Quint Jennifer K, O'Leary Caroline, Venerus Alessandra, Holmgren Ulf, Varghese Precil, Cabrera Claudia
Imperial College London, London, UK.
IQVIA, London, UK.
Pulm Ther. 2021 Jun;7(1):119-132. doi: 10.1007/s41030-020-00139-0. Epub 2020 Dec 7.
Outcomes in chronic obstructive pulmonary disease (COPD) such as symptoms, hospitalisations and mortality rise with increasing disease severity. However, the heterogeneity of electronic medical records presents a significant challenge in measuring severity across geographies. We aimed to develop and validate a method to approximate COPD severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 classification scheme, which categorises patients based on forced expiratory volume in 1 s, hospitalisations and the modified Medical Research Council dyspnoea scale or COPD Assessment Test.
This analysis was part of a comprehensive retrospective study, including patients sourced from the IQVIA Medical Research Data [IMRD; incorporating data from The Health Improvement Network (THIN), a Cegedim database] and the Clinical Practice Research Datalink (CPRD) in the UK, the Disease Analyzer in Germany and the Longitudinal Patient Data in Italy, France and Australia. Patients in the CPRD with the complete set of information required to calculate GOLD 2011 groups were used to develop the method. Ordinal logistic models at COPD diagnosis and at index (first episode of triple therapy) were then used to validate the method to estimate COPD severity, and this was applied to the full study population to estimate GOLD 2011 categories.
Overall, 4579 and 12,539 patients were included in the model at COPD diagnosis and at index, respectively. Models correctly classified 74.4% and 75.9% of patients into severe and non-severe categories at COPD diagnosis and at index, respectively. Age, gender, time between diagnosis and start of triple therapy, healthcare resource use, comorbid conditions and prescriptions were included as covariates.
This study developed and validated a method to approximate disease severity based on GOLD 2011 categories that can potentially be used in patients without all the key parameters needed for this calculation.
慢性阻塞性肺疾病(COPD)的症状、住院率和死亡率等结局会随着疾病严重程度的增加而上升。然而,电子病历的异质性给跨地区测量疾病严重程度带来了重大挑战。我们旨在开发并验证一种使用慢性阻塞性肺疾病全球倡议组织(GOLD)2011分类方案来估算COPD严重程度的方法,该方案根据1秒用力呼气量、住院情况以及改良的医学研究委员会呼吸困难量表或COPD评估测试对患者进行分类。
该分析是一项全面回顾性研究的一部分,纳入了来自IQVIA医学研究数据[IMRD;整合了Cegedim数据库中健康改善网络(THIN)的数据]以及英国临床实践研究数据链(CPRD)、德国疾病分析器和意大利、法国及澳大利亚纵向患者数据的患者。使用CPRD中具备计算GOLD 2011分组所需全套信息的患者来开发该方法。然后,在COPD诊断时和索引时(三联疗法的首次发作)使用有序逻辑模型来验证估算COPD严重程度的方法,并将其应用于整个研究人群以估算GOLD 2011类别。
总体而言,分别有4579名和12539名患者在COPD诊断时和索引时被纳入模型。模型在COPD诊断时和索引时分别将74.4%和75.9%的患者正确分类为重度和非重度类别。年龄、性别、诊断与开始三联疗法之间的时间、医疗资源使用情况、合并症和处方被纳入协变量。
本研究开发并验证了一种基于GOLD 2011类别估算疾病严重程度的方法,该方法可能适用于没有进行此计算所需所有关键参数的患者。