Application of multiple event analysis as an alternative approach to studying pulmonary exacerbations as an outcome measure.

Application of multiple event analysis as an alternative approach to studying pulmonary exacerbations as an outcome measure.
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将多个事件分析作为研究肺部加剧作为结果度量的替代方法。

DOI:
10.1016/j.jcf.2018.12.005
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发表时间:
2020-01
期刊:
Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society
影响因子:
--
通讯作者:
Wagner B
Wagner B
中科院分区:
其他
文献类型:
--
作者:
Juarez-Colunga E;Rosenfeld M;Zemanick ET;Wagner B

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肺恶化(PEx)是囊性纤维化(CF)发病率和死亡率的重要因素。了解PEx的风险因素对于改善治疗至关重要;肺部急性加重也是CF临床试验的重要结局。目前的风险估计通常仅评估至首次PEx的时间。在观察期内解释多次急性加重的方法可以提供更大的力量来检测重要的风险因素。早期假单胞菌感染控制(EPIC)观察性研究招募了2004年至2006年间年龄≤ 12岁且铜绿假单胞菌阴性的参与者。首次和多事件分析用于研究肺部急性加重的风险因素。我们在EPIC研究中评价了来自1,734名CF患者的总计5,129例PEX。与首起事件分析相比,多起事件分析确定了2个与PEx发生相关的因素。调整多个因素后,以下因素与PEX发生率较高相关:女性、入组时年龄较大、家庭吸烟暴露、最近一次就诊时咳嗽增加、自上次就诊以来使用抗生素、最近一次就诊时任何CF微生物培养阳性以及过去30天内发生PEX。多事件分析使用所有PEx事件,与至首次PEx的时间分析相比,可能识别出更多的PEx风险因素。我们已经提供了一个例子,说明如何应用这种类型的分析,以及如何在EPIC研究的背景下解释估计。
Pulmonary exacerbations (PEx) are important contributors to morbidity and mortality in cystic fibrosis (CF). Understanding risk factors for PEx is critical to improve treatment; pulmonary exacerbations also serve as an important outcome in CF clinical trials. Current risk estimates generally only evaluate time to the first PEx. Methods accounting for multiple exacerbations during the observation period could provide more power to detect significant risk factors. The Early Pseudomonas Infection Control (EPIC) Observational Study enrolled participants between 2004 and 2006 who were ≤ 12 years of age and negative for Pseudomonas aeruginosa. First and multiple event analyses were used to investigate risk factors for pulmonary exacerbations. We evaluated a total of 5,129 PEx from 1,734 CF patients in the EPIC study. Multiple event analysis identified 2 more factors associated with occurrence of PEx compared to first event analysis. After adjusting for multiple factors, the following were associated with higher occurrence of PExs: female gender, older age at enrollment, household cigarette smoke exposure, increased cough at the most recent encounter, having used antibiotics since the previous encounter, a positive culture for any CF organism at the most recent encounter, and having had a PEx in the last 30 days. Multiple event analyses use all PEx events and may identify more risk factors for PEx than analysis of time to first PEx. We have provided an example of how to apply this type of analysis and how to interpret estimates in the context of the EPIC study.
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