University of Washington School of Medicine, 1920 Terry Ave, Suite 400, Seattle, WA 98101, United States; CFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States.
CFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States.
J Cyst Fibros. 2023 Sep;22(5):864-867. doi: 10.1016/j.jcf.2023.02.006. Epub 2023 Feb 16.
CF registry pulmonary exacerbation (PEx) analyses have employed "before and after" spirometry recovery, where the best percent predicted forced expiratory volume in 1 s (ppFEV) prior to PEx ("baseline") is compared to the best ppFEV <3 months post-PEx. This methodology lacks comparators and ascribes recovery failure to PEx. Herein, we describe 2014 CF Foundation Patient Registry PEx analyses including a comparator: recovery around nonPEx events, birthdays. 49.6% of 7357 individuals with PEx achieved baseline ppFEV recovery while 36.6% of 14,141 achieved baseline recovery after birthdays; individuals with both PEx and birthdays were more likely to recover baseline after PEx than after birthdays (47% versus 34%); mean ppFEV declines were 0.3 (SD=9.3) and 3.1 (9.3), respectively. Post-event measure number had more effect on baseline recovery than did real ppFEV loss in simulations, suggesting that PEx recovery analyses lacking comparators are prone to artifact and poorly describe PEx contributions to disease progression.
CF 登记处的肺恶化(PEx)分析采用了“前后”肺活量恢复,其中将 PEx 前(“基线”)最佳预测百分比用力呼气量(ppFEV)与 PEx 后<3 个月的最佳 ppFEV 进行比较。这种方法缺乏对照,并将恢复失败归咎于 PEx。在此,我们描述了包括对照在内的 2014 年 CF 基金会患者登记处 PEx 分析:非 PEx 事件、生日的恢复。在 7357 名患有 PEx 的个体中,有 49.6%达到了基线 ppFEV 恢复,而在 14141 名个体中,有 36.6%在生日后达到了基线恢复;同时患有 PEx 和生日的个体在 PEx 后比生日后更有可能恢复基线(47%比 34%);平均 ppFEV 下降分别为 0.3(SD=9.3)和 3.1(9.3)。在模拟中,事件后测量次数对基线恢复的影响大于实际 ppFEV 损失,这表明缺乏对照的 PEx 恢复分析容易产生假象,并且无法很好地描述 PEx 对疾病进展的影响。