Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.
Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.
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DOI：
10.1161/circoutcomes.121.008690
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发表时间：
2023-03
影响因子：
6.9
通讯作者：
Grady, Kathleen L.
中科院分区：
文献类型：
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作者：
Hahn, Elizabeth A.;Walsh, Mary N.;Allen, Larry A.;Lee, Christopher S.;Denfeld, Quin E.;Teuteberg, Jeffrey J.;Beiser, David G.;McIlvennan, Colleen K.;Lindenfeld, JoAnn;Klein, Liviu;Adler, Eric D.;Stehlik, Josef;Ruo, Bernice;Bedjeti, Katy;Cummings, Peter D.;Vela, Alyssa M.;Grady, Kathleen L.
需要更好地了解左心室辅助装置（LVAD）植入对患者身体、精神和社会福祉的负担和益处。本报告的目的是评估患者报告的结果测量信息系统（PROMIS）测量LVAD患者的有效性，并估计可能对患者治疗或护理有影响的临床重要评分差异。来自美国所有地理区域12个地点的成年人在lvad植入后≥3个月完成了PROMIS测量。其他患者报告的结果（如堪萨斯城心肌病问卷-12项）、临床医生评分、性能测试和临床不良事件被用作效度指标。采用Pearson相关、ANOVA方法和Cohen效应量估计标准和结构效度及临床重要差异。参与者（n=648）平均年龄为58岁，大多数为男性（78%），非西班牙裔白人（68%），扩张型心肌病（55%），长期植入策略（57%），纽约心脏协会I级和II级（54%）。效度指标与PROMIS测量值的相关性大多为中~大（≥0.3;p<0.01）。大多数效度分析显示了中大型效应量（≥0.5）和临床重要的平均PROMIS评分差异（高达14.8分）。4项PROMIS测量的最小重要差异范围如下：疲劳（3 - 5分），身体功能（2-3分），参与社会角色和活动的能力（3分），以及对社会角色和活动的满意度（3 - 5分）。本研究结果为lvad植入后早期至晚期PROMIS生理、心理和社会健康措施的相关性和有效性提供了令人信服的证据。当患者考虑治疗方案时，研究结果可能会为共同决策提供信息。LVAD患者、他们的护理人员和他们的临床医生应该发现，解释他们的PROMIS评分与一般人群的关系是有用的，也就是说，PROMIS可能有助于监测他们在日常生活中恢复正常。
A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients’ physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care. Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes. Participants’ (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3–5 points), physical function (2–3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3–5). The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life.