Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMISA®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers
Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMISA®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers
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DOI：
10.1007/s11136-016-1468-2
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发表时间：
2017-03-01
影响因子：
3.5
通讯作者：
Cook, Karon F.
中科院分区：
文献类型：
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作者：
Morgan, Esi M.;Mara, Constance A.;Cook, Karon F.
患者报告的结果测量信息系统（PROMIS）措施越来越多地用于临床护理。然而，对于幼年特发性关节炎（JIA），评分缺乏一个解释临床严重程度的框架，最小重要差异（MID）尚未建立，这是必要的，以评估变化的重要性。我们确定了临床严重程度阈值的小儿PROMIS措施的流动性，上肢功能（UE），疲劳，疼痛干扰与青少年与JIA，JIA患者的父母，和临床医生，使用从教育测试修改的标准设置方法。项目参数用于开发一系列症状严重程度的临床小插曲。根据严重程度对小插曲进行排序，小组成员识别被认为代表分离类别切割点的上边界和下边界的相邻小插曲（即，从无/轻度问题到中度/重度）。为了定义MID，小组成员审查了一份关于小插曲的满分报告，并指出哪些项目需要改变，以及改变多少才能代表“足够的改善，以产生影响”。“对于疲劳和UE，面板之间的分界点在0.5 SD范围内。对于移动性和疼痛干扰，小组之间的分数差异较大，父母设置的最低分数为增加严重程度。MID的大小因利益相关者而异（父母估计最大，其次是患者，然后是临床医生）。MID也因症状的严重程度分类而异，我们从多个利益相关者的角度估计了JIA的PROMIS措施的临床相关严重程度临界点和MID，并发现了显著差异。
Patient-Reported Outcomes Measurement Information System (PROMIS) measures are used increasingly in clinical care. However, for juvenile idiopathic arthritis (JIA), scores lack a framework for interpretation of clinical severity, and minimally important differences (MID) have not been established, which are necessary to evaluate the importance of change.We identified clinical severity thresholds for pediatric PROMIS measures of mobility, upper extremity function (UE), fatigue, and pain interference working with adolescents with JIA, parents of JIA patients, and clinicians, using a standard setting methodology modified from educational testing. Item parameters were used to develop clinical vignettes across a range of symptom severity. Vignettes were ordered by severity, and panelists identified adjacent vignettes considered to represent upper and lower boundaries separating category cut-points (i.e., from none/mild problems to moderate/severe). To define MIDs, panelists reviewed a full score report for the vignettes and indicated which items would need to change and by how much to represent "just enough improvement to make a difference."For fatigue and UE, cut-points among panels were within 0.5 SD of each other. For mobility and pain interference, cut-scores among panels were more divergent, with parents setting the lowest cut-scores for increasing severity. The size of MIDs varied by stakeholders (parents estimated largest, followed by patients, then clinicians). MIDs also varied by severity classification of the symptom.We estimated clinically relevant severity cut-points and MIDs for PROMIS measures for JIA from the perspectives of multiple stakeholders and found notable differences in perspectives.