美国成人亚临床重症哮喘 CHRONICLE 研究:目标、设计和初步结果。

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL Pragmatic and Observational Research Pub Date : 2020-07-16 eCollection Date: 2020-01-01 DOI:10.2147/POR.S251120
Christopher S Ambrose, Bradley E Chipps, Wendy C Moore, Weily Soong, Jennifer Trevor, Dennis K Ledford, Warner W Carr, Njira Lugogo, Frank Trudo, Trung N Tran, Reynold A Panettieri
{"title":"美国成人亚临床重症哮喘 CHRONICLE 研究:目标、设计和初步结果。","authors":"Christopher S Ambrose, Bradley E Chipps, Wendy C Moore, Weily Soong, Jennifer Trevor, Dennis K Ledford, Warner W Carr, Njira Lugogo, Frank Trudo, Trung N Tran, Reynold A Panettieri","doi":"10.2147/POR.S251120","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Approximately 5-10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.</p><p><strong>Objective: </strong>Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.</p><p><strong>Study design: </strong>Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1-6 months.</p><p><strong>Initial results: </strong>From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18-89) and 26 (0-80) years, respectively. Median body mass index was 31 kg/m<sup>2</sup>; 3% and 29% were current or former smokers, respectively, and >60% reported ≥1 exacerbation in the prior year and suboptimal symptom control.</p><p><strong>Conclusion: </strong>CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":null,"pages":null},"PeriodicalIF":2.3000,"publicationDate":"2020-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b2/64/por-11-77.PMC7371434.pdf","citationCount":"0","resultStr":"{\"title\":\"The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results.\",\"authors\":\"Christopher S Ambrose, Bradley E Chipps, Wendy C Moore, Weily Soong, Jennifer Trevor, Dennis K Ledford, Warner W Carr, Njira Lugogo, Frank Trudo, Trung N Tran, Reynold A Panettieri\",\"doi\":\"10.2147/POR.S251120\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Approximately 5-10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.</p><p><strong>Objective: </strong>Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.</p><p><strong>Study design: </strong>Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1-6 months.</p><p><strong>Initial results: </strong>From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18-89) and 26 (0-80) years, respectively. Median body mass index was 31 kg/m<sup>2</sup>; 3% and 29% were current or former smokers, respectively, and >60% reported ≥1 exacerbation in the prior year and suboptimal symptom control.</p><p><strong>Conclusion: </strong>CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.</p>\",\"PeriodicalId\":20399,\"journal\":{\"name\":\"Pragmatic and Observational Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2020-07-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b2/64/por-11-77.PMC7371434.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pragmatic and Observational Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/POR.S251120\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2020/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pragmatic and Observational Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/POR.S251120","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

摘要

背景:约有 5-10% 的哮喘患者病情严重。需要进行高质量的真实世界研究,以确定需要改进管理的领域:与国际严重哮喘登记处保持一致,CHRONICLE 研究(ClinicalTrials.gov: NCT03373045)旨在满足美国的这一需求:研究设计:从之前的研究中汲取经验,针对美国确诊重症哮喘患者开展一项真实世界、前瞻性、非介入性研究,这些患者接受亚专科医生治疗,需要生物制剂或维持性全身免疫抑制剂治疗,或使用大剂量吸入皮质类固醇和其他控制剂仍无法控制病情。目标是招募 4000 名患者,观察期≥3 年。过敏症/免疫科医生和肺科医生会在不同的地理位置抽取样本,与他们护理的所有符合条件的患者接触,每 6 个月报告一次患者特征、治疗情况和健康结果。患者每 1-6 个月完成一次在线调查:从 2018 年 2 月到 2019 年 2 月,102 个研究点筛选了 1428 名符合条件的患者;936 名患者注册。研究地点(40% 为过敏/免疫科医生,42% 为肺科医生,18% 两者皆有)与美国其他哮喘亚专科样本相似。入组患者中 67% 为女性,入组和确诊时的中位年龄分别为 55 岁(18-89 岁)和 26 岁(0-80 岁)。体重指数中位数为 31 kg/m2;目前或曾经吸烟的患者分别占 3% 和 29%,超过 60% 的患者在过去一年中病情恶化≥1 次,症状控制不理想:CHRONICLE将提供由医疗服务提供者和患者报告的高质量数据,这些数据来自于一个大型的、真实世界的美国成年重症哮喘患者队列。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results.

Background: Approximately 5-10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.

Objective: Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.

Study design: Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1-6 months.

Initial results: From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18-89) and 26 (0-80) years, respectively. Median body mass index was 31 kg/m2; 3% and 29% were current or former smokers, respectively, and >60% reported ≥1 exacerbation in the prior year and suboptimal symptom control.

Conclusion: CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
自引率
0.00%
发文量
11
期刊介绍: Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
期刊最新文献
Improving the Transparency and Replicability of Consensus Methods: Respiratory Medicine as a Case Example. Non-Alcoholic Steatohepatitis Patient Characterization and Real-World Management Approaches in Italy. Comparing Machine Learning and Advanced Methods with Traditional Methods to Generate Weights in Inverse Probability of Treatment Weighting: The INFORM Study. Involvement of Root Canal Treatment in Pro-Inflammatory Processes - A Real-World Study. UK Electronic Healthcare Records for Research: A Scientometric Analysis of Respiratory, Cardiovascular, and COVID-19 Publications.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1