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Background: The risk of subsequent infections in rheumatoid arthritis (RA) patients who receive biologic therapy after a serious infection is unclear., Objective: To compare the subsequent risk of hospitalised infections associated with specific biologic agents among RA patients previously hospitalised for infection while receiving anti-tumour necrosis factor (anti-TNF) therapy., Methods: Using 2006-2010 Medicare data for 100% of beneficiaries with RA enrolled in Medicare, we identified patients hospitalised with an infection while on anti-TNF agents. Follow-up began 61 days after hospital discharge and ended at the earliest of: next infection, loss of Medicare coverage or 18 months after start of follow-up. We calculated the incidence rate of subsequent hospitalised infection for each biologic and used Cox regression to control for potential confounders., Results: 10 794 eligible hospitalised infections among 10183 unique RA patients who contributed at least 1 day of biologic exposure during follow-up. We identified 7807 person-years of exposure to selected biologics--333 abatacept, 133 rituximab and 7341 anti-TNFs (1797 etanercept, 1405 adalimumab, 4139 infliximab)--and 2666 associated infections. Mean age across biologic exposure cohorts was 64-69 years. The crude incidence rate of subsequent hospitalised infection ranged from 27.1 to 34.6 per 100 person-years. After multivariable adjustment, abatacept (HR: 0.80, 95% CI 0.64 to 0.99) and etanercept (HR: 0.83, 95% CI 0.72 to 0.96) users had significantly lower risks of subsequent infection compared to infliximab users., Conclusions: Among RA patients who experienced a hospitalised infection while on anti-TNF therapy, abatacept and etanercept were associated with the lowest risk of subsequent infection compared to other biologic therapies., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objectives: Few studies have assessed the effectiveness of different drugs for osteoporosis (OP). We aimed to determine if fracture and mortality rates vary among patients initiating different OP medications., Methods: We used the Medicare 5% sample to identify new users of intravenous (IV) zoledronic acid (n=1.674), oral bisphosphonates (n=32.626), IV ibandronate (n=492), calcitonin (n=2.606), raloxifene (n=1.950), or parathyroid hormone (n=549). We included beneficiaries who were ≥65 years of age, were continuously enrolled in fee-for-service Medicare and initiated therapy during 2007-2009. Outcomes were hip fracture, clinical vertebral fracture, and all-cause mortality, identified using inpatient and physician diagnosis codes for fracture, procedure codes for fracture repair, and vital status information. Cox regression models compared users of each medication to users of IV zoledronic acid, adjusting for multiple confounders., Results: During follow-up (median, 0.8-1.5 years depending on the drug), 787 subjects had hip fractures, 986 had clinical vertebral fractures, and 2.999 died. Positive associations included IV ibandronate with hip fracture (adjusted hazard ratio (HR), 2.37; 95% confidence interval (CI) 1.25-4.51), calcitonin with vertebral fracture (HR=1.59, 95%CI 1.04-2.43), and calcitonin with mortality (HR=1.31; 95%CI 1.02-1.68). Adjusted HRs for other drug-outcome comparisons were not statistically significant., Conclusions: IV ibandronate and calcitonin were associated with higher rates of some types of fracture when compared to IV zolendronic acid. The relatively high mortality associated with use of calcitonin may reflect the poorer health of users of this agent.

Low statin adherence and discontinuation of statins are common in patients with coronary heart disease. We hypothesized that low antihypertensive medication adherence would be associated with future statin discontinuation and low adherence in patients initiating statins. Using a 5% national sample of Medicare beneficiaries, we conducted a cohort study of Medicare beneficiaries initiating statins after hospitalization for acute myocardial infarction or coronary revascularization in 2007, 2008, and 2009. Antihypertensive medication adherence, defined using the average proportion of days covered across 5 classes during the 365 days before hospitalization, was categorized as ≥80% (high), 50% to <80% (medium), and <50% (low). Statin discontinuation was defined as failure to refill a statin within 365 days of hospital discharge, and low adherence was defined as proportion of days covered for statins <80%. In 2,695 Medicare beneficiaries who initiated statins after hospital discharge, 6.0%, 8.4%, and 14.5% with high, medium, and low antihypertensive medication adherence discontinued statins. After multivariable adjustment, the risk ratios (95% confidence interval) for statin discontinuation were 1.38 (0.98 to 1.95) and 2.41 (1.51 to 3.87) for beneficiaries with medium and low versus high antihypertensive medication adherence, respectively. In beneficiaries who did not discontinue statins, 36.2% had low statin adherence. Compared with high adherence, medium and low antihypertensive medication adherences were associated with multivariable adjusted risk ratios (95% confidence interval) for low statin adherence of 1.33 (1.14 to 1.55) and 1.62 (1.25 to 2.10), respectively. In conclusion, low antihypertensive medication adherence before initiating statins is associated with future statin discontinuation and low statin adherence., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: The purpose of the study was to investigate secular changes in coronary heart disease (CHD) incidence and mortality among adults with and without diabetes and to determine the effect of increased lipid-lowering medication use and reductions in low-density lipoprotein cholesterol (LDL-C) levels on these changes., Methods: We analyzed data on participants aged 45 to 64 years from the Atherosclerosis Risk in Communities Study in 1987-1996 (early period) and the Reasons for Geographic and Racial Differences in Stroke Study in 2003-2009 (late period). Hazard ratios (HRs) for the association of diabetes and period with incident CHD and CHD mortality were obtained after adjustment for sociodemographics cardiovascular risk factors, lipid-lowering medication use, and LDL-C., Results: After multivariable adjustment, diabetes was associated with an increased CHD risk during the early (HR = 1.99, 95% confidence interval = 1.59-2.49) and late (HR = 2.39, 95% confidence interval = 1.69-3.35) periods. CHD incidence and mortality declined between the early and late periods for individuals with and without diabetes. Increased use of lipid-lowering medication and lower LDL-C explained 33.6% and 27.2% of the decline in CHD incidence and CHD mortality, respectively, for those with diabetes., Conclusions: Although rates have declined, diabetes remains associated with an increased risk of CHD incidence and mortality, highlighting the need for continuing diabetes prevention and cardiovascular risk factor management., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Statins reduce the risk of coronary heart disease (CHD) in individuals with a history of CHD or risk equivalents. A 10-year CHD risk >20% is considered a risk equivalent but is frequently not detected. Statin use and low-density lipoprotein cholesterol (LDL-C) control were examined among participants with CHD or risk equivalents in the nationwide Reasons for Geographic and Racial Differences in Stroke study (n = 8812)., Methods: Participants were categorized into 4 mutually exclusive groups: (1) history of CHD (n = 4025); (2) no history of CHD but with a history of stroke and/or abdominal aortic aneurysm (AAA) (n = 946); (3) no history of CHD or stroke/AAA but with diabetes mellitus (n = 3134); or (4) no history of the conditions in (1) through (3) but with 10-year Framingham CHD risk score (FRS) >20% calculated using the third Adult Treatment Panel point scoring system (n = 707)., Results: Statins were used by 58.4% of those in the CHD group and 41.7%, 40.4% and 20.1% of those in the stroke/AAA, diabetes mellitus and FRS >20% groups, respectively. Among those taking statins, 65.1% had LDL-C <100 mg/dL, with no difference between the CHD, stroke/AAA, or diabetes mellitus groups. However, compared with those in the CHD group, LDL-C <100 mg/dL was less common among participants in the FRS >20% group (multivariable adjusted prevalence ratio: 0.72; 95% confidence interval: 0.62-0.85). Results were similar using the 2013 American College of Cardiology/American Heart Association cholesterol treatment guideline., Conclusions: These data suggest that many people with high CHD risk, especially those with an FRS >20%, do not receive guideline-concordant lipid-lowering therapy and do not achieve an LDL-C <100 mg/dL.

Purpose: The aim of this analysis was to implement a claims-based algorithm to estimate biologic cost per effectively treated patient for biologics approved for moderate to severe rheumatoid arthritis (RA)., Methods: This retrospective analysis included commercially insured adults (aged 18-63 years) with RA in a commercial database, who initiated biologic treatment with abatacept, adalimumab, etanercept, golimumab, or infliximab between 2007 and 2010. The algorithm defined effectiveness as having all of the following: high adherence, no biologic dose increase, no biologic switching, no new nonbiologic disease-modifying antirheumatic drug, no increased or new oral glucocorticoid use, and no more than 1 glucocorticoid injection. For each biologic, cost per effectively treated patient was defined as total drug and administration costs (from allowed amounts on claims), divided by the number of patients categorized as effectively treated., Findings: Of 15,351 patients, 12,018 (78.3%) were women, and the mean (SD) age was 49.7 (9.6) years. The algorithm categorized treatment as effective in the first year for 30% (1899/6374) of etanercept, 30% (1396/4661) of adalimumab, 20% (560/2765) of infliximab, 27% (361/1338) of abatacept, and 29% (62/213) of golimumab treated patients. The 1-year biologic cost per effectively treated patient, as defined by the algorithm, was nominally lower for subcutaneously injected biologics than for infused biologics. The 1-year biologic cost per effectively treated patient, as defined by the algorithm, was lowest for etanercept ($49,952), followed by golimumab ($50,189), adalimumab ($52,858), abatacept ($71,866), and infliximab ($104,333)., Implications: Algorithm-defined effectiveness was similar for biologics other than infliximab. The 1-year biologic cost per effectively treated patient, as defined by the algorithm, was nominally lower for subcutaneously injected biologics than for infused biologics., (Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.)

Marked increases in the awareness, treatment, and control of high low-density lipoprotein (LDL) cholesterol occurred among United States (US) adults from 1988-1994 to 1999-2004. An update to the Third Adult Treatment Panel guidelines was published in 2004, and it is unknown if these improvements have continued since the publication of these revised treatment recommendations. The aim of this study was to determine trends in the awareness, treatment, and control of high LDL cholesterol among US adults from 1999-2000 to 2009-2010 using nationally representative samples of US adults aged ≥20 years from 6 consecutive National Health and Nutrition Examination Surveys (NHANES) in 1999-2000 (n = 1,659), 2001-2002 (n = 1,897), 2003-2004 (n = 1,698), 2005-2006 (n = 1,692), 2007-2008 (n = 2,044), and 2009-2010 (n = 2,318). LDL cholesterol was measured after an overnight fast, and high LDL cholesterol and controlled LDL cholesterol were defined using the 2004 updated Third Adult Treatment Panel guidelines. Awareness and treatment of high cholesterol were defined using self-report. Among US adults, the prevalence of high LDL cholesterol did not change from 1999-2000 (37.2%) to 2009-2010 (37.8%). Awareness of high LDL cholesterol increased from 48.9% in 1999-2000 to 62.8% in 2003-2004 but did not increase further through 2009-2010 (61.5%). Among those aware of having high LDL cholesterol, treatment increased from 41.3% in 1999-2000 to 72.6% in 2007-2008 and was 70.0% in 2009-2010. Among US adults receiving treatment for high LDL cholesterol, the percentage with controlled LDL cholesterol increased from 45.0% in 1999-2000 to 65.3% in 2005-2006 and had decreased slightly by 2009-2010 (63.6%). In conclusion, high LDL cholesterol remains common among US adults. Additional efforts are needed to prevent high LDL cholesterol and increase the awareness, treatment, and control of high LDL cholesterol among US adults., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Osteoporosis is a leading health problem worldwide due to the morbidity and mortality associated with fractures. However, a large number of fractures occur in persons without osteoporosis, when defined by bone mineral density alone. Numerous studies have shown that the risk of subsequent fracture is increased following fractures at most sites, and the increased risk is not limited to prior hip and vertebral fractures only. In addition, the amount of trauma present at the time of a fracture event appears to have limited impact on future fracture risk. Thus, even fractures that occur in the presence of high trauma should be recognized as evidence of possible bone fragility. Further methods to better identify persons at risk of future fracture are needed, such as through evaluation of other indicators of bone strength or recognition of modifiable, non-bone factors. Any initial fracture event is important for patients and caregivers to recognize as an implication for future fracture risk.

Long-term bisphosphonate use may be associated with several rare adverse events. Such associations are not optimally evaluated in conventional randomized controlled trials due to the requirements of large numbers of patients and long-term follow-up. Alternatively, administrative claims data from various sources such as Medicare have been used. Because claims data are collected for billing and reimbursement purposes, they have limitations, including uncertain diagnostic validity and lack of detailed clinical information. Using such data for pharmacoepidemiologic research requires complex methodologies that may be less familiar to many researchers and clinicians. In this review, we discuss the strengths and limitations of using claims data for osteoporosis drug safety research, summarize recent advancements in methodologies that may be used to address the limitations, and present directions for future research using claims data.

Background: Osteoporosis-related fractures impose a large and growing societal burden, including adverse health effects and direct medical costs. Postfracture utilization of health care services represents an alternative measure of the resource costs associated with these fractures., Methods: We use a 5% random sample of Medicare claims data to construct annual cohorts (2000-2004) of beneficiaries diagnosed with incident fractures at one of seven sites--clinical vertebral, hip pelvis, femur, tibia/fibula, humerus, and distal radius/ulna. We use person-specific changes in health services utilization (eg, inpatient acute/postacute days, home health visits, physical, and occupational therapy) before/after fractures and probabilities of entry into (long-term) nursing home residency to estimate the utilization burden associated with fractures., Results: Relative to the prior 6-month period, rates of acute hospitalization are between 19.5 (distal radius/ulna) and 72.4 (hip) percentage points higher in the 6 months after fractures. Average acute inpatient days are 1.9 (distal radius/ulna) to 8.7 (hip) higher in the postfracture period. Fractures are associated with large increases in all forms of postacute care, including postacute hospitalizations (13.1-71.5 percentage points), postacute inpatient days (6.1-31.4), home health care hours (3.4-8.4), and hours of physical (5.2-23.6) and occupational (4.3-14.0) therapy. Among patients who were community dwelling at the time of the initial fracture, 0.9%-1.1% (2.4%-4.0%) were living in a nursing home 6 months (1 year) after the fracture., Conclusions: Fractures are associated with significant increases in health services utilization relative to prefracture levels. Additional research is needed to assess the determinants and effectiveness of alternative forms of fracture care.

Background: Home health and hospice services can constitute important elements in the continuum of care for older adults diagnosed with cancer. The Balanced Budget Act (BBA) of 1997 included provisions affecting those services., Objectives: The first objective of this study is to assess the effect of the BBA of 1997 on home health and hospice service utilization in older cancer patients. The second objective is to estimate the effect of the BBA of 1997 on costs associated specifically with home health and hospice services and on total costs of care. The final objective is to evaluate the effect of the BBA of 1997 on mortality in these patients., Research Design: Longitudinal analysis using the Surveillance, Epidemiology, and End Results-Medicare Database, covering a service area that includes 26% of the US population., Participants: Community-dwelling Medicare beneficiaries 65 years of age and older., Measures: Utilization rates of home health and hospice services; costs associated with those services, and total costs of care; and mortality., Results: Home health utilization rates dropped substantially and hospice utilization rates increased after the BBA. Medicare costs for home health services declined as did total Medicare costs but hospice costs increased. There was no discernable effect on mortality rates., Conclusions: The BBA was successful in containing the costs of home health services and resulted in savings in overall costs of care for older cancer patients. Reduction in utilization of home health services did not seem to negatively affect outcomes. The BBA may have contributed to the trend of increasing use of hospice care.

Introduction: Bayesian data mining methods have been used to evaluate drug safety signals from adverse event reporting systems and allow for evaluation of multiple endpoints that are not prespecified. Their adaptation for use with longitudinal data such as administrative claims has not been previously evaluated or validated., Methods: In this pilot study, we evaluated the feasibility of adapting data mining methods using the empirical Bayes Multi-item Gamma Poisson Shrinkage (MGPS) algorithm to longitudinal administrative claims data. The Medicare Current Beneficiary Survey was used to identify a cohort of Medicare enrollees who were exposed to cyclooxygenase selective (coxib) or nonselective nonsteroidal anti-inflammatory drugs (NS-NSAIDs) from 1999 to 2003. Empirical Bayes MGPS algorithm was used to simultaneously evaluate 259 outcomes associated with current use of coxibs versus NS-NSAIDs while adjusting for key covariates and multiple comparisons. For comparison, a parallel analysis used traditional epidemiologic methods to evaluate the relationship between coxib versus NS-NSAID use and acute myocardial infarction, with the goal of establishing the concurrent validity of the data mining approach., Results: Among 9431 Medicare beneficiaries using NSAIDs and considering all 259 possible outcomes, empirical Bayes MGPS identified an association between current celecoxib use and acute myocardial infarction (Empirical Bayes Geometric Mean ratio 1.91) but not other outcomes. Rofecoxib use was associated with acute cerebrovascular events (Empirical Bayes Geometric Mean ratio 1.85) and several other diagnoses that likely represented indications for the drug. Results from the analyses using traditional epidemiologic methods were similar and indicated that the data mining results were valid., Discussion: Bayesian data mining methods seem useful to evaluate drug safety using administrative data. Further work will be needed to extend these findings to different types of drug exposures and to other claims databases.

Much attention has been focused on how the nursing shortage will impact the growing number of aging Americans. This study was conducted as a first step in understanding nursing supply relative to potential pediatric demand using merged data from the American Hospital Association's annual survey and Census data by state from the year 2000. Findings indicate that there is tremendous variability among reporting states related to estimated pediatric nurses (registered nurse full-time equivalents), potential pediatric demand (persons from birth to 18 years), and allocated pediatric beds. Future research will examine how this supply-demand chain impacts clinical and cost outcomes for pediatric patients.

Background: We measured 13-year trends in operative mortality for six cancer resections. We then examined whether these trends are driven by changes in hospital and surgeon volume or by changes that occurred among all providers, regardless of volume., Methods: We analyzed administrative discharge data on patients who received one of six cancer resections in Florida, New Jersey, and New York for three time periods: 1988 to 1991, 1992 to 1996, and 1997 to 2000. Descriptive statistics and nested regression models were used to test for changes in the association between inpatient mortality and annual hospital and annual surgeon volume over time, adjusting for patient and hospital characteristics., Results: Unadjusted inpatient mortality rates for the six cancer resections declined between .8 and 4.0 percentage points between the time periods 1988 to 1991 and 1997 to 2000. Over this time period, annual hospital and surgeon volumes for the six cancer operations increased an average of 24.3% and 24.2%, respectively. The logistic regressions indicated a relatively stable relationship over time between both increased hospital and surgeon volume and lower inpatient mortality. Simulations suggest that increases in hospital and surgeon procedure volume over time led to a reduction in inpatient mortality ranging from .1 percentage points for rectal cancer to 2.3 percentage points for pneumonectomy., Conclusions: Persistence of the volume-outcome relation and increasing hospital and surgeon volumes explain much of the decline over time in inpatient mortality for five of the six cancer operations studied. Concentrating cancer resections among high-volume providers should lead to further reduced inpatient mortality.