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背痛试验中主要结局指标的使用可能需要彻底重新评估。

Primary outcome measure use in back pain trials may need radical reassessment.

作者信息

Froud Robert, Ellard David, Patel Shilpa, Eldridge Sandra, Underwood Martin

机构信息

Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, UK.

Norges Helsehøyskole, Campus Kristiania, Prinsens Gate 7-9, Oslo, 0152, Norway.

出版信息

BMC Musculoskelet Disord. 2015 Apr 14;16:88. doi: 10.1186/s12891-015-0534-1.

Abstract

BACKGROUND

The answers to patient reported outcome measures and global transition questions for back pain can be discordant. For example, the most commonly used outcome measure in back pain trials, the Roland Morris Disability Questionnaire (RMDQ), can show improvement even though participants say that their back pain is worse. This gives cause for concern as transition questions are used as anchors to estimate minimally important change (MIC) thresholds on patient reported outcome measures such as the RMDQ. We aimed to explore and compare what people with back pain think when they respond to a transition question and when they complete the RMDQ.

METHODS

We purposively sampled people enrolled on a back pain randomised controlled trial who completed the RMDQ and two transition questions. One enquired about change in ability to perform tasks, the other about change in back pain. We sampled participants with discordance (in both directions), and participants with concordant scores. We explored participants' thought processes using in-depth interviews.

RESULTS

We completed 35 in-depth interviews. People with discordant RMDQ change and transition question responses attend to different factors when responding to transition questions compared to people with concordant scores. In particular, those for whom the RMDQ change indicated greater improvement than transition questions, prioritised their pain ahead of functional disability. When completing the RMDQ, participants' thought processes were comparatively more objective, and specific to each statement.

CONCLUSION

Approaches to primary outcome assessment in back pain needs re-assessment. The RMDQ may be unsuitable for use as a primary outcome measure since patients may not attend to thinking about their back pain when completing it: patients' abilities to cope with tasks can be independent of the change in their back pain. Some participants who improve on the RMDQ consider themselves globally worse. As transition questions can be driven by pain and other physical factors, transition questions should not be used to anchor minimally important change thresholds on the RMDQ.

摘要

背景

患者报告的背痛结局测量指标答案与整体转变问题的答案可能不一致。例如,背痛试验中最常用的结局测量指标——罗兰·莫里斯残疾问卷(RMDQ),即便参与者表示背痛加重,但该问卷仍可能显示出改善情况。这令人担忧,因为转变问题被用作锚定指标,以估计诸如RMDQ等患者报告结局测量指标的最小重要变化(MIC)阈值。我们旨在探究并比较背痛患者在回答转变问题和完成RMDQ时的想法。

方法

我们有目的地抽取了参加背痛随机对照试验的人员,这些人员完成了RMDQ和两个转变问题。一个问题询问执行任务能力的变化,另一个问题询问背痛的变化。我们抽取了答案不一致(两个方向均有)的参与者以及得分一致的参与者。我们通过深入访谈探究参与者的思维过程。

结果

我们完成了35次深入访谈。与得分一致的参与者相比,RMDQ变化与转变问题答案不一致的参与者在回答转变问题时关注的因素不同。特别是,那些RMDQ变化表明改善程度大于转变问题所显示的参与者,将疼痛置于功能残疾之前予以优先考虑。在完成RMDQ时,参与者的思维过程相对更客观,且针对每个陈述都很具体。

结论

背痛主要结局评估方法需要重新评估。RMDQ可能不适宜用作主要结局测量指标,因为患者在完成该问卷时可能不会去思考自己的背痛:患者应对任务的能力可能独立于其背痛的变化。一些在RMDQ上显示改善的参与者却认为自己整体状况更差。由于转变问题可能受疼痛和其他身体因素驱动,因此转变问题不应被用于锚定RMDQ的最小重要变化阈值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8f3/4419506/61964dd70a6f/12891_2015_534_Fig1_HTML.jpg

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