372 research outputs found

    International consensus statement on allergy and rhinology: Sinonasal tumors

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    Background: Sinonasal neoplasms, whether benign and malignant, pose a significant challenge to clinicians and represents a model area for multidisciplinary collaboration in order to optimize patient care. The International Consensus Statement on Allergy and Rhinology: Sinonasal Tumors (ICSNT) aims to summarize the best available evidence and presents 48 thematic and histopathology-based topics spanning the field. Methods: In accordance with prior ICAR documents, ICSNT assigned each topic as an Evidence-Based Review with Recommendations, Evidence-Based Review, and Literature Review based on level of evidence. An international group of multidisciplinary author teams were assembled for the topic reviews using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses format, and completed sections underwent a thorough and iterative consensus-building process. The final document underwent rigorous synthesis and review prior to publication. Results: The ICNST document consists of 4 major sections: general principles, benign neoplasms and lesions, malignant neoplasms, and quality of life and surveillance. It covers 48 conceptual and/or histopathology-based topics relevant to sinonasal neoplasms and masses. Topics with a high level of evidence provided specific recommendations, while other areas summarized the current state of evidence. A final section highlights research opportunities and future directions, contributing to advancing knowledge and community intervention. Conclusion: As an embodiment of the multidisciplinary and collaborative model of care in sinonasal neoplasms and masses, ICSNT was designed as a comprehensive, international, and multidisciplinary collaborative endeavor. Its primary objective is to summarize the existing evidence in the field of sinonasal neoplasms and masses. This article is protected by copyright. All rights reserved

    Angststörungen

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    Angststörungen stellen in europäischen Ländern mit einer 1-Jahres-Prävalenz von ca. 14 % die häufigsten psychischen Erkrankungen in der Allgemeinbevölkerung dar (Wittchen et al. 2011). Sie umfassen gemäß der europäischen International Classification of Diseases (ICD-10) die Phobischen Störungen mit der Agoraphobie mit oder ohne Panikstörung, der Sozialen Angststörung und den Spezifischen Phobien sowie die Anderen Angststörungen mit der Panikstörung, der Generalisierten Angststörung und der Diagnose Angst und Depression gemischt. Das vorliegende Kapitel beschäftigt sich mit Besonderheiten und empirischen Befunden zu internet- und mobilbasierten Interventionen (IMIs) bei den genannten Angststörungen

    Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial

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    BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4

    Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial

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    BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4

    Effects of a Mobile-Based Intervention for Parents of Children With Crying, Sleeping, and Feeding Problems: Randomized Controlled Trial

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    Excessive crying, sleeping, and feeding problems in early childhood are major stressors that can result in parents feeling socially isolated and having low self-efficacy. Affected children are a risk group for being maltreated and developing emotional and behavioral problems. Thus, the development of an innovative and interactive psychoeducational app for parents of children with crying, sleeping, and feeding problems may provide low-threshold access to scientifically based information and reduce negative outcomes in parents and children. We aimed to investigate whether following the use of a newly developed psychoeducational app, the parents of children with crying, sleeping, or feeding problems experienced less parenting stress; gained more knowledge about crying, sleeping, and feeding problems; and perceived themselves as more self-effective and as better socially supported and whether their children's symptoms decreased more than those of the parents who did not use the app. Our clinical sample consisted of 136 parents of children (aged 0-24 months) who contacted a cry baby outpatient clinic in Bavaria (Southern Germany) for an initial consultation. Using a randomized controlled design, families were randomly allocated to either an intervention group (IG; 73/136, 53.7%) or a waitlist control group (WCG; 63/136, 46.3%) during the usual waiting time until consultation. The IG was given a psychoeducational app that included evidence-based information via text and videos, a child behavior diary function, a parent chat forum and experience report, tips on relaxation, an emergency plan, and a regional directory of specialized counseling centers. Outcome variables were assessed using validated questionnaires at baseline test and posttest. Both groups were compared at posttest regarding changes in parenting stress (primary outcome) and secondary outcomes, namely knowledge about crying, sleeping, and feeding problems; perceived self-efficacy; perceived social support; and child symptoms. The mean individual study duration was 23.41 (SD 10.42) days. The IG reported significantly lower levels of parenting stress (mean 83.18, SD 19.94) after app use compared with the WCG (mean 87.46, SD 16.67; P=.03; Cohen d=0.23). Furthermore, parents in the IG reported a higher level of knowledge about crying, sleeping, and feeding (mean 62.91, SD 4.30) than those in the WCG (mean 61.15, SD 4.46; P<.001; Cohen d=0.38). No differences at posttest were found between groups in terms of parental efficacy (P=.34; Cohen d=0.05), perceived social support (P=.66; Cohen d=0.04), and child symptoms (P=.35; Cohen d=0.10). This study provides initial evidence of the efficacy of a psychoeducational app for parents with child crying, sleeping, and feeding problems. By reducing parental stress and increasing knowledge of children's symptoms, the app has the potential to serve as an effective secondary preventive measure. Additional large-scale studies are needed to investigate long-term benefits. German Clinical Trials Register DRKS00019001; https://drks.de/search/en/trial/DRKS00019001

    Efficacy and safety of immune checkpoint inhibitor rechallenge in individuals with hepatocellular carcinoma

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    BACKGROUND & AIMS: We investigated the efficacy and safety of immune checkpoint inhibitor (ICI) rechallenge in patients with hepatocellular carcinoma (HCC) who received ICI-based therapies in a previous systemic line. METHODS: In this international, retrospective multicenter study, patients with HCC who received at least two lines of ICI-based therapies (ICI-1, ICI-2) at 14 institutions were eligible. The main outcomes included best overall response and treatment-related adverse events. RESULTS: Of 994 ICI-treated patients screened, a total of 58 patients (male, n = 41; 71%) with a mean age of 65.0±9.0 years were included. Median systemic treatment lines of ICI-1 and ICI-2 were 1 (range, 1-4) and 3 (range, 2-9), respectively. ICI-based therapies used at ICI-1 and ICI-2 included ICI alone (ICI-1, n = 26, 45%; ICI-2, n = 4, 7%), dual ICI regimens (n = 1, 2%; n = 12, 21%), or ICI combined with targeted therapies/anti-VEGF (n = 31, 53%; n = 42, 72%). Most patients discontinued ICI-1 due to progression (n = 52, 90%). Objective response rate was 22% at ICI-1 and 26% at ICI-2. Responses at ICI-2 were also seen in patients who had progressive disease as best overall response at ICI-1 (n = 11/21; 52%). Median time-to-progression at ICI-1 and ICI-2 was 5.4 (95% CI 3.0-7.7) months and 5.2 (95% CI 3.3-7.0) months, respectively. Treatment-related adverse events of grade 3-4 at ICI-1 and ICI-2 were observed in 9 (16%) and 10 (17%) patients, respectively. CONCLUSIONS: ICI rechallenge was safe and resulted in a treatment benefit in a meaningful proportion of patients with HCC. These data provide a rationale for investigating ICI-based regimens in patients who progressed on first-line immunotherapy in prospective trials. IMPACT AND IMPLICATIONS: Therapeutic sequencing after first-line immune checkpoint inhibitor (ICI)-based therapy for advanced hepatocellular carcinoma (HCC) remains a challenge as no available second-line treatment options have been studied in immunotherapy-pretreated patients. Particularly, the role of ICI rechallenge in patients with HCC is unclear, as data from prospective trials are lacking. We investigated the efficacy and safety of ICI-based regimens in patients with HCC pretreated with immunotherapy in a retrospective, international, multicenter study. Our data provide the rationale for prospective trials investigating the role of ICI-based regimens in patients who have progressed on first-line immunotherapy

    Continuous population-level monitoring of SARS-CoV-2 seroprevalence in a large European metropolitan region.

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    Effective public health measures against SARS-CoV-2 require granular knowledge of population-level immune responses. We developed a Tripartite Automated Blood Immunoassay (TRABI) to assess the IgG response against three SARS-CoV-2 proteins. We used TRABI for continuous seromonitoring of hospital patients and blood donors (n = 72'250) in the canton of Zurich from December 2019 to December 2020 (pre-vaccine period). We found that antibodies waned with a half-life of 75 days, whereas the cumulative incidence rose from 2.3% in June 2020 to 12.2% in mid-December 2020. A follow-up health survey indicated that about 10% of patients infected with wildtype SARS-CoV-2 sustained some symptoms at least twelve months post COVID-19. Crucially, we found no evidence of a difference in long-term complications between those whose infection was symptomatic and those with asymptomatic acute infection. The cohort of asymptomatic SARS-CoV-2-infected subjects represents a resource for the study of chronic and possibly unexpected sequelae

    A draft human pangenome reference

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    Here the Human Pangenome Reference Consortium presents a first draft of the human pangenome reference. The pangenome contains 47 phased, diploid assemblies from a cohort of genetically diverse individuals 1. These assemblies cover more than 99% of the expected sequence in each genome and are more than 99% accurate at the structural and base pair levels. Based on alignments of the assemblies, we generate a draft pangenome that captures known variants and haplotypes and reveals new alleles at structurally complex loci. We also add 119 million base pairs of euchromatic polymorphic sequences and 1,115 gene duplications relative to the existing reference GRCh38. Roughly 90 million of the additional base pairs are derived from structural variation. Using our draft pangenome to analyse short-read data reduced small variant discovery errors by 34% and increased the number of structural variants detected per haplotype by 104% compared with GRCh38-based workflows, which enabled the typing of the vast majority of structural variant alleles per sample.</p

    Case report for an internet- and mobile-based intervention for internet use disorder

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    Background and aimsInternet use disorder (IUD), characterized as the inability to control one’s internet use, is associated with reduced quality of life and mental health comorbidities such as depression, substance abuse, or anxiety. Evidence-based treatment options are scarce due to the novelty of the diagnosis. Internet- and mobile-based interventions (IMI) may be an effective means to deliver psychological treatment to individuals with IUD as they address affected individuals in their online setting. This study presents a newly developed IMI for IUD disclosing treatment satisfaction and preliminary effects by exemplifying with a case report.MethodsThe case of a female participant with IUD, characterized by an excessive use of social media, is analyzed. The case report follows the CARE guidelines and presents qualitative and quantitative outcomes regarding potential symptom reduction measured by the Internet Addiction Test (IAT) and Compulsive Internet Use Scale (CIUS), treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ) and feasibility by analyzing participant’s written feedback during treatment.ResultsThe case report shows that internet- and mobile-based interventions may be feasible in supporting an individual in reducing symptoms of IUD as well as depressive symptoms, anxiety and procrastination behavior. Treatment satisfaction was reported as good.Discussion and conclusionsThis case report illustrates that IMIs can have the potential to be an easily accessible and possibly effective treatment option for IUD. Case studies on IMIs may provide insights into important mechanisms for symptom change. Further studies are needed to expand our understanding of this diverse disorder to provide adequate treatment

    International consensus statement on allergy and rhinology: Sinonasal tumors.

    No full text
    BACKGROUND: Sinonasal neoplasms, whether benign and malignant, pose a significant challenge to clinicians and represents a model area for multidisciplinary collaboration in order to optimize patient care. The International Consensus Statement on Allergy and Rhinology: Sinonasal Tumors (ICSNT) aims to summarize the best available evidence and presents 48 thematic and histopathology-based topics spanning the field. METHODS: In accordance with prior ICAR documents, ICSNT assigned each topic as an Evidence-Based Review with Recommendations, Evidence-Based Review, and Literature Review based on level of evidence. An international group of multidisciplinary author teams were assembled for the topic reviews using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses format, and completed sections underwent a thorough and iterative consensus-building process. The final document underwent rigorous synthesis and review prior to publication. RESULTS: The ICNST document consists of 4 major sections: general principles, benign neoplasms and lesions, malignant neoplasms, and quality of life and surveillance. It covers 48 conceptual and/or histopathology-based topics relevant to sinonasal neoplasms and masses. Topics with a high level of evidence provided specific recommendations, while other areas summarized the current state of evidence. A final section highlights research opportunities and future directions, contributing to advancing knowledge and community intervention. CONCLUSION: As an embodiment of the multidisciplinary and collaborative model of care in sinonasal neoplasms and masses, ICSNT was designed as a comprehensive, international, and multidisciplinary collaborative endeavor. Its primary objective is to summarize the existing evidence in the field of sinonasal neoplasms and masses. This article is protected by copyright. All rights reserved
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