Abstract：
OBJECTIVE: In a clinical phenotype-based management strategy for COPD, it would be preferable to at least assign all patients to a phenotype, but to a single phenotype only. The aim of this study was to evaluate whether all patients are assigned to one and only one phenotype using the Spanish COPD guidelines (GesEPOC) 2017 and to evaluate the criteria that define these categories.
METHODS: The Time-based Register and Analysis of COPD Endpoints study (TRACE; clinicaltrials.gov NCT03485690) is a prospective cohort of COPD patients attending annual visits since 2012, which collects GesEPOC phenotypes. Although the GesEPOC recommends that patients considered to be at low risk are not phenotyped, an analysis of the criteria for identifying high- and low-risk phenotypes was performed, comparing the distribution of phenotypes and the criteria applied between these 2 groups.
RESULTS: The cohort included 970 patients with a confirmed diagnosis of COPD, divided into 427 (44.02%) low-risk and 543 (55.9%) high-risk patients. The most frequent phenotype was the non-exacerbator (44.9% of high-risk patients). Overall, 20.6% of low-risk patients met criteria for asthma-COPD overlap syndrome, while 9.2% of the cohort did not meet the diagnostic criteria for any phenotype, and 19.1% met the criteria for 2 phenotypes, with no differences between risk groups.
CONCLUSIONS: Our data highlight some of the weaknesses of the current clinical phenotype strategy, revealing overlapping categories in some cases, and patients to whom no phenotype was assigned.
METHODS: The Time-based Register and Analysis of COPD Endpoints study (TRACE; clinicaltrials.gov NCT03485690) is a prospective cohort of COPD patients attending annual visits since 2012, which collects GesEPOC phenotypes. Although the GesEPOC recommends that patients considered to be at low risk are not phenotyped, an analysis of the criteria for identifying high- and low-risk phenotypes was performed, comparing the distribution of phenotypes and the criteria applied between these 2 groups.
RESULTS: The cohort included 970 patients with a confirmed diagnosis of COPD, divided into 427 (44.02%) low-risk and 543 (55.9%) high-risk patients. The most frequent phenotype was the non-exacerbator (44.9% of high-risk patients). Overall, 20.6% of low-risk patients met criteria for asthma-COPD overlap syndrome, while 9.2% of the cohort did not meet the diagnostic criteria for any phenotype, and 19.1% met the criteria for 2 phenotypes, with no differences between risk groups.
CONCLUSIONS: Our data highlight some of the weaknesses of the current clinical phenotype strategy, revealing overlapping categories in some cases, and patients to whom no phenotype was assigned.
摘要：
目的：在基于临床表型的COPD管理策略中，最好至少将所有患者分配给一种表型，但只有一个表型。这项研究的目的是使用西班牙COPD指南（GesEPOC）2017评估所有患者是否被分配到一种且仅一种表型，并评估定义这些类别的标准。
方法：基于时间的COPD终点注册和分析研究（TRACE;clinicaltrials.govNCT03485690）是自2012年以来每年就诊的COPD患者的前瞻性队列，该队列收集了GesEPOC表型。虽然GesEPOC建议被认为是低风险的患者不进行表型分析，对确定高风险和低风险表型的标准进行了分析，比较这两组之间的表型分布和应用标准。
结果：该队列包括970名确诊为COPD的患者，分为427例(44.02%)低危患者和543例(55.9%)高危患者。最常见的表型是非加重患者（高危患者占44.9%）。总的来说,20.6%的低危患者符合哮喘-COPD重叠综合征标准,虽然9.2%的队列不符合任何表型的诊断标准，19.1%符合2种表型的标准，风险组之间没有差异。
结论：我们的数据突出了当前临床表型策略的一些弱点，在某些情况下揭示重叠的类别，和未分配表型的患者。
方法：基于时间的COPD终点注册和分析研究（TRACE;clinicaltrials.govNCT03485690）是自2012年以来每年就诊的COPD患者的前瞻性队列，该队列收集了GesEPOC表型。虽然GesEPOC建议被认为是低风险的患者不进行表型分析，对确定高风险和低风险表型的标准进行了分析，比较这两组之间的表型分布和应用标准。
结果：该队列包括970名确诊为COPD的患者，分为427例(44.02%)低危患者和543例(55.9%)高危患者。最常见的表型是非加重患者（高危患者占44.9%）。总的来说,20.6%的低危患者符合哮喘-COPD重叠综合征标准,虽然9.2%的队列不符合任何表型的诊断标准，19.1%符合2种表型的标准，风险组之间没有差异。
结论：我们的数据突出了当前临床表型策略的一些弱点，在某些情况下揭示重叠的类别，和未分配表型的患者。
