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DISCLOSURES Funding for this summary was contributed by Arnold Ventures, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Sun Life Financial, uniQure, and United Healthcare. Agboola, Herron-Smith, Nhan, Rind, and Pearson are employed by ICER. Through their affiliated institutions, Atlas, Brouwer, Carlson, and Hansen received funding from ICER for the work described in this summary.BACKGROUND Community pharmacists are well positioned to improve patient access to care, which may assist value-based care programs in reaching patients. While pharmacy accessibility is broadly acknowledged, much of the research supporting accessibility claims is poor quality. OBJECTIVE To quantify the accessibility of pharmacists in comparison with physicians or qualified health care professionals (QHP) in a commercially insured population. METHODS IBM MarketScan claims data from 2018 were used for this cross-sectional study. Beneficiaries included in the primary analysis were aged 18-64 years, enrolled with pharmacy benefits in 2018 for 12 months, and had at least 1 valid prescription drug claim or evaluation and management (E&M) code in 2018. Unique pharmacy visits were defined using a 6-day fill window for prescription fill dates, while visits to physicians or other QHP were defined as unique service dates tied to an E&M code. We assessed differences in visit frequency for the full sample, those with multis they visit their physicians or other QHP. Study findings emphasize the accessibility of community pharmacists and highlight the role of community pharmacists in improving patient engagement in all care programs, including value-based care programs. DISCLOSURES The database infrastructure used for this project was funded by the Department of Epidemiology, University of North Carolina (UNC) Gillings School of Global Public Health; the Cecil G. Sheps Center for Health Services Research, UNC; the CER Strategic Initiative of UNC's Clinical Translational Science Award (UL1TR001111); and the UNC School of Medicine. All authors are employed by the UNC School of Pharmacy. learn more Urick declares consulting fees from Cardinal Health. The other authors have no conflicts of interest to disclose. Portions of this work were previously presented at the AMCP 2021 Virtual, April 12-16, 2021.Aim To attend stem cell (SC) seminars hosted by US-based direct-to-consumer SC businesses either in person or via online 'webinars' to determine accuracy and regulatory oversight of the advertised SC therapies. Methods The therapeutic claims, costs, risks, scientific evidence in support of a therapy and any regulatory oversight were collated using pre-established checklists. Participation consisted of one live attendance of a seminar, and following COVID-19 restrictions, review of seven recorded presentations available on the internet from SC businesses. Results & conclusion None of the SC therapies advertised by direct-to-consumer clinics reviewed were supported by proper clinical evidence nor substantiated by peer reviewed literature.Following the onset of the COVID-19 pandemic, Israel established a number of 'corona hotels' - hybrid spaces that were neither fully treatment-oriented nor fully incarcerational, in which people known or suspected to be infected with the coronavirus were confined, sometimes for prolonged and indefinite periods. This paper describes the experience of 25 people who were confined in corona recovery and isolation hotels between March and July 2020. The corona hotels exemplify how remote medical technology and digital medicine together enable a new 'technogeography of care', where care and abandonment are inextricably linked. The paper adds to the growing number of critical studies on digital health by showing how the employed technologies impact the concepts of human embodiment, subjectivity and social relations, as well as how the occupants negotiated the meaning of these technologies and resisted their effects.

In many randomized controlled trials, a substantial proportion of patients do not comply with the treatment protocol to which they have been randomly assigned. Randomized controlled trials are required to report results according to the intention-to-treat estimand, but recent methodological guidance recognizes the importance of estimating other causal quantities.

This article outlines an analytical framework for randomized controlled trials with non-compliance. We apply the ICH E9 (R1) addendum and combine it with the potential outcomes framework to define key estimands, outline the major assumptions for identification of each estimand, and highlight the assumptions that cannot be verified from the randomized controlled trial data. We contrast the assumptions and estimates in a re-analysis of the REFLUX trial. We report alternative estimates for the effectiveness of receipt of laparoscopic surgery versus medical management for patients with gastro-intestinal reflux disease.

The article finds that adjusted as-treated and per-protocol estimates were similar in magnitude to those based intention-to-treat methods. Instrumental variable estimates of the complier average causal effect were larger, with wider confidence intervals.

We recommend that in randomized controlled trials with non-compliance, studies should outline which estimand is most relevant to the study context, evaluate key assumptions, and present estimates from a range of methods as a sensitivity analysis.

We recommend that in randomized controlled trials with non-compliance, studies should outline which estimand is most relevant to the study context, evaluate key assumptions, and present estimates from a range of methods as a sensitivity analysis.

A novel familial arrhythmia syndrome, cardiac ryanodine receptor (RyR2) calcium release deficiency syndrome (CRDS), has recently been described. We evaluated a large and well characterized family to assess provocation testing, risk factor stratification and response to therapy in CRDS.

We present a family with multiple unheralded sudden cardiac deaths and aborted cardiac arrests, primarily in children and young adults, with no clear phenotype on standard clinical testing.

Genetic analysis, including whole genome sequencing, firmly established that a missense mutation in

, Ala4142Thr, was the underlying cause of disease in the family. Functional study of the variant in a cell model showed RyR2 loss-of-function, indicating that the family was affected by CRDS. EPS (Electrophysiological Study) was undertaken in 9 subjects known to carry the mutation, including a survivor of aborted sudden cardiac death, and the effects of flecainide alone and in combination with metoprolol were tested. There was a clear 4142Thr mutation of RYR2 causes the novel heritable arrhythmia syndrome CRDS, which is characterized by familial sudden death in the absence of prior symptoms or a recognizable phenotype on ambulatory monitoring or exercise stress testing. We increase the experience of a specific EPS protocol in human subjects and show that it is helpful in establishing the clinical status of gene carriers, with potential utility for risk stratification. Our data provide evidence that flecainide is protective in human subjects with CRDS, consistent with the effect previously shown in a mouse model.

Sudden cardiac arrest (SCA) and sudden unexplained death (SUD) are feared sequelae of many genetic heart diseases. In rare circumstances, pathogenic variants in cardiomyopathy-susceptibility genes may result in electrical instability leading to SCA/SUD before any structural manifestations of underlying cardiomyopathy are evident.

Collectively, 38 unexplained SCA survivors (21 males; mean age at SCA 26.4±13.1 years), 68 autopsy-inconclusive SUD cases (46 males; mean age at death 20.4±9.0 years) without disease-causative variants in the channelopathy genes, and 973 ostensibly healthy controls were included. Following exome sequencing, ultrarare (minor allele frequency ≤0.00005 in any ethnic group within Genome Aggregation Database [gnomAD, N=141 456 individuals]) nonsynonymous variants identified in 24 Clinical Genome Resource adjudicated definitive/strong evidence cardiomyopathy-susceptibility genes were analyzed. Eligible variants were adjudicated as pathogenic, likely pathogenic, or variant of uncertain evidence cardiomyopathy-susceptibility genes on the genetic testing panels used to evaluate unexplained SCA survivors and autopsy-inconclusive/negative SUD decedents. However, to avoid diagnostic miscues, the careful interpretation of genetic test results in patients without overt phenotypes is vital.

Our data further supports the inclusion of strong evidence cardiomyopathy-susceptibility genes on the genetic testing panels used to evaluate unexplained SCA survivors and autopsy-inconclusive/negative SUD decedents. However, to avoid diagnostic miscues, the careful interpretation of genetic test results in patients without overt phenotypes is vital.

Prospective studies demonstrate that aggressive pharmacological therapy combined with pump speed optimization may result in myocardial recovery in larger numbers of patients supported with left ventricular assist device (LVAD). This study sought to determine whether the use of machine learning (ML) based models predict LVAD patients with myocardial recovery resulting in pump explant.

A total of 20 270 adult patients with a durable continuous-flow LVAD in the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support) were included in the study. Ninety-eight raw clinical variables were screened using the least absolute shrinkage and selection operator for selection of features associated with LVAD-induced myocardial recovery. ML models were developed in the training data set (70%) and were assessed in the validation data set (30%) by receiver operating curve and Kaplan-Meier analysis.

Least absolute shrinkage and selection operator identified 28 unique clinical features associotocols.

ML can be a valuable tool to identify subsets of LVAD patients who may be more likely to respond to myocardial recovery protocols.Occupational therapy knowledge emerged in the 19th century as reformist movements responded to the industrialisation of society and capitalist expansion. In the Global North, it was institutionalised by State apparatuses during the First and Second World Wars. Although biomedicine contributed to the rapid expansion and establishment of occupational therapy as a health discipline, its domestication by the biomedical model led to an overly regulated profession that betrays its reformist ideals. Drawing on the work of Deleuze and Guattari, our aim in this article is to deconstruct the biomedicalisation of occupational therapy and demonstrate how resistance to this process is critical for the future of this discipline. The use of arts and crafts in occupational therapy may be conceptualised as a 'nomad science' aesthetically resisting the domination of industrialism and medical reductionism. Through the war efforts, a coalition of progressive nurses, social workers, teachers, artisans and activists metamorphosed into occupational therapists.