Division of Cardiology, Department of Medicine (F.S.A.), Northwestern University Feinberg School of Medicine, Chicago, IL.
Center for Health Information Partnerships, Institute of Public Health and Medicine (F.S.A.), Northwestern University Feinberg School of Medicine, Chicago, IL.
Circ Heart Fail. 2019 Jun;12(6):e005751. doi: 10.1161/CIRCHEARTFAILURE.118.005751. Epub 2019 Jun 5.
Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile measure-a HF-specific instrument based on the generic PROMIS. We conducted 8 focus groups with 61 patients with HF and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In a 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman ρ correlations with Kansas City Cardiomyopathy Questionnaire subscores. In a longitudinal sample, we performed responsiveness testing (paired t tests) with 75 patients with HF receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach α) coefficients ranged from 0.52 to 0.96, with α≥0.70 in 12 of 17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with Kansas City Cardiomyopathy Questionnaire subscores supported expected convergent ( r/ρ>0.60) and divergent validity ( r/ρ<0.30). In the longitudinal sample, 10 of 18 domains had improved ( P<0.05) scores from baseline to follow-up. Conclusions The PROMIS-Plus-HF profile measure-a complete assessment of physical, mental, and social health-exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains and items can be used depending on the clinical or research purpose.
将通用和心力衰竭（HF）特定项目合并到公开可用的患者报告结局测量工具中，可能有助于常规健康状况评估，以改善临床护理和共同决策、评估护理质量、评估新干预措施以及比较具有不同条件的组。
我们进行了一项混合方法研究，以开发和验证 PROMIS®-Plus-HF（患者报告结局测量信息系统®-Plus-心力衰竭）概况测量工具-一种基于通用 PROMIS 的 HF 特定仪器。我们进行了 8 次有 61 名 HF 患者参加的焦点小组和 10 次 HF 临床医生的电话访谈。该测量工具是通过审查现有 PROMIS 项目和开发及测试新的 HF 项目的迭代过程开发的。在 600 名患者样本中，我们估计了可靠性（内部一致性；测试-重测，n=100 名参与者）。我们使用 Pearson r 和 Spearman ρ 与堪萨斯城心肌病问卷亚量表的相关性进行了有效性分析。在一个纵向样本中，我们对 75 名接受预期健康状况改善干预措施的 HF 患者进行了反应性测试（配对 t 检验）。PROMIS-Plus-HF 量表包括 18 个领域的 86 个项目（64 个现有；22 个新）。17 个领域中有 12 个领域的内部一致性可靠性（Cronbach α）系数为 0.52 至 0.96，α≥0.70。测试-重测的组内相关系数≥0.90。与堪萨斯城心肌病问卷亚量表的相关性支持预期的收敛性（r/ρ>0.60）和发散性有效性（r/ρ<0.30）。在纵向样本中，18 个领域中有 10 个领域的基线到随访的评分提高（P<0.05）。
PROMIS-Plus-HF 概况测量工具-对身体、心理和社会健康的全面评估-表现出良好的心理计量学特性，可能有助于以患者为中心的护理和研究。可以根据临床或研究目的使用域和项目的子集。
