美国队列研究：961 例慢性丙型肝炎患者直接作用抗病毒治疗药物的 PROMIS 短表的心理计量学特性。
Psychometric properties of the PROMIS short form measures in a U.S. cohort of 961 patients with chronic hepatitis C prescribed direct acting antiviral therapy.
机构信息
Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, USA.
Department of Biostatistics, University of North Carolina, Chapel Hill, USA.
出版信息
Aliment Pharmacol Ther. 2018 Apr;47(7):1001-1011. doi: 10.1111/apt.14531. Epub 2018 Jan 29.
BACKGROUND
To better understand symptoms experienced by patients infected with chronic hepatitis C virus (HCV), valid and reliable patient-reported outcome (PRO) measures are needed.
AIM
To assess the reliability and validity of 10 patient-reported outcomes measurement information system (PROMIS) measures and the Headache Impact Test-6 (HIT-6) in a large national sample of patients with HCV.
METHODS
Pre-treatment data from 961 patients with HCV starting direct acting antiviral therapy at 11 U.S. liver centers were analyzed. Internal reliability was evaluated using Cronbach's alpha coefficient; frequency distributions were examined for floor and ceiling effects; structural validity was investigated via item-response-theory models; convergent validity was evaluated using correlations with theoretically-similar items from the HCV-PRO and memorial symptom assessment scale (MSAS); and known-groups validity was investigated by observing PRO differences by liver disease status and number of comorbidities.
RESULTS
The HIT-6 and the majority of the PROMIS measures yielded excellent reliability (alphas ≥ 0.87). Ceiling effects were infrequent ( < 4%), while 30%-59% of patients reported no symptoms (floor effects). The data supported structural validity of the HIT-6 and most PROMIS measures. The PROMIS measures showed moderate to strong correlations with theoretically-similar items from the HCV-PRO and MSAS (0.39-0.77). Trends were observed between worse PRO scores and advanced cirrhosis and greater number of comorbidities, lending support for known-groups validity.
CONCLUSIONS
The psychometric properties of the HIT-6 and PROMIS measures performed satisfactorily in this large cohort of patients with HCV starting direct acting antiviral therapy. Opportunities exist for further refinement of these PROs. Evaluation of performance over time and in under-represented subgroups is needed.
背景
为了更好地了解慢性丙型肝炎病毒（HCV）感染患者的症状，需要有效的和可靠的患者报告结局（PRO）测量工具。
目的
在一个大型的美国 HCV 患者样本中，评估 10 个患者报告结局测量信息系统（PROMIS）测量工具和头痛影响测试-6（HIT-6）的可靠性和有效性。
方法
分析了 11 个美国肝脏中心的 961 名开始直接作用抗病毒治疗的 HCV 患者的治疗前数据。使用 Cronbach's alpha 系数评估内部可靠性；通过频率分布检查地板和天花板效应；通过项目反应理论模型研究结构有效性；通过与 HCV-PRO 和记忆症状评估量表（MSAS）中理论上相似的项目的相关性评估收敛有效性；通过观察肝病状况和合并症数量的 PRO 差异来研究已知组有效性。
结果
HIT-6 和大多数 PROMIS 测量工具的可靠性都很高（alpha 值≥0.87）。天花板效应很少见（<4%），而 30%-59%的患者报告没有症状（地板效应）。数据支持 HIT-6 和大多数 PROMIS 测量工具的结构有效性。PROMIS 测量工具与 HCV-PRO 和 MSAS 中理论上相似的项目之间存在中度至高度相关性（0.39-0.77）。在更严重的 PRO 评分和晚期肝硬化以及更多的合并症之间观察到趋势，这支持了已知组的有效性。
结论
在开始直接作用抗病毒治疗的大型 HCV 患者队列中，HIT-6 和 PROMIS 测量工具的心理测量学特性表现令人满意。这些 PRO 有进一步完善的空间。需要评估随着时间的推移和代表性不足的亚组中的表现。
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