimbursement systems.

In the United States, many healthcare organizations are being transformed into large integrated delivery systems, even though currently available empirical evidence does not provide strong or unequivocal support for or against vertical integration. Unfortunately, the manager cannot delay organizational changes until further research has been completed, especially when further research is not likely to reveal a single, correct solution for the diverse healthcare systems in existence. Managers must therefore carefully evaluate the expected effects of integration on their individual organizations. Vertical integration may be appropriate if conditions facing the healthcare organization provide opportunities for efficiency gains through reorganization strategies. Managers must consider (1) how changes in the healthcare market have affected the dynamics of production efficiency and transaction costs; (2) the likelihood that integration strategies will achieve increases in efficiency or reductions in transaction costs; and (3) how vertical integration will affect other costs, and whether the benefits gained will outweigh additional costs and efficiency losses. This article presents reimbursement systems as an example of how recent changes in the industry may have changed the dynamics and efficiency of production. Evaluation of the effects of vertical integration should allow for reasonable adjustment time, but obviously unsuccessful strategies should not be followed or maintained.

Evaluation of the VA mobile clinics demonstration project.

In 1988 the Veterans' Benefits and Services Act attempted to solve the problem of the lack of adequate VA healthcare facilities in rural areas by establishing a demonstration program using mobile clinics. Six clinics operated in areas that were at least 100 miles from a VA healthcare facility during the time period between October 1, 1992 and May 28, 1994. This article evaluated the effect of the mobile clinics' structural limitations on clinical care, the increased number of sites on VA usage, and cost. Limited space for storage of medical records and the unavailability of laboratory, electrocardiographic, or radiographic facilities significantly affected clinical practice. However, even with these space limitations, veterans' use of healthcare in the areas served by the mobile clinics increased significantly in comparison to reference areas. The direct costs per visit averaged more than three times what the VA would have reimbursed the private sector.

Forecasting areawide hospital utilization: a comparison of five univariate time series techniques.

Time series analysis is one of the methods health services researchers, managers and planners have to examine and predict utilization over time. The focus of this study is univariate time series techniques, which model the change in a dependent variable over time, using time as the only independent variable. These techniques can be used with administrative healthcare databases, which typically contain reliable, time-specific utilization variables, but may lack adequate numbers of variables needed for behavioral or economic modeling. The inpatient discharge database of the Department of Veterans Affairs, the Patient Treatment File, was used to calculate monthly time series over a six-year period for the nation and across US Census Bureau regions for three hospital utilization indicators: average length of stay, discharge rate, and multiple stay ratio, a measure of readmissions. The first purpose of this study was to determine the accuracy of forecasting these indicators 24 months into the future using five univariate time series techniques. In almost all cases, techniques were able to forecast the magnitude and direction of future utilization within a 10% mean monthly error. The second purpose of the study was to describe time series of the three hospital utilization indicators. This approach raised several questions concerning Department of Veterans Affairs hospital utilization.