Medical Social Sciences (E.A.H., K.B., P.D.C.), Northwestern University Feinberg School of Medicine, Chicago, IL.
Ascension St. Vincent Heart Center, Indianapolis, IN (M.N.W.).
Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e008690. doi: 10.1161/CIRCOUTCOMES.121.008690. Epub 2023 Feb 8.
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; <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.
需要更好地了解左心室辅助装置（LVAD）植入对患者身体、心理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局测量信息系统（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 植入后至少 3 个月完成了 PROMIS 测量。其他患者报告的结局（例如堪萨斯城心肌病问卷 12 项）、临床医生评分、绩效测试和临床不良事件被用作有效性指标。使用 Pearson 相关系数、方差分析方法和 Cohen d 效应大小来估计标准和构念效度以及临床重要差异。
参与者（n=648）的平均年龄为 58 岁，大多数是男性（78%）、非西班牙裔白人（68%）、扩张型心肌病（55%）、长期植入策略（57%）和纽约心脏协会 I 级和 II 级（54%）。有效性指标与 PROMIS 测量之间的大多数相关性均为中等至较大（≥0.3；<0.01）。大多数有效性分析表明，PROMIS 评分的平均差异具有中到大（≥0.5）和临床重要性（高达 14.8 分）。4 项 PROMIS 测量的最小临床重要差异范围如下：疲劳（3-5 分）、身体机能（2-3 分）、参与社会角色和活动的能力（3 分）和对社会角色和活动的满意度（3-5 分）。
这些发现为 PROMIS 身体、心理和社会健康测量在 LVAD 植入后早期至晚期患者中的相关性和有效性提供了令人信服的证据。这些发现可能有助于患者在考虑治疗方案时做出共同决策。LVAD 患者、其照顾者及其临床医生应该发现 PROMIS 评分与一般人群相关的含义有用，也就是说，PROMIS 可能有助于监测日常生活中恢复正常的情况。
