Signature for Pain Recovery IN Teens (SPRINT): protocol for a multisite prospective signature study in chronic musculoskeletal pain.

Signature for Pain Recovery IN Teens (SPRINT): protocol for a multisite prospective signature study in chronic musculoskeletal pain.
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DOI:
10.1136/bmjopen-2022-061548
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发表时间:
2022-06-08
期刊:
影响因子:
2.9
通讯作者:
Heirich, Marissa
Heirich, Marissa
中科院分区:
医学3区
文献类型:
--
作者:
Simons, Laura;Moayedi, Massieh;Coghill, Robert C.;Stinson, Jennifer;Angst, Martin S.;Aghaeepour, Nima;Gaudilliere, Brice;King, Christopher D.;Lopez-Sola, Marina;Hoeppli, Marie-Eve;Biggs, Emma;Ganio, Ed;Williams, Sara E.;Goldschneider, Kenneth R.;Campbell, Fiona;Ruskin, Danielle;Krane, Elliot J.;Walker, Suellen;Rush, Gillian;Heirich, Marissa

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目前慢性肌肉骨骼(MSK)疼痛的治疗是次优的。发现强有力的预后标志物,将患者从持续性疼痛和残疾患者中分离出来,对于制定患者特异性治疗策略和构思使所有患者受益的新方法至关重要。鉴于慢性疼痛是一个生物心理社会过程,本研究旨在发现和验证一个强大的预后特征,该特征通过计算分析管道在同一青少年患者队列中的多个维度进行测量。这将有助于对患有慢性MSK疼痛的青少年患者进行风险分层,并将患者更灵活地分配给昂贵且可能负担沉重的多学科疼痛治疗方法。在这里,我们描述了一个多机构的努力,收集,策划和分析一个高维数据集,包括流行病学,心理测量,定量感官,脑成像和生物信息收集了12个月的过程中。这项工作的目的是推导出一个多变量模型,具有很强的预后能力,关于青少年MSK疼痛和功能的临床过程。本研究符合美国国立卫生研究院关于多中心研究使用单一内部审查委员会(sIRB)的政策,辛辛那提儿童医院医学中心审查委员会作为审查IRB。斯坦福大学的IRB是sIRB中的一个依赖IRB。作为外国机构,多伦多大学和病童医院(SickKids)由各自的道德委员会监督。所有受试者均签署知情同意书。我们致力于开放获取出版物,以便患者,临床医生和科学家可以访问研究数据和衍生签名。在研究结果公布后,我们将上传一个有限的数据集,以便在适用的存储库中与其他研究人员共享。NCT 04285112。
Current treatments for chronic musculoskeletal (MSK) pain are suboptimal. Discovery of robust prognostic markers separating patients who recover from patients with persistent pain and disability is critical for developing patient-specific treatment strategies and conceiving novel approaches that benefit all patients. Given that chronic pain is a biopsychosocial process, this study aims to discover and validate a robust prognostic signature that measures across multiple dimensions in the same adolescent patient cohort with a computational analysis pipeline. This will facilitate risk stratification in adolescent patients with chronic MSK pain and more resourceful allocation of patients to costly and potentially burdensome multidisciplinary pain treatment approaches. Here we describe a multi-institutional effort to collect, curate and analyse a high dimensional data set including epidemiological, psychometric, quantitative sensory, brain imaging and biological information collected over the course of 12 months. The aim of this effort is to derive a multivariate model with strong prognostic power regarding the clinical course of adolescent MSK pain and function. The study complies with the National Institutes of Health policy on the use of a single internal review board (sIRB) for multisite research, with Cincinnati Children’s Hospital Medical Center Review Board as the reviewing IRB. Stanford’s IRB is a relying IRB within the sIRB. As foreign institutions, the University of Toronto and The Hospital for Sick Children (SickKids) are overseen by their respective ethics boards. All participants provide signed informed consent. We are committed to open-access publication, so that patients, clinicians and scientists have access to the study data and the signature(s) derived. After findings are published, we will upload a limited data set for sharing with other investigators on applicable repositories. NCT04285112.
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