Search Results (10)

Background: Over the last few decades, the efficacy of biological therapies for COPD has been evaluated by different randomized controlled trials (RCTs). Still, the evaluation of real-world data and patient-reported outcome measures (PROMs) have not been performed in this field before. In the current work, we present a systematic literature review of the real-world data and PROMs of biological treatments for COPD. Methods: Three large databases (MEDLINE/PubMed, Scopus, and ScienceDirect) were utilized for the systematic literature review. Clinical studies (RCT, cohorts, case series/reports) assessing patients with COPD treated by any biological therapy were included. Results: The review resulted in twelve eligible studies (nine randomized controlled trials and three “real-world” case series/reports). The evaluation of PROMs in the included studies was mainly limited to the severity and burden of respiratory symptoms. Most biological therapies were associated with improved PROMs compared to the baseline, although not for the placebo. Dupilumab was the only biologic therapy with proven efficacy in RCT for both objective and subjective measures. One prior study reported patients’ self-perceived drug effects, and none evaluated patients’ perceived disease status. Only 25 patients were assessed in a real-world setting for all biologic therapies combined. Real-world data were retrospective in the form of case reports or series. Conclusions: There are limited data on patients’ experience with biological therapies for COPD. While real-world data and PROMs are missing, biases such as a placebo effect must be considered, requiring their incorporation with objective outcomes from prospective controlled trials. Full article

Introduction: Juvenile recurrent parotitis (JRP) is characterized by intermittent swelling of one or both parotid glands, accompanied by pain and associated with non-obstructive sialectasia. Sialoendoscopy is considered a significant treatment for JRP, being a safe and minimally invasive treatment method with good clinical outcomes. The purpose of this study was to assess the procedure of sialoendoscopy as a treatment modality for JRP and discuss the relevant literature on this topic. Methods: This study retrospectively reviewed clinical records of children diagnosed with JRP who were treated in the Maxillofacial Department of the Tzafon Medical Center, Poriya, Israel, with sialoendoscopy between May 2016 and March 2023. Data on demographics, the site of symptoms, follow-up duration, treatment outcome, and complications were collected for each patient. The inclusion criteria were patients not older than 16 years of age, with at least two episodes of swelling of the parotid gland unilaterally or bilaterally during a time period of 6 months. The exclusion criteria were patients older than 16 years of age, and patients who were diagnosed with sialolithiasis or Sjogren’s syndrome. Results: The study included 17 children, of whom 12 (70%) were boys and 5 (30%) were girls. The mean age of the children at the time of the procedure was 6.7 years and ranged from 3 to 16. The affected parotid gland was the left in 7 children (41%), right in 9 children (53%), and bilateral in 1 child (6%). The average follow-up time was 45.17 months and ranged from 5 to 81 months. A total of 15 children (88%) were deemed to have a successful treatment result regarding the frequency of episodes after therapy and subjective improvement. Full resolution was seen in 10 children (59%). The sialoendoscopy findings were avascularity in the walls of the parotid duct, strictures, and mucous plugs. Pathological findings in sialoendoscopy were found in 11 out of 12 asymptomatic contralateral glands (p-value > 0.001). Conclusions: Sialoendoscopy under general anesthesia is a worthwhile and practicable treatment method for treating JRP. Satisfactory results were seen in the vast majority of patients. It is recommended to perform bilateral sialoendoscopy also in cases of a unilateral symptomatic gland. This treatment method is effective, safe, and potentially repeatable. Full article

Hypersensitivity pneumonitis (HP) is a heterogeneous interstitial lung disease (ILD) that may be difficult to confidently diagnose. Recently, the 2020 ATS/JRS/ALAT HP diagnostic guidelines were published, yet data validating their performance in real-life settings are scarce. We aimed to assess the diagnostic performance of the HP guidelines compared to the gold-standard multidisciplinary discussion (MDD). For this purpose, we included consecutive ILD patients that underwent diagnostic bronchoscopy between 2017 and 2020 in three large medical centers. Four diagnostic factors (antigen exposure history, chest computed tomography pattern, bronchoalveolar lavage lymphocyte count, and histology results) were used to assign guidelines-based HP diagnostic confidence levels for each patient. A sensitivity analysis was performed, with MDD diagnosis as the reference standard. Overall, 213 ILD patients were included, 45 (21%) with an MDD diagnosis of HP. The guidelines’ moderate (≥70%) confidence threshold produced optimal performance with 73% sensitivity for HP, 89% specificity, and a J-index of 0.62. The area under the receiver operating characteristic curve (AUC) for a correct guidelines-based diagnosis was 0.86. The guidelines had better performance for non-fibrotic than fibrotic HP (AUC 0.92 vs. 0.82). All diagnostic factors, except bronchoalveolar lavage lymphocyte count, were independent predictors for MDD diagnosis of HP in a multivariate analysis. In conclusion, the HP guidelines exhibited a good diagnostic performance compared to MDD diagnosis in real-life setting. Full article

Background: Risk stratification models have been developed to identify patients that are at a higher risk of COVID-19 infection and severe illness. Objectives To develop and implement a scoring tool to identify COVID-19 patients that are at risk for severe illness during the Omicron wave. Methods: This is a retrospective cohort study that was conducted in Israel’s second-largest healthcare maintenance organization. All patients with a new episode of COVID-19 between 26 November 2021 and 18 January 2022 were included. A model was developed to predict severe illness (COVID-19-related hospitalization or death) based on one-third of the study population (the train group). The model was then applied to the remaining two-thirds of the study population (the test group). Risk score sensitivity, specificity, and positive predictive value rates, and receiver operating characteristics (ROC) were calculated to describe the performance of the model. Results: A total of 409,693 patients were diagnosed with COVID-19 over the two-month study period, of which 0.4% had severe illness. Factors that were associated with severe disease were age (age > 75, OR-70.4, 95% confidence interval [CI] 42.8–115.9), immunosuppression (OR-4.8, 95% CI 3.4–6.7), and pregnancy (5 months or more, OR-82.9, 95% CI 53–129.6). Factors that were associated with a reduced risk for severe disease were vaccination status (patients vaccinated in the previous six months OR-0.6, 95% CI 0.4–0.8) and a prior episode of COVID-19 (OR-0.3, 95% CI 0.2–0.5). According to the model, patients who were in the 10th percentile of the risk severity score were considered at an increased risk for severe disease. The model accuracy was 88.7%. Conclusions: This model has allowed us to prioritize patients requiring closer follow-up by their physicians and outreach services, as well as identify those that are most likely to benefit from anti-viral treatment during the fifth wave of infection in Israel, dominated by the Omicron variant. Full article

The objectives of the research were to analyze the association between Body Mass Index (BMI) and dental caries using novel approaches of both statistical and machine learning (ML) models while adjusting for cardiovascular risk factors and metabolic syndrome (MetS) components, consequences, and related conditions. This research is a data-driven analysis of the Dental, Oral, Medical Epidemiological (DOME) big data repository, that integrates comprehensive socio-demographic, medical, and dental databases of a nationwide sample of dental attendees to military dental clinics for 1 year aged 18–50 years. Obesity categories were defined according to the World Health Organization (WHO): under-weight: BMI < 18.5 kg/m², normal weight: BMI 18.5 to 24.9 kg/m², overweight: BMI 25 to 29.9 kg/m², and obesity: BMI ≥ 30 kg/m². General linear models were used with the mean number of decayed teeth as the dependent variable across BMI categories, adjusted for (1) socio-demographics, (2) health-related habits, and (3) each of the diseases comprising the MetS definition MetS and long-term sequelae as well as associated illnesses, such as hypertension, diabetes, hyperlipidemia, cardiovascular disease, obstructive sleep apnea (OSA) and non-alcoholic fatty liver disease (NAFLD). After the statistical analysis, we run the XGBoost machine learning algorithm on the same set of clinical features to explore the features’ importance according to the dichotomous target variable of decayed teeth as well as the obesity category. The study included 66,790 subjects with a mean age of 22.8 ± 7.1. The mean BMI score was 24.2 ± 4.3 kg/m². The distribution of BMI categories: underweight (3113 subjects, 4.7%), normal weight (38,924 subjects, 59.2%), overweight (16,966, 25.8%), and obesity (6736, 10.2%). Compared to normal weight (2.02 ± 2.79), the number of decayed teeth was statistically significantly higher in subjects with obesity [2.40 ± 3.00; OR = 1.46 (1.35–1.57)], underweight [2.36 ± 3.04; OR = 1.40 (1.26–1.56)] and overweight [2.08 ± 2.76, OR = 1.05 (1.01–1.11)]. Following adjustment, the associations persisted for obesity [OR = 1.56 (1.39–1.76)] and underweight [OR = 1.29 (1.16–1.45)], but not for overweight [OR = 1.11 (1.05–1.17)]. Features important according to the XGBoost model were socioeconomic status, teeth brushing, birth country, and sweetened beverage consumption, which are well-known risk factors of caries. Among those variables was also our main theory independent variable: BMI categories. We also performed clinical features importance based on XGBoost with obesity set as the target variable and received an AUC of 0.702, and accuracy of 0.896, which are considered excellent discrimination, and the major features that are increasing the risk of obesity there were: hypertension, NAFLD, SES, smoking, teeth brushing, age as well as our main theory dependent variable: caries as a dichotomized variable (Yes/no). The study demonstrates a positive association between underweight and obesity BMI categories and caries, independent of the socio-demographic, health-related practices, and other systemic conditions related to MetS that were studied. Better allocation of resources is recommended, focusing on populations underweight and obese in need of dental care. Full article

Introduction: Several dry-powder inhalers (DPIs) contain lactose which may be contaminated with milk proteins. Confusion exists pertaining to DPI use in patients with cow’s milk protein allergy (CMPA). Methods: A computerized survey sent via e-mail to pediatric pulmonologists and allergologists. Results: A total of 77 out of 232 (33.2%) doctors replied, of whom 80.5% were pediatric pulmonologists. A total of 69 of 77 (89.6%) were specialists, 37.6% with more than 15 years of experience. The most commonly used DPIs were formoterol + budesonide and vilanterol + fluticasone. A total of 62 out of 77 (80.5%) responders knew these DPIs contained lactose. A total of 35 out of 77 (45.5%) doctors who replied did not know that DPI leaflets list CMPA as a contra-indication to DPI administration. Of these, 4 (11.4%) stated that they would instruct patients with CMPA to stop DPIs, and 7 (20%) would avoid recommending DPIs. A total of 42 out of 77 (54.5%) responders were aware of this warning, yet 13 of these 42 (30.9%) continued to recommend lactose-containing DPIs without hesitation and 18 of these 42 (42.8%) responders prescribed DPIs but considered allergy severity. Conclusions: Almost half of certified, experienced pediatric pulmonologists and allergologists were unaware of the warning to administer DPIs to patients with CMPA. Most doctors who do know of this warning still continue to prescribe these DPIs. Full article

Background: Late preterm (34⁰–36⁶ weeks gestational age [GA]) infants may have abnormal pulmonary development and possible exercise physiology parameters. We aim to assess the effect of late prematurity on exercise capacity in childhood and to compare it to early preterm (EP) (born < 30⁰ GA), and to term healthy control (TC) (>37⁰ week GA). Methods: Late preterm and early preterm (7–10 years) completed a cardiopulmonary exercise test (CPET) and spirometry and were compared to EP and to TC. Results: Eighty-four children (age 9.6 ± 1.0 years, 48% girls) participated. Twenty-one former LP were compared to 38 EP (15 with Bronchopulmonary dysplasia (BPD) [EP+], 23 without BPD [EP−]) and to 25 TC children. Peak oxygen uptake (peakV̇O₂) was statistically lower than in the TC, but within the normal range, and without difference from the EP (LP 90.2 ± 15.1%, TC 112.4 ± 16.9%, p < 0.001; EP+ 97.3 ± 25.5%, EP− 85.4 ± 20.8%, p = 0.016 and p < 0.001, respectively, when compared with TC). Lung function (FEV1) was lower than normal only in the EP+ (75.6 ± 14.9% predicted, compared with 12.5 ± 87.8 in EP−, 87.5 ± 16.9 in LP and 91.0 ± 11.7 in TC). Respiratory and cardiac limitations were similar between all four study groups. Conclusions: This study demonstrated lower exercise capacity (peakV̇O₂) in former LP children compared with healthy term children. Exercise capacity in LP was comparable to that of EP, with and without BPD. However, the exercise test parameters, specifically peakV̇O₂, were within the normal range, and no significant physiological exercise limitations were found. Full article

Background: SARS-CoV-2 is a novel human pathogen causing Coronavirus Disease 2019 that has caused widespread global mortality and morbidity. Since health workers in Israel were among the first to be vaccinated, we had a unique opportunity to investigate the post-vaccination level of IgG anti-S levels antibodies (Abs) and their dynamics by demographic and professional factors. Methods: Prospective Serological Survey during December 2020–August 2021 at Barzilai Medical Center among 458 health care workers (HCW) followed for 6 months after the second BNT162b2 vaccine dose. Results: Antibody levels before the second dose, and 30, 90 and 180 days after were 57.1 ± 29.2, 223 ± 70.2, 172.8 ± 73.3 and 166.4 ± 100.7 AU/mL, respectively. From GEE analysis, females had higher Abs levels (β = 26.37 AU/mL, p = 0.002). Age was negatively associated with Abs, with a 1.17 AU/mL decrease for each additional year (p < 0.001). Direct contact with patients was associated with lower Abs by 25.02 AU/mL (p = 0.009) compared to working with no such contact. The average decline rate overall for the study period was 3.0 ± 2.9 AU/mL per week without differences by demographic parameters and was faster during the first 3 months after vaccination than in the subsequent 3 months. Conclusions: All demographic groups experienced a decline in Abs over time, faster during the first 3 months. Findings of overall Abs lower in males, workers with direct contact with patients, and older workers, should be considered for policy-making about choosing priority populations for additional vaccine doses in hospital settings. Full article

Background: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, immune-mediated inflammatory bowel diseases (IBD) affecting millions of people worldwide. IBD therapies, designed for continuous immune suppression, often render patients more susceptible to infections. The effect of the immune suppression on the risk of coronavirus disease-19 (COVID-19) is not fully determined yet. Objective: To describe COVID-19 characteristics and outcomes and to evaluate the association between IBD phenotypes, infection outcomes and immunomodulatory therapies. Methods: In this multi-center study, we prospectively followed IBD patients with proven COVID-19. De-identified data from medical charts were collected including age, gender, IBD type, IBD clinical activity, IBD treatments, comorbidities, symptoms and outcomes of COVID-19. A multivariable regression model was used to examine the effect of immunosuppressant drugs on the risk of infection by COVID-19 and the outcomes. Results: Of 144 IBD patients, 104 (72%) were CD and 40 (28%) were UC. Mean age was 32.2 ± 12.6 years. No mortalities were reported. In total, 94 patients (65.3%) received biologic therapy. Of them, 51 (54%) at escalated doses, 10 (11%) in combination with immunomodulators and 9 (10%) with concomitant corticosteroids. Disease location, behavior and activity did not correlate with the severity of COVID-19. Biologics as monotherapy or with immunomodulators or corticosteroids were not associated with more severe infection. On the contrary, patients receiving biologics had significantly milder infection course (p = 0.001) and were less likely to be hospitalized (p = 0.001). Treatment was postponed in 34.7% of patients until recovery from COVID-19, without consequent exacerbation. Conclusion: We did not witness aggravated COVID-19 outcomes in patients with IBD. Patients treated with biologics had a favorable outcome. Full article