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强化疼痛知识对自我报告疼痛教育需求较高的纤维肌痛患者核心结局的影响:使用DANFIB注册库进行的目标试验模拟

Impact of enhanced pain knowledge on core outcomes in fibromyalgia patients with high self-reported pain education needs: a target trial emulation using the DANFIB registry.

作者信息

Amris Kirstine, Christensen Robin, Wæhrens Eva Ejlersen, Duhn Pernille Hurup, Henriksen Marius

机构信息

The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Frederiksberg, Denmark

Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Frederiksberg, Denmark.

出版信息

RMD Open. 2025 Jun 12;11(2):e005576. doi: 10.1136/rmdopen-2025-005576.

Abstract

OBJECTIVE

Relationships between patient education and long-term clinical outcomes are complex. This study used real-world data to evaluate the impact of improved pain knowledge on clinical outcomes in fibromyalgia patients.

METHODS

Prospectively collected registry-based observational data were analysed to emulate a randomised clinical trial. Study participants were diagnosed with fibromyalgia, had a high need to learn about pain (Numeric Rating Scale >7), had attended a 2-day therapeutic educational programme and re-rated their learning needs after the programme. A good educational outcome was defined as a re-rating score <5, while a poor outcome was ≥5. The primary endpoint at 9 months was the overall impact of fibromyalgia, measured by the Fibromyalgia Impact Questionnaire Revised (FIQR) impact subscale.

RESULTS

The eligible cohort comprised 450 participants. The intention-to-treat from population included 121 participants (26.9%) with a good educational outcome and 329 participants (73.1%) with a poor educational outcome (comparator group). Missing outcome data were handled implicitly by the repeated measures linear mixed models, assuming data are missing at random.At the 9-month endpoint, the fully adjusted FIQR impact subscale score was lower in the good educational outcome group (8.0 (95% CI 7.3 to 8.7)) compared with the poor educational outcome group (9.6 (95% CI 9.0 to 10.2)), indicating a better clinical outcome for those with a good educational outcome. The model-estimated between-group difference was -1.6 (95% CI -2.5 to -0.7; p=0.0006) FIQR impact subscale units.

CONCLUSIONS

This study suggests that achieving pain educational learning objectives leads to better clinical outcomes in fibromyalgia patients, supporting the integration of pain education into patient programmes.

摘要

目的

患者教育与长期临床结果之间的关系很复杂。本研究使用真实世界数据来评估改善疼痛知识对纤维肌痛患者临床结果的影响。

方法

对前瞻性收集的基于注册登记的观察性数据进行分析,以模拟一项随机临床试验。研究参与者被诊断为纤维肌痛,有很高的疼痛知识学习需求(数字评定量表>7),参加了一个为期2天的治疗性教育项目,并在项目结束后重新评定了他们的学习需求。良好的教育结果定义为重新评定分数<5,而不良结果为≥5。9个月时的主要终点是纤维肌痛的总体影响,通过纤维肌痛影响问卷修订版(FIQR)影响子量表进行测量。

结果

符合条件的队列包括450名参与者。意向性分析人群包括121名(26.9%)教育结果良好的参与者和329名(73.1%)教育结果不良的参与者(对照组)。重复测量线性混合模型隐式处理缺失的结果数据,假设数据是随机缺失的。在9个月的终点,良好教育结果组的完全调整后的FIQR影响子量表得分(8.0(95%CI 7.3至8.7))低于不良教育结果组(9.6(95%CI 9.0至10.2)),表明教育结果良好的患者临床结果更好。模型估计的组间差异为-1.6(95%CI -2.5至-0.7;p = 0.0006)FIQR影响子量表单位。

结论

本研究表明,实现疼痛教育学习目标可使纤维肌痛患者获得更好的临床结果,支持将疼痛教育纳入患者项目。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/58a5/12164631/7de54cf431b0/rmdopen-11-2-g001.jpg

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