Real Study Research Articles

Effect of a multi-ingredient coriolus-versicolor-based vaginal gel in women with HPV-dependent cervical lesions: the PAPILOBS real-life prospective study

Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a Coriolus-versicolor-based vaginal gel (Papilocare®) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women _ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study’s duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild–moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare® vaginal gel than spontaneous regression rates reported in the literature.

Health-related quality of life measured with K-BILD is associated with survival in patients with idiopathic pulmonary fibrosis

BackgroundHealth-related quality of life (HRQoL) assessments and estimates of prognosis are needed for comprehensive care and planning of subsequent treatment in patients with idiopathic pulmonary fibrosis (IPF). We investigated HRQoL and its association with survival using a disease-specific tool in patients with IPF.MethodsThe patients were recruited from the real-life FinnishIPF study in 2015. HRQoL was assessed with the King’s Brief Interstitial Lung Disease (K-BILD) questionnaire every six months for 2.5 years. Dyspnoea was assessed with the modified Medical Research Council (mMRC) dyspnoea scale. Survival was registered until 31 December 2022. Patient survival according to the K-BILD total score was evaluated using the Kaplan‒Meier method. The Friedman test was used to compare the K-BILD total scores longitudinally, and the Mann‒Whitney U test was used to compare the mMRC groups. P values < 0.05 were considered statistically significant.ResultsThe median K-BILD total score (n = 245) was 51.6. At baseline, patients in the highest HRQoL quartile (K-BILD scores 58.9–100) had a longer median survival time (5.3 years) than did those with scores of 51.7–58.8 (3.1 years), 45.7–51.6 (2.3 years), and 0.0–45.6 (1.8 years). A decrease in the K-BILD total score of ≥ 5 units in the preceding 12 or 24 months showed a trend towards poorer survival, although statistical significance was not reached. Ninety-four patients survived more than 2.5 years and had available K-BILD data at all time points. The K-BILD total score remained higher in patients with a baseline mMRC of 0–1 than in those with a mMRC of 2–4, and the total score decreased only modestly in both groups (median of 3.3 and 4.8 units in patients with mMRC scores of 0–1 and 2–4, respectively).ConclusionsIn IPF, a reduced HRQoL is associated with impaired survival. A K-BILD total score less than approximately 50 units is associated with a median survival of approximately two years. In addition to assessing the treatment needs of patients with IPF using K-BILD, a decreased score may be useful for facilitating advance care planning and transplantation assessment.

Penile curvature severity in patients with Peyronie's disease does not correlate with dynamic color doppler duplex ultrasound parameters: findings from a real-life cross-sectional study.

There is inconsistent data regarding the possible inaccuracies in dynamic penile color Doppler duplex ultrasound (CDDU) measurements in men with penile curvature because of Peyronie's disease (PD). We sought to explore the relationship between the degree of penile curvature and CDDU parameters in men with PD. Comprehensive data from 154 consecutive men presenting with PD as their primary complaint at a single academic center were prospectively collected and analyzed. All men underwent CDDU. Penile curvature was measured using a goniometer at time of maximum erection during CDDU. Patients were grouped based on CDDU parameters into-normal (average peak systolic velocity [PSV] ≥ 35cm/s and resistance index [RI] ≥ 0.85) and pathological CDDU (average PSV<35cm/s and/or RI<0.85). Descriptive statistics was used to compare the two subcohorts. Linear regression models were fitted to explore the association between the degree of penile curvature and dynamic CDDU parameters. Overall, the median interquartile range (IQR) age was 56 (48-63) years. The median (IQR) PSV and degree of penile curvature were 48.8cm/s (37.9-58.5) and 40 degrees (30-60), respectively. At CDDU, the degrees of penile curvature were as follows: 10-30 degrees in 63 (40.9%) men, 30-70 degrees in 70 (45.5%) men, and 70-90 degrees in 21 (13.6%) men, respectively. Of all, 116 (75.3%) patients showed a PSV>35cm/s and RI ≥ 0.85. Patients with pathologic vs. normal CDDU parameters did not differ in median (IQR) curvature (32.5° [30°-58.7°] vs. 40° [30°-65°], p=0.5) or in the distribution across curvature range groups. Linear regression analysis revealed that the degree of penile curvature did not significantly correlate with PSV at CDDU (coefficient: 0.06, p=0.3). Our study confirms the lack of a significant correlation between the severity of penile curvature and CDDU parameters in men presenting with PD. These findings emerge to be relevant in terms of a more accurate management work-up for PD patients and hold insightful medicolegal implications and in the real-life setting.

Multi-objective intermodal transportation planning with real-life application

ABSTRACT This paper explores the optimal route selection problem within an intermodal transportation network that comprises road, rail, sea, and inland waterways. Initially, we propose a multi-objective integer linear programming model that aims to minimize total cost, transport time, and carbon emissions. Subsequently, we apply two multi-objective programming approaches: Fuzzy Goal Programming and Compromise Programming. These approaches are implemented in a real-life case study, aiming to determine the optimal intermodal transportation route from Türkiye (Denizli) to Germany (Duisburg). Four out of the six methods suggest the same road and maritime pathway. Furthermore, this model has the potential to aid decision-makers in selecting routes based on customer requirements and serve as a valuable tool for policymakers in establishing an efficient intermodal transport network.

GLP-1 Receptor Agonists and SGLT2 Inhibitors in Type 2 Diabetes: Pleiotropic Cardiometabolic Effects and Add-on Value of a Combined Therapy.

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter 2 inhibitors (SGLT2is) have proven efficacy and safety in randomized clinical trials and observational real-life studies. Besides improving glucose control, reducing body weight, and lowering arterial blood pressure (surrogate endpoints), the breakthroughs were the demonstration of a significant reduction in cardiovascular and renal events in patients with type 2 diabetes at high risk. GLP-1RAs reduce events linked to atherogenic cardiovascular disease (especially ischemic stroke) and also renal outcomes (FLOW trial with semaglutide), with a limited effect on heart failure. The most striking protective effects of SGLT2is were a marked reduction in hospitalization for heart failure and a remarkable reduced progression of chronic kidney disease. These benefits have been attributed to numerous pleiotropic effects beyond glucose-lowering action. Underlying mechanisms contributing to cardiovascular and renal protection are at least partially different between GLP-1RAs (mainly anti-atherogenic and vascular effects) and SGLT2is (mainly systemic and intrarenal hemodynamic changes). Thus, patients at high risk may benefit from complementary actions when being treated with a GLP-1RA/SGLT2i combination. Such combination has proven its efficacy on surrogate endpoints. Furthermore, posthoc subgroup analyses of cardiovascular outcome trials have suggested a greater cardiorenal protection in patients treated with a combination versus either monotherapy. The benefits of a combined therapy have been confirmed in a few retrospective cohort studies. A dedicated prospective trial comparing a combined therapy versus either monotherapy is ongoing (PRECIDENTD); however, several challenges still remain, especially the higher cost of a combined therapy and the worldwide underuse of either GLP-1RAs or SGLT2is in clinical practice, even in patients at high cardiorenal risk.

First-Line Use of Daratumumab in Patients with Multiple Myeloma Shows Delayed Neutrophil and Platelet Engraftment after Autologous Stem Cell Transplantation: Results from a Real-Life Single-Center Study.

This real-life study aimed to investigate the possible impact of D-VTd induction therapy on hematopoietic engraftment after autologous stem cell transplantation (auto-SCT). Sixty consecutive NDMM patients received four cycles of induction therapy with D-VTd. The conditioning regimen consisted of melphalan 200 mg/m2. These patients were compared with a historical control group of 80 patients who received four cycles of VTd as induction therapy. The median days to reach neutrophil and platelet engraftment significantly differed between patients treated with D-VTd (11 and 13 days, respectively) and VTd (10 and 12 days). Univariate Cox analyses show that patients treated with D-VTd had a hazard ratio of neutrophil engraftment that was 42% significantly lower than those in the VTd arm (HR: 0.58, p = 0.002), and a multivariate model confirmed this result. Patients treated with D-VTd developed FN more frequently. Univariate and multivariate logistic regressions revealed an association between D-VTd and FN. Delayed engraftment did not correlate with more extended hospitalization. No patients died in the first six months after transplantation. Our real-life study showed that a four-drug induction therapy containing DARA does not impact transplant safety outcomes.

Cutoff Values of Aldosterone and the Aldosterone-Renin Ratio for Predicting Primary Aldosteronism in Patients with Resistant Hypertension: A Real-Life Study.

Primary aldosteronism (PA) is commonly associated with resistant hypertension. Biochemical tests can be clinically useful in the screening and diagnosis of primary aldosteronism. This study aimed to identify the cutoff values of aldosterone levels (A) and the aldosterone-renin ratio (ARR) for an accurate prediction of PA in patients with apparent resistant hypertension in a real-life scenario. This database-based study included a historical cohort of male and female patients with apparent resistant hypertension, aged 18 years or older and surveyed for PA in a specialized center from 2008 to 2018. Aldosterone and plasma renin activity (PRA) or the plasma renin concentration (PRC) were measured in the treated hypertensive patients. The patients with positive screening results were subsequently referred to the endocrinology department for confirmatory tests. The patients with confirmed PA were included in the case group, and the others remained as controls. Receiver-operating characteristic (ROC) curves were used to identify the cutoff points for aldosterone and the ARR, thereby analyzing their sensitivity and specificity for confirmed PA. Among the 3464 patients (59 ± 13 years old, 41% male) who had apparent resistance hypertension screened, PA was confirmed in 276 individuals (8%). A ≥ 16.95 ng/dL (95% CI: 0.908-0.933) had an odds ratio of 6.24 for PA, while A/PRA ≥ 29.88 (95% CI: 0.942-0.984) or an A/PRC ≥ 2.44 (95% CI: 0.978-0.990) had an odds ratio of 216.17 for PA diagnoses. Our findings suggest that a positive PA screening with aldosterone ≥ 17 ng/dL associated with A/PRA ≥ 29.88 or an A/PRC ratio of ≥2.44 should be sufficient to confirm the diagnosis of PA without confirmatory testing.

Designing a sustainable delivery network with parcel locker systems as collection and transfer points

Collection and delivery points, both attended and fully automated, have emerged as a popular solution in last-mile delivery. They offer not only operational advantages for the delivery company but also present a pathway to mitigating the negative environmental impact of parcel delivery operations. In this study, we explore a new approach, where parcel locker systems have a dual role: as collection points for customers and as transfer points for the delivery company. We introduce a variant of the Location-Routing Problem, optimizing the strategic location and capacity size of parcel locker systems as well as the delivery routes from those points. We develop an efficient branch-and-price algorithm and apply it to a real-life case study that focuses on the design of a delivery network with parcel lockers in a residential neighborhood in the city of Groningen, the Netherlands. Our case study findings underscore that the dual role of parcel locker systems considerably reduces the travel distance of delivery vehicles, is well-suited to deal with potential future increase in demand for parcel collection, and reduces the likelihood of customers traveling to parcel locker by car.

Assessing Gender Differences in Neuropathic Pain Management: Findings from a Real-Life Clinical Cross-Sectional Observational Study

Introduction: Neuropathic pain is defined as pain induced by a lesion or disease of the somatosensory nervous system. Pharmacological and non-pharmacological treatments are frequently employed. In the current clinical investigation, we assessed the effects of sex on the safety and effectiveness of medications used to treat neuropathic pain. Methods: We conducted a prospective analysis between 1 February 2021 and 20 April 2024, involving patients with neuropathic pain referred to the Ambulatory of Pain Medicine of “Renato Dulbecco” University Hospital in Catanzaro (Calabria, Italy). Patients over 18 years old with signs of neuropathic pain (Douleur Neuropathique en 4 questionnaire ≥ 4) were included. Exclusion criteria comprised patients with Alzheimer’s disease; patients with nociplastic or nociceptive pain; and patients with neoplasms. Patients with fewer than two accesses to ambulatory care were excluded, as were those who did not sign the informed consent. Clinical data were collected from each enrolled patient and subsequently analyzed, considering clinical outcomes. Sex and gender differences in efficacy were estimated using multivariate linear modeling and propensity-score matching. Results: During the study, 531 patients were screened, and 174 were enrolled (33.5%, mean age 61.5 ± 13.1; 64 males and 110 females, mean age 60.6 ± 13.4 and 61.96 ± 13.0) in accordance with the inclusion and exclusion criteria. Only minor differences in treatment prescription were observed based on age, body mass index, and comorbidities. Smoking, sex, educational level, and body mass index did not induce a significant change in pain perception. Males required slightly higher, though not significantly, doses of drugs for pain control than females. The treatment was not significantly more effective for females than for males. Females did not exhibit a significantly lower number of adverse drug reactions compared to males. Conclusions: The current study found that there are no appreciable differences between the sexes when it comes to the treatment of neuropathic pain.

Carbon Dioxide Laser as Adjuvant Therapy for Human Papillomavirus-Related Squamous Intraepithelial Vulvar Lesions in Chronically Immunosuppressed Women: A Long-Term Real-Life Study

Carbon Dioxide Laser as Adjuvant Therapy for Human Papillomavirus-Related Squamous Intraepithelial Vulvar Lesions in Chronically Immunosuppressed Women: A Long-Term Real-Life Study

The gaps between the guidelines definitions and routine of care adopted in primary health care regarding diabetes kidney disease: a real-life study

The gaps between the guidelines definitions and routine of care adopted in primary health care regarding diabetes kidney disease: a real-life study

Calcitonin Gene-Related Peptide Monoclonal Antibodies: Key Lessons from Real-World Evidence.

The advent of monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway has transformed the management of migraine, offering newfound optimism for clinicians and individuals with episodic migraine (EM) and chronic migraine (CM). While randomized controlled trials (RCTs) have provided crucial insights into the effectiveness and safety profiles of these treatments, their translation into real-world clinical practice remains a challenge. This review aims to conduct a comprehensive assessment of real-world studies, offering valuable insights tailored for practical application in clinical settings. We conducted a comprehensive literature search in PubMed, SCOPUS, and MEDLINE for real-life studies on erenumab, fremanezumab, and galcanezumab. Abstracts underwent rigorous screening by two reviewers for relevance. Data extraction from selected articles was performed using a standardized form, with verification by a second reviewer. Data synthesis was narrative, following PRISMA guidelines. Our search included 61 pertinent studies conducted between 2019 and 1 March 2024. Real-world study designs demonstrated notable variability in the selection and inclusion of migraine patients, influenced by factors such as attack frequency, data collection criteria, and primary/secondary objectives. Key findings commonly reported considerable improvements in efficacy outcomes (migraine frequency, analgesic use, pain severity, and disability), high responder rates, and optimal safety and tolerability profiles. Real-world evidence underscores the role of anti-CGRP mAbs as targeted therapies for both CM and EM patients. The overall results indicate that the effectiveness and tolerability of anti-CGRP mAbs in real-world applications may exceed those observed in RCTs, an extraordinary finding in clinical neurology.

Effectiveness of anti-IL5/5Rα biologics in severe asthma in real world studies: a systematic review and meta-analysis

BackgroundThree biologics targeting interleukin 5 (anti-IL5) or its receptor-α (anti-IL5Ra) are approved for patients with severe asthma.MethodsWe conducted a systematic search until May 1, 2023, to identify observational studies and non-randomised trials that assess the response to anti-IL5/5Rα of real-life patients with severe eosinophilic asthma in MEDLINE and EMBASE. We performed random-effects meta-analyses.ResultsWe identified 6,401 studies of which 92 with 9546 patients were analysed. Biologics use was associated with 62% reduction in severe exacerbations (risk ratio, RR, 0.38, 95%CI 0.29 to 0.50) and 54% reduction in hospitalisations (RR 0.46, 95%CI 0.35 to 0.61) at 12 months of treatment, compared to pre-treatment. Biologics improved asthma control [decrease in asthma control questionnaire (ACQ) by 1.11 points (95%CI −1.29 to −0.94) and increase in asthma control test (ACT) by 6.41 points (95%CI 5.66 to 7.16)], and increased the asthma quality of life questionnaire (AQLQ) by 1.08 points (95%CI 0.88 to 1.28) and forced expiratory volume in 1 s (FEV1) by 0.21 L (95% CI 0.15 to 0.27) at 12 months. There was a significant reduction in oral corticosteroids use by 51% (RR 0.49, 95%CI 0.42 to 0.56), with a mean dose reduction of 6.01 mg/d (95%CI −7.55 to −4.48) at 12 months of treatment. Similar findings were observed at 3–4, 6 and 24 months. Biomarker-related response to treatment was also noted.ConclusionsThis comprehensive meta-analysis summarises the significant clinical response to anti-IL5/5Rα biologics in real-life studies, providing important insights for clinical practice use of these agents.

Elexacaftor/tezacaftor/ivacaftor, a game-changer in cystic fibrosis: The Portuguese experience

BackgroundPhase 3 trials of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) combination treatment in people with cystic fibrosis (CF) with ≥1 F508del-CFTR allele showed profound short-term effects on lung function, weight, and pulmonary exacerbations (PEx). The authors conducted a 12-month study to add evidence on the real-world long-term effectiveness and safety of CFTR modulator therapy with ELX/TEZ/IVA in Portuguese CF adult population. MethodsAmbispective, multicentre, observational, real-life study involving all the Portuguese CF Reference Centres. Adult patients on treatment with ELX/TEZ/IVA combination outside clinical trials were included. Demographics, efficacy, and safety variables on the first 12 months of treatment were compared with the pre-treatment year. Results132 adult people with CF were included, of which 119 completed 12 months treatment (mean duration of treatment 21.5 months). Mean age was 31.7 ± 11.0 years, 53 % patients were homozygous for the F508del variant, baseline sweat chloride was 86.7 ± 25.9 mmol/L and pre-treatment percent-predicted FEV1 was 77.9 ± 19.7 %. At 1 year, mean absolute change from baseline in FEV1 was +0.46L (95 % CI: 0.37, 0.55; p < 0.001) and +13.9 percentage points (95 % CI: 11.5, 16.2; p < 0.001). PEx episodes decreased by 78 % (p < 0.001) and hospitalizations for PEx decreased by 91.4 % (p < 0.001). Body mass index (BMI) increased 1.2 kg/m2 (95 % CI: 0.9, 1.5; p < 0.001). Mean sweat chloride variation was −44.5 mmol/L (95 % CI: −49.8, −39.2; p < 0.001). No correlation was found between sweat chloride and lung function (r = −0.116, p = 0.335). There were no major safety concerns. Of note, headache was reported in 7.6 % and neuropsychiatric manifestations occurred in 12.6 % treated patients, being anxiety and depressive disorders the most common. ConclusionsELX/TEZ/IVA treatment in Portuguese adults with CF was associated with significant improvement in lung function, a drop in PEx and PEx-related hospitalizations and increase in BMI at 12 months and was well tolerated. These results add knowledge to our understanding of clinical benefits and tolerability of ELX/TEZ/IVA. Careful evaluation of adverse effects of ELX/TEZ/IVA therapy and its determinants, mainly concerning mental health, are a research priority.

Long-Term Outcome of Patients with Low-Risk Differentiated Thyroid Cancer Treated with Total Thyroidectomy Alone.

Differentiated thyroid carcinoma (DTC), mainly papillary (PTC), at low risk of recurrence is currently managed with active surveillance strategies or less aggressive surgeries. However, total thyroidectomy with 131I treatment is still performed both if these tumors are diagnosed before or occasionally after surgery. This real-life study aimed to evaluate the rate of biochemical, structural, and functional events in a large series of consecutive DTCs at low risk of recurrence treated by total thyroidectomy, but not with 131I, in a medium-long-term follow-up. We evaluated clinical-pathologic data of 383 consecutive patients (2006-2012) with unifocal DTC [T1a/b(s)] at low risk of recurrence, treated with total thyroidectomy but without lymph node dissection and 131I treatment after surgery. We evaluated if structural, biochemical, and functional events were detected during the follow-up. Females accounted for 75.7% of our study group, and the median age was 50 years. The median tumor dimension was 0.4 cm (range 0.1-1.2). Most of the patients had a unifocal T1a tumor (98.9%), and 73.6% had a classic variant of PTC. We divided the patients according to the absence (group A-n = 276) or presence (group B-n = 107) of interfering TgAb at first control after surgery. After a median follow-up of 10 years, no structural events were detected. Sixteen out of three hundred and eighty-three (4.2%) patients developed biochemical events: 12/276 (4.3%) in group A and 4/107 (3.7%) in group B. The median time elapsed from surgery to detecting a biochemical event was 14.5 and 77.5 months in groups A and B, respectively. No patients performed additional treatments and were followed up with an active surveillance strategy. This study confirmed that patients with DTC at low risk of recurrence showed an excellent outcome in a medium long-term follow-up since no structural events were diagnosed. Significant variations in Tg/TgAb were detected in a few cases, all managed with an active surveillance strategy without the need for other treatments. Therefore, a relaxed follow-up with neck ultrasound and Tg/TgAb measurement is enough to early identify those very unusual cases of recurrence.

Sustainable management of polyethylene terephthalate waste flow using a fuzzy frank weighted assessment model

The consequences for the ecosystem of polyethylene terephthalate (PET) waste are becoming increasingly significant and widespread. Companies managing PET waste strive to enhance sustainability in all areas. The development of systematic decision-making approaches and frameworks for PET waste management is strongly needed. This research aims to present a new methodological framework for the categorization of the most efficient PET waste management solutions. The introduced fuzzy Frank weighted sum product assessment (FWESPA) model enables rational and flexible reasoning by nonlinearly processing uncertain information. A nonlinear aggregation function is proposed for the fusion of fuzzy strategic options. It is advantageous in simulating the impact of strategic options on a final decision. An integral part of the introduced fuzzy FWESPA model is a reverse sorting algorithm. This innovative algorithm can improve the performance of traditional normalization techniques. Also, an improved fuzzy Frank ordinal priority approach linear model is formulated to define the significance of evaluation criteria. The comprehensive real-life study demonstrates the proposed decision-analytics-based approach. The results showed the following rankings of considered alternatives: “recycling” (ℤA2 = 0.8565) > “energy recovery” (ℤA1 = 0.7364) > “remanufacturing” (ℤA4 = 0.690) > “incineration” (ℤA3 = 0.6592). Based on the results presented, alternatives “recycling” (A2) and “energy recovery” (A1) represent dominant alternatives with a slight advantage of recycling. Research findings can be used when deciding the appropriate way to enhance PET waste handling. The findings also describe the benefits and limitations of each treatment option for PET waste, as well as highlight the crucial challenges.

Impact analysis of SARS-CoV-2 vaccination in patients treated with monoclonal antibodies: A monocentric experience

BackgroundSince the discovery of SARS-CoV-2, no treatment has been able to completely eradicate the virus. The study aimed to evaluate the virological and clinical impact of the vaccination in SARS-CoV-2 infected patients treated with monoclonal antibodies (mAbs). MethodsThis single-centre, observational, retrospective, real-life study was performed on SARS-CoV-2 symptomatic outpatients and inpatients treated with mAbs from March 2021 to November 2022 includes 726 patients. Each patient received available mAbs (bamlanivimab-etesevimab or casirivimab-indevimab or sotrovimab or tixagevimab-cilgavimab) according to the circulating virus strains. Age, comorbidities, vaccination status, death rates, duration of virological clearance, average length of stay, risk factors, and hospitalization or ICU admission were recorded. ResultsOf 726 patients with complete data analyzed (median age 64), 516 outpatients and 210 inpatients were included. Vaccination status was known for all participants: 74.4 % and 51.7 % were vaccinated against SARS-CoV-2 among inpatients and outpatients, respectively. A shorter duration of virological clearance was observed in the vaccinated group, with a median of 16 days (IQR 15–17), compared to 19 days (IQR 18–21) in the unvaccinated group [HR 1.21; p < 0.032]. Multivariate analysis of virological clearance also showed statistical significance with tixagevimab cilgavimab 300 mg/300 mg (HR 2.73, p value < 0.001). No significant difference was found in worsening [OR 1,29; p = 0.57] and mortality [OR 0.65; p = 0.81] rates between vaccinated and unvaccinated patients treated with mAbs. ConclusionsKey findings include a shorter duration of virological clearance in vaccinated outpatients but no significant differences in worsening or mortality rates between vaccinated and unvaccinated patients treated with mAbs. The study suggests a potential synergistic role of mAbs in accelerating virological clearance in vaccinated patients with mild to moderate COVID-19, with differing effects in hospitalized patients. Therefore, it is essential to implement health surveillance in high-risk patients with comorbidities in order to identify early any variants that might otherwise escape neutralizing antibodies.

Long-Term Change in BMI for Children with Obesity Treated in Family-Centered Lifestyle Interventions

Introduction: Several evaluations of lifestyle interventions for childhood obesity exist; however, follow-up beyond 2 years is necessary to validate the effect. The aim of the present study was to investigate long-term weight development following children participating in one of two pragmatic family-centered lifestyle interventions treating childhood obesity. Methods: This real-life observational study included Danish children 4–17 years of age classified as having obesity. Data from 2010 to 2020, from two community-based family-centered lifestyle interventions (designated hereafter as the Aarhus- and the Randers-intervention) were merged with national registers and routine health check-ups, including height and weight. Adjusted mixed effect models were used to model changes in body mass index (BMI) z score. We performed exploratory analyses of the development in BMI z-score within stratified subgroups of children treated in the interventions before investigating potential effect modifications induced by sex, age, family structure, socioeconomic, or immigration status. Results: With a median follow-up of 2.8 years (interquartile range: 1.3; 4.8), 703 children participated in an intervention (445 the Aarhus-intervention; 258 the Randers-intervention) and 2,337 children were not invited to participate (no-intervention). Children in both interventions experienced a comparable reduction in BMI z-scores during the first 6 months compared to the no-intervention group (Aarhus-intervention: −0.12 SD/year and Randers-intervention: −0.25 SD/year). Only children in the Randers-intervention reduced their BMI z-score throughout follow-up (Aarhus-intervention vs. no-intervention: 0.01 SD/year; confidence interval [CI]: −0.01; 0.04; Randers-intervention vs. no-intervention: −0.05 SD/year; CI: −0.08; −0.02). In subgroup comparisons, combining the two interventions, family income below the median (−0.05 SD/year, CI: −0.02; −0.09), immigrant background (0.04 SD/year, CI: 0.00; 0.07), or receiving intervention less than 1 year (0.04 SD/year, CI: 0.00; 0.08) were associated with a yearly increase in BMI z score. In addition, effect modification analyses did not observe any interaction by sex, age, family structure, socioeconomic, or immigration. Conclusions: Although the more dynamic intervention with longer duration obtained and sustained a minor reduction in BMI z score, the clinical impact may only be modest and still not effective enough to induce a long-term beneficial development in BMI in children with obesity.

Beta-blockers and breastfeeding: a real-life prospective study.

At Lille University Hospital, a pregnancy heart team including cardiologists, obstetricians, pediatricians, anesthetists, geneticists, and pharmacologists discusses about treatment compatibility taken during breastfeeding in pregnant women (or those wishing to be pregnant) with complex cardiovascular pathologies. Beta-blockers are among the drug most often used in these patients, and data are missing or suggest a risk to the breastfed child. The aim of this study was to evaluate the proportion of women treated with beta-blockers, identified during the multidisciplinary meeting, who breastfed and to monitor adverse effects (AEs) in newborns. A prospective descriptive study was conducted from 1 December 2017 to 1 December 2021. All pregnant patients followed up by the pregnancy heart team in Lille University Hospital, treated with beta-blockers and who gave birth, were contacted as part of the pharmacovigilance follow-up. The proportion of women treated with beta-blockers intending to breastfeed was 69.8%. Among the 53 women interviewed, 49% did not breastfeed, including 10 because of the theoretical incompatibility of their beta-blocker with breastfeeding. Among the 27 women who breastfed, 30% breastfed while treated with a theoretically incompatible beta-blocker; 56% was changed from their initial beta-blocker to allow safe breastfeeding. No serious AE was observed. To our knowledge, our study is the largest series of patients treated with beta-blockers during breastfeeding. Taking a treatment can be an obstacle to breastfeeding, but for the particular case of beta-blockers, even if the available data are few and sometimes worrying, the data from this study are reassuring.

Impact of biological therapies on laboratory outcomes and FEV1 in patients with severe eosinophilic asthma with chronic rhinosinusitis: a real-life study from Saudi Arabia.

From March to September 2022, a retrospective observational cohort study was undertaken at the severe asthma clinics of the Armed Forces Hospital-Southern Region (AFHSR) and King Khalid University Hospital, Abha, Saudi Arabia, to delineate the effects of 3 biological therapies (benralizumab, dupilumab, and omalizumab) in adults with SA and concomitant CRS in terms of FEV1 and laboratory parameters (serum IgE and eosinophilic counts). Eighty patients were enrolled, with a mean age of 46.68. There were 45 (56%) females and 35 (44%) males. There were significant improvements in FEV1 and laboratory parameters (serum IgE and eosinophilic counts) after 6 &12 months of biological therapies compared to pre-biological therapies (p<0.001, each). The response was different among different biological therapies. The improvements in FEV1, serum IgE, and eosinophilic counts were manifest with benralizumab and dupilumab but not with omalizumab. Results from the first study from two large Saudi Arabian tertiary centers for patients with severe asthma and chronic rhinosinusitis agree with and support those of worldwide real-life ones. One-year follow-up of patients with SA and CRS showed the effectiveness of benralizumab and dupilumab, but not omalizumab, regarding FEV1, serum IgE, and eosinophilic counts. Further prospective multicenter studies are warranted.