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比较患者整体严重程度印象和患者整体变化印象评估抑郁、非小细胞肺癌和哮喘测量的重测信度。

Comparing patient global impression of severity and patient global impression of change to evaluate test-retest reliability of depression, non-small cell lung cancer, and asthma measures.

机构信息

Critical Path Institute, 1730 East River Road, Suite 200, Tucson, AZ, USA.

GlaxoSmithKline, Collegeville, PA, USA.

出版信息

Qual Life Res. 2022 Dec;31(12):3501-3512. doi: 10.1007/s11136-022-03180-5. Epub 2022 Jul 19.

Abstract

PURPOSE

Score reproducibility is an important measurement property of fit-for-purpose patient-reported outcome (PRO) measures. It is commonly assessed via test-retest reliability, and best evaluated with a stable participant sample, which can be challenging to identify in diseases with highly variable symptoms. To provide empirical evidence comparing the retrospective (patient global impression of change [PGIC]) and current state (patient global impression of severity [PGIS]) approaches to identifying a stable subgroup for test-retest analyses, 3 PRO Consortium working groups collected data using both items as anchor measures.

METHODS

The PGIS was completed on Day 1 and Day 8 + 3 for the depression and non-small cell lung cancer (NSCLC) studies, and daily for the asthma study and compared between Day 3 and 10. The PGIC was completed on the final day in each study. Scores were compared using an intraclass correlation coefficient (ICC) for participants who reported "no change" between timepoints for each anchor.

RESULTS

ICCs using the PGIS "no change" group were higher for depression (0.84 vs. 0.74), nighttime asthma (0.95 vs. 0.53) and daytime asthma (0.86 vs. 0.68) compared to the PGIC "no change" group. ICCs were similar for NSCLC (PGIS: 0.87; PGIC: 0.85).

CONCLUSION

When considering anchor measures to identify a stable subgroup for test-retest reliability analyses, current state anchors perform better than retrospective anchors. Researchers should carefully consider the type of anchor selected, the time period covered, and should ensure anchor content is consistent with the target measure concept, as well as inclusion of both current and retrospective anchor measures.

摘要

目的

适用于特定目的的患者报告结局(PRO)测量的评分可重复性是一项重要的测量特性。它通常通过重测信度进行评估,最好在具有稳定参与者样本的情况下进行评估,而在症状高度变化的疾病中,这可能很难确定。为了提供比较回顾性(患者整体印象变化 [PGIC])和当前状态(患者整体印象严重程度 [PGIS])方法以确定用于重测分析的稳定亚组的经验证据,3 个 PRO 联盟工作组使用这两个项目作为锚定测量收集数据。

方法

在抑郁症和非小细胞肺癌(NSCLC)研究中,PGIS 在第 1 天和第 8 天+3 天完成,在哮喘研究中每天完成,并在第 3 天和第 10 天之间进行比较。PGIC 在每个研究的最后一天完成。对于每个锚定点报告在两个时间点之间“无变化”的参与者,使用组内相关系数(ICC)比较分数。

结果

使用 PGIS“无变化”组的 ICC 对于抑郁症(0.84 与 0.74)、夜间哮喘(0.95 与 0.53)和日间哮喘(0.86 与 0.68),高于 PGIC“无变化”组。对于 NSCLC(PGIS:0.87;PGIC:0.85),ICC 相似。

结论

在考虑用于识别重测可靠性分析的稳定亚组的锚定测量时,当前状态的锚定比回顾性的锚定表现更好。研究人员应仔细考虑所选的锚定类型、涵盖的时间段,并应确保锚定内容与目标测量概念一致,以及包括当前和回顾性的锚定测量。

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Memory-Assisted Global Impression of Change (MAGIC).记忆辅助整体变化印象(MAGIC)。
Ther Innov Regul Sci. 2022 May;56(3):454-463. doi: 10.1007/s43441-022-00377-1. Epub 2022 Feb 22.

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