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Amy S Mudano,1,2,3 Lisa C Gary,1,2,3 Ana L Oliveira,1,2,3 Mary Melton,1,2,3 Nicole C Wright,1,2,3 Jeffrey R Curtis,1,2,3 Elizabeth Delzell,1,2,3 T Michael Harrington,1,2,3 Meredith L Kilgore,1,2,3 Cora Elizabeth Lewis,1,2,3 Jasvinder A Singh,1,2,3,4 Amy H Warriner,1,2,3 Wilson D Pace,5 Kenneth G Saag1,2,31Center for Education and Research on Therapeutics (CERTs), 2Center for Outcomes Effectiveness Research and Education (COERE), and 3Center for Clinical and Translational Sciences (CCTS), (University of Alabama at Birmingham, Birmingham, AL, USA); 4Veterans Affairs Medical Center, Birmingham, AL, USA; 5Distributed Ambulatory Research in Therapeutics Network (DARTNet), American Academy of Family Physicians (AAFP), University of Colorado, Denver, CO, USAIntroduction: Pragmatic clinical trials (PCTs) provide large sample sizes and enhanced generalizability to assess therapeutic effectiveness, but efficient patient enrollment procedures are a challenge, especially for community physicians. Advances in technology may improve methods of patient recruitment and screening in PCTs. Our study looked at a tablet computer versus an integrated voice response system (IVRS) for patient recruitment and screening for an osteoporosis PCT in community physician offices.Materials and methods: We recruited women ≥ 65 years of age from community physician offices to answer screening questions for a hypothetical osteoporosis active comparator PCT using a tablet computer or IVRS. We assessed the feasibility of these technologies for patient recruitment as well as for patient, physician, and office staff satisfaction with the process. We also evaluated the implications of these novel recruitment processes in determining the number of primary care practices and screened patients needed to conduct the proposed trial.Results: A total of 160 women (80% of those approached) agreed to complete the osteoporosis screening questions in ten family physicians’ offices. Women using the tablet computer were able to complete all screening questions consistently and showed a nonsignificant trend towards greater ease of use and willingness to spend more time in their physician's office compared to those using IVRS. Using the proportion of women found to be eligible in this study (almost 20%) and other eligibility scenarios, we determined that between 240 and 670 community physician offices would be needed to recruit ample patients for our hypothetical study.Conclusion: We found good satisfaction and feasibility with a tablet computer interface for the recruitment and screening of patients for a hypothetical osteoporosis PCT in community office settings. In addition, we used this experience to estimate the number of research sites needed for such a study.Keywords: osteoporosis, clinical trial, pragmatic clinical trials, computer applications

Background: Despite 100,000 ventral hernia repairs (VHR) being performed annually, no gold standard for the technique exists. Mesh has been shown to decrease recurrence rates, yet, concerns of increased complications and costs prevent its systematic use. We examined the cost-effectiveness of open suture (OS) versus open mesh (OM) in primary VHR.Methods: A decision analysis model from the payer's perspective comparing OS to OM was constructed for calculating the total costs and cost-effectiveness. Probabilities for complications and outcomes were derived from the literature. The costs represented institutional fixed costs. The outcome measure of effectiveness was recurrence. One-way sensitivity analysis and a probabilistic analysis using Monte Carlo simulation were performed.Results: OS was associated with a total cost of $16,355 (+/-6,041) per repair, while OM was $16,947 (+/-7,252). At 3-year follow-up, OM was the more effective treatment with 73.8% being recurrence-free, compared with 56.3% in the OS group. The incremental cost to prevent one recurrence by the placement of mesh was $1,878. OM became the less effective treatment strategy when the infection rate exceeded 35%. At a willingness to pay level of $5,500, OM was the more cost-effective treatment strategy.Conclusion: In subjects without contraindication to mesh placement, OM repair is the more effective surgical treatment for VHR, with a lower risk of recurrence at a small cost to the payer. [ABSTRACT FROM AUTHOR]

Context: Concern about additional costs for direct patient care impedes efforts to enroll patients in clinical trials. But generalizable evidence substantiating these concerns is lacking.Objective: To assess the additional cost of treating cancer patients in the National Cancer Institute (NCI)-sponsored clinical trials in the United States across a range of trial phases, treatment modalities, and patient care settings.Design: Retrospective cost study using a multistage, stratified, random sample of patients enrolled in 1 of 35 active phase 3 trials or phase 1 or any phase 2 trials between October 1, 1998, and December 31, 1999. Unadjusted and adjusted costs were compared and related to trial phase, institution type, and vital status.Setting and Participants: A representative sample of 932 cancer patients enrolled in nonpediatric, NCI-sponsored clinical trials and 696 nonparticipants with a similar stage of disease not enrolled in a research protocol from 83 cancer clinical research institutions across the United States.Main Outcome Measures: Direct treatment costs as measured using a combination of medical records, telephone survey, and Medicare claims data. Administrative and other research costs were excluded.Results: The incremental costs of direct care in trials were modest. Over approximately a 2.5-year period, adjusted costs were 6.5% higher for trial participants than nonparticipants (35,418 dollars vs 33,248 dollars; P =.11). Cost differences for phase 3 studies were 3.5% (P =.22), lower than for phase 1 or 2 trials (12.8%; P =.20). Trial participants who died had higher costs than nonparticipants who died (17.9%; 39,420 dollars vs 33,432 dollars, respectively; P =.15).Conclusions: Treatment costs for nonpediatric clinical trial participants are on average 6.5% higher than what they would be if patients did not enroll. This implies total incremental treatment costs for NCI-sponsored trials of 16 million dollars in 1999. Incremental costs were higher for patients who died and who were in early phase studies although these findings deserve further scrutiny. Overall, the additional treatment costs of an open reimbursement policy for government-sponsored cancer clinical trials appear minimal. [ABSTRACT FROM AUTHOR]

Early diagnosis and curative resection are significant predictors of survival in patients with pancreatic cancer. We hypothesize that cholecystectomy within 12 months of pancreatic cancer affects 1-year survival. The Surveillance Epidemiology and End Result (SEER) database linked to Medicare data was used to identify patients diagnosed with pancreatic cancer who underwent cholecystectomy 1 to 12 months prior to cancer diagnosis. The SEER database identified 32,569 patients from 1995 to 2002; 415 (1.3%) underwent cholecystectomy prior to cancer diagnosis. Patients who underwent cholecystectomy had a higher proportion of diabetes (40.2% vs 20.5%; P < 0.01), obesity (8.9% vs 3.1%; P < 0.01), jaundice (17.3% vs 0.7%; P < 0.01), cholelithiasis (70.4% vs 4.2%; P < 0.01), choledocholithiasis (0.7% vs 0.0%; P < 0.01), weight loss (17.3% vs 4.7%; P < 0.01), abdominal pain (79.5% vs 22.5%), steatorrhea (0.7% vs 0.0%; P < 0.01), and cholecystitis (32.3% vs 1.7% ; P < 0.0001). After controlling for tumor stage, patient demographics, and symptoms, survival at 1 year was significantly lower in patients undergoing cholecystectomy (OR, 0.75; 95% CI, 0.58-0.97). Recent cholecystectomy is associated with decreased 1-year survival among patients with pancreatic cancer. For patients older than 65 years of age, further evaluation prior to cholecystectomy may be necessary to exclude pancreatic cancer, especially patients with jaundice, weight loss, and steatorrhea. [ABSTRACT FROM AUTHOR]

The comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors versus angiotensin II type 1 receptor blockers (ARBs) in real-world older heart failure (HF) patients remains unclear. Of the 8,049 hospitalized HF patients aged ≥ 65 years discharged alive from 106 Alabama hospitals, 4,044 received discharge prescriptions of either ACE inhibitors (n = 3,383) or ARBs (n = 661). Propensity scores for ARB use, calculated for each of 4,044 patients, were used to match 655 (99% of 661) patients receiving ARBs with 661 patients receiving ACE inhibitors. The assembled cohort of 655 pairs of patients was well balanced on 56 baseline characteristics. During >8 years of follow-up, all-cause mortality occurred in 63% and 68% of matched patients receiving ARBs and ACE inhibitors, respectively (hazard ratio [HR] associated with ARB use 0.86, 95% confidence interval [CI] 0.75 to 0.99, p = 0.031). Among the 956 matched patients with data on the left ventricular ejection fraction (LVEF), the association between ARB (vs ACE inhibitor) use was significant in only 419 patients with LVEFs ≥ 45% (HR 0.65, 95% CI 0.51 to 0.84, p = 0.001) but not in the 537 patients with LVEFs < 45% (HR 1.00, 95% CI 0.81 to 1.23, p = 0.999; p for interaction = 0.012). HRs for HF hospitalization associated with ARB use were 0.99 (95% CI 0.86 to 1.14, p = 0.876) overall, 0.80 (95% CI 0.63 to 1.03, p = 0.080) in those with LVEFs ≥45%, and 1.14 (95% CI 0.91 to 1.43, p = 0.246) in those with LVEFs <45% (p for interaction = 0.060). In conclusion, in older HF patients with preserved LVEFs, discharge prescriptions of ARBs (vs ACE inhibitors) were associated with lower mortality and a trend toward lower HF hospitalization, findings that need replication in other HF populations. [ABSTRACT FROM AUTHOR]

Introduction: Undertreatment of osteoporosis is common, even for high-risk patients. Among the reasons for undertreatment may be a clinician''s perception of a lack of treatment benefit, particularly in light of patients'' expected future mortality. Among US Medicare beneficiaries, we evaluated the risk for second fracture versus death in the 5 years following a hip, clinical vertebral, and wrist/forearm fracture. Methods: Using data from 1999 to 2006 for a random 5% sample of US Medicare beneficiaries, we identified individuals who experienced an incident hip, clinical vertebral, or wrist/forearm fracture in 2000 or 2001. We evaluated the risk for a second incident fracture versus death in the following 5 years. Results were stratified by age, gender, race/ethnicity, and medical comorbidities. In light of the competing mortality risk, and assuming 30% efficacy of an osteoporosis medication to prevent a second fracture, we calculated the number of individuals needed to treat (NNT) for 5 years after first fracture to prevent 1 additional subsequent fracture. Results: We identified 18,853, 12,751, and 7635 persons with an incident hip, clinical vertebral, and wrist/forearm fracture, respectively. Although the 5-year risk of death usually exceeded the risk for second fracture across age, gender, racial groups, and primary fracture type (median ratio of death to second fracture=1.4, interquartile range 0.9, 2.0), the 5-year risk for second fracture was high, varying from a low of 13% to a high of 43%. Across demographic groups, the NNT to prevent a second fracture was low, ranging from 8 to 46. Conclusion: Among older persons with hip, clinical vertebral, or wrist/forearm fracture, although the risk for death was usually greater than the risk for a second fracture, both were high. The relatively low NNT to prevent 1 additional subsequent fracture fell within a range generally considered acceptable for secondary prevention strategies. [ABSTRACT FROM AUTHOR]

Background: Guidelines recommend adults who discontinue statin therapy because of statin-associated symptoms be reinitiated. Low-density lipoprotein cholesterol (LDL-C) levels achieved after statin reinitiation are unknown., Objective: The objective of this study was to determine LDL-C levels after statin reinitiation., Methods: We analyzed data from 5498 participants in the REasons for Geographic And Racial Differences in Stroke study who reported ever taking a statin. We categorized participants according to their pattern of statin use including those taking a statin who did not experience statin-associated symptoms and continued treatment, and those who discontinued statins because of statin-associated symptoms and were not reinitiated, reinitiated and remained on treatment, and discontinued treatment after being reinitiated. Mortality and vascular event reduction with statin reinitiation was estimated using data from the Cholesterol-Lowering Treatment Trialists Collaboration., Results: After multivariable adjustment, LDL-C was 14.1 (95% CI: 9.9-18.3) mg/dL higher among participants reinitiated and taking a statin compared with those without statin-associated symptoms who continued statin therapy. Mean LDL-C was 18.1 mg/dL (95% CI: 13.0-23.1) and 27.5 mg/dL (95% CI: 20.7-34.4) lower among participants reinitiated and taking a statin compared with those who discontinued statin therapy and were not reinitiated and those who discontinued statins after being reinitiated, respectively. An LDL-C reduction of 18.1 mg/dL with statin reinitiation was projected to reduce all-cause and coronary heart disease mortality by 5.6% and 8.9%, respectively, and myocardial infarction or coronary heart disease death and major vascular events by 10.7% and 9.8%, respectively, over 5 years., Conclusion: Reinitiating individuals who discontinue statin therapy may reduce LDL-C and cardiovascular risk., (Copyright © 2020 National Lipid Association. All rights reserved.)

Introduction: The best strategy to increase awareness of and access to living kidney donation remains unknown. To build upon the existing strategies, we developed the Living Donor Navigator program, combining advocacy training of patient advocates with enhanced health-care systems training of patient navigators to address potential living donor concerns during the evaluation process. Herein, we describe a systematic assessment of the delivery and content of the program through focus group discussion., Methods: We conducted focus groups with 9 advocate participants in the Living Donor Navigator program to identify knowledge, skills, and abilities needed for both advocates and navigators. We focused on 2 organizational levels: (1) the participant level or the advocacy training of the advocates and (2) the programmatic level or the support role provided by the navigators and administration of the program., Findings: From 4 common themes (communication, education, support, and commitment), we identified several core competencies and promising practices, at both the participant and programmatic levels. These themes highlighted the potential for several improvements of program content and delivery, the importance of cultural sensitivity among the Living Donor navigators, and the opportunity for informal caregiver support and accountability provided by the program., Discussion: These competencies and promising practices represent actionable strategies for content refinement, optimal training of advocates, and engagement of potential living donors through the Living Donor Navigator program. These findings may also assist with program implementation at other transplant centers in the future.

Among nonelderly adults with diabetes, we compared hospitalizations for ambulatory care-sensitive conditions from 2013 (pre-Medicaid expansion) and 2014 (post-Medicaid expansion) for 13 expansion and 4 nonexpansion states using State Inpatient Databases. Medicaid expansion was associated with decreases in proportions of hospitalizations for chronic conditions (difference between 2014 and 2013 -0.17 percentage points in expansion and 0.37 in nonexpansion states, P = .04), specifically diabetes short-term complications (difference between 2014 and 2013 -0.05 percentage points in expansion and 0.21 in nonexpansion states, P = .04). Increased access to care through Medicaid expansion may improve disease management in nonelderly adults with diabetes.

Importance: High-intensity statin use after myocardial infarction (MI) varies by patient characteristics, but little is known about differences in use by hospital or region., Objective: To explore the relative strength of associations of region and hospital and patient characteristics with high-intensity statin use after MI., Design, Setting, and Participants: This retrospective cohort analysis used Medicare administrative claims and enrollment data to evaluate fee-for-service Medicare beneficiaries 66 years or older who were hospitalized for MI from January 1, 2011, through June 30, 2015, with a statin prescription claim within 30 days of discharge. Data were analyzed from January 4, 2017, through May 12, 2019., Exposures: Beneficiary characteristics were abstracted from Medicare data. Hospital characteristics were obtained from the 2014 American Hospital Association Survey and Hospital Compare quality metrics. Nine regions were defined according to the US Census., Main Outcomes and Measures: Intensity of the first statin claim after discharge characterized as high (atorvastatin calcium, 40-80 mg, or rosuvastatin calcium, 20-40 mg/d) vs low to moderate (all other statin types and doses). Trends in high-intensity statins were examined from 2011 through 2015. Associations of region and beneficiary and hospital characteristics with high-intensity statin use from January 1, 2014, to June 15, 2015, were examined using Poisson distribution mixed models., Results: Among the 139 643 fee-for-service beneficiaries included (69 968 men [50.1%] and 69 675 women [49.9%]; mean [SD] age, 76.7 [7.5] years), high-intensity statin use overall increased from 23.4% in 2011 to 55.6% in 2015, but treatment gaps persisted across regions. In models considering region and beneficiary and hospital characteristics, region was the strongest correlate of high-intensity statin use, with 66% higher use in New England than in the West South Central region (risk ratio [RR], 1.66; 95% CI, 1.47-1.87). Hospital size of at least 500 beds (RR, 1.15; 95% CI, 1.07-1.23), medical school affiliation (RR, 1.11; 95% CI, 1.05-1.17), male sex (RR, 1.10; 95% CI, 1.07-1.13), and patient receipt of a stent (RR, 1.35; 95% CI, 1.31-1.39) were associated with greater high-intensity statin use. For-profit hospital ownership, patient age older than 75 years, prior coronary disease, and other comorbidities were associated with lower use., Conclusions and Relevance: This study's findings suggest that geographic region is the strongest correlate of high-intensity statin use after MI, leading to large treatment disparities.

Purpose: Intensity modulated radiation therapy (IMRT) is widely used in the treatment of head and neck cancers (HNC). There is not enough evidence to suggest that some radiation oncologists (ROs) are associated with better outcomes in patients with HNC. We conducted a cross-sectional analysis to evaluate the effect of ROs' characteristics on outcomes in patients with HNC treated with IMRT., Methods and Materials: The study used the Surveillance Epidemiology and End Results-Medicare linked database to identify patient characteristics. Physician records were obtained from the American Medical Association. Logistic regression models with propensity scores were analyzed to look for an association between RO characteristics and patient outcomes., Results: RO characteristics showed that approximately 30% of ROS completed their training in or after the year 2000 (recently trained), and 17% were in top decile of treatment volume (high volume). Less than 3% of ROs work in academic settings. We found that ROs who were recently trained have higher odds (odds ratio [OR]: 1.10; 95% confidence interval [CI], 1.011-1.191) compared with those who were not. In addition, ROs who were treating high volumes of patients have higher odds (OR: 1.08; 95% CI, 1.010-1.165) compared with those treating low volumes of an event of adverse effect of IMRT or death among patients. ROs who work in academic settings have a protective effect (OR: 0.72; 95% CI, 0.569-0.925)., Conclusions: ROs who were recently trained and had a high treatment volume are associated with poorer outcomes among patients with HNC who receive IMRT treatment., (Copyright © 2019 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Background: The evidence-based beta-blockers carvedilol, bisoprolol, and metoprolol succinate reduce mortality and hospitalizations among patients with heart failure with reduced ejection fraction (HFrEF). Use of these medications is not well described in the general population of patients with HFrEF, especially among patients with potential contraindications., Objectives: Our goal was to describe the patterns of prescription fills for carvedilol, bisoprolol, and metoprolol succinate among Medicare beneficiaries hospitalized for HFrEF, as well as to estimate the associations between specific contraindications for beta-blocker therapy and those patterns., Methods and Results: With the use of the cohort of 15,205 Medicare beneficiaries hospitalized for HFrEF from 2007 to 2013 in the 5% Medicare random sample, we described prescription fills (30 days after discharge) and dosage patterns (1 year after discharge) for beta-blockers. By means of of Fine and Gray competing risk models, we estimated the associations between potential contraindications (hypotension, chronic obstructive pulmonary disease [COPD], asthma, and syncope) and prescription fill and dosing patterns while adjusting for demographics, comorbidities, and health care utilization. For beneficiaries who did not die or readmitted to the hospital, 38% of hospitalizations were followed by a prescription fill for an evidence-based beta-blocker within 30 days, 12% were followed by prescription fills for at least 50% of the recommended dose of an evidence-based beta-blocker within 1 year, and 9% were followed by a prescription fill for an up-titrated dose of an evidence-based beta-blocker within 1 year. The prevalence of the contraindications were 21% for hypotension, 48% for COPD, 15% for asthma, and 12% for syncope. Among beneficiaries who did not fill a prescription for an evidence-based beta-blocker within 30 days, 67% had at least 1 of these contraindications. Hypotension, COPD, and syncope were each associated with a ∼10% lower risk of filling a prescription for an evidence-based beta-blocker., Conclusions: Prescription fill and up-titration rates for evidence-based beta-blockers are low among Medicare beneficiaries with HFrEF, but contraindications explain only a minor part of these low rates., (Copyright © 2018 Elsevier Inc. All rights reserved.)

A 9-point risk assessment identified persons with a history of injection drug use who were safe for discharge. "Low-risk" patients were discharged with outpatient antibiotics; others continued inpatient treatment. Use of the assessment reduced the mean length of stay by 20 days and total direct cost by 33%, creating capacity for an additional 333 patients., (© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Objective: The Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 mandates equivalent insurance coverage for mental health (MH) and substance use disorders (SUD) to other medical and surgical services covered by group insurance plans, Medicaid, and Children's Health Insurance Programs (CHIP). We explored the impact of MHPAEA on enrollees in ALL Kids, the Alabama CHIP., Methods: We use ALL Kids claims data for October 2008 to December 2014. October 2008 through September 2009 marks the period before MHPAEA implementation. We evaluated changes in MH/SUD-related utilization and program costs and changes in racial/ethnic disparities in the use of MH/SUD services for ALL Kids enrollees using 2-part models. This allowed analyses of changes from no use to any use, as well as in intensity of use., Results: No significant effect was found on overall MH service-use. There were statistically significant increases in inpatient visits and length of stay and some increase in overall MH costs. These increases may not be clinically important and were concentrated in 2009 to 2011. Disparities in utilization between African-American and non-Hispanic white enrollees were somewhat exacerbated, whereas disparities between other minorities and non-Hispanic whites were reduced., Conclusions: Findings indicate that MHPAEA led to a 14.3% increase in inpatient visits, a 12.5% increase in length of inpatient stay, and a 7.8% increase in MH costs. The increases appear limited to 2009 to 2011, suggesting existing pent-up "needs" among enrollees for added MH/SUD services that resulted in a temporary spike in service use and cost immediately after MHPAEA, which subsequently subsided., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: Assess the validity of Medicare claims for identifying myocardial infarction (MI)., Methods: We used data from 9951 Medicare beneficiaries 65 years and above in the Reasons for Geographic And Racial Differences in Stroke study. Between 2003 and 2012, 669 participants had an MI identified and adjudicated through study procedures (ie, the gold standard), and 552 had an overnight inpatient claim with a code for MI (ICD-9 code 410.x0 or 410.x1) in any discharge diagnosis position., Results: Using Medicare claims with a discharge diagnosis code for MI in any position, the positive predictive value (PPV) was 84.3% [95% confidence interval (CI), 80.9%-87.3%] and the sensitivity was 49.0% (95% CI, 44.9%-53.1%). Sensitivity was lower for men (45.8%) versus women (55.1%), microsize MIs (13.7%) versus other MIs (64.7%), type 2 (30.9%), and 4-5 MIs (11.1%) versus type 1 MIs (76.6%), and MIs occurring in-hospital (28.8%) versus out-of-hospital (66.7%). Using Medicare claims with a code for MI in the primary discharge diagnosis position, the PPV was 89.7% (95% CI, 86.3%-92.5%) and sensitivity was 40.1% (95% CI, 36.1%-44.2%). The sensitivity of claims with a code for MI in the primary discharge diagnosis position was lower for microsize versus other MIs, type 2 and 4-5 MIs versus type 1 MIs and MIs occurring in-hospital versus out-of-hospital. Hazard ratios for MI associated with participant characteristics were similar using adjudicated MIs identified through study procedures or claims for MI without further adjudication., Conclusions: Medicare claims have a high PPV but low sensitivity for identifying MI and can be used to investigate individual-level characteristics associated with MI.

Objective: To identify hospital/county characteristics and sources of regional heterogeneity associated with readmission penalties., Data Sources/study Setting: Acute care hospitals under the Hospital Readmissions Reduction Program from fiscal years 2013 to 2018 were linked to data from the Annual Hospital Association, Centers for Medicare and Medicaid Services, Medicare claims, Hospital Compare, Nursing Home Compare, Area Resource File, Health Inequity Project, and Long-term Care Focus. The final sample contained 3,156 hospitals in 1,504 counties., Data Collection/extraction Methods: Data sources were combined using Medicare hospital identifiers or Federal Information Processing Standard codes., Study Design: A two-level hierarchical model with correlated random effects, also known as the Mundlak correction, was employed with hospitals nested within counties., Principal Findings: Over a third of the variation in readmission penalties was attributed to the county level. Patient sociodemographics and the surrounding access to and quality of care were significantly associated with penalties. Hospital measures of Medicare volume, percentage dual-eligible and Black patients, and patient experience were correlated with unobserved area-level factors that also impact penalties., Conclusions: As the readmission risk adjustment does not include any community-level characteristics or geographic controls, the resulting endogeneity bias has the potential to disparately penalize certain hospitals., (© Health Research and Educational Trust.)

Purpose: Compare medical expenditures among adults with statin-associated adverse effects (SAAE) and high statin adherence (HSA) following myocardial infarction (MI)., Methods: We analyzed expenditures in 2016 US dollars among Medicare beneficiaries with SAAE (n = 1741) and HSA (n = 55,567) who were ≥ 66 years of age and initiated moderate/high-intensity statins following an MI in 2007-2013. SAAE were identified through a claims-based algorithm, which included down-titrating statins and initiating ezetimibe, switching to ezetimibe monotherapy, having a rhabdomyolysis or antihyperlipidemic adverse event followed by statin down-titration or discontinuation, or switching between ≥ 3 statin types within 365 days following MI. HSA was defined by having a statin available to take for ≥ 80% of the days in the 365 days following MI., Results: Expenditures among beneficiaries with SAAE and HSA were $40,776 (95% CI $38,329-$43,223) and $26,728 ($26,482-$26,974), respectively, in the 365 days following MI, and $34,238 ($31,396-$37,080) and $29,053 ($28,605-$29,500), respectively, for every year after the first 365 days. Multivariable-adjusted ratios comparing expenditures among beneficiaries with SAAE versus HSA in the first 365 days and after the first 365 days following MI were 1.51 (95% CI 1.43-1.59) and 1.23 (1.12-1.34), respectively. Inpatient and outpatient expenditures were higher among beneficiaries with SAAE versus HSA during and after the first 365 days following MI. Compared to beneficiaries with HSA, medication expenditures among those with SAAE were similar in the 365 days following MI, but higher afterwards. Other medical expenditures were higher among beneficiaries with SAAE versus HSA., Conclusion: SAAE are associated with increased expenditures following MI compared with HSA.

Background: Living donor kidney transplantation has declined in the United States since 2004, but the relationship between population characteristics and rate of living donation is unknown. The goal of our study was to use data on general population health and socioeconomic status to investigate the association with living donation., Methods: This cross-sectional, ecological study used population health and socioeconomic status data from the CDC Behavioral Risk Factor Surveillance System to investigate the association with living donation. Transplant centers performing 10 or greater kidney transplants reported to the Scientific Registry of Transplant Recipients in 2015 were included. Center rate of living donation was defined as the proportion of all kidney transplants performed at a center that were from living donors., Results: In a linear mixed-effects model, a composite index of health and socioeconomic status factors was negatively associated with living donation, with a rate of living donation that was on average 7.3 percentage points lower among centers in areas with more comorbid disease and poorer socioeconomic status (95% confidence interval, -12.2 to -2.3, P = 0.004). Transplant centers in areas with higher prevalence of minorities had a rate of living donation that was 7.1 percentage points lower than centers with fewer minorities (95% confidence interval, -11.8 to -2.3, P = 0.004)., Conclusions: Center-level variation in living donation was associated with population characteristics and minority prevalence. Further examination of these factors in the context of patient and center-level barriers to living donation is warranted.

Background: This study examines effects of mobility and multimorbidity on hospitalization and inpatient and postacute care (PAC) facility days among older men., Methods: Prospective study of 1,701 men (mean age 79.3 years) participating in Osteoporotic Fractures in Men (MrOS) Study Year 7 (Y7) examination (2007-2008) linked with their Medicare claims. At Y7, mobility ascertained by usual gait speed and categorized as poor, intermediate, or good. Multimorbidity quantified by applying Elixhauser algorithm to inpatient and outpatient claims and categorized as none, mild-moderate, or high. Hospitalizations and PAC facility stays ascertained during 12 months following Y7., Results: Reduced mobility and greater multimorbidity burden were independently associated with a higher risk of inpatient and PAC facility utilization, after accounting for each other and traditional indicators. Adjusted mean total facility days per year were 1.13 (95% confidence interval [CI] = 0.74-1.40) among men with good mobility increasing to 2.43 (95% CI = 1.17-3.84) among men with poor mobility, and 0.67 (95% CI = 0.38-0.91) among men without multimorbidity increasing to 2.70 (95% CI = 1.58-3.77) among men with high multimorbidity. Men with poor mobility and high multimorbidity had a ninefold increase in mean total facility days per year (5.50, 95% CI = 2.78-10.87) compared with men with good mobility without multimorbidity (0.59, 95% CI = 0.37-0.95)., Conclusions: Among older men, mobility limitations and multimorbidity were independent predictors of higher inpatient and PAC utilization after considering each other and conventional predictors. Marked combined effects of reduced mobility and multimorbidity burden may be important to consider in clinical decision-making and planning health care delivery strategies for the growing aged population.

Aim: To identify the costs of replacing an entire malfunctioning AUS device versus an individual component at the time of device malfunction., Methods: Decision analysis was performed by analyzing the costs associated with revising a malfunctioning artificial urinary sphincter using one of two techniques: either individual or entire device replacement. Costs were determined by including actual institutional costs. Model assumptions were based on a summary of published literature and were created based on a time horizon of 0-5 years since the original, primary AUS was placed, and models were created for malfunction of each individual component. Sensitivity analysis was done adjusting for costs of the device and failure rates., Results: Total costs to replace an individual component were $8330 for the pump, $7611 for the cuff, and $5599 for the balloon, while entire device replacement cost $15 069. Over a 5-year time horizon the cost per patient for replacement of a balloon, pump, or cuff were $14 407, $17 491, and $15 212, respectively, versus $18 001 if the entire device was replaced. To be less costly to replace the entire device, balloon, pump, and cuff failure rates would need to be >55%, >25%, or >37.5% during the first 2 years after placement., Conclusion: In the event of failure of the artificial urinary sphincter, cost analysis demonstrates that removal and replacement of the entire device is more expensive than replacement of a malfunctioning component at any point up to 5 years after initial AUS placement., (© 2018 Wiley Periodicals, Inc.)

Background Claims data from Medicare or other payers might not generalize to other populations regarding service use after stroke especially among younger patients. However, high agreement between self-report and Medicare claims data would support the use of self-reported healthcare utilization data in these populations. Methods A population-based sample of 147 stroke participants with traditional fee-for service Medicare and their family caregivers was examined. Concordance with Medicare claims was examined for stroke participant self-report for Emergency Room visits, hospitalizations, and physician visits for a six-month period after stroke, and for both stroke participant and caregiver reports of receipt of Physical Therapy (PT), Speech and Language Pathology (SLP), or Home Health Agency (HHA) visits. Results Agreement was good for Emergency Room visits (kappa 0.75), hospitalization (kappa 0.70), and physician visits (Prevalence Adjusted Bias Adjusted Kappa [PABAK] 0.69) but more moderate for physical therapy, speech and language therapy, and home health agency visits (kappa 0.56-0.63). Caregiver agreement with Medicare claims was similar to stroke participant agreement. African Americans were less likely to self-report therapy compared to whites (OR 0.32 PT, 0.38 SLP, 0.29 HHA, p < 0.03). Younger stroke participants reported lower levels of Emergency Room visits than claims (OR 0.81, p = 0.001). Conclusion Healthcare utilization after stroke can be reliably assessed from Medicare claims, Stroke participant, or Caregiver report for salient events such as hospitalizations and Emergency Room visits. Self-report and caregiver report appear to be less reliable for identifying use of therapy or home health services. Caution should be used when interpreting disparities based on self-report data alone in these areas.

Background: Cause of death is often not available in administrative claims data., Objective: To develop claims-based algorithms to identify deaths due to fatal cardiovascular disease (CVD; ie, fatal coronary heart disease [CHD] or stroke), CHD, and stroke., Methods: Reasons for Geographic and Racial Differences in Stroke (REGARDS) study data were linked with Medicare claims to develop the algorithms. Events adjudicated by REGARDS study investigators were used as the gold standard. Stepwise selection was used to choose predictors from Medicare data for inclusion in the algorithms. C-index, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were used to assess algorithm performance. Net reclassification index (NRI) was used to compare the algorithms with an approach of classifying all deaths within 28 days following hospitalization for myocardial infarction and stroke to be fatal CVD., Results: Data from 2,685 REGARDS participants with linkage to Medicare, who died between 2003 and 2013, were analyzed. The C-index for discriminating fatal CVD from other causes of death was 0.87. Using a cut-point that provided the closest observed-to-predicted number of fatal CVD events, the sensitivity was 0.64, specificity 0.90, PPV 0.65, and NPV 0.90. The algorithms resulted in positive NRIs compared with using deaths within 28 days following hospitalization for myocardial infarction and stroke. Claims-based algorithms for discriminating fatal CHD and fatal stroke performed similarly to fatal CVD., Conclusion: The claims-based algorithms developed to discriminate fatal CVD events from other causes of death performed better than the method of using hospital discharge diagnosis codes., (Copyright © 2018 John Wiley & Sons, Ltd.)

Background: Contact with the healthcare system represents an opportunity for individuals who discontinue statins to re-initiate treatment. To help identify opportunities for healthcare providers to emphasize the risk-lowering benefits accrued through restarting statins, we determined the types of healthcare utilization associated with statin re-initiation among patients with history of a myocardial infarction., Methods and Results: Medicare beneficiaries with a statin pharmacy fill claim within 30 days of hospital discharge for a myocardial infarction in 2007 to 2012 (n=158 795) were followed for 182 days postdischarge to identify treatment discontinuation, defined as 60 continuous days without statins (n=24 461). Re-initiation was defined as a statin fill within 365 days of the discontinuation date (n=13 136). Using a case-crossover study design and each beneficiary as their own control, healthcare utilization during 0 to 14 days before statin re-initiation (case period) was compared with healthcare utilization 30 to 44 days before statin re-initiation (control period). The mean age of beneficiaries was 75.4 years; 52.8% were women and 81.9% were white. For routine healthcare utilization, the odds ratio (95% confidence interval) for statin re-initiation associated with lipid panel testing was 2.65 (1.93-3.65), outpatient primary care was 1.31 (1.23-1.40), and outpatient cardiologist care was 1.38 (1.28-1.50). For acute healthcare utilization, the odds ratio (95% confidence interval) for statin re-initiation associated with emergency department visits was 1.77 (1.31-2.40), coronary heart disease (CHD) hospitalizations was 3.16 (2.41-4.14) and non-coronary heart disease hospitalizations was 1.73 (1.49-2.01)., Conclusions: The weaker association of routine versus acute healthcare utilization with statin re-initiation suggests missed opportunities to reinforce the importance of statin therapy for secondary prevention., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Although the reverse syphilis screening algorithm is more efficient than the traditional algorithm, it may lead to exorbitant costs for health systems serving persons living with HIV needing annual syphilis screening. Alternatively, the traditional screening algorithm is cost saving in many scenarios.

Background/objectives: Social support can prevent or delay long-term nursing home placement (NHP). The purpose of our study was to understand how the availability of a caregiver can affect NHP after ischemic stroke and how this affects different subgroups differently., Design: Nested cohort study., Setting: Nationally based REasons for Geographic and Racial Differences in Stroke (REGARDS) study., Participants: Stroke survivors aged 65 to 100 (256 men, 304 women)., Measurements: Data were from Medicare claims from January 2003 to December 2013 and REGARDS baseline interviews conducted from January 2003 to October 2007. Caregiver support was measured by asking, "If you had a serious illness or became disabled, do you have someone who would be able to provide care for you on an on-going basis?" Diagnosis of ischemic stroke was derived from inpatient claims. NHP was determined using a validated claims algorithm for stays of 100 days and longer. Risk was estimated using Cox regression., Results: Within 5 years of stroke, 119 (21.3%) participants had been placed in a nursing home. Risk of NHP was greater in those lacking available caregivers (log-rank P = .006). After adjustment for covariates, lacking an available caregiver increased the risk of NHP after stroke within 1 year by 70% (hazard ratio (HR) = 1.70, 95% confidence interval (CI) = 0.97-2.99) and within 5 years by 68% (HR = 1.68, 95% CI = 1.10-2.58). The effect of caregiver availability on NHP within 5 years was limited to men (HR = 3.15, 95% CI = 1.49-6.67)., Conclusion: In men aged 65 and older who have survived an ischemic stroke, the lack of an available caregiver is associated with triple the risk of NHP within 5 years., (© 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.)

Background: We had previously developed an algorithm for Medicare claims data to detect bone metastases associated with breast, prostate, or lung cancer. This study was conducted to examine whether this algorithm accurately documents bone metastases on the basis of diagnosis codes in Medicare claims data., Methods: We obtained data from Medicare claims and electronic medical records of patients 65 years or older with a breast, prostate, or lung cancer diagnosis at a teaching hospital and/or affiliated clinics during 2005 or 2006. We calculated the sensitivity and positive predictive value (PPV) of our algorithm using medical records as the "gold standard." The κ statistic was used to measure agreement between claims and medical record data., Results: The agreement between claims and medical record data for bone metastases among breast, prostate, and lung cancer patients was 0.93, 0.90, and 0.69, respectively. The sensitivities of our algorithm for bone metastasis in patients with breast, prostate, and lung were 96.8% [95% confidence interval (CI)=83.8% to 99.4%], 91.7% (95% CI=78.2% to 97.1%), and 74.1% (95% CI=55.3% to 86.8%), respectively; and the PPVs were 90.9% (95% CI=76.4% to 96.9%), 91.7% (95% CI=78.2% to 97.1%), and 71.4% (95% CI=52.9% to 84.8%), respectively., Conclusions: The algorithm for detecting bone metastases in claims data had high sensitivity and PPV for breast and prostate cancer patients. Sensitivity and PPV were lower but still moderate for lung cancer patients.

Background: Although the benefits of statins accrue over time, treatment discontinuation is common. Examining the patterns of statin discontinuation, reinitiation, and persistence after reinitiation among Medicare beneficiaries after hospital discharge for a myocardial infarction may help increase statin use in high-risk patients., Methods and Results: Medicare beneficiaries with a statin fill claim within 30 days after hospital discharge for myocardial infarction in 2007 to 2012 (n=158 795) were followed for 182 days post-discharge to identify discontinuation, defined as 60 continuous days without statins available. Reinitiation, defined by a statin fill, was identified in the 365 days post-discontinuation. High persistence was defined as proportion of days covered ≥80% with ≥1 day of statin supply 182 days after reinitiation. Follow-up ended on December 31, 2014. In the 182 days after myocardial infarction hospital discharge, 15.4% of beneficiaries discontinued statins. Of this group, 53.7% reinitiated statins. On reinitiation, 27.1% changed statin type, 6.9% up-titrated intensity, 14.4% down-titrated intensity, and 66.0% had the same statin and intensity. In the 182 days after reinitiation, 45.8% had high persistence. Moderate- and high- versus low-intensity statins were associated with a lower risk for statin discontinuation (moderate intensity: relative risk [RR], 0.93; 95% confidence interval [CI], 0.89-0.96; high-intensity: RR, 0.95; 95% CI, 0.91-0.99). High persistence was less common after reinitiating high- versus low-intensity statins (RR, 0.80; 95% CI, 0.75-0.86), but no association was present for those reinitiating a moderate- versus low-intensity statin (RR, 0.95; 95% CI, 0.90-1.01). Down-titrating versus reinitiating the same statin intensity (RR, 1.10; 95% CI, 1.05-1.16) and reinitiating a different versus the same statin (RR, 1.10; 95% CI, 1.06-1.14) were associated with high persistence after treatment reinitiation., Conclusions: Although many people who discontinue a statin reinitiate treatment, statin persistence after reinitiation was low. Reinitiating therapy with moderate-intensity statins, down-titration, and using a different statin may promote persistence., (© 2017 American Heart Association, Inc.)

Background: Less intensive treatment for heart failure with reduced ejection fraction (HFrEF) may be appropriate for patients in long-term care settings because of limited life expectancy, frailty, comorbidities, and emphasis on quality of life., Methods: We compared treatment patterns between REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants discharged to long-term care versus home following HFrEF hospitalizations. We examined medical records and Medicare pharmacy claims for 147 HFrEF hospitalizations among 80 participants to obtain information about discharge disposition and medication prescriptions and fills., Results: Discharge to long-term care followed 22 of 147 HFrEF hospitalizations (15%). Participants discharged to long-term care were more likely to be prescribed beta-blockers and less likely to be prescribed aldosterone receptor antagonists and hydralazine/isosorbide dinitrate (96%, 14%, and 5%, respectively) compared to participants discharged home (81%, 22%, and 23%, respectively). The percentages of participants discharged to long-term care and home who had claims for filled prescriptions were similar for beta-blockers (68% versus 66%) and angiotensin converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARBs) (45% versus 47%) after 1 year. Smaller percentages of participants discharged to long-term care had claims for filled prescriptions of other medications compared to participants discharged home (diuretics: long-term care-50%, home-72%; hydralazine/isosorbide dinitrate: long-term care-5%, home-23%; aldosterone receptor antagonists: long-term care-5%, home-23%)., Conclusions: Differences in medication prescriptions and fills among individuals with HFrEF discharged to long-term care versus home may reflect prioritization of some medical therapies over others for patients in long-term care.

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow., Introduction: The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question., Methods: We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization., Results: Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study., Conclusions: Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

This study examined whether access to and use of patient-centered medical home (PCMH) practices is associated with reduced nonurgent emergency department (ED) use, especially among the uninsured population. This retrospective study used 2010-2011 Medical Expenditure Panel Survey data. Difference-in-difference methods, multivariate logit model, marginal effect, and survey procedures were employed. A total of 1287 adults had any ED visit in 2011, which represented weighted 29 463 684 people in the population. Reductions in odds of nonurgent ED use between the full PCMH group and the "no regular provider" group was significantly larger for the uninsured group than publicly and privately insured groups (β = -1.70, P = .009, and β = -1.04, P = .040, respectively). Similar results were found between the partial PCMH group and the "no regular provider" group for the uninsured group compared to the public group (β = -1.67, P = .019). PCMH models demonstrate higher odds of reduced nonurgent ED use among uninsured individuals compared to public and private enrollees nationwide.

Background: After older adults experience episodes of poor health or are hospitalized, they may not return to premorbid or prehospitalization eating behaviors. Furthermore, poor nutrition increases hospital readmission risk, but evidence-based interventions addressing these risks are limited., Objective: This pilot study's objective was to evaluate the feasibility of conducting a randomized controlled trial assessing a post-discharge home-delivered meal program's impact on older adults' nutritional intake and hospital readmissions and to assess patient acceptability and satisfaction with the program. The aims of the study were to evaluate successful recruitment, randomization, and retention of at least 80% of the 24 participants sought; to compare the outcomes of hospital readmission and total daily caloric intake between participants in the intervention and control groups; and to assess patient acceptability and satisfaction with the program., Design: This study used a two-arm randomized controlled trial design, and baseline data were collected at enrollment; three 24-hour food recalls were collected during the intervention period; and health services utilization and intervention satisfaction was evaluated 45 days post-discharge., Participants/setting: Twenty-four patients from the University of Alabama at Birmingham Hospital's Acute Care for Elders (ACE) Unit were enrolled from May 2014 to June 2015. They were 65 years or older; at risk for malnutrition; cognitively intact; able to communicate; discharged to a place where the patient or family was responsible for preparing meals; and diagnosed with congestive heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, or pneumonia. Final analysis included 21 participants., Intervention: The intervention group received 10 days of home-delivered meals and nutrition education; the control group received usual care and nutrition education., Main Outcome Measures: The main outcome was intervention feasibility, measured by recruitment and retention goals. Hospital readmissions, caloric intake, and satisfaction with the intervention were also evaluated., Statistical Analyses Performed: Univariate and bivariate parametric statistics were used to evaluate differences between groups. Goals for success were identified to assess feasibility of conducting a full-scale study and outcomes were measured against the goals., Results: Of the randomized participants, 87.5% were retained for final data collection, indicating that this intervention study is feasible. There were no significant differences between groups for hospital readmissions; however, caloric intake during the intervention period was greater for intervention vs control participants (1,595 vs 1,235; P=0.03). Participants were overwhelmingly satisfied (82% to 100% satisfied or very satisfied) with staff performance, meal quality, and delivery processes., Conclusions: Conducting a randomized controlled trial to assess outcomes of providing home-delivered meals to older adults after hospital discharge in partnership with a small nonprofit organization is feasible and warrants future research., (Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Background: Apparent treatment-resistant hypertension (aTRH) is associated with an increased risk of adverse cardiovascular outcomes. We studied the frequency and intensity of care for aTRH among participants aged 65 years and older in the US-based REGARDS study linked with Medicare claims., Methods: Blood pressure (BP) was measured twice and averaged. aTRH was defined by the use of ≥3 classes of antihypertensive medication and uncontrolled BP (UaTRH, systolic/diastolic BP ≥140/90 mmHg), or ≥4 classes with controlled BP (CaTRH). Participants were categorized as not having aTRH (no aTRH), CaTRH or UaTRH., Results: Among 4650 participants with hypertension, 468 (10.1%) had UaTRH, 247 (5.3%) had CaTRH, and 3935 (84.6%) had hypertension but did not have aTRH. For hypertension-related visits, those with UaTRH saw primary care physicians and cardiologists more frequently than those without aTRH (mean primary care visits per year: 2.77 vs 2.27, P<.001; cardiologists: 0.50 vs 0.35, P=.014). Among those with UaTRH, CaTRH, and no aTRH, respectively 73.5%, 68.0%, and 67.5% had >1 hypertension-related visit per year. Among those with UaTRH, males vs females (prevalence ratio=0.78; 95% CI 0.69-0.89), whites vs blacks (0.88; 95% CI 0.78-0.99), and current smokers vs non-smokers (0.66; 95% CI 0.48-0.89) were less likely to receive >1 hypertension-related visit per year. Diagnostic intensity, measured by testing for end organ damage and secondary hypertension, was similar between groups., Conclusions: Many people with UaTRH are not seen more than once per year for hypertension and may benefit from increased care., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Introduction: Treat to target guidelines recommend achieving remission or low disease activity in rheumatoid arthritis (RA). However, the reduction in adverse events and costs associated with lower disease activity is unclear., Methods: We used Corrona linked to Medicare data to identify RA patients. Time varying disease activity was measured using Clinical Disease Activity Index (CDAI); outcomes included all-cause hospitalization, a composite of hospitalization or emergency department (ED) visits, mortality, and medical costs. Outcome-specific Cox proportional models evaluated the adjusted hazard ratios between disease activity and outcomes, controlling for potential confounders including comorbidities grouped into four patient phenotypes. Costs were analyzed with mixed models using a Gaussian distribution with log transformation., Results: Depending on outcome, 4593 RA patients contributed up to 12 001 person years. Median age was 71 years, 75% women. At baseline, approximately 50-60% of patients were in remission or low disease activity. There was a dose-response relationship between RA disease activity (remission, low, moderate, and high) and the incidence of hospitalizations (13.1, 17.8, 21.2, 27.5 per 100 py, respectively); all adjusted hazard ratios were significant: 0.68 (remission), 0.87 (low), and 1.24 (high) compared with moderate disease activity. Similar trends were observed for ED visits and mortality. The crude difference in annual medical costs between remission ($11 145) and moderate disease activity ($17 646) was $-6 500; the adjusted difference (95%CI) was $-3133 (-4737.72, -1528.43)., Conclusion: Leveraging the benefits of linking registry and administrative data together, lower disease activity in RA was associated with incrementally reduced risks of all-cause hospitalization, ED visits, mortality, and medical costs in a dose-dependent fashion. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Purpose: To measure transarterial chemoembolization utilization and survival benefit among patients with hepatocellular carcinoma (HCC) in the Surveillance, Epidemiology, and End Results (SEER) patient population., Materials and Methods: A retrospective study identified 37,832 patients with HCC diagnosed between 1991 and 2011. Survival was estimated by Kaplan-Meier method and compared by log-rank test. Propensity-score matching was used to address an imbalance of covariates., Results: More than 75% of patients with HCC did not receive any HCC-directed treatment. Transarterial chemoembolization was the most common initial therapy (15.9%). Factors associated with the use of chemoembolization included younger age, more HCC risk factors, more comorbidities, higher socioeconomic status, intrahepatic tumor, unifocal tumor, vascular invasion, and smaller tumor size (all P < .001). Median survival was improved in patients treated with chemoembolization compared with those not treated with chemoembolization (20.1 vs 4.3 mo; P < .0001). Similar findings were demonstrated in propensity-scoring analysis (14.5 vs 4.2 mo; P < .0001) and immortal time bias sensitivity analysis (9.5 vs 3.6 mo; P < .0001). There was a significantly improved survival hazard ratio (HR) in patients treated with chemoembolization (HR, 0.42; 95% confidence interval, 0.39-0.45)., Conclusions: Patients with HCC treated with transarterial chemoembolization experienced a significant survival advantage compared with those not treated with transarterial chemoembolization. More than 75% of SEER/Medicare patients diagnosed with HCC received no identifiable oncologic treatment. There is a significant public health need to increase awareness of efficacious HCC treatments such as transarterial chemoembolization., (Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.)

Background: Better cardiovascular health is associated with lower cardiovascular disease risk., Methods and Results: We determined the association between cardiovascular health and healthcare utilization and expenditures in the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. We included 6262 participants ≥65 years with Medicare fee-for-service coverage for the year after their baseline study visit in 2003-2007. Cardiovascular health at baseline was assessed using the American Heart Association's Life's Simple 7 (LS7) metric, which includes 7 factors: cigarette smoking, physical activity, diet, body mass index, blood pressure, cholesterol, and glucose. Healthcare utilization and expenditures were ascertained using Medicare claims in the year following baseline. Overall, 17.2%, 31.1%, 29.0%, 16.4% and 6.4% of participants had 0 to 1, 2, 3, 4, and 5 to 7 ideal LS7 factors, respectively. The multivariable-adjusted relative risk (95% confidence interval [CI]) for having any inpatient and outpatient encounters comparing participants with 5 to 7 versus 0 to 1 ideal LS7 factors were 0.55 (0.39, 0.76) and 1.00 (0.98, 1.02), respectively. Among participants with 0 to 1 and 5 to 7 ideal LS7 factors, mean inpatient expenditures were $3995 and $1250, respectively, mean outpatient expenditures were $5166 and $2853, respectively, and mean total expenditures were $9147 and $4111, respectively. After multivariable adjustment, the mean (95% CI) cost difference comparing participants with 5 to 7 versus 0 to 1 ideal LS7 factors was -$2551 (-$3667, -$1435) for inpatient, -$2410 (-$3089, -$1731) for outpatient, and -$5016 (-$6577, -$3454) for total expenditures., Conclusions: Better cardiovascular health is associated with lower risk for inpatient encounters and lower inpatient and outpatient healthcare expenditures., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Objectives: We analyzed a standard children's quality measure for attention-deficit/hyperactivity disorder (ADHD) using data from a single state to understand the characteristics of those meeting the measure, potential barriers to meeting the measure, and how meeting the measure affected outcomes., Study Design: Retrospective study using claims from Alabama's Children's Health Insurance Program from 1999 to 2012., Methods: We calculated the quality measure for ADHD care, as specified within CMS' Child Core Set and with an expanded denominator. We described the eligible population meeting the measure, assessed potential barriers, and measured the association with health expenditures using logit regressions and log-Poisson models., Results: Among those receiving ADHD medication, 11% of enrollees were eligible for annual measure calculation during our study period. Calculated as specified by CMS, 38% of enrollees met the measure. Using an expanded denominator of 7615 eligible medication episodes, 14% met all aspects of the measure. Primary reasons for failing to meet the measure were lacking medication coverage (64%) and lacking a follow-up visit within 30 days (62%). The rate of meeting the measure decreased with age and was lower for black enrollees. Health service utilization and costs were greater among children meeting the measure., Conclusions: Too few children are eligible for inclusion, and systematic differences exist among those who meet the measure. The measure may be sensitive to arbitrary criteria while missing potentially relevant clinical care. Refinements to the measure should be considered to improve generalizability to all children with ADHD and improve clinical relevance. States must consider additional analyses to direct quality improvement.

Objective: The patient-centered medical home (PCMH) has emerged as an innovative healthcare delivery model that holds the conceptual promise to improve healthcare quality and patient experience. This study examined how patient perceived PCMH is related to patient satisfaction and experience nationwide. This study advances academic discussion in that it is among the first to examine empirical evidence using a U.S. nationally representative sample., Methods: This retrospective cohort study used data from the 2010 to 2011 Medical Expenditure Panel Survey. This study focused on insured individuals aged 18 and older. We measured and identified cohorts for a "full PCMH," a "partial PCMH" (i.e., with a usual source of care but not a PCMH), and an "unknown PCMH," with the reference group being the "no regular provider" group and the partial PCMH group, respectively. Using logit models, we assessed patient experiences of the PCMH use controlling for covariates in 2010. Given the nature of the complex survey design, the weights and variance were adjusted using the survey procedures to yield nationally representative results., Results: The final study sample consisted of 7,743 individuals, representing 191 million individuals in the weighted population. After controlling for covariates in 2010, the full PCMH group was consistently observed to have higher odds of positive patient experience than individuals with no usual source of care: odds ratio (OR) = 1.89 (p = .003) for providers "listened carefully to you"; OR = 1.81 (p = .001) for providers "spent enough time with you"; OR = 1.85 (p = .007) for providers "showed respect for what you had to say"; and OR = 1.89 (p < .001) for the composite patient experience. Similarly, compared with the partial PCMH group, consistently higher odds of patient satisfaction among all patient experience measures were observed for the full medical home group: OR = 1.45 (p = .070, significant at α = 0.1 level) for providers "explained things so you understood"; OR = 1.69 (p = .002) for providers "listened carefully to you"; OR = 1.57 (p = .003) for providers "spent enough time with you"; OR = 1.48 (p = .039) for providers "showed respect for what you had to say"; and OR = 1.56 (p = .001) for the composite patient experience., Conclusions: Overall, the PCMH model was associated with improved patient satisfaction nationwide. Findings from this study have shed light on strategies of innovative healthcare delivery models in improving patient experience, which in turn, may translate to patients' compliance to treatment regimen and improved health outcomes.

Background: For women who have had a previous low transverse cesarean delivery, the decision to undergo a trial of labor after cesarean (TOLAC) or an elective repeat cesarean delivery (ERCD) has important clinical and economic ramifications., Objectives: To evaluate the cost-effectiveness of the alternative choices of a TOLAC and an ERCD for women with low-risk, singleton gestation pregnancies., Methods: We searched EMBASE, MEDLINE, CINAHL, Cochrane Library, EconLit, and the Cost-Effectiveness Analysis Registry with no language, publication, or date restrictions up until October 2015. Studies were included if they were primary research, compared a TOLAC with an ERCD, and provided information on the relative cost of the alternatives. Abstracts and partial economic evaluations were excluded., Results: Of 310 studies initially reviewed, 7 studies were included in the systematic review. In the base-case analyses, 4 studies concluded that TOLAC was dominant over ERCD, 1 study found ERCD to be dominant, and 2 studies found that although TOLAC was more costly, it offered more benefits and was thus cost-effective from a population perspective when considering societal willingness to pay for better outcomes. In sensitivity analyses, cost-effectiveness was found to be dependent on a high likelihood of TOLAC success, low risk of uterine rupture, and low relative cost of TOLAC compared with ERCD., Conclusions: For women who are likely to have a successful vaginal delivery, routine ERCD may result in excess morbidity and cost from a population perspective., (Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

The evidence regarding recommendations of calorie restriction as part of a comprehensive lifestyle intervention to promote weight loss in obese older adults has remained equivocal for more than a decade. The older adult population is the fastest growing segment of the US population and a greater proportion of them are entering old age obese. These older adults require treatments based on solid evidence. Therefore the purpose of this review is three-fold: 1) to provide a more current status of the knowledge regarding recommendations of calorie restriction as part of a comprehensive lifestyle intervention to promote weight loss in obese older adults, 2) to determine what benefits and/or risks calorie restriction adds to exercise interventions in obese older adults, and 3) to consider not only outcomes related to changes in body composition, bone health, cardiometabolic disease risk, markers of inflammation, and physical function, but, also patient-centered outcomes that evaluate changes in cognitive status, quality of life, out-of-pocket costs, and mortality. Seven randomized controlled trials were identified that examined calorie restriction while controlling for exercise intervention effects. Overall, the studies found that calorie restriction combined with exercise is effective for weight loss. Evidence was mixed regarding other outcomes. The risk-benefit ratio regarding calorie restriction in older adults remains uncertain. Greater long-term follow-up is necessary, and complementary effectiveness studies are needed to identify strategies currently used by obese older adults in community settings., Competing Interests: Potential Conflicts of Interest: None, (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: To investigate whether early or regular preventive dental visit (PDV) reduces restorative or emergency dental care and costs for low-income children., Study Setting: Enrollees during 1998-2012 in the Alabama CHIP program, ALL Kids., Study Design: Retrospective cohort study using claims data for children continuously enrolled in ALL Kids for at least 4 years. Analyses are conducted separately for children 0-4 years, 4-9 years, and >9 years. For 0-4 years, the intervention of interest is whether they have at least one PDV before age 3. For the other two age groups, interventions of interest are if they have regular PDVs during each of the first 3 years, and if they have claims for a sealant in the first 3 years. Outcomes-namely restorative and emergency dental service and costs-are measured in the fourth year. To account for selection into PDV, a high-dimensional propensity scores approach is utilized., Data Extraction: Claims data were obtained from ALL Kids., Principal Findings: Only sealants are associated with a reduced likelihood of using restorative and emergency services and costs., Conclusions: Whether PDVs without sealants actually reduce restorative/emergency pediatric dental services is questionable. Further research into benefits of PDV is needed., (© Health Research and Educational Trust.)

Background: Fibrinogen repletion in patients with acquired bleeding disorders can be accomplished by transfusing cryoprecipitate AHF (cryo) or fibrinogen concentrate (FC); thus, we undertook an economic evaluation from the transfusion service perspective regarding the use of cryo vs. FC in patients with acquired bleeding., Methods: We created a model comparing the cost of cryo vs. FC from the transfusion service perspective. A patient with acquired bleeding requiring fibrinogen replacement could receive either 15-20 cryo units or 3-4 g FC, consistent with the guidelines from the European Task Force for Advanced Bleeding Care in Trauma. All model parameters were estimated from institutional experiences and the medical literature. Additionally, a survey of US Transfusion Medicine fellowship directors was conducted., Results: After adjusting for 28% wastage and technologist salary, cryo cost is $414/5-unit pool. Depending on the dose, FC is more expensive by $976-$1303. To be competitive with cryo, FC cost must decrease by 44% or be shown to save 0·25-0·66 ICU days. Of the 30 survey replies, 96·7% of US centres do not use FC for acquired bleeding with the top three reasons being cost (30%), off-label usage (27%) and insufficient evidence for usage (20%). Only 47% are willing to pay more for FC, with $437/g as the median amount., Conclusion: Fibrinogen concentrate is more expensive than cryo, even after adjusting for cryo wastage. To be economically competitive with cryo, FC must cost $414/g, or save on ICU length of stay, consistent with the survey's results., (© 2016 International Society of Blood Transfusion.)

Objective: To compare the costs between planned cesarean delivery (CD) and induction of labor (IOL) in women with class III obesity., Methods: We conducted a cost-minimization analysis using data from a previous study of women with a BMI ≥40 kg/m(2) delivering term singletons via planned CD or after IOL. Decision trees were built with branches for two "treatments": planned CD and IOL (probabilities derived from parent study). Direct and total costs were obtained for each mother-infant pair. Sensitivity analyses for probability of successful IOL were performed., Results: A total of 661 mother-infant pairs were included - 399 IOLs and 262 planned CDs. Of 399 IOLs, 236 (59%) delivered vaginally and 163 (41%) had a CD. IOL was slightly less costly. For IOL and planned CD, respectively, direct costs were $7416 versus $7474, and total costs were $11 545 versus $11 665. Sensitivity analyses indicated that IOL was the least costly strategy if the probability of vaginal delivery after IOL was >57% (0.575 for direct costs; 0.570 for total costs). There was, however, a slight cost advantage to planned CD in women with a prior cesarean., Conclusions: In women with class III obesity, IOL is less costly than planned CD if the probability of vaginal delivery after IOL in an individual patient is greater than 57%.