The development and initial validation of the PROMIS®+HF-27 and PROMIS+HF-10 profiles.
The development and initial validation of the PROMIS®+HF-27 and PROMIS+HF-10 profiles.
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心力衰竭(HF)是一种影响多个健康领域的常见病态疾病。我们之前报告了PROMIS®-Plus-HF(PROMIS+HF)剖面测量的开发，包括通用项目和特定于HF的项目。为了方便使用，我们开发了更短的PROMIS+HF配置文件，用于研究和临床使用。候选条目是根据心理测量学特性和症状范围覆盖范围来选择的。心衰临床医生(n=43)评定项目重要性和临床可操作性。基于这些结果，我们开发了PROMIS+HF-27和PROMIS+HF-10简表，总体、身体、心理和社会健康的总分(0-100)。在横断面样本中，我们测量了内部一致性信度(Cronbach‘s Alpha和Spearman-Brown)、重测信度(组内系数；n=0.100)、通过纽约心脏协会(NYHA)班级的已知分组效度，以及与堪萨斯城心肌病问卷(KCCQ)得分的收敛效度。在纵向样本(n=975)中，我们通过计算均数差异和Cohen‘s d并与配对t检验进行比较来评估基线/随访分数的反应性。所有PROMIS+HF-27评分的内部一致性均为良至优(α0.82~0.94)，PROMIS+HF-10评分的内部一致性可接受(α/Spearman-Brown 0.60~0.85)。重测组内系数为优(0.75~0.97)。这两个档案都显示了已知群体对基于NYHA类别的总体和身体健康总结分数的有效性，以及与KCCQ分数相比几乎所有分数的收敛有效性。在纵向样本中，我们展示了PROMIS+HF-27和PROMIS+HF-10总体和身体总结分数的反应性。对于PROMIS+HF的总体总结分数，基于组的7.6-8.3分的增加代表着小到中等的变化(Cohen的d=100.40-0.42)。对于PROMIS+HF的身体总结分数，基于组的5.0-5.9分的增加代表了一个小到中等的变化(Cohen‘s d=30.29-0.35)。PROMIS+HF-27和PROMIS+HF-10具有良好的心理测量学特征，表明PROMIS+HF-27和PROMIS+HF-10对整体和身体健康具有良好的反应能力。这些新措施可以促进以患者为中心的研究和临床护理，例如通过症状监测提高护理质量，促进共同决策，评估护理质量，评估新的干预措施，以及在指南指导的医疗疗法的启动和滴定期间进行监测。
Heart failure (HF) is a common and morbid condition impacting multiple health domains. We previously reported the development of the PROMIS®‐Plus‐HF (PROMIS+HF) profile measure, including universal and HF‐specific items. To facilitate use, we developed shorter, PROMIS+HF profiles intended for research and clinical use. Candidate items were selected based on psychometric properties and symptom range coverage. HF clinicians (n = 43) rated item importance and clinical actionability. Based on these results, we developed the PROMIS+HF‐27 and PROMIS+HF‐10 profiles with summary scores (0–100) for overall, physical, mental, and social health. In a cross‐sectional sample (n = 600), we measured internal consistency reliability (Cronbach's alpha and Spearman–Brown), test–retest reliability (intraclass coefficient; n = 100), known‐groups validity via New York Heart Association (NYHA) class, and convergent validity with Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. In a longitudinal sample (n = 75), we evaluated responsiveness of baseline/follow‐up scores by calculating mean differences and Cohen's d and comparing with paired t‐tests. Internal consistency was good to excellent (α 0.82–0.94) for all PROMIS+HF‐27 scores and acceptable to good (α/Spearman–Brown 0.60–0.85) for PROMIS+HF‐10 scores. Test–retest intraclass coefficients were acceptable to excellent (0.75–0.97). Both profiles demonstrated known‐groups validity for the overall and physical health summary scores based on NYHA class, and convergent validity for nearly all scores compared with KCCQ scores. In the longitudinal sample, we demonstrated responsiveness for PROMIS+HF‐27 and PROMIS+HF‐10 overall and physical summary scores. For the PROMIS+HF overall summary scores, a group‐based increase of 7.6–8.3 points represented a small to medium change (Cohen's d = 0.40–0.42). For the PROMIS+HF physical summary scores, a group‐based increase of 5.0–5.9 points represented a small to medium change (Cohen's d = 0.29–0.35). The PROMIS+HF‐27 and PROMIS+HF‐10 profiles demonstrated good psychometric characteristics with evidence of responsiveness for overall and physical health. These new measures can facilitate patient‐centred research and clinical care, such as improving care quality through symptom monitoring, facilitating shared decision‐making, evaluating quality of care, assessing new interventions, and monitoring during the initiation and titration of guideline‐directed medical therapy.
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影响因子：
8.3
作者：
Bragazzi, Nicola Luigi;Zhong, Wen;Dai, Haijiang
通讯作者：
Dai, Haijiang
DOI：
10.1016/j.jpeds.2020.11.053
发表时间：
2021-03
期刊：
The Journal of pediatrics
影响因子：
--
作者：
Cox ED;Dobrozsi SK;Forrest CB;Gerhardt WE;Kliems H;Reeve BB;Rothrock NE;Lai JS;Svenson JM;Thompson LA;Tran TDN;Tucker CA
通讯作者：
Tucker CA
影响因子：
2.7
作者：
Hays, Ron D.;Schalet, Benjamin D.;Cella, David
通讯作者：
Cella, David
影响因子：
5.7
作者：
Hays, Ron D.;Spritzer, Karen L.;Cella, David
通讯作者：
Cella, David
影响因子：
2.7
作者：
Lewis, Eldrin F.;Coles, Theresa M.;Chang, Chunlan G.
通讯作者：
Chang, Chunlan G.