Background: Incomplete and inconsistent reporting of adverse events (AEs) through multiple sources can distort impressions of the overall safety of the medical interventions examined as well as the benefit-risk relationship. We aimed to assess completed allergic rhinitis (AR) trials registered in ClinicalTrials.gov for completeness and consistency of AEs reporting comparing ClinicalTrials.gov and corresponding publications. Methods: We retrospectively examined completed randomised controlled trials on AR registered in ClinicalTrials.gov on or after 9/27/2009 to trials updated with results on or before 12/31/2021 along with any corresponding publications. Complete reporting of AEs in ClinicalTrials.gov were summarised in tables describing AE information, and complete reporting in publications was an explicit statement of serious AE, death or other AE. Difference in completeness, number, or description of AEs between ClinicalTrials.gov and publication was classified as inconsistent reporting of AEs. Results: There were 99 registered trials with 45 (45.5%) available publications. All published trials completely reported AEs in ClinicalTrials.gov, and 21 (46.7%) in publications (P < .001). In 43 (95.6%) publications, there was at least one inconsistency in the reporting of AEs (P < .001). 8 (17.8%) publications had different number of serious AEs (P = .003), 36 (80.0%) of other AEs (P < .001) while deaths reporting was inconsistent in 8 (57.1%) publications (P = .127). Conclusion: The reporting of AEs from AR trials is complete in ClinicalTrials.gov and incomplete and inconsistent in corresponding publications. There is a need to improve the reporting of AEs from AR trials in corresponding publications, and thus to improve patient safety.
Nephrotic syndrome is a clinical syndrome characterized by massive proteinuria, called nephrotic range proteinuria (over 3.5 g per day in adults or 40 mg/m2 per hour in children), hypoalbuminemia, oncotic edema, and hyperlipidemia, with an increasing incidence over several years. Nephrotic syndrome carries severe morbidity and mortality risk. The main pathophysiological event in nephrotic syndrome is increased glomerular permeability due to immunological, paraneoplastic, genetic, or infective triggers. Because of the marked increase in the glomerular permeability to macromolecules and the associated urinary loss of albumins and hormone-binding proteins, many metabolic and endocrine abnormalities are present. Some of them are well known, such as overt or subclinical hypothyroidism, growth hormone depletion, lack of testosterone, vitamin D, and calcium deficiency. The exact prevalence of these disorders is unknown because of the complexity of the human endocrine system and the differences in their prevalence. This review aims to comprehensively analyze all potential endocrine and hormonal complications of nephrotic syndrome and, vice versa, possible kidney complications of endocrine diseases that might remain unrecognized in everyday clinical practice.
Background: Expression of the epidermal growth factor receptor (EGFR) and human papillomavirus (HPV) DNA can serve as independent prognostic factors in squamous cell carcinoma (SCC) of the larynx. EGFR correlation with the course of disease and its effect on survival makes EGFR expression a negative prognostic factor, whereas HPV DNA is a positive prognostic factor. Aim: To assess the association of EGFR expression with clinical outcome of laryngeal HPV SCC. Materials and methods: This retrospective study included 196 SCC patients operated on at the Department of ENT, Head and Neck Surgery, Split University Hospital Center in Split, Croatia, between 1 January 2000 and 31 December 2009. Results: The association of HPV infection and EGFR expression was found to be statistically significant, and so was the difference in survival between patient groups with different HPV to EGFR expression ratio. Conclusions: The group of laryngeal HPV SCC patients with increased EGFR expression had shorter survival, confirming EGFR as a major component in predicting patient prognosis and survival. Significance: This article confirms the importance of EGFR expression as a biomarker in laryngeal SCC.
Background Clinical studies suggest that vestibular migraine patients have psychiatric comorbidities and low life quality. However, the absence of a multidisciplinary approach to vestibular migraine patients, including otorhinolaryngologists and psychiatrists, is concerning. We aimed to investigate these patients comprehensively and to compare the results of three questionnaires—the Hospital Anxiety and Depression Scale (HADS), Dizziness Handicap Inventory (DHI), and Short Form Health Survey (SF-36)—between patients with definite vestibular migraine (dVM), migraine without vertigo (MO), and healthy controls (HCs). Methods: A total of 104 participants were divided into 3 groups: dVM patients (19 participants), MO patients (22 participants), and HCs (63 participants). The scores of the three questionnaires across the three groups were compared using analysis of variance, and linear regression was used to examine the associations between the questionnaire scores within each group. Results: Compared to MO patients and HCs, dVM patients had significantly higher total scores on the HADS (p < 0.0001) and DHI (p < 0.0001) scales, and lower scores for all nine components of the SF-36, indicating poorer health. In the vestibular migraine group, the DHI score was strongly negatively correlated with the Physical Functioning subscale of the SF-36. Conclusions: Anxiety and depression are more prevalent in patients with definite vestibular migraine compared to patients with migraine without vertigo and healthy controls. The physical functioning of patients with definite vestibular migraine is highly affected by their dizziness, resulting in a lower quality of life. Timely screening for psychiatric comorbidity in vestibular migraine patients is essential to prevent psychiatric consequences.
Background/Objectives: The most frequent neurologic cause of recurrent vertigo is vestibular migraine (VM). However, its diagnosis relies primarily on patients’ histories, as specific diagnostic tests for VM are currently lacking. We aimed to examine and compare clinical features, vestibulo-ocular reflexes (VORs), and subjective visual vertical (SVV) between the ictal (IC) and inter-ictal (II) phases in VM patients. Methods: A repeated-measures study involved 31 patients with definite VM. Vestibular function was assessed using a video head impulse test (vHIT) to evaluate VOR results, and SVV testing to determine verticality perception. Otoneurological examination, including migraine-related disability, was noted. Analyses of repeated measures for numerical traits (SVV deviations, VOR, and clinical outcomes) were conducted using a linear mixed model (LMM), with phase, age, and sex as fixed effects and individual-specific random intercepts. Differences between the IC and II phases for dichotomous variables were analyzed using the χ2 or Fisher’s exact test. Results: The LMM analysis revealed that SVV deviations were significantly higher ictally (IC-ly) (β = 0.678, p = 1.51 × 10−6) than interictally (II-ly). VOR results remained normal across phases (p > 0.05), and refixation saccades did not differ significantly based on vHIT results (p > 0.05). Nausea (100% vs. 38.71%, p = 6.591 × 10−8), photophobia (100% vs. 35.48%, p = 1.839 × 10−8), and phonophobia (90.32% vs. 6.45%, p = 9.336 × 10−12) were significantly more frequent IC-ly than II-ly. Conclusions: Our findings highlight phase-dependent alterations in spatial orientation, with increased SVV deviations IC-ly despite stable VOR. The significant differences in migraine-associated symptoms reinforce the dynamic nature of VM. These results emphasize the importance of timing in vestibular assessments and suggest that SVV testing during IC VM episodes may enhance diagnostic accuracy.
15 March 2016 in Endocrine Oncology and Metabolism