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Nevin Manimala Statistics

Comparison of Efficacy and Safety of XEN45 Implant Versus Trabeculectomy in Asian Eyes

J Glaucoma. 2021 Nov 3. doi: 10.1097/IJG.0000000000001954. Online ahead of print.

ABSTRACT

PRECIS: Combined phacoemulsification and trabeculectomy is able to achieve greater reduction in intraocular pressure (IOP), higher rates of complete surgical success and fewer postoperative manipulations and visits compared with combined phacoemulsification and Xen implantation in glaucomatous eyes.

PURPOSE: Our study aims to compare and understand the differences between the efficacy and safety of XEN45 implantation and trabeculectomy in Asian eyes with glaucoma.

MATERIALS AND METHODS: This was a retrospective, single-center, comparative study of consecutive patients who underwent combined phacoemulsification and trabeculectomy (Phaco-Trab) from January 2013 to June 2014 and combined phacoemulsification and XEN45 implantation (Phaco-Xen) from May 2017 to September 2018 in a tertiary Ophthalmology center in Singapore. Outcome measures included IOP, number of anti-glaucoma eyedrops, success rate, factors leading to success/failure, number of postoperative interventions and visits required, and surgical complications.

RESULTS: A total of 137 eyes (91 Phaco-Trab, 46 Phaco-Xen) were included. Phaco-Trab group had greater mean IOP reduction at all time points beyond postoperative month (POM) 1 (mean difference 2.9 to 3.8 mm Hg; P<0.05), and greater reduction in mean number of antiglaucoma eyedrops beyond POM3, thought this was not statistically significant. At POM12, complete success was achieved in 83.5% in Phaco-Trab and 52.2% of Phaco-Xen group, respectively (P<0.001). There was no significant factor associated with surgical failure, other than the difference in surgical procedure. Phaco-Trab group required fewer number of postoperative interventions (P=0.009), with only a mean of 0.1 bleb interventions required per patient, versus 1.5 in Phaco-Xen group (P<0.001). Safety profiles in both groups were comparable, with no statistically significant difference in intraoperative/postoperative complications.

CONCLUSION: Phaco-Trab has significantly higher reduction in both IOP and number of antiglaucoma medications compared with Phaco-Xen group, with greater surgical success and fewer postoperative manipulations and visits. Safety profiles were comparable.

PMID:34731866 | DOI:10.1097/IJG.0000000000001954

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Nevin Manimala Statistics

Minimally Invasive Micro Sclerostomy (MIMS) Procedure – A Novel Glaucoma Filtration Procedure

J Glaucoma. 2021 Nov 3. doi: 10.1097/IJG.0000000000001955. Online ahead of print.

ABSTRACT

PRECIS: Intermediate term results suggest that ab-interno Minimally Invasive Micro Sclerostomy (MIMS) stent less subconjunctival filtration procedure is a promising treatment option for patients with open angle glaucoma.

PURPOSE: Minimally Invasive Micro Sclerostomy (MIMS) is a novel ab-interno, stent-less, subconjunctival filtration procedure. This study set to investigate the safety, performance and efficacy of MIMS in open angle glaucoma patients.

METHODS: Prospective, open-label, single arm clinical trial with intra-subject comparisons. Study participants were adults with open angle glaucoma who were candidates for a filtration procedure. Patients were operated by a single surgeon (A.A) in Chennai, India. Following mitomycin C pretreatment, Ab-interno MIMS procedure was performed alone or combined with Phacoemulsification surgery. Procedure-related complications and adverse events were assessed. Primary outcomes: patients (%) achieving an IOP≥5▒mmHg and ≤18▒mmHg, and an IOP reduction of >20% as compared to baseline, with or without hypotensive medications, with no need for recurrent surgery.

RESULTS: 21 Phacoemulsification-MIMS and 10 standalone MIMS procedures were performed. Mean age was 63.94±6.33 years. Mean duration of MIMS was 1:58±0:25 (min:sec). Scleral tunnels were achieved in all cases. No device malfunctions, intra-operative complications, or serious adverse events were reported. Five (16.12%) patients presented with iris clogging 1-24 weeks following procedure. Two were treated with laser and 3 required trabeculectomy. Mean IOP change from baseline at 24 weeks was 47.4% (31.2 to 16.4▒mmHg, P<0.0001, n=23). The mean difference was -14.8▒mmHg (95% CI: -17.6, -11.9) with no statistically significant differences between groups. Qualified success was achieved in 21 (84%), 17 (74%) and 13 (93%) after 12, 24, and 52 weeks, respectively. Complete success was achieved in 17 (68%), 13 (57%) and 8 (57%) after 12, 24, and 52 weeks, respectively.

CONCLUSIONS: The interim results suggest that MIMS procedure may be a simple and effective surgical option for early open angle glaucoma patients requiring target IOP in high teens although iris clogging of incision site is the major concern with this procedure.

PMID:34731867 | DOI:10.1097/IJG.0000000000001955

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Nevin Manimala Statistics

Review of available data for the efficacy and effectiveness of nabiximols oromucosal spray (Sativex) in multiple sclerosis patients with moderate to severe spasticity

Neurodegener Dis. 2021 Nov 3. doi: 10.1159/000520560. Online ahead of print.

ABSTRACT

BACKGROUND: Sativex (USAN: nabiximols) oromucosal spray is indicated for treatment of multiple sclerosis (MS) patients with moderate to severe spasticity and inadequate response to other antispasticity medications who demonstrate clinically significant improvement during an initial trial of therapy. This narrative review investigated the efficacy and effectiveness of nabiximols oromucosal spray for moderate to severe MS spasticity by examining spasticity 010 Numerical Rating Scale (NRS) data from interventional and observational studies which featured a 4-week trial period as per the European Union approved label.

SUMMARY: Across both study types, clinically relevant and statistically significant reductions in mean MS spasticity 0-10 NRS scores were measured soon after treatment start and were maintained in the mid to long term in treatment responders. Initial responder rates (≥ 20% NRS improvement from baseline at week 4) ranged from 47.6% to 81.4%, tending lower in the randomized clinical trials setting. Clinically relevant responder rates (≥ 30% NRS improvement from baseline at week 12) were similar between study types (range 3041%) except for one outlier (74% in an observational study). Two open studies reported treatment continuation for ≥ 18 months in approximately half of patients who initiated treatment. In most longer-term studies, symptomatic improvement in MS spasticity was maintained at mean daily dosages of about 67 sprays/day. Safety was consistent with the known profile of nabiximols. Key messages: Experimental and observational studies of nabiximols oromucosal spray recorded similar findings. About half to two-thirds of MS patients who begin treatment will perceive initial symptomatic relief of spasticity within the 4-week trial period. About 40% of patients who initiate treatment will reach the ≥ 30% NRS improvement threshold at 3 months, comprising the majority of patients who continue long-term treatment. A trial of therapy with nabiximols is useful to identify patients most likely to gain longer-term improvement in spasticity symptoms and discontinue those with insufficient benefit.

PMID:34731865 | DOI:10.1159/000520560

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Impact of work routines on parents’ and children’s sleep during the COVID-19 pandemic lockdown

Sleep Med. 2021 Oct 15;88:61-67. doi: 10.1016/j.sleep.2021.10.005. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effects of parental sleep and work arrangements on children’s sleep duration during the national lockdown period, referred to as ‘Circuit Breaker’ (CB), due to COVID-19.

METHODS: Cross-sectional, anonymous, online questionnaire to parents with school-going children aged between 3 and 16 years. Child and parental sleep duration in relation to change in parental work arrangements, housing type and number of individuals in the household as reported by parents were evaluated. Descriptive statistics and tests of comparison were used to evaluate data.

RESULTS: School-going children (n = 593) had a mean age of 8.68 (SD = 3.65; median 7) years. Both, fathers and mothers had gains in sleep during CB (based on self-reported sleep data), compared to pre-CB. Change in both maternal and paternal sleep duration positively correlated with change in child sleep duration (based on parent-reported sleep data) among all children (r2 = 0.27, p < 0.001 and r2 = 0.17, p < 0.001 respectively); pre-schoolers mirrored their mothers’ sleep more closely. Parents who changed to working from home during the CB (compared to working from outside home previously) had the greatest gains in sleep during this period. Housing type was not significantly associated with change in child sleep duration from pre-CB to CB.

CONCLUSIONS: Greater gains in sleep in parents was associated with working from home during CB. Child sleep duration mirrored gains in parental sleep, especially in pre-school and primary-school-going children. Optimising parental sleep may therefore be one of the means to improve child sleep.

PMID:34731830 | DOI:10.1016/j.sleep.2021.10.005

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The Association between Serum Bilirubin and Kernicterus Spectrum Disorder: A Systematic Review and Meta-Analysis

Neonatology. 2021 Nov 3:1-11. doi: 10.1159/000519497. Online ahead of print.

ABSTRACT

BACKGROUND: Total serum bilirubin (TSB) is used in managing neonates with jaundice, but clear evidence on its association with major outcomes is lacking.

OBJECTIVES: We evaluated the association between TSB and kernicterus spectrum disorder (KSD).

METHODS: We searched PubMed, EMBASE, and CENTRAL till July 2021. Two authors independently selected relevant cohort studies, extracted data (CHARMS checklist), assessed risk of bias (RoB) (QUIPS tool), and rated certainty-of-evidence (Grades of Recommendation, Assessment, Development, and Evaluation). We pooled adjusted odds ratio (aOR) (random-effect) via generic inverse variance methods.

RESULTS: From 2,826 records retrieved, we included 37 studies (n = 648,979). Fifteen studies had low, 16 moderate, and 6 high RoB, with majority having concerns on confounder adjustment and statistical analysis. Twenty-two studies contributed meta-analysis data, and 15 were summarized narratively. TSB appears associated with KSD in infants with certain risk factors (aOR 1.10, 95% CI: 1.07-1.13; 5 studies [n = 4,484]). However, TSB (aOR 1.10, 95% CI: 0.98-1.23; 1 study [n = 34,533]) or hyperbilirubinemia (aOR 1.00, 95% CI: 0.51-1.95; 2 studies [n = 56,578]) have no clear association with kernicterus or neurological diagnosis in overall neonatal population (moderate-certainty-evidence). One study shows that infants with hyperbilirubinemia appear likelier to develop attention-deficit disorder (aOR 1.90, 95% CI: 1.10-3.28) and autistic spectrum disorder (aOR 1.60, 95% CI: 1.03-2.49, n = 56,019) (low-certainty-evidence). Certain clinical factors appear associated with KSD, although very few studies contributed to the analyses.

CONCLUSIONS: Despite the importance of this question, there is insufficient high-quality evidence on the independent prognostic value of TSB for adverse neurodevelopmental outcomes in most neonatal populations. Future studies should incorporate all known risk factors alongside TSB in a multivariable analysis to improve certainty-of-evidence.

PMID:34731859 | DOI:10.1159/000519497

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Nevin Manimala Statistics

Rational addiction and time-consistency: An empirical test

J Health Econ. 2021 Oct 24;80:102546. doi: 10.1016/j.jhealeco.2021.102546. Online ahead of print.

ABSTRACT

This paper addresses one of the main empirical problems associated with rational addiction theory, namely, that its derived demand equation is not empirically distinguishable from those of models with forward-looking behavior but with time-inconsistent preferences. Using an encompassing general specification of the rational addiction model we derive a microfounded test of time-consistency. The test allows us to distinguish between time-consistent versus time-inconsistent naïve agents. The results obtained from a panel of Russian individuals conform to the theoretical predictions of the rational addiction model and the proposed test for time-consistency does not reject the hypothesis that Russian cigarette consumers are time-consistent.

PMID:34731726 | DOI:10.1016/j.jhealeco.2021.102546

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Effect of resveratrol supplementation on biomarkers associated with atherosclerosis in humans

Complement Ther Clin Pract. 2021 Oct 6;46:101491. doi: 10.1016/j.ctcp.2021.101491. Online ahead of print.

ABSTRACT

Previous studies have suggested the beneficial effects of resveratrol against cardiovascular disease (CVD). However, there are inconsistent results on cardiovascular-related biomarkers mainly because of variable dosage, intervention time and baseline characteristics of the population. Thus, the exact effect of resveratrol remains unclear. We conducted a review to classify the studies that applied resveratrol to supplement humans according to the major biomarkers and identify which protocol characteristics would be associated with each result profile. Randomized clinical trials that assessed resveratrol effect on biomarkers related to atherosclerosis were searched in databases. Biochemical data were collected from 27 studies on the baseline and post-intervention time. We selected 12 biomarkers to compose the matrix, based on their clinical relevance and higher variation level. A total of 32 assays were obtained from these 27 studies. The net change (%) was calculated for each biomarker. Applying multivariate analysis, the assays were grouped into 3 clusters. Studies that composed Cluster II were characterized by a mean dose of 454.14 mg/day for 74.21 days and showed higher reduction of triglyceride concentration and blood pressure, while those composing Cluster III applied doses around 273.75 mg/day for about 175.33 days and showed the highest HDL increase. Thus, interventions with resveratrol could be customized according to the patient condition, in terms of “dose/time of intervention”. This information can be applied to combine resveratrol with drugs to reduce blood pressure or improve lipid profile in further clinical studies.

PMID:34731768 | DOI:10.1016/j.ctcp.2021.101491

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Nevin Manimala Statistics

Modeling defluoridation of real-life groundwater by a green adsorbent aluminum/olivine composite: Isotherm, kinetics, thermodynamics and novel framework based on artificial neural network and support vector machine

J Environ Manage. 2021 Oct 30;302(Pt A):113965. doi: 10.1016/j.jenvman.2021.113965. Online ahead of print.

ABSTRACT

The kinetic, isotherm, and thermodynamics of adsorptive removal of fluoride from the real-life groundwater was evaluated to assess the applicability of a green adsorbent, aluminum/olivine composite (AOC). The isotherm and kinetics were demonstrated by the Freundlich and Elovich model indicating significant surface heterogeneity of AOC in favouring the fluoride sorption. The fluoride removal efficiency of AOC was achieved as 87.5% after 240 min of contact time. The diffusion kinetic model exhibited that both the intra-particle and film diffusion together control the rate-limiting step of fluoride adsorption. A negative value of ΔG0 (-19.919 kJ/mol) at 303 K confirmed the spontaneous adsorption reaction of fluoride, and its endothermic nature was supported by the negative value of ΔH0 (39.504 kJ/mol). A novel framework for a predictive model by artificial neural network (ANN), and support vector machine (SVM) considering the real and synthetic fluoride-containing water was developed to assess the efficiency of adsorbent under different scenarios. ANN model was observed to be statistically significant (RMSE: 1.0955 and R2: 0.9982) and the proposed method may be instrumental in a similar area for benchmarking the synthetic and real-life samples. The low desorption potential of the spent adsorbent exhibited safe disposal of sludge and the secondary-pollutant-free treated water by the efficient and green adsorbent AOC enhanced the field-scale applicability of the green technology.

PMID:34731705 | DOI:10.1016/j.jenvman.2021.113965

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Antiepileptic drug management in pediatric patients with brain tumor-related epilepsy

Epilepsy Behav. 2021 Oct 28;125:108359. doi: 10.1016/j.yebeh.2021.108359. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with brain tumor-related epilepsy (BTRE) are at a higher risk of significant morbidity, lower quality of life, and increased risk of mortality. We surveyed providers regarding anti-seizure medication (ASM) management in pediatric BTRE to determine if practices are standard or markedly variable.

METHODS: An anonymous voluntary online survey was sent to members of the Child Neurology Society. Providers were asked specific questions regarding initiation and wean of ASMs and if this was dependent on multiple factors. Demographic information was collected.

RESULTS: Fifty-one providers responded to the survey. Ninety-four percent of providers would start an ASM after a second seizure. Eighty-four percent chose levetiracetam as the preferred ASM. Management was variable when based on tumor location, extent of surgical resection, pathology, and tumor prognosis. Statistically significant differences in responses regarding management were identified when comparing neurologists and epileptologists, providers with formal neuro-oncology or epilepsy training, providers at large institutions, and years of experience. For patients who underwent a gross total resection of the tumor, neuro-oncology and epilepsy-trained providers were more likely to wean off ASMs (p < 0.049). Providers without formal training in neuro-oncology or epilepsy were more likely to get an EEG prior to making a decision about weaning off ASMs (p < 0.016).

CONCLUSION: These results suggest that ASM management in BTRE varies greatly according to sub-specialty and experience. Further studies and potential development of guidelines are needed to identify the most appropriate management of ASMs for BTRE.

PMID:34731721 | DOI:10.1016/j.yebeh.2021.108359

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Nevin Manimala Statistics

Data-driven method based on deep learning algorithm for detecting fat, oil, and grease (FOG) of sewer networks in urban commercial areas

Water Res. 2021 Oct 25;207:117797. doi: 10.1016/j.watres.2021.117797. Online ahead of print.

ABSTRACT

The content of fat, oil and grease (FOG) in the sewer network sediments is the key indicator for diagnosing sewer blockage and overflow. However, the traditional FOG detection is time-consuming and costly, and the establishment of mathematical models based on statistical methods to predict the content of FOG fail to provide satisfactory accuracy. Herein, a deep learning algorithm used a data-driven FOG content prediction model is proposed to achieve a more accurate prediction of FOG content. Meanwhile, global sensitivity analysis (GSA) is exploited to evaluate the contribution of input indicators to the output indicator (FOG) in the model, so that some input indicators that have less impact on the prediction performance can be screened out, the best combination of input indicators can be determined, and the operation cost of the model can be reduced. To evaluate the effectiveness of the proposed model, a case study was conducted in a city in southern China. The experimental results indicate that the prediction model obtains good FOG estimations and performs well from a single site to multiple sites with a mean R2 of 0.922, showing a good generalization performance. Through GSA, the key input indicators in the model were identified as pH, water temperature (T), relative humidity (RH), sewage flow (Flow), drinking water supply (DWS), velocity (V) and conductivity (σ), and the input indicators such as air pressure (AP), population (Pop.), and liquid level (LV) can be reduced without affecting the prediction accuracy of the model.

PMID:34731668 | DOI:10.1016/j.watres.2021.117797