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在STarT Back试验中识别治疗效果修饰因素:一项二次分析

Identifying Treatment Effect Modifiers in the STarT Back Trial: A Secondary Analysis.

作者信息

Beneciuk Jason M, Hill Jonathan C, Campbell Paul, Afolabi Ebenezer, George Steven Z, Dunn Kate M, Foster Nadine E

机构信息

Department of Physical Therapy, University of Florida, Gainesville, Florida; Brooks Rehabilitation-College of Public Health and Health Professions (University of Florida) Research Collaboration, University of Florida, Gainesville, Florida.

Arthritis Research UK Primary Care Centre, Research Institute of Primary Care and Health Sciences, Keele University, Staffordshire, United Kingdom.

出版信息

J Pain. 2017 Jan;18(1):54-65. doi: 10.1016/j.jpain.2016.10.002. Epub 2016 Oct 17.

DOI:10.1016/j.jpain.2016.10.002
PMID:27765643
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5270590/
Abstract

UNLABELLED

Identification of patient characteristics influencing treatment outcomes is a top low back pain (LBP) research priority. Results from the STarT Back trial support the effectiveness of prognostic stratified care for LBP compared with current best care, however, patient characteristics associated with treatment response have not yet been explored. The purpose of this secondary analysis was to identify treatment effect modifiers within the STarT Back trial at 4-month follow-up (n = 688). Treatment response was dichotomized using back-specific physical disability measured using the Roland-Morris Disability Questionnaire (≥7). Candidate modifiers were identified using previous literature and evaluated using logistic regression with statistical interaction terms to provide preliminary evidence of treatment effect modification. Socioeconomic status (SES) was identified as an effect modifier for disability outcomes (odds ratio [OR] = 1.71, P = .028). High SES patients receiving prognostic stratified care were 2.5 times less likely to have a poor outcome compared with low SES patients receiving best current care (OR = .40, P = .006). Education level (OR = 1.33, P = .109) and number of pain medications (OR = .64, P = .140) met our criteria for effect modification with weaker evidence (.20 > P ≥ .05). These findings provide preliminary evidence for SES, education, and number of pain medications as treatment effect modifiers of prognostic stratified care delivered in the STarT Back Trial.

PERSPECTIVE

This analysis provides preliminary exploratory findings about the characteristics of patients who might least likely benefit from targeted treatment using prognostic stratified care for LBP.

摘要

未标注

确定影响治疗结果的患者特征是下腰痛(LBP)研究的首要重点。STarT Back试验的结果支持了与当前最佳治疗相比,预后分层护理对LBP的有效性,然而,尚未探索与治疗反应相关的患者特征。这项二次分析的目的是在STarT Back试验4个月随访时(n = 688)确定治疗效果修饰因素。使用罗兰-莫里斯残疾问卷测量的背部特异性身体残疾(≥7)将治疗反应进行二分法分类。使用先前的文献确定候选修饰因素,并使用带有统计交互项的逻辑回归进行评估,以提供治疗效果修饰的初步证据。社会经济地位(SES)被确定为残疾结果的效果修饰因素(优势比[OR]=1.71,P = 0.028)。与接受当前最佳护理的低SES患者相比,接受预后分层护理的高SES患者预后不良的可能性低2.5倍(OR = 0.40,P = 0.006)。教育水平(OR = 1.33,P = 0.109)和止痛药物数量(OR = 0.64,P = 0.140)符合我们效果修饰的标准,但证据较弱(0.20 > P≥0.05)。这些发现为SES、教育水平和止痛药物数量作为STarT Back试验中预后分层护理的治疗效果修饰因素提供了初步证据。

观点

这项分析提供了关于哪些患者可能最不可能从针对LBP的预后分层护理靶向治疗中获益的初步探索性发现。