Tag: nevin manimala

Hormones (Athens). 2022 Sep 21. doi: 10.1007/s42000-022-00396-5. Online ahead of print.

ABSTRACT

PURPOSE: There is controversy regarding the optimal statistical method to interpret how robust is a statistically significant result. The fragility index (FI) and the reverse fragility index (RFI) are quantitative measures that can facilitate the appraisal of a clinical trial’s robustness. This study was performed to evaluate the FI and RFI of randomized controlled trials (RCTs) examining nutritional interventions in patients with diabetes mellitus, focusing on cardiovascular outcomes.

METHODS: A systematic search was conducted and relevant RCTs were identified in three databases. RCTs examining nutritional interventions (supplements or dietary patterns) in patients with DM with dichotomous primary endpoints involving cardiovascular outcomes were eligible. Data were extracted to compose 2 × 2 event tables and the FI and RFI were calculated for each comparison, using Fisher’s exact test. Risk of bias (RoB) of the included RCTs was assessed with the Cochrane RoB 2.0 tool.

RESULTS: A total of 14,315 records were screened and 10 RCTs were included in the analyses. The median FI of the paired comparisons was 3 (IQR: 2-4) and the median RFI was 8 (IQR: 4.5-17). RoB and heterogeneity were low.

CONCLUSIONS: RCTs examining nutritional interventions and cardiovascular outcomes among patients with diabetes mellitus appear to be statistically fragile. Τhe FI and the RFI can be reported and interpreted as an additional perspective of a trial’s robustness.

HIGHLIGHTS: • In the evidence-healthcare era, assessing how robust statistically significant results are remains a matter of controversy. • Recently, the fragility index (FI) and reverse fragility index (RFI) were proposed to assess the robustness of randomized controlled trials (RCTs) with 2 × 2 comparisons. • When applying the FI and RFI, RCTs examining nutritional interventions and cardiovascular outcomes among patients with diabetes mellitus (DM) appear to be statistically fragile. • Τhe FI and the RFI can be reported and interpreted as an additional perspective of a trial’s robustness. • RCTs implementing nutrition interventions among patients with DM can improve their methodology.

PMID:36129664 | DOI:10.1007/s42000-022-00396-5

Updates Surg. 2022 Sep 21. doi: 10.1007/s13304-022-01384-5. Online ahead of print.

ABSTRACT

Total esophagogastric dissociation (TEGD) was proposed to treat gastroesophageal reflux disease (GERD) both as a rescue in case of fundoplication failure and as first-line surgery in neurologically impaired children (NIC). Aim of the study is to evaluate the impact of TEGD on the quality of life (QoL) of both NIC and their caregivers focusing on the parents’ point of view. A retrospective observational study was conducted on all NIC who underwent TEGD in our center between 2012 and 2022. A questionnaire centered on the parents’ point of view and investigating QoL of NIC and their caregivers was administered to all patients’ parents. Data were compared using Fisher exact test and Mann-Whitney test; a p-value < 0.05 was considered statistically significant. 12 patients were enrolled in the study. Parents reported improvements in weight gain (p = 0.03), sleep disorders, apnea, regurgitation and vomiting (p < 0.01). Caregivers also declared a decrease in number of hospitalizations, particularly related to severe respiratory infections and ab ingestis pneumonia (p = 0.01). We also documented a reduction of caregivers’ worries during food administration (p < 0.01). 50% of parents whose children were subjected to both fundoplication and TEGD would suggest TEGD as first line surgical treatment instead of fundoplication. According to parents’ point of view, TEGD improves significantly NIC QoL and 50% of them would enthusiastically suggest TEGD as first-line surgical approach to GERD in NIC.

PMID:36129620 | DOI:10.1007/s13304-022-01384-5

Neurol Sci. 2022 Sep 21. doi: 10.1007/s10072-022-06393-1. Online ahead of print.

ABSTRACT

INTRODUCTION: The safety and efficacy of a formulation high in cannabidiol (CBD) and low in ∆⁹-tetrahydrocannabinol (THC) to treat drug-resistant epilepsy have been examined previously in children, but not in adult population. The aim of this study was to evaluate whether CBD-rich oil, as an add-on treatment to conventional antiepileptic drugs, was effective, safe, and well-tolerated in adults with drug-resistant focal epilepsy (DRFE).

METHODS: An open-label, prospective cohort, single-center in adult patients with DRFE, were receiving stable doses of antiepileptic drugs (AEDs). A cannabis based-magistral formulation (CBMF) (100 mg/ml CBD and THC <1.9 mg/ml) was administrated 0.1 ml sublingually every 12 hours, up-titrated weekly. The primary outcome was to establish a reduction in seizures frequency >50% at 12 weeks. Adverse-drug reactions monitoring was done. p-value <0.05 was statistically significant.

RESULTS: Between August 2020 and July 2022, 44 (38.6%) patients completed >3 months of follow-up. The median daily dose of CBD was 200 mg, that of THC was 4 mg, and that of CBD per kilogram of weight was 3.7 mg. The median number of seizures per month before CBD treatment was 11, and after CBD treatment was 2.5 (p<0.001). A reduction in seizures >50% at 12 week was achieved in 79.5% of the patients. The median percentage change in seizure frequency per month was 84.1% at 12 weeks. Five patients reported any adverse-drug reactions.

CONCLUSION: The CBMF is a highly effective and safety therapy to treat adult patients with DRFE. The reduction in seizures frequency is maintained over time.

PMID:36129615 | DOI:10.1007/s10072-022-06393-1

Int Ophthalmol. 2022 Sep 21. doi: 10.1007/s10792-022-02519-8. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study is to investigate changes in choroidal and optic nerve morphological parameters following MicroShunt PreserFlo implantation. The secondary aim is to investigate how the structural changes relate to the decrease in intraocular pressure (IOP).

METHODS: Prospective observational study on 15 eyes with glaucoma requiring MicroShunt implantation. Optical coherence tomography was used to measure macular choroidal thickness (MCT), peripapillary choroidal thickness (PCT), lamina cribrosa depth (LCD), cup depth and prelaminar tissue thickness (PLT), before and one day after surgery. Results were expressed in median and interquartile range (IQR) and correlated with IOP results.

RESULTS: The IOP decreased from a median of 25 (IQR = 11) mmHg to 8 (IQR = 2) mmHg the day after surgery. Median MCT increased after MicroShunt implantation from 252.1 (IQR = 156.4) µm to a postoperative value of 318.1 (IQR = 166.6) µm (p < 0.001), with a median increase of + 87.7 µm (+ 26.4%). PCT increased from 157.2 (IQR = 109.1) µm before surgery to 206.0 (IQR = 136.1) µm after surgery (p < 0.001). Moreover, we found a significant post-operative decrease in cup depth (median reduction of – 29.3 µm, p < 0.001) and an increase in PLT (median increase of 27.3 µm, p = 0.028). On the other side, LCD reduction 24 h after surgery didn’t reach any statistical significance.

CONCLUSION: PreserFlo implantation determines retinal structural changes which appear similar to those caused by traditional filtering surgery, confirming the effectiveness of this device, meantime carrying a much smaller complications rate when compared to trabeculectomy.

PMID:36129605 | DOI:10.1007/s10792-022-02519-8

Sleep Breath. 2022 Sep 21. doi: 10.1007/s11325-022-02695-y. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to study the effect of obstructive sleep apnea (OSA) on cancer risk.

METHODS: We searched PubMed, Embase, and Cochrane databases for relevant studies. The qualities of included studies were assessed using Newcastle-Ottawa Scale (NOS). Unadjusted and adjusted analyses were performed. We also conducted subgroup analyses stratified by gender, severity of OSA, study design, and cancer type.

RESULTS: After literatures search, 18 studies were included in the present study. In the unadjusted analysis, we discovered an increased cancer risk in patients with OSA with a pooled relative risk (RR) in the OSA group of 1.49 (95% confidence interval (CI): 1.32-1.69, I² = 32%, P = 0.15). In adjusted analysis, OSA correlated with cancer risk (RR: 1.36, 95% CI: 1.18-1.56, I² = 54%, P < 0.01). In subgroup stratified by gender and OSA severity, OSA statistically with cancer risk in females (RR: 1.27, 95% CI: 1.06-1.51) and moderate to severe OSA groups (RR: 2.62, 95% CI: 1.64; 4.19). In subgroup stratified by study design, a trend toward statistically significant differences was observed in prospective studies (RR: 1.21, 95% CI: 0.99-1.48) and cross-sectional studies (RR: 1.81, 95% CI: 0.96-3.41). Patients with OSA in the retrospective study group had a statistically higher chance of developing cancer (RR: 1.41, 95% CI: 1.11-1.79). When stratified by cancer group, statistically significant differences was observed in many types of cancer (breast cancer: RR: 1.32, 95% CI: 1.03-1.70; central nervous system cancer: RR: 1.71, 95% CI: 1.06-2.75; kidney cancer: RR: 1.81, 95% CI: 1.20-2.74; liver cancer: RR: 1.19, 95% CI: 1.10-1.29; and pancreatic cancer: RR: 1.23, 95% CI: 1.14-1.33).

CONCLUSIONS: This systematic review and meta-analysis suggests that obstructive sleep apnea may increase risk of cancer.

PMID:36129602 | DOI:10.1007/s11325-022-02695-y

Int J Biometeorol. 2022 Sep 21. doi: 10.1007/s00484-022-02369-0. Online ahead of print.

ABSTRACT

The global burden of neurodegenerative disorders is significantly increasing as life expectancy rises but currently there is no cure for these conditions. An extensive search on MEDLINE (PubMed) and PEDro databases was conducted selecting clinical trials, Randomized Controlled Trials, and longitudinal studies published in the last 20 years in order to highlight what evidence there is for a role of spa rehabilitative interventions for patients with neurodegenerative diseases, in terms of motor function, symptoms, and quality of life (QoL) improvement and cost-effectiveness. A total of 225 publications were analyzed. Only three manuscripts were selected for review because they matched the inclusion criteria. These studies demonstrated statistically significant differences in the outcomes evaluated among patients affected by Parkinson’s disease after thermal rehabilitative treatments: motor function, balance, QoL, and psychological well-being statistically improved. In addition, rehabilitation in the spa setting seemed to be cost-effective for these patients. However, further studies are needed to define the role of spa rehabilitative interventions for these patients as the literature is still limited.

PMID:36129582 | DOI:10.1007/s00484-022-02369-0

Clin Rheumatol. 2022 Sep 21. doi: 10.1007/s10067-022-06366-x. Online ahead of print.

ABSTRACT

OBJECTIVES: We aimed to evaluate the clinical and laboratory characteristics of patients with Kawasaki disease (KD) before and after therapy.

METHODS: Patients with KD were divided into different groups according to their responsiveness to initial intravenous immunoglobulin (IVIG) treatment and coronary status. The clinical and laboratory parameters before and after therapy were compared. Multivariate analysis was performed to identify the independent risk factors, and the receiver operating characteristic (ROC) curve was applied to assess and compare the prediction ability of risk factors and their fluctuations.

RESULTS: Of the 153 patients included in the study, 41 (26.8%) had IVIG resistance and 37 (24.2%) had developed CAA. After stratifying by therapy response, the two groups differed in the levels of total bilirubin (TSB), albumin, and sodium, neutrophil-to-lymphocyte count ratio (NLR), platelet-to-lymphocyte count ratio (PLR), TSB-to-albumin (B/A) ratio, and prognostic nutritional index (PNI) before IVIG, and in the white blood cell count (WBC), neutrophil count, levels of hemoglobin, C-reactive protein (CRP), alanine aminotransferase (ALT), and albumin, NLR, PNI, capillary leakage index (CLI), and systemic immune-inflammation index (SII) after IVIG. Multivariate analysis revealed that the B/A ratio before IVIG and CLI and SII after IVIG were significantly and positively associated with IVIG resistance and that there was a larger decline in the B/A ratio and smaller decline in CLI and SII pre- and post-treatment in the IVIG-resistant group than in the IVIG-responsive group. However, no statistical differences in the fluctuations of the B/A ratio, CLI, and SII as well as all parameters before and after therapy were observed in patients with and without CAA. ROC curve analyses found a greater AUC value of post-treatment parameters (0.751 and 0.706 for CLI and SII, respectively) compared with pre-treatment parameters (0.654 for B/A ratio) in predicting IVIG resistance; however, the predictive ability of the fluctuations in risk factors before and after therapy was not superior to that of baseline values.

CONCLUSIONS: The B/A ratio before IVIG and CLI and SII after IVIG were risk factors for IVIG resistance in patients with KD, independent of CAA development. Key Points • A high total bilirubin-to-albumin ratio before IVIG and high capillary leakage and systemic immune-inflammation indices after IVIG may indicate an increased risk of intravenous immunoglobulin resistance in patients with Kawasaki disease. • Post-treatment parameters were superior to pre-treatment parameters in terms of prediction; therefore, rapid and repeated assessment of risk factors before and after treatment must be considered in children in whom the vital signs and symptoms do not improve after treatment.

PMID:36129563 | DOI:10.1007/s10067-022-06366-x

Environ Monit Assess. 2022 Sep 21;194(11):809. doi: 10.1007/s10661-022-10431-y.

ABSTRACT

Reservoir storage is compromised by sedimentation for which reason it has become an important matter in reservoir operation and management. While many studies have investigated sediment deposition rate in reservoirs, few have analyzed reservoir sedimentation from their catchment’s land use change perspective. Based on bathymetric survey conducted on two reservoirs in the White Volta Basin in 2020 and analysis of four Landsat satellite imagery (1986, 1996, 2006, and 2020) within their watersheds, this study assessed the land cover change within the watersheds to draw inferences on the rate of sedimentation of the reservoirs located downstream of their catchments. The results revealed rapid sedimentation in the small-sized reservoir (Vea), with an annual sedimentation rate of 0.304% and a nominal sedimentation rate of 0.17% for the mid-sized reservoir (Tono). Furthermore, the savannah forest within the Vea catchment declined drastically from 29.4% (1985) to 9.9% (2020) influenced by the rapid expansion of farmlands from 18.7% to 47.9% within the same period, respectively. On the other hand, the savannah forest within the Tono catchment declined from 34.7% (1985) to 21.6% (2020) due to farmland expansion from 19.2% to 39% within the same period, respectively. The higher sedimentation rate observed in the small-sized reservoir was observed to be worsened by extensive tree cover removal in its catchment. Therefore, land cover characteristics within a watershed have a significant bearing on the rate of sedimentation in the reservoirs located downstream of their catchment. Hence, adopting a multi-sectorial approach to dealing with land use management is necessary to sustain reservoirs’ storage.

PMID:36129559 | DOI:10.1007/s10661-022-10431-y

Environ Monit Assess. 2022 Sep 21;194(11):811. doi: 10.1007/s10661-022-10497-8.

ABSTRACT

Greenhouse gas emissions and their effects on global warming are one of the serious challenges of developed and developing countries. Investigating the amount of greenhouse gas emissions of different countries makes it possible to determine the share of countries in the production of greenhouse gases. The purpose of this study is to use DAYCENT and DNDC models to estimate the emission rate of methane, nitrous oxide, and carbon dioxide greenhouse gases as well as to estimate the global warming potential in Khuzestan agricultural lands in Iran. For this purpose, the gas sampling was done in rice, wheat, and sugarcane fields using a static chamber, and then the concentration of methane, nitrous oxide, and carbon dioxide was determined by using gas chromatography. In the following, DAYCENT and DNDC models were used to estimate gas emissions and the global warming potential of these gases was estimated. Finally, TOPSIS method was used to prioritize gas emissions. In order to evaluate the modeling accuracy, the statistical indicators of maximum error, root mean square error, determination coefficient, model efficiency, and residual mass coefficient were used. According to the results, the highest measured gas flux was obtained for rice fields at Baghmalek and the lowest for sugarcane in Abadan. The results of DAYCENT model estimation showed that the highest emissions were obtained for methane gas and rice cultivation, and lowest gas emissions were obtained for sugarcane cultivation. The results of DNDC model estimation also showed that the highest flux was determined for nitrous oxide gas in rice cultivation. The results of the estimation of global warming potential also showed that it was the highest in sugarcane cultivation (Shushtar station) and the DAYCENT model, and the lowest was also in wheat cultivation and the DNDC model. The statistical results of the estimation of DAYCENT and DNDC models showed that the DAYCENT model in sugarcane cultivation (Shushtar station) was the most accurate in estimating carbon dioxide gas, and the lowest accuracy was related to the DNDC model and sugarcane cultivation (Shushtar station) in estimating nitrous oxide gas. According to the results of agricultural activities in Khuzestan province, they have made a major contribution to the production of greenhouse gases, which, or the lack of attention to this issue, will have an effect on the future climate of this region.

PMID:36129556 | DOI:10.1007/s10661-022-10497-8

J Cancer Res Clin Oncol. 2022 Sep 21. doi: 10.1007/s00432-022-04245-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Invasive breast cancer prognosis has significantly improved over time; however, there are few data about the long-term survival.

MATERIALS AND METHODS: We analysed the data on female breast cancer incident during 2004-2005 in the area of the Tuscan Cancer Registry, distinguishing them in five subtypes, according to ER, PgR, HER2, and Ki67 expression: luminal A, luminal B, luminal B/HER2 + , triple-negative, and HER2 + . Effects of subtypes and age on 10 years breast cancer specific survival were analysed by Kaplan-Meier and multivariate Cox analysis.

RESULTS: The majority of breast cancer were luminal B (57%), and 45% of them were diagnosed at pathological stage I. The 10-year survival rates (p < 0.001) were higher among luminal A (90.2%) and lower among HER-2 + patients (70.3%). Prognostic effect of age was statistically significant (p < 0.0004): the 10-year cancer specific survival rates were higher among 40-59 years of age patients (88.5%), lower among 0-39 (75.8%). Luminal A breast cancer patients had a constant low risk throughout 10 years of follow up, while luminal B/HER2 + and triple negative tumours showed a peak 5 years after the diagnosis and then declined.

DISCUSSION: Our study confirmed the prognostic effect of biological subtype also in a long term follow up study; moreover, age at diagnosis showed to influence the outcome, other than stage at diagnosis and treatment. The long term follow up showed a constant risk of death for luminal A and B tumours, whereas for non-luminal cancer a peak 5 years after the diagnosis was found.

PMID:36129548 | DOI:10.1007/s00432-022-04245-1