Tag: nevin manimala

Int J Med Inform. 2022 Jun 30;165:104828. doi: 10.1016/j.ijmedinf.2022.104828. Online ahead of print.

ABSTRACT

BACKGROUND: Machine learning (ML), a type of artificial intelligence (AI) technology that uses a data-driven approach for pattern recognition, has been shown to be beneficial for many tasks across healthcare. To characterize the commercial availability of AI/ML applications in the clinic, we performed a detailed analysis of AI/ML-enabled medical devices approved/cleared by the US Food and Drug Administration (FDA) by June 2021.

METHODS/MATERIALS: The publicly available approval letters by the FDA on 343 AI/ML-enabled medical devices compiled by the agency were reviewed. The characteristics of the devices and the patterns of their intended use were analyzed, and basic descriptive statistical analysis was performed on the aggregated data.

RESULTS: Most devices were reviewed by radiology (70.3%) and cardiovascular (12.0%) medical specialty panels. The growth of these devices sharply rose since the mid-2010s. Most (95.0%) devices were cleared under the 510(k) premarket notification pathway, and 69.4% were software as a medical device (SaMD). Of the 241 radiology-related devices, the most common applications were for diagnostic assistance (48.5%) and image reconstruction (14.1%). Of the 117 radiology-related devices for diagnostic assistance, 20.5% were developed for breast lesion assessment and 14.5% for cardiac function assessment on echocardiogram. Of the 41 cardiology-related devices, the most common applications were electrocardiography-based arrhythmia detection (46.3%) and hemodynamics & vital signs monitoring (26.8%).

CONCLUSION: In this study, we characterized the patterns and trends of AI/ML-enabled medical devices approved or cleared by the FDA. To our knowledge, this is the most up-to-date and comprehensive analysis of the landscape as of 2021.

PMID:35780651 | DOI:10.1016/j.ijmedinf.2022.104828

Mar Pollut Bull. 2022 Jun 30;181:113879. doi: 10.1016/j.marpolbul.2022.113879. Online ahead of print.

ABSTRACT

The water quality of the northern Caspian Sea has not been well-known, and its contamination can adversely affect the health of swimmers and seashore residents. The study sought to determine the contamination state of the Caspian Sea in Kazakhstan and quantify human health risks coming from the existing heavy metals concentration. The Caspian Sea was found to be “fairly to marginally” contaminated (24 < CCME-WQI < 64), with Cd influencing the index significantly. Concentrations of Cd and Pb increase over time (seasonal Kendall test, p-values = 2-4 %) in sites near oil fields and ports, suggesting the significant role of anthropogenic sources in causing diverse pollution events. Pb demonstrated the highest variability and number of outliers (4.3 % of all samples with coefficients of variation reaching up to 175 %). The principal component analysis further revealed that various discharges from oilfields and upstream transport could contribute to the contamination by heavy metals and their concentrations. Contamination is associated with up to 6 % cancer risk for adults. The long exposure duration of swimmers in water increases risks by up to 18 %, indicating the local population is at a higher risk. In conclusion, statistical tests and analysis indicate the presence of anthropogenic sources, and risk assessment reveals swimming can contribute to cancer risk.

PMID:35780631 | DOI:10.1016/j.marpolbul.2022.113879

Eur J Obstet Gynecol Reprod Biol. 2022 Jun 27;275:110-114. doi: 10.1016/j.ejogrb.2022.06.020. Online ahead of print.

ABSTRACT

RESEARCH QUESTION: The purpose of this study is to investigate whether the mitochondrial DNA (mtDNA) content can reflect the state of mosaic embryos.

DESIGN: The study included 1669 blastocysts derived from 394 PGT-A cycles between January 2018 and December 2020, in which preimplantation genetic testing for aneuploidy was performed and mtDNA content was determined. The standard deviation (SD) of whole genomic sequencing data was calculated for quality control. mtDNA content was measured as the proportion of mtDNA to genomic DNA. 1558 blastocysts with SD values less than 4.0 and mtDNA values less than 0.4% were selected for statistical analysis.

RESULTS: The mtDNA content of the PGT mosaic group was significantly higher than that of the PGT normal group (P < 0.001). Twenty-six mosaic embryos were transferred, and the results were as follows: 2 out of 26 had undergone a spontaneous miscarriage, 15 were not pregnant, and 9 resulted in a live birth. There were significant differences in the mtDNA content between the miscarriage/non-pregnancy group and the live birth group (**P < 0.01; ***P < 0.001). There was no mosaic embryo with more than 0.157% mtDNA content found in the live birth group.

CONCLUSIONS: This study demonstrates that mtDNA analysis has the ability to identify mosaic embryos with high developmental potential. It can be a valuable supplementary index for the selection of mosaic embryos for transfer. Larger studies with a greater sample size will further our understanding of the relationships between metabolic activity and mosaicism.

PMID:35780625 | DOI:10.1016/j.ejogrb.2022.06.020

Biomed Pharmacother. 2022 Jun 30;153:113316. doi: 10.1016/j.biopha.2022.113316. Online ahead of print.

ABSTRACT

Nephrotoxicity is one of the most severe late-term side effects after chemotherapy. It is important to evaluate the possible risks and provide valuable treatment and follow-up for the patient.

METHODS: the data was observed from 50 patients from 0 till 18 years old that were treated for childhood cancer and was collected according to methodological recommendations.

RESULTS: 28 boys and 22 girls were included and the average age of all patients when the diagnosis was made was five years. 56% have faced kidney and urinary tract related complications. 75% of those patients have faced nephrotoxicity, 10,71 – urinary tract related complications and 14,29 have faced both – nephrotoxicity and urinary tract related complications. GFR was decreased in one case, increased in three cases and normal in the remaining cases. There was no statistical significance between kidney and urinary tract related complications and patient’s age at the time of treatment, type of cancer (except for sarcomas), type of surgery or radiotherapy. Nephrotoxicity had statistical significance to occur more commonly during the first two years after treatment, while urinary tract related complications occurred more frequently during five years after treatment. Doxorubicin and Ifosfamide had statistical significance with kidney-related long-side effect; Lomustine also had a close relation. Chemotherapy drug’s cumulative dose also had statistical significance of the same chemotherapy drugs.

CONCLUSIONS: this study suggests that chemotherapy drug and its cumulative dosage has the most influence on kidney and urinary tract related complications.

PMID:35780616 | DOI:10.1016/j.biopha.2022.113316

Phytomedicine. 2022 Jun 15;104:154278. doi: 10.1016/j.phymed.2022.154278. Online ahead of print.

ABSTRACT

BACKGROUND: The Qilong capsule (QLC) is a Chinese patented medicine characterized by an equal emphasis on replenishing Qi and activating blood circulation. In 2000, China’s FDA approved the use of QLC for ischemic stroke (IS). However, there is not yet much high-quality evidence of the clinical effectiveness of QLC combined with conventional treatment (CT) for IS with Qi deficiency and blood stasis syndrome.

PURPOSE: In this study, we conducted a prospective, multicenter, non-randomized controlled trial at 7 hospitals in China to investigate the clinical effectiveness of QLC combined with CT for IS with Qi deficiency and blood stasis syndrome.

METHODS: Participants aged 35 to 80 years old diagnosed as IS with Qi deficiency and blood stasis syndrome in TCM were recruited. Participants were treated with QLC (intervention group) or non-QLC (control group). The intervention course of QLC was 12 weeks. All participants in two groups received standard treatment. All participants returned for in-person follow-up visits at the 12th week and 24th week. Primary outcome measures included a modified Rankin Scale (mRS), the National Institute of Health Stroke Scale (NIHSS), and the Barthel Index (BI). Secondary outcome measures included TCM syndromes (Qi deficiency syndrome score, blood stasis syndrome score), psychological index (self-rating depression scale, SDS; self-rating anxiety scale, SAS), blood lipid index, blood coagulation index, homocysteine, and favorable functional outcome (mRS 0 – 3). Multiple imputations were used for any missing data. Propensity score matching (PSM) was used to deal with any confounding factors (age, gender, scale score, etc.). Rank alignment transformation variance analysis (ART ANOVA) and generalized linear mixed model (GLMM) were introduced to improve the scientific and accuracy of repeated measurement data. All statistical calculations were carried out with R 3.6.1 statistical analysis software.

RESULTS: A total of 2468 participants were screened from November 2016 to January 2019. Finally, 2302 eligible participants were included in the analysis. There were 1260 participants in the intervention group (QLC group) and 1042 participants in the control group (non-QLC group). After PSM matching, sub-samples of 300 participants in the QLC group and 300 participants in the non-QLC group were finally formed. The final results of clinical effectiveness are the same results shared by the total samples and sub-samples after PSM. In the 24th week after treatment, QLC combined with CT proved to be significantly better than CT alone in reducing the scores of mRS (p < 0.05), NIHSS (p < 0.001), Qi deficiency syndrome (p < 0.01), and blood stasis syndrome (p < 0.001), SAS (p < 0.05), as well as in improving BI score (p < 0.05). The favourable functional outcome (mRS score of 0 to 3 at week 12) was statistically different between QLC and non-QLC group in the sub-samples (p < 0.01, 97% vs 91.7%). The results of the ART ANOVA showed that the improvement of mRS (p < 0.01), BI (p < 0.05) and NIHSS (p < 0.001) in QLC group was better than non-QLC group when the interaction effect was considered. The results of GLMM showed that the reduction of mRS and NIHSS scores of patients in the QLC group were better than those of the non-QLC group (p < 0.001). The BI score of the QLC group in the sub-samples after PSM increased more than the non-QLC group (p < 0.001). There was no evidence showing that QLC can cause serious adverse reactions (ADRs) in treating patients with IS.

CONCLUSION: QLC combined with CT was better than CT alone in reducing mRS score, NIHSS score, Qi deficiency syndrome score, blood stasis syndrome score, and SAS score, as well as improving BI score after treatment. Further high-quality RCTs are needed to confirm the positive results. The study protocol was embedded in a registry study that registered in the Clinical Trials USA Registry (registration No. NCT03174535).

PMID:35780589 | DOI:10.1016/j.phymed.2022.154278

Accid Anal Prev. 2022 Jun 30;174:106763. doi: 10.1016/j.aap.2022.106763. Online ahead of print.

ABSTRACT

Among all crashes involving cyclists, a motorist approaching from behind a cyclist on a shared lane is particularly dangerous and likely to result in serious injuries and fatalities. Previous research has highlighted that inadequate lateral distance and high vehicle speed are among the main contributing factors of crashes involving cars overtaking cyclists. A new advanced driver assistance system (ADAS) which supports drivers as they overtake cyclists was designed to avoid or, at least, mitigate crashes. In human-machine interface (HMI) design, the information was presented via multiple modalities with a multistage warning system. A combination of lateral clearance (LC) and time-to-danger (TTD) parameters was used as ADAS activation criterion. Experimentation was carried out using the medium-fidelity driving simulator at the Transportation Research Institute (IMOB) of Hasselt University in Belgium. Forty-eight drivers drove the two-lane rural experimental route two times, in baseline condition and with the ADAS activated, testing three overtaking events. Statistical tests showed that the proposed in-vehicle driving assistance system had a significant effect in increasing 1) the length of the passing phase, 2) the LC in the overtaking passing phase, and 3) the TTD along the overtaking maneuver. No effect of the ADAS system on vehicle speed was observed. Overall, the designed system is effective in improving car-cyclist overtaking behaviour in terms of both safety and cyclists’ mobility.

PMID:35780562 | DOI:10.1016/j.aap.2022.106763

Int J Drug Policy. 2022 Jun 29;107:103770. doi: 10.1016/j.drugpo.2022.103770. Online ahead of print.

ABSTRACT

BACKGROUND: Most states in the U.S. have enacted prescription opioid quantity limits to curb long-term opioid dependency. While several studies of these policies find reductions in subsequent prescriptions, others find mixed results in reducing overall opioid prescriptions and prescription length. Our objective was to examine three opioid restriction policies implemented in Louisiana Medicaid: (1) a 15-day quantity limit for opioid-naïve acute pain patients, (2) a subsequent further reduction to a 7-day quantity limit and a Morphine Milligram Equivalent Dosing (MME) limit of 120mg per day, and (3) a final reduction in daily MMEs to 90mg per day.

METHODS: Using interrupted time series (ITS) models with Medicaid pharmacy claims data, we estimated changes in trends of opioid prescription fills associated with opioid restriction policies in Louisiana Medicaid. Outcomes of interest included average opioid prescription length, average MMEs per day, and the likelihood that an opioid-naïve beneficiary who received their first opioid prescription filled a second prescription within 30 or 60 days of their initial fill.

RESULTS: 15-day and 7-day opioid prescription quantity limits were associated with a 0.720 and a 0.401 day reduction in average opioid prescription lengths. 7-day limits were associated with a 2.7 and a 3.0 percentage point reduction in the likelihood of a second opioid prescription fill within 30 or 60 days of the initial fill. The 120mg per day MME limit was associated with a 0.80 MMEs per day reduction in average daily MMEs. Further restricting daily MMEs to 90mg per day had no statistically significant association with average daily MMEs.

CONCLUSION: These findings suggest that efforts to limit opioid exposure through the implementation of prescription quantity limits and MME restrictions in Louisiana’s Medicaid program were successful and are likely to be associated with a reduction in future opioid dependency among the state’s Medicaid population.

PMID:35780564 | DOI:10.1016/j.drugpo.2022.103770

Comput Methods Programs Biomed. 2022 May 25;223:106898. doi: 10.1016/j.cmpb.2022.106898. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Recent clinical data suggest that 75% of patients undergoing surgery are anxious, despite pharmacological measures to relieve anxiety. As an alternative to the administration of drugs, the scientific literature reports the relevant psychophysiological effects of auditory and visual stimulation in reducing preoperative anxiety. The main objective of this study is the development of a portable computer-controlled device for the simultaneous combined administration of audio-visual stimuli and the evaluation of this device through the collection and the statistical analysis of psychophysiological parameters strictly related to the state of anxiety.

METHODS: A new algorithmic approach for the real-time association of sounds and colours is proposed and implemented in a low-cost architectural platform. The combined administration of auditory and visual stimuli is tested on 220 subjects undergoing dental surgery; in particular, psychophysiological parameters are collected and evaluated in four experimental conditions, in order to demonstrate the efficacy of cross-modal stimulation (auditory and visual) compared to non-pharmacological treatments based on monomodal stimuli (auditory or visual).

RESULTS: Non-parametric statistical techniques applied to the recorded experimental data show that the experimental conditions considered significantly differ. Pairwise comparisons between experimental groups show that the combined administration of sounds and colors significantly reduces the level of anxiety, systolic blood pressure and heart rate to a greater extent than monomodal stimulation.

CONCLUSION: The study demonstrates the potential benefits of a device for the combined administration of auditory and visual stimuli. The developed device has proven effective in reducing preoperative anxiety levels, becoming a serious candidate for non-pharmacological therapies. The study also encourages a deeper investigation of models capable of better capturing the potential of cross-modal stimulation, maximizing the desired effects (relaxation, arousal) on patients awaiting specific medical treatments.

PMID:35780520 | DOI:10.1016/j.cmpb.2022.106898

Epidemics. 2022 Jun 22;40:100604. doi: 10.1016/j.epidem.2022.100604. Online ahead of print.

ABSTRACT

The time-varying reproduction number (R_t) can change rapidly over the course of a pandemic due to changing restrictions, behaviours, and levels of population immunity. Many methods exist that allow the estimation of R_t from case data. However, these are not easily adapted to point prevalence data nor can they infer R_t across periods of missing data. We developed a Bayesian P-spline model suitable for fitting to a wide range of epidemic time-series, including point-prevalence data. We demonstrate the utility of the model by fitting to periodic daily SARS-CoV-2 swab-positivity data in England from the first 7 rounds (May 2020-December 2020) of the REal-time Assessment of Community Transmission-1 (REACT-1) study. Estimates of R_t over the period of two subsequent rounds (6-8 weeks) and single rounds (2-3 weeks) inferred using the Bayesian P-spline model were broadly consistent with estimates from a simple exponential model, with overlapping credible intervals. However, there were sometimes substantial differences in point estimates. The Bayesian P-spline model was further able to infer changes in R_t over shorter periods tracking a temporary increase above one during late-May 2020, a gradual increase in R_t over the summer of 2020 as restrictions were eased, and a reduction in R_t during England’s second national lockdown followed by an increase as the Alpha variant surged. The model is robust against both under-fitting and over-fitting and is able to interpolate between periods of available data; it is a particularly versatile model when growth rate can change over small timescales, as in the current SARS-CoV-2 pandemic. This work highlights the importance of pairing robust methods with representative samples to track pandemics.

PMID:35780515 | DOI:10.1016/j.epidem.2022.100604

Eur J Heart Fail. 2022 Jul 3. doi: 10.1002/ejhf.2602. Online ahead of print.

ABSTRACT

AIMS: Benzodiazepines have been used as safe anxiolytic drugs for decades and some authors have suggested they could be an alternative for morphine for treating acute cardiogenic pulmonary edema (ACPE). We compared the efficacy and safety of midazolam and morphine in patients with ACPE.

METHODS AND RESULTS: A randomized, multicenter, open-label, blinded endpoint clinical trial was performed in 7 Spanish emergency departments (EDs). Patients >18 years old clinically diagnosed with ACPE and with dyspnea and anxiety were randomized (1:1) at ED arrival to receive either intravenous midazolam or morphine. Efficacy was assessed by in-hospital all-cause mortality (primary endpoint). Safety was assessed through serious adverse event (SAE) reporting, and composite endpoint included 30-day mortality and SAE. Analyses were made on an intention-to-treat basis. The trial was stopped early after a planned interim analysis by the safety monitoring committee. At that time, 111 patients had been randomized: 55 to midazolam and 56 to morphine. There were no statistically significantly differences in primary endpoint (in-hospital mortality for midazolam/morphine 12.7%/17.9%, Risk Ratio[RR], 0.71; 95% confidence interval[CI], 0.29 to 1.74; P=0.60). SAE were less common with midazolam (18.2%/42.9%, RR, 0.42; 95%CI, 0.22 to 0.80; P=0.007), as were the composite safety endpoint (23.6%/44.6%, RR, 0.53; 95% CI, 0.30 to 0.92; P=0.03).

CONCLUSION: Although the number of patients was too small to draw final conclusions and there were no significant differences in mortality between midazolam and morphine, a significantly higher rate of SAEs was found in the morphine group.

PMID:35780488 | DOI:10.1002/ejhf.2602