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扩展临床试验数据收集:扩展索尔福德肺部研究队列。

Extending the data collection from a clinical trial: The Extended Salford Lung Study research cohort.

机构信息

GSK, Brentford, United Kingdom.

GSK, Collegeville, PA, USA.

出版信息

NPJ Prim Care Respir Med. 2023 Jan 18;33(1):4. doi: 10.1038/s41533-022-00322-7.

DOI:10.1038/s41533-022-00322-7
PMID:36650154
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9845305/
Abstract

The Extended Salford Lung Study (Ext-SLS) is an extension of the Salford Lung Studies (SLS) in asthma and chronic obstructive pulmonary disease (COPD) through retrospective and prospective collection of patient-level electronic health record (EHR) data. We compared the Ext-SLS cohort with the SLS intention-to-treat populations using descriptive analyses to determine if the strengths (e.g. randomization) of the clinical trial were maintained in the new cohort. Historical and patient-reported outcome data were captured from asthma-/COPD-specific questionnaires (e.g., Asthma Control Test [ACT]/COPD Assessment Test [CAT]). The Ext-SLS included 1147 participants (n = 798, SLS asthma; n = 349, SLS COPD). Of participants answering the ACT, 39% scored <20, suggesting poorly controlled asthma. For COPD, 61% of participants answering the CAT scored ≥21, demonstrating a high disease burden. Demographic/clinical characteristics of the cohorts were similar at SLS baseline. EHR data provided a long-term view of participants' disease, and questionnaires provided information not typically captured. The Ext-SLS cohort is a valuable resource for respiratory research, and ongoing prospective data collection will add further value and ensure the Ext-SLS is an important source of patient-level information on obstructive airways disease.

摘要

扩展索尔福德肺部研究(Ext-SLS)是索尔福德肺部研究(SLS)在哮喘和慢性阻塞性肺疾病(COPD)方面的扩展,通过回顾性和前瞻性收集患者级别的电子健康记录(EHR)数据。我们使用描述性分析将 Ext-SLS 队列与 SLS 意向治疗人群进行了比较,以确定新队列中是否保持了临床试验的优势(例如随机化)。历史和患者报告的结果数据是从哮喘/COPD 特定问卷中捕获的(例如,哮喘控制测试[ACT]/COPD 评估测试[CAT])。Ext-SLS 包括 1147 名参与者(n=798,SLS 哮喘;n=349,SLS COPD)。在回答 ACT 的参与者中,39%的人得分<20,表明哮喘控制不佳。对于 COPD,回答 CAT 的 61%的参与者得分≥21,表明疾病负担很高。两个队列在 SLS 基线时的人口统计学/临床特征相似。EHR 数据提供了参与者疾病的长期视图,而问卷提供了通常无法捕获的信息。Ext-SLS 队列是呼吸研究的宝贵资源,正在进行的前瞻性数据收集将增加更多价值,并确保 Ext-SLS 成为阻塞性气道疾病患者级信息的重要来源。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/546f/9845305/16cb19a4f54a/41533_2022_322_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/546f/9845305/2bf9fbd05413/41533_2022_322_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/546f/9845305/ba7c1c975e8d/41533_2022_322_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/546f/9845305/16cb19a4f54a/41533_2022_322_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/546f/9845305/2bf9fbd05413/41533_2022_322_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/546f/9845305/ba7c1c975e8d/41533_2022_322_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/546f/9845305/16cb19a4f54a/41533_2022_322_Fig3_HTML.jpg

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