Preoperative breast MRI and mortality in older women with breast cancer.

PURPOSE: The survival benefit from detecting additional breast cancers by preoperative magnetic resonance imaging (MRI) continues to be controversial. METHODS: We followed a cohort of 4454 women diagnosed with non-metastatic breast cancer (stage I-III) from 2/2005-6/2010 in five registries of the breast cancer surveillance consortium (BCSC). BCSC clinical and registry data were linked to Medicare claims and enrollment data. We estimated the cumulative probability of breast cancer-specific and all-cause mortality. We tested the association of preoperative MRI with all-cause mortality using a Cox proportional hazards model. RESULTS: 917 (20.6%) women underwent preoperative MRI. No significant difference in the cumulative probability of breast cancer-specific mortality was found. We observed no significant difference in the hazard of all-cause mortality during the follow-up period after adjusting for sociodemographic and clinical factors among women with MRI (HR 0.90; 95% CI 0.72-1.12) compared to those without MRI. CONCLUSION: Our findings of no breast cancer-specific or all-cause mortality benefit supplement prior results that indicate a lack of improvement in surgical outcomes associated with use of preoperative MRI. In combination with other reports, the results of this analysis highlight the importance of exploring the benefit of preoperative MRI in patient-reported outcomes such as women's decision quality and confidence levels with decisions involving treatment choices.

Pre-fracture individual characteristics associated with high total health care costs after hip fracture.

Older women with pre-fracture slow walk speed, high body mass index, and/or a high level of multimorbidity have significantly higher health care costs after hip fracture compared to those without those characteristics. Studies to investigate if targeted health care interventions for these individuals can reduce hip fracture costs are warranted. INTRODUCTION: The aim of this study is to estimate the associations of individual pre-fracture characteristics with total health care costs after hip fracture, using Study of Osteoporotic Fractures (SOF) cohort data linked to Medicare claims. METHODS: Our study population was 738 women age 70 and older enrolled in Medicare Fee for Service (FFS) who experienced an incident hip fracture between January 1, 1992 and December 31, 2009. We assessed pre-fracture individual characteristics at SOF study visits and estimated costs of hospitalizations, skilled nursing facility and inpatient rehabilitation stays, home health care visits, and outpatient utilization from Medicare FFS claims. We used generalized linear models to estimate the associations of predictor variables with total health care costs (2010 US dollars) after hip fracture. RESULTS: Median total health care costs for 1 year after hip fracture were $35,536 (inter-quartile range $24,830 to $50,903). Multivariable-adjusted total health care costs for 1 year after hip fracture were 14 % higher ($5256, 95 % CI $156 to $10,356) in those with walk speed <0.6 m/s compared to ≥1.0 m/s, 25 % higher ($9601, 95 % CI $3314 to $16,069) in those with body mass index ≥30 kg/m2 compared to 20 to 24.9 mg/kg2, and 21 % higher ($7936, 95 % CI $346 to $15,526) for those with seven or more compared to no comorbid medical conditions. CONCLUSIONS: Pre-fracture poor mobility, obesity, and multiple comorbidities are associated with higher total health care costs after hip fracture in older women. Studies to investigate if targeted health care interventions for these individuals can reduce the costs of hip fractures are warranted.

The impact of center accreditation on hematopoietic cell transplantation (HCT).

There are two voluntary center-accrediting organizations in the USA, the Foundation for the Accreditation of Cellular Therapy (FACT) and core Clinical Trial Network (CTN) certification, that are thought to improve and ensure hematopoietic cell transplantation (HCT) center quality care and certify clinical excellence. We sought to observe whether there are differences in outcomes between HLA-matched and -mismatched HCT by CTN and FACT status. Using the 2008-2010 Center for International Blood & Marrow Transplant Research data we created three center categories: non-FACT centers (24 centers), FACT-only certified centers (106 centers) and FACT and core clinical trial network (FACT/CTN) certified centers (32 centers). We identified patient characteristics within these centers and the relationship between FACT certification and survival. Our cohort consisted of 12 993 transplants conducted in 162 centers. After adjusting for patient and center characteristics we found that FACT/CTN centers had consistently superior results relative to non-FACT and FACT-only centers (P<0.05) especially for more complex HCT. However, non-FACT centers were comparable to FACT-only centers for matched related and unrelated patients. Although FACT status is an important standard of quality control that begins to define improved OS, our results indicate that FACT status alone is not an indicator for superior outcomes.

Magnitude and consequences of misclassification of incident hip fractures in large cohort studies: the Study of Osteoporotic Fractures and Medicare claims data.

UNLABELLED: In the Study of Osteoporotic Fractures (SOF), 18.5 % of incident hip fractures identified in Medicare Fee-for-Service claims data were not reported to or confirmed by the cohort. Cognitive impairment was a modest risk factor for false-negative hip fracture ascertainment via self-report. INTRODUCTION: Prospective cohort studies of fractures that rely on participant self-report to be the initial signal of an incident fracture could be prone to bias if a significant proportion of fractures are not self-reported. METHODS: We used data from the SOF merged with Medicare Fee-for-Service claims data to estimate the proportion of participants who had an incident hip fracture identified in Medicare claims that was either not self-reported or confirmed (by review of radiographic reports) in SOF. RESULTS: Between 1/1/1991 and 12/31/2007, 647 SOF participants had a hip fracture identified in Medicare claims, but 120 (18.5 %) were either not reported to or confirmed by the cohort. False-negative hip fracture ascertainment was associated with a reduced modified Mini-Mental State Exam (MMSE) score (odds ratio 1.31 per SD decrease, 95 % C.I. 1.06-1.63). Point estimates of associations of predictors of incident hip fracture were changed minimally when the misclassification of incident hip fracture status was corrected with use of claims data. CONCLUSIONS: A substantial minority of incident hip fractures were not reported to or confirmed in the SOF. Cognitive impairment was modestly associated with false-negative hip fracture ascertainment. While there was no evidence to suggest that misclassification of incident hip fracture status resulted in biased associations of potential predictors with hip fracture in this study, false-negative incident fracture ascertainment in smaller cohort studies with limited power may increase the risk of type 2 error (not finding significant associations of predictors with incident fractures).

Early work patterns for gynaecological cancer survivors in the USA.

BACKGROUND: Little is known about the balance between work demands and treatment plans for >4.3 million working-age cancer survivors in the USA. AIMS: To describe changes in work status for gynaecological cancer survivors during the first 6 months following diagnosis and their experience with their employers' programmes and policies. METHODS: One hundred and ten gynaecological cancer survivors who were working at the time of their cancer diagnosis completed a survey. Case record reviews documented their clinical characteristics and treatment details. RESULTS: Ninety-five women (86%) had surgery; 81 (74%) received chemotherapy, radiotherapy or both in addition to surgery. Nine per cent of women said that they changed their treatment plan because of their jobs; in contrast, 62% of women said that they changed their work situation to accommodate their treatment plan. Overall, the most common month for women to stop working was Month 1 (41%), to decrease hours was Month 2 (32%) and to increase hours was Month 6 (8%). Twenty-eight per cent of women were aware of employer policies that assisted the return to work process; 70% of women were familiar with the Family and Medical Leave Act (FMLA) and 56% with the Americans with Disabilities Act (ADA). Only 26% completed a formal request for work accommodations. After 6 months, 56 of 83 women (67%) remained working or had returned to work. CONCLUSIONS: Work patterns varied for these gynaecological cancer survivors over the first 6 months following diagnosis. Opportunities exist to improve communication about work and treatment expectations between cancer survivors, occupational health professionals, employers and treating clinicians.

Surgery alone is adequate treatment for early stage soft tissue sarcoma of the extremity.

BACKGROUND: Evolving evidence suggests that, in selected patients with tumour category 1 (T1) extremity soft tissue sarcoma (ESTS), surgery alone offers satisfactory results without decreasing survival. This study assessed the effect of sarcoma treatments on survival outcomes of T1 ESTS in a population-based data set. METHODS: Using the Surveillance, Epidemiology, and End Results database, 1618 patients with primary ESTS underwent limb-sparing surgery. Multivariable analysis was used to assess the impact of radiotherapy on overall survival (OS) and sarcoma-specific survival (SSS), adjusting for co-variables. RESULTS: Some 803 patients (49.6 per cent) underwent surgery alone for T1 ESTS. Radiotherapy in patients with low- and high-grade tumours did not result in any significant difference in OS or SSS. When stratified by grade, multivariable analysis showed that adjuvant radiotherapy was not an independent predictor of SSS (hazard ratio (HR) 1.05; P = 0.906) or OS (HR 0.89; P = 0.695) in low-grade tumours. Neither was radiotherapy a significant predictor of SSS (HR 0.87; P = 0.608) or OS (HR 0.67; P = 0.071) in high-grade tumours. CONCLUSION: This population-based appraisal validated previous evidence supporting a role for surgery alone in the treatment of T1 ESTS. Future policies should be tailored to offer patients minimal yet effective therapy, rather than maximum tolerated therapy.

Predictors of Clostridium difficile colitis infections in hospitals.

Hospital-level predictors of high rates of 'Clostridium difficile-associated disease' (CDAD) were evaluated in over 2300 hospitals across California, Arizona, and Minnesota. American Hospital Association data were used to determine hospital characteristics associated with high rates of CDAD. Significant correlations were found between hospital rates of CDAD, common infections and other identified pathogens. Hospitals in urban areas had higher average rates of CDAD; yet, irrespective of geographic location, hospital rates of CDAD were associated with other infections. In addition, hospitals with 'high CDAD' rates had slower turnover of beds and were more likely to offer transplant services. These results reveal large differences in rates of CDAD across regions. Hospitals with high rates of CDAD have high rates of other common infections, suggesting a need for broad infection control policies.

Hospice use in Medicare managed care and fee-for-service systems.

OBJECTIVE: To examine whether patterns of hospice use by older Medicare beneficiaries are consistent with the differing financial incentives in Medicare managed care (MC) and fee-for-service (FFS) settings. Specifically, are use patterns consistent with incentives that might encourage hospice use for MC enrollees and discourage hospice use for FFS enrollees? STUDY DESIGN: One-year study of hospice use by Medicare beneficiaries dying in 1996. PATIENTS AND METHODS: Medicare enrollment and hospice administrative data were used to examine hospice use before death for all elderly individuals residing in 100 US counties with high MC enrollment in 1996. Age-, sex-, and race-adjusted rate of hospice use and length of stay in hospice are compared between FFS and MC enrollees across and within (when possible) the 100 counties. RESULTS: Rates of hospice use were significantly higher for MC enrollees than for FFS enrollees (26.6 vs 17.0 per 100 deaths; P < .001). These differences persisted within age, sex, and race groups but were not related to area MC enrollment rate or the amount of money paid to managed care organizations. Age-, sex-, and race-adjusted differences were observed in 94 of 100 counties. Length of stay in hospice was marginally longer for MC enrollees than for FFS enrollees (median, 24 vs 21 days; P < .0001). CONCLUSIONS: System of care is an important determinant of hospice use in the elderly Medicare population.

Administrative data for public health surveillance and planning.

Electronically available administrative data are increasingly used by public health researchers and planners. The validity of the data source has been established, and its strengths and weaknesses relative to data abstracted from medical records and obtained via survey are documented. Administrative data are available from a variety of state, federal, and private sources and can, in many cases, be combined. As a tool for planning and surveillance, administrative data show great promise: They contain consistent elements, are available in a timely manner, and provide information about large numbers of individuals. Because they are available in an electronic format, they are relatively inexpensive to obtain and use. In the United States, however, there is no administrative data set covering the entire population. Although Medicare provides health care for an estimated 96% of the elderly, age 65 years and older, there is no comparable source for those under 65.

Geographic variation in hospice use prior to death.

OBJECTIVES: To examine national variation in use of the Medicare hospice benefit by older individuals before their death, and to identify individual characteristics and local market factors associated with hospice use. DESIGN: Retrospective analysis of Medicare administrative data. SETTING: Hospice care. PARTICIPANTS: Older Medicare enrollees who died in 1996. MEASUREMENTS: Rate of hospice use per 1,000 older Medicare beneficiary deaths. RESULTS: Overall, 155 of every 1,000 older Medicare beneficiaries who die use hospice before death. This rate is significantly higher among younger older persons (P < .001), non-blacks (P < .001), persons living in wealthier areas (P < .001), and persons in urban areas (P < .001). Areas with a higher proportion of non-cancer diagnoses among hospice users have higher rates of hospice use for both cancer and non-cancer reasons than areas with a majority of hospice users having cancer diagnoses (P < .001). Hospice use is higher in areas with fewer hospital beds per capita (P < .001), areas with lower in-hospital death rates (P < .001), and areas with higher HMO enrollment (P < .001). Rates of hospice use are also positively related to average reimbursements for health care (P < .001) and to physicians per capita (P < .001). In the largest metropolitan statistical areas (MSAs), rates of hospice use vary more than 11-fold from a low of 35.15 (Portland, ME) to a high of 397.2 per 1,000 deaths (Ft. Lauderdale, FL). CONCLUSIONS: The wide variation in hospice use suggests that there is great potential to increase the number of users of the Medicare hospice benefit.

Medicare HMO disenrollment and selective use of medical care: osteoarthritis-related joint replacement.

OBJECTIVE: Recent Medicare health maintenance organization (HMO) disenrollees use a high level of medical services. This study examined admissions for total hip arthroplasty (THA) and osteoarthritis-related knee replacements (OKR) among Medicare HMO disenrollees and continuously enrolled fee-for-service (FFS) beneficiaries to determine whether Medicare beneficiaries are returning to the FFS system to receive quality-of-life enhancing elective care. STUDY DESIGN: Retrospective analysis of Medicare inpatient claims for elderly Medicare beneficiaries residing in South Florida between 1990 and 1993. METHODS: Inpatient admission rates for THA, OKR, and for 2 acute conditions--total hip replacements related to fracture of the hip (HRF) and acute myocardial infarction (AMI)--were estimated for Medicare HMO disenrollees over the 3-month period immediately following their disenrollment. These rates were compared with standardized rates for Medicare FFS enrollees. RESULTS: The annualized adjusted rates of both THA and OKR were 3.5 to 4 times higher among Medicare HMO disenrollees than among FFS beneficiaries (P < or = .0001 for both procedures); substantially smaller differences were noted for HRF (P < or = .05), and no difference was present for AMI. HMO disenrollees and FFS enrollees did not differ in their levels of comorbidity at the time of admission. CONCLUSIONS: These data provide indirect evidence that Medicare HMOs in South Florida are rationing THA and OKR and that beneficiaries respond by returning to the FFS system to seek care. This apparent rationing has important implications regarding for the management of serious, but nonemergent, medical conditions within the evolving Medicare system.

Survival analysis using Medicare data: example and methods.

OBJECTIVE: To describe key methods and issues in conducting survival analyses, especially using Medicare (and other) administrative data. PRINCIPAL FINDINGS: Survival analyses are rich , informative, and underutilized methods for examining out comes whose timing is important . Medicare files contain the necessary information for conducting such analyses, including identification of cohorts, definition of events, censoring of observations, and adjustment for covariates. CONCLUSION: Survival analyses can readily be conducted using the information contained in administrative data files.

Do Medicare HMOs and Medicare FFS differ in their use of the Medicare hospice benefit?

This study compares use of the hospice benefit in Medicare fee-for-service (FFS) and Medicare risk-health maintenance organization (HMO) options in South Florida in 1992. A higher percentage of deaths occurred in hospice in the HMO option than in the FFS option. Compared to individuals in the FFS option, HMO-enrolled hospice users had longer lengths of hospice stay, lower 7-day mortality and higher 180-day (6 month) survival. These differences are consistent with the physician's financial incentives associated with the two programs.

Racial and income differences in use of the hospice benefit between the medicare managed care and medicare fee-for-service.

OBJECTIVE: To examine whether use of the Medicare Hospice Benefit between health maintenance organization (HMO) and Fee-For-Service (FFS)-enrolled beneficiaries varies by income or race. DATA SOURCE: Medicare enrollment and claims data for South Florida. RESULTS: In the FFS system, rate of death in hospice varied by income. In the HMO system, it did not. Time spent in hospice varied by income in the HMO system and not in the FFS system. There was little evidence that racial differences in hospice use differed between FFS and HMO options. CONCLUSIONS: These differences raise questions about whether some hospice use may be in response to system-level incentives.

Medicare HMOs: who joins and who leaves?

Medicare risk health maintenance organizations (HMOs) are an increasingly common alternative to fee-for-service Medicare. To date, there has been no examination of whether the HMO program is preferentially used by blacks or by persons living in lower-income areas or whether race and income are associated with reversing Medicare HMO selection. This question is important because evidence suggests that these beneficiaries receive poorer care under the fee-for-service-system than do whites and persons from wealthier areas. Medicare enrollment data from South Florida were examined for 1990 to 1993. Four overlapping groups of enrollees were examined: all age-eligible (age 65 and over) beneficiaries in 1990; all age-eligible beneficiaries in 1993; all age-eligible beneficiaries residing in South Florida during the period 1990 to 1993; and all beneficiaries who became age-eligible for Medicare benefits between 1990 and 1993. The associations between race or income and choice of Medicare option were examined by logistic regression. The association between the demographic characteristics and time staying with a particular option was examined with Kaplan-Meier methods and Cox Proportional Hazards modeling. Enrollment in Medicare risk HMOs steadily increased over the 4-year study period. In the overall Medicare population, the following statistically significant patterns of enrollment in Medicare HMOs were seen: enrollment of blacks was two times higher than that of non-blacks; enrollment decreased with age; and enrollment decreased as income level increased. For the newly eligible population, initial selection of Medicare option was strongly linked to income; race effects were weak but statistically significant. The data for disenrollment from an HMO revealed a similar demographic pattern. At 6 months, higher percentages of blacks, older beneficiaries (older than 85), and individuals from the lowest income area (less than $15,000 per year) had disenrolled. A small percentage of beneficiaries moved between HMOs and FFS plans multiple times. These data on Medicare HMO populations in South Florida, an area with a high concentration of elderly individuals and with one of the highest HMO enrollment rates in the country, indicate that enrollment into and disenrollment from Medicare risk HMOs are associated with certain demographic characteristics, specifically, black race or residence in a low-income area.

Treatment and health outcomes of women and men in a cohort with coronary artery disease.

BACKGROUND: Women with coronary artery disease are treated differently than men. Although mortality has been studied, functional outcomes for women and men have not been prospectively compared. METHODS: The Manitoba Health Reform Impact Study used hospital databases to identify all residents aged 45 years and older in Manitoba who were hospitalized for a myocardial infarction between October 1, 1991, and September 30, 1992. Cohort members were interviewed twice, an average of 16 and 25 months after hospitalization. Baseline and follow-up measures included treatments (eg, physician visits, diagnostic testing, revascularization, and cardiac medications), physical health status (physical component summary [PCS] score derived from the Medical Outcomes Study Short Form 36), reinfarction, and mortality. RESULTS: Of the 820 patients who completed the initial survey, 31 died during the follow-up period, and 734 completed the follow-up survey. Data were complete for the primary outcome (PCS score) and all relevant covariates for the 677 patients who were included in this study Women constituted 34% of this cohort. Although women had more physician visits during follow-up, they were less likely to have undergone treadmill testing or angiography (odds ratio, 0.68; 95% confidence interval, 0.46-0.99). Women were equally likely to report taking beta-adrenergic blocking agents, but were less likely than men to report the use of aspirin (odds ratio, 0.69; 95% confidence interval, 0.48-0.98). After adjusting for baseline differences in PCS scores, age, income, social supports, and the levels of angina and dyspnea, the PCS score for women declined by 1.4 points, while the score for men improved by 0.2 points (P = .03). During the follow-up period, reinfarction and mortality rates were low overall, but were not different in men and women. CONCLUSIONS: In this cohort of patients with known coronary artery disease, we found less aggressive treatment of coronary artery disease and less use of aspirin among women than among men during 1 year of observation. After controlling for baseline differences, women with coronary artery disease experienced a more rapid decline in physical health status than did men during 1 year of follow-up.

The Medicare-HMO revolving door--the healthy go in and the sick go out.

BACKGROUND: Enrollment in Medicare health maintenance organizations (HMOs) is encouraged because of the expectation that HMOs can help slow the growth of Medicare costs. However, Medicare HMOs, which are paid 95 percent of average yearly fee-for-service Medicare expenditures, are increasingly believed to benefit from the selective enrollment of healthier Medicare recipients. Furthermore, whether sicker patients are more likely to disenroll from Medicare HMOs, thus raising average fee-for-service costs, is not clear. METHODS: We used Medicare enrollment and inpatient billing records for southern Florida from 1990 through 1993 to examine differences in the use of inpatient medical services by 375,406 beneficiaries in the Medicare fee-for-service system, 48,380 HMO enrollees before enrollment, and 23,870 HMO enrollees after disenrollment. We also determined whether these differences were related to demographic characteristics and whether the pattern of use after disenrollment persisted over time. RESULTS: The rate of use of inpatient services in the HMO-enrollment group during the year before enrollment was 66 percent of the rate in the fee-for-service group, whereas the rate in the HMO-disenrollment group after disenrollment was 180 percent of that in the fee-for-service group. Beneficiaries who disenrolled from HMOs re-enrolled at about the time that their level of use dropped to that in the fee-for-service group. CONCLUSIONS: These data show marked selection biases with respect to HMO enrollment and disenrollment. These biases undermine the effectiveness of the Medicare managed-care system and highlight the need for longitudinal and population-based studies.

Public policy governing organ and tissue procurement in the United States. Results from the National Organ and Tissue Procurement Study.

OBJECTIVE: To determine why Required Request policies, which mandate that hospitals request donation from donor-eligible families, have not resulted in increased organ procurement. SETTING: Stratified sample of 23 acute-care general hospitals in two metropolitan areas. DESIGN: Chart review identified all eligible donors in study hospitals during a 20-month period. Health care professionals who spoke with the families of eligible donors after death were interviewed to determine families' and health care providers' behaviors after patients' deaths with reference to the donation process. PARTICIPANTS: All patient deaths (n = 10,681) were reviewed, and 841 donor-eligible cases were chosen for in-depth study; 1809 health care professionals who provided care to these patients were interviewed. MEASUREMENTS: The ability of health care providers to identify donor-eligible patients, approach families about donation, and obtain families' consent to donation. RESULTS: 83% of health care professionals correctly identified donor-eligible patients. The families of donor-eligible patients were approached about donation in 73.0% of the cases. Families were more likely to be approached about organ (86.6%) donation than either tissue (69.5%) or cornea (67.3%) donation (P < 0.001). The families of organ-eligible patients were less likely to be approached if the patient was female, was on a general medical or surgical floor, or was being cared for by internists. Only 46.5% of families of eligible donors agreed to donate organs, 34.5% agreed to donate tissues, and 23.5% agreed to donate corneas. CONCLUSIONS: Although health care professionals do request that families donate, families consent to donation less frequently than was previously assumed. Empirically based education campaigns are needed so that health care professionals can improve their communication skills and so that discussion about this important issue can be stimulated among family members.

Assessing the significance of treatment effects: comments from the perspective of ethics.

The process of designing research protocols for testing treatment effects and reporting the results of such research demands both explicit and implicit value judgments. When measuring the effects of alternative treatments, those judgments can include decisions about what outcomes to measure and for which persons they should be measured, how to aggregate disparate outcomes, and how to decide whether differences are substantial enough to differentiate between treatments. Researchers and reviewers often do not acknowledge problems of this sort, and default solutions are based on common usage rather than any epistemologic justification. Acknowledging the value commitments inherent in choices about research methods should serve to increase variation in methods rather than constrain them within conventional patterns. Especially with research intended to shape policy and practice, more thoughtful choices, humility in recognizing the limits of available methods, and flexibility in establishing the thresholds for significant differences for each study seem to be justified. The choices researchers make should be documented and the reasons for those choices should be given explicitly in publications and presentations so that readers and other users of the information are enabled and expected to bear more responsibility for interpreting and applying the findings appropriately.