Edwards Chelsea L, Kaplan Alan G, Yawn Barbara P, Kocks Janwillem W H, Bulathsinhala Lakmini, Carter Victoria A, Chang Ku-Lang, Fox Chester, Gopalan Gokul, Han MeiLan K, Kruszyk Maja, Le Lievre Chantal E, Mahle Cathy, Make Barry, Pace Wilson D, Price Chris, Shaikh Asif, Skolnik Neil, Price David B
Optimum Patient Care, Cambridge, United Kingdom.
Observational and Pragmatic Research Institute, Singapore.
Chronic Obstr Pulm Dis. 2021 Jan;8(1):135-51. doi: 10.15326/jcopdf.2020.0154.
Chronic obstructive pulmonary disease (COPD) is commonly managed by family physicians, but little is known about specifics of management and how this may be improved. The Advancing the Patient Experience in COPD (APEX COPD) registry will be the first U.S. primary care, health system-based registry following patients diagnosed with COPD longitudinally, using a standardized set of variables to investigate how patients are managed in real life and assess outcomes of various management strategies.
Gaining expert consensus on a standardized list of variables to capture in the APEX COPD registry.
A modified, Delphi process was used to reach consensus on which data to collect in the registry from electronic health records (EHRs), patient-reported information (PRI) and patient-reported outcomes (PRO), and by physicians during subsequent office visits. The Delphi panel comprised 14 primary care and specialty COPD experts from the United States and internationally. The process consisted of 3 iterative rounds. Responses were collected electronically.
Of the initial 195 variables considered, consensus was reached to include up to 115 EHR variables, 34 PRI/PRO variables and 5 office-visit variables in the APEX COPD registry. These should include information on symptom burden, diagnosis, COPD exacerbations, lung function, quality of life, comorbidities, smoking status/history, treatment specifics (including side effects), inhaler management, and patient education/self-management.
COPD experts agreed upon the core variables to collect from EHR data and from patients to populate the APEX COPD registry. Data will eventually be integrated, standardized and stored in the APEX COPD database and used for approved COPD-related research.
慢性阻塞性肺疾病（COPD）通常由家庭医生进行管理，但对于管理细节以及如何改进知之甚少。慢性阻塞性肺疾病患者体验提升（APEX COPD）登记系统将是美国首个基于初级保健、卫生系统的登记系统，对诊断为COPD的患者进行纵向跟踪，使用一组标准化变量来研究患者在现实生活中的管理方式，并评估各种管理策略的效果。
就APEX COPD登记系统中要收集的标准化变量列表达成专家共识。
采用改良的德尔菲法，就登记系统中要从电子健康记录（EHR）、患者报告信息（PRI）和患者报告结局（PRO）以及医生在后续门诊就诊时收集的数据达成共识。德尔菲小组由来自美国和国际的14名初级保健和COPD专科专家组成。该过程包括3轮迭代。通过电子方式收集回复。
在最初考虑的195个变量中，已达成共识，APEX COPD登记系统将纳入多达115个EHR变量、34个PRI/PRO变量和5个门诊就诊变量。这些变量应包括症状负担、诊断、COPD急性加重、肺功能、生活质量、合并症、吸烟状况/病史、治疗细节（包括副作用）、吸入器管理以及患者教育/自我管理等信息。
COPD专家就从EHR数据和患者中收集的核心变量达成一致，以填充APEX COPD登记系统。数据最终将被整合、标准化并存储在APEX COPD数据库中，并用于经批准的与COPD相关的研究。
