US Practice Research Articles

Assessing the state of care for Huntington disease in the United States: Results from a survey of practices treating Huntington disease patients

BackgroundNo study to date has thoroughly examined US Huntington disease (HD) care delivery in a variety of clinic settings by HD specialists and non-specialists. ObjectiveTo obtain a clearer understanding of current care structure and delivery of care through a survey of representative US physicians treating HD patients. MethodsWe designed and fielded a survey of 40 closed-ended evaluative items and one open-ended item to a sample of 339 US practices. Unique to this survey was the inclusion of non-specialists. ResultsResponses were received from 156 practices (overall response rate 46.02 %), with 52.6 % from academic sites, 35.3 % from private practices, and 12.2 % from the VA. More than half (63.5 %) of the practice leads were movement disorder trained or Directors of HDSA Centers of Excellence and 58.3 % had an HD or multidisciplinary care clinic. However, 48.7 % of the practices saw 1–25 HD patients, 28.2 % saw 26–100 HD patients, and 23.1 % served over 100 HD patients annually. Most practices (>69 %) reported having difficulty providing social work, genetic counseling, care coordination and psychologists/psychiatrists. Increased HD practice size was associated with higher rates of pre-visit screenings, care navigator/care coordinators, routine monitoring of weight, and provision of genetic counseling by genetic counselors. ConclusionsNot surprisingly, we found that HD care was inconsistently applied across the US. Practices led by neurologists trained in movement disorders, and higher HD volume practices, tended to be better equipped to provide multi-disciplinary staffing and procedures as compared to those with fewer numbers of HD patients.

POSC389 Characterisation of Existing Treatment Patterns in Muscle-Invasive Urothelial Carcinoma (MIUC) Across North America, Europe, and East Asia

Radical resection (RR), the current standard of care for MIUC, can be combined with neoadjuvant or adjuvant cisplatin-based therapy depending on cisplatin eligibility. This study assessed treatment patterns in MIUC in clinical practice in EU5 (France, Germany, Italy, Spain, UK), US, Canada, China, and Japan.

Intersectionaliteiten in actie: articulaties van een reizend concept in de activistische praktijk

Intersectionality, arguably the most well-known theoretical and political sensibility to emerge out of US black feminism, has proven a particularly mobile concept, informing and shaping feminist scholarship both in the US and beyond. While academics have traced its various trajectories and its reception in non-US settings, little attention has been paid to how intersectionality is articulated in different nationally situated activist communities. In this exploratory study of the intersectionality concept in Dutch climate activism and Dutch queer activism, we trace how Dutch activists articulate the meaning and relevance of intersectionality to their own practice. Our data demonstrate that intersectionality is problematized differently in these two settings: among climate activists, it functions as a horizon to aspire to and as a risky ‘add-on’ to existing practice, while within queer activism, intersectionality is understood as an already existing reality that requires careful calibration and practices of ‘calling in’. It is also associated with particular risks: in climate activism, its status as a horizon to aspire to raises questions about the community’s understanding of climate activism itself, while the queer activists, ‘always having been intersectional’, struggle with the question: when are we intersectional enough? In examining these different articulations of intersectionality, we develop an understanding of intersectionality as a travelling and situated concept beyond the US academy and practice, and comment especially on its Janus-faced character as a both politicizing and depoliticising tool in activists’ practice.

A Review of Non-Tariff Measures with Particular Focus on the US and China Practices

The US-China trade war that started with the focus on tariffs has provided impetus for hostilities on the front of non-tariff measures (NTMs) also. The first objective of this paper is to appraise the current knowledge of NTMs with respect to its classification, determinants and importantly its impact on international trade by intensively reviewing the exiting literature on the subject matter. The implementation of NTMs primarily results in negative effect on trade, though some positive effects could also be observed. Secondly, the paper delves into the understanding of the past NTM practices of the US and China, thereby leading to the knowledge on its potential use in the future. Both countries instigated a large number of NTMs towards their trading partners and also against each other. Besides, they have mainly used TBT and SPS aspects of NTMs which are primarily agriculture related products. With the escalation of the trade war, there is a greater likelihood that the scale and scope on the use of NTMs gets amplified.

Barriers to telehealth usage by maternal fetal medicine providers by US region and urbanicity

Delivery of prenatal care via telehealth has the potential to improve access to care and decrease health disparities. The Covid-19 pandemic precipitated changes to healthcare service provision including increased use of telehealth. The experience of Maternal Fetal Medicine (MFM) providers can help identify barriers encountered in the implementation of telehealth. We aimed to identify differences in barriers experienced by MFM providers by US region and urbanicity. We conducted a web-based, anonymous survey of the Society for Maternal-Fetal Medicine membership in December 2020, assessing telehealth use during the Covid-19 pandemic. Users of telehealth were defined by reported use of live video consultations before or after the start of the pandemic. Comparisons by region and urbanicity were performed using Fisher’s exact test and a p-value of < 0.05 was considered significant. The survey response rate was 16%. Out of 373 completed surveys, 330 (88%) were users of telehealth. Respondents practiced in the South (31%), West (28%), Northeast (21%), and Midwest (20%). Practice location was 65% urban, 21% suburban, and 14% rural or small town. There was no difference by telehealth user status and region (p=0.29) or urbanicity (p=0.13). A majority providers reported practicing in a university hospital setting (52%). 51% of respondents cited patient access to internet/data plans as a barrier to telehealth usage, independent of region or urbanicity. 45% reported software/hardware usability as a telehealth barrier across all regions and practice locations. Of the total respondents, less than 25% of providers reported patient privacy concerns or telehealth set-up costs as barriers to telehealth in their practice. Maternal fetal medicine providers face similar barriers, independent of US region or practice setting. It is important to identify barriers to telehealth to ensure more equitable access across US regions and urban and rural practice settings. These results highlight opportunities to advance telehealth, in effort to improve overall perinatal health.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

“If relatives inherited the gene, they should inherit the data.” Bringing the family into the room where bioethics happens

Biological kin share up to half of their genetic material, including predisposition to disease. Thus, variants of clinical significance identified in each individual’s genome can implicate an exponential number of relatives at potential risk. This has renewed the dilemma over family access to research participant’s genetic results, since prevailing US practices treat these as private, controlled by the individual. These individual-based ethics contrast with the family-based ethics – in which genetic information, privacy, and autonomy are considered to be familial – endorsed in UK genomic medicine and by participants in a multi-method study of US research participants presented here. The dilemma reflects a conflict between US legal and ethical frameworks that privilege “the individual” and exclude “the family” versus actual human genetics that are simultaneously individual and familial. Can human genetics succeed in challenging bioethics’ hegemonic individualism to recognize and place the family at the center of the room where bioethics happens?

Findings from the Hispanic Community Health Study/Study of Latinos on the Importance of Sociocultural Environmental Interactors: Polygenic Risk Score-by-Immigration and Dietary Interactions.

Introduction: Hispanic/Latinos experience a disproportionate burden of obesity. Acculturation to US obesogenic diet and practices may lead to an exacerbation of innate genetic susceptibility. We examined the role of gene–environment interactions to better characterize the sociocultural environmental determinants and their genome-scale interactions, which may contribute to missing heritability of obesity. We utilized polygenic risk scores (PRSs) for body mass index (BMI) to perform analyses of PRS-by-acculturation and other environmental interactors among self-identified Hispanic/Latino adults from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Methods: PRSs were derived using genome-wide association study (GWAS) weights from a publicly available, large meta-analysis of European ancestry samples. Generalized linear models were run using a set of a priori acculturation-related and environmental factors measured at visit 1 (2008–2011) and visit 2 (2014–2016) in an analytic subsample of 8,109 unrelated individuals with genotypic, phenotypic, and complete case data at both visits. We evaluated continuous measures of BMI and waist-to-hip ratio. All models were weighted for complex sampling design, combined, and sex-stratified. Results: Overall, we observed a consistent increase of BMI with greater PRS across both visits. We found the best-fitting model adjusted for top five principal components of ancestry, sex, age, study site, Hispanic/Latino background genetic ancestry group, sociocultural factors and PRS interactions with age at immigration, years since first arrival to the United States (p < 0.0104), and healthy diet (p < 0.0036) and explained 16% of the variation in BMI. For every 1-SD increase in PRS, there was a corresponding 1.10 kg/m2 increase in BMI (p < 0.001). When these results were stratified by sex, we observed that this 1-SD effect of PRS on BMI was greater for women than men (1.45 vs. 0.79 kg/m2, p < 0.001). Discussion: We observe that age at immigration and the adoption of certain dietary patterns may play a significant role in modifying the effect of genetic risk on obesity. Careful consideration of sociocultural and immigration-related factors should be evaluated. The role of nongenetic factors, including the social environment, should not be overlooked when describing the performance of PRS or for promoting population health in understudied populations in genomics.

Time to inclusion in clinical guidance documents for non-oncological orphan drugs and biologics with expedited FDA designations: a retrospective survival analysis

ObjectivesDrug and biological products that treat rare, serious or life-threatening conditions can receive US Food and Drug Administration (FDA) orphan designation and expedited programme designations (accelerated approval, breakthrough therapy, fast...

“Whatever you hide, also hides you”: A discourse analysis on mental health and service use in an American community of Somalis

After decades of refugee displacement, Somalis are at increased risk for poor mental health. However, uptake of treatment referrals in primary care is low among Somalis compared to other refugee groups. The objective of this analysis was to understand specific resistances to US mental health care contributing to this gap in coverage. One hundred and sixty-eight Somali men and women over the age of 14, participated in 28 focus group from October 2017 to November 2018 discussing wellbeing and healthcare in the US. Transcripts were analyzed based on critical discourse theory, informed by the theoretical work of Michel Foucault. This study identified two primary discourses, one biomedical and the other driven by Somali community mental health knowledge and social practice. Mental health as an object of Muslim faith, nosological fusion of psychiatric illness terms, and stigmatization and internal social control to limit disclosure were discussed. US mental health services were described as giving off a bad vibe, and represented external institutions of power, exacerbated by perceived discrimination. Somali youth occupied social bridging positions between cultural vs. US knowledge and practice. Three negotiating discourses emerged wherein participants created discursive solutions to these sites of resistance, including 1) how the social acceptability of seeking psychological care might be increased while maintaining Somali emotional resilience, 2) stressing the need to seek medical care as a practical supplement to spiritual care, and 3) highlighting the need for Somali youth to enter health fields. Findings suggest that intervention strategies not only ensure that services are culturally appropriate and sensitive to religion, but also consider that services are potentially seen as both an extension of US institutional power and an affront to Somali identity making. Overcoming these challenges may involve nurturing the negotiating discourses taken up by communities.

Review of Neonatal and Infant Cranial US.

Review of Neonatal and Infant Cranial US.

TCT-274 Differences in Risk Profile, Management, and Outcomes of STEMI Among Asian vs White Patients in Contemporary US Practice

TCT-274 Differences in Risk Profile, Management, and Outcomes of STEMI Among Asian vs White Patients in Contemporary US Practice

Statin Intolerance and Noncompliance: An Empiric Approach

Statin Intolerance and Noncompliance: An Empiric Approach

Is Currency Undervaluation a Subsidy: US Law and Practice and the WTO Compatibility

On 4 February 2020, the Department of Commerce (Commerce) adopted revised Regulations Regarding Benefit and Specificity in Countervailing Duties Proceedings after reviewing solicited comments. Soon after, the Commerce initiated countervailing investigations against Vietnamese passenger vehicle tires and Chinese twist ties, and for the first time imposed preliminary countervailing duties (CVDs) against these two countries based on currency undervaluation. This article considers the revised regulations, two CVD investigations and their WTOcompatibility. We argue that views on whether or not currency undervaluation constitutes a subsidy reflect divergences between the US and other negotiating parties during the Uruguay Round on the definition of a subsidy. Whereas currency undervaluation does confer benefits to producers and exporters, it does not fulfill the criteria of ‘financial contribution’ and specificity as laid down in the Subsidies and Countervailing Measures (SCM) Agreement; thus the CVD decisions of the Commerce are WTO-incompatible. Currency undervaluation, Countervailing duties, subsidy, specificity, financial contribution

Modern Slavery, Human Trafficking, and Child Labor in Corporate Supply Chains: Creating Oppression-Free Portfolios

Environmental, social, and governance (ESG) standards do not permit complicity in modern slavery, human trafficking, or child labor (Principles for Responsible Investment [PRI] 2021, 4). And yet, the breadth and depth of oppressive labor practices in US and global corporate supply chains is, in a word, staggering. Across industry and geographic boundaries, throughout corporate America and the world, modern slavery, human trafficking, and child labor support a myriad of goods and services produced, supplied, and consumed daily. The coffee you drank this morning; the car in your driveway; the shirt, pants, dress, or shoes you’re wearing; the phone in your hand and computer on your desk; the salad you might have had yesterday and the shrimp you may be served tonight; the hotel room prepared for your recent night’s sleep and chocolate on your bedside; the mask you’ve been wearing because of COVID-19—all may have been grown, harvested, mined, sewn, or assembled, in part, by adults and children, some as young as four or five, compelled to work unwillingly under threat of bodily harm, torture, or even death.Modern slavery, human trafficking, and child labor, which we label for this paper “oppressive labor”, is a global societal problem demanding a strong public reaction from responsible investors. Investing in companies harvesting oppressive labor is neither ethically nor morally responsible, contravenes fundamental notions of social justice contained in modern ESG standards, and may result in disappointing financial performance in those companies found to be so engaged. Investors wishing to follow ESG best practices should disinvest from companies whose supply chains are linked to oppressive labor practices. We construct oppression-free portfolios with acceptable tracking errors to four popular indexes.

Treatment Effect of Percutaneous Coronary Intervention in Men Versus Women With ST-Segment-Elevation Myocardial Infarction.

BackgroundWomen are less likely to receive primary percutaneous coronary intervention (pPCI) than men. A potential reason is risk aversion because of the worse outcomes with pPCI among women. However, whether pPCI is associated with a comparable mortality benefit in men and women remains unknown.Methods and ResultsWe selected patients admitted with a principal diagnosis of ST‐segment–elevation myocardial infarction in the National Inpatient Sample (2016–2018). We used propensity‐score matching to calculate average treatment effects of pPCI for in‐hospital mortality, major complications, length of stay, and cost. As a sensitivity analysis, we used logit models followed by a marginal command to calculate the average marginal effect. We included 413 500 weighted hospitalizations (30.7% women, 69.3% men). Women had more comorbidities except smoking and prior sternotomy. Compared with men, women were less likely to undergo angiography (81.0% versus 87.0%; adjusted odds ratio [OR], 0.77; 95% CI, 0.74–0.81; P<0.001) or pPCI (74.0% versus 82.0%; adjusted OR, 0.76; 95% CI, 0.73–0.79; P<0.001). There were no significant differences in average treatment effects of pPCI on mortality between men (−8.4% [−9.3% to −7.6%], P<0.001), and women (−9.5% [−10.8% to −8.3%], P<0.001) (P interaction=0.16). This persisted in age‐stratified analyses (≥85, 65–84, 45–64, <45 years) and sensitivity analysis, excluding emergent admissions. The average treatment effects of pPCI on major complications were comparable except for acute stroke, leaving against medical advice, and palliative encounter. There were no differences in the average treatment effects of pPCI on length of stay, but the proportional increase in cost with pPCI was higher in women.ConclusionspPCI results in a comparable reduction in in‐hospital mortality in men and women. Nonetheless, risk‐adjusted rates of pPCI remain lower in women in contemporary US practice.

682P Real-world utilization and outcomes of immune-based combination therapies or tyrosine kinase inhibitors (TKIs) for advanced renal cell carcinoma (aRCC)

Nivolumab plus ipilimumab (NIVO+IPI) and pembrolizumab plus axitinib (PEM+AXI) received US FDA approval in 2018 and 2019, respectively, as first-line (1L) therapy for patients (pts) with aRCC, with superior efficacy versus sunitinib. This real-world study assessed characteristics, clinical outcomes, and safety profiles of aRCC pts receiving each 1L regimen at nonacademic US practices.

Vaccine Protection Efficiency Compared with the Smart Application of Common-Sense Pandemic Control Measures

Most recent NIH studies and CDC publication were able to estimate the vaccine efficacy variation overtime, and to remove the previous vail of ultimate and absolute protection against SARS-CoV-2, known as COVID-19 with respect to delta variant, propagated in the USA. The statistical data shows clear that Vaccines as Pfizer ad Moderna works, in spite their efficacies are decreasing with about 5%/month, are still able to protect in a more complex manner than masks and nano-engineered aerodynamics based protection measures. If these measures are referring to preventing inhalation of any hazardous material, no matter the type of viruses, the vaccine is dealing with the effects of virus inside the body after the intake took place. These vaccines were considered an ultimate protection and praised as such, as being in fact big pharma business, easy to be understood by masses with a real nature hazard mitigation IQ level much lower than the one made at national level based on the actual IQ tests customized to keep happy Caucasians, but fit well on Pacific Rim Asians. The problem with engineered protection is that one needs a smart population, cooperating synergistically, and be knowledgeable on when and how to use the protection in order to stop pandemic, insulate aggressor virus, create a vaccine and terminate the hazard. The current US practice is dominated by high-level mis-information and politicization of pandemic, where the actual spike in delta variant is due to CDC suppression of masks, without reaching a heard immunity, praising and enforcing vaccination aggravated by the incompetence of conservatives, who do not understand that a sick or dead person cannot enjoy constitutional freedoms, and do not distinguish between a life threat and a right, simply opposing to government without coming with alternate measures, having a disastrous effect on US population which with only 4% of world’s population delivered more than 25% of world’s causalities. The current milestone of 610,000 deaths and 40 million infected made the world leery about US exceptionalism and its planetary leadership.

The Right to Residency: Mobility, Tuition, and Public Higher Education Access

AbstractThis article argues that the now-widespread US practice of residency-based tuition differentials for public higher education institutions is a twentieth-century form of higher education exceptionalism carved out in law and state policy, contradicting otherwise cherished and protected rights of free movement. This contradiction has been enabled in part by the vague standard of constitutional protection for the right to interstate mobility and in part by fiscal deference to public universities that quickly recognized the potential benefits of higher nonresident tuition rates. By both defining higher education as outside of the “necessities of life” and upholding a narrative that the children of state residents had a special entitlement to lower tuition as a kind of “legacy” taxpayer inheritance, courts, legislatures, and educational institutions built a modern higher education finance structure that discriminates against the mobility of “newcomers” and any student with a complicated family structure or residency status.

Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease–Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients

Clinical trial data have demonstrated the efficacy of etelcalcetide for reducing parathyroid hormone (PTH) levels in hemodialysis (HD) patients. We provide a real-world summary of etelcalcetide utilization, dosing, effectiveness, and discontinuation since its US introduction in April2017. New-user design within prospective cohort. 2,596 new users of etelcalcetide from April 2017 through August 2019 in a national sample of adult maintenance HD patients in the US Dialysis Outcomes and Practice Patterns Study (DOPPS). Baseline PTH, prior cinacalcet use, initial etelcalcetide dose. Trajectories of etelcalcetide dose, chronic kidney disease-mineral and bone disease (CKD-MBD) medications, and levels of PTH, serum calcium, and phosphorus in the 12 months after etelcalcetide initiation. Cumulative incidence methods for etelcalcetide discontinuation and linear generalized estimating equations for trajectory analyses. By August 2019, etelcalcetide prescriptions increased to 6% of HD patients from their first use in April 2017. Starting etelcalcetide dose was 15 mg/wk in 70% of patients and 7.5 mg/wk in 27% of patients; 49% of new users were prescribed cinacalcet in the prior 3 months. Etelcalcetide discontinuation was 9%, 17%, and 27% by 3, 6, and 12 months after initiation. One year after etelcalcetide initiation, mean PTH levels declined by 40%, from 948 to 566 pg/mL, and the proportion of patients with PTH within target (150-599 pg/mL) increased from 33% to 64% overall, from 0 to 60% among patients with baseline PTH≥ 600 pg/mL, and from 30% to 63% among patients with prior cinacalcet use. The proportion of patients with serum phosphorus > 5.5 mg/dL decreased from 55% to 45%, while the prevalence of albumin-corrected serum calcium< 7.5 mg/dL remained at 1%-2%. There were increases in use of active vitamin D (from 77% to 87%) and calcium-based phosphate binders (from 41% to 50%) in the 12 months after etelcalcetide initiation. Data are unavailable for provider dosing protocols, dose holds, or reasons for discontinuation. In the 12 months after etelcalcetide initiation, patients had large and sustained reductions in PTH levels. These results support the utility of etelcalcetide as an effective therapy to achieve the KDIGO-recommended guidelines for CKD-MBD markers in HD patients.

Quantifying and Understanding the Higher Risk of Atherosclerotic Cardiovascular Disease Among South Asian Individuals: Results From the UK Biobank Prospective Cohort Study.

Individuals of South Asian ancestry represent 23% of the global population, corresponding to 1.8 billion people, and have substantially higher risk of atherosclerotic cardiovascular disease compared with most other ethnicities. US practice guidelines now recognize South Asian ancestry as an important risk-enhancing factor. The magnitude of enhanced risk within the context of contemporary clinical care, the extent to which it is captured by existing risk estimators, and its potential mechanisms warrant additional study. Within the UK Biobank prospective cohort study, 8124 middle-aged participants of South Asian ancestry and 449 349 participants of European ancestry who were free of atherosclerotic cardiovascular disease at the time of enrollment were examined. The relationship of ancestry to risk of incident atherosclerotic cardiovascular disease-defined as myocardial infarction, coronary revascularization, or ischemic stroke-was assessed with Cox proportional hazards regression, along with examination of a broad range of clinical, anthropometric, and lifestyle mediators. The mean age at study enrollment was 57 years, and 202 405 (44%) were male. Over a median follow-up of 11 years, 554 of 8124 (6.8%) individuals of South Asian ancestry experienced an atherosclerotic cardiovascular disease event compared with 19 756 of 449 349 (4.4%) individuals of European ancestry, corresponding to an adjusted hazard ratio of 2.03 (95% CI, 1.86-2.22; P<0.001). This higher relative risk was largely consistent across a range of age, sex, and clinical subgroups. Despite the >2-fold higher observed risk, the predicted 10-year risk of cardiovascular disease according to the American Heart Association/American College of Cardiology Pooled Cohort equations and QRISK3 equations was nearly identical for individuals of South Asian and European ancestry. Adjustment for a broad range of clinical, anthropometric, and lifestyle risk factors led to only modest attenuation of the observed hazard ratio to 1.45 (95% CI, 1.28-1.65, P<0.001). Assessment of variance explained by 18 candidate risk factors suggested greater importance of hypertension, diabetes, and central adiposity in South Asian individuals. Within a large prospective study, South Asian individuals had substantially higher risk of atherosclerotic cardiovascular disease compared with individuals of European ancestry, and this risk was not captured by the Pooled Cohort Equations.