Follow-up prostate cancer treatments after radical prostatectomy: a population-based study.

BACKGROUND: Radical prostatectomy is one of the most commonly used curative procedures for the treatment of localized prostate cancer. The probability that a patient will undergo additional cancer therapy after this procedure is largely unknown. PURPOSE: The objective was to determine the likelihood of additional cancer therapy after radical prostatectomy. METHODS: Data for this study were derived from a linked dataset that combined information from the Surveillance, Epidemiology, and End Results Program and Medicare hospital and physician claims. Records were included in this study if patient histories met the following criteria: (a) residing in Connecticut, Washington (Seattle-Puget Sound), or Georgia (Metropolitan Atlanta); (b) having been diagnosed with prostate cancer during the period from January 1, 1985, through December 31, 1991; (c) undergoing radical prostatectomy by December 31, 1992; and (d) having no evidence of other types of cancer. Patients were considered to have had additional cancer therapy if they had had radiation therapy, orchiectomy, and/or androgen-deprivation therapy by injection after radical prostatectomy. The interval between the initial treatment and any follow-up treatment was calculated from the date of radical prostatectomy to the 1st day of the follow-up cancer therapy. All presented probabilities are based on Kaplan-Meier estimates. RESULTS: The study population consisted of 3494 Medicare patients, 3173 of whom underwent radical prostatectomy within 3 months of prostate cancer diagnosis. Although radical prostatectomy is often reserved for localized cancer, less than 60% (1934) of patients whose records were included in this study had organ-confined disease, according to final surgical pathology. Overall, the 5-year cumulative incidence of having any additional cancer treatment after radical prostatectomy reached 34.9% (95% confidence interval [CI] = 31.5%-38.5%). For patients with pathologically organ-confined cancer, the 5-year cumulative incidence was 24.3% (95% CI = 20.0%-29.3%) overall and ranged from 15.6% (95% CI = 9.7%-24.5%) for well-differentiated cancer (Gleason scores 2-4) to 41.5% (95% CI = 27.9%-58.4%) for poorly differentiated cancer (Gleason scores 8-10). The corresponding figures for pathologically regional cancer were 22.7% (95% CI = 12.0%-40.5%) and 68.1% (95% CI = 58.7%-77.1%). CONCLUSION: Further treatment of prostate cancer was done in about one third of patients who had had a radical prostatectomy with curative intent and in about one quarter of patients who were found to have organ-confined disease. IMPLICATIONS: Given the common requirement for follow-up cancer treatments after radical prostatectomy and the uncertainties about the effectiveness of the various follow-up treatment strategies, further investigation of these treatments is warranted.

Changes in tonsillectomy rates associated with feedback and review.

Among 13 Vermont Hospital Service Areas, tonsillectomy rates decreased over a five-year period. In 1969, the rates in seven areas exceeded the estimated United States national rate; by 1973, the average rate for all areas had declined 46% and only one area remained above the U.S. rate. Much of the change occurred after feedback of data to the Vermont State Medical Society demonstrating 1969 variations. In 12 of the 13 areas, the relationship between feedback and change in clinical practices could not be documented; however, physicians in the area with the highest rate reviewed the indications for tonsillectomy and adopted a second opinion procedure for reviewing candidates for the surgery. The experience suggests that feedback of population-based data on incidence of procedures may be a valuable tool for the peer review process.

Using administrative data to describe casemix: a comparison with the medical record.

We compared the coding of comorbid conditions in an administrative database to that found in medical records for 485 men who had undergone a prostatectomy. Only a few specific conditions showed good agreement between charts and claims. Most showed poor agreement and appeared more frequently in the chart. A comorbidity index calculated from each of these sources was used to explore the differences in mortality for patients who had undergone transurethral vs open prostatectomy. The claims-based comorbidity index most often underestimated the index from the chart. Proportional hazards analysis showed that models including either comorbidity index were better than those without an index and models with information from both indices were best. No analysis eliminated the effect of type of prostatectomy on long-term mortality. Claims-based measures of comorbidity tend to underrepresent some conditions but may be an acceptable first step in controlling for differences across patient populations.

Influence of patient preferences and local health system characteristics on the place of death. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Risks and Outcomes of Treatment.

OBJECTIVE: To examine the degree to which variation in place of death is explained by differences in the characteristics of patients, including preferences for dying at home, and by differences in the characteristics of local health systems. DESIGN: We drew on a clinically rich database to carry out a prospective study using data from the observational phase of the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT component). We used administrative databases for the Medicare program to carry out a national cross-sectional analysis of Medicare enrollees place of death (Medicare component). SETTING: Five teaching hospitals (SUPPORT); All U.S. Hospital Referral Regions (Medicare). STUDY POPULATIONS: Patients dying after the enrollment hospitalization in the observational phase of SUPPORT for whom place of death and preferences were known. Medicare beneficiaries who died in 1992 or 1993. MAIN OUTCOME MEASURES: Place of death (hospital vs non-hospital). RESULTS: In SUPPORT, most patients expressed a preference for dying at home, yet most died in the hospital. The percent of SUPPORT patients dying in-hospital varied by greater than 2-fold across the five SUPPORT sites (29 to 66%). For Medicare beneficiaries, the percent dying in-hospital varied from 23 to 54% across U.S. Hospital Referral Regions (HRRs). In SUPPORT, variations in place of death across site were not explained by sociodemographic or clinical characteristics or patient preferences. Patient level (SUPPORT) and national cross-sectional (Medicare) multivariate models gave consistent results. The risk of in-hospital death was increased for residents of regions with greater hospital bed availability and use; the risk of in-hospital death was decreased in regions with greater nursing home and hospice availability and use. Measures of hospital bed availability and use were the most powerful predictors of place of death across HRRs. CONCLUSIONS: Whether people die in the hospital or not is powerfully influenced by characteristics of the local health system but not by patient preferences or other patient characteristics. These findings may explain the failure of the SUPPORT intervention to alter care patterns for seriously ill and dying patients. Reforming the care of dying patients may require modification of local resource availability and provider routines.

Regional organization for outcomes research.

Methods for achieving improvement in medical and surgical outcomes are often discussed, but rarely achieved. We report on a regional voluntary consortium founded in 1987 to provide information about the management of cardiovascular disease in northern New England. Members include all cardiothoracic surgeons and interventional cardiologists in the region, as well as administrators and scientists associated with the five institutions that provide advanced cardiac services in this region. The group maintains registries for coronary artery bypass grafting, coronary angioplasty, and heart valve surgery and has investigated institutional differences in mortality rates; the development and use of clinical prediction rules; the reasons for excess mortality among women undergoing bypass graft surgery; and time trends in the use of myocardial revascularization. This consortium is an inter-institutional model for the continuous improvement of medical and surgical care.

Variation profiles of common surgical procedures.

BACKGROUND: Rates of many surgical procedures vary widely across both large and small geographic regions. Although variation in health care use has long been described, few studies have systematically compared variation profiles across surgical procedures. The goal of this study was to examine current patterns of regional variation in the rates of common surgical procedures. METHODS: The study population consisted of patients enrolled in Medicare in 1995, excluding those enrolled in risk-bearing health maintenance organizations. Patients ranged in age from 65 to 99 years. Using data from hospital discharge abstracts, we calculated rates of 11 common inpatient procedures for each of 306 US hospital referral regions (HRRs). To assess the relative variability of each procedure, we determined the number of low and high outlier regions (HRRs with rates < 50% or > 150% the national average) and the ratio of highest to lowest HRR rates. RESULTS: Procedures differed markedly in their variability. Rates of hip fracture repair, resection for colorectal cancer, and cholecystectomy varied only 1.9- to 2.9-fold across HRRs (0, 0, and 4 outlier regions, respectively). Coronary artery bypass grafting, transurethral prostatectomy, mastectomy, and total hip replacement had intermediate variation profiles, varying 3.5- to 4.7-fold across regions (8, 10, 16, and 17 outlier regions, respectively). Lower extremity revascularization, carotid endarterectomy, back surgery, and radical prostatectomy had the highest variation profiles, varying 6.5- to 10.1-fold across HRRs (25, 32, 39, and 56 outlier regions, respectively). CONCLUSIONS: Although the use of many surgical procedures varies widely across geographic areas, rates of "discretionary" procedures are most variable. To avoid potential overuse or underuse, efforts to increase consensus in clinical decision making should focus on these high variation procedures.

Patient-reported complications and follow-up treatment after radical prostatectomy. The National Medicare Experience: 1988-1990 (updated June 1993).

To estimate the probabilities of complications and follow-up treatment, a sample of Medicare patients who underwent radical prostatectomy (1988 through 1990) was surveyed by mail, telephone, and personal interview. Respondents reported their current status with respect to continence and sexual function as well as post-surgical treatments they had had to treat residual or recurrent cancer or surgical complications. Over 30 percent reported currently wearing pads or clamps to deal with wetness; over 40 percent said they drip urine when they cough or when their bladders are full; 23 percent reported daily wetting of more than a few drops. About 60 percent of patients reported having no full or partial erections since their surgery, and only 11 percent had any erections sufficient for intercourse during the month prior to the survey. Six percent had surgery after the radical prostatectomy to treat incontinence; 15 percent had treatments or used devices to help with sexual function; 20 percent report having had post-surgical treatment for urethral strictures. In addition 16 percent, 22 percent, and 28 percent reported follow-up treatment for cancer (radiation or androgen deprivation therapy) at two, three, and four years after radical prostatectomy. These estimates of complication and follow-up treatment rates are generally higher, and almost certainly more representative for older men, than estimates previously published. Patients and physicians may want to weight heavily the complications and need for follow-up treatments when considering radical prostatectomy for prostate cancer.

Transurethral resection of the prostate among Medicare beneficiaries in the United States: time trends and outcomes. Prostate Patient Outcomes Research Team (PORT).

OBJECTIVES: The purpose of this study was to examine the epidemiology of transurethral resection of the prostate (TURP) and associated risks among Medicare beneficiaries during the period of 1984 to 1990. METHODS: Medicare hospital claims for a 20% national sample of Medicare beneficiaries were used to identify TURPs performed during the study period. All reported rates were adjusted to the composition of the 1990 Medicare population. Risks of mortality and reoperation were evaluated using life-table methods. RESULTS: The age-adjusted rate of TURP reached a peak in 1987 and declined thereafter. Similar trends were observed for all age groups. In 1990, the rates of TURP (including all indications) were approximately 25, 19, and 13 per 1000 for men over the age of 75, 70 to 74, and 65 to 69, respectively. The 30-day mortality following TURP for the treatment of benign prostatic hyperplasia (BPH) decreased from 1.20% in 1984 to 0.77% in 1990 (linear trend, p = 0.0001). The cumulative incidence of a second TURP among men with BPH has likewise decreased steadily over time; in this study, the average was 7.2% over 7 years (5.5% when the indication for the second TURP was restricted to BPH only). CONCLUSIONS: The rate of TURP has been declining since 1987, conceivably due to increasing availability of alternative treatments or changes in treatment preferences of patients and physicians. Over the same period, the outcomes following TURPs have improved, perhaps due to improved surgical care and changes in patient selection.

Finding equilibrium in U.S. physician supply.

One essential component of health system reform is to bring the number of physicians in line with the needs of the population. The physician supply policies of prepaid group practice health maintenance organizations have been cited as one model to achieve this goal. Planning for physician supply should be an explicit public-sector activity and should not be left to the private sector, because some areas are not sufficiently populated to support competing providers under a managed competition scheme. A new model for planning for physician supply should include the following strategies: (1) erecting barriers to entry into medical practice; (2) encouraging early retirement; (3) restructuring economic incentives; (4) reallocating physicians to underserved areas in the United States and abroad; and (5) creating new areas of professional responsibility for physicians.

Associations among hospital capacity, utilization, and mortality of US Medicare beneficiaries, controlling for sociodemographic factors.

OBJECTIVE: To explore whether geographic variations in Medicare hospital utilization rates are due to differences in local hospital capacity, after controlling for socioeconomic status and disease burden, and to determine whether greater hospital capacity is associated with lower Medicare mortality rates. DATA SOURCES/STUDY SETTING: The study population: a 20 percent sample of 1989 Medicare enrollees. Measures of resources were based on a national small area analysis of 313 Hospital Referral Regions (HRR). Demographic and socioeconomic data were obtained from the 1990 U.S. Census. Measures of local disease burden were developed using Medicare claims files. STUDY DESIGN: The study was a cross-sectional analysis of the relationship between per capita measures of hospital resources in each region and hospital utilization and mortality rates among Medicare enrollees. Regression techniques were used to control for differences in sociodemographic characteristics and disease burden across areas. DATA COLLECTION/EXTRACTION METHODS: Data on the study population were obtained from Medicare enrollment (Denominator File) and hospital claims files (MedPAR) and U.S. Census files. PRINCIPAL FINDINGS: The per capita supply of hospital beds varied by more than twofold across U.S. regions. Residents of areas with more beds were up to 30 percent more likely to be hospitalized, controlling for ecologic measures of socioeconomic characteristics and disease burden. A greater proportion of the population was hospitalized at least once during the year in areas with more beds; death was also more likely to take place in an inpatient setting. All effects were consistent across racial and income groups. Residence in areas with greater levels of hospital resources was not associated with a decreased risk of death. CONCLUSIONS: Residence in areas of greater hospital capacity is associated with substantially increased use of the hospital, even after controlling for socioeconomic characteristics and illness burden. This increased use provides no detectable mortality benefit.

Using diagnosis-related groups for studying variations in hospital admissions.

The diagnosis-related groups (DRG's) have classically focused on resources consumed during a hospital stay. DRG's can also be considered categories for describing cases admitted to a hospital. In this article, we illustrate how consistent patterns of variations in admission rates can be used to classify DRG categories according to the Index of Discretionary Admissions. The consistency of variation in admission rates for modified DRG categories across hospital service areas in Iowa, California, Massachusetts, and Maine was high. The proportion of hospital admissions in the DRG's judged to be most discretionary ranged from 22 percent in Iowa to 14 percent in California.

Professional uncertainty and the problem of supplier-induced demand.

This paper discusses the puzzling problem of large differences in per capita use of certain common surgical procedures among neighboring populations, which by all available measures are quite similar in need for and access to services. The evidence reviewed here supports the hypothesis that variations occur to a large extent because of differences among physicians in their evaluation of patients (diagnosis) or in their belief in the value of the procedures for meeting patient needs (therapy). This hypothesis, which we call the professional uncertainty hypothesis, is germane to current controversies concerning the nature and extent of supplier influence on the demand for medical services. It is also important because of its implications for health regulatory policy. Our plan is to (1) review the relevance of the hypotheses for the supplier-induced demand controversy; (2) review the epidemiologic evidence on the nature and causes of variation; (3) examine patterns of use of common surgical procedures to illustrate the importance of supplier influence on utilization; and (4) consider some of the implications of the professional uncertainty hypotheses for public policy.

Dealing with geographic variations in the use of hospitals. The experience of the Maine Medical Assessment Foundation Orthopaedic Study Group.

Orthopaedists and other physicians in Maine organized the Maine Medical Assessment Foundation to deal with the problem of variations in the rates of hospitalization for orthopaedic conditions. Five musculoskeletal injuries and five orthopaedic procedures were selected for study. The variation in decision-making by orthopaedists was least for fractures of the ankle and fractures of the hip and was greatest for fractures of the forearm, derangement of the knee, and lumbosacral sprain. The rates in an area tended to be consistently high or low for the same treatments. The major reasons for the variations appeared to be related to lack of agreement about optimum treatment. Feedback of data to physicians on variations in patterns of practice reduced the variations.

Outcomes after displaced fractures of the femoral neck. A meta-analysis of one hundred and six published reports.

Methods of meta-analysis, a technique for the combination of data from multiple sources, were applied to analyze 106 reports of the treatment of displaced fractures of the femoral neck. Two years or less after primary internal fixation of a displaced fracture of the femoral neck, a non-union had developed in 33 per cent of the patients and avascular necrosis, in 16 per cent. The rate of performance of a second operation within two years ranged from 20 to 36 per cent after internal fixation and from 6 to 18 per cent after hemiarthroplasty (relative risk, 2.6; 95 per cent confidence interval, 1.4 to 4.6). Conversion to an arthroplasty was the most common reoperation after internal fixation and accounted for about two-thirds of these procedures. The remaining one-third of the reoperations were for removal of the implant or revision of the internal fixation. For the patients who had had a hemiarthroplasty, the most common reoperations were conversion to a total hip replacement, removal or revision of the prosthesis, and débridement of the wound. Although we observed an increase in the rate of mortality at thirty days after primary hemiarthroplasty compared with that after primary internal fixation, the difference was not significant (p = 0.22) and did not persist beyond three months. The absolute difference in perioperative mortality between the two groups was small. An anterior operative approach for arthroplasty consistently was associated with a lower rate of mortality at two months than was a posterior approach. Some reports showed promising results after total hip replacement for displaced fractures of the femoral neck; however, randomized clinical trials are still needed to establish the value of this treatment.

Health care reform and professionalism.

With its emphasis on consumer choice of health plans, the current health care debate neglects a more fundamental crisis: changes in the traditional physician-patient relationship. This paper discusses how this relationship is being redefined and what it means for professionals in the future, particularly in the context of managed competition. The paper asserts that the final health reform plan must address flaws in the scientific and ethical basis of clinical practice. It calls for a flexible workforce policy that promotes shared decision making, lifetime learning, professional commitment to improved quality of care, a national evaluation program, and organizations to coordinate these efforts.

Are randomized controlled trials controlled? Patient preferences and unblind trials.

The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions--for example, between treatment preferences and treatment effects--is generally subordinated in the quest for evidence about main treatment effects. If patient preferences can influence the effectiveness of treatments through poorly understood (psychological) pathways, then RCTs, particularly when unblinded, may wrongly attribute effects solely to a treatment's physiological/pharmacological properties. To interpret the RCT evidence base it is important to know whether any preference effects exist and, if so, by how much they affect outcome. Reliable measurement of these effects is difficult and will require new approaches to the conduct of trials. In view of the fanciful image with which such effects are portrayed and the uncertainties about their true nature and biological mechanisms, existing evidence is unlikely to provide sufficient justification for investment in trials. This is a Catch 22. Until an escape is found we might never know, even approximately, how much of modern medicine is attributable to psychological processes.