哮喘日间症状日记(ADSD)和哮喘夜间症状日记(ANSD)：新患者报告症状监测的测量特性
2021/12/24
摘要
背景：哮喘日间症状日记(ADSD)和哮喘夜间症状日记(ANSD) 的开发是为了满足标准化的患者报告的哮喘症状测量标准的需要而开发的，以评估成人和青少年的治疗试验结果。
目的：确定ADSD/ANSD的评分并评估其测量特性。
方法：患有哮喘的青少年（12-17岁）和成人（18岁以上）完成为期10天的8项ADSD/ANSD电子版草案，以及成人哮喘症状日常量表（AASD）和患者严重程度总体印象量表（PGIS）。使用经典和现代心理测量学方法，初步分析评估ADSD/ANSD条目的可操作性，以提供得分信息。随后的分析评估了ADSD/ANSD评分的信度和效度。
结果：纳入了人口统计学和临床多样性样本(130名青少年；89名成年人)。条目可操作性普遍强劲。然而，评估胸压和粘液/痰的条目显示冗余且表现较差，因此被删除。主成分分析、验证性因素分析和项目反应理论支持项目组合形成6个条目的ADSD/ANSD总分。内部一致性(α=0.94~0.95)和重测信度(组内相关系数=0.86~0.95)较高。ADSD评分与评估哮喘症状频率、困扰和对活动的影响的AASDS条目之间存在很强的相关性(r=0.72~0.80)。在按哮喘严重程度（PGIS）、哮喘控制、吸入器使用、雾化器使用、活动限制和夜间觉醒分类的各组之间，观察到平均ADSD/ANSD得分存在显著差异（p<0.001）。
结论：ADSD/ANSD条目和得分具有很强的信度和效度。在干预性研究中这些措施的实施将能够评估反应性及有意义的患者内在变化。
Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD): Measurement Properties of Novel Patient-Reported Symptom Measures
Adam Gater, Linda Nelsen, Cheryl D Coon, Sonya Eremenco, Sean O'Quinn, Asif H Khan, Laurent Eckert, Hannah Staunton, Nicola Bonner, Rebecca Hall, Jerry A Krishnan, Stuart Stoloff, Michael Schatz, John Haughney, Stephen Joel Coons
Abstract
BACKGROUND：The Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) were developed to meet the need for standardized patient-reported measures of asthma symptoms to assess treatment trial outcomes in adults and adolescents.
OBJECTIVE: To determine scoring and evaluate the measurement properties of the ADSD/ANSD.
METHODS: Adolescents (12-17 years) and adults (18+ years) with asthma completed draft 8-item electronic versions of the ADSD/ANSD for 10 days alongside the Adult Asthma Symptom Daily Scales (AASDS) and a patient global impression of severity (PGIS). Using classical and modern psychometric methods, initial analyses evaluated the performance of ADSD/ANSD items to inform scoring. Subsequent analyses evaluated the reliability and validity of ADSD/ANSD scores.
RESULTS: A demographically and clinically diverse sample (n=130 adolescents; n=89 adults) was recruited. Item performance was generally strong. However, items assessing chest pressure and mucus/phlegm demonstrated redundancy and poorer performance and were removed. Principal components analysis, confirmatory factor analysis, and item response theory supported combining items to form 6-item total ADSD/ANSD scores. Internal consistency (α=0.94-0.95) and test-retest reliability (intraclass correlation coefficient=0.86-0.95) were strong. Strong correlations (r=0.72-0.80) were observed between ADSD scores and AASDS items assessing asthma symptom frequency, bother, and impact on activities. Significant differences (p<0.001) in mean ADSD/ANSD scores were observed between groups categorized by asthma severity (PGIS), asthma control, inhaler use, nebulizer use, activity limitations, and nighttime awakenings.
CONCLUSION:The ADSD/ANSD items and scores demonstrated strong reliability and validity. Implementation of the measures in interventional studies will enable the evaluation of responsiveness and meaningful within-patient change.
背景：哮喘日间症状日记(ADSD)和哮喘夜间症状日记(ANSD) 的开发是为了满足标准化的患者报告的哮喘症状测量标准的需要而开发的，以评估成人和青少年的治疗试验结果。
目的：确定ADSD/ANSD的评分并评估其测量特性。
方法：患有哮喘的青少年（12-17岁）和成人（18岁以上）完成为期10天的8项ADSD/ANSD电子版草案，以及成人哮喘症状日常量表（AASD）和患者严重程度总体印象量表（PGIS）。使用经典和现代心理测量学方法，初步分析评估ADSD/ANSD条目的可操作性，以提供得分信息。随后的分析评估了ADSD/ANSD评分的信度和效度。
结果：纳入了人口统计学和临床多样性样本(130名青少年；89名成年人)。条目可操作性普遍强劲。然而，评估胸压和粘液/痰的条目显示冗余且表现较差，因此被删除。主成分分析、验证性因素分析和项目反应理论支持项目组合形成6个条目的ADSD/ANSD总分。内部一致性(α=0.94~0.95)和重测信度(组内相关系数=0.86~0.95)较高。ADSD评分与评估哮喘症状频率、困扰和对活动的影响的AASDS条目之间存在很强的相关性(r=0.72~0.80)。在按哮喘严重程度（PGIS）、哮喘控制、吸入器使用、雾化器使用、活动限制和夜间觉醒分类的各组之间，观察到平均ADSD/ANSD得分存在显著差异（p<0.001）。
结论：ADSD/ANSD条目和得分具有很强的信度和效度。在干预性研究中这些措施的实施将能够评估反应性及有意义的患者内在变化。
(中日友好医院呼吸与危重症医学科 王静茹 摘译 林江涛 审校)
(J Allergy Clin Immunol Pract. 2021 Dec 8;S2213-2198(21)01362-3. doi: 10.1016/j.jaip.2021.11.026.)
(J Allergy Clin Immunol Pract. 2021 Dec 8;S2213-2198(21)01362-3. doi: 10.1016/j.jaip.2021.11.026.)
Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD): Measurement Properties of Novel Patient-Reported Symptom Measures
Adam Gater, Linda Nelsen, Cheryl D Coon, Sonya Eremenco, Sean O'Quinn, Asif H Khan, Laurent Eckert, Hannah Staunton, Nicola Bonner, Rebecca Hall, Jerry A Krishnan, Stuart Stoloff, Michael Schatz, John Haughney, Stephen Joel Coons
Abstract
BACKGROUND：The Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) were developed to meet the need for standardized patient-reported measures of asthma symptoms to assess treatment trial outcomes in adults and adolescents.
OBJECTIVE: To determine scoring and evaluate the measurement properties of the ADSD/ANSD.
METHODS: Adolescents (12-17 years) and adults (18+ years) with asthma completed draft 8-item electronic versions of the ADSD/ANSD for 10 days alongside the Adult Asthma Symptom Daily Scales (AASDS) and a patient global impression of severity (PGIS). Using classical and modern psychometric methods, initial analyses evaluated the performance of ADSD/ANSD items to inform scoring. Subsequent analyses evaluated the reliability and validity of ADSD/ANSD scores.
RESULTS: A demographically and clinically diverse sample (n=130 adolescents; n=89 adults) was recruited. Item performance was generally strong. However, items assessing chest pressure and mucus/phlegm demonstrated redundancy and poorer performance and were removed. Principal components analysis, confirmatory factor analysis, and item response theory supported combining items to form 6-item total ADSD/ANSD scores. Internal consistency (α=0.94-0.95) and test-retest reliability (intraclass correlation coefficient=0.86-0.95) were strong. Strong correlations (r=0.72-0.80) were observed between ADSD scores and AASDS items assessing asthma symptom frequency, bother, and impact on activities. Significant differences (p<0.001) in mean ADSD/ANSD scores were observed between groups categorized by asthma severity (PGIS), asthma control, inhaler use, nebulizer use, activity limitations, and nighttime awakenings.
CONCLUSION:The ADSD/ANSD items and scores demonstrated strong reliability and validity. Implementation of the measures in interventional studies will enable the evaluation of responsiveness and meaningful within-patient change.
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磁共振成像评估哮喘患者支气管壁厚度
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支气管舒张试验后肺功能改变量可为FEV1≥80%预计值的患者预测哮喘诊断与治疗反应
