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Pharmaceutical innovation can contribute to reducing the burden of disease in human populations. This research asks whether products approved by the US Food and Drug Administration (FDA) from 2010 to 2019 and expedited review programmes incentivising development of products for serious disease were aligned with the US or global burden of disease.
Cross-sectional study.
Association of FDA product approvals (2010–2019), first approved indications, designations for expedited review with the burden of disease (disability-adjusted life years (DALYs)), years of life lost (YLL) and years of life lived with disability (YLD) for 122 WHO Global Health Estimates (GHE) conditions in US and global (ex-US) populations.
The FDA approved 387 drugs in 2010–2019 with lead indications associated with 59/122 GHE conditions. Conditions with at least one new drug had greater US DALYs (p=0.001), US YLL (p1) with US and global YLL.
FDA drug approvals from 2010 to 2019 were more strongly aligned with US than global disease burden. Designations for expedited review were not aligned with either the US or global burdens of disease and may inadvertently disincentivise development of products addressing global disease burdens. These results may inform policies to better align pharmaceutical innovation with the burdens of disease.
Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).
The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.
Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.
Background
The prevalence of short sleep duration is rising and is linked to chronic comorbidities, such as metabolic syndrome (MetS). Sleep extension interventions in adults with MetS comorbidities and short sleep duration are limited and vary widely in terms of approach and duration.
Objectives
This pilot study aimed to test the feasibility and acceptability of a personalized 12-week systematic sleep time extension intervention on post-intervention sleep outcomes in middle-aged adults at risk for MetS with actigraphy-estimated short sleep duration.
Methods
A single-arm, 12-week, 12-session systematic sleep time extension intervention was delivered weekly via videoconferencing. Feasibility and acceptability were assessed using retention rates and mean sleep diary completions. Sleep was estimated for 14 consecutive days prior to and immediately following the 12-week intervention using wrist actigraphy. Daytime sleepiness was assessed using the Epworth Sleepiness Scale. Paired sample t-tests modeled changes in study outcomes.
Results
Study participants (N = 41) had a mean age of 52 years and were mostly female and White; 86% attended >80% of sessions, and mean sleep diary completion was 6.7 diaries/week. Significant improvements in sleep from pre- to post-intervention included increased total sleep time, earlier sleep onsets, more regular sleep onsets, a higher sleep regularity index, and reduced daytime sleepiness. Extending sleep, as well as improving sleep timing and regularity in middle-aged adults with actigraphy-estimated short sleep duration and at risk for MetS, is feasible and acceptable.
Discussion
Behavioral sleep characteristics may be modifiable and present a novel behavioral paradigm for mitigating MetS risk. This pilot study provides a proof of concept for the feasibility, acceptability, and preliminary effectiveness of a systematic sleep time extension for middle-aged adults at risk for MetS with actigraphy-estimated short sleep duration. Systematic review of SARS-CoV-2 seroprevalence studies undertaken in the WHO European Region to measure pre-existing and cumulative seropositivity prior to the roll out of vaccination programmes.
A systematic review of the literature.
We searched MEDLINE, EMBASE and the preprint servers MedRxiv and BioRxiv in the WHO ‘COVID-19 Global literature on coronavirus disease’ database using a predefined search strategy. Articles were supplemented with unpublished WHO-supported Unity-aligned seroprevalence studies and other studies reported directly to WHO Regional Office for Europe and European Centre for Disease Prevention and Control.
Studies published before the widespread implementation of COVID-19 vaccination programmes in January 2021 among the general population and blood donors, at national and regional levels.
At least two independent researchers extracted the eligible studies; a third researcher resolved any disagreements. Study risk of bias was assessed using a quality scoring system based on sample size, sampling and testing methodologies.
In total, 111 studies from 26 countries published or conducted between 1 January 2020 and 31 December 2020 across the WHO European Region were included. A significant heterogeneity in implementation was noted across the studies, with a paucity of studies from the east of the Region. Sixty-four (58%) studies were assessed to be of medium to high risk of bias. Overall, SARS-CoV-2 seropositivity prior to widespread community circulation was very low. National seroprevalence estimates after circulation started ranged from 0% to 51.3% (median 2.2% (IQR 0.7–5.2%); n=124), while subnational estimates ranged from 0% to 52% (median 5.8% (IQR 2.3%–12%); n=101), with the highest estimates in areas following widespread local transmission.
The low levels of SARS-CoV-2 antibody in most populations prior to the start of vaccine programmes underlines the critical importance of targeted vaccination of priority groups at risk of severe disease, while maintaining reduced levels of transmission to minimise population morbidity and mortality.
Background
Engagement with self-monitoring of blood pressure (BP) declines, on average, over time but may vary substantially by individual.
Objectives
We aimed to describe different 1-year patterns (groups) of self-monitoring of BP behaviors, identify predictors of those groups, and examine the association of self-monitoring of BP groups with BP levels over time.
Methods
We analyzed device-recorded BP measurements collected by the Health eHeart Study—an ongoing prospective eCohort study—from participants with a wireless consumer-purchased device that transmitted date- and time-stamped BP data to the study through a full 12 months of observation starting from the first day they used the device. Participants received no instruction on device use. We applied clustering analysis to identify 1-year self-monitoring, of BP patterns.
Results
Participants had a mean age of 52 years and were male and White. Using clustering algorithms, we found that a model with three groups fit the data well: persistent daily use (9.1% of participants), persistent weekly use (21.2%), and sporadic use only (69.7%). Persistent daily use was more common among older participants who had higher Week 1 self-monitoring of BP frequency and was associated with lower BP levels than the persistent weekly use or sporadic use groups throughout the year.
Conclusion
We identified three distinct self-monitoring of BP groups, with nearly 10% sustaining a daily use pattern associated with lower BP levels. 
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