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Nevin Manimala Statistics

Perampanel and lacosamide monotherapy in pediatric patients with newly diagnosed focal epilepsy: A prospective study evaluating efficacy, tolerability, and behavior

Epilepsy Behav. 2023 Jul 21;146:109353. doi: 10.1016/j.yebeh.2023.109353. Online ahead of print.

ABSTRACT

PURPOSE: Perampanel (PER) and lacosamide (LCM) are the new third-generation anti-seizure medications (ASMs) that were approved for the monotherapy of focal epilepsy in children over four years of age in China, in 2021. Very few studies have analyzed the application of PER monotherapy among pediatric patients aged ≥four years, and no study compared the efficacy and tolerability of PER monotherapy with LCM monotherapy in pediatric patients with focal epilepsy. The present study aimed to investigate the efficacy, tolerability, and effect on behavior and emotion of PER and LCM as monotherapy in pediatric patients with newly diagnosed focal epilepsy, which is beneficial for clinicians to have more choices to treat pediatric patients with focal epilepsy.

METHODS: This was a prospective, single-center, observational study that involved pediatric patients (disease onset age ≥four years) with newly diagnosed focal epilepsy treated with PER or LCM as primary monotherapy. Outcomes included retention, being responders, and seizure-free rates after 3, 6, and 12 months. Adverse events (AEs) were noticed throughout the follow-up period. Behavioral outcomes were evaluated with Achenbach Child Behavior Checklist (CBCL/4-16) at baseline and after three and six months.

RESULTS: Using randomization, 60 patients receiving PER (31 females, 29 males, median age: 7.79 [5.34, 10.16] years, median dose: 3.0 [2.0, 4.0] mg/day) and 60 patients receiving LCM (25 females, 35 males, median age: 7.72 [5.91, 10.72] years, median dose: 150.0 [100.0, 200.0] mg/day) were enrolled in the study. At the 12-month follow-up, the retention rates in the PER and LCM groups, both were 90.4%, and the responder rates were 65.4% and 71.2%, while seizure-free rates were 57.7% and 67.3%, respectively. There were no significant differences in the retention, responder and seizure-free rates between the two groups (P > 0.05). There were no significant differences in the responder rates between patients with BECTS, abnormal brain magnetic resonance imaging (MRI), or types of seizure in the two groups (P > 0.05). In the PER group, 28.8% (15/52) of patients experienced AEs, of which the most frequently reported were irritability (n = 7; 13.5%), dizziness (n = 5; 9.6%), somnolence (n = 3; 5.8%), ataxia (n = 1; 1.9%), headache (n = 1; 1.9%), and rash (n = 1; 1.9%). In the LCM group, 15.4% (8/52) of the patients had AEs, including headache (n = 4; 7.5%), dizziness (n = 4; 7.5%), nausea (n = 2; 3.8%), somnolence (n = 2; 3.8%), irritability (n = 1; 1.9%), stomach ache (n = 1; 1.9%), and vomiting (n = 1; 1.9%). The incidence of irritability was significantly higher in the PER group than in the LCM group (13.5% vs. 1.9%, P = 0.031), which occurred mainly within eight weeks after drug administration. Patients with irritability were not dangerous to surrounding people by the assessment of parental observation in the life. And the symptoms were relieved spontaneously within a few months. The outcomes of total scores, internalizing scores, and externalizing scores of the CBCL did not show statistically significant differences in the PER and LCM groups between baseline and three and six months. Characteristics of behavior and emotion did not have substantial changes in patients treated with PER and LCM monotherapy.

CONCLUSIONS: The present study documented similar good effectiveness and good tolerance of PER and LCM as monotherapy in pediatric patients with newly diagnosed focal epilepsy and showed no behavioral or emotional impact, as assessed by the CBCL. Though the incidence of irritability with PER monotherapy may be higher than that with LCM monotherapy soon after medication initiation, this side effect appears to resolve spontaneously within a few months. At present, this study was the first research about PER and LCM monotherapy in pediatric patients with newly diagnosed focal epilepsy evaluating efficacy, tolerability, and behavior in China.

PMID:37481960 | DOI:10.1016/j.yebeh.2023.109353

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Nevin Manimala Statistics

Working 40 years as medical doctors.

Orv Hetil. 2023 Jul 23;164(29):1127-1133. doi: 10.1556/650.2023.32811. Print 2023 Jul 23.

ABSTRACT

The health status of health professionals, including medical doctors is an important topic, although it is an under-researched area in Hungary and in the East-Central European countries as well. Our quasi-cohort research was focused on the health status, morbidities, anthropometric parameters, lifestyle and professional career of Hungarian medical doctors who graduated in 1979, following them 25y, 30y and 40y after graduation, seeking differences between professional groups and genders. In 2019, the mean age of participants was 64.9y, the average number of children was 2.08, higher among surgical professionals (2.43). Men reported higher number of own children. The number of night shifts decreased during the past decades. Most of them is already retired, 70% is working besides receiving a pension. 27% changed their medical specialty, 36% intended to work in another field of medicine, when graduated. About 10% of them achieved scientific (PhD) degree, most of them were satisfied with own professional carrier. The body weight and BMI significantly increased during decades, without statistical difference between genders and professional groups. Diabetes was self reported in 7%, hypertension in 44%. Men neglected more frequently their regular health check-up. Compared to their patients at the same age, 71% rated their own health status better. Among those, who reported regular physical activities, the ratio of men was higher; the average time spent on sport was the same as in the past decades, although the ratio of persons who had regular physical activity decreased, fewer participated in team sport activities. Their sleeping habit is quiet, the time is 6.3 h between workdays and 7.7 h on weekends. Burn-out was not reported. The ratio of smokers decreased; the self-reported daily intake of alcoholic beverages was 1.3, the weekly 3.7 units. Differences described earlier between professional groups disappeared. The problems of the recent Hungarian health care system were similarly rated, although the income of Hungarian physicians has increased to a great extent in the past years. Orv Hetil. 2023; 164(29): 1127-1133.

PMID:37481769 | DOI:10.1556/650.2023.32811

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Nevin Manimala Statistics

Early effects of very early cochlear implant activation on tinnitus

J Chin Med Assoc. 2023 Jul 24. doi: 10.1097/JCMA.0000000000000968. Online ahead of print.

ABSTRACT

BACKGROUND: Cochlear implantation (CI) has long been the standard of care for patients with severe-to-profound hearing impairment. Yet the benefits of CI extend far beyond speech understanding, with mounting recent literature supporting its role in tinnitus abatement. However, those studies have uniformly analyzed the effects of tinnitus after the traditional 3-4 week waiting period between CI surgery and device activation. As many clinics are shifting these waiting intervals to become shorter (in some cases within 24 hours, little is known about tinnitus abatement very early in the post-operative period. The aim of this study is to compare pre- and post-operative tinnitus handicap in this unique but growing population of very early activated patients.

METHODS: Twenty-seven adults with severe-to-profound hearing impairment with chronic tinnitus (> 6 months) were included. Patients with concomitant psychiatric disorders were excluded. All patients were implanted with the same array and were switched on within 24 hours after the surgery. Tinnitus Handicap Inventory (THI) was recorded pre-operatively, immediately after activation at 24 hours post-operatively, at 1 week, 2 weeks, and I month after activation. Wilcoxon signed-rank test was used to compare values between pre-operative assessment and respective fitting sessions.

RESULTS: Mean THI 24 hours after implantation increased in comparison to that assessed pre-operatively (77.6 vs. 72.5, p = .001). By one week after surgery, the THI had decreased to 54.9 (p<0.001). This trend continued and was statistically significant at 2 weeks (36.0, p < .001) and 1 month (28.5, p < .001).

CONCLUSION: On average, most patients with tinnitus will note a significant improvement in their tinnitus handicap when activated within 24 hours of cochlear implantation. However, tinnitus does increase between surgery and 24 hours, most likely reflecting not only intracochlear changes, but modulation of the entire auditory pathway. Following this early rise, the tinnitus continues to abate over the following month. Patients with tinnitus may benefit from early activation, though should be counseled that they may experience an exacerbation during the very early post-operative period.

PMID:37481759 | DOI:10.1097/JCMA.0000000000000968

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Nevin Manimala Statistics

Autonomy with responsibility ¿Is informed consent just a signature on a paper? Evaluation in patients who underwent spine’s surgery

Eur Spine J. 2023 Jul 23. doi: 10.1007/s00586-023-07867-2. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the information that patients undergoing spine surgery truly receive and assimilate when they sign their informed consent documents.

METHODS: This was a retrospective study on patients who underwent spine arthrodesis or spine discectomy. Patients were given a full explanation of the surgical technique to be employed and its potential risks before they were included on the surgical waiting list. Before surgery, they were asked to sign an informed consent form. The studied variables included whether patients read the informed consent form, whether they recalled the surgical technique used or the spinal segment operated, whether they were aware of the surgical risks involved, and if they had looked for information about their procedure elsewhere. Answers were analyzed by age and educational level.

RESULTS: Of a total of 458 total patients, only 51.9% answered all the questions. Sixty-three percent of patients said they had read the informed consent document before surgery. Although 91.6% of patients were aware of the spine segment operated, only 73.5% remembered the surgical technique employed. A total of 63.9% of patients could recall the vertebral levels operated. 39.1% were not aware of the surgical risks involved, and only 16.0% of patients admitted having looked for additional information. A statistically significant correlation was found between the search for additional information and young age (p < 0.001) on the one hand, and high educational level on the other (p = 0.023).

CONCLUSION: Even though obtaining informed consent is an important procedure before spinal surgery, almost 40% of the patients in this study underwent surgery without reading the informed consent document or being aware of the risks posed by the procedure.

PMID:37481758 | DOI:10.1007/s00586-023-07867-2

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Sensory and affective aspects of the perception of respiratory resistance

Biol Futur. 2023 Jul 23. doi: 10.1007/s42977-023-00173-4. Online ahead of print.

ABSTRACT

Perception of airway resistance has a sensory and an affective aspect, i.e., perceived resistance and unpleasantness, respectively. The current study aimed to shed more light on the relationship of these aspects, as well as their malleability to trait-like aspects of body awareness. In a laboratory study, 71 young participants completed two respiratory resistive load discrimination tasks relying on sensory and affective evaluation, respectively, and filled out questionnaires assessing somatosensory amplification, anxiety sensitivity, somatic symptoms distress, and breath awareness. Frequentist and Bayesian statistical analysis revealed no differences in discrimination accuracy with respect to the sensory and affective aspect of perceived resistance. Psychological traits were not associated with accuracy scores. In conclusion, affective evaluation of respiratory load is as accurate as sensory evaluation. Neither sensory not affective accuracy is influenced by various aspects of body awareness.

PMID:37481740 | DOI:10.1007/s42977-023-00173-4

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Surgical treatment of popliteomeniscal fascicles tears is associated with better patient-reported outcome measures. A systematic review and meta-analysis

Eur J Orthop Surg Traumatol. 2023 Jul 23. doi: 10.1007/s00590-023-03645-4. Online ahead of print.

ABSTRACT

PURPOSE: Popliteomeniscal fascicles (PMFs) are a component of the popliteal hiatus complex in the knee, and their injury primarily affects young athletes participating in sports activities involving twisting movements. The identification of PMFs tears presents a challenge, often accompanied by lateral pain and a locking sensation. The objective of this systematic review (SR) and meta-analysis is to enhance the suspicion and recognition of PMFs tears, aiming to facilitate the treatment of this condition, particularly in symptomatic young patients.

METHODS: A comprehensive search, focused on studies examining PMFs injuries and their treatment, was conducted in four databases, PubMed, Scopus, Embase, and Web of Science. The ROBINS-I tool was used to evaluate the risks of bias. The PRISMA flow diagram was used to conduct the research and select the included studies. A meta-analysis was conducted for the Lysholm score, the Tegner Activity Scale, and the subjective IKDC score. The present SR and meta-analysis was registered on PROSPERO.

RESULTS: Five clinical studies were included in the final analysis, comprising 96 patients. All the patients underwent a preoperative MRI assessment and a diagnostic arthroscopy to detect the PMFs tears, with a subsequent surgical procedure either open or arthroscopically performed. Surgery was associated with the resolution of symptoms. A statistically significant improvement in the Lysholm score (p: 0.0005) and the subjective IKDC score (p: 0.003) after the surgical procedure with respect to the preoperative evaluation was found.

CONCLUSION: This SR and meta-analysis showed a significant improvement in the Lysholm score and subjective IKDC score following surgery for PMFs tears. However, controversy persists regarding the optimal surgical approach, with current literature favoring arthroscopic procedures.

LEVEL OF EVIDENCE: IV.

PMID:37481735 | DOI:10.1007/s00590-023-03645-4

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A survey by the European Society of Breast Imaging on radiologists’ preferences regarding quality assurance measures of image interpretation in screening and diagnostic mammography

Eur Radiol. 2023 Jul 22. doi: 10.1007/s00330-023-09973-7. Online ahead of print.

ABSTRACT

OBJECTIVES: Quality assurance (QA) of image interpretation plays a key role in screening and diagnostic mammography, maintaining minimum standards and supporting continuous improvement in interpreting images. However, the QA structure across Europe shows considerable variation. The European Society of Breast Imaging (EUSOBI) conducted a survey among the members to collect information on radiologists’ preferences regarding QA measures in mammography.

MATERIALS AND METHODS: An anonymous online survey consisting of 25 questions was distributed to all EUSOBI members and national breast radiology bodies in Europe. The questions were designed to collect demographic characteristics, information on responders’ mammography workload and data about QA measures currently used in their country. Data was analysed using descriptive statistical analysis, the χ2 test, linear regression, and Durbin-Watson statistic test.

RESULTS: In total, 251 breast radiologists from 34 countries completed the survey. Most respondents were providing both screening and symptomatic services (137/251, 54.6%), working in an academic hospital (85/251, 33.9%) and reading 1000-4999 cases per year (109/251, 43.4%). More than half of them (133/251, 53%) had established QA measures in their workplace. Although less than one-third (71/251, 28.3%) had to participate in regular performance testing, the vast majority (190/251, 75.7%) agreed that a mandatory test would be helpful to improve their skills.

CONCLUSION: QA measures were in place for more than half of the respondents working in screening and diagnostic mammography to evaluate their breast imaging performance. Although there were substantial differences between countries, the importance of having QA in the workplace and implemented was widely acknowledged by radiologists.

CLINICAL RELEVANCE STATEMENT: Although several quality assurance (QA) measures of image interpretation are recommended by European bodies or national organisations, the QA in mammography is quite heterogenous between countries and reporting settings, and not always actively implemented across Europe.

KEY POINTS: The first survey that presents radiologists’ preferences regarding QA measures of image interpretation in mammography. Quality assurance measures in the workplace are better-established for breast screening compared to diagnostic mammography. Radiologists consider that performance tests would help to improve their mammography interpretation skills.

PMID:37481690 | DOI:10.1007/s00330-023-09973-7

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Nevin Manimala Statistics

Intact predictive processing in autistic adults: evidence from statistical learning

Sci Rep. 2023 Jul 22;13(1):11873. doi: 10.1038/s41598-023-38708-3.

ABSTRACT

Impairment in predictive processes gained a lot of attention in recent years as an explanation for autistic symptoms. However, empirical evidence does not always underpin this framework. Thus, it is unclear what aspects of predictive processing are affected in autism spectrum disorder. In this study, we tested autistic adults on a task in which participants acquire probability-based regularities (that is, a statistical learning task). Twenty neurotypical and 22 autistic adults learned a probabilistic, temporally distributed regularity for about 40 min. Using frequentist and Bayesian methods, we found that autistic adults performed comparably to neurotypical adults, and the dynamics of learning did not differ between groups either. Thus, our study provides evidence for intact statistical learning in autistic adults. Furthermore, we discuss potential ways this result can extend the scope of the predictive processing framework, noting that atypical processing might not always mean a deficit in performance.

PMID:37481676 | DOI:10.1038/s41598-023-38708-3

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Fussy Eating Rescue, a mobile-web app for responsive feeding practises among parents of toddlers: protocol for a pilot randomised controlled feasibility trial

Pilot Feasibility Stud. 2023 Jul 22;9(1):128. doi: 10.1186/s40814-023-01278-2.

ABSTRACT

BACKGROUND: Fussy eating is most often a developmentally typical behaviour, generally presenting during toddlerhood. However, up to half of parents of young children are concerned about fussy eating, and this concern may mediate the use of nonresponsive feeding practises, such as coercive or unstructured feeding and using food to reward eating. Despite the high prevalence of parental concern for fussy eating and the negative impacts nonresponsive feeding practises have on children’s health and diets, no previous digital intervention to improve the feeding practises of parents of toddlers concerned about fussy eating has been evaluated.

AIM: This article describes the protocol of a randomised controlled feasibility pilot aiming to evaluate Fussy Eating Rescue, a purely web app based intervention for parents of toddlers. The primary aim is to investigate feasibility and acceptability; secondary aims are to explore indications of intervention effect on parents’ feeding practises or children’s eating behaviours.

METHODS: Fussy Eating Rescue features include: (1) a Tracker, that allows parents to track repeated offers of food, (2) Topics, providing information on fussy eating, effective feeding strategies, and general nutrition, (3) Rescues, containing quick references to material supporting Topics contents, (4) Recipes, and (5) SMS notifications. Parents of toddlers (12-36 months old, n = 50) who have concerns about fussy eating will be recruited via Facebook. Parents will be randomised to an intervention group, which receives access to the app for 6 weeks, or to wait-listed control. Outcomes will be assessed at baseline and 6 weeks after app use, using online questionnaires and app usage statistics. Primary outcomes include participant retention rate, intervention engagement, app usability, perceived ease in using the app, perceived usefulness of the app, and user satisfaction. Secondary outcome measures include parents’ feeding practises and children’s eating behaviours.

DISCUSSION: Results will inform whether Fussy Eating Rescue is a feasible way to engage parents concerned for their toddler’s fussy eating behaviours. If feasible and acceptable to users, a larger trial will further examine the efficacy of the Fussy Eating app in improving parents’ feeding practises and children’s eating behaviours.

TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry on 15 July, 2021 (ACTRN12621000925842).

PMID:37481664 | DOI:10.1186/s40814-023-01278-2

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Nevin Manimala Statistics

Future increased risk from extratropical windstorms in northern Europe

Nat Commun. 2023 Jul 22;14(1):4434. doi: 10.1038/s41467-023-40102-6.

ABSTRACT

European windstorms cause socioeconomic losses due to wind damage. Projections of future losses from such storms are subject to uncertainties from the frequency and tracks of the storms, their intensities and definitions thereof, and socio-economic scenarios. We use two storm severity indices applied to objectively identified extratropical cyclone footprints from a multi-model ensemble of state-of-the-art climate models under different future socio-economic scenarios. Here we show storm frequency increases across northern and central Europe, where the meteorological storm severity index more than doubles. The population-weighted storm severity index more than triples, due to projected population increases. Adapting to the increasing wind speeds using future damage thresholds, the population weighted storm severity index increases are only partially offset, despite a reduction in the meteorological storm severity through adaptation. Through following lower emissions scenarios, the future increase in risk is reduced, with the population-weighted storm severity index increase more than halved.

PMID:37481655 | DOI:10.1038/s41467-023-40102-6