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
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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。
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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.

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来源期刊
Pragmatic and Observational Research
Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-
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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.
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