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最小重要差异研究中存在严重的报告缺陷:现状与改进建议。

Serious reporting deficiencies exist in minimal important difference studies: current state and suggestions for improvement.

作者信息

Carrasco-Labra Alonso, Devji Tahira, Qasim Anila, Phillips Mark, Johnston Bradley C, Devasenapathy Niveditha, Zeraatkar Dena, Bhatt Meha, Jin Xuejing, Brignardello-Petersen Romina, Urquhart Olivia, Foroutan Farid, Schandelmaier Stefan, Pardo-Hernandez Hector, Vernooij Robin Wm, Huang Hsiaomin, Rizwan Yamna, Siemieniuk Reed, Lytvyn Lyubov, Patrick Donald L, Ebrahim Shanil, Furukawa Toshi A, Nesrallah Gihad, Schunemann Holger J, Bhandari Mohit, Thabane Lehana, Guyatt Gordon H

机构信息

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario, Canada L8S 4L8; Center for Integrative Global Oral Health, University of Pennsylvania, School of Dental Medicine, 240 S. 40th Street, 3rd Fl East, Philadelphia, PA 19104, USA.

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main St East, Hamilton, Ontario, Canada L8S 4L8.

出版信息

J Clin Epidemiol. 2022 Oct;150:25-32. doi: 10.1016/j.jclinepi.2022.06.010. Epub 2022 Jun 24.

DOI:10.1016/j.jclinepi.2022.06.010
PMID:35760237
Abstract

BACKGROUND AND OBJECTIVES

To evaluate reporting of minimal important difference (MID) estimates using anchor-based methods for patient-reported outcome measures (PROMs), and the association with reporting deficiencies on their credibility.

METHODS

Systematic survey of primary studies empirically estimating MIDs. We searched Medline, EMBASE, PsycINFO, and the Patient-Reported Outcome and Quality of Life Instruments Database until October 2018. We evaluated study reporting, focusing on participants' demographics, intervention(s), characteristics of PROMs and anchors, and MID estimation method(s). We assessed the impact of reporting issues on credibility of MID estimates.

RESULTS

In 585 studies reporting on 5,324 MID estimates for 526 distinct PROMs, authors frequently failed to adequately report key characteristics of PROMs and MIDs, including minimum and maximum values of PROM scale, measure of variability accompanying the MID estimate and number of participants included in the MID calculation. Across MID estimates (n = 5,324), the most serious reporting issues impacting credibility included infrequent reporting of the correlation between the anchor and PROM (66%), inadequate details to judge precision of MID point estimate (13%), and insufficient information about the threshold used to ascertain MIDs (16%).

CONCLUSION

Serious issues of incomplete reporting in the MID literature threaten the optimal use of MID estimates to inform the magnitude of effects of interventions on PROMs.

摘要

背景与目的

评估使用基于锚定法的患者报告结局指标(PROMs)最小重要差异(MID)估计值的报告情况,以及报告缺陷与其可信度之间的关联。

方法

对实证估计MIDs的原始研究进行系统调查。我们检索了Medline、EMBASE、PsycINFO以及患者报告结局与生活质量量表数据库,检索截止至2018年10月。我们评估研究报告,重点关注参与者的人口统计学特征、干预措施、PROMs和锚定指标的特征以及MID估计方法。我们评估报告问题对MID估计值可信度的影响。

结果

在585项研究中报告了526种不同PROMs的5324个MID估计值,作者经常未能充分报告PROMs和MIDs的关键特征,包括PROM量表的最小值和最大值、MID估计值伴随的变异性测量以及MID计算中纳入的参与者数量。在所有MID估计值(n = 5324)中,影响可信度的最严重报告问题包括锚定指标与PROM之间相关性报告频率低(66%)、判断MID点估计精度的细节不足(13%)以及用于确定MIDs的阈值信息不足(16%)。

结论

MID文献中存在的严重报告不完整问题,威胁到MID估计值在告知干预措施对PROMs影响程度方面的最佳应用。

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