A Risk-Difference Meta-Analysis for the Prophylactic Treatments of Chronic Migraine.

Chronic migraine (CM) imposes significant personal, societal, and financial burdens, historically lacking specific prophylactic treatments. Monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) represent a novel, mechanism-based, and migraine-specific prophylactic approach. Four mAbs, namely, erenumab, fremanezumab, galcanezumab, and eptinezumab, have been marketed, although head-to-head trials with standard anti-migraine treatments are absent. This study aimed to compare the efficacy and safety of anti-CGRP mAbs with standard anti-migraine treatments using a cross-trial indirect model of the absolute risk difference (ARD) of a 50% responder rate, in order to express the final results in terms of the number needed to treat (NNT) and number needed to harm (NNH). Phase 3 and 2b randomized controlled trials (RCTs) for CM prophylaxis were searched in the MEDLINE and CENTRAL databases with specific inclusion and exclusion criteria. The ARD between groups for the percentage of trial participants who reported a 50% reduction in monthly migraine days and the differences in the number of adverse events (AEs), serious adverse events (SAEs), and participants who withdrew from each RCT were calculated, and subsequently, the NNT and NNH were calculated for each one of the outcome measures. In total, eight RCTs were considered eligible. A similar efficacy and safety have been demonstrated among CGRP mAbs and all standard CM treatments. The results of the ARD for the total number of studies concerning efficacy, total adverse events, serious adverse events, and dropout from the RCTs ranged from -0.688 (95% confidence interval (CI): -0.821-(-0.513)) to -0.018 (95% CI: -0.044-(0.007)), from 0.032 (95% CI: -0.041, 0.104) to -0.380 (95% CI: -0.589, -0.126), from -0.025 (95% CI: -0.046, -0.006) to 0.014 (95% CI: -0.015, 0.42), from 0.048 (95% CI: -0.112, 0.014) to 0.232 (95% CI: -0.016, 0.458) correspondingly. All anti-CGRP mAbs showed a roughly equal statistically significant ARD and similar NNTs, ranging from 5 to 8, while the ARD of onbotulinum toxin A (oBTA) was not significant with an NNT 56. The two studies of topiramate showed contradictory results, the one significant while the other not, with NNTs 2 and 22, respectively. All four anti-CGRP mAbs showed an invariably high efficacy among their studies, in terms of the ARD and its derivative measure of NNT, in contrast to oBTA, while in topiramate, the results are contradictory between the two studies.

Cerebrospinal Fluid Concentrations of Neurotransmitters in a Greek Pediatric Reference Population.

BACKGROUND: Biogenic amines and pterins analysis in cerebrospinal fluid (CSF) are reliable biomarkers for the diagnosis of inherited disorders of monoamine neurotransmitters. OBJECTIVE: The objectives of this study were the establishment of reference values of CSF biogenic amine metabolites in a cohort of Greek children, the detection of primary defects of biogenic amine metabolism, and the assessment of biogenic amine metabolites in children with different neurological disorders. METHODS: CSF biogenic amine metabolites and pterins (biopterin and neopterin) were analyzed using high-performance liquid chromatography with electrochemical and fluorescence detection. Three hundred sixty-three samples were analyzed: 60 infants and children with no history of neurological disorder, 6 with inherited disorders of monoamine neurotransmitters, and 297 with diverse neurological disorders. RESULTS: Reference values were stratified into six age groups. A strong correlation between homovanillic acid (HVA) and 5-hydroxyindoleacetic acid (5HIAA) levels with age was detected (p < 0.001). Two patients were diagnosed with a defect of the biogenic amine synthetic pathway and three with a defect of tetrahydrobiopterin cofactor production. HVA and 5HIAA abnormalities were detected within different groups of neurological disorders, but none followed a specific pattern of HVA and 5HIAA abnormalities. CONCLUSION: In the current study, Greek reference values of biogenic amines and pterins in CSF are presented. Five new patients with inherited monoamine neurotransmitter disorders are described. Nonspecific secondary biogenic amine disturbances can be seen in patients with different neurological disorders.

Health literacy of parents/caregivers of paediatric surgical patients: A study on 1000 individuals.

PURPOSE: There is a paucity of studies concerning health literacy (HL) of parents/guardians of patients in paediatric surgery. The purpose of our study is to measure HL levels of parents/guardians of paediatric surgery patients and to explore the determinants of low HL levels in this population. MATERIALS AND METHODS: We conducted a cross-sectional study from December 2016 to July 2018 through in-person interviews of parents/guardians of paediatric surgical patients. Sociodemographic and clinical data were recorded, and HL levels were calculated using a validated tool (HLS-EU-Q16). In order to examine the impact of various sociodemographic variables and clinical data on HL, a multivariate regression model was run. RESULTS: A total of 1000 participants were recruited (recruitment rate 93.5%). Slightly less than half (44.2%) presented problematic or inadequate HL levels. The results of the regression analysis showed that nationality other than Greek (ß = -2.180, P < 0.001) and lower health insurance status (ß = -0.461, P < 0.05) were associated with lower HL levels. HL was found positively associated with the educational level of the parent (ß = -0.775, P < 0.001) and being a health professional (ß = 1.791, P < 0.001). CONCLUSION: The prevalence of low HL levels in the parents/guardians of paediatric surgical patients is high and should not be neglected both in the pre-operative and post-operative setting. Communication should be tailored to the specific needs of each individual to achieve better engagement and quality of care.

Parental anxiety in pediatric surgery consultations: the role of health literacy and need for information.

INTRODUCTION: Although important, parental anxiety, health literacy and need-for-information in pediatric surgery outpatient clinics have not been extensively studied. Lower educational attainments, minorities and lower socioeconomic status have been associated with limited health literacy. Parental anxiety has been related to health literacy, sex, education and information needs. The aim of this study is to investigate health literacy and need-for-information and their association to parental anxiety in consultations of pediatric surgery. MATERIALS & METHODS: We conducted an observational, cross-sectional study in the outpatient pediatric surgery clinic from December 2016 to October 2017. Health literacy, anxiety and need-for-information of parents/guardians of children waiting for pediatric surgical consultation were evaluated. Multivariate regression analysis was used to examine the impact of health literacy and need-for-information on parental/guardian anxiety considering sociodemographic and clinical characteristics of the participants. RESULTS: Almost half (46.1%) of the 664 parents/guardians recruited had limited or problematic health literacy and 79.8% of the sample was classified as being anxious. Parental/guardian anxiety was associated at the multiple regression analysis with parental health literacy level (ß = -0.282, p < 0.001), need-for-information preoperatively (ß = 0.907, p < 0.001), educational level (ß = -0.716, p = 0.001), sex (ß = 1.563, p < 0.001), and severity of the condition of the child (ß = 0.379, p < 0.001). CONCLUSION: Parents/guardians experience high levels of anxiety, which is associated to health literacy and need-for-information. These factors should be considered in pediatric surgical consultations, aiming to reduce parental anxiety. TYPE OF STUDY: Retrospective Study. LEVEL OF EVIDENCE: Level II.

Changes in Simple Spirometric Parameters After Lobectomy for Bronchial Carcinoma.

INTRODUCTION: The purpose of this study was to describe the postoperative changes in lung function after pure open lobectomy for lung carcinoma. METHODS: 30 patients (mean age 64 ± 7 years old, 16 men and 14 women) underwent a left or right lobectomy. They underwent spirometric pulmonary tests preoperatively, and at 1 and 6 months after the operation. RESULTS: The average preoperative forced expiratory volume in 1 second (FEV1) was 2.55±0.62lt and the mean postoperative FEV1 at 1 and 6 months was 1.97 ± 0.59 L and 2.15±0.66 L respectively. The percentage losses for FEV1 were 22.7% and 15.4% after 1 and 6 months respectively. An average percentage increase of 9.4% for FEV1 was estimated at the time of 6 months in comparison with this of 1 month after the operation. The average preoperative forced vital capacity (FVC) was 3.17 ± 0.81 L and the mean postoperative FVC at 1 and 6 months after the operation was 2.50 ± 0.63 L and 2.72 ± 0.67 L respectively. The percentage losses for FVC were 21.1% and 14.2% after 1 and 6 months respectively. An average percentage increase of 8.7% was observed at the time period of 6 months in comparison with this of 1 month after the operation. CONCLUSION: Although, we observed a significant decrease in FEV1 and FVC after the operation, all patients were in excellent clinical status. FEV1 and FVC of 6 months were increased in comparison with the respective values of 1 month after the operation, but did not reach the preoperative values in any patient.