支气管扩张后 FEV1/FVC < 0.7 对慢性阻塞性肺疾病诊断和治疗的影响:回归不连续设计

Alexander T Moffett, Scott D Halpern, Gary Eric Weissman
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摘要

背景全球慢性阻塞性肺病倡议(GOLD)指南建议,只有支气管扩张剂后 1 秒用力呼气容积与用力肺活量之比(FEV1/FVC)小于 0.7 的患者才能诊断为慢性阻塞性肺病(COPD)。但这一建议对临床实践的影响尚不清楚。研究问题有记录的支气管扩张剂后 FEV1/FVC < 0.7 对慢性阻塞性肺疾病的诊断和治疗有什么影响?研究设计与方法我们利用全国电子健康记录数据库,识别了 2007 年至 2022 年期间记录有支气管扩张剂后 FEV1/FVC 值的 18 岁及以上患者的临床就诊情况。如果分配了慢性阻塞性肺病的诊断代码,则该就诊与慢性阻塞性肺病诊断相关;如果在 90 天内开具了治疗慢性阻塞性肺病的常用药物处方,则该就诊与慢性阻塞性肺病治疗相关。我们采用回归不连续设计来测量支气管扩张剂后 FEV1/FVC < 0.7 对慢性阻塞性肺病诊断和治疗的影响。结果在 27 817 次临床会诊(涉及 18 991 名患者)中,14 876 人(53.4%)存在支气管扩张剂后 FEV1/FVC <0.7。有记录的支气管扩张剂后 FEV1/FVC < 0.7 对慢性阻塞性肺病的诊断概率影响较小,从略高于 0.7 临界值的 38.0% 到略低于 0.7 临界值的 44.0%,增加了 26.0%(95% 置信区间 [CI] 1.1% 到 10.9%)。是否存在有记录的支气管扩张剂后 FEV1/FVC 对治疗 COPD 的概率没有影响(-2.1%,95% CI -7.2% 至 3.0%)。解释有记录的支气管扩张剂后 FEV1/FVC < 0.7 对临床医生做出与指南一致的慢性阻塞性肺疾病诊断的概率只有很小的影响,对相应的治疗决策没有影响。
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The Effect of a Post-Bronchodilator FEV1/FVC < 0.7 on COPD Diagnosis and Treatment: A Regression Discontinuity Design
Background Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend the diagnosis of chronic obstructive pulmonary disease (COPD) only in patients with a post-bronchodilator forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) less than 0.7. However the impact of this recommendation on clinical practice is unknown. Research Question What is the effect of a documented post-bronchodilator FEV1/FVC < 0.7 on the diagnosis and treatment of COPD? Study Design and Methods We used a national electronic health record database to identify clinical encounters be- tween 2007 to 2022 with patients 18 years of age and older in which a post-bronchodilator FEV1/FVC value was documented. An encounter was associated with a COPD diagnosis if a diagnostic code for COPD was assigned, and was associated with COPD treatment if a prescription for a medication commonly used to treat COPD was filled within 90 days. We used a regression discontinuity design to measure the effect of a post-bronchodilator FEV1/FVC < 0.7 on COPD diagnosis and treatment. Results Among 27 817 clinical encounters, involving 18 991 patients, a post-bronchodilator FEV1/FVC < 0.7 was present in 14 876 (53.4%). The presence of a documented post-bronchodilator FEV1/FVC < 0.7 had a small effect on the probability of a COPD diagnosis, increasing by 26.0% (95% confidence interval [CI] 1.1% to 10.9%) from 38.0% just above the 0.7 cutoff to 44.0% just below this cutoff. The presence of a documented post-bronchodilator FEV1/FVC had no effect on the probability of COPD treatment (−2.1%, 95% CI −7.2% to 3.0%). Interpretation The presence of a documented post-bronchodilator FEV1/FVC < 0.7 has only a small effect on the probability that a clinician will make a guideline-concordant diagnosis of COPD and has no effect on corresponding treatment decisions.
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