Efficacy and tolerability of concomitant use of bedaquiline and delamanid for multidrug- and extensively drug-resistant tuberculosis: a systematic review and meta-analysis

alexandrossfakianakis shared this article with you from Inoreader Efficacy and tolerability of concomitant use of bedaquiline and delamanid for multidrug- and extensively drug-resistant tuberculosis: a systematic review and meta-analysis via Clinical Infectious Diseases Advance Access Abstract The introduction of two novel drugs, bedaquiline and delamanid, has given hope for better and shorter treatments of drug-resistant tuberculosis. A systematic review was conducted to evaluate the efficacy and safety of concomitant bedaquiline and delamanid administration. Pooled estimates of WHO-defined favorable treatment outcome and significant QTc-interval prolongation (QTc ≥500 ms or ≥60 ms increase from baseline) were calculated using a random effects model. Thirteen studies including a total of 1031 individuals with multidrug-resistant/rifampicin-resistant tuberculosis who received bedaquiline and delamanid were included. The pooled estimate of favorable treatment outcome was 73.1% (95%CI: 64.3-81.8). Sputum culture conversion at six months ranged from 61-95%. Overall, the pooled proportion of QTc-prolongation was 7.8% (95%CI: 4.1-11.6) and few cardiac events were reported (0.8%, n = 6/798). Rates of sputum culture conversion and favorable treatment outcome were high in patients treated concomitantly with bedaquiline and delamanid, and the treatment seemed tolerable with low rates of clinically significant cardiac toxicity. View on Web

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A novel stapler‐assisted technique for closure of persistent tracheoesophageal puncture fistula

alexandrossfakianakis shared this article with you from Inoreader A novel stapler‐assisted technique for closure of persistent tracheoesophageal puncture fistula via Head & Neck Abstract Tracheoesophageal puncture (TEP) is a reliable method to restore voice and is an important part of voice rehabilitation following laryngectomy. However, complications following this procedure, including peri-prosthetic leakage and resulting aspiration pneumonia, may necessitate surgical closure. In this study, we present an effective and reliable method for TEP closure using a stapler-assisted technique. Case series study for patients who underwent stapler-assisted TEP closure reviewed from 2017 to 2021. All five patients had successful closure of their TEP tract without further leakage. No postoperative bleeding, wound infection, or esophageal stenosis occurred. One patient had postoperative stomal stenosis. The stapler-assisted technique for TEP closure is easy, quick, and effective. The reliability and quick return to oral intake post-operatively make it a preferable option over previous techniques. View on Web

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Efficacy and safety of rituximab biosimilars or reference product as first‐line treatment in patients with low‐tumour‐burden follicular lymphoma: A systematic review and meta‐analysis

alexandrossfakianakis shared this article with you from Inoreader Efficacy and safety of rituximab biosimilars or reference product as first‐line treatment in patients with low‐tumour‐burden follicular lymphoma: A systematic review and meta‐analysis via Journal of Clinical Pharmacy and Therapeutics Follicular lymphoma is a subtype of B-cell Non-Hodgkin lymphoma and is the second most common lymphoma diagnosed in the United States and Western Europe. The role of rituximab in the first-line treatment of low-tumour-burden follicular lymphoma has been supported by a large number of data. However, whether rituximab biosimilars have the same efficacy and safety as the reference drug (MabThera) is still controversial. Electronic databases and the ClinicalTrail.gov website were extensively searched using relevant search criteria. Studies were screened according to inclusion and exclusion criteria. Then the risk of bias of the included studies was assessed using the RoB 2 assessment scale, and the RevMan 5.4 statistical software was used for meta-analysis. Finally, four clinical randomized controlled trials involving 1223 patients were included. There were no statistically significant differences in efficacy and safety between biosimilars and MabThera groups. Our study concluded that the efficacy and safety of rituximab biosimilars in the treatment of low-tumour-burden follicular lymphoma are highly similar to those of the original drug. Abstract What is Known and Objective The role of rituximab in the first-line treatment of low-tumour-burden follicular lymphoma (LTB-FL) has been supported by a large number of data. However, whether rituximab biosimilars have the same efficacy and safety as the reference drug (MabThera) is still controversial. Methods Electronic databases and the ClinicalTrail.gov website were extensively searched using relevant search criteria. The risk of bias of the included studies was assessed using the RoB 2 assessment scale, and the RevMan 5.4 statistical software was used for meta-analysis. Results and Discussion A total of 1223 patients were included in four clinical randomized controlled trials. There was no statistical difference in efficacy between biosimilars and MabThera groups (the objective response rate: RR = 1.00, 95% CI: 0.93–1.08, p = 0.92; the progression-free survival: RR = 1.04, 95% CI: 0.96–1.12, p = 0.30; the overall survival: RR = 1.00, 95% CI: 0.98–1.03, p = 0.76; the serious adverse events: RR = 1.15, 95% CI: 0.69–1.89, p = 0.59; the infusion-related reaction: RR = 0.91, 95% CI: 0.77–1.09, p = 0.32). In terms of safety, there was also no significant difference between two groups. What is New and Conclusion Our study concluded that the efficacy and safety of rituximab biosimilars in the treatment of LTB-FL are highly similar to those of the original drug. View on Web

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A Breakthrough Improvement Collaborative Significantly Reduces Hospital Stay After Elective Colectomy for Cancer Across a Healthcare System

alexandrossfakianakis shared this article with you from Inoreader A Breakthrough Improvement Collaborative Significantly Reduces Hospital Stay After Elective Colectomy for Cancer Across a Healthcare System via Annals of Surgery - Most Popular Articles Objective: This multicenter study aimed to assess (1) the effect of an improvement collaborative on enhanced recovery after surgery (ERAS) protocol adherence after elective colectomy and (2) the association between adherence and patient outcomes. Background: ERAS pathways provide a framework to standardize care processes and improve postoperative outcomes in patients after colon surgery. Despite growing evidence of its effectiveness, adherence to these guidelines remains a challenge. Methods: This prospective, multicenter collaborative was initiated throughout 11 hospitals in Flanders, Belgium. A structured audit tool was used to study patient outcomes and adherence to 12 ERAS components, defined by the collaborative. Three retrospective audits (based on patient record analysis) were conducted in 2017, 2019, and 2021, respectively. Results: Overall, 740 patients were included (45.4% female; mean±SD age, 71±12 years). The overall adherence increased from 42.8% in 2017 to 58.4% in 2019 and 69.2% in 2021. Compared with low adherence, length of stay was increasingly reduced by 1.3 days for medium [95% confidence interval (95% CI): −2.5; 0.0], 3.6 days for high (95% CI: −4.9; −2.2), and up to 4.4 days for very high adherence (95% CI: −6.1; −2.7). Corresponding odds ratios for postoperative complications were 0.62 (95% CI: 0.33; 1.17), 0.19 (95% CI: 0.09; 0.43), and 0.14 (95% CI: 0.05; 0.39), respectively. No increase in 30-day readmissions was observed. Conclusions: A peer-constructed improvement collaborative effectively increases adherence to an ERAS protocol in individual hospitals. Across time, length of stay and postoperative complications decreased significantly, and a dose-response relationship was observed. View on Web

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Evaluation of the transdentinal capability of the intrinsic antibacterial cetylpyridinium chloride/cholesterol sterosomes in vitro and in vivo

alexandrossfakianakis shared this article with you from Inoreader Evaluation of the transdentinal capability of the intrinsic antibacterial cetylpyridinium chloride/cholesterol sterosomes in vitro and in vivo via International Endodontic Journal Abstract Abstract Aim Dentinal tubules serve as disease-causing channels for infiltration and penetration of bacteria and their by-products; which are regarded as the major driver of pathogenesis in pulpal inflammation and infection. In this study, we aimed to evaluate the transdentinal potential of nanoscale cetylpyridinium chloride/cholesterol (CPC/Chol) sterosomes, which are a recently developed type of cationic non-phospholipid liposomal nanocarrier; as well as their intrinsic and universal antibacterial activity. Methodology CPC/Chol sterosomes were formulated, with a hydrodynamic diameter of 134 ± 4 nm, a low polydisperse index of 0.161 ± 0.007, and a positive zeta potential of 41 ± 3 mV at pH 7.4. Transdentinal diffusion ability of sterosomes was evaluated using human dentine blocks in vitro, and Wistar rat molar teeth in vivo. The intrinsic antibacterial activities of CPC/Chol sterosomes against E. faecalis, S. mutans, F. nucleatum, and P. gingivalis were further examined. Results CPC/Chol sterosomes successfully penetrated through the dentinal tubules, and diffused into the pulp, which could be internalized by dental pulp cells with a high efficiency. Additionally, they exhibited substantial levels of intrinsic antibacterial activity against these Gram-positive and Gram-negative endodontic bacteria and their biofilms. Conclusions Given its high penetration and diffusion ability through the dentine and pulp, great potential for multi-drug delivery, and distinct intrinsic antibacterial activity; sterosome-based nanocarriers might serve as a promising therapeutic strategy aimed at targeting various specific pathways associated with pulpal diseases. This will help determine and characterize the most appropriate prophylactic and therapeutic targets for early intervention in our future dentistry practice. View on Web

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Medical body modification in youth with gender dysphoria or body dysmorphic disorder – is current practice coherent and evidence‐based?

alexandrossfakianakis shared this article with you from Inoreader Editorial Perspective: Medical body modification in youth with gender dysphoria or body dysmorphic disorder – is current practice coherent and evidence‐based? via Journal of Child Psychology and Psychiatry In recent decades, there has been a steady increase in the number of people, including adolescents, undergoing medical body modification (MBM) to alter their physically healthy bodies in invasive and nearly irreversible ways through medical treatment (e.g. surgery). While MBM is often recommended for youth with persisting gender dysphoria (GD), in body dysmorphic disorder (BDD) it has been considered contraindicated. Here, we outline the current controversies surrounding MBM practice and recommendations in adolescents with GD versus those with BDD in order to better understand under what circumstances we may or may not support adolescents who want to change their bodies medically and often irreversibly. We compare the two disorders in terms of the overlap and uniqueness of their behavioural and psychological features. In doing so, we discuss limitations of the existing (often low-quality) evidence for and against MBM in young patients. We conclude that the c urrently available evidence is too preliminary and far from conclusive to make any robust recommendations in terms of benefits and harms of MBM in youth with persisting GD or BDD. However, we strongly recommend further urgent scientific discussions and systematic research efforts into more robust evaluations and the identification of more precise psychological characteristics that may serve as decision criteria for or against MBM – particularly in those adolescents who did not respond to non-MBM, that is, psychiatric/psychological treatment and psychosocial support, if available at all. This will greatly benefit youth healthcare professionals in their challenging clinical practice of making decisions regarding MBM today and in the future. View on Web

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Corticosteroid Nasal Irrigation as Early Treatment of Olfactory Dysfunction in COVID‐19: A prospective randomized controlled trial

alexandrossfakianakis shared this article with you from Inoreader Corticosteroid Nasal Irrigation as Early Treatment of Olfactory Dysfunction in COVID‐19: A prospective randomized controlled trial via Clinical Otolaryngology Abstract Objective This study aimed to evaluate the efficacy of corticosteroid irrigation compared to saline to no nasal irrigation in COVID-19 patients with olfactory loss. Design and Setting A randomized controlled study was conducted at the Otolaryngology-Head & Neck Surgery Department, Ramathibodi Hospital, Faculty of Medicine, Mahidol University. Participants Two hundred thirty-seven COVID-19 participants with a new-onset smell loss were recruited into the study. Two hundred twenty-two participants met the inclusion criteria and were randomized into three groups; corticosteroid irrigation, saline irrigation, and no treatment. Main outcome measures The primary outcome was the mean difference in the smell sensation score among the groups after treatment at 1, 2, and 6 weeks. The secondary outcomes measurements included 1)a self-rating quality of life(QOL)-related smell dysfunction score, 2)the change over time in smell sensation score and self-rating QOL-related smell dysfunction score, and 3)the median time to complete recovery of smell loss. Results The mean differences in smell sensation scores among the three groups were not statistically significant at any follow-up period. The mean score of self-rating QOL-related smell dysfunction in the corticosteroid group was significantly better than the other groups at one week. The change of outcome scores showed significant improvement over time, regardless of the treatments. The median time to complete smell recovery was similar: three weeks. Conclusion This study emphasized that corticosteroid nasal irrigation is not superior to saline or no nasal irrigation in restoring the sense of smell in COVID-19-associated olfactory loss. This article is protected by copyright. All rights reserved. View on Web

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Polygenic risk scores for prediction of breast cancer

alexandrossfakianakis shared this article with you from Inoreader Polygenic risk scores for prediction of breast cancer in Korean women via International Journal of Epidemiology - Advance Access Abstract Background Polygenic risk scores (PRSs) for breast cancer, developed using European and Asian genome-wide association studies (GWAS), have been shown to have good discrimination in Asian women. However, prospective calibration of absolute risk prediction models, based on a PRS or PRS combined with lifestyle, clinical and environmental factors, in Asian women is limited. Methods We consider several PRSs trained using European and/or Asian GWAS. For each PRS, we evaluate the discrimination and calibration of three absolute risk models among 41 031 women from the Korean Cancer Prevention Study (KCPS)-II Biobank: (i) a model using incidence, mortality and risk factor distributions (reference inputs) among US women and European relative risks; (ii) a recalibrated model, using Korean reference but European relative risks; and (iii) a fully Korean-based model using Korean reference and relative risk estimates from KCPS. Results< /div>All Asian and European PRS improved discrimination over lifestyle, clinical and environmental (Qx) factors in Korean women. US-based absolute risk models overestimated the risks for women aged ≥50 years, and this overestimation was larger for models that only included PRS (expected-to-observed ratio E/O = 1.2 for women <50, E/O = 2.7 for women ≥50). Recalibrated and Korean-based risk models had better calibration in the large, although the risk in the highest decile was consistently overestimated. Absolute risk projections suggest that risk-reducing lifestyle changes would lead to larger absolute risk reductions among women at higher PRS. Conclusions Absolute risk models incorporating PRS trained in European and Asian GWAS and population-appropriate average age-specific incidences may be useful for risk-stratified interventions in Korean women. View on Web

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Testing different sources of environmental unpredictability on adolescent functioning: ancestral cue versus statistical learning and the role of temperament

alexandrossfakianakis shared this article with you from Inoreader Testing different sources of environmental unpredictability on adolescent functioning: ancestral cue versus statistical learning and the role of temperament via Journal of Child Psychology and Psychiatry Background The dimensional model of environmental adversity highlighted the effects of an unpredictable environment in promoting risky development. Toward gaining greater specificity in understanding, this multimethod, longitudinal study investigated the role of two sources of environmental unpredictability—ancestral cues versus statistical learning, and their interaction with dove temperament conceptualized within the evolutionary model of temperament, in shaping adolescent functioning. Methods Participants were 192 families with an adolescent (M age = 12.4) followed for two annual waves. We measured unpredictability within the ancestral-cue approach as incidents of disruptive family events, and statistical-learning unpredictability as the random variability in observed moment-to-moment maternal hostility during parent–child interaction. We focused on dove temperament, which characterizes strategies of cautious and inhibited behavior in novel contexts and persistence and intrinsic engagement in benign contexts. Results Findings indicated unique effects of ancestral-cue versus statistical-learning unpredictability—in interaction with dove temperament—in association with adolescent functioning. Ancestral-cue unpredictability interacted with dove temperament in association with vagal stress reactivity, and the interactive effects of statistical-learning unpredictability were only associated with set-shifting. Furthermore, the family instability-x-dove temperament interaction was linked to adolescent adjustment via vagal reactivity. Adolescents with lower dove temperament showed dampened vagal reactivity within the more unpredictable environments, which was in turn associated with a greater decrease in social withdrawal over time. Conclusions The findings highlighted the specificity in different sources of environmental unpredictability in shaping adolescent development. View on Web

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Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning

alexandrossfakianakis shared this article with you from Inoreader Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning via American Journal of Epidemiology - Advance Access Abstract We sought to determine whether machine learning and natural language processing (NLP) applied to electronic medical records could improve performance of automated healthcare claims-based algorithms to identify anaphylaxis events using data on 516 patients with outpatient, emergency department, or inpatient anaphylaxis diagnosis codes during 2015-2019 in two integrated healthcare institutions in the Northwest United States. We used one site's manually reviewed gold standard outcomes data for model development and the other's for external validation based on cross-validated (cv) area under the receiver operating characteristic curve (cv AUC), positive predictive value (PPV), and sensitivity. In the development site 154 (64%) of 239 potential events met adjudication criteria for anaphylaxis compared to 180 (65%) of 277 in the validation site. Logistic regression models using only structured claims data achieved a cv-AUC of 0.58 (95% CI: 0.54, 0. 63). Machine learning improved cv-AUC to 0.62 (0.58, 0.66); incorporating NLP-derived covariates further increased cv AUCs to 0.70 (0.66, 0.75) in development and 0.67 (0.63, 0.71) in external validation data. A classification threshold with cv-PPV of 79% and cv-sensitivity of 66% in development data had cv-PPV of 78% and cv-sensitivity of 56% in external data. Machine learning and NLP-derived data improved identification of validated anaphylaxis events. View on Web

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