Santanello Nancy C, Norquist Josephine M, Nelsen Linda M, Williams Valerie S L, Hill Cheryl D, Bisgaard Hans
Merck Research Laboratories, West Point, Pennsylvania 19486, USA.
Pediatr Pulmonol. 2005 Jul;40(1):31-8. doi: 10.1002/ppul.20232.
Acute respiratory syncytial virus (RSV)-induced bronchiolitis is often associated with continuing respiratory symptoms following hospitalization. To date, there is no validated objective measure to evaluate symptoms of RSV-induced bronchiolitis. We report on the reliability, validity, and responsiveness of the bronchiolitis caregiver diary (BCD) of symptoms and healthcare utilization associated with postacute RSV. The BCD measures four symptoms (daytime cough, wheeze, trouble breathing, and nighttime cough), healthcare utilization, and rescue medication for worsening of lung symptoms. Data from the 4-week treatment period of the reported prospective, placebo-controlled trial of montelukast for treatment of postacute RSV were used to assess reliability (internal consistency and test-retest), construct validity (cross-sectional and longitudinal correlations), discriminant validity (known-groups analyses), and responsiveness. The primary outcome of this study was the percentage of symptom-free days (SFD). The secondary outcome was a composite symptom score (CSS; average of daytime cough, wheezing, and trouble breathing). Cronbach's alpha of 0.85 indicated that the four symptoms were internally consistent, supporting a unidimensional scale structure. Test-retest reliabilities for the percentage of SFD and CSS were above the recommended cut point of 0.70. Cross-sectional and longitudinal correlations were sizeable and statistically significant, demonstrating construct validity. Hypothesized known-group differences were statistically significant in the appropriate direction. Responsiveness analyses indicated moderate effect sizes for percentage of SFD. In conclusion, the BCD provides a valid, reliable, and responsive tool for the assessment of symptoms of postacute RSV-induced bronchiolitis, capable of measuring moderate effect sizes, and demonstrating responsiveness to therapy.
急性呼吸道合胞病毒（RSV）引起的细支气管炎常与住院后持续的呼吸道症状相关。迄今为止，尚无经过验证的客观指标来评估RSV引起的细支气管炎症状。我们报告了细支气管炎护理者日记（BCD）在评估急性RSV后相关症状及医疗资源利用方面的可靠性、有效性和反应性。BCD测量四种症状（日间咳嗽、喘息、呼吸困难和夜间咳嗽）、医疗资源利用情况以及用于缓解肺部症状恶化的急救药物。已发表的关于孟鲁司特治疗急性RSV后症状的前瞻性、安慰剂对照试验中4周治疗期的数据，用于评估可靠性（内部一致性和重测信度）、结构效度（横断面和纵向相关性）、区分效度（已知组分析）和反应性。本研究的主要结局是无症状天数（SFD）的百分比。次要结局是综合症状评分（CSS；日间咳嗽、喘息和呼吸困难的平均值）。Cronbach's α系数为0.85，表明这四种症状具有内部一致性，支持单维量表结构。SFD百分比和CSS的重测信度高于推荐的0.70切点。横断面和纵向相关性显著且具有统计学意义，证明了结构效度。假设的已知组差异在适当方向上具有统计学意义。反应性分析表明SFD百分比的效应大小适中。总之，BCD为评估急性RSV后细支气管炎症状提供了一个有效、可靠且具有反应性的工具，能够测量适中的效应大小，并显示出对治疗的反应性。
