ARISE研究中患者的试验行为、基线特征和症状负担。
IF 2.3
Q2 RESPIRATORY SYSTEM
引用次数: 0
摘要
ARISE是一项全球临床试验，旨在提供证据，证明患者报告的结局仪器——生活质量——支气管扩张（QOL-B）[仅限呼吸域（RD）]和患者报告的结局测量信息系统简表v1.0-疲劳7a （PROMIS F SF-7a）在新诊断或复发的禽分枝杆菌复杂肺病（MACLD）患者中的效用。在这里，我们描述了临床试验行为、患者特征和患者报告的基线症状。方法：纳入未对当前MAC感染进行抗生素治疗的新诊断或复发的非腔型MACLD成年患者；在筛查期间收集包括合并症和MACLD病史在内的数据。采用QOL-B、PROMIS F SF-7a和慢性疾病治疗功能评估（FACIT）问卷对症状负担进行评估。结果：来自12个国家的99例患者纳入了ARISE，中位年龄为69.0岁；以白人（80.8%）和女性（77.8%）居多。这是72.7%的患者首次诊断为MACLD。患者经常报告合并呼吸系统疾病：支气管扩张（49.5%）、哮喘（21.2%）和慢性阻塞性肺疾病（16.2%）。基线时，平均（±SD）和中位QOL-B RD评分分别为65.0（±15.3）和66.7；PROMIS F SF-7a t评分分别为53.8（±8.2）和55.1；FACIT-Fatigue评分分别为35.0（±9.6）和37.0。结论：ARISE的患者代表了现实世界的MACLD患者群体。合并慢性呼吸系统疾病在新发或复发的MACLD患者中很常见，当医生开始MACLD治疗时，大量的疾病负担可以通过疲劳和QOL-B域的测量值来证明。临床试验：政府标识符：NCT04677543。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Trial Conduct, Baseline Characteristics, and Symptom Burden of Patients in the ARISE Study.
Introduction: ARISE was a global clinical trial designed to generate evidence demonstrating the utility of the patient-reported outcome instruments Quality of Life-Bronchiectasis (QOL-B) [Respiratory Domain (RD) only] and Patient-Reported Outcomes Measurement Information System Short Form v1.0-Fatigue 7a (PROMIS F SF-7a) in patients with newly diagnosed or recurrent Mycobacterium avium complex lung disease (MACLD). Here, we describe trial conduct, patient characteristics, and patient-reported symptoms at baseline among patients enrolled in ARISE.
Methods: Adult patients with newly diagnosed or recurrent non-cavitary MACLD who had not initiated antibiotic treatment for their current MAC infection were enrolled; data including comorbidities and prior MACLD history were collected during screening. Symptom burden was assessed using QOL-B, PROMIS F SF-7a, and Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires.
Results: Of 99 patients from 12 countries enrolled in ARISE, the median age was 69.0 years; most were white (80.8%) and female (77.8%). This was the first diagnosis of MACLD for 72.7% of patients. Patients frequently reported having a comorbid respiratory disorder: bronchiectasis (49.5%), asthma (21.2%), and chronic obstructive pulmonary disease (16.2%). At baseline, mean (± SD) and median QOL-B RD scores were 65.0 (± 15.3) and 66.7; PROMIS F SF-7a T-scores were 53.8 (± 8.2) and 55.1; and FACIT-Fatigue scores were 35.0 (± 9.6) and 37.0.
Conclusions: Patients in ARISE were representative of a real-world patient population with MACLD. Comorbid chronic respiratory diseases were common in patients with new or recurrent MACLD, and substantial disease burden at the time physicians initiated MACLD treatment was evidenced by impairment across measures of fatigue and QOL-B domains.
Clinicaltrials:
Gov identifier: NCT04677543.
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来源期刊
Pulmonary Therapy
Medicine-Pulmonary and Respiratory Medicine
CiteScore
5.20
自引率
3.30%
发文量
24
审稿时长
6 weeks
期刊介绍：
Aims and Scope
Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques.
Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Pulmonary Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals.
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The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of pulmonary therapies.
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All articles published by Pulmonary Therapy are open access.
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The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research.
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Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €4500/ $5100/ £3650. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis.
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