Sazgar IoT: A Device-Centric IoT Framework and Approximation Technique for Efficient and Scalable IoT Data Processing.

The Internet of Things (IoT) plays a fundamental role in monitoring applications; however, existing approaches relying on cloud and edge-based IoT data analysis encounter issues such as network delays and high costs, which can adversely impact time-sensitive applications. To address these challenges, this paper proposes an IoT framework called Sazgar IoT. Unlike existing solutions, Sazgar IoT leverages only IoT devices and IoT data analysis approximation techniques to meet the time-bounds of time-sensitive IoT applications. In this framework, the computing resources onboard the IoT devices are utilised to process the data analysis tasks of each time-sensitive IoT application. This eliminates the network delays associated with transferring large volumes of high-velocity IoT data to cloud or edge computers. To ensure that each task meets its application-specific time-bound and accuracy requirements, we employ approximation techniques for the data analysis tasks of time-sensitive IoT applications. These techniques take into account the available computing resources and optimise the processing accordingly. To evaluate the effectiveness of Sazgar IoT, experimental validation has been conducted. The results demonstrate that the framework successfully meets the time-bound and accuracy requirements of the COVID-19 citizen compliance monitoring application by effectively utilising the available IoT devices. The experimental validation further confirms that Sazgar IoT is an efficient and scalable solution for IoT data processing, addressing existing network delay issues for time-sensitive applications and significantly reducing the cost related to cloud and edge computing devices procurement, deployment, and maintenance.

Remdesivir-associated bradycardia in COVID-19: a rapid review protocol.

INTRODUCTION: Remdesivir is an antiviral medication that is used in the treatment of severe COVID-19. Research has highlighted the potential cardiac side effects of remdesivir, including the occurrence of remdesivir-associated bradycardia (RAB), but these findings have not been consistent. In addition, very little is known about the clinical implications and outcomes of RAB. The aim of this rapid systematic review is to determine the event rate of developing bradycardia while receiving remdesivir treatment compared with not receiving remdesivir in patients diagnosed with COVID-19. METHODS AND ANALYSIS: This study follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol guidelines and will include original papers related to COVID-19, remdesivir and bradycardia. Only English language papers published from 1 December 2019 to 31 December 2022 will be included. The following databases will be searched using keywords and controlled vocabulary: Ovid MEDLINE, Ovid EMBASE, Scopus, Cochrane, PubMed and Web of Science. Two reviewers will independently perform screening and data abstraction. Data will be synthesised qualitatively as well as quantitatively. A random-effects model will be used to calculate the pooled estimates. ETHICS AND DISSEMINATION: This review will systematically analyse the clinical studies available to help better characterise RAB. The results will support a retrospective study investigating RAB that is currently being conducted at the University Medical Center of Southern Nevada in Las Vegas, Nevada. PROSPERO REGISTRATION NUMBER: This protocol has been submitted to and approved by PROSPERO (Protocol ID: CRD42022331614).

Paper and screen media in current health education practices aimed at older adults: a scoping review protocol.

INTRODUCTION: With technological advancement and the COVID-19 pandemic, paper-based media are giving way to screen-based media to promote healthy ageing. However, there is no review available covering paper and screen media use by older people, so the objective of this review is to map the current use of paper-based and/or screen-based media for health education aimed at older people. METHODS AND ANALYSIS: The literature will be searched in Scopus, Web of Science, Medline, Embase, Cinahl, The ACM Guide to Computing Literature and Psyinfo databases. Studies in English, Portuguese, Italian or Spanish published from 2012 to the date of the search will be examined. In addition, an additional strategy will be carried out, which will be a Google Scholar search, in which the first 300 studies according to Google's relevance algorithm will be verified. The terms used in the search strategy will be focused on older adults, health education, paper-based and screen-based media, preferences, intervention and other related terms. This review will include studies where the average age of the participants was 60 years or older and were users of health education strategies through paper-based or screen-based media. Two reviewers will carry out the selection of studies in five steps: identification of studies and removal of duplicates, pilot test, selection by reading titles and abstracts, full-text inclusion and search for additional sources. A third reviewer will resolve disagreements. To record information from the included studies, a data extraction form will be used. The quantitative data will be presented in a descriptive way and the qualitative data through Bardin's content analysis. ETHICS AND DISSEMINATION: Ethical approval is not applicable to the scoping review. The results will be disseminated through presentations at significant scientific events and published in journals in the area. PROTOCOL REGISTRATION NUMBER: Open science framework (DOI: DOI 10.17605/OSF.IO/GKEAH).

Use of eco-mapping in health services research: a scoping review protocol.

INTRODUCTION: People with complex health and social needs often require care from different providers and services. Identifying their existing sources of support could assist with addressing potential gaps and opportunities for enhanced service delivery. Eco-mapping is an approach used to visually capture people's social relationships and their linkages to the larger social systems. As it is an emerging and promising approach in the health services field, a scoping review on eco-mapping is warranted. This scoping review aims to synthesise the empirical literature that has focused on the application of eco-mapping by describing characteristics, populations, methodological approaches and other features of eco-mapping in health services research. METHODS AND ANALYSIS: This scoping review will follow the Joanna Briggs Institute methodology. From the date of database construction to 16 January 2023, the following databases in English will be searched: Ovid Medline, Ovid Embase, CINAHL Ultimate (EBSCOhost), Emcare (Ovid), Cochrane Central Register of Controlled Trials (Ovid) and Cochrane Database of Systematic Reviews (Ovid) Study/Source of Evidence selection. The inclusion criteria consist of empirical literature that uses eco-mapping or a related tool in the context of health services research. Two researchers will independently screen references against inclusion and exclusion criteria using Covidence software. Once screened, the data will be extracted and organised according to the following research questions: (1) What research questions and phenomena of interest do researchers address when using eco-mapping? (2) What are the characteristics of studies that use eco-mapping in health services research? (3) What are the methodological considerations for eco-mapping in health services research? ETHICS AND DISSEMINATION: This scoping review does not require ethical approval. The findings will be disseminated through publications, conference presentations and stakeholder meetings. TRIAL REGISTRATION NUMBER: https://doi.org/10.17605/OSF.IO/GAWYN.

Compassion fatigue in healthcare providers during the COVID-19 pandemic: a scoping review protocol.

INTRODUCTION: The COVID-19 pandemic has negatively impacted the psychological health and well-being of healthcare providers. An amplification in chronic stressors, workload and fatalities may have increased the risk of compassion fatigue and disrupted the quality of patient care. Although current studies have explored the general psychological status of healthcare providers during the COVID-19 pandemic, few have focused on compassion fatigue. The purpose of this review is to explore the impacts of the COVID-19 pandemic on compassion fatigue in healthcare providers and the repercussions of compassion fatigue on patient care. METHODS AND ANALYSIS: This scoping review will follow Joanna Briggs Institute and Arksey and O'Malley scoping review methodology. Comprehensive searches will be conducted in the following relevant databases: MEDLINE (Ovid), PsycINFO (Ovid), Embase (Ovid), CINAHL, Scopus, Web of Science. To expand the search, reference lists of included studies will be handsearched for additional relevant studies. Included studies must report on the impact of COVID-19 pandemic on compassion fatigue in healthcare providers and have been published in English since January 2020. ETHICS AND DISSEMINATION: This review does not require research ethics board approval. By examining the impacts of the COVID-19 pandemic on compassion fatigue in healthcare providers, this scoping review can offer important insight into the possible risks, protective factors and strategies to support healthcare providers' psychological health and patient care amidst persisting stressful conditions.

Defining estimands in clinical trials: A unified procedure.

The ICH E9 (R1) addendum proposes five strategies to define estimands by addressing intercurrent events. However, mathematical forms of these targeted quantities are lacking, which might lead to discordance between statisticians who estimate these quantities and clinicians, drug sponsors, and regulators who interpret them. To improve the concordance, we provide a unified four-step procedure for constructing the mathematical estimands. We apply the procedure for each strategy to derive the mathematical estimands and compare the five strategies in practical interpretations, data collection, and analytical methods. Finally, we show that the procedure can help ease tasks of defining estimands in settings with multiple types of intercurrent events using two real clinical trials.

Artificial intelligence in cardiovascular prevention: new ways will open new doors.

Prevention and effective treatment of cardiovascular disease are progressive issues that grow in tandem with the average age of the world population. Over recent decades, the potential role of artificial intelligence in cardiovascular medicine has been increasingly recognized because of the incredible amount of real-world data (RWD) regarding patient health status and healthcare delivery that can be collated from a variety of sources wherein patient information is routinely collected, including patient registries, clinical case reports, reimbursement claims and billing reports, medical devices, and electronic health records. Like any other (health) data, RWD can be analysed in accordance with high-quality research methods, and its analysis can deliver valuable patient-centric insights complementing the information obtained from conventional clinical trials. Artificial intelligence application on RWD has the potential to detect a patient's health trajectory leading to personalized medicine and tailored treatment. This article reviews the benefits of artificial intelligence in cardiovascular prevention and management, focusing on diagnostic and therapeutic improvements without neglecting the limitations of this new scientific approach.

Clinics Optimizing MEthadone Take-homes for opioid use disorder (COMET): Protocol for a stepped-wedge randomized trial to facilitate clinic level changes.

INTRODUCTION: Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take-home dosing (THD) of methadone offer an opportunity to improve quality of care with a lifesaving treatment. There is a pressing need for research to study the long-term effects of the new PHE THD rules and to test data-driven interventions to promote more effective adoption by opioid treatment programs (OTPs). We propose a two-phase project to develop and test a multidimensional intervention for OTPs that leverages information from large State administrative data. METHODS AND ANALYSIS: We propose a two-phased project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework (HEIF). In phase 1, we will employ an explanatory sequential mixed methods design to combine analysis of large state administrative databases-Medicaid, treatment registry, THD reporting-with qualitative interviews to develop and refine the intervention. In phase 2, we will conduct a stepped-wedge trial over three years with 36 OTPs randomized to 6 cohorts of a six-month clinic-level intervention. The trial will test intervention effects on OTP-level implementation outcomes and patient outcomes (1) THD use; 2) retention in care; and 3) adverse healthcare events). We will specifically examine intervention effects for Black and Latinx clients. A concurrent triangulation mixed methods design will be used: quantitative and qualitative data collection will occur concurrently and results will be integrated after analysis of each. We will employ generalized linear mixed models (GLMMs) in the analysis of stepped-wedge trials. The primary outcome will be weekly or greater THD. The semi-structured interviews will be transcribed and analyzed with Dedoose to identify key facilitators, barriers, and experiences according to HEIF constructs using directed content analysis. DISCUSSION: This multi-phase, embedded mixed methods project addresses a critical need to support long-term practice changes in methadone treatment for opioid use disorder following systemic changes emerging from the PHE-particularly for Black and Latinx individuals with opioid use disorder. By combining findings from analyses of large administrative data with lessons gleaned from qualitative interviews of OTPs that were flexible with THD and those that were not, we will build and test the intervention to coach clinics to increase flexibility with THD. The findings will inform policy at the local and national level.

Risk-Based Monitoring in Clinical Trials: 2021 Update.

Clinical trial quality depends on ensuring participant safety and data integrity, which require careful management throughout the trial lifecycle, from protocol development to final data analysis and submission. Recent developments-including new regulatory requirements, emerging technologies, and trial decentralization-have increased adoption of risk-based monitoring (RBM) and its parent framework, risk-based quality management (RBQM) in clinical trials. The Association of Clinical Research Organizations (ACRO), recognizing the growing importance of these approaches, initiated an ongoing RBM/RBQM landscape survey project in 2019 to track adoption of the eight functional components of RBQM. Here we present results from the third annual survey, which included data from 4889 clinical trials ongoing in 2021. At least one RBQM component was implemented in 88% of trials in the 2021 survey, compared with 77% in 2020 and 53% in 2019. The most frequently implemented components in 2021 were initial and ongoing risk assessments (80 and 78% of trials, respectively). Only 7% of RBQM trials were Phase IV, while the proportions of Phase I-III trials ranged 27-36%. Small trials (< 300 participants) accounted for 60% of those implementing RBQM. The therapeutic areas with the largest number of RBQM trials were oncology (38%), neurology (10%), and infectious diseases (9%). The 2021 survey confirmed a pattern of increasing RBM/RBQM adoption seen in earlier surveys, with risk assessments, which have broad regulatory support, driving RBQM growth; however, one area requiring further development is implementation of centralized monitoring combined with reductions in source data verification (SDV) and source data review (SDR).

Adapting the ethical review process for COVID-19 research: reviewers’ perspectives from Pakistan

Background:Research ethics committees (RECs) globally have adapted their responses to provide timely reviews of research proposals in the wake of the COVID-19 pandemic. The REC of the National Bioethics Committee (NBC) of Pakistan has followed suit.Aims:To explore perceptions of NBC-REC reviewers who reviewed COVID-19 research proposals while describing the newly instituted Rapid Turnaround Review (RTR) system.Methods:This cross-sectional study used 3 methods of data collection: a demographic questionnaire filled in by permanent members and co-opted reviewers; qualitative in-depth interviews conducted with both groups; and document review related to COVID-19 research proposals.Results:Eight permanent members and 3 co-opted members participated. Under the RTR system, the time for review was established as 72 hours after receipt of the proposal. The Committee reviewed 55 projects over 10 months. Participants described numerous strengths of the new system, including introduction of online discussions via Zoom as well as presence of co-opted members leading to learning opportunities, particularly for junior members. The RTR system also allowed NBC-REC to gain recognition it had not enjoyed previously. Challenges identified by respondents included initial difficulty in initiating the system and tighter deadlines that may have compromised review quality. Poor scientific quality of proposals, compounded by external pressures to provide rapid approval, added to reviewers’ frustrations. While fruitful, the RTR system was considered unsustainable beyond a public health emergency.Conclusion:Adaptation of ethical review processes is essential in emergencies; however, existing guidelines have to be modified to suit contextual needs.

Safety of COVID-19 vaccine in patients with myasthenia gravis: a self-controlled case series study.

Background: The safety of COVID-19 vaccines has been clarified in clinical trials; however, some immunocompromised patients, such as myasthenia gravis (MG) patients, are still hesitant to receive vaccines. Whether COVID-19 vaccination increases the risk of disease worsening in these patients remains unknown. This study aims to evaluate the risk of disease exacerbation in COVID-19-vaccinated MG patients. Methods: The data in this study were collected from the MG database at Tangdu Hospital, the Fourth Military Medical University, and the Tertiary Referral Diagnostic Center at Huashan Hospital, Fudan University, from 1 April 2022 to 31 October 2022. A self-controlled case series method was applied, and the incidence rate ratios were calculated in the prespecified risk period using conditional Poisson regression. Results: Inactivated COVID-19 vaccines did not increase the risk of disease exacerbation in MG patients with stable disease status. A few patients experienced transient disease worsening, but the symptoms were mild. It is noted that more attention should be paid to thymoma-related MG, especially within 1 week after COVID-19 vaccination. Conclusion: COVID-19 vaccination has no long-term impact on MG relapse.

Towards Automated COVID-19 Presence and Severity Classification.

COVID-19 presence classification and severity prediction via (3D) thorax computed tomography scans have become important tasks in recent times. Especially for capacity planning of intensive care units, predicting the future severity of a COVID-19 patient is crucial. The presented approach follows state-of-theart techniques to aid medical professionals in these situations. It comprises an ensemble learning strategy via 5-fold cross-validation that includes transfer learning and combines pre-trained 3D-versions of ResNet34 and DenseNet121 for COVID19 classification and severity prediction respectively. Further, domain-specific preprocessing was applied to optimize model performance. In addition, medical information like the infection-lung-ratio, patient age, and sex were included. The presented model achieves an AUC of 79.0% to predict COVID-19 severity, and 83.7% AUC to classify the presence of an infection, which is comparable with other currently popular methods. This approach is implemented using the AUCMEDI framework and relies on well-known network architectures to ensure robustness and reproducibility.

From pandemic to Plandemic: Examining the amplification and attenuation of COVID-19 misinformation on social media.

This study examines the proliferation of COVID-19 misinformation through Plandemic-a pseudo-documentary of COVID-19 conspiracy theories-on social media and examines how factors such as (a) themes of misinformation, (b) types of misinformation, (c) sources of misinformation, (d) emotions of misinformation, and (e) fact-checking labels amplify or attenuate online misinformation during the early days of the pandemic. Using CrowdTangle, a Facebook API, we collected a total of 5732 publicly available Facebook pages posts containing Plandemic-related keywords from January 1 to December 19, 2020. A random sample of 600 posts was subsequently coded, and the data were analyzed using negative binomial regression to examine factors associated with amplification and attenuation. Overall, the extended an extended Social Amplification of Risk Framework (SARF) provided a theoretical lens to understand why certain misinformation was amplified, while others were attenuated. As for posts with misinformation, results showed that themes related to private firms, treatment and prevention of virus transmission, diagnosis and health impacts, virus origins, and social impact were more likely to be amplified. While the different types of misinformation (manipulated, fabricated, or satire) and emotions were not associated with amplification, the type of fact-check labels did influence the virality of misinformation. Specifically, posts that were flagged as false by Facebook were more likely to be amplified, while the virality of posts flagged as containing partially false information was attenuated. Theoretical and practical implications were discussed.

Stratified Simple Random Sampling Versus Volunteer Community-Wide Sampling for Estimates of COVID-19 Prevalence.

Objectives. To evaluate community-wide prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection using stratified simple random sampling. Methods. We obtained data for the prevalence of SARS-CoV-2 in Jefferson County, Kentucky, from adult random (n = 7296) and volunteer (n = 7919) sampling over 8 waves from June 2020 through August 2021. We compared results with administratively reported rates of COVID-19. Results. Randomized and volunteer samples produced equivalent prevalence estimates (P < .001), which exceeded the administratively reported rates of prevalence. Differences between them decreased as time passed, likely because of seroprevalence temporal detection limitations. Conclusions. Structured targeted sampling for seropositivity against SARS-CoV-2, randomized or voluntary, provided better estimates of prevalence than administrative estimates based on incident disease. A low response rate to stratified simple random sampling may produce quantified disease prevalence estimates similar to a volunteer sample. Public Health Implications. Randomized targeted and invited sampling approaches provided better estimates of disease prevalence than administratively reported data. Cost and time permitting, targeted sampling is a superior modality for estimating community-wide prevalence of infectious disease, especially among Black individuals and those living in disadvantaged neighborhoods. (Am J Public Health. 2023;113(7):768-777. https://doi.org/10.2105/AJPH.2023.307303).

Use of a novel smartphone-based application tool for enrolment and randomisation in pre-hospital clinical trials.

The effective recruitment and randomisation of patients in pre-hospital clinical trials presents unique challenges. Owing to the time critical nature of many pre-hospital emergencies and limited resourcing, the use of traditional methods of randomisation that may include centralised telephone or web-based systems are often not practicable or feasible. Previous technological limitations have necessitated that pre-hospital trialists strike a compromise between implementing pragmatic, deliverable study designs, with robust enrolment and randomisation methodologies. In this commentary piece, we present a novel smartphone-based solution that has the potential to align pre-hospital clinical trial recruitment processes to that of best-in-practice in-hospital and ambulatory care based studies.

Coping strategies of the incarcerated during the COVID-19 pandemic: a scoping review protocol of quantitative and qualitative evidence.

INTRODUCTION: To reduce the transmission of COVID-19, regulations included the use of cloth masks, sanitising regularly, maintaining social distance and having minimal personal contact. COVID-19 affected many different groups of people including service providers and users of correctional centres. In this protocol, we aim to establish evidence on the challenges and coping strategies adopted by the incarcerated and service providers of the incarcerated during the COVID-19 pandemic. METHODS AND ANALYSIS: In this scoping review, we will use the Arksey and O'Malley framework. We will consult PubMed, PsycInfo, SAGE, JSTOR, African Journals and Google Scholar as our databases to search for evidence, and run a continuous search of articles from June 2022 until we conduct an analysis to ensure that our search results are updated. Two reviewers will independently screen the titles, abstracts and full texts for inclusion. All results will be compiled, and duplicates will be removed. Discrepancies and conflicts will be discussed with the third reviewer. All articles that meet the full-text criteria will be included for data extraction. Results will be reported in line with the review objectives and the Donabedian conceptual framework. DISSEMINATION: Ethical approval of the study will not be applicable in this scoping review. Our findings will be disseminated in different ways, such as publishing in peer-reviewed journals and to other key correctional system stakeholders, as well as submitting a policy brief for prison decision makers and policy makers.