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Aims: To examine whether polyuse of cigarettes and other smoked products (polysmoking) is predictive of quit attempts and quit success. Design: A prospective multi‐country cohort design. Setting: Australia, Canada, England and the United States. Participants: A total of 3983 adult daily cigarette smokers were surveyed in 2016 (wave 1 of data collection) and were re‐contacted in 2018 (wave 2) (i.e. waves 1–2 cohort) in the International Tobacco Control Four Country Smoking and Vaping (ITC 4CV) surveys; and 3736 smokers were surveyed in 2018 and re‐contacted in 2020 (wave 3) (i.e. waves 2–3 cohort). Measurements Participants were asked about their cigarette smoking and use of cigars, cigarillos, pipes and waterpipes. Outcomes were quit attempts between two survey waves and success, defined as having quit smoking all the combustible tobacco at the subsequent survey for 1 month or more. Findings Levels of polysmoking were 12.7% in the waves 1–2 cohort and 10.5% for the waves 2–3 cohort. Compared with cigarette‐only smokers, polysmokers were more likely to attempt to quit between waves 1 and 2 [54.9 versus 42.7%, adjusted odds ratio (aOR) = 1.37, 95% confidence interval (CI) = 1.08–1.74, P < 0.01], but not between waves 2 and 3 (43.8 versus 40.1%, aOR = 0.94, 95% CI = 0.72–1.22). Polysmoking predicted reduced likelihood of success in both cohorts among attempters and the overall samples. Between waves 2 and 3 there were significantly more transitions to non‐daily smoking among the polysmokers (12.4 versus 5.3%, χ2 = 40.4, P < 0.001). Conclusions: There is a consistent association between polysmoking (use of cigarettes together with other smoked products) and reduced quit success for combustible tobacco, but it is probably due to increased likelihood of transitioning to non‐daily use rather than complete cessation. [ABSTRACT FROM AUTHOR]

Objectives: To examine the association between metabolic syndrome (MetS) and frailty, and determine whether co-existent MetS and frailty affect disability-free survival (DFS), assessed through a composite of death, dementia or physical disability. Design: Longitudinal study. Setting and Participants: Community-dwelling older adults from Australia and the United States (n=18,264) from "ASPirin in Reducing Events in the Elderly" (ASPREE) study. Measurements: MetS was defined according to American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines (2018). A modified Fried phenotype and a deficit accumulation Frailty Index (FI) were used to assess frailty. Association between MetS and frailty was examined using multinomial logistic regression. Cox regression was used to analyze the association between MetS, frailty and DFS over a median follow-up of 4.7 years. Results: Among 18,264 participants, 49.9% met the criteria for MetS at baseline. Participants with Mets were more likely to be pre-frail [Relative Risk Ratio (RRR): 1.22; 95%Confidence Interval (CI): 1.14, 1.30)] or frail (RRR: 1.66; 95%CI: 1.32, 2.08) than those without MetS. MetS alone did not shorten DFS while pre-frailty or frailty alone did [Hazard Ratio (HR): 1.68; 95%CI: 1.45, 1.94; HR: 2.65; 95%CI:1.92, 3.66, respectively]. Co-existent MetS with pre-frailty/frailty did not change the risk of shortened DFS. Conclusions: MetS was associated with pre-frailty or frailty in community-dwelling older individuals. Pre-frailty or frailty increased the risk of reduced DFS but presence of MetS did not change this risk. Assessment of frailty may be more important than MetS in predicting survival free of dementia or physical disability. [ABSTRACT FROM AUTHOR]

Summary: Background. Previous research focused on the clinical evidence supporting new cancer drugs' initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit. Objectives. To examine the clinical trial evidence supporting new targeted cancer drugs' initial and supplementary indication approval in the US, EU, Canada, and Australia. Data and Methods. 25 cancer drugs across 100 indications were identified with FDA approval between 2009–2019. Data on regulatory approval and clinical trials were extracted from the FDA, European Medicines Agency (EMA), Health Canada (HC), Australian Therapeutic Goods Administration (TGA), and clinicaltrials.gov. Regional variations were compared with χ2-tests. Multivariate logistic regressions compared characteristics of initial and supplementary indication approvals, reporting adjusted odds ratios (AOR) with 95% confidence intervals (CI). Results. Out of 100 considered cancer indications, the FDA approved 96, the EMA 92, HC 86, and the TGA 83 (83%, p < 0.05). The FDA more frequently granted priority review, conditional approval, and orphan designations than other agencies. Initial approvals were more likely to receive conditional / accelerated approval (AOR: 2.69, 95%CI [1.07–6.77], p < 0.05), an orphan designation (AOR: 3.32, 95%CI [1.38–8.00], p < 0.01), be under priority review (AOR: 2.60, 95%CI [1.17–5.78], p < 0.05), and be monotherapies (AOR: 5.91, 95%CI [1.14–30.65], p < 0.05) than supplementary indications. Initial indications' pivotal trials tended to be shorter (AOR per month: 0.96, 95%CI [0.93–0.99], p < 0.05), of lower phase design (AOR per clinical phase: 0.28, 95%CI [0.09–0.85], p < 0.05), and enroll more patients (AOR per 100 patients: 1.19, 95%CI [1.01–1.39], p < 0.05). Conclusions. Targeted cancer drugs are increasingly approved for multiple indications of varying clinical benefit. Drugs are first approved as monotherapies in rare diseases with a high unmet need. Whilst expedited regulatory review incentivizes this prioritization, indication-specific safety, efficacy, and pricing policies are necessary to reflect each indication's differential clinical and economic value. [ABSTRACT FROM AUTHOR]

Child maltreatment (CM) is a global public health problem. Evidence-based home visiting programs, such as SafeCare®, reduce CM risk, and enhance parent-child relationships and other protective factors. As the result of the COVID-19 pandemic and resulting restrictions, SafeCare Providers transitioned from home to virtual delivery for the SafeCare curriculum. The purpose of this study is to 1) examine active SafeCare Providers' opinions on the feasibility and effectiveness of SafeCare via remote delivery, and 2) better understand workforce concerns for human service professionals within the context of COVID-19 mitigation efforts. Data are from a cross-sectional survey of SafeCare Providers (N = 303) in the United States, Canada, and Australia. The majority of Providers reported they were actively delivering SafeCare virtually and were comfortable with the delivery format. Providers indicated that the majority of SafeCare families are making progress on target skills, and that engagement is high among many families. Some service delivery challenges were reported, ranging from family data plan limitations to difficulty with delivery of specific components of the SafeCare curriculum related to modeling and assessment. The impact of COVID-19 on Providers' daily routines, stress level, and work-life balance has been significant. Remote, virtual delivery of CM prevention programming offers the opportunity to continue serving vulnerable families in the midst of a pandemic. Barriers related to family technology and data access must be addressed to ensure reach and the effective delivery of prevention programming during the pandemic and beyond. [ABSTRACT FROM AUTHOR]

The aim of the study was to examine the mental well-being of audiologists in the midst of the COVID-19 pandemic. A cross-sectional online survey was conducted during the COVID-19 pandemic, between 23 June and 13 August 2020. A self-report survey included screening measures for psychological distress (PHQ-4: anxiety and depression) and loneliness (UCLA-3). 239 audiologists from around the world. The prevalence of psychological distress was 12.1% (subscales for anxiety 16.3% and depression 10.4%), and loneliness 32.2%. Depression and loneliness were higher in those participants self-reporting perceived job insecurity, with psychological distress (anxiety and depression) higher in those from South Africa. Accessibility to Employee Assistance Programs (EAPs) appears to be a protective factor. Well-being interventions, such as EAPS, are needed to support audiologists during challenging times like the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]