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.

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.

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.

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.

A trial for comparing methods for eliciting treatment preferences from men with advanced prostate cancer: results from the initial visit.

OBJECTIVE: The objective of this study was to evaluate the convergent validity of 3 types of utility measures: standard gamble, time tradeoff, and rating scale. RESEARCH DESIGN: A prospective cohort of 120 men with advanced prostate cancer were first asked to rank order 8 health states, and then utility values were obtained from each participant for each of the 8 health states through 2 of the 3 techniques evaluated (standard gamble, time tradeoff and rating scale). Participants were randomly assigned to 1 of 3 possible pairs of techniques. The validity of the 3 methods, as measured by the convergence and raw score differences of the techniques, was assessed with ANOVA. The ability of the techniques to differentiate health states was determined. The inconsistencies between rankings and utility values were also measured. Proportions of illogical utility responses were assessed as the percent of times when states with more symptoms were given higher or equal utility values than states with fewer symptoms. RESULTS: There were significant differences in raw scores between techniques, but the values were correlated across health states. Utility values were often inconsistent with the rank order of health states. In addition, utility assessment did not differentiate the health states as well as the rank order. Furthermore, utility values were often illogical in that states with more symptoms received equal or higher utility values than states with fewer symptoms. CONCLUSIONS: Use of the utility techniques in cost-effectiveness analysis and decision making has been widely recommended. The results of this study raise serious questions as to the validity and usefulness of the measures.

Veterans Affairs Quality Enhancement Research Initiative in chronic heart failure.

Chronic heart failure (CHF) is a highly prevalent condition associated with serious morbidity, intense levels of health services use, and shortened survival. It is also a condition for which ameliorative therapies exist. The evidence indicates that there is substantial need to change clinical practice and health care delivery for people with CHF and thereby improve their outcomes. The goal of the Veterans Affairs (VA) Quality Enhancement Research Initiative in CHF (CHF QUERI) is to create measurable, rapid, and sustainable improvements in quality of care and health outcomes of veterans with heart failure. This article describes the current state of knowledge and practice in care for people with CHF. Using the framework of the 5 steps of the QUERI process, we point out the gaps in research and practice that must be filled if the CHF QUERI is to achieve its goal. We relate our recommendations for how the VA can put its research and administrative infrastructure to work to fill the gaps. Lessons learned about CHF in the course of the CHF QUERI will be applicable to all people with heart failure and to all health care systems--VA as well as non-VA--that care for them.

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.

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.

An empirical assessment of the validity of explicit and implicit process-of-care criteria for quality assessment.

OBJECTIVE: To evaluate the validity of three criteria-based methods of quality assessment: unit weighted explicit process-of-care criteria; differentially weighted explicit process-of-care criteria; and structured implicit process-of-care criteria. METHODS: The three methods were applied to records of index hospitalizations in a study of unplanned readmission involving roughly 2,500 patients with one of three diagnoses treated at 12 Veterans Affairs hospitals. Convergent validity among the three methods was estimated using Spearman rank correlation. Predictive validity was evaluated by comparing process-of-care scores between patients who were or were not subsequently readmitted within 14 days. RESULTS: The three methods displayed high convergent validity and substantial predictive validity. Index-stay mean scores, using explicit criteria, were generally lower in patients subsequently readmitted, and differences between readmitted and nonreadmitted patients achieved statistical significance as follows: mean readiness-for-discharge scores were significantly lower in patients with heart failure or with diabetes who were readmitted; and mean admission work-up scores were significantly lower in patients with lung disease who were readmitted. Scores derived from the structured implicit review were lower in patients eventually readmitted but significantly so only in diabetics. CONCLUSIONS: These three criteria-based methods of assessing process of care appear to be measuring the same construct, presumably "quality of care." Both the explicit and implicit methods had substantial validity, but the explicit method is preferable. In this study, as in others, it had greater inter-rater reliability.

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.

Assessing the performance of utility techniques in the absence of a gold standard.

BACKGROUND: Utility techniques are the most commonly used means to assess patient preferences for health outcomes. However, whether utility techniques produce valid measures of preference has been difficult to determine in the absence of a gold standard. OBJECTIVE: To introduce and demonstrate two methods that can be used to evaluate how well utility techniques measure patients' preferences. SUBJECTS AND DESIGN: Patients treated for advanced prostate cancer (n = 57) first ranked eight health states in order of preference. Four utility techniques were then used to elicit patients' utilities for each health state. MEASURES: The rating scale, standard gamble, time trade-off, and a modified version of willingness-to-pay techniques were used to elicit patients' utilities. Technique performance was assessed by computing a differentiation and inconsistency score for each technique. RESULTS: Differentiation scores indicated the rating scale permitted respondents to assign unique utility values to about 70% of the health states that should have received unique values. When the other techniques were used, about 40% or less of the health states that should have received unique utility scores actually did receive unique utility scores. Inconsistency scores, which indicate how often participants assign utility scores that contradict how they value health states, indicated that the willingness-to-pay technique produced the lowest rate of inconsistency (10%). However, this technique did not differ significantly from the rating scale or standard gamble on this dimension. CONCLUSIONS: Differentiation and inconsistency offer a means to evaluate the performance of utility techniques, thereby allowing investigators to determine the extent to which utilities they have elicited for a given decision problem are valid. In the current investigation, the differentiation and inconsistency methods indicated that all four techniques performed at sub-optimal levels, though the rating scale out-performed the standard gamble, time trade-off, and willingness-to-pay techniques.

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.

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.

The association of quality of care and occurrence of in-hospital, treatment-related complications.

BACKGROUND: Little data exist supporting the association of quality of care and nonfatal adverse outcomes in hospitalized patients, yet those outcomes are routinely scrutinized in quality assessment efforts. OBJECTIVE: To determine whether measurable differences in quality of care are associated with the occurrence of non-fatal, in-hospital, and treatment-related complications. DESIGN: Retrospective cohort study. SUBJECTS: A total of 2,268 patients who were discharged alive from 9 Southwestern Veterans Affairs Medical Centers with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or diabetes mellitus. MEASURES: Retrospective chart review was performed to collect information on patient severity of illness, in-hospital complication occurrence, and process quality of care. Process quality was assessed as the adherence scores for admission work-up and for treatment during the hospital stay. Process quality represents the proportion of applicable admission or treatment criteria that were met by that patient's care providers. Once severity of illness was taken into account Cox proportional hazards regression was used to assess the independent contribution of process quality of care to complication occurrence. RESULTS: Higher admission work-up adherence scores for COPD patients and higher treatment adherence scores for COPD and diabetes patients were associated with a lower risk of complication occurrence. The adjusted risk ratios of complications for higher versus lower adherence scores (with 95% CI) were 0.64 (0.43, 0.97) and 0.52 (0.33, 0.80) for admission and treatment, respectively, in COPD patients, and 0.51 (0.31, 0.83) for treatment in diabetics. No significant association was found in CHF patients. CONCLUSION: Better admission work-up and treatment quality in COPD patients, as well as treatment quality in diabetic patients, are associated with lower risk of nonfatal treatment-related complications in the study population.

Geographic variations in utilization rates in Veterans Affairs hospitals and clinics.

BACKGROUND: In the United States, geographic variation in hospital use is common. It is uncertain whether there are similar geographic variations in the health care system of the Department of Veterans Affairs (VA), which differs from the private sector because it predominantly serves men with annual incomes below $20,000, has a central system of administration, and uses salaried physicians. Thus, it might be less likely to have geographic variations. METHODS: We used VA data bases to obtain information on patients treated for eight diseases (chronic obstructive pulmonary disease, pneumonia, congestive heart failure, angina, diabetes, chronic renal failure, bipolar disorder, and major depression). We analyzed their use of hospital and outpatient services by assessing the risk-adjusted numbers of hospital days (the average number of days a patient spent in the hospital per 12 months of follow-up, regardless of the number of hospital stays), hospital-discharge rates, and clinic-visit rates from 1991 through 1995 for the entire system and within the 22 geographically based health care networks. RESULTS: We found substantial geographic variation in hospital use for all eight cohorts of patients and all the years studied. Variations in the numbers of hospital days per person-year among the networks were greatest among patients with chronic obstructive pulmonary disease (ranging from a factor of 2.7 to a factor of 3.1) during a given year and smallest among patients with angina (ranging from a factor of 1.5 to a factor of 2.1). Levels of hospital use were highest in the Northeast and lowest in the West. The variation in the rates of clinic visits for principal medical care among the networks ranged from a factor of approximately 1.6 to a factor of 4.0; variations in the rates were greatest among patients with chronic renal failure and smallest among patients with chronic obstructive pulmonary disease. There was no clear geographic pattern in the rates of outpatient-clinic use. CONCLUSIONS: There are significant geographic variations in the use of hospital and outpatient services in the VA health care system. Because VA physicians are unable to increase their income by changing their patterns of practice, our findings suggest that their practice styles are similar to those of other physicians in their geographic regions.

Impact of an all-inclusive diagnosis-related group payment system on inpatient utilization.

OBJECTIVES: Although case-based payment is one of the main reimbursement mechanisms for hospitals, little is known about its effects in the general population. Prior studies have focused on Medicare or on all-payer systems in particular states. This study estimates the effect of a prospective payment system based on diagnosis-related groups (DRGs) nationwide in the Department of Veterans Affairs. METHODS: Multiple regression analysis was used to estimate the effect of Department of Veterans Affairs's diagnosis-related group system separately for 22 diagnoses. The dependent variables were length of stay, inpatient days per patient, and discharges per patient. Covariates included patient, hospital, and area characteristics. RESULTS: Department of Veterans Affairs's diagnosis-related group system reduced lengths of stay and inpatient days per patient. The largest impacts were for the psychiatric diagnoses and several surgical procedures. The magnitudes of the effects were generally moderate. Department of Veterans Affairs's case-based system had a negligible effect on discharges per patient. CONCLUSIONS: Per case reimbursement is a potentially useful tool for improving the efficiency of inpatient care for all types of diagnoses and age groups. The effect may be larger than estimated here because of institutional barriers and caps on financial impact.

The Veterans Affairs medical care system: hospital and clinic utilization statistics for 1994.

OBJECTIVES: The authors describe the role the Veterans Affairs (VA) medical system plays as a provider of clinic and hospital services by examining utilization levels and users' characteristics. METHODS: The Veterans Affairs hospital discharge database, the Veterans Affairs outpatient clinic files, and the veteran population files were used to estimate the number of persons using the Veterans Affairs medical care system in 1994 and the intensity of their clinic and hospital use. Demographic and clinical characteristics of users were tabulated. RESULTS: In 1994, 2.7 million veterans, 10.3% of all US veterans, and approximately 23% of veterans who would have met the statutory eligibility requirements for Veterans Affairs care, used the hospital and/or clinic components of the Veterans Affairs medical system. Sixty-three percent of the system's users were younger than age 65, and 10.5% were women. These 2.7 million veterans had 901,665 Veterans Affairs hospital stays, 15.5 million bed-days, and 31.2 million outpatient visits in fiscal year 1994. The average number of hospitalizations per hospital user was 1.71; the average number of visits per clinic user was 11.7. Medical, surgical, and psychiatric diagnosis-related groups (DRGs) accounted for 56%, 21%, and 23%, respectively, of hospitalizations, but psychiatric diagnosis-related groups accounted for 43% of all inpatient days. Principal medicine clinic visits and psychiatry clinic visits accounted for 21% and 16% of Veterans Affairs ambulatory care. CONCLUSIONS: Because the patient population served by the Veterans Affairs system is skewed in a number of ways, its contribution as a provider of health services in the United States varies by gender, age, socioeconomic status, and diagnosis.

Symptomatic syndrome of inappropriate antidiuretic hormone secretion associated with azithromycin.

OBJECTIVE: To report a case of symptomatic syndrome of inappropriate antidiuretic hormone (SIADH) secretion associated with azithromycin and review the literature related to this adverse drug reaction. DATA SOURCES: Review articles identified by a computerized (MEDLINE) (1966-April 1996) and manual (Index Medicus) search. DATA SYNTHESIS: Azithromycin is a well-tolerated broad-spectrum macrolide antibiotic. We report a symptomatic case of SIADH secretion associated with azithromycin. The patient received two doses of azithromycin before the development of sudden mental status changes associated with severe hyponatremia. All other potential causes were ruled out. No previous reports exist in the literature. CONCLUSIONS: Azithromycin may be associated with symptomatic SIADH secretion. Awareness and attention are required if patients develop mental status changes or hyponatremia while receiving azithromycin so that appropriate diagnostic and therapeutic actions can be implemented.