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1.
J Manag Care Spec Pharm ; 26(4): 562-567, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32223594

RESUMO

BACKGROUND: Prostaglandin analogs are the most effective treatment for glaucoma, a common condition among older adults. Despite the availability of generic drugs, the costs associated with these prescription drugs are rising. OBJECTIVE: To characterize Medicare prescription drug plan (PDP) formulary coverage and beneficiary out-of-pocket cost for prostaglandin analogs from 2009 to 2017 and Medicare spending on prostaglandin analogs from 2013 to 2017. METHODS: This study was a retrospective analysis. We used 2009, 2013, and 2017 Medicare PDP formulary, beneficiary cost, and pricing files to determine beneficiary first-prescription out-of-pocket costs and plan coverage (unrestricted, restricted, or not covered) of branded latanoprost 0.005%, travoprost 0.004%, bimatoprost 0.03% and 0.01%, and tafluprost 0.0015% and of generic latanoprost 0.005% and generic bimatoprost 0.03%. We also used Medicare Part D spending data to determine aggregate spend in 2013 and 2017. RESULTS: In 2009, 92% of plans covered branded latanoprost, 83% covered branded bimatoprost; and 49% covered branded travoprost, whereas in 2017, 6% of plans covered branded latanoprost; 95% covered branded bimatoprost; and 96% covered branded travoprost. Although generic latanoprost was universally covered, generic bimatoprost was only covered by 35% of plans in 2017. Median out-of-pocket cost of branded prostaglandins without generic equivalents was $35 (IQR = $29-$40) in 2009, $45 (IQR = $42-$101) in 2013, and $90 (IQR = $45-$159) in 2017. Median out-of-pocket cost of all available generic prostaglandins was $10 (IQR = $5-$33) in 2013 and $10 (IQR = $4-$15) in 2017. In 2013, Medicare spent $733 million on prostaglandin analogs; in 2017, this increased to $1.09 billion, with $943 million (86%) spent on branded prostaglandins and $148 million (14%) spent on generics. CONCLUSIONS: Medicare PDP coverage of branded prostaglandins remained stable from 2009 to 2017. While median beneficiary out-of-pocket costs associated with generic prostaglandins remained stable, those associated with branded prostaglandins increased nearly 3-fold. DISCLOSURES: Research reported in this publication was supported by National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number T35HL007649. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Shah has received research support through Mayo Clinic from the U.S. Food and Drug Administration (FDA) to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI); the Agency for Healthcare Research and Quality (U19HS024075, R01HS025164, R01HS025402, R03HS025517); and the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496, R01HL131535), National Science Foundation, and the Patient Centered Outcomes Research Institute to develop a clinical data research network. Ross has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; Medtronic and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585); the FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Blue Cross Blue Shield Association to better understand medical technology evaluation; the Centers of Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I); the Agency for Healthcare Research and Quality (R01HS022882); the National Heart, Lung and Blood Institute of the NIH (R01HS025164); and the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and the Collaboration on Research Integrity and Transparency at Yale. The other authors have nothing to disclose.

2.
Heart Rhythm ; 2020 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-32145348

RESUMO

BACKGROUND: In the CASTLE-AF trial, catheter ablation reduced the risk of death and heart failure (HF) hospitalization in patients with atrial fibrillation (AF) and HF by 40%. OBJECTIVES: The study aimed to assess the generalizability of CASTLE-AF to routine clinical practice. METHODS: Using a large US administrative database, we identified 289,831 patients with AF and HF treated with ablation (N=7,465) or medical therapy alone (N=282,366) from 1/1/2008-8/31/2018. Patients were divided into three groups based on trial eligibility: (1) eligible for CASTLE-AF; (2) failing to meet the inclusion criterion; and (3) meeting ≥1 of the exclusion criteria. Propensity score overlap weighting was used to balance ablated and drug-treated patients on 90 baseline characteristics. Cox proportional hazards regression was used to compare ablation to medical therapy for the primary outcome, a composite endpoint of all-cause mortality and HF hospitalization. RESULTS: Only 7.8% of patients would have been eligible for the trial, 91.0% failed to meet the trial inclusion criteria, and 15.5% met the exclusion criteria. Ablation was associated with a lower risk of the primary outcome in the overall cohort (hazard ratio [HR] 0.81 [0.76-0.87], p<0.001), in the trial-eligible cohort (HR 0.82 [0.70-0.96], p=0.01), and in patients who failed to meet inclusion criteria (HR 0.79 [0.73-0.86], p<0.001), but not in patients who met exclusion criteria (HR 0.97 [0.81-1.17]). The relative risk reduction was consistent regardless of whether patients had HFrEF. CONCLUSIONS: The benefit associated with ablation appears to be more modest in practice than that reported in the CASTLE-AF trial.

3.
Am J Manag Care ; 26(3): 112-117, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32181626

RESUMO

OBJECTIVES: To examine differences in the out-of-pocket costs for common generic drugs used to treat chronic conditions when individuals used their Medicare prescription drug plan (PDP) or when purchased through Walmart's generic drug discount programs (GDDPs) from 2009 to 2017. STUDY DESIGN: A retrospective analysis of Medicare PDP Formulary files and Walmart's GDDP retail drug lists from 2009 to 2017. METHODS: We identified all generic drugs used to treat chronic conditions that were on Walmart's GDDP retail drug list from 2009 to 2017. We then determined the out-of-pocket costs for each drug for each Medicare PDP and compared those costs with Walmart's GDDP cash price. RESULTS: There were 62 and 43 generic medications used to treat common chronic diseases available through Walmart's GDDP in 2009 and 2017, respectively. Across all PDPs, the median beneficiary out-of-pocket expenditure for a 30-day supply of the GDDP-available medications for chronic diseases decreased from $5.70 (interquartile range [IQR], $2.55-$7.98) in 2009 to $2.00 (IQR, $0.00-$4.00) in 2017 (P <.001) Approximately three-fifths (60.2%) of PDPs required beneficiaries to pay out-of-pocket costs higher than those of Walmart's GDDP in 2009, but only one-third (33.4%) did so in 2017. CONCLUSIONS: Although Medicare beneficiary out-of-pocket costs for commonly used generic drug prescriptions generally decreased over time, Medicare beneficiaries may still be paying more for the same drugs than they would through Walmart's GDDP. Increased generic drug price transparency, including enforcing bans on gag clauses, is needed to ensure that Medicare beneficiaries obtain drugs using the most affordable options.

4.
JAMA Netw Open ; 3(3): e200618, 2020 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-32150271

RESUMO

Importance: Despite advances in cancer treatment and cancer-related outcomes, disparities in cancer mortality remain. Lower rates of cancer prevention screening and consequent delays in diagnosis may exacerbate these disparities. Better understanding of the association between area-level social determinants of health and cancer screening may be helpful to increase screening rates. Objective: To examine the association between area deprivation, rurality, and screening for breast, cervical, and colorectal cancer in patients from an integrated health care delivery system in 3 US Midwest states (Minnesota, Iowa, and Wisconsin). Design, Setting, and Participants: In this cross-sectional study of adults receiving primary care at 75 primary care practices in Minnesota, Iowa, and Wisconsin, rates of recommended breast, cervical, and colorectal cancer screening completion were ascertained using electronic health records between July 1, 2016, and June 30, 2017. The area deprivation index (ADI) is a composite measure of social determinants of health composed of 17 US Census indicators and was calculated for all census block groups in Minnesota, Iowa, and Wisconsin (11 230 census block groups). Rurality was defined at the zip code level. Using multivariable logistic regression, this study examined the association between the ADI, rurality, and completion of cancer screening after adjusting for age, Charlson Comorbidity Index, race, and sex (for colorectal cancer only). Main Outcomes and Measures: Completion of recommended breast, cervical, and colorectal cancer screening. Results: The study cohorts were composed of 78 302 patients eligible for breast cancer screening (mean [SD] age, 61.8 [7.1] years), 126 731 patients eligible for cervical cancer screening (mean [SD] age, 42.6 [13.2] years), and 145 550 patients eligible for colorectal cancer screening (mean [SD] age, 62.4 [7.0] years; 52.9% [77 048 of 145 550] female). The odds of completing recommended screening were decreased for individuals living in the most deprived (highest ADI) census block group quintile compared with the least deprived (lowest ADI) quintile: the odds ratios were 0.51 (95% CI, 0.46-0.57) for breast cancer, 0.58 (95% CI, 0.54-0.62) for cervical cancer, and 0.57 (95% CI, 0.53-0.61) for colorectal cancer. Individuals living in rural areas compared with urban areas also had lower rates of cancer screening: the odds ratios were 0.76 (95% CI, 0.72-0.79) for breast cancer, 0.81 (95% CI, 0.79-0.83) for cervical cancer, and 0.93 (95% CI, 0.91-0.96) for colorectal cancer. Conclusions and Relevance: Individuals living in areas of greater deprivation and rurality had lower rates of recommended cancer screening, signaling the need for effective intervention strategies that may include improved community partnerships and patient engagement to enhance access to screening in highest-risk populations.

6.
Circ Cardiovasc Qual Outcomes ; 13(3): e005984, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32106704

RESUMO

BACKGROUND: The National Comprehensive Cancer Network and American Society of Clinical Oncology recommend consideration of the use of echocardiography 6 to 12 months after completion of anthracycline-based chemotherapy in at-risk populations. Assessment of BNP (B-type natriuretic peptide) has also been suggested by the American College of Cardiology/American Heart Association/Heart Failure Society of America for the identification of Stage A (at risk) heart failure patients. The real-world frequency of the use of these tests in patients after receipt of anthracycline therapy, however, has not been studied previously. METHODS AND RESULTS: In this retrospective study, using administrative claims data from the OptumLabs Data Warehouse, we identified 31 447 breast cancer and lymphoma patients (age ≥18 years) who were treated with an anthracycline in the United States between January 1, 2008 and January 31, 2018. Continuous medical and pharmacy coverage was required for at least 6 months before the initial anthracycline dose and 12 months after the final dose. Only 36.1% of patients had any type of cardiac surveillance (echocardiography, BNP, or cardiac imaging) in the year following completion of anthracycline therapy (29.7% echocardiography). Surveillance rate increased from 37.5% in 2008 to 42.7% in 2018 (25.6% in 2008 to 40.5% echocardiography in 2018). Lymphoma patients had a lower likelihood of any surveillance compared with patients with breast cancer (odds ratio, 0.79 [95% CI, 0.74-0.85]; P<0.001). Patients with preexisting diagnoses of coronary artery disease and arrhythmia had the highest likelihood of cardiac surveillance (odds ratio, 1.54 [95% CI, 1.39-1.69] and odds ratio, 1.42 [95% CI, 1.3-1.53]; P<0.001 for both), although no single comorbidity was associated with a >50% rate of surveillance. CONCLUSIONS: The majority of survivors of breast cancer and lymphoma who have received anthracycline-based chemotherapy do not undergo cardiac surveillance after treatment, including those with a history of cardiovascular comorbidities, such as heart failure.

7.
JAMA ; 2020 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-32040163

RESUMO

Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding. Results: Among 28 304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.

8.
Artigo em Inglês | MEDLINE | ID: mdl-32075810

RESUMO

INTRODUCTION: Glycemic targets and glucose-lowering regimens should be individualized based on multiple factors, including the presence of comorbidities. We examined contemporary patterns of glycemic control and use of medications known to cause hypoglycemia among adults with diabetes across age and multimorbidity. RESEARCH DESIGN AND METHODS: We retrospectively examined glycosylated hemoglobin (HbA1c) levels and rates of insulin/sulfonylurea use as a function of age and multimorbidity using administrative claims and laboratory data for adults with type 2 diabetes included in OptumLabs Data Warehouse, 1 January 2014 to 31 December 2016. Comorbidity burden was assessed by counts of any of 16 comorbidities specified by guidelines as warranting relaxation of HbA1c targets, classified as being diabetes concordant (diabetes complications or risk factors), discordant (unrelated to diabetes), or advanced (life limiting). RESULTS: Among 194 157 patients with type 2 diabetes included in the study, 45.2% had only concordant comorbidities, 30.6% concordant and discordant, 2.7% only discordant, and 13.0% had ≥1 advanced comorbidity. Mean HbA1c was 7.7% among 18-44 year-olds versus 6.9% among ≥75 year-olds, and was higher among patients with comorbidities: 7.3% with concordant only, 7.1% with discordant only, 7.1% with concordant and discordant, and 7.0% with advanced comorbidities compared with 7.4% among patients without comorbidities. The odds of insulin use decreased with age (OR 0.51 (95% CI 0.48 to 0.54) for age ≥75 vs 18-44 years) but increased with accumulation of concordant (OR 5.50 (95% CI 5.22 to 5.79) for ≥3 vs none), discordant (OR 1.72 (95% CI 1.60 to 1.86) for ≥3 vs none), and advanced (OR 1.45 (95% CI 1.25 to 1.68) for ≥2 vs none) comorbidities. Conversely, sulfonylurea use increased with age (OR 1.36 (95% CI 1.29 to 1.44) for age ≥75 vs 18-44 years) but decreased with accumulation of concordant (OR 0.76 (95% CI 0.73 to 0.79) for ≥3 vs none), discordant (OR 0.70 (95% CI 0.64 to 0.76) for ≥3 vs none), but not advanced (OR 0.86 (95% CI 0.74 to 1.01) for ≥2 vs none) comorbidities. CONCLUSIONS: The proportion of patients achieving low HbA1c levels was highest among older and multimorbid patients. Older patients and patients with higher comorbidity burden were more likely to be treated with insulin to achieve these HbA1c levels despite potential for hypoglycemia and uncertain long-term benefit.

9.
JAMA Netw Open ; 3(1): e1919099, 2020 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-31922562

RESUMO

Importance: Severe hypoglycemia is a serious and potentially preventable complication of diabetes, with some of the most severe episodes requiring emergency department (ED) care or hospitalization. A variety of health conditions increase the risk of hypoglycemia. People with diabetes often have multiple comorbidities, and the association of such multimorbidity with hypoglycemia risk in the context of other risk factors is uncertain. Objective: To examine the associations of age, cumulative multimorbidity, glycated hemoglobin (HbA1c) level, and use of glucose level-lowering medication with hypoglycemia-related ED visits and hospitalizations. Design, Setting, and Participants: Cohort study of claims and laboratory data from OptumLabs Data Warehouse, an administrative claims database of commercially insured and Medicare Advantage beneficiaries in the United States. Participants were adults (aged ≥18 years) with diabetes who had an available HbA1c level result in 2015. Data from January 1, 2014, to December 31, 2016, were analyzed. Final analyses were conducted from December 2017 to September 2018. Main Outcomes and Measures: This study calculated rates of hypoglycemia-related ED visits and hospitalizations during the year after the index HbA1c level was obtained, stratified by patient demographic characteristics, diabetes type, comorbidities (from 16 guideline-specified high-risk conditions), index HbA1c level, and glucose level-lowering medication use. The association of each variable with hypoglycemia-related ED and hospital care was examined using multivariable Poisson regression analysis overall and by diabetes type. Results: The study cohort was composed of 201 705 adults with diabetes (mean [SD] age, 65.8 [12.1] years; 102 668 [50.9%] women; 118 804 [58.9%] white; mean [SD] index HbA1c level, 7.2% [1.5%]). Overall, there were 9.06 (95% CI, 8.64-9.47) hypoglycemia-related ED visits and hospitalizations per 1000 persons per year. The risk of hypoglycemia-related ED visits and hospitalizations was increased by age 75 years or older (incidence rate ratio [IRR], 1.56 [95% CI, 1.23-2.02] vs 18-44 years), black race/ethnicity (IRR, 1.30 [95% CI, 1.16-1.46] vs white race/ethnicity), lower annual household income (IRR, 0.63 [95% CI, 0.53-0.74] for ≥$100 000 vs <$40 000), number of comorbidities (increasing from IRR of 1.66 [95% CI, 1.42-1.95] in the presence of 2 comorbidities to IRR of 4.12 [95% CI, 3.07-5.51] with ≥8 comorbidities compared with ≤1), prior hypoglycemia-related ED visit or hospitalization (IRR, 6.60 [95% CI, 5.77-7.56]), and glucose level-lowering treatment regimen (IRR, 6.73 [95% CI, 4.93-9.22] for sulfonylurea; 12.53 [95% CI, 8.90-17.64] for basal insulin; and 27.65 [95% CI, 20.32-37.63] for basal plus bolus insulin compared with other medications). Independent of these factors, having type 1 diabetes was associated with a 34% increase in the risk of hypoglycemia-related ED visits or hospitalizations (IRR, 1.34 [95% CI, 1.15-1.55]). The index HbA1c level was associated with hypoglycemia-related ED visits and hospitalizations when both low (IRR, 1.45 [95% CI, 1.12-1.87] for HbA1c level ≤5.6% vs 6.5%-6.9%) and high (IRR, 1.24 [95% CI, 1.02-1.50] for HbA1c level ≥10%). Conclusions and Relevance: In this cohort study of adults with diabetes, the risk of an ED visit or hospitalization for hypoglycemia appeared to be highest among patients with type 1 diabetes, multiple comorbidities, prior severe hypoglycemia, and sulfonylurea and/or insulin use. At-risk patients may benefit from individualized treatment regimens to decrease their risk of hypoglycemia.

10.
Am Heart J ; 219: 31-36, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31710842

RESUMO

BACKGROUND: A deep learning algorithm to detect low ejection fraction (EF) using routine 12-lead electrocardiogram (ECG) has recently been developed and validated. The algorithm was incorporated into the electronic health record (EHR) to automatically screen for low EF, encouraging clinicians to obtain a confirmatory transthoracic echocardiogram (TTE) for previously undiagnosed patients, thereby facilitating early diagnosis and treatment. OBJECTIVES: To prospectively evaluate a novel artificial intelligence (AI) screening tool for detecting low EF in primary care practices. DESIGN: The EAGLE trial is a pragmatic two-arm cluster randomized trial (NCT04000087) that will randomize >100 clinical teams (i.e., clusters) to either intervention (access to the new AI screening tool) or control (usual care) at 48 primary care practices across Minnesota and Wisconsin. The trial is expected to involve approximately 400 clinicians and 20,000 patients. The primary endpoint is newly discovered EF ≤50%. Eligible patients will include adults who undergo ECG for any reason and have not been previously diagnosed with low EF. Data will be pulled from the EHR, and no contact will be made with patients. A positive deviance qualitative study and a post-implementation survey will be conducted among select clinicians to identify facilitators and barriers to using the new screening report. SUMMARY: This trial will examine the effectiveness of the AI-enabled ECG for detection of asymptomatic low EF in routine primary care practices and will be among the first to prospectively evaluate the value of AI in real-world practice. Its findings will inform future implementation strategies for the translation of other AI-enabled algorithms.

11.
Cancer ; 126(4): 757-764, 2020 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-31714588

RESUMO

BACKGROUND: Prior studies in oncology have shown that a higher annual facility patient volume is associated with reduced mortality. Because classic Hodgkin lymphoma is uncommon but highly curable, this study used the National Cancer Database (2003-2014) to analyze whether such a relationship exists for this disease. METHODS: The facilities were classified by quartiles, and random intercepts were used to account for clustering of patients within facilities. A Cox regression model was used to determine the volume-outcome relationship. RESULTS: There were 47,633 patients with classic Hodgkin lymphoma treated at 1310 facilities. The first quartile (Q1), which included 58.4% of the facilities, treated 3 or fewer patients per year, whereas the fourth quartile (Q4), which included 5.9% of the facilities, treated more than 9 patients per year. Compared with the patients treated at Q4 facilities, those treated at lower quartile facilities had a higher risk of death (hazard ratio for the third quartile [HR], 1.19; 95% confidence interval [CI], 1.1-1.29; HR for the second quartile, 1.28; 95% CI, 1.19-1.38; HR for Q1, 1.29; 95% CI, 1.2-1.39) after adjustments for all other factors (P < .0001). Compared with facilities treating 10 patients per year, facilities treating 40 patients per year had approximately 27% lower overall mortality rates. CONCLUSIONS: Patients with classic Hodgkin lymphoma treated at high-volume centers had lower overall mortality than those treated at lower volume centers. Because this is a highly curable malignancy, such differences may suggest a benefit from referral to higher volume facilities or the emulation of their care models.

12.
Urology ; 136: 105-111, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31715273

RESUMO

OBJECTIVE: To evaluate temporal trends in prescriptions for extended-duration pharmacologic prophylaxis (EDPP) intended to prevent venous thromboembolism following radical cystectomy (RC). MATERIALS AND METHODS: We used OptumLabs Data Warehouse, a national administrative claims database, to identify patients undergoing RC for bladder cancer from 2012 to 2017. Rates of outpatient prescriptions for EDPP following RC were assessed, and rate over time was evaluated using the Cochran-Armitage test for trend. Multivariable logistic regression was used to examine associations between clinical and practice-level characteristics with EDPP prescriptions. RESULTS: A total of 2054 patients were identified, including 386 (19%) who received an EDPP prescription. The rate of EDPP prescriptions increased significantly over the study period, from 9% of cases in 2012 to 26% of cases in 2017 (P <.001). On multivariable logistic regression, age <65 (OR 1.79, 95% CI 1.39-2.33; P <.001), receipt of neoadjuvant chemotherapy (OR 1.33, 95% CI 1.04-1.71; P = .02), more recent procedure year (OR 4.11, 95% CI 2.35-7.18; P <.001), treatment in a public as compared to a for-profit hospital (OR 3.38, 95% CI 1.31-8.74; P = .01), and treatment at a hospital with residency training (OR 4.45, 95% CI 1.26-15.7; P = .02) or a surgical robot (OR 3.44, 95% CI 1.31-9.08; P = .01) were significantly associated with increased odds of receiving EDPP. CONCLUSION: EDPP following RC has increased over time, but is still provided for only a minority of patients. These data may be useful for guiding quality improvement efforts given recent literature supporting the use of EDPP.


Assuntos
Anticoagulantes/administração & dosagem , Cistectomia , Complicações Pós-Operatórias/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Idoso , Estudos de Coortes , Cistectomia/métodos , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
13.
J Natl Cancer Inst ; 112(1): 111-113, 2020 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-31613369

RESUMO

Breast cancer survivorship guidelines recommend at least annual follow-up visits, yet the degree to which this occurs in clinical practice is uncertain. Claims data from a US commercial insurance database (OptumLabs) were used to identify women treated with curative intent surgery for newly diagnosed breast cancer between 2006 and 2014. In 25 035 women, median follow-up was 3 years. In the second year after surgery, 9.6% of the patients did not visit a primary care provider, an oncologist, or a surgeon (guideline-nonadherent). The guideline-nonadherent proportion increased from 7.8% in women diagnosed in 2006 to 12.2% in those diagnosed in 2014 (two-sided Wald P < .001). During years 2-6, guideline-nonadherence was also associated with older age, nonwhite race, no radiation, no chemotherapy, no endocrine therapy, and increasing time after surgery. There is a substantial and increasing rate of inadequate follow-up among breast cancer survivors. This has the potential to impair outcomes.

14.
Clin Gastroenterol Hepatol ; 18(2): 337-346.e19, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31108228

RESUMO

BACKGROUND & AIMS: The safety of different antithrombotic strategies for patients with 1 or more indication for antithrombotic drugs has not been determined. We investigated the risk and time frame for gastrointestinal bleeding (GIB) in patients prescribed different antithrombotic regimens. We proposed that risk would increase over time and with combination regimens, especially among elderly patients. METHODS: We performed a retrospective analysis of nationwide claims data from privately insured and Medicare Advantage enrollees who received anticoagulant and/or antiplatelet agents from October 1, 2010, through May 31, 2017. Patients were stratified by their prescriptions (anticoagulant alone, antiplatelet alone, or a combination) and by their primary diagnosis (atrial fibrillation, ischemic heart disease, or venous thromboembolism). The 1-year GIB risk was estimated using parametric time-to-event survival models and expressed as annualized risk and number needed to harm (NNH). RESULTS: Our final analysis included 311,211 patients (mean ages, 67 years for monotherapy and 69.8 years for combination antithrombotic therapy). There was no significant difference in the proportion of patients with bleeding after anticoagulant or antiplatelet monotherapy (∼3.5%/year). Combination antithrombotic therapy increased GIB risk compared with anticoagulant (NNH, 29) or antiplatelet (NNH, 31) monotherapy, regardless of the patients' diagnosis or time point analyzed. Advancing age was associated with increasing 1-year probability of GIB. Patients prescribed combination therapy were at the greatest risk for GIB, especially after the age of 75 years (GIB occurred in 10%-17.5% of patients/y). CONCLUSIONS: In an analysis of nationwide insurance and Medicare claims data, we found GIB to occur in a higher proportion of patients prescribed combinations of anticoagulant and antiplatelet agents compared with monotherapy. Among all drug exposure categories and cardiovascular conditions, the risk of GIB increased with age, especially among patients older than 75 years.

15.
J Allergy Clin Immunol Pract ; 8(2): 549-554.e1, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31472294

RESUMO

BACKGROUND: From 2003 to 2015, only 1 biologic was approved for the treatment of moderate to severe asthma in the United States. Since 2015, 4 new asthma biologics were approved by the US Food and Drug Administration. OBJECTIVE: To describe trends and disparities of asthma biologic use in the United States from 2003 to 2018. METHODS: We conducted a retrospective analysis using a cohort developed from the OptumLabs Data Warehouse. Prevalent and incident asthma biologic users were identified, and characteristics of users and nonusers were analyzed using regression analysis. Clinician prescribing behavior was described. RESULTS: Use of biologic medications remains uncommon among individuals with asthma, with prevalence peaking in 2006 at 3 in 1000 individuals with asthma. Several factors are associated with a higher likelihood of asthma biologic use: middle age, higher income, commercial insurance, and access to a specialist. Most clinicians (65%) in the cohort prescribed only 1 biologic. CONCLUSIONS: We report low overall use of asthma biologics and evidence of disparities in access to asthma biologics.

16.
Health Expect ; 23(1): 63-74, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31758633

RESUMO

OBJECTIVE: To test the hypotheses that use of the Head CT Choice decision aid would be similarly effective in all parent/patient dyads but parents with high (vs low) numeracy experience a greater increase in knowledge while those with low (vs high) health literacy experience a greater increase in trust. METHODS: This was a secondary analysis of a cluster randomized trial conducted at seven sites. One hundred seventy-two clinicians caring for 971 children at intermediate risk for clinically important traumatic brain injuries were randomized to shared decision making facilitated by the DA (n = 493) or to usual care (n = 478). We assessed for subgroup effects based on patient and parent characteristics, including socioeconomic status (health literacy, numeracy and income). We tested for interactions using regression models with indicators for arm assignment and study site. RESULTS: The decision aid did not increase knowledge more in parents with high numeracy (P for interaction [Pint ] = 0.14) or physician trust more in parents with low health literacy (Pint  = 0.34). The decision aid decreased decisional conflict more in non-white parents (decisional conflict scale, -8.14, 95% CI: -12.33 to -3.95; Pint  = 0.05) and increased physician trust more in socioeconomically disadvantaged parents (trust in physician scale, OR: 8.59, 95% CI: 2.35-14.83; Pint  = 0.04). CONCLUSIONS: Use of the Head CT Choice decision aid resulted in less decisional conflict in non-white parents and greater physician trust in socioeconomically disadvantaged parents. Decision aids may be particularly effective in potentially vulnerable parents.

17.
JACC Heart Fail ; 8(1): 43-54, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31838035

RESUMO

OBJECTIVES: This paper aims to compare the effectiveness of sacubitril-valsartan and angiotensin-converting enzyme inhibitor (ACE)/angiotensin receptor blocker (ARB) in systolic heart failure (HF). BACKGROUND: Sacubitril-valsartan reduced risks of death and hospitalization for HF versus enalapril in ambulatory patients with HF and reduced ejection fraction in the PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor with Angiotensin Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in HF) trial. However, the comparative effectiveness of sacubitril-valsartan and ACE/ARB in patients treated in routine clinical practice is unclear. METHODS: We identified patients with systolic HF in a U.S. administrative claims database treated with sacubitril-valsartan or ACE/ARB from July 1, 2015, to February 2, 2018. One-to-one propensity score matching was used to balance patients on 29 clinical variables. Cox models were used to compare outcomes between treatment groups. RESULTS: A total of 7,893 matched pairs were included; mean (SD) follow-up was 6.3 (5.4) months. Sacubitril-valsartan was associated with lower risks of all-cause mortality or all-cause hospitalization (hazard ratio [HR]: 0.86, 95% confidence interval (CI): 0.81 to 0.91; p < 0.001), all-cause mortality (HR: 0.80, 95% CI: 0.66 to 0.97; p = 0.027), and all-cause hospitalization (HR: 0.86, 95% CI: 0.80 to 0.91; p < 0.001), but not HF hospitalization (HR: 1.07, 95% CI: 0.96 to 1.19; p = 0.26). A lower risk of the primary outcome with sacubitril-valsartan was observed in white patients (HR: 0.83, 95% CI: 0.76 to 0.90) but not black patients (21% of population, HR: 1.00, 95% CI: 0.88 to 1.15; interaction p = 0.032). No statistically significant differences in treatment response by sex or age were observed. CONCLUSIONS: Sacubitril-valsartan was associated with lower risks of death and hospitalization compared with ACE/ARB in a heterogeneous cohort of patients with systolic HF. However, our finding that outcomes with sacubitril-valsartan and ACE/ARBs were similar in black patients warrants further evaluation.

18.
Eur Urol Focus ; 6(2): 273-279, 2020 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-30219709

RESUMO

BACKGROUND: Magnetic resonance imaging (MRI) of the prostate and fusion biopsy have been advanced to improve the detection of clinically significant prostate cancer (PCa). Yet, frequency of their use and contemporary attitudes among radiation oncologists (ROs) and urologists (UROs) remain largely unknown. OBJECTIVE: We performed a national survey of UROs and ROs to assess the perceived attitudes towards and frequency of prostate MRI and fusion biopsy. DESIGN, SETTING, AND PARTICIPANTS: We conducted a national survey of 915 ROs and 940 UROs about prostate MRI and fusion biopsy in 2017. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The survey queried respondents about perceptions of prostate MRI and fusion biopsy and inquired about self-reported utilization. Pearson chi-square test and multivariable logistic regression were used to identify physician characteristics associated with survey responses. RESULTS AND LIMITATIONS: The overall response rate was 37% (n=691). Both UROs and ROs demonstrated similar positive views that MRI with fusion biopsy improves PCa risk stratification (67% vs 71%; p=0.19) and fusion biopsy increases the confidence recommending active surveillance (55% vs 60%; p=0.18). Yet, only a quarter of both specialties reported frequent use of prostate MRI for treatment decisions for low- and intermediate-risk PCa. Compared with respondents practicing in community practices, those in academic practices were more likely to report using prostate MRI for low- (44% vs 19%; adjusted odds ratio [OR]: 3.96; p<0.001) and intermediate-risk PCa (42% vs 24%; adjusted OR: 2.49; p<0.001). Our study was limited by a modestly lower response rate. CONCLUSIONS: While both specialties have perceived value in favor of prostate MRI and fusion biopsy, only a quarter of respondents report their use in clinical practice. Physicians practicing in academic medical centers had greater self-reported use. PATIENT SUMMARY: Magnetic resonance imaging of the prostate and targeted biopsies have growing evidence of their use as a superior diagnostic methodology for prostate cancer diagnosis and treatment decisions. Our survey study found that a majority of radiation oncologists and urologists view both favorably in improving prostate cancer detection and treatment decisions. Yet, only a quarter report using it in routine clinical practice for men diagnosed with prostate cancer.

19.
Med Care ; 58(1): 4-12, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31651743

RESUMO

OBJECTIVE: Experts cautioned that patients affected by the November 2010 withdrawal of the opioid analgesic propoxyphene might receive riskier prescriptions. To explore this, we compared drug receipts and outcomes among propoxyphene users before and aftermarket withdrawal. STUDY DESIGN: Using OptumLabs data, we studied 3 populations: commercial, Medicare Advantage (MA) aged (age 65+ y) and MA disabled (age below 65 y) enrollees. The exposed enrollees received propoxyphene in the 3 months before market withdrawal (n=13,622); historical controls (unexposed) received propoxyphene 1 year earlier (n=9971). Regression models estimated daily milligrams morphine equivalent (MME), daily prescription acetaminophen dose, potentially toxic acetaminophen doses, nonopioid prescription analgesics receipt, emergency room visits, and diagnosed falls, motor vehicle accidents, and hip fractures. PRINCIPAL FINDINGS: Aged MA enrollees illustrate the experience of all 3 populations examined. Following the market withdrawal, propoxyphene users in the exposed cohort experienced an abrupt decline of 69% in average daily MME, compared with a 14% decline in the unexposed. Opioids were discontinued by 34% of the exposed cohort and 18% of the unexposed. Tramadol and hydrocodone were the most common opioids substituted for propoxyphene. The proportion of each group receiving ≥4 g of prescription acetaminophen per day decreased from 12% to 2% in the exposed group but increased from 6% to 8% among the unexposed. Adverse events were rare and not significantly different in exposed versus unexposed groups. CONCLUSIONS: After propoxyphene market withdrawal, many individuals experienced abrupt discontinuation of opioids. Policymakers might consider supporting appropriate treatment transitions and monitoring responses following drug withdrawals.

20.
J Gen Intern Med ; 2019 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-31792867

RESUMO

BACKGROUND: People with chronic kidney disease (CKD) are at risk for adverse events and/or CKD progression with use of renally eliminated or nephrotoxic medications. OBJECTIVE: To examine the prevalence of potentially inappropriate medication (PIM) use by U.S. adults by CKD stage and self-reported CKD awareness. DESIGN: Cross-sectional analysis of National Health and Nutrition Examination Surveys, 2011-2016 PARTICIPANTS: Non-pregnant adults with stages 3a (eGFR 45-59 mL/min/1.73 m2), 3b (eGFR 30-44), or 4-5 (eGFR < 30) CKD, stratified as CKD-aware/unaware. MAIN MEASURES: PIMs were identified on the basis of KDIGO guidelines, label information, and literature review. We calculated proportions using any and individual PIMs, assessing for differences over CKD awareness within each CKD stage. Analyses were adjusted for age, sex, race/ethnicity, education, comorbidities, and insurance type. KEY RESULTS: Adjusted proportions of U.S. adults taking any PIM(s) exceeded 50% for all CKD stages and awareness categories, and were highest among CKD-unaware patients with stages 4-5 CKD: 66.6% (95% CI, 55.5-77.8). Proton pump inhibitors, opioids, metformin, sulfonylureas, and non-steroidal anti-inflammatory drugs (NSAIDs) were all used frequently across CKD stages. NSAIDs were used less frequently when CKD-aware by patients with stage 3a CKD (2.2% [95% CI, - 0.3 to 4.7] vs. 10.7% [95% CI, 7.6 to 13.8]) and stages 4-5 CKD (0.8% [95% CI, - 0.9 to 2.5] vs. 16.5% [95% CI, 4.0 to 29.0]). Metformin was used less frequently when CKD-aware by patients with stage 3b CKD (8.1% [95% CI, 0.3-15.9] vs. 26.5% [95% CI, 17.4-35.7]) and stages 4-5 CKD (none vs. 20.8% [95% CI, 1.8-39.8]). The impact of CKD awareness was statistically significant after correction for multiple comparisons only for NSAIDs in stage 3a CKD. CONCLUSIONS: PIMs are frequently used by people with CKD, with some impact of CKD awareness on NSAID and metformin use. This may lead to adverse outcomes or hasten CKD progression, reinforcing the need for improved medication management among people with CKD.

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