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3种用于腰痛的电子患者报告结局指标的反应性、可靠性、最小重要变化和最小可检测变化:验证研究

Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study.

作者信息

Froud Robert, Fawkes Carol, Foss Jonathan, Underwood Martin, Carnes Dawn

机构信息

Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom.

Institute of Health Sciences, Kristiania University College, Oslo, Norway.

出版信息

J Med Internet Res. 2018 Oct 24;20(10):e272. doi: 10.2196/jmir.9828.

Abstract

BACKGROUND

The Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) of pain intensity, and numerical rating scale (NRS) are among the most commonly used outcome measures in trials of interventions for low back pain. Their use in paper form is well established. Few data are available on the metric properties of electronic counterparts.

OBJECTIVE

The goal of our research was to establish responsiveness, minimally important change (MIC) thresholds, reliability, and minimal detectable change at a 95% level (MDC) for electronic versions of the RMDQ, VAS, and NRS as delivered via iOS and Android apps and Web browser.

METHODS

We recruited adults with low back pain who visited osteopaths. We invited participants to complete the eRMDQ, eVAS, and eNRS at baseline, 1 week, and 6 weeks along with a health transition question at 1 and 6 weeks. Data from participants reporting recovery were used in MIC and responsiveness analyses using receiver operator characteristic (ROC) curves and areas under the ROC curves (AUCs). Data from participants reporting stability were used for analyses of reliability (intraclass correlation coefficient [ICC] agreement) and MDC.

RESULTS

We included 442 participants. At 1 and 6 weeks, ROC AUCs were 0.69 (95% CI 0.59 to 0.80) and 0.67 (95% CI 0.46 to 0.87) for the eRMDQ, 0.69 (95% CI 0.58 to 0.80) and 0.74 (95% CI 0.53 to 0.95) for the eVAS, and 0.73 (95% CI 0.66 to 0.80) and 0.81 (95% CI 0.69 to 0.92) for the eNRS, respectively. Associated MIC thresholds were estimated as 1 (0 to 2) and 2 (-1 to 5), 13 (9 to 17) and 7 (-12 to 26), and 2 (1 to 3) and 1 (0 to 2) points, respectively. Over a 1-week period in participants categorized as "stable" and "about the same" using the transition question, ICCs were 0.87 (95% CI 0.66 to 0.95) and 0.84 (95% CI 0.73 to 0.91) for the eRMDQ with MDC of 4 and 5, 0.31 (95% CI -0.25 to 0.71) and 0.61 (95% CI 0.36 to 0.77) for the eVAS with MDC of 39 and 34, and 0.52 (95% CI 0.14 to 0.77) to 0.67 (95% CI 0.51 to 0.78) with MDC of 4 and 3 for the eNRS.

CONCLUSIONS

The eRMDQ was reliable with borderline adequate responsiveness. The eNRS was responsive with borderline reliability. While the eVAS had adequate responsiveness, it did not have an attractive reliability profile. Thus, the eNRS might be preferred over the eVAS for measuring pain intensity. The observed electronic outcome measures' metric properties are within the ranges of values reported in the literature for their paper counterparts and are adequate for measuring changes in a low back pain population.

摘要

背景

罗兰·莫里斯残疾问卷(RMDQ)、疼痛强度视觉模拟量表(VAS)和数字评定量表(NRS)是腰痛干预试验中最常用的结局指标。它们以纸质形式使用已很成熟。关于电子版本的度量特性的数据很少。

目的

我们研究的目的是确定通过iOS和安卓应用程序以及网络浏览器提供的RMDQ、VAS和NRS电子版本在95%水平下的反应度、最小重要变化(MIC)阈值、可靠性和最小可检测变化(MDC)。

方法

我们招募了拜访整骨疗法医生的成年腰痛患者。我们邀请参与者在基线、第1周和第6周完成电子RMDQ、电子VAS和电子NRS,并在第1周和第6周回答一个健康转变问题。报告康复的参与者的数据用于使用受试者工作特征(ROC)曲线和ROC曲线下面积(AUC)进行的MIC和反应度分析。报告病情稳定的参与者的数据用于可靠性分析(组内相关系数[ICC]一致性)和MDC分析。

结果

我们纳入了442名参与者。在第1周和第6周,电子RMDQ的ROC AUC分别为0.69(95%CI 0.59至0.80)和0.67(95%CI 0.46至0.87),电子VAS的为0.69(95%CI 0.58至0.80)和0.74(95%CI 0.53至0.95),电子NRS的为0.73(95%CI 0.66至0.80)和0.81(95%CI 0.69至0.92)。相关的MIC阈值估计分别为1(0至2)和2(-1至5)分、13(9至17)和7(-12至26)分、2(1至3)和1(0至2)分。在使用转变问题归类为“稳定”和“大致相同”的参与者中,在1周期间,电子RMDQ的ICC分别为0.87(95%CI 0.66至0.95)和0.84(95%CI 0.73至0.91),MDC分别为4和5;电子VAS的ICC分别为0.31(95%CI -0.25至0.71)和0.61(95%CI 0.36至0.77),MDC分别为39和34;电子NRS的ICC为0.52(95%CI 0.14至0.77)至0.67(95%CI 0.51至0.78),MDC分别为4和3。

结论

电子RMDQ可靠,反应度勉强足够。电子NRS反应度良好,可靠性勉强足够。虽然电子VAS反应度足够,但可靠性不佳。因此,在测量疼痛强度方面,电子NRS可能比电子VAS更受青睐。观察到的电子结局指标的度量特性在文献中报告的纸质对应指标的值范围内,足以测量腰痛人群的变化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae13/6231814/c8e066c16701/jmir_v20i10e272_fig1.jpg

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