Smart Wearables: The Overlooked and Underrated Essential Worker

This Note argues that the FDA should revamp its criteria for regulating medical devices to unambiguously include smart wearables. Specifically, this Note calls for the FDA to amend its definition of “medical device” to focus on what a device is technologically capable of rather than its intended use. Part I will examine the established legislation regarding medical devices; in particular, it will examine the relationship between FDA regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and argue that when taken together, HIPAA creates a strong presumption that smart wearables should be regulated by the FDA. This Part will also discuss a recent legislative proposal that supports the call for smart wearable regulation. Part II will address alternative approaches for the proper regulation of smart wearables. Finally, Part III proposes a unique solution for regulating smart wearables as medical devices and will discuss various policy implications and will address and rebut counterclaims. Additionally, this Part considers the argument that smart wearables fit within the scope of the FDA’s current definition of a medical device and identifies loopholes that prevent them from being sufficiently regulated. This Part will conclude by providing examples of modernized smart wearables that demonstrate the need for smart wearables to be subject to the FDA’s medical device regulations. This abstract has been taken from the author\u27s introduction

Qualitative evaluation of adherence therapy in Parkinson’s disease: a multidirectional model

Background: Medication can control the symptoms of Parkinson’s disease (PD). Despite this, non-adherence with medication is prevalent in PD. Treatments for improving adherence with medication have been investigated in many chronic conditions, including PD. However, few researchers have evaluated their interventions qualitatively. We investigated the acceptability and potential mechanism of action of adherence therapy (AT) in PD patients and their spouse/carers who received the intervention as part of a randomized controlled trial. Methods: Sixteen participants (ten patients and six spouses/carers) who had recently completed the trial were purposely selected in order to cover a range of ages and disease severity. Semi-structured interviews were conducted in the participants’ homes. Data were transcribed and analyzed using a thematic approach. A second researcher, naïve to PD and AT, analyzed the data independently to limit bias. Results: The trial showed that AT significantly improved both medication adherence and quality of life in people with PD. Specifically, patients who received AT reported improvements in mobility, activities of daily living, emotional wellbeing, cognition, communication, and body discomfort. General beliefs about medication also significantly improved in those who received AT compared with controls. In the current qualitative evaluation, a total of 175 codes were generated, which formed eleven subthemes. These could be grouped under three overarching themes, ie, perceptions prior to AT, positive effects of AT, and attributes of AT. Conclusion: This randomized controlled trial is the first to investigate AT in PD. The acceptability and underlying mechanism of the intervention suggest a new multidirectional model of AT in PD which future research should seek to confirm. The findings provide a deeper understanding of AT and will allow clinicians to modify the delivery of the intervention by acknowledging various pathways to improved outcomes

Do grandparents matter? : The impact of Grandparenting on the wellbeing of children

This timely and important report shows the immense value of grandparents in 21st century family life. It reveals a unique relationship that exists between the older generation and the youngest: a relationship of love and trust that enables the children to use their grandparents as confidantes and counsellors as well as playmates and cookery instructors. The report shows that children value the non-critical support, emotional advice and guidance that grandparents offer and enjoy the quality time their grandparents give them. It also found that the relationship has benefits for grandparents adding to their raison d’être and contributing to their health and longevity. The report also notes the change in the nature of family relationships in Britain throughout the 20th century, from the extended family to the nuclear family to the current variety of relationships, formal and informal, in which both the elderly and the young suffer neglect. With today’s increased incidence of divorce and family breakdown, grandparents can sometimes provide the only stable family relationship in a child’s life, and yet grandparents often lose contact with their grandchildren during or after a divorce or relationship breakup and have no legal rights through the Family Court to continue offering loving care and support to their grandchildren. The report concludes that there is need for much greater understanding of the role and function of grandparents in family life today.Final Published versio

Putting It Together: A New Idea for DEIA Staff Development

The success of DEIA initiatives truly does begin with the staff. Library staffs are a microcosm of the community they serve, and when all voices are part of the conversation, an organization that supports diversity, equity, inclusion, and accessibility can be created. Success begins with commitment from the employees, and staff development regarding DEIA is part of that success. But how do we put it together? How do we design training that will ensure staff buy-in? This presentation seeks to provide a new idea for DEIA staff development that will be engaging and educational, and one that can be implemented at your own library. You can create staff development programs that are creative, fun, and educational. Having the vision, the execution and putting it together, that’s what counts

Collaborative Learning in Practice (CLIP): Evaluation of a new approach to clinical learning

Background: There are challenges in creating positive clinical learning environments. A new model of practice learning for pre-registration nurse education was pilot-tested in the East of England. The Collaborative Learning in Practice model (CLIP) was developed from a similar model of practice learning used in the Netherlands. Objectives: We undertook an evaluation of a new approach to clinical learning. The aims of the project were to consider the challenges of implementation; consider the perception of gains and losses of students and stakeholders experiencing the new model of practice learning; and consider the sustainability of the new model in the context of service delivery. Methods: Mixed methods were used. Data were collected in three forms: (1) a survey of students undertaking the CLIP model and those learning within the existing mentorship model to assess the supervisory relationships and pedagogical atmosphere experienced; (2) student focus groups; and (3) qualitative one-to-one interviews with key stakeholders in the provision of practice learning environments. Results: A total of 607 questionnaires were returned out of the 738 distributed, five focus groups of a total of 30 students were undertaken, and 13 stakeholders were interviewed. Students who had experienced CLIP reported lower supervisory relationship scores compared with those without experience (mean difference = −0.24 points, 95% CI −0.21 to −0.094, p = 0.001). There was no difference in pedagogical atmosphere scores (mean difference −0.085 points, 95% CI −0.21 to 0.040, p = 0.19). Analysis of qualitative data produced two themes: ‘Adapting the environment’ illustrated the importance of learning context and ‘learning to fly’ highlighted the process of students gaining greater autonomy. Conclusion: Our findings suggest that collaborative learning in practice offers many benefits as an approach to clinical learning but with important caveats. Attention needs to be paid to particular aspects of the model such as sufficient numbers of students, and an acknowledgement of perceived losses as well as gains

Pharmacokinetics of lamivudine and lamivudine-triphosphate after administration of 300 milligrams and 150 milligrams once daily to healthy volunteers: Results of the ENCORE 2 Study

There is interest in evaluating the efficacy of lower doses of certain antiretrovirals for clinical care. We determined here the bio-equivalence of plasma lamivudine (3TC) and intracellular 3TC-triphosphate (3TC-TP) concentrations after the administration of two different doses. ENCORE 2 was a randomized crossover study. Subjects received 3TC at 300 and 150 mg once daily for 10 days (arm 1; n = 13) or vice versa (arm 2; n = 11), separated by a 10-day washout. Pharmacokinetic (PK) profiles (0 to 24 h) were assessed on days 10 and 30. Plasma 3TC and 3TC-TP levels in peripheral blood mononuclear cells were quantified by high-performance liquid chromatography-tandem mass spectrometry. Within-subject changes in PK parameters (the area under the concentration-time curve from 0 to 24 h [AUC0-24], the trough concentration of drug in plasma at 24 h [C24], and the maximum concentration of drug in plasma [Cmax]) were evaluated by determining the geometric mean ratios (GMRs) adjusted for study arm, period, and intra-individual variation. Regimens were considered bioequivalent if the 90% confidence interval (90% CI) fell within the range of 0.8 to 1.25. A total of 24 subjects completed the study. The GM (90% CI) 3TC AUC0-24), expressed as ng•h/ml, for the 300- and 150-mg doses were 8,354 (7,609 to 9,172) and 4,773 (4,408 to 5,169), respectively. Bioequivalence in 3TC PK following the administration of 300 and 150 mg was not demonstrated: the GMRs for AUC0-24, C24, and Cmax were 0.57 (0.55 to 0.60), 0.63 (0.59 to 0.67), and 0.56 (0.53 to 0.60), respectively. The GM (90% CI) 3TC-TP AUC0-24 values (pmol•h/106 cells) for the 300- and 150-mg doses were 59.5 (51.8 to 68.3) and 44.0 (38.0 to 51.0), respectively. Bioequivalence in 3TC-TP PK following the administration of 300 and 150 mg was not demonstrated: the GMRs for AUC0-24, C24, and Cmax were 0.73 (0.64 to 0.83), 0.82 (0.68 to 0.99), and 0.70 (0.61 to 0.82), respectively. We found that 3TC at 150 mg is not bioequivalent to the standard regimen of 300 mg, indicating that saturation of cytosine phosphorylation pathways is not achieved at a dose of 150 mg

eIF4A2 drives repression of translation at initiation by Ccr4-Not through purine-rich motifs in the 5'UTR

Background: Regulation of the mRNA life cycle is central to gene expression control and determination of cell fate. miRNAs represent a critical mRNA regulatory mechanism, but despite decades of research, their mode of action is still not fully understood. Results: Here, we show that eIF4A2 is a major effector of the repressive miRNA pathway functioning via the Ccr4-Not complex. We demonstrate that while DDX6 interacts with Ccr4-Not, its effects in the mechanism are not as pronounced. Through its interaction with the Ccr4-Not complex, eIF4A2 represses mRNAs at translation initiation. We show evidence that native eIF4A2 has similar RNA selectivity to chemically inhibited eIF4A1. eIF4A2 exerts its repressive effect by binding purine-rich motifs which are enriched in the 5′UTR of target mRNAs directly upstream of the AUG start codon. Conclusions: Our data support a model whereby purine motifs towards the 3′ end of the 5′UTR are associated with increased ribosome occupancy and possible uORF activation upon eIF4A2 binding

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

Abstract: Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions. Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated ‘standard’ or ‘COVID-altered’, in the preoperative, operative and post-operative setting. Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had ‘COVID-altered’ management. ‘Bridging’ endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2–9%) using ‘NHS Predict’. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey. Conclusions: The majority of ‘COVID-altered’ management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown

Hospital admission and emergency care attendance risk for SARS-CoV-2 delta (B.1.617.2) compared with alpha (B.1.1.7) variants of concern: a cohort study

Background: The SARS-CoV-2 delta (B.1.617.2) variant was first detected in England in March, 2021. It has since rapidly become the predominant lineage, owing to high transmissibility. It is suspected that the delta variant is associated with more severe disease than the previously dominant alpha (B.1.1.7) variant. We aimed to characterise the severity of the delta variant compared with the alpha variant by determining the relative risk of hospital attendance outcomes. Methods: This cohort study was done among all patients with COVID-19 in England between March 29 and May 23, 2021, who were identified as being infected with either the alpha or delta SARS-CoV-2 variant through whole-genome sequencing. Individual-level data on these patients were linked to routine health-care datasets on vaccination, emergency care attendance, hospital admission, and mortality (data from Public Health England's Second Generation Surveillance System and COVID-19-associated deaths dataset; the National Immunisation Management System; and NHS Digital Secondary Uses Services and Emergency Care Data Set). The risk for hospital admission and emergency care attendance were compared between patients with sequencing-confirmed delta and alpha variants for the whole cohort and by vaccination status subgroups. Stratified Cox regression was used to adjust for age, sex, ethnicity, deprivation, recent international travel, area of residence, calendar week, and vaccination status. Findings: Individual-level data on 43 338 COVID-19-positive patients (8682 with the delta variant, 34 656 with the alpha variant; median age 31 years [IQR 17–43]) were included in our analysis. 196 (2·3%) patients with the delta variant versus 764 (2·2%) patients with the alpha variant were admitted to hospital within 14 days after the specimen was taken (adjusted hazard ratio [HR] 2·26 [95% CI 1·32–3·89]). 498 (5·7%) patients with the delta variant versus 1448 (4·2%) patients with the alpha variant were admitted to hospital or attended emergency care within 14 days (adjusted HR 1·45 [1·08–1·95]). Most patients were unvaccinated (32 078 [74·0%] across both groups). The HRs for vaccinated patients with the delta variant versus the alpha variant (adjusted HR for hospital admission 1·94 [95% CI 0·47–8·05] and for hospital admission or emergency care attendance 1·58 [0·69–3·61]) were similar to the HRs for unvaccinated patients (2·32 [1·29–4·16] and 1·43 [1·04–1·97]; p=0·82 for both) but the precision for the vaccinated subgroup was low. Interpretation: This large national study found a higher hospital admission or emergency care attendance risk for patients with COVID-19 infected with the delta variant compared with the alpha variant. Results suggest that outbreaks of the delta variant in unvaccinated populations might lead to a greater burden on health-care services than the alpha variant. Funding: Medical Research Council; UK Research and Innovation; Department of Health and Social Care; and National Institute for Health Research