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2.
JAMA Otolaryngol Head Neck Surg ; 149(12): 1083-1090, 2023 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-37707824

RESUMO

Importance: Among adults who present for clinical evaluation of dizziness, there is a critical need to identify interventions, such as physical therapy (PT), to mitigate the risk of falls over time. Objective: The primary objective was to examine the association between receipt of PT and falls requiring medical care within 12 months of presentation for dizziness. Secondary objectives included identification of factors associated with falls requiring medical care and factors associated with receipt of PT after presentation for dizziness. Design, Setting, and Participants: This cross-sectional study examined US commercial insurance and Medicare Advantage claims from January 1, 2006, through December 31, 2015. In all, 805 454 patients 18 years or older with a new diagnosis of symptomatic dizziness or vestibular disorders were identified. Data were analyzed from October 1, 2021, to February 1, 2023. Main Outcomes and Measures: Receipt of PT services and the incidence of falls requiring medical care were measured. The association between receipt of PT and falls that occurred 12 months after presentation for dizziness was estimated after accounting for presentation setting (outpatient clinic or emergency department), Charlson Comorbidity Index (CCI; with higher scores indicating greater morbidity), diagnosis code, and sociodemographic characteristics. Results: A total of 805 454 patients presented for dizziness from 2006 through 2015 (median [range] age, 52 [18-87] years; 502 055 females [62%]). Of these patients, 45 771 (6%) received PT within 3 months of presentation for dizziness and 60 060 (7%) experienced a fall resulting in a medical encounter within 12 months after presentation for dizziness. In adjusted models, patients least likely to receive PT were female (adjusted odds ratio [AOR], 0.80; 95% CI, 0.78-0.81), those aged 50 to 59 years (AOR, 0.67 [95% CI, 0.65-0.70] compared with patients aged 18-39 years), and those with more comorbidities (AOR, 0.71 [95% CI, 0.70-0.73] for CCI ≥ 2 vs 0). Receipt of PT services within 3 months of presentation for dizziness was associated with a reduced risk of falls over the subsequent 12 months, with the greatest risk reduction found within 3 months after PT (AOR, 0.14 [95% CI, 0.14-0.15] at 3-12 months vs 0.18 [95% CI, 0.18-0.19] at 6-12 months and 0.23 [95% CI, 0.23-0.24] at 9-12 months). Conclusions and Relevance: Results of this cohort study suggest that receipt of PT after presentation for dizziness was associated with a reduction in fall risk during the subsequent 12 months; thus, timely PT referral for dizziness may be beneficial for these patients. Future research, ideally with a clinical trial design, is needed to explore the independent impact of PT on subsequent falls for adults with dizziness.


Assuntos
Acidentes por Quedas , Tontura , Adulto , Humanos , Idoso , Feminino , Estados Unidos/epidemiologia , Pessoa de Meia-Idade , Masculino , Tontura/epidemiologia , Tontura/etiologia , Tontura/terapia , Estudos de Coortes , Estudos Transversais , Medicare , Modalidades de Fisioterapia , Vertigem
3.
Med Care ; 61(10): 636-643, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37582298

RESUMO

BACKGROUND: Recent literature has found rapid uptake of short-acting filgrastim biosimilars but slower uptake of other biosimilars, such as infliximab, in both Medicare and privately insured enrollees. OBJECTIVES: To describe patient, provider, and health plan characteristics associated with a switch to biosimilar among existing infliximab patients. RESEARCH DESIGN: We constructed a retrospective panel dataset of patients undergoing active infliximab treatments and the choice of infliximab drug for each infusion. We used mixed logit regression controlling for patient, provider, and health plan characteristics as well as time-fixed effects. SUBJECTS: Medicare Advantage and privately insured enrollees with evidence of active infliximab treatments between 2016 and 2020 (n=357,430). MEASURES: Our primary outcome of interest was to switch from infliximab originator to one of the infliximab biosimilars. Exposure variables of interest variables such as out-of-pocket, site of care, and in-network deductible. RESULTS: Our study found nominally low switching among existing infliximab originator users (3.4%). We found that patients who previously received 1 infliximab originator infusion were 63.7% more likely to switch to biosimilar compared with patients who previously received administration of 20 infliximab originators. We found that biosimilar's placement as health's plan preferred drug was attributed to higher likelihood of biosimilar use (odds ratio: 1.666; P -value=0.001). We did not observe any statistically significant effect among out-of-pocket amount or deductible with respect to switch to infliximab biosimilar. CONCLUSIONS: To encourage uptake and switch to biosimilar, policymakers should consider targeted policies that include leveraging health plan tools such as placement of biosimilar as preferred drug and aim to educate patients on the clinical equivalence between infliximab biosimilar and originator.


Assuntos
Medicamentos Biossimilares , Idoso , Humanos , Estados Unidos , Infliximab/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Estudos Retrospectivos , Medicare , Substituição de Medicamentos
4.
Cost Eff Resour Alloc ; 21(1): 47, 2023 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-37516870

RESUMO

BACKGROUND: Breast cancer-related lymphedema (BCRL) imposes a significant economic burden on patients, providers, and society. There is no curative therapy for BCRL, but management through self-care can reduce symptoms and lower the risk of adverse events. MAIN BODY: The economic burden of BCRL stems from related adverse events, reductions in productivity and employment, and the burden placed on non-medical caregivers. Self-care regimens often include manual lymphatic drainage, compression garments, and meticulous skin care, and may incorporate pneumatic compression devices. These regimens can be effective in managing BCRL, but patients cite inconvenience and interference with daily activities as potential barriers to self-care adherence. As a result, adherence is generally poor and often worsens with time. Because self-care is on-going, poor adherence reduces the effectiveness of regimens and leads to costly treatment of BCRL complications. CONCLUSION: Novel self-care solutions that are more convenient and that interfere less with daily activities could increase self-care adherence and ultimately reduce complication-related costs of BCRL.

5.
Jt Comm J Qual Patient Saf ; 49(9): 458-466, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37380503

RESUMO

BACKGROUND: The objective of this study was to describe changes in testosterone prescribing following a 2014 US Food and Drug Administration (FDA) safety communication and how changes varied by physician characteristics. METHODS: Data were extracted from a 20% random sample of Medicare fee-for-service administrative claims data from 2011 through 2019. The sample included 1,544,604 unique male beneficiaries who received evaluation and management (E&M) services from 58,819 unique physicians that prescribed testosterone between 2011 and 2013. Patients were categorized based on presence of coronary artery disease (CAD) and non-age-related hypogonadism. Physician characteristics were identified in the OneKey database and included specialty and affiliations with teaching hospitals, for-profit hospitals, hospitals in integrated delivery networks, and hospitals in the top decile of case mix index. Linear segmented models described how testosterone prescriptions changed following a 2014 FDA safety communication and how changes were associated with physician and organizational characteristics. RESULTS: Among 65,089,560 physician-patient-quarter-year observations, mean (standard deviation) age ranged from 72.16 (5.84) years for observations without CAD or non-age-related hypogonadism to 75.73 (6.92) years with CAD and without non-age-related hypogonadism. Following the safety communication, immediate changes in off-label testosterone prescription levels fell by 0.22 percentage points (pp) (95% confidence interval [CI] -0.33 to -0.11) for patients with CAD and by -0.16 pp (95% CI -0.19 to -0.16) for patients without CAD. A similar change was noticed in on-label prescribing levels. Off-label testosterone prescription quarterly trend, however, increased for patients with CAD and without CAD; on-label testosterone prescription trends declined for both groups. Declines in off-label prescribing were larger when treated by primary care physicians vs. non-primary care physicians, and physicians affiliated with teaching compared to nonteaching hospitals. Physician and organizational characteristics were not associated with changes in on-label prescribing. CONCLUSION: On-label and off-label testosterone therapy declined following the FDA safety communication. Certain physician characteristics were associated with changes in off-label, but not on-label, prescribing.


Assuntos
Hipogonadismo , Testosterona , Humanos , Masculino , Idoso , Estados Unidos , Testosterona/uso terapêutico , Uso Off-Label , United States Food and Drug Administration , Padrões de Prática Médica , Medicare , Hipogonadismo/tratamento farmacológico
6.
JAMA Health Forum ; 4(6): e231485, 2023 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-37351874

RESUMO

Importance: Previous studies have found that hospitals participating in the 340B Drug Pricing Program have higher Medicare Part B spending and expansion into affluent neighborhoods. Less is known about the association of 340B participation with spending by commercial insurance, where reimbursements are higher than Medicare. Objective: To use the Affordable Care Act expansion of eligibility for the 340B Drug Pricing Program to study the association between participation and spending on outpatient-administered oncological drugs for commercially insured patients. Design, Setting, and Participants: This cohort study included a balanced panel hospital cohort containing new and never 340B program participants between 2007 and 2019; more recent data were not included to avoid the effect of disruptions in care due to the COVID-19 pandemic. Descriptive analyses documented spending trends for patients receiving common outpatient-administered biologics used in cancer treatments (bevacizumab, filgrastim, pegfilgrastim, rituximab, and trastuzumab) at 340B (treated) and non-340B (control) hospitals. A difference-in-differences model assessed changes in episode drug spending. Analyses were conducted between December 2021 and June 2022. Exposure: New 340B program participation between 2010 and 2016. Main Outcome and Measures: Total drug episode spending, with control variables including total billed units, drug, calendar-year fixed effects, and hospital fixed effects. Results: Of 95 127 included episodes (56 917 [59.8%] episodes in female patients) across 478 hospitals, patients seen in 340B and non-340B hospitals were similar in sex and drug used, and 340B hospital patients were older than non-340B patients (median [IQR] age for all patients, 61 [51-71] years). New 340B participating hospitals were more likely to be small (<50 beds) and more likely to be in rural settings. In the difference-in-differences analysis, total episode drug spending increased by $4074.69 (95% CI, $1592.84-$6556.70; P = .001) in the year following start of 340B program participation relative to nonparticipants. Heterogeneous group time effects were seen, with earlier participants less likely to have increased episode spending. Conclusions and Relevance: In this cohort study, new 340B participation was associated with statistically significant higher oncological drug episode spending compared with nonparticipants after changes in 340B inclusion rules in 2010. These findings raise questions about unintended consequences of the 340B program on drug spending from the commercially insured population.


Assuntos
Produtos Biológicos , COVID-19 , Medicare Part B , Humanos , Feminino , Idoso , Estados Unidos , Pessoa de Meia-Idade , Estudos de Coortes , Pacientes Ambulatoriais , Pandemias , Patient Protection and Affordable Care Act , COVID-19/epidemiologia
7.
Am J Manag Care ; 29(5): e155-e158, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-37229790

RESUMO

In this article, we used administrative claims data from the OptumLabs Data Warehouse and American Hospital Association Annual Survey data to examine associations between hospital characteristics and uptake of biosimilar granulocyte colony-stimulating factor treatments. We found that 340B-participating hospitals and non-rural referral center (RRC) hospitals that reported owning rural health clinics were less likely to administer the lower-cost biosimilars, whereas the opposite was true for hospitals that are RRCs. To our knowledge, our study offers a first look at an underappreciated source of disparities in access to lower-cost medications such as biosimilars. Results from our study reveal opportunities for targeted policies to encourage adoption of lower-cost treatments, particularly among hospitals that serve rural communities where patients often have fewer choices in care site.


Assuntos
Medicamentos Biossimilares , Estados Unidos , Humanos , Filgrastim/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Custos de Medicamentos
8.
Health Aff (Millwood) ; 42(3): 383-391, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36877901

RESUMO

Interventions to address social drivers of health (SDH), such as food insecurity, transportation, and housing, can reduce future health care costs but require up-front investment. Although Medicaid managed care organizations have incentives to reduce costs, volatile enrollment patterns and coverage changes may prevent them from realizing the full benefits of their SDH investments. This phenomenon results in the "wrong-pocket problem," in which managed care organizations underinvest in SDH interventions because they cannot capture the full benefit. We propose a financial innovation, an SDH bond, to increase investments in SDH interventions. Issued by multiple managed care organizations in a Medicaid coverage region, the bond would raise immediate funds for SDH interventions that are coordinated across the organizations and delivered to all enrollees of the region. As the benefits of SDH interventions accrue and cost savings are realized, the amount managed care organizations must pay back to bond holders adjusts according to enrollment, addressing the wrong-pocket problem.


Assuntos
Investimentos em Saúde , Medicaid , Estados Unidos , Humanos , Redução de Custos , Custos de Cuidados de Saúde , Programas de Assistência Gerenciada
9.
JAMA ; 329(2): 144-156, 2023 01 10.
Artigo em Inglês | MEDLINE | ID: mdl-36625811

RESUMO

Importance: Most regulated medical devices enter the US market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are "substantially equivalent" to 1 or more "predicate" devices (legally marketed medical devices with similar intended use). Most recalled medical devices are 510(k) devices. Objective: To examine the association between characteristics of predicate medical devices and recall probability for 510(k) devices. Design, Setting, and Participants: In this exploratory cross-sectional analysis of medical devices cleared by the US Food and Drug Administration (FDA) between 2003 and 2018 via the 510(k) regulatory submission pathway, linear probability models were used to examine associations between a 510(k) device's recall status and characteristics of its predicate medical devices. Public documents for the 510(k) medical devices were collected using FDA databases. A text extraction algorithm was applied to identify predicate medical devices cited in 510(k) regulatory submissions. Algorithm-derived metadata were combined with 2003-2020 FDA recall data. Exposures: Citation of predicate medical devices with certain characteristics in 510(k) regulatory submissions, including the total number of predicate medical devices cited by the applicant device, the age of the predicate medical devices, the lack of similarity of the predicate medical devices to the applicant device, and the recall status of the predicate medical devices. Main Outcomes and Measures: Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020. Results: The sample included 35 176 medical devices, of which 4007 (11.4%) were recalled. The applicant devices cited a mean of 2.6 predicate medical devices, with mean ages of 3.6 years and 7.4 years for the newest and oldest, respectively, predicate medical devices. Of the applicant devices, 93.9% cited predicate medical devices with no ongoing recalls, 4.3% cited predicate medical devices with 1 ongoing class I or class II recall, 1.0% cited predicate medical devices with 2 ongoing recalls, and 0.8% cited predicate medical devices with 3 or more ongoing recalls. Applicant devices citing predicate medical devices with 3 or more ongoing recalls were significantly associated with a 9.31-percentage-point increase (95% CI, 2.84-15.77 percentage points) in recall probability compared with devices without ongoing recalls of predicate medical devices, or an 81.2% increase in recall probability relative to the mean recall probability. A 1-SD increase in the total number of predicate medical devices cited by the applicant device was significantly associated with a 1.25-percentage-point increase (95% CI, 0.62-1.87 percentage points) in recall probability, or an 11.0% increase in recall probability relative to the mean recall probability. A 1-SD increase in the newest age of a predicate medical device was significantly associated with a 0.78-percentage-point decrease (95% CI, 1.29-0.30 percentage points) in recall probability, or a 6.8% decrease in recall probability relative to the mean recall probability. Conclusions and Relevance: This exploratory cross-sectional study of 510(k) medical devices cleared by the FDA between 2003 and 2018 demonstrated significant associations between 510(k) submission characteristics and recalls of medical devices. Further research is needed to understand the implications of these associations.


Assuntos
Aprovação de Equipamentos , Recall de Dispositivo Médico , United States Food and Drug Administration , Algoritmos , Estudos Transversais , Bases de Dados Factuais , Aprovação de Equipamentos/legislação & jurisprudência , Aprovação de Equipamentos/normas , Recall de Dispositivo Médico/legislação & jurisprudência , Recall de Dispositivo Médico/normas , Estados Unidos
11.
Med Care Res Rev ; 80(2): 236-244, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-35848406

RESUMO

Since the summer of 2020, the rate of coronavirus cases in the United States has been higher in rural areas than in urban areas, raising concerns that patients with coronavirus disease 2019 (COVID-19) will overwhelm under-resourced rural hospitals. Using data from the University of Minnesota COVID-19 Hospitalization Tracking Project and the U.S. Department of Health and Human Services, we document disparities in COVID-19 hospitalization rates between rural and urban areas. We show that rural-urban differences in COVID-19 admission rates were minimal in the summer of 2020 but began to diverge in fall 2020. Rural areas had statistically higher hospitalization rates from September 2020 through early 2021, after which rural-urban admission rates re-converged. The insights in this article are relevant to policymakers as they consider the adequacy of hospital resources across rural and urban areas during the COVID-19 pandemic.


Assuntos
COVID-19 , Humanos , Estados Unidos/epidemiologia , COVID-19/epidemiologia , Pandemias , Hospitalização , População Rural , Hospitais Rurais , População Urbana
12.
Am J Manag Care ; 28(10): 507-513, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36252169

RESUMO

OBJECTIVES: After the release of the CDC guidelines in March 2016, the rate of opioid prescriptions decreased. How or whether pharmaceutical companies changed their opioid marketing practices post release of the CDC guidelines is unknown. Our objectives were to (1) evaluate whether the release of the guidelines was associated with changes in total monthly marketing spending received per physician, monthly marketing encounter frequency per physician, and spending per encounter during opioid marketing; and (2) evaluate whether such changes in marketing differed between specialist physicians and primary care physicians (PCPs) and between urban and rural primary care service areas (PCSAs). STUDY DESIGN: Retrospective observational cross-sectional study using opioid marketing spending data from the CMS Open Payments database between August 2013 and December 2017. METHODS: Single-group and multiple-group interrupted time series analyses were used to evaluate differences in the immediate changes in level and trend over time in opioid marketing practices post release of the CDC guidelines. RESULTS: Post release of the CDC guidelines, the monthly number of marketing encounters per physician and total monthly amount received per physician decreased. However, the amount spent at each marketing encounter increased. The release of the CDC guidelines was associated with an immediate increase in level of opioid marketing spending per encounter by $0.59 (95% CI, $0.51-$0.68; P < .001) and an over-time increase in rate of spending per encounter of $0.04 per month (95% CI, $0.03-$0.05; P < .001). These changes differed between specialists and PCPs and between urban and rural PCSAs. CONCLUSIONS: It is important to continue ongoing education for physicians on changes in pharmaceutical opioid marketing practices.


Assuntos
Analgésicos Opioides , Padrões de Prática Médica , Analgésicos Opioides/uso terapêutico , Centers for Disease Control and Prevention, U.S. , Estudos Transversais , Humanos , Marketing , Preparações Farmacêuticas , Estudos Retrospectivos , Estados Unidos
13.
Contemp Clin Trials ; 121: 106905, 2022 10.
Artigo em Inglês | MEDLINE | ID: mdl-36057376

RESUMO

BACKGROUND: Primary care is a frequent source of pain treatment and opioid prescribing. The objective of the Prescribing Interventions for Chronic Pain using the Electronic health record (PRINCE) study is to assess the effects of two behavioral economics-informed interventions embedded within the electronic health record (EHR) on guideline-concordant pain treatment and opioid prescribing decisions in primary care settings. METHODS: Setting: The setting for this study is 43 primary care clinics in Minnesota. DESIGN: The PRINCE study uses a cluster-randomized 2 × 2 factorial design to test the effects of two interventions. An adaptive design allows for the possibility of secondary randomization to test if interventions can be titrated while maintaining efficacy. INTERVENTIONS: One intervention alters the "choice architecture" within the EHR to nudge clinicians toward non-opioid treatments for opioid-naïve patients and toward tapering for patients currently receiving a "high risk" opioid. The other intervention integrates the prescription drug monitoring program (PDMP) directly within the EHR. OUTCOME: The primary outcome for opioid-naïve patients is whether an opioid is prescribed in a primary care visit without a non-opioid alternative pain treatment. The primary outcome for current opioid-using patients is whether opioid prescriptions were tapered with a documented rationale. DISCUSSION: The PRINCE study will provide real-world evidence on two approaches to improving pain treatment in primary care using the EHR. The adaptive study design strikes a balance between establishing intervention efficacy and testing whether efficacy varies with intervention intensity.


Assuntos
Dor Crônica , Analgésicos Opioides , Dor Crônica/tratamento farmacológico , Registros Eletrônicos de Saúde , Humanos , Padrões de Prática Médica , Prescrições
14.
JAMA Health Forum ; 3(6): e221852, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35977248

RESUMO

Importance: Tools that are directly integrated with the electronic health record (EHR) workflow can reduce the hassle cost of certain guideline-concordant practices, such as querying a prescription drug monitoring program (PDMP) before prescribing opioids. Objective: To investigate the effect of integrating access to a PDMP within the EHR on the frequency of program queries by primary care clinicians. Design Settings and Participants: The PRINCE (Prescribing Interventions for Chronic Pain Using the Electronic Health Record) randomized trial used a factorial cluster design at the clinic level in 43 primary care clinics in Minnesota. In all, 309 clinicians participated; 161 clinicians were given EHR-integrated access to PDMP at the intervention clinics, and 148 clinicians had the usual access at the control clinics. The intervention went live on August 27, 2020, and data were collected through March 3, 2021. Intervention: Single sign-on access to the Minnesota PDMP was integrated into the EHR, allowing clinicians to query a patient's controlled substance prescription and dispensing history as recorded in the Minnesota PDMP directly from the patient's EHR record without logging into a separate web portal. Additionally, the integration tool alerted clinicians and reminded them to review the PDMP if a patient had 3 or more opioid prescriptions in the past year and 1 or more in the past 6 months. Clinics in the control group did not receive access to the EHR-integrated PDMP tool; instead, these participants logged into the PDMP web portal separately. Main Outcomes and Measures: Monthly PDMP query counts for primary care clinicians, overall and by modality (EHR-based, web-based, via a clinical delegate), adjusted for clinician characteristics, including type (physician, nurse practitioner, physician assistant), sex, and years in practice. Data were analyzed from August 2021 to May 2022. Results: Of the 43 participating clinics with 309 clinicians, 21 clinics with 161 clinicians (102 [63.4%] women; 114 [70.8%] physicians; tenure, 10.6 [4.4] years) received the PDMP integration intervention. Baseline unadjusted monthly PDMP query rates for the average clinician were 6.6 (95% CI, 4.4-9.9) vs 8.8 (95% CI, 6.0-13.1) queries in the control vs the PDMP integration group, respectively. During the intervention, PDMP query rates for the average clinician were 6.9 (95% CI, 4.7-10.3) vs 14.8 (95% CI, 10.0-22.0) queries among the control vs the PDMP integration group, respectively. Compared with the control group, the EHR-integrated PDMP tool produced a 60% greater increase in the relative change in monthly PDMP queries (95% CI, 51%-70%). An increase in PDMP queries via the EHR-integrated PDMP tool drove this increase, while web-based and delegate queries declined by 39% more among the intervention compared with the control group (95% CI, 34%-43%). Conclusions and Relevance: This cluster randomized clinical trial found that integrating access to the PDMP in the EHR increased PDMP-querying rates, suggesting that direct access reduced hassle costs and can dramatically improve adherence to guideline-concordant care practices among primary care clinicians. Trial Registration: ClinicalTrials.gov Identifier: NCT04601506.


Assuntos
Programas de Monitoramento de Prescrição de Medicamentos , Analgésicos Opioides/uso terapêutico , Substâncias Controladas , Registros Eletrônicos de Saúde , Feminino , Humanos , Masculino , Atenção Primária à Saúde
15.
Sci Rep ; 12(1): 14005, 2022 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-35977981

RESUMO

Lower extremity lymphedema (LEL) can result in detriments to quality of life (QOL) and impose a significant economic burden on patients and payers. A common component of treatment is pneumatic compression, which requires patients to remain immobile. We investigated a novel non-pneumatic compression device (NPCD) that allows patients to remain active during compression treatment, to see if it reduces swelling and improves QOL. We conducted a non-randomized, open-label, 12-week pilot study of adult patients with primary or secondary unilateral LEL, and measured changes in limb edema and QOL using the Lymphedema Quality of Life Questionnaire (LYMQOL). Twenty-four subjects were enrolled; the majority were female (17) with secondary lymphedema (21). Eighteen completed the study. Statistically significant improvements were observed in overall QOL, aggregated LYMQOL total score, and three of four LYMQOL subscales (Function, Appearance, Mood). The fourth (Symptoms) trended toward significant improvement (p = 0.06). The average reduction in affected limb edema was 39.4%. The novel NPCD produced statistically significant improvements in QOL, functioning, and edema volume of patients with LEL. Innovations in devices to manage LEL can be effective while allowing patients to maintain mobility and physical activity during treatment.


Assuntos
Linfedema , Qualidade de Vida , Adulto , Edema , Feminino , Humanos , Extremidade Inferior , Linfedema/terapia , Masculino , Projetos Piloto , Resultado do Tratamento
16.
Med Care ; 60(7): 538-544, 2022 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-35471645

RESUMO

IMPORTANCE: As states reopened their economies state and local officials made decisions on policies and restrictions that had an impact on the evolution of the pandemic and the health of the citizens. Some states made the decision to lift mask mandates starting spring 2021. Data-driven methods help evaluate the appropriateness and consequences of such decisions. OBJECTIVE: To investigate the association of lifting the mask mandate with changes in the cumulative coronavirus case rate. DESIGN: Synthetic control study design on lifting mask mandate in the state of Iowa implemented on February 7, 2021. SETTING: Daily state-level data from the COVID-19 Community Profile Report published by the US Department of Health & Human Services, COVIDcast dataset of the Delphi Research Group, and Google Community Mobility Reports. EXPOSURES AND OUTCOME: Mask mandate policy lift at the state level. State-day observations of the cumulative case rate measured as the cumulative number of new cases per 100,000 people in the previous 7 days. RESULTS: The cumulative case rate in Iowa increased by 20%-30% within 3 weeks of lifting the mask mandate as compared with a synthetic control unit. This association appeared to be related to people, in fact, reducing their mask-wearing habits. CONCLUSIONS: Lifting the mask mandate in Iowa was associated with an increase in new COVID-19 cases. Caution should be applied when making this type of policy decision before having achieved a more stable control of the pandemic.


Assuntos
COVID-19 , COVID-19/prevenção & controle , Humanos , Iowa/epidemiologia , Pandemias , Políticas , SARS-CoV-2
18.
Am J Manag Care ; 28(3): e78-e79, 2022 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-35404550

RESUMO

In response to study findings showing the risk of cardiovascular adverse events associated with testosterone therapy, the FDA issued safety warnings in 2014 and modified testosterone labeling in March 2015 to indicate the increased risk of stroke and heart attack. It is unknown whether there were changes in testosterone marketing practices by pharmaceutical companies following the FDA label warning. Both primary care physicians (PCPs) and non-PCPs prescribe testosterone and are targeted by pharmaceutical marketing representatives to encourage testosterone prescribing. Likewise, pharmaceutical marketing occurs in both urban and rural areas. Our study is the first to examine testosterone marketing practices around the period of the testosterone label warning by physician specialty and rural vs urban primary care service area. In this study, we found that testosterone marketing efforts such as marketing spending per encounter, quarterly marketing spending per physician, and quarterly number of encounters per physician increased among non-PCPs and urban physicians for 4 quarters following an FDA boxed warning in 2015 on testosterone prescriptions. After the black box warning, off-label testosterone advertisements stopped. This reduction in advertising could have made it more attractive for pharmaceutical companies to increase their marketing spending targeting non-PCPs and physicians in urban areas. Understanding responses of pharmaceutical companies to FDA guidelines is important and can help inform future guideline initiatives.


Assuntos
Médicos , Testosterona , Humanos , Marketing , Preparações Farmacêuticas , Padrões de Prática Médica , Testosterona/efeitos adversos , Estados Unidos , United States Food and Drug Administration
19.
JAMA Otolaryngol Head Neck Surg ; 148(5): 465-473, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35389454

RESUMO

Importance: Overuse of costly neuroimaging technology is associated with low-value care for the prevalent symptom of dizziness. Although quality improvement initiatives have focused on the overuse of computed tomography (CT) scans in emergency departments (EDs), most patients with dizziness present to outpatient clinics. To inform practice and policy, a comprehensive understanding of the uses and costs of neuroimaging across settings and episodes of care is needed. Objective: To characterize neuroimaging use, timing, and spending as well as factors associated with imaging acquisition within 6 months of presentation for dizziness in outpatient vs ED settings. Design, Setting, and Participants: This cross-sectional study of commercial and Medicare Advantage claims for 805 454 adults (≥18 years of age) with new diagnoses of dizziness was conducted from January 1, 2006, through December 31, 2015. Data were analyzed from October 1, 2020, to September 30, 2021. Main Outcomes and Measures: Use of neuroimaging (CT scan, magnetic resonance imaging [MRI], angiography, and ultrasonography) and total spending on neuroimaging were measured. Kaplan-Meier analysis was performed. The associations of neuroimaging with setting, sociodemographic characteristics, and clinicians were estimated with multivariable analyses. Results: A total of 805 454 individuals with dizziness (502 055 women [62%]; median age, 52 years [range, 18-87 years]) were included in this study; 156 969 (20%) underwent neuroimaging within 6 months of presentation (65 738 of 185 338 [36%] presented to EDs and 91 231 of 620 116 [15%] presented to outpatient clinics). The median time to neuroimaging was 0 days (95% CI, 0-2 days) after ED presentation and 10 days (95% CI, 9-10 days) after outpatient presentation. Neuroimaging was independently associated with advanced age, comorbidity, race and ethnicity, ED presentation, and outpatient clinician specialty. Across sites, a head CT scan was the most used test on presentation date (92% of tests [46 852 of 51 022]). Within 6 months of presentation, a head CT scan was the most used test (47% of all tests [177 949 of 376 149]), followed by brain MRI (25% [93 130 of 376 149]), cerebrovascular ultrasonography (15% [56 175 of 376 149]), and magnetic resonance angiography (9% [34 026 of 376 149]). Of $88 646 047.03 in total neuroimaging spending, MRI accounted for 70% ($61 730 251.95), CT scans for 19% ($16 910 506.24), and ultrasonography for 11% ($10 005 288.84). Per-test median spending ranged from $68.97 (CT scan of the head) to $319.63 (MRI of the brain) among commercially insured individuals and $43.21 (CT scan of the head) to $362.02 (MRI of the orbit, face, and neck) among Medicare Advantage beneficiaries. Conclusions and Relevance: The findings of this cross-sectional study suggest that use of neuroimaging for dizziness is prevalent across settings. Interventions to optimize the use of neuroimaging must occur early in the patient care journey to discourage guideline-discordant use of CT scans, advocate for judicious MRI use (particularly in ambulatory settings), and account for the effects of price transparency.


Assuntos
Tontura , Medicare , Adulto , Idoso , Instituições de Assistência Ambulatorial , Estudos Transversais , Tontura/diagnóstico por imagem , Serviço Hospitalar de Emergência , Feminino , Humanos , Pessoa de Meia-Idade , Neuroimagem , Estados Unidos , Vertigem/diagnóstico
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