关键词: core outcomes kidney transplantation life participation patient-centered outcomes patient-reported outcome measures quality of life

来  源:   DOI:10.1016/j.ekir.2023.10.018   PDF(Pubmed)

Abstract:
UNASSIGNED: Life participation has been established as a critically important core for trials in kidney transplantation. We aimed to validate a patient-reported outcome measure for life participation in kidney transplant recipients.
UNASSIGNED: A psychometric evaluation of the Standardized Outcomes in Nephrology life participation (SONG-LP) measure was conducted in adult kidney transplant recipients. The measure includes 4 items of life participation (leisure, family, work, and social) each with a 5-point Likert scale. Each item is scored from 0 (never) to 4 (always) and the summary measure score the average of each item.
UNASSIGNED: A total of 249 adult kidney transplant recipients from 20 countries participated. The SONG-LP instrument demonstrated internal consistency (Cronbach\'s α = 0.87; 95% confidence intervals [CI]: 0.83-0.90, baseline) and test-retest reliability over 1 week (intraclass correlation coefficient of 0.62; 95% CI: 0.54-0.70). There was moderate to high correlation (0.65; 95% CI: 0.57-0.72) with the PROMIS Ability to Participate in Social Roles and Activities Short Form 8a that assessed a similar construct, and moderate correlation with measures that assessed related concepts (i.e., EQ5D 0.57; 95% CI: 0.49-0.65), PROMIS Cognitive Functional Abilities Subset Short Form 4a (0.40; 95% CI: 0.29-0.50).
UNASSIGNED: The SONG-LP instrument is a simple, internally consistent, reliable measure for kidney transplant recipients and correlates with similar measures. Routine incorporation in clinical trials will ensure consistent and appropriate assessment of life participation for informed patient-centered decision-making.
摘要:
生命参与已被确立为肾移植试验的重要核心。我们旨在验证患者报告的肾脏移植受者生命参与的结局指标。
在成人肾移植受者中对肾脏病学生活参与标准化结果(SONG-LP)进行了心理评估。该措施包括4项生活参与(休闲,家庭,工作,和社交)每个都有5分的李克特量表。每个项目的得分从0(从不)到4(总是),汇总测量得分每个项目的平均值。
共有来自20个国家的249名成人肾移植受者参加。SONG-LP仪器在1周内表现出内部一致性(Cronbach\sα=0.87;95%置信区间[CI]:0.83-0.90,基线)和重测可靠性(组内相关系数为0.62;95%CI:0.54-0.70)。与评估类似结构的PROMIS参与社交角色和活动能力简短形式8a存在中度到高度相关性(0.65;95%CI:0.57-0.72),以及与评估相关概念的度量的适度相关性(即,EQ5D0.57;95%CI:0.49-0.65),PROMIS认知功能能力子集简表4a(0.40;95%CI:0.29-0.50)。
SONG-LP乐器是一个简单的,内部一致,肾移植受者的可靠措施,并与类似措施相关。常规纳入临床试验将确保对生命参与进行一致和适当的评估,以知情的以患者为中心的决策。
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