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International Journal of Molecular... Aug 2021Biofilms formed by methicillin-resistant (MRSA) are among the most frequent causes of biomedical device-related infection, which are difficult to treat and are often... (Review)
Review
Biofilms formed by methicillin-resistant (MRSA) are among the most frequent causes of biomedical device-related infection, which are difficult to treat and are often persistent and recurrent. Thus, new and effective antibiofilm agents are urgently needed. In this article, we review the most relevant literature of the recent years reporting on promising anti-MRSA biofilm agents derived from the genus bacteria, and discuss the potential contribution of these newly reported antibiofilm compounds to the current strategies in preventing biofilm formation and eradicating pre-existing biofilms of the clinically important pathogen MRSA. Many efforts are evidenced to address biofilm-related infections, and some novel strategies have been developed and demonstrated encouraging results in preclinical studies. Nevertheless, more in vivo studies with appropriate biofilm models and well-designed multicenter clinical trials are needed to assess the prospects of these strategies.
Topics: Anti-Bacterial Agents; Biofilms; Equipment and Supplies; Humans; Methicillin-Resistant Staphylococcus aureus; Prosthesis-Related Infections; Staphylococcal Infections; Streptomyces
PubMed: 34502269
DOI: 10.3390/ijms22179360 -
Hospital Pediatrics Jan 2019Children with medical complexity (CMC) are commonly assisted by medical devices to support essential body functions, although complications may lead to preventable...
OBJECTIVES
Children with medical complexity (CMC) are commonly assisted by medical devices to support essential body functions, although complications may lead to preventable emergency department (ED) and hospital use. Our objective was to identify predictors of device-complicated ED visits and hospitalizations.
METHODS
This single-center retrospective cohort study included patients referred to a Pediatric Complex Care Program between April 1, 2014, and April 30, 2016, assisted by at least 1 medical device. Hospitalizations and ED visits in the year before enrollment were rated for likelihood for being due to device complications. Interrater reliability among 3 independent reviewers was assessed. Bivariate followed by multivariate logistic regression clustered by patient helped us identify associations between demographic, clinical, and device characteristics associated with device-complicated ED or hospital encounters.
RESULTS
Interrater reliability was high (κ = 0.92). Among 98 CMC, device-complicated encounters represented 17% of 258 hospitalizations and 31% of 228 ED visits. Complications of 3 devices (central venous catheters, enteral tubes, and tracheostomy tubes) accounted for 13% of overall hospitalizations and 28% of overall ED visits. Central venous catheter presence (adjusted odds ratio [aOR] 3.2 [95% confidence interval (CI) 1.1-9.5]) was associated with device-complicated ED visits. Gastrojejunostomy/jejunostomy tube presence (aOR 3.3 [95% CI 1.5-7.5]) or tracheostomies with (aOR 8.1 [95% CI 2.3-28.5]) or without (aOR 4.5 [95% CI 1.7-7.5]) ventilator use was associated with device-complicated hospitalizations. Clinical variables were poor predictors of device-complicated encounters.
CONCLUSIONS
Device-complicated ED visits and hospitalizations comprised a substantial proportion of total hospital and ED use. Developing interventions to prevent device complications may be a promising strategy to reduce overall CMC use.
Topics: Child; Child, Hospitalized; Cohort Studies; Emergency Service, Hospital; Equipment Failure; Equipment and Supplies; Female; Hospitalization; Humans; Male; Reproducibility of Results; Retrospective Studies
PubMed: 30530805
DOI: 10.1542/hpeds.2018-0103 -
Journal of Diabetes Science and... Nov 2019Randomized clinical trials (RCTs) are no longer the sole source of data to inform guidelines, regulatory, and policy decisions. Real-world data (RWD), collected from...
Randomized clinical trials (RCTs) are no longer the sole source of data to inform guidelines, regulatory, and policy decisions. Real-world data (RWD), collected from registries, electronic health records, insurance claims, pharmacy records, social media, and sensor outputs from devices form real-world evidence (RWE), which can supplement evidence from RCTs. Benefits of using RWE include less time and cost to produce meaningful data; the ability to capture additional information, including social determinants of health that can impact health outcomes; detection of uncommon adverse events; and the potential to apply machine learning and artificial intelligence to the delivery of health care. Overall, combining data from RCTs and RWE would allow regulators to make ongoing and more evidence-based decisions in approving and monitoring products for diabetes.
Topics: Decision Making; Device Approval; Diabetes Mellitus; Equipment and Supplies; Evidence-Based Medicine; Health Policy; Humans; Pharmaceutical Preparations; Randomized Controlled Trials as Topic
PubMed: 30943790
DOI: 10.1177/1932296819839996 -
The Lancet. Digital Health Mar 2021There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which... (Comparative Study)
Comparative Study Review
There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governmental and non-governmental databases to identify 222 devices approved in the USA and 240 devices in Europe. The number of approved AI/ML-based devices has increased substantially since 2015, with many being approved for use in radiology. However, few were qualified as high-risk devices. Of the 124 AI/ML-based devices commonly approved in the USA and Europe, 80 were first approved in Europe. One possible reason for approval in Europe before the USA might be the potentially relatively less rigorous evaluation of medical devices in Europe. The substantial number of approved devices highlight the need to ensure rigorous regulation of these devices. Currently, there is no specific regulatory pathway for AI/ML-based medical devices in the USA or Europe. We recommend more transparency on how devices are regulated and approved to enable and improve public trust, efficacy, safety, and quality of AI/ML-based medical devices. A comprehensive, publicly accessible database with device details for Conformité Européene (CE)-marked medical devices in Europe and US Food and Drug Administration approved devices is needed.
Topics: Artificial Intelligence; Biomedical Technology; Databases, Factual; Device Approval; Equipment and Supplies; Europe; Government Regulation; Humans; Machine Learning; Radiology; United States; United States Food and Drug Administration
PubMed: 33478929
DOI: 10.1016/S2589-7500(20)30292-2 -
JMIR MHealth and UHealth Nov 2023The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and...
BACKGROUND
The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app's effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses.
OBJECTIVE
This systematic review aims to address 2 critical questions regarding clinical trials of software as a medical device (SaMD) apps: How well do researchers report adherence and engagement metrics for studies of effectiveness and efficacy? and What efficacy analyses do researchers use to account for nonadherence and how appropriate are their methods?
METHODS
We searched the Food and Drug Administration's registration database for registrations of repeated-use, patient-facing SaMD therapeutics. For each such registration, we searched ClinicalTrials.gov, company websites, and MEDLINE for the corresponding clinical trial and study articles through March 2022. Adherence and engagement data were summarized for each of the 24 identified articles, corresponding to 10 SaMD therapeutics. Each article was analyzed with a framework developed using the Cochrane risk-of-bias questions to estimate the potential effects of imperfect adherence on SaMD effectiveness. This review, funded by the Richard King Mellon Foundation, is registered on the Open Science Framework.
RESULTS
We found that although most articles (23/24, 96%) reported collecting information about SaMD therapeutic engagement, of the 20 articles for apps with prescribed use, only 9 (45%) reported adherence information across all aspects of prescribed use: 15 (75%) reported metrics for the initiation of therapeutic use, 16 (80%) reported metrics reporting adherence between the initiation and discontinuation of the therapeutic (implementation), and 4 (20%) reported the discontinuation of the therapeutic (persistence). The articles varied in the reported metrics. For trials that reported adherence or engagement, there were 4 definitions of initiation, 8 definitions of implementation, and 4 definitions of persistence. All articles studying a therapeutic with a prescribed use reported effectiveness estimates that might have been affected by nonadherence; only a few (2/20, 10%) used methods appropriate to evaluate efficacy.
CONCLUSIONS
This review identifies 5 areas for improving future SaMD trials and studies: use consistent metrics for reporting adherence, use reliable adherence metrics, preregister analyses for observational studies, use less biased efficacy analysis methods, and fully report statistical methods and assumptions.
Topics: Mobile Applications; United States; Software; Equipment and Supplies; Clinical Trials as Topic
PubMed: 37966871
DOI: 10.2196/46237 -
The New England Journal of Medicine Apr 2020
Topics: COVID-19; Coronavirus Infections; Equipment and Supplies, Hospital; Federal Government; Government Regulation; Infection Control; Masks; Massachusetts; Materials Management, Hospital; Pandemics; Personal Protective Equipment; Pneumonia, Viral; United States; Ventilators, Mechanical
PubMed: 32302080
DOI: 10.1056/NEJMc2010025 -
Circulation Journal : Official Journal... Jan 2018The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention... (Review)
Review
BACKGROUND
The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI.
CONCLUSIONS
Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.
Topics: Epidemiological Monitoring; Equipment and Supplies; Humans; Peripheral Arterial Disease; Reference Standards; Registries
PubMed: 29367497
DOI: 10.1253/circj.CJ-17-1156 -
Archives of Iranian Medicine Feb 2021In November 2018, the United States withdrew from the Joint Comprehensive Plan of Action (JCPOA), known commonly as the Iran nuclear deal, and imposed severe sanctions...
BACKGROUND
In November 2018, the United States withdrew from the Joint Comprehensive Plan of Action (JCPOA), known commonly as the Iran nuclear deal, and imposed severe sanctions on Iran. This study explores the impact of US sanctions in Iran's health research system.
METHODS
This phenomenological study interviewed 24 Iranian health science scholars through purposeful sampling to learn about their experiences and thoughts regarding the impact of US sanctions on Iran's health research system.
RESULTS
The impact of sanctions on Iran's health research system were classified into five categories: () financial issues, () difficulty in supplying laboratory materials and () equipment, () disruption in international research collaboration and activities, and () other issues (e.g., increased stress and workload).
CONCLUSION
This study indicated that since research centers in Iran are highly dependent on governmental budgets, sanctions have greatly affected the health research system in Iran. Financial and economic problems, restrictions in transferring funds, and the disruption in political and international relations have created many challenges for supplying medical laboratory materials and equipment for medical and health research centers in Iran.
Topics: Biomedical Research; Equipment and Supplies; Humans; Internationality; Iran; Laboratories; Qualitative Research; United States
PubMed: 33636976
DOI: 10.34172/aim.2021.15 -
Antimicrobial Resistance and Infection... May 2021Aerosolization may occur during reprocessing of medical devices. With the current coronavirus disease 2019 pandemic, it is important to understand the necessity of using...
Aerosolization may occur during reprocessing of medical devices. With the current coronavirus disease 2019 pandemic, it is important to understand the necessity of using respirators in the cleaning area of the sterile processing department. To evaluate the presence of severe acute respiratory syndrome coronavirus (SARS-CoV-2) in the air of the sterile processing department during the reprocessing of contaminated medical devices. Air and surface samples were collected from the sterile processing department of two teaching tertiary hospitals during the reprocessing of respiratory equipment used in patients diagnosed with coronavirus disease 2019 and from intensive care units during treatment of these patients. SARS-CoV-2 was detected only in 1 air sample before the beginning of decontamination process. Viable severe acute respiratory syndrome coronavirus 2 RNA was not detected in any sample collected from around symptomatic patients or in sterile processing department samples. The cleaning of respiratory equipment does not cause aerosolization of SARS-CoV-2. We believe that the use of medical masks is sufficient while reprocessing medical devices during the coronavirus disease 2019 pandemic.
Topics: Aerosols; Air Microbiology; Cross-Sectional Studies; Decontamination; Equipment Reuse; Equipment and Supplies, Hospital; Personal Protective Equipment; RNA, Viral; SARS-CoV-2; Tertiary Care Centers; Ventilators, Mechanical
PubMed: 34044893
DOI: 10.1186/s13756-021-00955-2 -
PharmacoEconomics Apr 2020The objective of this study was to develop a French value set for the EQ-5D-5L, for academic and clinical research, and for regulatory requirements for price-setting of...
OBJECTIVE
The objective of this study was to develop a French value set for the EQ-5D-5L, for academic and clinical research, and for regulatory requirements for price-setting of drugs and medical devices.
METHOD
This study used the standardized valuation protocol developed by EuroQol, using computer-assisted personal interview software. A representative sample of 1048 French residents were interviewed by a market research company, under the supervision of the research team. Health states were valued using composite time trade-off and a discrete choice experiment. Modeling was used to create values for the 3125 possible health states. The composite time trade-off data were modeled using a Tobit model with censored observations at -1 and correcting for heteroscedasticity. A conditional logit model was used for the discrete choice results, and both models were combined using a hybrid model. An adjusted hybrid model was tested to correct for imbalance in the sample on age and sex compared with the general population. A comparison with the 3-level (3L) value set was performed.
RESULTS
The adjusted model was preferred to comply with the representativeness of the general population. It provided a value set for which all coefficients were logically consistent. Values ranged from - 0.525 to 1. The distribution of values presented a shift towards higher values versus the 3L value set. Ranking of dimensions changed. Pain and discomfort and mobility were the dimensions with the highest potential for disutility compared with mobility and self-care for the 3L instrument.
CONCLUSIONS
This study provides a value set based on societal preferences of the French population, using an improved descriptive instrument of health-related quality-of-life health states. It will contribute to improve the quality of cost-effectiveness analysis in the French context and help stimulate disease-specific quality-of-life references for academic-, institutional-, and industry-promoted studies.
Topics: Cost-Benefit Analysis; Decision Making, Organizational; Drug Costs; Equipment and Supplies; Female; France; Humans; Male; Middle Aged; Mobility Limitation; Models, Economic; Patient Preference; Quality of Life; Quality-Adjusted Life Years; Self Care; Surveys and Questionnaires
PubMed: 31912325
DOI: 10.1007/s40273-019-00876-4