Bernardo Sousa-Pinto,Aiste Ramanauskaite,Sophia Neisinger,Ellen Witte-Händel,Ana M Gimenez-Arnau,Carole Guillet,Claudio Alberto S Parisi,Constance H Katelaris,Daria Fomina,Désirée Larenas-Linnemann,Elizabeth García,Emek Kocatürk,Frank Siebenhaar,Hermenio Lima,Igor Kaidashev,Iman Nasr,Isabel Ogueta Canales,Ivan Cherrez Ojeda,Jacques Hébert,Jean Bousquet,Jonathan A Bernstein,Jonny Peter,Jorge Sanchez,Jose Ignacio Larco Sousa,Kanokvalai Kulthanan,Karsten Weller,Kiran Godse,Krzysztof Rutkowski,Lasma Lapina,Laurence Bouillet,Leo Lianyi Han,Luis Felipe Ensina,Margarida Gonçalo,Markus Magerl,Martijn van Doorn,Martin Metz,Maryam Khoshkhui,Michihiro Hide,Murat Türk,Nataļja Kurjāne,Niall Conlon,Pascale Salameh,Pavel Kolkhir,Riccardo Asero,Roman Stepanenko,Sabine Altrichter,Sara Gil-Mata,Simon Francis Thomsen,Torsten Zuberbier,Vladyslav Tsaryk,Young-Min Ye,Zenon Brzoza,Zuotao Zhao,Marcus Maurer
BACKGROUNDCRUSE® is an app that allows patients with chronic spontaneous urticaria (CSU) to monitor their daily disease activity through the use of visual analogue scales (VASs). We aimed to determine the concurrent validity, reliability, responsiveness and minimal important difference (MID) of CRUSE® VASs.METHODSWe evaluated the properties of three daily VASs: VAS for how much patients were affected by their CSU ('VAS urticaria'), VAS for the impact of urticaria on work/school productivity ('VAS productivity') and the VAS of EQ-5D. Concurrent validity was assessed by measuring the association between each VAS and the Urticaria Activity Score (UAS). Intra-rater reliability was determined based on the data of users providing multiple daily questionnaires within the same day. Test-retest reliability and responsiveness (ability to change), respectively, were tested in clinically stable and clinically unstable users. MIDs were determined using distribution-based methods.RESULTSWe included 5938 patients (67,380 days). Concurrent validity was high, with VAS urticaria being more strongly associated with the UAS score than the remaining VASs. Intra-rater reliability was also high, with intraclass correlation coefficients (ICC) being above 0.950 for all VASs. Moderate-high test-retest reliability and responsiveness were observed, with reliability ICC being highest for VAS EQ-5D and responsiveness being highest for VAS urticaria. The MID for VAS urticaria was 17 (out of 100) units, compared to 15 units for VAS productivity and 11 units for VAS EQ-5D.CONCLUSIONDaily VASs for CSU available in the CRUSE® app display high concurrent validity and intra-rater reliability and moderate-high test-retest reliability and responsiveness.
背景CRUSE®是一款应用程序,它允许慢性自发性荨麻疹(CSU)患者通过使用视觉模拟量表(VAS)来监测日常疾病活动。我们旨在确定 CRUSE® VASs 的并发有效性、可靠性、响应性和最小重要差异 (MID):我们评估了三种日常 VAS 的特性:患者受 CSU 影响程度的 VAS("荨麻疹 VAS")、荨麻疹对工作/学习效率影响的 VAS("生产力 VAS")以及 EQ-5D 的 VAS。通过测量每种 VAS 与荨麻疹活动评分(UAS)之间的关联性来评估并发有效性。根据用户在同一天内提供多份每日问卷的数据,确定了评分者内部的可靠性。在临床稳定和临床不稳定的用户中分别测试了重测可靠性和响应性(改变能力)。结果我们共纳入了 5938 名患者(67380 天)。并发有效性很高,VAS荨麻疹与 UAS 评分的相关性比其他 VAS 更强。评分者内部的可靠性也很高,所有 VAS 的类内相关系数 (ICC) 均高于 0.950。测试间隔可靠性和响应性均达到中等水平,其中 VAS EQ-5D 的可靠性 ICC 最高,VAS 荨麻疹的响应性最高。结论 CRUSE® 应用程序中的 CSU 日常 VAS 具有较高的并发有效性和评分者内部可靠性,以及中等偏上的测试再测可靠性和响应性。
{"title":"Validity, reliability and responsiveness of digital visual analogue scales for chronic spontaneous urticaria monitoring: A CRUSE® mobile health study.","authors":"Bernardo Sousa-Pinto,Aiste Ramanauskaite,Sophia Neisinger,Ellen Witte-Händel,Ana M Gimenez-Arnau,Carole Guillet,Claudio Alberto S Parisi,Constance H Katelaris,Daria Fomina,Désirée Larenas-Linnemann,Elizabeth García,Emek Kocatürk,Frank Siebenhaar,Hermenio Lima,Igor Kaidashev,Iman Nasr,Isabel Ogueta Canales,Ivan Cherrez Ojeda,Jacques Hébert,Jean Bousquet,Jonathan A Bernstein,Jonny Peter,Jorge Sanchez,Jose Ignacio Larco Sousa,Kanokvalai Kulthanan,Karsten Weller,Kiran Godse,Krzysztof Rutkowski,Lasma Lapina,Laurence Bouillet,Leo Lianyi Han,Luis Felipe Ensina,Margarida Gonçalo,Markus Magerl,Martijn van Doorn,Martin Metz,Maryam Khoshkhui,Michihiro Hide,Murat Türk,Nataļja Kurjāne,Niall Conlon,Pascale Salameh,Pavel Kolkhir,Riccardo Asero,Roman Stepanenko,Sabine Altrichter,Sara Gil-Mata,Simon Francis Thomsen,Torsten Zuberbier,Vladyslav Tsaryk,Young-Min Ye,Zenon Brzoza,Zuotao Zhao,Marcus Maurer","doi":"10.1111/all.16371","DOIUrl":"https://doi.org/10.1111/all.16371","url":null,"abstract":"BACKGROUNDCRUSE® is an app that allows patients with chronic spontaneous urticaria (CSU) to monitor their daily disease activity through the use of visual analogue scales (VASs). We aimed to determine the concurrent validity, reliability, responsiveness and minimal important difference (MID) of CRUSE® VASs.METHODSWe evaluated the properties of three daily VASs: VAS for how much patients were affected by their CSU ('VAS urticaria'), VAS for the impact of urticaria on work/school productivity ('VAS productivity') and the VAS of EQ-5D. Concurrent validity was assessed by measuring the association between each VAS and the Urticaria Activity Score (UAS). Intra-rater reliability was determined based on the data of users providing multiple daily questionnaires within the same day. Test-retest reliability and responsiveness (ability to change), respectively, were tested in clinically stable and clinically unstable users. MIDs were determined using distribution-based methods.RESULTSWe included 5938 patients (67,380 days). Concurrent validity was high, with VAS urticaria being more strongly associated with the UAS score than the remaining VASs. Intra-rater reliability was also high, with intraclass correlation coefficients (ICC) being above 0.950 for all VASs. Moderate-high test-retest reliability and responsiveness were observed, with reliability ICC being highest for VAS EQ-5D and responsiveness being highest for VAS urticaria. The MID for VAS urticaria was 17 (out of 100) units, compared to 15 units for VAS productivity and 11 units for VAS EQ-5D.CONCLUSIONDaily VASs for CSU available in the CRUSE® app display high concurrent validity and intra-rater reliability and moderate-high test-retest reliability and responsiveness.","PeriodicalId":122,"journal":{"name":"Allergy","volume":"14 1","pages":""},"PeriodicalIF":12.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142489797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BACKGROUNDNatural allergen sources contain a variety of allergens, against which allergic subjects have developed individual sensitization profiles. Ideal allergen products for skin prick testing (SPT) and allergen immunotherapy (AIT) should contain the complete set of allergens of the respective allergen sources to cover all sensitization profiles. However, commercially available allergen products were shown to vary regarding their allergen composition.METHODSThe qualitative allergen composition of different SPT and AIT products produced from pollen of grasses, birch, mugwort and from house dust mites was assessed by a consistent high-resolution liquid chromatography-coupled tandem mass spectrometry method (LC-MS/MS).RESULTSAll major, mid-tier and most minor allergens were detected in each of the investigated three batches of SPT and AIT products, demonstrating the completeness of the allergen composition and a high degree of batch-to-batch consistency.CONCLUSIONThis is the first study using a single consistent high-resolution LC-MS/MS method to provide solid data on the qualitative allergen composition of SPT and AIT products manufactured from various common allergen sources. The applied method showed high reliability in qualitative batch-to-batch consistency testing and can be performed fast and with high throughput. High-resolution LC-MS/MS is applicable for process development and quality control to ensure market availability of allergen products corresponding to the composition of the respective natural allergen sources.
背景天然过敏原来源含有多种过敏原,过敏受试者对这些过敏原会产生不同的过敏特征。用于皮肤点刺试验(SPT)和过敏原免疫疗法(AIT)的理想过敏原产品应包含相应过敏原来源的全套过敏原,以涵盖所有过敏特征。方法采用一致的高分辨率液相色谱-耦合串联质谱法(LC-MS/MS)评估了由草、桦树、艾草花粉和屋尘螨生产的不同 SPT 和 AIT 产品的定性过敏原组成。结果在所调查的三个批次的 SPT 和 AIT 产品中,每个批次都检测到了所有主要、中级和大多数次要过敏原,这表明过敏原成分的完整性和批次间的高度一致性。所应用的方法在批次间定性一致性测试中表现出高度可靠性,并且可以快速、高通量地执行。高分辨率 LC-MS/MS 适用于工艺开发和质量控制,以确保市场上的过敏原产品与相应天然过敏原来源的成分一致。
{"title":"Improved quality control of allergen products: Assessing the molecular allergen composition by mass spectrometry.","authors":"Steffen Augustin,Thomas Eichhorn,Martin Wald,Frank Fischer,Marek Jutel,Oliver Pfaar,Christoph Willers","doi":"10.1111/all.16339","DOIUrl":"https://doi.org/10.1111/all.16339","url":null,"abstract":"BACKGROUNDNatural allergen sources contain a variety of allergens, against which allergic subjects have developed individual sensitization profiles. Ideal allergen products for skin prick testing (SPT) and allergen immunotherapy (AIT) should contain the complete set of allergens of the respective allergen sources to cover all sensitization profiles. However, commercially available allergen products were shown to vary regarding their allergen composition.METHODSThe qualitative allergen composition of different SPT and AIT products produced from pollen of grasses, birch, mugwort and from house dust mites was assessed by a consistent high-resolution liquid chromatography-coupled tandem mass spectrometry method (LC-MS/MS).RESULTSAll major, mid-tier and most minor allergens were detected in each of the investigated three batches of SPT and AIT products, demonstrating the completeness of the allergen composition and a high degree of batch-to-batch consistency.CONCLUSIONThis is the first study using a single consistent high-resolution LC-MS/MS method to provide solid data on the qualitative allergen composition of SPT and AIT products manufactured from various common allergen sources. The applied method showed high reliability in qualitative batch-to-batch consistency testing and can be performed fast and with high throughput. High-resolution LC-MS/MS is applicable for process development and quality control to ensure market availability of allergen products corresponding to the composition of the respective natural allergen sources.","PeriodicalId":122,"journal":{"name":"Allergy","volume":"211 1","pages":""},"PeriodicalIF":12.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142489670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katja Biering Leth-Møller,Marianne van Hage,Danijela Apostolovic,Jennifer Astrup Sørensen,Christian Vestergaard,Flemming Madsen,Lene Jung Kjær,Torben Hansen,Anna Jonsson,Simon Francis Thomsen,Allan Linneberg
BACKGROUNDAlpha-gal syndrome is a novel food allergy to the oligosaccharide galactose-α-1,3-galactose (alpha-gal) present in mammalian meat. Tick bites are considered an important route of sensitization to alpha-gal. Data on alpha-gal sensitization in the general population is scant. We utilized a unique data source of repeated population-based health examination studies to assess prevalence, time trends, risk factors, and characteristics of alpha-gal sensitization.METHODSAlpha-gal sensitization was assessed in >11.000 adults from four health examination studies of randomly invited residents in the Copenhagen region conducted in 1990-1991, 2011-2012, 2012-2015, and 2016-2017. Alpha-gal sensitization was defined as serum specific IgE (sIgE) to alpha-gal ≥0.1 kUA/L; ≥0.35 kUA/L; ≥0.7 kUA/L; ≥3.5 kUA/L. The population was characterized according to genetically determined ABO blood group, aeroallergen sensitization, and pets at home.RESULTSThe prevalence of sIgE to alpha-gal ≥0.1 kUA/L was 1.3% in 1990-1991, 3.7% in 2012-2015 and 3.2% in 2016-2017. Of those sensitized to alpha-gal >97% reported to consume red meat at least once a week, even for sIgE to alpha-gal ≥3.5 kUA/L. Male sex, older age, aeroallergen sensitization, cat at home, and blood group A were associated with increased odds of alpha-gal sensitization. The known protective effect of blood group B was confirmed.CONCLUSIONIn this general adult population, the prevalence of alpha-gal sensitization had doubled from 1990-1991 to 2016-2017. This could potentially be due to increased tick exposure and an increased atopic predisposition.
{"title":"Increasing prevalence of galactose-α-1,3-galactose sensitization in the Danish general adult population.","authors":"Katja Biering Leth-Møller,Marianne van Hage,Danijela Apostolovic,Jennifer Astrup Sørensen,Christian Vestergaard,Flemming Madsen,Lene Jung Kjær,Torben Hansen,Anna Jonsson,Simon Francis Thomsen,Allan Linneberg","doi":"10.1111/all.16360","DOIUrl":"https://doi.org/10.1111/all.16360","url":null,"abstract":"BACKGROUNDAlpha-gal syndrome is a novel food allergy to the oligosaccharide galactose-α-1,3-galactose (alpha-gal) present in mammalian meat. Tick bites are considered an important route of sensitization to alpha-gal. Data on alpha-gal sensitization in the general population is scant. We utilized a unique data source of repeated population-based health examination studies to assess prevalence, time trends, risk factors, and characteristics of alpha-gal sensitization.METHODSAlpha-gal sensitization was assessed in >11.000 adults from four health examination studies of randomly invited residents in the Copenhagen region conducted in 1990-1991, 2011-2012, 2012-2015, and 2016-2017. Alpha-gal sensitization was defined as serum specific IgE (sIgE) to alpha-gal ≥0.1 kUA/L; ≥0.35 kUA/L; ≥0.7 kUA/L; ≥3.5 kUA/L. The population was characterized according to genetically determined ABO blood group, aeroallergen sensitization, and pets at home.RESULTSThe prevalence of sIgE to alpha-gal ≥0.1 kUA/L was 1.3% in 1990-1991, 3.7% in 2012-2015 and 3.2% in 2016-2017. Of those sensitized to alpha-gal >97% reported to consume red meat at least once a week, even for sIgE to alpha-gal ≥3.5 kUA/L. Male sex, older age, aeroallergen sensitization, cat at home, and blood group A were associated with increased odds of alpha-gal sensitization. The known protective effect of blood group B was confirmed.CONCLUSIONIn this general adult population, the prevalence of alpha-gal sensitization had doubled from 1990-1991 to 2016-2017. This could potentially be due to increased tick exposure and an increased atopic predisposition.","PeriodicalId":122,"journal":{"name":"Allergy","volume":"194 1","pages":""},"PeriodicalIF":12.4,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zeynep Ece Kuloğlu, Şiran Keske, Mert Ahmet Kuşkucu, Füsun Can, Önder Ergönül
{"title":"Effectiveness of CoronaVac versus BNT162b2 based on neutralizing antibody response: A systematic review.","authors":"Zeynep Ece Kuloğlu, Şiran Keske, Mert Ahmet Kuşkucu, Füsun Can, Önder Ergönül","doi":"10.1111/all.16364","DOIUrl":"https://doi.org/10.1111/all.16364","url":null,"abstract":"","PeriodicalId":122,"journal":{"name":"Allergy","volume":" ","pages":""},"PeriodicalIF":12.6,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142453927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}