UNASSIGNED: This multisite, cross-sectional, observational study of individuals with FCS was conducted in the United States and Canada. Participants completed a survey composed of 7 PRO measures, including the FCS-SIS, and questions about clinical characteristics and demographics. The structure of the FCS-SIS was evaluated using inter-item and item-scale correlations and internal consistency reliability. Construct, known-groups, and criterion validity were evaluated by examining associations between FCS-SIS item and composite scores and other measures included within the survey.
UNASSIGNED: Most of the 33 participants were female (63.6%) and White (78.1%). On average, participants reported first noticing FCS symptoms at ~16 years, with abdominal pain the most frequently reported initial symptom (n=20). Participants reported 2.5 acute pancreatitis attacks on average over the past year. Average FCS-SIS symptom item scores ranged from 1.8 to 3.9 (on a 0-to-10 scale [none-to-worst-possible]) within the 24-hour recall period, with an average Symptom composite score of 2.7. The average impact item scores on the FCS-SIS ranged from 1.6 to 3.0 (on a 0-to-4 scale), with an average Impact composite score of 2.1. Inter-item correlations between the FCS-SIS Symptom items ranged from 0.32 to 0.78. Corrected item-total correlations were highly satisfactory for Impact items, ranging from 0.62 to 0.85. All a priori validity hypotheses were supported by observed correlations and score differences between known groups.
UNASSIGNED: The results of this study support the structure, reliability, and validity of the FCS-SIS, laying the psychometric groundwork for longitudinal evaluation of its utility in assessing treatment benefit in FCS clinical studies.
■此多站点,横截面,在美国和加拿大对FCS患者进行了观察性研究.参与者完成了一项由7项PRO措施组成的调查,包括FCS-SIS,以及有关临床特征和人口统计学的问题。FCS-SIS的结构使用项目间和项目-量表相关性以及内部一致性可靠性进行评估。Construct,已知团体,通过检查FCS-SIS项目与综合评分和调查中包含的其他指标之间的关联,评估了标准有效性。
■33名参与者中大多数是女性(63.6%)和白人(78.1%)。平均而言,参与者报告在约16岁时首次注意到FCS症状,腹痛是最常见的初始症状(n=20)。参与者报告过去一年平均有2.5次急性胰腺炎发作。在24小时召回期内,FCS-SIS症状项目的平均评分范围为1.8至3.9(以0至10的量表[从最坏到可能])。平均症状综合评分为2.7。FCS-SIS的平均影响项目得分范围为1.6至3.0(以0至4为量表),平均冲击综合评分为2.1。FCS-SIS症状项目之间的项目间相关性范围为0.32至0.78。校正后的项目-总相关性对于影响项目非常令人满意,范围从0.62到0.85。所有先验有效性假设均得到已知组之间观察到的相关性和得分差异的支持。
■这项研究的结果支持了该结构,可靠性,和FCS-SIS的有效性,为纵向评估其在FCS临床研究中评估治疗获益方面的效用奠定了心理计量学基础。