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与什么相比?一项分析临床试验对照物的研究,该研究为国家卫生与临床优化研究所(NICE)下腰痛指南提供了信息。

Compared to what? An analysis of comparators in trials informing the National Institute of Clinical Excellence (NICE) low back pain guideline.

机构信息

Brown University, Providence, RI, United States.

Ontario Tech University, Oshawa, Ontario, Canada.

出版信息

Braz J Phys Ther. 2023 Nov-Dec;27(6):100563. doi: 10.1016/j.bjpt.2023.100563. Epub 2023 Nov 14.

Abstract

BACKGROUND

Low back pain (LBP) is the leading cause of disability globally. Clinical practice guidelines (CPGs) have been developed in hopes of encouraging evidence-based care for LBP. However, poor quality of trials that underpin CPGs can lead to misleading recommendations for LBP.

OBJECTIVES

To categorize the comparator used in trials included in the National Institute of Clinical Excellence (NICE) LBP CPG and describe the proportion and association of suboptimal comparators with NICE recommendation.

METHODS

We conducted a cross-sectional analysis to describe the proportion of trials included in the NICE LBP CPG that used a suboptimal comparator. If comparators used an ineffective treatment, a treatment of unknown effectiveness, or no or minimal treatment then they were considered suboptimal.

RESULTS

We included 408 trials and analyzed 580 comparators used in the trials. 30.9% of the comparators used in the trials were suboptimal. Trials testing invasive treatments (32.4%) had the highest proportion of suboptimal comparators followed by non-surgical (32.3%) and pharmacological (19.0%) treatments. Trials using suboptimal treatments were less likely to have their treatment recommended (odds ratio: 0.68; 95% CI: 0.47, 0.98) for use by NICE.

CONCLUSION

There is a concerning proportion of suboptimal comparators used in LBP trials that may be misleading CPG recommendations, funding allocation decisions, and ultimately clinical practice. Efforts to increase the use of optimal comparators in LBP trials are urgently needed to better understand what treatments should be recommended.

摘要

背景

下腰痛(LBP)是全球致残的主要原因。临床实践指南(CPG)的制定是为了鼓励基于证据的 LBP 治疗。然而,支撑 CPG 的试验质量较差可能导致对 LBP 的误导性建议。

目的

对国家临床优化研究所(NICE)LBP CPG 中纳入的试验所使用的对照进行分类,并描述次优对照与 NICE 建议的比例和关联。

方法

我们进行了横断面分析,以描述 NICE LBP CPG 中纳入的试验中使用次优对照的比例。如果对照使用了无效治疗、疗效未知的治疗、或无治疗或最小治疗,则认为是次优的。

结果

我们纳入了 408 项试验,并分析了这些试验中使用的 580 个对照。30.9%的试验对照是次优的。试验测试侵袭性治疗(32.4%)的次优对照比例最高,其次是非手术(32.3%)和药物治疗(19.0%)。使用次优治疗的试验不太可能被 NICE 推荐使用其治疗方法(比值比:0.68;95%CI:0.47,0.98)。

结论

LBP 试验中使用次优对照的比例令人担忧,这可能会误导 CPG 建议、资金分配决策,最终影响临床实践。迫切需要努力增加 LBP 试验中使用最优对照,以更好地了解应推荐哪些治疗方法。

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