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.

中文翻译：

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PROMIS®-Plus-HF轮廓测量的开发和初步验证。

背景技术将通用和心力衰竭（HF）专用项目汇总到患者报告的可公开获得的成果测量中，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，评估新的干预措施并进行比较不同条件的团体。方法和结果我们进行了混合方法研究，以开发和验证PROMIS®-Plus-HF（患者报告的结果测量信息系统®-Plus-心脏衰竭）轮廓测量-一种基于通用PROMIS的HF专用仪器。我们对61名HF患者进行了8个焦点小组讨论，并与10名HF临床医生进行了电话访谈。该措施是通过反复审查现有的PROMIS项目以及开发和测试新的HF项目而制定的。在600名患者的样本中，我们评估了可靠性（内部一致性；重测，n = 100的参与者）。我们使用Pearson r和Spearmanρ相关系数与堪萨斯城心肌病问卷调查子评分进行了效度分析。在纵向样本中，我们对75例接受预期健康状况得到改善的HF患者进行了反应性测试（配对t检验）。PROMIS-Plus-HF措施涵盖18个域中的86项（现有64项；新增22项）。内部一致性可靠性（Cronbachα）系数介于0.52至0.96之间，在17个域中的12个域中α≥0.70。重测组内相关系数≥0.90。与堪萨斯城心肌病问卷调查的相关性支持预期的收敛性（r /ρ> 0.60）和发散的有效性（r /ρ<0.30）。在纵向样本中 从基线到随访，18个域中的10个域的评分得到改善（P <0.05）。结论PROMIS-Plus-HF轮廓测量法是对身体，心理和社会健康表现出的良好心理计量学特征的完整评估，可以促进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。