Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia.
Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia.
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DOI：
10.1038/sj.jp.7210963
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发表时间：
2003-09-01
期刊：
影响因子：
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通讯作者：
Fanaroff, Avroy
中科院分区：
文献类型：
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作者：
Walsh, Michele C;Wilson-Costello, Deanna;Fanaroff, Avroy
目的：支气管肺发育不良（BPD）是许多干预试验的焦点，但仅基于给氧的结局指标可能会受到医生之间不同给氧标准的混淆。因此，我们希望在36周校正年龄的标准化氧饱和度监测来定义BPD，并将此生理定义与标准临床定义的BPD仅基于氧administration.METHODOLOGY：共199个连续极低出生体重儿（VLBW，501至1500克出生体重）进行了前瞻性评估，在36+/-1周校正年龄。接受正压支持或接受>30%辅助供氧的新生儿被指定为BPD结局。那些接受<或=30%氧气的患者在连续观察和氧饱和度监测下，将补充氧气逐步减少2%至室内空气。测试的结果是“无BPD”（饱和度>或=88%，持续60分钟）或“BPD”（饱和度< 88%）。在测试结束时，所有婴儿都恢复到基线氧气水平。安全性（呼吸暂停，心动过缓，增加氧气的使用），评分间的可靠性，重测的可靠性，和有效性的生理定义与临床definitions.Results：共199 VLBW进行了评估，其中45（36%）被诊断为BPD的临床定义的氧气使用在36周的校正年龄。生理定义确定了15名接受氧气治疗的婴儿，他们成功通过了室内空气中的饱和度监测试验。在30例（24%）队列中，生理定义诊断为BPD。所有婴儿都接受了安全研究。该测试是高度可靠的（评分者间的可靠性，Kappa=1.0;重测信度，Kappa=0.83），并与出院回家在氧，住院时间的长度，并在第一年的生命再入院高度相关。结论：生理定义的BPD是安全的，可行的，可靠的，有效的，提高了BPD的诊断精度。这在未来的多中心临床试验中可能是有益的。
OBJECTIVE: Bronchopulmonary dysplasia (BPD) is the focus of many intervention trials, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. Thus, we wished to define BPD by a standardized oxygen saturation monitoring at 36 weeks corrected age, and compare this physiologic definition with the standard clinical definition of BPD based solely on oxygen administration.METHODOLOGY: A total of 199 consecutive very low birthweight infants (VLBW, 501 to 1500 g birthweight) were assessed prospectively at 36+/-1 weeks corrected age. Neonates on positive pressure support or receiving >30% supplemental oxygen were assigned the outcome BPD. Those receiving < or =30% oxygen underwent a stepwise 2% reduction in supplemental oxygen to room air while under continuous observation and oxygen saturation monitoring. Outcomes of the test were "no BPD" (saturations > or =88% for 60 minutes) or "BPD" (saturation < 88%). At the conclusion of the test, all infants were returned to their baseline oxygen. Safety (apnea, bradycardia, increased oxygen use), inter-rater reliability, test-retest reliability, and validity of the physiologic definition vs the clinical definition were assessed.RESULTS: A total of 199 VLBW were assessed, of whom 45 (36%) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age. The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air. The physiologic definition diagnosed BPD in 30 (24%) of the cohort. All infants were safely studied. The test was highly reliable (inter-rater reliability, kappa=1.0; test-retest reliability, kappa=0.83) and highly correlated with discharge home in oxygen, length of hospital stay, and hospital readmissions in the first year of life.CONCLUSIONS: The physiologic definition of BPD is safe, feasible, reliable, and valid and improves the precision of the diagnosis of BPD. This may be of benefit in future multicenter clinical trials.