Tag: nevin manimala

Pediatrics. 2023 Aug 29:e2022060751. doi: 10.1542/peds.2022-060751. Online ahead of print.

ABSTRACT

OBJECTIVES: Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials.

METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials’ primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.

RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.

CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.

PMID:37641881 | DOI:10.1542/peds.2022-060751

Eur J Neurosci. 2023 Aug 29. doi: 10.1111/ejn.16135. Online ahead of print.

ABSTRACT

Diffusion tensor imaging (DTI) has been used to study the developing brain in early childhood, infants and in utero studies. In infants, number of used diffusion encoding directions has traditionally been smaller in earlier studies down to the minimum of 6 orthogonal directions. Whereas the more recent studies often involve more directions, number of used directions remain an issue when acquisition time is optimized without compromising on data quality and in retrospective studies. Variability in the number of used directions may introduce bias and uncertainties to the DTI scalar estimates that affect cross-sectional and longitudinal study of the brain. We analysed DTI images of 133 neonates, each data having 54 directions after quality control, to evaluate the effect of number of diffusion weighting directions from 6 to 54 with interval of 6 to the DTI scalars with Tract-Based Spatial Statistics (TBSS) analysis. The TBSS analysis was applied to DTI scalar maps, and the mean region of interest (ROI) values were extracted using JHU atlas. We found significant bias in ROI mean values when only 6 directions were used (positive in fractional anisotropy [FA] and negative in fractional anisotropy [MD], axial diffusivity [AD] and fractional anisotropy [RD]), while when using 24 directions and above, the difference to scalar values calculated from 54 direction DTI was negligible. In repeated measures voxel-wise analysis, notable differences to 54 direction DTI were observed with 6, 12 and 18 directions. DTI measurements from data with at least 24 directions may be used in comparisons with DTI measurements from data with higher numbers of directions.

PMID:37641861 | DOI:10.1111/ejn.16135

Clin Exp Otorhinolaryngol. 2023 Aug 23. doi: 10.21053/ceo.2023.00486. Online ahead of print.

ABSTRACT

OBJECTIVES: Acute low-tone sensorineural hearing loss (ALHL) is thought to have a different etiology than idiopathic sudden sensorineural hearing loss. We hypothesized that endolymphatic hydrops (EH) in the inner ear organ contributes to ALHL, even in patients without vertigo. This study aimed to evaluate the presence of EH in ALHL and to compare the clinical characteristics of patients with or without EH.

METHODS: We retrospectively reviewed 38 patients diagnosed with ALHL without vertigo from January 2017 to March 2022. EH was measured in all patients using inner ear magnetic resonance imaging (MRI). In addition, we selected patients who showed only mid- or high-frequency hearing loss and had available MRI data as a control group and compared the difference between the ALHL and control groups.

RESULTS: After treatment, the pure-tone average at low frequencies was significantly improved compared with the initial hearing (P<0.001). Hearing recovery was observed in 63.1% of patients; however, the recovery rate did not differ based on treatment method. During the follow-up period, 6 patients (15.8%) progressed to Meniere’s disease, and 18 (47.4%) experienced recurrence. In the ALHL group, the cochlear hydrops ratio on the affected side (0.34 ± 0.09) was significantly higher than on the contralateral side (0.29 ± 0.12, P=0.005), and most patients showed hydrops in the apex area of the cochlea. Compared with the control group (0.25 ± 0.15), the ALHL group showed significantly higher cochlear hydrops ratio (P=0.043). The correlation analysis showed a tendency for hearing thresholds at low frequencies to increase as hydrops ratio increased, although there was no statistical significance.

CONCLUSION: Our study showed that the cochlear hydrops ratio, especially in the apex area on the affected side, was significantly higher in patients with ALHL, indicating that EH in the cochlea contributes to the pathogenesis of ALHL.

PMID:37641856 | DOI:10.21053/ceo.2023.00486

JBI Evid Synth. 2023 Aug 28. doi: 10.11124/JBIES-22-00443. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this review is to synthesize the effects of nutritional counseling compared with no intervention (maintaining lifestyle habits) or nutritional counseling in combination with other interventions (eg, nutritional supplementation, physical activity) on physical performance and muscle strength in older adults.

INTRODUCTION: Nutritional counseling, which is considered the first line of nutrition therapy, could play an important role in geriatric care programs by helping older adults understand the importance of nutrition and by promoting healthy, sustainable eating habits. However, the effects of nutritional counseling on physical function and muscle strength among older adults are not clear.

INCLUSION CRITERIA: This review will consider randomized controlled trials and non-randomized controlled trials. Participants aged 65 years or older, who have received nutritional counseling alone or in combination with another intervention (eg, nutritional supplementation, physical exercise) will be considered for inclusion. Comparators will include another intervention or no intervention, but physical performance (ie, gait, endurance, balance) or muscle strength must be measured.

METHODS: This systematic review will be conducted in accordance with the JBI methodology for systematic reviews of effectiveness. The databases to be searched include MEDLINE (Ovid), Embase (Elsevier), CENTRAL (Ovid), CINAHL (EBSCO), and Scopus. Sources of unpublished studies and gray literature include Google Scholar and protocol registers. Two independent reviewers will select relevant studies, critically appraise the studies, and extract data. Studies will be pooled in a statistical meta-analysis or presented in narrative format. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach will be used to grade the certainty of the evidence.

REVIEW REGISTRATION: PROSPERO CRD42022374527.

PMID:37641802 | DOI:10.11124/JBIES-22-00443

Med Hypothesis Discov Innov Ophthalmol. 2022 Sep 23;11(2):71-76. doi: 10.51329/mehdiophthal1448. eCollection 2022 Summer.

ABSTRACT

BACKGROUND: Neovascular age-related macular degeneration (nAMD) is one of the main causes of blindness in developed countries. Complement factor H (CFH) is one of the genes involved in the pathogenesis of nAMD. This study investigated the rs10737680 polymorphism in CFH and its conferred susceptibility to nAMD in Yogyakarta, Indonesia.

METHODS: This case-control hospital-based study recruited participants consisting of 96 patients with nAMD and 101 controls without nAMD from the Eye Polyclinic of Sardjito Hospital, YAP Eye Hospital, and Hardjolukito Hospital Yogyakarta. nAMD was diagnosed when fundus examination, fundus photographs, and optical coherence tomography revealed hard or soft drusen in the macular area measuring > 63 µm that appeared below the retinal pigment epithelium, with or without macular hypo- or hyperpigmentation, and was accompanied by choroidal neovascularization. Genomic DNA was extracted using a commercial DNA isolation kit. The restriction fragment length polymorphism technique was used to identify the rs10737680 polymorphism in CFH.

RESULTS: The mean (standard deviation [SD]) age of the nAMD group was not homogeneous with that of the control group (P < 0.05); 65.41 (9.74) years versus 68.24 (7.82) years. The number of patients with hypertension in the nAMD group was significantly higher than in the control group (P < 0.05). In the nAMD group, the genotype distribution indicated homozygous risk allele in 34.38%, heterozygous risk allele in 57.29%, and homozygous non-risk allele in 8.33%. In the control group, the genotype distribution indicated homozygous risk allele in 21.78%, heterozygous risk allele in 36.63%, and homozygous non-risk allele in 41.58%. Statistical analysis between the two study groups according to homozygous risk allele genotype (odds ratio [OR], 7.87; 95% confidence interval [CI], 2.88-22.79) and heterozygous genotype (OR, 7.80; 95% CI, 3.11-21.19) showed a significant difference (both P < 0.01).

CONCLUSIONS: Homozygous risk allele was less frequent than heterogeneous risk allele in patients with nAMD; however, both increased the risk for nAMD. Although the homozygous or heterozygous risk-alleles were detected in most patients, yet other important genetic or environmental factors could be involved in the pathogenesis of nAMD. Overall, we found a significant association between rs10737680 polymorphism in CFH and the susceptibility to nAMD in Yogyakarta, Indonesia; however, future studies are needed to fully delineate the mechanism.

PMID:37641789 | PMC:PMC10445304 | DOI:10.51329/mehdiophthal1448

Ther Clin Risk Manag. 2023 Aug 23;19:699-712. doi: 10.2147/TCRM.S420335. eCollection 2023.

ABSTRACT

OBJECTIVE: To investigate the correlation between serum parathyroid hormone (PTH) levels and in-hospital major adverse cardiovascular events (MACE) in patients with acute ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI), and establish a risk prediction model based on parameters such as PTH for in-hospital MACE.

METHODS: This observational retrospective study consecutively enrolled 340 patients who underwent primary PCI for STEMI between January 2016 and December 2020, divided into a MACE group (n=92) and a control group (n=248). The least absolute shrinkage and selection operator (LASSO) and logistic regression analyses were used to determine the risk factors for MACE after primary PCI. The rms package in R-studio statistical software was used to construct a nomogram, to detect the line chart C-index, and to draw a calibration curve. The decision curve analysis (DCA) method was used to evaluate the clinical application value and net benefit.

RESULTS: Correlation analysis revealed that PTH level positively correlated with the occurrence of in-hospital MACE. Receiver operating characteristic curve analyses revealed that PTH had a good predictive value for in-hospital MACE. Multivariate logistic regression analysis indicated that Killip class II-IV, and FBG were independently associated with in-hospital MACE after primary PCI. A nomogram model was constructed using the above parameters. The model C-index was 0.894 and the calibration curve indicated that the model was well calibrated. The DCA curve suggested that the nomogram model was better than TIMI score model in terms of net clinical benefit.

CONCLUSION: Serum PTH levels in patients with STEMI are associated with in-hospital MACE after primary PCI, and the nomogram risk prediction model based on PTH demonstrated good predictive ability with obvious clinical practical value.

PMID:37641783 | PMC:PMC10460584 | DOI:10.2147/TCRM.S420335

Cureus. 2023 Jul 27;15(7):e42582. doi: 10.7759/cureus.42582. eCollection 2023 Jul.

ABSTRACT

Background Chronic subdural hematoma (CSDH) is a common neurosurgical problem, which offers a good outcome following surgery. In many cases, burr hole irrigation and drainage under local anesthesia can provide satisfactory results. However, recurrence can be a cause for concern for both the surgeon and the patient. While recurrence is not a frequent phenomenon, studies have reported rates of up to 31.6%. Aims and objectives In this study, our objective is to examine a comprehensive range of potential risk factors and provide valuable insights into identifying patients at a higher risk of recurrence to aid in surgical decision-making. Methodology This study employed a prospective and retrospective design, conducted between 2017 and 2021, at Sri Ramachandra Institute of Higher Education and Research. The study received ethical approval from the Institutional Ethics Committee. The research aimed to assess patients who underwent surgery for CSDH, with a particular focus on those who experienced recurrence. Results The average age of patients with recurrence was 71.5 years compared to 65.2 years in the no-recurrence group, but this difference did not show a significant statistical correlation. A significant male predominance was observed, with 27 men and four women affected (out of a total of 147 men and 73 women in the study), resulting in a statistically significant p-value of 0.01. On multivariate analysis, heterogenous subtypes were a significant predictor of recurrence (OR: 8.88, 95% CI: 6.96-16.54, p = 0.01). The mean midline shift in those with recurrence was 11.4 mm compared to 7.09 mm in those without recurrence. This was a statistically significant correlation with a p-value of 0.02. Regarding those with recurrence, 24 patients underwent evacuation using two burr holes, with one placed in the frontal region and another in the parietal region. All of these patients had a subdural drain placed, which was removed on postoperative day 2. The remaining eight patients underwent a mini-craniotomy for evacuation. We had four cases of refractory CSDH, all of whom underwent the second evacuation using burr holes. Three of them underwent evacuation via craniotomy, while the family of the fourth patient did not give consent for the procedure. Conclusion Patient-related factors such as gender, bilateral presentation, and the presence of hypertension and radiological factors such as the presence of heterogenous subtype and a significant midline shift are clues toward a higher chance of recurrence.

PMID:37641767 | PMC:PMC10460295 | DOI:10.7759/cureus.42582

Cureus. 2023 Jul 28;15(7):e42608. doi: 10.7759/cureus.42608. eCollection 2023 Jul.

ABSTRACT

PURPOSE: We aimed to evaluate interventional radiologists’ compliance with patient care and the quality management process of cancer patients using a national survey.

METHODS: An electronic survey was designed with questions derived from the core criteria of the International Accreditation System for Interventional Oncology (IASIOS), with the approval of the IASIOS council. Among the interventional radiologists contacted by e-mail through the national association, 34 responded to the questionnaire. The agreement of the participants with the core requirements was evaluated in five questions consisting of 34 articles using the 5-point Likert scale.

RESULTS: Regarding the years of experience in interventional radiology (IR), the mean scale for the less than five-year group was 118.4, while that for the group with more than 15 years was 145.17 (p = 0.030). The mean scale of the five- to 15-year-old group was 121.75, versus that of more than 15 years, which was 145.17 (p = 0.028). Thus, significant differences arose between <five years versus >15 years and five to 15 years versus >15 years groups; later groups were more likely to comply. There was also a statistical difference between the groups formed according to the ratio of oncological interventions (<25% vs. 25%-50%) in the daily workload (p = 0.010).

CONCLUSION: Increased experience in IR and more relay on oncological interventions appear to augment compliance with the IASIOS criteria. We believe that interventional radiologists who have distinct territorial praxis could benefit from such a framework with improved self-awareness.

PMID:37641765 | PMC:PMC10460535 | DOI:10.7759/cureus.42608

Cureus. 2023 Jul 27;15(7):e42585. doi: 10.7759/cureus.42585. eCollection 2023 Jul.

ABSTRACT

BACKGROUND AND OBJECTIVES: Individuals with major depressive disorder exhibit a dysregulated metabolic profile. There are few studies on how vilazodone, escitalopram, and vortioxetine alter metabolic parameters. Our study aimed to determine the change in plasma glucose, HbA_1c, serum cholesterol, triglyceride, and creatinine at 12 weeks.

METHODS: An ongoing randomized, open-label, three-arm study’s interim analysis is portrayed here. The participants were assessed at baseline, 4, 8, and 12 weeks after receiving oral tablets of either vilazodone (20-40mg/d), escitalopram (10-20mg/d), or vortioxetine (5-20mg/d). This study is CTRI-registered (2022/07/043808).

RESULTS: Of 71 recruited participants, 49 (69%) completed the 12-week visit. The median Hamilton Depression Rating Scale (HDRS) scores of the participants in vilazodone, escitalopram, and vortioxetine groups were 30.0, 29.5, and 29.0 at baseline (p=0.76) and 19.5, 19.5, and 18.0 (p=0.18) at 12 weeks, respectively. The median fasting blood sugar (FBS) values were 98.5, 105.5, and 98.0 at baseline (p=0.07) and 94.0, 99.5, and 96.0 (p=0.19) at 12 weeks, for vilazodone, escitalopram, and vortioxetine groups, respectively. The post hoc analysis did not yield statistically significant differences regarding any parameters.

CONCLUSION: According to this interim study, the HDRS scores declined after 12 weeks of therapy. The subjects’ metabolic parameters did not significantly change. It is essential to perform further investigation regarding these impacts.

PMID:37641760 | PMC:PMC10460471 | DOI:10.7759/cureus.42585

Cureus. 2023 Jul 28;15(7):e42617. doi: 10.7759/cureus.42617. eCollection 2023 Jul.

ABSTRACT

Background Routine immunization of both girls and boys starting from nine years of age with the human papillomavirus (HPV) vaccine is the current recommendation. The objective of this retrospective study using National Health and Nutrition Examination Survey data was to evaluate the influence of sociodemographic factors on the series initiation and completion of the HPV vaccine from 2011 to 2020. Methodology The chi-square test was used to examine the statistical significance of the association between categorical variables and receipt of the HPV vaccine. The Cochran-Armitage test for trend was employed to assess the statistical significance of temporal trends in risk factors associated with rates of HPV vaccination. These trends were further quantified by a significant rate ratio by comparing them against the most recent survey years. Results HPV vaccine uptake was higher in the 9-14-year age group across survey years and had increased for both males and females over that time. The first dose of the HPV vaccine was most likely to be received by the 11-18-year age group. In the most recent survey of 2017-2020, the highest number of vaccination series completion was achieved for Gardasil®. Conclusions Improved physician efforts and strategies to vaccinate males, low socioeconomic strata patients, and ethnic minorities in more numbers are needed.

PMID:37641757 | PMC:PMC10460605 | DOI:10.7759/cureus.42617