Category: Nevin Manimala

Adv Respir Med. 2021;89(2):145-157. doi: 10.5603/ARM.a2021.0037.

ABSTRACT

INTRODUCTION: There is increasing scientific interest in the possible association between hypovitaminosis D and the risk of SARS-CoV-2 infection severity and/or mortality.

OBJECTIVE: To conduct a metanalysis of the association between 25-hydroxyvitamin D (25(OH)D) concentration and SARS-CoV-2 infection severity or mortality.

MATERIAL AND METHODS: We searched PubMed, EMBASE, Google scholar and the Cochrane Database of Systematic Reviews for studies published between December 2019 and December 2020. Effect statistics were pooled using random effects models. The quality of included studies was assessed with the Newcastle-Ottawa Scale (NOS). Targeted outcomes: mortality and severity proportions in COVID-19 patients with 25(OH)D deficiency, defined as serum 25(OH)D < 50 nmol/L.

RESULTS: In the 23 studies included (n = 2692), the mean age was 60.8 (SD ± 15.9) years and 53.8% were men. Results suggested that vitamin 25(OH)D deficiency was associated with increased risk of severe SARS-CoV-2 disease (RR 2.00; 95% CI 1.47-2.71, 17 studies) and mortality (RR 2.45; 95% CI 1.24-4.84, 13 studies). Only 7/23 studies reported C-reactive protein values, all of which were > 10 mg/L. Conclusions 25(OH)D deficiency seems associated with increased SARS-CoV-2 infection severity and mortality. However, findings do not imply causality, and randomized controlled trials are required, and new studies should be designed to determine if decreased 25(OH)D is an epiphenomenon or consequence of the inflammatory process associated with severe forms of SARS-CoV-2. Meanwhile, the concentration of 25(OH)D could be considered as a negative acute phase reactant and a poor prognosis in COVID-19 infection.

PMID:33966262 | DOI:10.5603/ARM.a2021.0037

Breast Cancer Res Treat. 2021 May 8. doi: 10.1007/s10549-021-06249-w. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the survival difference between limited axillary surgery and full axillary lymph node dissection (ALND) in patients with 1-3 positive sentinel lymph node biopsies (SLNBs) after neoadjuvant chemotherapy (NAC).

METHOD: We retrospectively analyzed data from 676 patients who underwent surgery between 2007 and 2017 with cT1-4, cN0-3, cM0 breast cancer at the time of diagnosis and 1-3 positive SLNBs after NAC. The patients received either SLNB only or completed level I or II ALND based on SLNB results. After propensity score matching, 483 patients who had undergone SLNB only (n = 188) and ALND (n = 295) were included. We examined overall survival, axillary recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival and compared them between the subgroups.

RESULT: At a median follow-up of 59.4 months, no significant statistical difference was observed in overall survival, axillary recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival between SLNB only and ALND. No significant differences were observed in the 5-year axillary recurrence-free survival (93.1% vs. 94.0%, hazard ratio [HR] = 0.94, 95% confidence interval [CI] = 0.43-2.05, p = 0.876) and 5-year overall survival (97.7% vs. 97.3%, HR = 1.65, 95% CI = 0.58-4.65, p = 0.347) between the two groups.

CONCLUSION: Our analysis suggests that SLNB alone may be a possible option for patients with 1-3 sentinel node-positive breast cancer following NAC without significant compromise of recurrence or overall survival.

PMID:33966181 | DOI:10.1007/s10549-021-06249-w

Drug Saf. 2021 May 9. doi: 10.1007/s40264-021-01073-z. Online ahead of print.

ABSTRACT

INTRODUCTION: Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications.

AIMS: This study aimed to identify signals of potentially teratogenic medications using EUROmediCAT registry data on medication exposure in pregnancies with a congenital anomaly, and to investigate the use of VigiBase reports of adverse events of medications in the evaluation of these signals.

METHODS: Signals of medication-congenital anomaly associations were identified in EUROmediCAT (21,636 congenital anomaly cases with 32,619 medication exposures), then investigated in a subset of VigiBase (45,749 cases and 165,121 exposures), by reviewing statistical reporting patterns and VigiBase case reports. Evidence from the literature and quantitative and qualitative aspects of both datasets were considered before recommending signals as warranting further independent investigation.

RESULTS: EUROmediCAT analysis identified 49 signals of medication-congenital anomaly associations. Incorporating investigation in VigiBase and the literature, these were categorised as follows: four non-specific medications; 11 likely due to maternal disease; 11 well-established teratogens; two reviewed in previous EUROmediCAT studies with limited additional evidence; and 13 with insufficient basis for recommending follow-up. Independent investigations are recommended for eight signals: pregnen (4) derivatives with limb reduction; nitrofuran derivatives with cleft palate and patent ductus arteriosus; salicylic acid and derivatives with atresia or stenosis of other parts of the small intestine and tetralogy of Fallot; carbamazepine with atrioventricular septal defect and severe congenital heart defect; and selective beta-2-adrenoreceptor agonists with posterior urethral valve and/or prune belly.

CONCLUSION: EUROmediCAT data should continue to be used for signal detection, accompanied by information from VigiBase and review of the existing literature to prioritise signals for further independent evaluation.

PMID:33966183 | DOI:10.1007/s40264-021-01073-z

Pharmacoecon Open. 2021 May 9. doi: 10.1007/s41669-021-00270-x. Online ahead of print.

ABSTRACT

INTRODUCTION: Carer quality of life (QoL) can be included in economic evaluations and captured using EQ-5D. Traditional valuation tasks require participants to imagine living in a health state for a number of years, without being told what to consider. This pilot study sought to investigate whether participants implicitly consider the impact of the health state on others, and the extent to which this may impact health state valuations.

METHODS: Composite time trade-off (TTO) interviews were conducted with a convenience sample. Each interview included a ‘traditional’ TTO exercise to value three health states, and a ‘combined’ TTO exercise, where participants valued the same health states again, having been informed that they would require a carer living in a particular health state. Qualitative feedback was collected after each exercise. Paired t-test comparisons of the utilities elicited in each exercise were made.

RESULTS: Thirty-three participants enrolled in the pilot. Mean differences between exercises were not statistically significant and differed in direction, although considerable heterogeneity was observed in individual response trajectories. Overall, 36% (n = 12) of participants expressed an unprompted concern about being a burden on others in the traditional exercise, and 67% (n = 22) of participants would have responded differently had the carer been in full health in the combined exercise.

CONCLUSION: Providing contextual information about carers may impact valuations. Further research is required to better understand the reasons behind the variation in individual response trajectories observed in this pilot study. The insights from this study may be useful for informing the design of related future studies.

PMID:33966180 | DOI:10.1007/s41669-021-00270-x

Int Ophthalmol. 2021 May 9. doi: 10.1007/s10792-021-01878-y. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the severity of primary open angle glaucoma (POAG) at presentation using visual field analysis and its relationship to demographic and ocular factors in patients presenting to a tertiary eye care centre.

DESIGN: Cross-sectional study.

METHODS: Newly diagnosed POAG patients were classified as early, moderate, or severe stage in the worse eye based on the Humphrey visual field testing using Hodapp-Parrish-Andersons criteria. The groups were compared for differences in demographics and ocular characteristics. Statistical analysis was done using STATA 14.1 (Texas, USA).

RESULTS: The average age of 71 eligible patients was 60.04 ± 9.53 years, and the cohort had 29.5% females. Among the subjects, 19 (26.7%) had early, 24 (33.3%) had moderate and 28 (38.89%) had severe POAG at presentation. There was no statistically significant difference among different stages of glaucoma with respect to age and sex groups. No statistical association was found with education, occupation status, presenting complaints, family history of glaucoma, or systemic diseases between the different stages of severity. 5.6% with severe disease presented with a relative afferent pupillary defect (RAPD). The mean intraocular pressure (IOP) in the severe stage was 22.54 ± 5.27 mmHg, which was not statistically higher than the other groups (P = 0.726).

CONCLUSIONS: Newly diagnosed POAG patients predominantly present at moderate or severe stage of disease, reflecting either the asymptomatic nature of the disease or a lack of access to vision care services. Existing screening programmes need to be improved, with special attention to women and individuals less than 50 years of age.

PMID:33966145 | DOI:10.1007/s10792-021-01878-y

Int Ophthalmol. 2021 May 9. doi: 10.1007/s10792-021-01774-5. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate choroidal thickness (CTh) in children with chronic heart failure (CHF) secondary to dilated cardiomyopathy (DCM) using spectral domain optical coherence tomography (SD-OCT) and to compare their values to those of healthy children.

METHODS: Sixty eyes of thirty children (mean age 9.9 ± 3.57 years) with chronic heart failure (left ventricular ejection fraction, LVEF ≤ 55%) due to DCM lasting for over 6 months were prospectively enrolled. The control group consisted of 30 age- (mean age 10.16 ± 3.42 years) and sex-matched healthy children. All participants underwent transthoracic echocardiography with LVEF measured using the Simpson method and had the blood serum level of N-terminal-pro-brain natriuretic peptide marker (NT-proBNP) determined. All children underwent SD-OCT and had subfoveal choroidal thickness (SFCTh) and CTh measured at 1500 µm (μm) nasally, temporally, superiorly and inferiorly from the fovea in both eyes by two investigators.

RESULTS: CTh at all locations was statistically significantly lower in children with DCM compared to the control group. Mean CTh in the group with CHF compared to the control group were (304.03 vs. 369.72 μm, p < 0.05) at the subfoveal location, (245.87 vs. 284 μm, p < 0.05) 1500 μm nasally from the fovea, (291.5 vs. 355.95 μm, p < 0.05) 1500 μm temporally from the fovea, (303.98 vs. 357.58 μm, p < 0.05) 1500 μm superiorly from the fovea and (290.92 vs. 344.96 μm, p < 0.05) 1500 μm inferiorly from the fovea. The average difference CTh between the study groups ranged from 38.13 to 65.69 μm at individual locations. In both groups, CTh was the thickest at subfoveal location (304.03 vs. 369.72 μm, p < 0.05) and the thinnest was 1500 μm nasally from the fovea (262.37 vs. 336.87 μm, p < 0.05). There was no correlation between CTh and age, gender, biometry and refractive error. No correlation was found between CTh and LVEF and NT-proBNP.

CONCLUSION: Patients with CHF due to DCM had a thinner CTh at all measured locations. The results of our research indicate that CHF affects CTh and this parameter may be very helpful in monitoring the clinical course of the disease in children with DCM.

PMID:33966146 | DOI:10.1007/s10792-021-01774-5

Bull Math Biol. 2021 May 8;83(6):68. doi: 10.1007/s11538-021-00902-7.

ABSTRACT

Non-small-cell lung carcinoma is a frequent type of lung cancer with a bad prognosis. Depending on the stage and genomics, several therapeutical approaches are used. Tyrosine Kinase Inhibitors (TKI) may be successful for a time in the treatment of EGFR-mutated non-small cells lung carcinoma. Our objective is here to introduce a survival assessment as their efficacy in the long run is challenging to evaluate. The study includes 17 patients diagnosed with EGFR-mutated non-small cell lung cancer and exposed to an EGFR-targeting TKI with 3 computed tomography (CT) scans of the primary tumor (one before the TKI introduction and two after). An imaging biomarker based on evolution of texture heterogeneity between the first and the third exams is derived and computed from a mathematical model and patient data. Defining the overall survival as the time between the introduction of the TKI treatment and the patient death, we obtain a statistically significant correlation between the overall survival and our imaging marker ([Formula: see text]). Using the ROC curve, the patients are separated into two populations and the comparison of the survival curves is statistically significant ([Formula: see text]). The baseline exam seems to have a significant role in the prediction of response to TKI treatment. More precisely, our imaging biomarker defined using only the CT scan before the TKI introduction allows to determine a first classification of the population which is improved over time using the imaging marker as soon as more CT scans are available. This exploratory study leads us to think that it is possible to obtain a survival assessment using only few CT scans of the primary tumor.

PMID:33966172 | DOI:10.1007/s11538-021-00902-7

Radiat Environ Biophys. 2021 May 8. doi: 10.1007/s00411-021-00913-x. Online ahead of print.

ABSTRACT

As part of the wider interest in the effects of ionizing radiation on non-human biota, this investigation was carried out to study early radiation damage to the eye-lenses of rainbow trout. Lenses were cultured and irradiated to doses of 1.1 Gy and 2.2 Gy with low-energy X-rays of 40 kV. Laser focal analysis was used to track changes in focal lengths across the lenses post-irradiation. Changes in focal length variability (FLV) were measured to determine whether this could give an indication of the early effects of radiation on lens health. No statistically significant differences in FLV between the control and irradiated lenses within 10 days post-irradiation were observed. FLV was found to be 0.09 ± 0.02 mm for 2.2 Gy lenses, 0.06 ± 0.01 mm for 1.1 Gy lenses, and 0.11 ± 0.02 mm for control lenses at the end of the observation period.

PMID:33966106 | DOI:10.1007/s00411-021-00913-x

Surg Endosc. 2021 May 8. doi: 10.1007/s00464-020-08210-2. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: There is wide variation in choice of sedation and airway management for endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study was to perform a systematic review and meta-analysis to investigate safety outcomes of deep sedation with monitored anesthesia care (MAC) versus general endotracheal anesthesia (GETA).

METHODS: Individualized search strategies were performed in accordance with PRISMA and MOOSE guidelines. This meta-analysis was performed by calculating pooled proportions using random effects models. Measured outcomes included procedure success, all-cause and anesthesia-associated adverse events, and post-procedure recovery time. Heterogeneity was assessed with I² statistics and publication bias by funnel plot and Egger regression testing.

RESULTS: Five studies (MAC: n = 1284 vs GETA: n = 615) were included. Patients in the GETA group were younger, had higher body mass index (BMI), and higher mean ASA scores (all P < 0.001) with no difference in Mallampati scores (P = 0.923). Procedure success, all-cause adverse events, and anesthesia-associated events were similar between groups [OR 1.16 (95% CI 0.51-2.64); OR 1.16 (95% CI 0.29-4.70); OR 1.33 (95% CI 0.27-6.49), respectively]. MAC resulted in fewer hypotensive episodes [OR 0.32 (95% CI 0.12-0.87], increased hypoxemic events [OR 5.61 (95% CI 1.54-20.37)], and no difference in cardiac arrhythmias [OR 0.48 (95% CI 0.13-1.78)]. Procedure time was decreased for MAC [standard difference – 0.39 (95% CI – 0.78-0.00)] with no difference in recovery time [standard difference – 0.48 (95% CI – 1.04-0.07)].

CONCLUSIONS: This study suggests MAC may be a safe alternative to GETA for ERCP; however, MAC may not be appropriate in all patients given an increased risk of hypoxemia.

PMID:33966121 | DOI:10.1007/s00464-020-08210-2

Int J Clin Oncol. 2021 May 9. doi: 10.1007/s10147-021-01923-x. Online ahead of print.

ABSTRACT

BACKGROUND: There are few studies developing a scoring system for short-term survival of patients with gynecologic malignancy.

METHODS: Seventy-three terminally ill patients with gynecologic malignancy who were admitted to our palliative care unit (PCU) from June 2009 to February 2018 were included. We accumulated routine blood data within 3 months before PCU discharge. Receiver-operating characteristic analysis was performed on each blood factor, and area under the curve (AUC) was calculated to determine the predictive value for 14-day survival after the blood test. Multivariable logistic regression analysis was performed to identify significant independent prognostic factors of 14-day mortality. To develop a scoring system for 14-day mortality, laboratory prognostic score for gynecologic malignancy (G-LPS) was calculated using the sum of indices of the independent prognostic factors.

RESULTS: Multivariable analysis showed that 6 of 24 indices, namely, C-reactive protein ≥ 13.3 mg/dL, total bilirubin ≥ 1.1 mg/dL, sodium < 131 mEq/L, blood urea nitrogen ≥ 28 mg/dL, white blood cell count ≥ 17.7 × 103/μL, and eosinophil level < 0.2%, were significant independent factors of 14-day survival. G-LPS was obtained from the sum of the six indices. The AUC was 0.7977 at the optimal cut-off value of G-LPS 3. G-LPS 3 predicted death within 14 days with a sensitivity of 72% and a specificity of 79%.

CONCLUSIONS: Six of the 24 laboratory indices were identified as independent prognostic factors of 14-day mortality in terminally ill patients with gynecologic malignancy. G-LPS showed acceptable ability of predicting 14-day survival.

PMID:33966125 | DOI:10.1007/s10147-021-01923-x