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Annals of the New York Academy of... Jan 2022For many years, it was believed that the aging process was inevitable and that age-related diseases could not be prevented or reversed. The geroscience hypothesis,... (Review)
Review
For many years, it was believed that the aging process was inevitable and that age-related diseases could not be prevented or reversed. The geroscience hypothesis, however, posits that aging is, in fact, malleable and, by targeting the hallmarks of biological aging, it is indeed possible to alleviate age-related diseases and dysfunction and extend longevity. This field of geroscience thus aims to prevent the development of multiple disorders with age, thereby extending healthspan, with the reduction of morbidity toward the end of life. Experts in the field have made remarkable advancements in understanding the mechanisms underlying biological aging and identified ways to target aging pathways using both novel agents and repurposed therapies. While geroscience researchers currently face significant barriers in bringing therapies through clinical development, proof-of-concept studies, as well as early-stage clinical trials, are underway to assess the feasibility of drug evaluation and lay a regulatory foundation for future FDA approvals in the future.
Topics: Aging; Autophagy; COVID-19; Cardiovascular Diseases; Congresses as Topic; Geroscience; Humans; Longevity; Metabolomics; Nervous System Diseases; Research Report; Stem Cell Transplantation
PubMed: 34498278
DOI: 10.1111/nyas.14681 -
JAMA Dec 2019The prevalence of e-cigarette use among US youth increased from 2011 to 2018. Continued monitoring of the prevalence of e-cigarette and other tobacco product use among...
IMPORTANCE
The prevalence of e-cigarette use among US youth increased from 2011 to 2018. Continued monitoring of the prevalence of e-cigarette and other tobacco product use among youth is important to inform public health policy, planning, and regulatory efforts.
OBJECTIVE
To estimate the prevalence of e-cigarette use among US high school and middle school students in 2019 including frequency of use, brands used, and use of flavored products.
DESIGN, SETTING, AND PARTICIPANTS
Cross-sectional analyses of a school-based nationally representative sample of 19 018 US students in grades 6 to 12 participating in the 2019 National Youth Tobacco Survey. The survey was conducted from February 15, 2019, to May 24, 2019.
MAIN OUTCOMES AND MEASURES
Self-reported current (past 30-day) e-cigarette use estimates among high school and middle school students; frequent use (≥20 days in the past 30 days) and usual e-cigarette brand among current e-cigarette users; and use of flavored e-cigarettes and flavor types among current exclusive e-cigarette users (no use of other tobacco products) by school level and usual brand. Prevalence estimates were weighted to account for the complex sampling design.
RESULTS
The survey included 10 097 high school students (mean [SD] age, 16.1 [3.0] years; 47.5% female) and 8837 middle school students (mean [SD] age, 12.7 [2.8] years; 48.7% female). The response rate was 66.3%. An estimated 27.5% (95% CI, 25.3%-29.7%) of high school students and 10.5% (95% CI, 9.4%-11.8%) of middle school students reported current e-cigarette use. Among current e-cigarette users, an estimated 34.2% (95% CI, 31.2%-37.3%) of high school students and 18.0% (95% CI, 15.2%-21.2%) of middle school students reported frequent use, and an estimated 63.6% (95% CI, 59.3%-67.8%) of high school students and 65.4% (95% CI, 60.6%-69.9%) of middle school students reported exclusive use of e-cigarettes. Among current e-cigarette users, an estimated 59.1% (95% CI, 54.8%-63.2%) of high school students and 54.1% (95% CI, 49.1%-59.0%) of middle school students reported JUUL as their usual e-cigarette brand in the past 30 days; among current e-cigarette users, 13.8% (95% CI, 12.0%-15.9%) of high school students and 16.8% (95% CI, 13.6%-20.7%) of middle school students reported not having a usual e-cigarette brand. Among current exclusive e-cigarette users, an estimated 72.2% (95% CI, 69.1%-75.1%) of high school students and 59.2% (95% CI, 54.8%-63.4%) of middle school students used flavored e-cigarettes, with fruit, menthol or mint, and candy, desserts, or other sweets being the most commonly reported flavors.
CONCLUSIONS AND RELEVANCE
In 2019, the prevalence of self-reported e-cigarette use was high among high school and middle school students, with many current e-cigarette users reporting frequent use and most of the exclusive e-cigarette users reporting use of flavored e-cigarettes.
Topics: Adolescent; Child; Cross-Sectional Studies; Electronic Nicotine Delivery Systems; Female; Flavoring Agents; Humans; Male; Prevalence; Self Report; United States; Vaping
PubMed: 31688912
DOI: 10.1001/jama.2019.18387 -
Yearbook of Medical Informatics Aug 2020To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2019. (Review)
Review
OBJECTIVES
To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2019.
METHOD
A bibliographic search using a combination of MeSH descriptors and free-text terms on CRI was performed using PubMed, followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. After peer-review ranking, a consensus meeting between the two section editors and the editorial team was organized to finally conclude on the selected three best papers.
RESULTS
Among the 517 papers, published in 2019, returned by the search, that were in the scope of the various areas of CRI, the full review process selected three best papers. The first best paper describes the use of a homomorphic encryption technique to enable federated analysis of real-world data while complying more easily with data protection requirements. The authors of the second best paper demonstrate the evidence value of federated data networks reporting a large real world data study related to the first line treatment for hypertension. The third best paper reports the migration of the US Food and Drug Administration (FDA) adverse event reporting system database to the OMOP common data model. This work opens the combined analysis of both spontaneous reporting system and electronic health record (EHR) data for pharmacovigilance.
CONCLUSIONS
The most significant research efforts in the CRI field are currently focusing on real world evidence generation and especially the reuse of EHR data. With the progress achieved this year in the areas of phenotyping, data integration, semantic interoperability, and data quality assessment, real world data is becoming more accessible and reusable. High quality data sets are key assets not only for large scale observational studies or for changing the way clinical trials are conducted but also for developing or evaluating artificial intelligence algorithms guiding clinical decision for more personalized care. And lastly, security and confidentiality, ethical and regulatory issues, and more generally speaking data governance are still active research areas this year.
Topics: Adverse Drug Reaction Reporting Systems; Biomedical Research; Computer Security; Data Accuracy; Data Management; Electronic Health Records; Humans; Hypertension; Medical Informatics; Neoplasms; Precision Medicine; Treatment Outcome
PubMed: 32823317
DOI: 10.1055/s-0040-1702007 -
Therapeutic Advances in Drug Safety 2022Comprehensive methods for evaluating safety are needed to objectively assess the full risk profile of a medication. The confidence of the prescribing provider in the... (Review)
Review
UNLABELLED
Comprehensive methods for evaluating safety are needed to objectively assess the full risk profile of a medication. The confidence of the prescribing provider in the safety and effectiveness of pharmaceuticals is extremely important. Pharmacovigilance is a key component of drug safety regulatory processes and is paramount for ensuring the safety profile of medications used to treat patients. All participants in the healthcare system, including healthcare providers and consumers, should understand and meaningfully engage in the pharmacovigilance process; healthcare providers should integrate pharmacovigilance into everyday practice, inviting feedback from patients. This narrative review aims to give an overview of the main topics underlying pharmacovigilance and drug safety in pharmaceutical research phase after the authorization of a drug in the United States. The US Food and Drug Administration guidance and post-approval regulatory actions are considered from an industry perspective.
PLAIN LANGUAGE SUMMARY
Government agencies regulate the safe use of medicinal products. By determining and enforcing pharmacovigilance, the monitoring of drugs for potential risks, they safeguard the welfare of consumers of medicines. Comprehensive, documented methods for evaluating the safety of a drug during its development and its subsequent use allow identification of any risks associated with the drug's use throughout its lifetime. The comprehensive identification of safety issues associated with a drug is improved when all parties involved in the development and use of drugs participate in the pharmacovigilance process. For example, clinicians should regularly ask their patients if they are experiencing any issues with their treatment, and patients should be encouraged to report problems they encounter with a particular medication to their healthcare provider. This narrative review provides an overview of the main topics underlying pharmacovigilance and drug safety after approval of a drug in the United States. Guidelines and actions from the US Food and Drug Administration are considered from an industry perspective.
PubMed: 36187302
DOI: 10.1177/20420986221125006 -
Current Opinion in Gastroenterology Jan 2020Complicated intra-abdominal infections (cIAIs) are associated with significant morbidity and mortality. Clinical trials should help guide and improve the management of... (Review)
Review
PURPOSE OF REVIEW
Complicated intra-abdominal infections (cIAIs) are associated with significant morbidity and mortality. Clinical trials should help guide and improve the management of cIAIs. However, inappropriate selection or measurement of outcomes in cIAIs clinical trials can lead to misleading results on the effectiveness of interventions. This review aims to describe how outcomes are reported in randomized controlled trials evaluating antibiotic treatment for cIAIs and discuss how outcome reporting may be improved.
RECENT FINDINGS
Commonly used primary outcomes are treatment success or failure, and these outcomes are endorsed by regulatory bodies. However, a consensus objective definition of either is not available and current measures are prone to bias. Variation exists in timing of outcome evaluation and analysis populations, which can lead to further bias. Use of core outcome sets can help standardize outcome reporting.
SUMMARY
Inconsistency in outcome selection and reporting can lead to misleading results and impedes meta-analysis of data. Further progress, engaging clinical trialists, regulatory authorities, clinicians and patients is required to achieve consensus on which outcomes should be reported and how and when to measure them.
Topics: Abdominal Abscess; Anti-Bacterial Agents; Humans; Intraabdominal Infections; Outcome Assessment, Health Care; Peritonitis; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31567430
DOI: 10.1097/MOG.0000000000000591 -
Cancer Medicine Jun 2021In recent years, the field of artificial intelligence (AI) in oncology has grown exponentially. AI solutions have been developed to tackle a variety of cancer-related... (Review)
Review
In recent years, the field of artificial intelligence (AI) in oncology has grown exponentially. AI solutions have been developed to tackle a variety of cancer-related challenges. Medical institutions, hospital systems, and technology companies are developing AI tools aimed at supporting clinical decision making, increasing access to cancer care, and improving clinical efficiency while delivering safe, high-value oncology care. AI in oncology has demonstrated accurate technical performance in image analysis, predictive analytics, and precision oncology delivery. Yet, adoption of AI tools is not widespread, and the impact of AI on patient outcomes remains uncertain. Major barriers for AI implementation in oncology include biased and heterogeneous data, data management and collection burdens, a lack of standardized research reporting, insufficient clinical validation, workflow and user-design challenges, outdated regulatory and legal frameworks, and dynamic knowledge and data. Concrete actions that major stakeholders can take to overcome barriers to AI implementation in oncology include training and educating the oncology workforce in AI; standardizing data, model validation methods, and legal and safety regulations; funding and conducting future research; and developing, studying, and deploying AI tools through multidisciplinary collaboration.
Topics: Artificial Intelligence; Bias; Data Collection; Decision Support Systems, Clinical; Humans; Image Interpretation, Computer-Assisted; Machine Learning; Medical Oncology; Precision Medicine; Research Report
PubMed: 33960708
DOI: 10.1002/cam4.3935 -
Antimicrobial Stewardship & Healthcare... 2022Hospital-onset sepsis accounts for 10%-15% of all sepsis cases and is associated with very high mortality rates, yet to date most hospitals have paid little attention to...
Hospital-onset sepsis accounts for 10%-15% of all sepsis cases and is associated with very high mortality rates, yet to date most hospitals have paid little attention to tracking its incidence and outcomes. This contrasts sharply with the substantial effort that hospitals and regulatory agencies spend tracking and reporting a limited subset of healthcare-associated infections. The recent development of the Center for Disease Control and Prevention's hospital-onset Adult Sepsis Event (ASE) definition, however, provides a validated and standardized mechanism for facilities to identify patients with nosocomial sepsis using routinely available electronic health record data. Recent data have demonstrated that hospital-onset ASE surveillance identifies many infections that are largely missed by current reportable healthcare-associated infections and that are associated with much higher mortality rates. Expanding the breadth of surveillance to include these highly consequential infections could help identify new targets for prevention and quality improvement and ultimately catalyze better outcomes for hospitalized patients. More work is needed, however, to characterize the preventability of hospital-onset ASE, develop and validate robust case-mix adjustment tools, and facilitate widespread uptake in hospitals with limited resources.
PubMed: 36310798
DOI: 10.1017/ash.2022.16 -
BMC Medical Informatics and Decision... Jun 2018A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to... (Review)
Review
BACKGROUND
A scoping review to characterize the literature on the use of conversations in social media as a potential source of data for detecting adverse events (AEs) related to health products.
METHODS
Our specific research questions were (1) What social media listening platforms exist to detect adverse events related to health products, and what are their capabilities and characteristics? (2) What is the validity and reliability of data from social media for detecting these adverse events? MEDLINE, EMBASE, Cochrane Library, and relevant websites were searched from inception to May 2016. Any type of document (e.g., manuscripts, reports) that described the use of social media data for detecting health product AEs was included. Two reviewers independently screened citations and full-texts, and one reviewer and one verifier performed data abstraction. Descriptive synthesis was conducted.
RESULTS
After screening 3631 citations and 321 full-texts, 70 unique documents with 7 companion reports available from 2001 to 2016 were included. Forty-six documents (66%) described an automated or semi-automated information extraction system to detect health product AEs from social media conversations (in the developmental phase). Seven pre-existing information extraction systems to mine social media data were identified in eight documents. Nineteen documents compared AEs reported in social media data with validated data and found consistent AE discovery in all except two documents. None of the documents reported the validity and reliability of the overall system, but some reported on the performance of individual steps in processing the data. The validity and reliability results were found for the following steps in the data processing pipeline: data de-identification (n = 1), concept identification (n = 3), concept normalization (n = 2), and relation extraction (n = 8). The methods varied widely, and some approaches yielded better results than others.
CONCLUSIONS
Our results suggest that the use of social media conversations for pharmacovigilance is in its infancy. Although social media data has the potential to supplement data from regulatory agency databases; is able to capture less frequently reported AEs; and can identify AEs earlier than official alerts or regulatory changes, the utility and validity of the data source remains under-studied.
TRIAL REGISTRATION
Open Science Framework ( https://osf.io/kv9hu/ ).
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Social Media
PubMed: 29898743
DOI: 10.1186/s12911-018-0621-y -
Medical Devices (Auckland, N.Z.) 2017Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate... (Review)
Review
Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human-machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals with gait disabilities to safely and independently ambulate.
PubMed: 28533700
DOI: 10.2147/MDER.S107134 -
British Journal of Clinical Pharmacology Jul 2016Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not... (Review)
Review
AIM
Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems.
METHODS
We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full-texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software.
RESULTS
We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA).
CONCLUSION
We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 27016266
DOI: 10.1111/bcp.12944