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ImportanceImmunotherapies reflect an important breakthrough in cancer treatment, substantially improving outcomes for patients with a variety of cancer types, yet little is known about which practices have adopted this novel therapy or the pace of adoption.ObjectiveTo assess adoption of immunotherapies across US oncology practices and examine variation in adoption by practice type.Design, Setting, and ParticipantsThis cohort study used data from Medicare fee-for-service beneficiaries undergoing 6-month chemotherapy episodes between 2010 and 2017. Data were analyzed January 19, 2021, to September 28, 2022, for patients with cancer types for which immunotherapy was approved by the US Food and Drug Administration (FDA) during the study period: melanoma, kidney cancer, lung cancer, and head and neck cancer.ExposuresOncology practice location (rural vs urban), affiliation type (academic system, nonacademic system, independent), and size (1 to 5 physicians vs 6 or more physicians).Main Outcomes and MeasuresThe primary outcome was whether a practice adopted immunotherapy. Adoption rates for each practice type were estimated using multivariate linear models that adjusted for patient characteristics (age, sex, race and ethnicity, cancer type, Charlson Comorbidity Index, and median household income).ResultsData included 71 659 episodes at 1732 oncology practices. Of these, 264 practices (15%) were rural, 900 (52%) were independent, and 492 (28%) had 1 to 5 physicians. Most practices adopted immunotherapy within 2 years of FDA approval, but there was substantial variation in adoption rates across practice types. After FDA approval, adoption of immunotherapy was 11 (95% CI, −16 to −6) percentage points lower at rural practices than urban practices and 27 (95% CI, −32 to −22) percentage points lower at practices with 1 to 5 physicians than practices with 6 or more physicians. Adoption rates were similar at independent practices and nonacademic systems; however, both practice types had lower adoption than academic systems (independent practice difference, −6 [95% CI, −9 to −3] percentage points; nonacademic systems difference, −9 [95% CI, −11 to −6] percentage points).Conclusions and RelevanceIn this cohort study of Medicare claims, practice characteristics, especially practice size and rural location, were associated with adoption of immunotherapy. These findings suggest that there may be geographic disparities in access to important innovations for treating patients with cancer.

To analyze cardiovascular death in a national end-stage renal disease (ESRD) population.This retrospective, observational study with data from the US Renal Data Systems analyzed 1380 deaths from 1990 to 1996 among patients who started ESRD therapy as children and died before 30 years of age.Percentage of cardiac deaths (n = 311) varied by age and was higher among black patients (0-4 years, 36%; 5-9 years, 18%; 10-14 years, 35%; 15-19 years, 22%; 20-30 years, 32%) than white patients (18%, 12%, 17%, 14%, and 23%, respectively). Among black patients, cardiac deaths occurred in 11% of transplant recipients, 34% of dialysis patients, and among white patients 9% and 25%, respectively. Black patients were 1.6 times more likely to die of a cardiac death (P.001) than white patients. Transplant recipients had 78% lower risk of cardiac death than dialysis patients (odds ratio = 0.22; P =.0001). The cardiac death rate among dialysis patients was 21.4 per 1000 patient-years in black patients compared with 20.5 in white patients. Transplantation cardiac death rates were lower in black patients, 2.1 per 1000 patient-years, and 1.3 in white patients.Cardiovascular death accounts for 23% of pediatric and young adult ESRD deaths. Black patients and dialysis patients are at higher risk of a cardiac death compared with white patients and transplant recipients. Further studies are needed to identify risk factors associated with cardiovascular death in patients with ESRD.

Disease management (DM) is becoming an increasingly important tool for use in end-stage renal disease (ESRD). The goal of a DM program is to offer a continuum of care that uses guidelines and case management protocols to prevent acute care episodes, achieve improved outcomes and reduce health care costs. This article reviews the theory behind DM, describes key components of DM programs and explains the financial incentives for DM in ESRD. Of key importance in the increasing role of DM for ESRD has been the development of nationally recognized guidelines, the effects of which are now beginning to emerge. At the same time, recent studies have identified targeted opportunities for DM programs to improve outcomes and costs, including anemia management, dialysis dose, and vascular access. DM, through the use of guidelines and targeted toward these and other areas, has the potential to significantly impact the quality of care provided to ESRD patients.

Survival advantage in Asian American end-stage renal disease patients. Background An earlier study documented a lower mortality risk for end-stage renal disease (ESRD) patients in Japan compared with the United States. We compared the mortality of Caucasian (white) and Asian American dialysis patients in the United States to evaluate whether Asian ancestry was associated with lower mortality in the United States. Methods The study sample from the U.S. Renal Data System census of ESRD patients treated in the United States included 84,192 white or Asian patients starting dialysis during May 1995 to April 1997, of whom 18,435 died by April 30, 1997. Patient characteristics were described by race. Relative mortality risks (RRs) for Asian Americans relative to whites were analyzed by Cox proportional hazards regression models adjusting for characteristics and comorbidities. Population death rates were derived from vital statistics for the United States and Japan by age and sex. Results Adjusting for demographics, diabetes, comorbidities, and nutritional factors, the RR for Asian Americans was 0.75 ( P = 0.0001). Race-specific background population death rates accounted for over half of the race-related mortality difference. For whites, mortality decreased as the body mass index (BMI) increased. For Asians, the relationship between BMI and survival was u-shaped. The ratio of Asian American/white dialysis death rates and the ratio of Asian American/white general population death rates both varied by age in a similar pattern. The population death rates of Asian American and Japanese were also similar. Conclusion Among dialysis patients, Asian Americans had a markedly lower adjusted RR than whites. The effect of BMI on survival differed by race. Compared with the respective general population, dialysis patients had the same relative increase in death rates for both races. The difference in death rates between the United States and Japan does not appear to be primarily treatment related, but rather is related to background death rates.

OBJECTIVE—To compare estimates of the medical costs of smoking in the United States and to consider their relevance to assessing the costs of smoking in developing countries and the net economic burden of smoking. DATA SOURCES—A Medline search through early 1999 using keywords "smoking" and "cost", with review of article reference lists. STUDY SELECTION—Peer-reviewed papers examining medical costs in a single year, covering the non-institutionalised American population. DATA EXTRACTION—Methods underlying study estimates were identified, described, and compared with attributable expenditure methodology in the literature dealing with costs of illness. Differences in methods were associated with implied differences in findings. DATA SYNTHESIS—With one exception, the studies find the annual medical costs of smoking to constitute approximately 6-8% of American personal health expenditures. The exception, a recent study, found much larger attributable expenditures. The lower estimates may reflect the limitation of analysis to costs associated with the principal smoking-related diseases. The higher estimate derives from analysis of smoking-attributable differences in all medical costs. However, the finding from the most recent study, also considering all medical costs, fell in the 6-8% range. CONCLUSIONS—The medical costs of smoking in the United States equal, and may well exceed, the commonly referenced figure of 6-8%. This literature has direct methodological relevance to developing countries interested in assessing the magnitude of their current cost-of-smoking burden and their future burdens, with differences in tobacco use histories and the availability of chronic disease treatment affecting country-specific estimates. The debate over the use of gross or net medical cost estimates is likely to intensify with the proliferation of lawsuits against the tobacco industry to recover expenditures on tobacco-produced disease. Keywords: medical costs; smoking; United States

The type of dialysis membrane used for routine therapy has been recently shown to correlate with the survival of chronic hemodialysis patients. We examined whether this effect of dialysis membrane could be explained by differences in dialyzer removal of middle molecules using data from the 1991 Case Mix Adequacy Study of the United States Renal Data System. The sample analyzed included patients who had been treated by hemodialysis for 1 year or more, who were dialyzed with the 19 most commonly used dialyzers in 1991, and for whom delivered urea Kt/V could be calculated from predialysis and postdialysis blood urea nitrogen concentrations. Vitamin B12 (1,355 daltons) was used as a marker for middle molecules, and the clearance of vitamin B12 was estimated based on in vitro data. After adjustments for case mix, comorbidities, and urea Kt/V, the relative risk of mortality for a 10% higher calculated total cleared volume of vitamin B12 was 0.953 (P < 0.0001 v 1.000). Similar results were obtained when middle molecule removal was adjusted for body size. We conclude that both small and middle molecule removal indices appear to be independently associated with the risk of mortality in chronic hemodialysis patients. Differences in mortality when using different types of dialysis membrane may be explained by differences in middle molecule removal.

The dose of hemodialysis and patient mortality. The relationship between the delivered dose of hemodialysis and patient mortality remains somewhat controversial. Several observational studies have shown improved patient survival with higher levels of delivered dialysis dose. However, several other unmeasured variables, changes in patient mix or medical management may have impacted on this reported difference in mortality. The current study of a U.S. national sample of 2,311 patients from 347 dialysis units estimates the relationship of delivered hemodialysis dose to mortality, with a statistical adjustment for an extensive list of comorbidity/risk factors. Additionally this study investigated the existence of a dose beyond which more dialysis does not appear to lower mortality. We estimated patient survival using proportional hazards regression techniques, adjusting for 21 patient comorbidity/risk factors with stratification for nine Census regions. The patient sample was 2,311 Medicare hemodialysis patients treated with bicarbonate dialysate as of 12/31/90 who had end-stage renal disease for at least one year. Patient follow-up ranged between 1.5 and 2.4 years. The measurement of delivered therapy was based on two alternative measures of intradialytic urea reduction, the urea reduction ratio (URR) and Kt/V (with adjustment for urea generation and ultrafiltration). Hemodialysis patient mortality showed a strong and robust inverse correlation with delivered hemodialysis dose whether measured by Kt/V or by URR. Mortality risk was lower by 7% ( P = 0.001) with each 0.1 higher level of delivered Kt/V. (Expressed in terms of URR, mortality was lower by 11% with each 5 percentage point higher URR; P=0.001). Above a URR of 70% or a Kt/V of 1.3 these data did not provide statistical evidence of further reductions in mortality. In conclusion, the delivered dose of hemodialysis therapy is an important predictor of patient mortality. In a population of dialysis patients with a very high mortality rate, it appears that increasing the level of delivered therapy offers a practical and efficient means of lowering the mortality rate. The level of hemodialysis dose measured by URR or Kt/V beyond which the mortality rate does not continue to decrease, though not well defined with this study, appears to be above current levels of typical treatment of hemodialysis patients in the U.S.

There is an ongoing discussion in the renal community about how to monitor the treatment of hemodialysis patients in the United States. Comparison of the US patient experience to that of other countries with populations of similar heath status is one way to assess treatment. Another technique involves examining the level of dialysis therapy US patients receive. This paper reviews recent studies which found that the United States has higher mortality than both Japan and Europe and provides additional information as to why those comparisons might be underestimating the mortality differences. We also examine the data on the level of dialysis US patients receive, both as a prescription and as delivered care. We conclude that US patients receive less hemodialysis therapy than their European and Japanese counterparts, and that in general US patients are not receiving the level of dialysis they were prescribed. These factors are correlated with an increased mortality among US hemodialysis patients.

In Reply. —We agree with Dr Sadler on the importance of measuring the quality of Medicare data when using this database for scientific analyses. Our estimates published in this article are similar to our findings from a large data validation study. 1 However, objectivity requires us to be constantly critical, especially for untested data items such as rHuEPO. Dr Sadler takes our minor discussion point out of context and thereby generalizes that we have "challenged the validity of the PMMIS." This is not our position. We basically agree with his four technical points (listed herein); however, our analyses show that our data quality estimates remain virtually unchanged. First, the point that we "used incomplete PMMIS files": PMMIS files are always incomplete. We used a file that was over 15 months old since US Renal Data System analyses suggest that by 15 months these files can be considered complete for most

Objective. —To quantify access to recombinant human erythropoietin (EPO) among patients with dialysis-dependent end-stage renal disease (ESRD). Design. —National random sample of hemodialysis patients from a random sample of dialysis units, using data abstracted from patients' medical records. Setting. —All US hemodialysis units. Participants. —A total of 4024 Medicare-entitled in-center hemodialysis patients. Main Outcome Measures. —The relative odds that black patients received EPO (compared with white patients). Results. —There was no evidence in this national study that black hemodialysis patients were more or less likely to receive EPO than white patients (P=.74) Conclusions. —Three years after Food and Drug Administration approval and Medicare coverage of EPO, there was no evidence of racial disparity in access to EPO among Medicare patients with ESRD who were receiving long-term hemodialysis. However, there was evidence of greater need for EPO among black patients. (JAMA. 1994;271:1760-1763)