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1.
Circ Cardiovasc Qual Outcomes ; 13(2): e005871, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32063041

RESUMO

BACKGROUND: Previous provider-directed electronic messaging interventions have not by themselves improved anticoagulation use in patients with atrial fibrillation. Direct engagement with providers using academic detailing coupled with electronic messaging may overcome the limitations of the prior interventions. METHODS AND RESULTS: We randomized outpatient providers affiliated with our health system in a 2.5:1 ratio to our electronic profiling/messaging combined with academic detailing intervention. In the intervention, we emailed providers monthly reports of their anticoagulation percentage relative to peers for atrial fibrillation patients with elevated stroke risk (CHA2DS2-VASc ≥2). We also sent electronic medical record-based messages shortly before an appointment with an anticoagulation-eligible but untreated atrial fibrillation patient. Providers had the option to send responses with explanations for prescribing decisions. We also offered to meet with intervention providers using an academic detailing approach developed based on knowledge gaps discussed in provider focus groups. To assess feasibility, we tracked provider review of our messages. To assess effectiveness, we measured the change in anticoagulation for patients of intervention providers relative to controls. We identified 85 intervention and 34 control providers taking care of 3591 and 1908 patients, respectively; 33 intervention providers participated in academic detailing. More than 80% of intervention providers read our emails, and 98% of the time a provider reviewed our in-basket messages. Replies to messages identified patient refusal as the most common reason for patients not being on anticoagulation (11.2%). For the group of patients not on anticoagulation at baseline assigned to an intervention versus control provider, the adjusted percent increase in the use of anticoagulation over 6 months was 5.2% versus 7.4%, respectively (P=0.21). CONCLUSIONS: Our electronic messaging and academic detailing intervention was feasible but did not increase anticoagulation use. Patient-directed interventions or provider interventions targeting patients declining anticoagulation may be necessary to raise the rate of anticoagulation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03583008.

2.
Eur Radiol ; 2020 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-32020398

RESUMO

OBJECTIVES: To compare interreader agreement and diagnostic accuracy of LI-RADS v2018 categorization using quantitative versus qualitative MRI assessment of arterial phase hyperenhancement (APHE) and washout (WO) of focal liver lesions. METHODS: Sixty patients (19 female; mean age, 56 years) at risk for HCC with 71 liver lesions (28 HCCs, 43 benign) who underwent contrast-enhanced MRI were included in this retrospective study. Four blinded radiologists independently assigned a qualitative LI-RADS score per lesion. Two other radiologists placed ROIs within the lesion, adjacent liver parenchyma, and paraspinal musculature on pre- and post-contrast MR images. The percentage of arterial enhancement and the liver-to-lesion contrast ratio were calculated for quantification of APHE and WO. Using these quantitative parameters, a quantitative LI-RADS score was assigned. Interreader agreement and AUCs were calculated. RESULTS: Interreader agreement was similar for qualitative and quantitative LI-RADS (κ = 0.38 vs. 0.40-0.47) with a tendency towards improved agreement for quantitatively assessed APHE (κ = 0.65 vs. 0.81) and WO (κ = 0.53 vs. 0.78). Qualitative LI-RADS showed an AUC of 0.86, 0.94, 0.94, and 0.91 for readers 1, 2, 3, and 4, respectively. The quantitative LI-RADS score where APHE/WO/or both were replaced showed an AUC of 0.89/0.84/0.89, 0.95/0.92/0.92, 0.93/0.91/0.89, and 0.91/0.86/0.88 for readers 1, 2, 3, and 4, respectively. Sensitivity of LR-4/5 slightly increased, while specificity slightly decreased using quantitative APHE. CONCLUSION: Qualitative and quantitative LI-RADS showed similar performance. Quantitatively assessed APHE showed the potential to increase interreader agreement and sensitivity of HCC diagnosis, whereas quantitatively assessed WO had the opposite effect and needs to be redefined. KEY POINTS: • Quantitative assessment of arterial phase hyperenhancement shows the potential to increase interreader agreement and sensitivity to diagnose hepatocellular carcinoma. • Adding quantitative measurements of major LI-RADS features does not improve accuracy over qualitative assessment alone according to the LI-RADS v2018 algorithm.

3.
Health Aff (Millwood) ; 39(2): 280-288, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32011952

RESUMO

Ambulatory antibiotic stewardship policies focus on prescribing decisions made when patients present to clinicians with possible infections. They do not capture antibiotics prescribed outside of clinician visits or without clear indications for use. Antibiotic prescribing for vulnerable patients in the US has not been comprehensively measured. We measured the frequency with which all filled antibiotic prescriptions were associated with infections and in-person visits for Medicaid patients in the period 2004-13. We found that among 298 million antibiotic fills (62 percent for children) for 53 million patients, 55 percent were for clinician visits with an infection-related diagnosis, 17 percent were for clinician visits without an infection-related diagnosis, and 28 percent were not associated with a visit. Non-visit-based antibiotic prescriptions were less common for children than for adults and more common in the West than in other US regions. Large fractions of antibiotic prescriptions are filled without evidence of infection-related diagnoses or accompanying clinician visits. Current ambulatory antibiotic stewardship policies miss about half of antibiotic prescribing.

5.
Curr Diab Rep ; 19(12): 140, 2019 Nov 21.
Artigo em Inglês | MEDLINE | ID: mdl-31754838

RESUMO

PURPOSE OF REVIEW: Educating clinicians on how to improve the medical management of type 2 diabetes in the modern pharmacologic era represents an enormous challenge given the number of medications available and the diversity across guideline recommendations. Academic detailing uses active social marketing techniques to deliver in-office, face-to-face educational encounters between a trained clinical educator (academic detailer) and a primary care clinician and can improve the quality of prescribing and management decisions, leading to better patient outcomes. RECENT FINDINGS: This updated review provides context on how academic detailing programs can improve diabetes-related clinical knowledge and practice among primary care providers, incorporating the perspective of a field-based academic detailer. It also profiles 4 diabetes-specific academic detailing programs varying in geographic scope and detailing approach, based in Massachusetts, Pennsylvania, Vermont, and Saskatchewan Province (Canada). Academic detailing can effectively overcome challenges to increasing the evidence-based use of newer glucose-lowering medications in primary care settings.

6.
J Manag Care Spec Pharm ; 25(11): 1210-1224, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31663459

RESUMO

BACKGROUND: Step therapy policies that require prescribers to follow an ordered protocol for drug choices are widely used by public and private insurers to manage medication costs; however, the perceptions of prescribing physicians regarding these policies have not been studied. OBJECTIVE: To determine physician attitudes toward step therapy policies and the correlation of these beliefs with physician characteristics. METHODS: A sample of clinically active physicians specializing in internal medicine, cardiology, or endocrinology received a survey administered online or via mail. Five-point Likert scale questions assessed physicians' opinions of clinical, economic, and implementation elements of prior authorization policies; physician demographic characteristics; and the extent of their interactions with the pharmaceutical industry. RESULTS: 686 physicians (48%) responded to the survey, which was evenly divided among primary care physicians, endocrinologists, and cardiologists. Many respondents (70%) had interactions with industry, including receipt of meals or gifts and use of medication samples. Physicians reported that step therapy policies could improve the affordability of medication use (55% agree vs. 26% disagree) and its clinical appropriateness (59% agree vs. 19% disagree). By similar margins, however, physicians stated that step therapy policies were implemented inefficiently and inflexibly and often did not incorporate relevant patient-specific information. Physicians in subspecialties, especially endocrinology, and those who had interactions with the pharmaceutical industry were more likely to hold negative views of step therapy policies. CONCLUSIONS: Most physicians recognize the potential of step therapy to improve the quality and cost-effectiveness of prescribing, although interactions with industry may affect these opinions. Physician perception of ineffective implementation of these policies, however, undermines their acceptability. DISCLOSURES: The American Board of Internal Medicine (ABIM) funded the survey used in this study. The ABIM had no role in the design and conduct of the study or development and preparation of the manuscript. Survey honoraria was provided by the Consumers Union. Kesselheim and Avorn's work is funded by the Laura and John Arnold Foundation. Kesselheim is also supported by the Harvard-MIT Center for Regulatory Science, Arnold Ventures, and the Engelberg Foundation. Ross is employed by the ABIM. Fischer, Lu, and Tessema have nothing to disclose.

7.
8.
Semin Arthritis Rheum ; 49(3): 389-395, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31280938

RESUMO

BACKGROUND: Patients with systemic lupus erythematosus (SLE) have a similar risk of myocardial infarction as those with diabetes mellitus (DM). Whether the risk of heart failure (HF) in SLE is similar to the elevated risk in DM is unknown. We sought to estimate the rates and risks for HF hospitalization among US Medicaid patients with SLE and to compare them to those for DM and the general Medicaid population. METHODS: Using U.S. Medicaid data from 2007-2010, we identified patients with SLE or DM, and a matched cohort from the general Medicaid population and calculated incidence rates (IR), incidence rate ratios (IRR) and adjusted hazard ratios (HR) of a first HF hospitalization. RESULTS: We identified 37,902 SLE (93% female, mean age 40.1 ±â€¯12.1), 76,657 DM (93% female, mean age 40.0 ±â€¯12.1), and 158,695 general Medicaid patients (93% female, mean age 40.2 ±â€¯12.1). The IR per 1000-person years was 6.9 (95% CI 6.3-7.5) for SLE, 6.6 (95% CI 6.2-7.0) for DM, and 1.6 (95% CI 1.5-1.8) for general Medicaid patients. The highest IRR compared to general Medicaid was seen among SLE patients in age group 18-39 (14.7, 95% CI 13.9-15.5). Multivariable-adjusted HRs for HF compared to general Medicaid population were similar for SLE (2.7, 95% CI 2.3-3.1) and DM (3.0, 95% CI 2.6-3.4). CONCLUSION: The incidence of HF among SLE patients was 2.7-fold higher than general Medicaid patients, and similar to DM. Further investigation into the biologic mechanism of HF among SLE compared to non-SLE and DM patients may shed light on the findings of this study.

10.
BMJ Qual Saf ; 28(10): 835-842, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31243156

RESUMO

BACKGROUND: Clinical guidelines recommend anticoagulation for patients with atrial fibrillation (AF) at high risk of stroke; however, studies report 40% of this population is not anticoagulated. OBJECTIVE: To evaluate a population health intervention to increase anticoagulation use in high-risk patients with AF. METHODS: We used machine learning algorithms to identify patients with AF from electronic health records at high risk of stroke (CHA2DS2-VASc risk score ≥2), and no anticoagulant prescriptions within 12 months. A clinical pharmacist in the anticoagulation service reviewed charts for algorithm-identified patients to assess appropriateness of initiating an anticoagulant. The pharmacist then contacted primary care providers of potentially undertreated patients and offered assistance with anticoagulation management. We used a stepped-wedge design, evaluating the proportion of potentially undertreated patients with AF started on anticoagulant therapy within 28 days for clinics randomised to intervention versus usual care. RESULTS: Of 1727 algorithm-identified high-risk patients with AF in clinics at the time of randomisation to intervention, 432 (25%) lacked evidence of anticoagulant prescriptions in the prior year. After pharmacist review, only 17% (75 of 432) of algorithm-identified patients were considered potentially undertreated at the time their clinic was randomised to intervention. Over a third (155 of 432) were excluded because they had a single prior AF episode (transient or provoked by serious illness); 36 (8%) had documented refusal of anticoagulation, the remainder had other reasons for exclusion. The intervention did not increase new anticoagulant prescriptions (intervention: 4.1% vs usual care: 4.0%, p=0.86). CONCLUSIONS: Algorithms to identify underuse of anticoagulation among patients with AF in healthcare databases may not capture clinical subtleties or patient preferences and may overestimate the extent of undertreatment. Changing clinician behaviour remains challenging.

11.
PLoS Med ; 16(3): e1002763, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30865626

RESUMO

BACKGROUND: To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing brand-name and generic drugs are susceptible to bias favoring the brand-name drugs. We used authorized generic (AG) products, which are identical in composition and appearance to brand-name products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus brand medications. METHODS AND FINDINGS: For commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004-2013) and (2) Truven MarketScan (years: 2003-2015). For a total of 8 drug products, the following groups were compared using a cohort study design: (1) patients switching from brand-name products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied brand-name use, addressing negative perception bias, and (2) patients initiating generic versus brand-name products (bias-prone direct comparison) and patients initiating AG versus brand-name products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine brand-name: HR [95% CI] 0.92 [0.88-0.97]). The comparison between generic and brand-name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus brand-name products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84-0.99] and 0.84 [0.76-0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01-1.10] and 1.07 [1.01-1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to brand-name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98-1.13] and 1.11 [1.05-1.18], respectively), suggesting that the differences observed between brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from brand products to generics. CONCLUSIONS: In this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.


Assuntos
Bases de Dados Factuais/tendências , Uso de Medicamentos/tendências , Medicamentos Genéricos/uso terapêutico , Revisão da Utilização de Seguros/tendências , Seguro Saúde/tendências , Idoso , Citalopram/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores de Captação de Serotonina/uso terapêutico , Sertralina/uso terapêutico , Resultado do Tratamento , Estados Unidos/epidemiologia
12.
BMC Med Imaging ; 19(1): 17, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30767773

RESUMO

BACKGROUND: The clinical and research value of Computed Tomography (CT) volumetry of esophageal cancer tumor size remains controversial. Development in CT technique and image analysis has made CT volumetry less cumbersome and it has gained renewed attention. The aim of this study was to assess esophageal tumor volume by semi-automatic measurements as compared to manual. METHODS: A total of 23 esophageal cancer patients (median age 65, range 51-71), undergoing CT in the portal-venous phase for tumor staging, were retrospectively included between 2007 and 2012. One radiology resident and one consultant radiologist measured the tumor volume by semiautomatic segmentation and manual segmentation. Reproducibility of the respective measurements was assessed by intraclass correlation coefficients (ICC) and by average deviation from mean. RESULTS: Mean tumor volume was 46 ml (range 5-137 ml) using manual segmentation and 42 ml (range 3-111 ml) using semiautomatic segmentation. Semiautomatic measurement provided better inter-observer agreement than traditional manual segmentation. The ICC was significantly higher for semiautomatic segmentation in comparison to manual segmentation (0.86, 0.56, p < 0.01). The average absolute percentage difference from mean was reduced from 24 to 14% (p < 0.001) when using semiautomatic segmentation. CONCLUSIONS: Semiautomatic analysis outperforms manual analysis for assessment of esophageal tumor volume, improving reproducibility.


Assuntos
Tomografia Computadorizada de Feixe Cônico/métodos , Neoplasias Esofágicas/diagnóstico por imagem , Neoplasias Esofágicas/patologia , Idoso , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Estadiamento de Neoplasias , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos
13.
BMJ ; 364: k5092, 2019 01 16.
Artigo em Inglês | MEDLINE | ID: mdl-30651273

RESUMO

OBJECTIVE: To assess the appropriateness of outpatient antibiotic prescribing for privately insured children and non-elderly adults in the US using a comprehensive classification scheme of diagnosis codes in ICD-10-CM (international classification of diseases-clinical modification, 10th revision), which replaced ICD-9-CM in the US on 1 October 2015. DESIGN: Cross sectional study. SETTING: MarketScan Commercial Claims and Encounters database, 2016. PARTICIPANTS: 19.2 million enrollees aged 0-64 years. MAIN OUTCOME MEASURES: A classification scheme was developed that determined whether each of the 91 738 ICD-10-CM diagnosis codes "always," "sometimes," or "never" justified antibiotics. For each antibiotic prescription fill, this scheme was used to classify all diagnosis codes in claims during a look back period that began three days before antibiotic prescription fills and ended on the day fills occurred. The main outcome was the proportion of fills in each of four mutually exclusive categories: "appropriate" (associated with at least one "always" code during the look back period, "potentially appropriate" (associated with at least one "sometimes" but no "always" codes), "inappropriate" (associated only with "never" codes), and "not associated with a recent diagnosis code" (no codes during the look back period). RESULTS: The cohort (n=19 203 264) comprised 14 571 944 (75.9%) adult and 9 935 791 (51.7%) female enrollees. Among 15 455 834 outpatient antibiotic prescription fills by the cohort, the most common antibiotics were azithromycin (2 931 242, 19.0%), amoxicillin (2 818 939, 18.2%), and amoxicillin-clavulanate (1 784 921, 11.6%). Among these 15 455 834 fills, 1 973 873 (12.8%) were appropriate, 5 487 003 (35.5%) were potentially appropriate, 3 592 183 (23.2%) were inappropriate, and 4 402 775 (28.5%) were not associated with a recent diagnosis code. Among the 3 592 183 inappropriate fills, 2 541 125 (70.7%) were written in office based settings, 222 804 (6.2%) in urgent care centers, and 168 396 (4.7%) in emergency departments. In 2016, 2 697 918 (14.1%) of the 19 203 264 enrollees filled at least one inappropriate antibiotic prescription, including 490 475 out of 4 631 320 children (10.6%) and 2 207 173 out of 14 571 944 adults (15.2%). CONCLUSIONS: Among all outpatient antibiotic prescription fills by 19 203 264 privately insured US children and non-elderly adults in 2016, 23.2% were inappropriate, 35.5% were potentially appropriate, and 28.5% were not associated with a recent diagnosis code. Approximately 1 in 7 enrollees filled at least one inappropriate antibiotic prescription in 2016. The classification scheme could facilitate future efforts to comprehensively measure outpatient antibiotic appropriateness in the US, and it could be adapted for use in other countries that use ICD-10 codes.


Assuntos
Antibacterianos/administração & dosagem , Prescrição Inadequada/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Adolescente , Adulto , Criança , Pré-Escolar , Estudos Transversais , Bases de Dados Factuais , Feminino , Humanos , Prescrição Inadequada/classificação , Lactente , Recém-Nascido , Seguro Saúde/estatística & dados numéricos , Classificação Internacional de Doenças , Masculino , Pessoa de Meia-Idade , Estados Unidos , Adulto Jovem
14.
Arthritis Care Res (Hoboken) ; 71(1): 104-115, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29648687

RESUMO

OBJECTIVE: Cardiovascular disease (CVD) risks in systemic lupus erythematosus (SLE) are similar to those in diabetes mellitus (DM). We investigated whether the numbers of lipid tests and statin prescriptions in patients with SLE are comparable with those in patients with DM and those in individuals without either disease. METHODS: Using Analytic eXtract files from 29 states for 2007-2010, we identified a cohort of US Medicaid beneficiaries, ages 18-65 years, with prevalent SLE. Each SLE patient was matched for age and sex with 2 patients with DM and 4 individuals in the general Medicaid population who did not have either SLE or DM. We compared the proportions of patients in each cohort who received ≥1 lipid test and ≥1 statin prescription during 1-year follow-up. We used multivariable logistic regression to calculate the odds of lipid testing and receiving prescriptions for statins and conditional logistic regression to compare the matched cohorts. RESULTS: We identified 3 Medicaid cohorts: 25,950 patients with SLE, 51,900 patients with DM, and 103,800 Medicaid recipients without either condition. In these cohorts, lipid testing was performed in 24% of patients in the SLE group, 43% of patients in the DM group, and 16% of individuals in the group with neither condition, and statin prescriptions were dispensed in 11%, 33%, and 7% of these groups, respectively. SLE patients were 66% less likely (odds ratio [OR] 0.34, 95% confidence interval [95% CI] 0.34-0.35) to have lipid tests and 82% less likely (OR 0.18, 95% CI 0.18-0.18) to fill a statin prescription compared with DM patients. SLE patients were also less likely (OR 0.89, 95% CI 0.84-0.94) to fill a statin prescription compared with individuals in the general Medicaid population. CONCLUSION: Despite having an elevated risk of CVD, SLE patients received less lipid testing and received fewer statin prescriptions compared with age- and sex-matched DM patients and individuals in the general Medicaid population; this gap should be a target for improvement.


Assuntos
Diabetes Mellitus/sangue , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Lipídeos/sangue , Lúpus Eritematoso Sistêmico/sangue , Medicaid/tendências , Vigilância da População , Adolescente , Adulto , Idoso , Estudos de Coortes , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/epidemiologia , Prescrições de Medicamentos , Feminino , Seguimentos , Testes Hematológicos/tendências , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Lúpus Eritematoso Sistêmico/epidemiologia , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologia , Adulto Jovem
15.
Acta Radiol ; 60(3): 293-300, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29933715

RESUMO

BACKGROUND: X-ray tube voltage (kVp) reduction increases intravenous contrast medium (CM) attenuation at computed tomography (CT), but tube output limits its use in large patients. PURPOSE: To evaluate the feasibility and image quality of reducing CM dose by low kVp and using dual X-ray source at liver CT. MATERIAL AND METHODS: Patients with estimated glomerular filtration rate (eGFR) < 45 mL/min (n = 43) aged 60-91 years (75 ± 7.7), weighing 42-114 kg (75 ± 15) were prospectively scanned using a reduced CM dose of 0.25 or 0.3 g iodine (I)/kg with 70 or 80 kVp respectively, using either single-source or dual-source CT depending on patient size. Liver contrast-to-noise ratio (CNR), liver noise, and muscle noise were quantitatively compared with those of 43 consecutive patients aged > 65 years with eGFR > 45 mL/min scanned using a standard abdominal protocol at 120 kVp after receiving 0.5 gI/kg. RESULTS: There was no statistically significant difference in CNR, liver noise, or muscle noise at reduced CM protocols compared to the standard protocol: CNR was 4.6 (95% CI = 4.2-5.0) vs. 5.0 (95% CI = 4.5-5.5), liver noise was 11.1 (95% CI = 10.7-11.6) vs. 11.0 (95% CI = 10.5-11.6), muscle noise was 11.7 (95% CI = 11.2-12.1) vs. 10.8 (95% CI = 10.1-11.4). The mean SSDE was 70% higher with the reduced CM protocol. CONCLUSION: CM dosage can be reduced by 40-50% with maintained measured noise and CNR in patients with BMIs of 15-36 kg/m2 by lowering the tube voltage and dual-source CT scanning of the liver.


Assuntos
Meios de Contraste/administração & dosagem , Fígado Gorduroso/diagnóstico por imagem , Radiografia Abdominal/métodos , Insuficiência Renal/fisiopatologia , Tomografia Computadorizada por Raios X/métodos , Idoso , Idoso de 80 Anos ou mais , Tamanho Corporal , Estudos de Casos e Controles , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
16.
Drug Saf ; 42(1): 85-93, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30066315

RESUMO

INTRODUCTION: Lawyer-submitted reports may have unintended consequences on safety signal detection in spontaneous adverse event reporting systems. OBJECTIVE: Our objective was to assess the impact of lawyer-submitted reports primarily for one adverse event (AE) on the ability to detect a signal of disproportional reporting for another AE for the same drug in the US FDA Adverse Event Reporting System (FAERS). METHODS: FAERS reports from January 2004 to September 2015 were used to estimate yearly cumulative proportional reporting ratios (PRRs) for three known drug-AE pairs-isotretinoin-birth defects, atorvastatin-rhabdomyolysis, and rosuvastatin-rhabdomyolysis-with and without lawyer-submitted reports. Isotretinoin and atorvastatin have been the subject of high-profile tort litigation regarding other AEs. A lower bound of the 95% confidence interval (CI) of one or more based on three or more reports defined a signal. RESULTS: Cumulative PRRs met signaling criteria in all analyses. For isotretinoin, lawyer-submitted reports increased PRRs for birth defects before 2008, with the largest increase in 2006 (2.9 [95% CI 2.4-3.5] to 3.3 [95% CI 2.8-3.9]); lawyer-submitted reports decreased PRRs for birth defects after 2011, with the largest decrease in 2013 (2.2 [95% CI 2.0-2.5] to 1.9 [95% CI 1.7-2.1]). For atorvastatin, lawyer-submitted reports reduced PRRs for rhabdomyolysis after 2013, with the largest decrease in 2015 (18.0 [95% CI 17.1-19.1] to 15.4 [95% CI 14.5-16.2]). Lawyer-submitted reports had little impact on PRRs for rosuvastatin and rhabdomyolysis. CONCLUSIONS: Inclusion of lawyer-submitted reports in FAERS did not meaningfully distort known safety signals for two drugs subject to high-profile tort litigation for other AEs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/legislação & jurisprudência , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Advogados/legislação & jurisprudência , United States Food and Drug Administration/legislação & jurisprudência , Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Atorvastatina/efeitos adversos , Fármacos Dermatológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Isotretinoína/efeitos adversos , Advogados/normas , Rosuvastatina Cálcica/efeitos adversos , Estados Unidos/epidemiologia , United States Food and Drug Administration/normas
17.
Semin Arthritis Rheum ; 48(5): 840-846, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30205982

RESUMO

OBJECTIVE: Systemic lupus erythematosus (SLE), which is associated with increased stroke risk, is more prevalent and often more severe among Blacks, Asians, and Hispanics than Whites. We examined racial/ethnic variation in stroke rates and risks, overall and by hemorrhagic versus ischemic subtype, among SLE patients. METHODS: Within Medicaid (2000-2010), we identified patients aged 18-65 with SLE (≥ 3 ICD-9 710.0 codes, ≥ 30days apart) and ≥12 months of continuous enrollment. Subjects were followed from index date to first stroke event, death, disenrollment, or end of follow-up. Race/ethnicity-specific annual event rates were calculated for stroke overall and by subtypes (hemorrhagic vs. ischemic). We used Cox proportional hazard models to estimate hazard ratios (HR) of stroke by race/ethnicity, adjusting for comorbidities and the competing risk of death. RESULTS: Of 65,788 SLE patients, 93.1% were female. Racial/ethnic breakdown was 42% Black, 38% White, 16% Hispanic, 3% Asian, and 1% American Indian/Alaska Natives. Mean follow-up was 3.7 ± 3.0years. After multivariable adjustment, Blacks were at increased risk of overall stroke (HR 1.34 [95%CI 1.18-1.53), hemorrhagic stroke (HR 1.42 [1.00-2.01]), and ischemic stroke (HR 1.33 [1.15-1.52]) compared to Whites. Hispanics were at increased risk of overall stroke (HR 1.25 [1.06-1.47)] and hemorrhagic stroke (HR 1.79 [95% CI 1.22-2.61]), but not ischemic stroke, compared to Whites. CONCLUSION: Among SLE patients enrolled in Medicaid, we observed elevated stroke risk (overall and by subtype) among Blacks and Hispanics compared to Whites, suggesting the importance of early recognition and screening for stroke risk factors among Blacks and Hispanics.


Assuntos
Lúpus Eritematoso Sistêmico/etnologia , Acidente Vascular Cerebral/etnologia , Adulto , Afro-Americanos/estatística & dados numéricos , Idoso , Americanos Asiáticos/estatística & dados numéricos , Estudos de Coortes , Comorbidade , Grupo com Ancestrais do Continente Europeu/estatística & dados numéricos , Feminino , Hispano-Americanos/estatística & dados numéricos , Humanos , Índios Norte-Americanos/estatística & dados numéricos , Masculino , Medicaid/estatística & dados numéricos , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estados Unidos/epidemiologia , Adulto Jovem
18.
Eur Radiol ; 29(5): 2207-2217, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30519934

RESUMO

PURPOSE: To evaluate the diagnostic performance of bone texture analysis (TA) combined with machine learning (ML) algorithms in standard CT scans to identify patients with vertebrae at risk for insufficiency fractures. MATERIALS AND METHODS: Standard CT scans of 58 patients with insufficiency fractures of the spine, performed between 2006 and 2013, were analyzed retrospectively. Every included patient had at least two CT scans. Intact vertebrae in a first scan that either fractured ("unstable") or remained intact ("stable") in the consecutive scan were manually segmented on mid-sagittal reformations. TA features for all vertebrae were extracted using open-source software (MaZda). In a paired control study, all vertebrae of the study cohort "cases" and matched controls were classified using ROC analysis of Hounsfield unit (HU) measurements and supervised ML techniques. In a within-subject vertebra comparison, vertebrae of the cases were classified into "unstable" and "stable" using identical techniques. RESULTS: One hundred twenty vertebrae were included. Classification of cases/controls using ROC analysis of HU measurements showed an AUC of 0.83 (95% confidence interval [CI], 0.77-0.88), and ML-based classification showed an AUC of 0.97 (CI, 0.97-0.98). Classification of unstable/stable vertebrae using ROC analysis showed an AUC of 0.52 (CI, 0.42-0.63), and ML-based classification showed an AUC of 0.64 (CI, 0.61-0.67). CONCLUSION: TA combined with ML allows to identifying patients who will suffer from vertebral insufficiency fractures in standard CT scans with high accuracy. However, identification of single vertebra at risk remains challenging. KEY POINTS: • Bone texture analysis combined with machine learning allows to identify patients at risk for vertebral body insufficiency fractures on standard CT scans with high accuracy. • Compared to mere Hounsfield unit measurements on CT scans, application of bone texture analysis combined with machine learning improve fracture risk prediction. • This analysis has the potential to identify vertebrae at risk for insufficiency fracture and may thus increase diagnostic value of standard CT scans.


Assuntos
Fraturas de Estresse/diagnóstico , Vértebras Lombares/lesões , Aprendizado de Máquina , Fraturas da Coluna Vertebral/diagnóstico , Vértebras Torácicas/lesões , Tomografia Computadorizada por Raios X/métodos , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea , Estudos de Casos e Controles , Feminino , Humanos , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Curva ROC , Estudos Retrospectivos , Vértebras Torácicas/diagnóstico por imagem
19.
Invest Radiol ; 54(4): 212-220, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30444794

RESUMO

OBJECTIVES: The aim of this study was to quantitatively assess changes in collagen structure using MR T1- and T2*-mapping in a novel controlled ex vivo tendon model setup. MATERIALS AND METHODS: Twenty-four cadaveric bovine flexor tendons underwent MRI at 3 T before and after chemical modifications, representing mechanical degeneration and augmentation. Collagen degradation (COL), augmenting collagen fiber cross-linking (CXL), and a control (phosphate-buffered saline [PBS]) were examined in experimental groups, using histopathology as standard of reference. Variable echo-time and variable-flip angle gradient-echo sequences were used for T2*- and T1-mapping, respectively. Standard T1- and T2-weighted spin-echo sequences were acquired for visual assessment of tendon texture. Tendons were assessed subsequently for their biomechanical properties and compared with quantitative MRI analysis. RESULTS: T1- and T2*-mapping was feasible and repeatable for untreated (mean, 545 milliseconds, 2.0 milliseconds) and treated tendons. Mean T1 and T2* values of COL, CXL, and PBS tendons were 1459, 934, and 1017 milliseconds, and 5.5, 3.6, and 2.5 milliseconds, respectively. T2* values were significantly different between enzymatically degraded tendons, cross-linked tendons, and controls, and were significantly correlated with mechanical tendon properties (r = -0.74, P < 0.01). T1 values and visual assessment could not differentiate CXL from PBS tendons. Photo-spectroscopy showed increased autofluorescence of cross-linked tendons, whereas histopathology verified degenerative lesions of enzymatically degraded tendons. CONCLUSIONS: T2*-mapping has the potential to detect and quantify subtle changes in tendon collagen structure not visible on conventional clinical MRI. Tendon T2* values might serve as a biomarker for biochemical alterations associated with tendon pathology.


Assuntos
Imagem por Ressonância Magnética/métodos , Imagens de Fantasmas , Tendões/diagnóstico por imagem , Tendões/fisiologia , Animais , Bovinos , Colágeno/fisiologia , Humanos , Modelos Animais
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