Bracing in Adolescent Idiopathic Scoliosis (BrAIST)

青少年特发性脊柱侧凸 (BrAIST) 的支具

基本信息

批准号：
6579555
负责人：
Stuart Leslie WEINSTEIN
金额：
$ 13.53万
依托单位：
UNIVERSITY OF IOWA
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-23 至 2004-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6579555
关键词：
adolescence (12-20) assistive device /technology clinical research clinical trials experimental designs human subject human therapy evaluation orthotics patient oriented research scoliosis therapy compliance

项目摘要

DESCRIPTION (provided by applicant): Several studies have examined the effect of thoracolumbosacral orthoses on adolescent idiopathic scoliosis (AIS), however, neither the positive nor the negative studies meet current standards for scientific evidence. This lack of evidence was highlighted by the United States Preventive Services Task Force, when they concluded there is not sufficient evidence for bracing to endorse mandatory screening for AIS. A randomized, prospective, controlled study is proposed to quantify the risk associated with TLSO use relative to observation alone. If results of this study show that bracing has no benefit over watchful waiting, the public health impact will be enormous. States will need to re-evaluate the usefulness of screening for AIS and physicians will need to re-evaluate their treatment practices. The resources spent on AIS could be used for other evidence-based initiatives. If the results of this study show an improvement of outcome with bracing in AIS, it will provide additional impetus to endorse screening programs across the nation. The results of this study will also provide physicians and patients with definitive information about the improvement that can be expected with bracing, and for whom bracing will provide the most benefit. Despite the growing realization within the healthcare community that we do our patients and our profession a disservice by continuing to practice based on tradition, personal experience and anecdotal accounts, many barriers still exist to the critical review of current practice. This grant will serve to address several of these barriers, including the extensive planning, review and organizational logistics of a multicenter trial. This proposal seeks resources to plan and initiate the first prospective, randomized controlled trial of bracing in adolescent idiopathic scoliosis. To this end, the aims of our proposed planning grant are to further refine and operationalize aspects of the trial. Major areas of activity include: developing the organizational structure of the trial, establishing major work centers, estimating sample sizes through simulated patient recruitment, mapping the model of psychosocial reaction to the condition and its treatment, modeling psychological models of treatment adherence and the development of objective measures of adherence, validating radiographic measurement software, establishing quality control standards and reporting mechanisms, and completing the Manual of Operations and Procedures.

描述（由申请人提供）：几项研究检查了胸骨骨矫形器对青少年特发性脊柱侧弯（AIS）的影响，但是，正面和负面研究都不符合当前的科学证据标准。当美国预防服务工作组得出结论时，没有足够的证据来支持AIS的强制性筛查，因此他们没有足够的证据来强调证据。提出了一项随机，前瞻性，对照研究，以量化与单独观察相对于TLSO使用的风险。如果这项研究的结果表明，支撑没有受到注意等待的好处，那么公共卫生的影响将是巨大的。各州将需要重新评估AIS筛查的实用性，并且医生需要重新评估其治疗方法。在AIS上花费的资源可用于其他基于证据的计划。如果这项研究的结果表明在AIS中进行支撑的结果有所改善，则它将为全国各地的筛查计划提供更多动力。这项研究的结果还将为医生和患者提供有关支架可以预期的改善的明确信息，而支撑将为谁提供最大的好处。尽管医疗保健社区内的认识越来越多，我们通过继续基于传统，个人经验和轶事帐户进行实践来使我们的患者和职业造成了损害，但对当前实践的批判性审查仍然存在许多障碍。该赠款将用于解决这些障碍中的一些，包括多中心试验的广泛计划，审查和组织后勤。该提案寻求资源来计划和启动青少年特发性脊柱侧弯的第一个前瞻性，随机对照试验。为此，我们拟议的计划赠款的目的是进一步完善和操作试验的各个方面。主要活动领域包括：开发试验的组织结构，建立主要的工作中心，通过模拟的患者招聘来估算样本量，将心理社会反应的模型映射到疾病及其治疗中，建模治疗依从性的心理模型以及依从性的客观测量的发展，并验证质量控制标准和报告机构和完成的机构，并确定良好的质量控制标准和措施。

项目成果

期刊论文数量（5）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis.

DOI：
10.1097/brs.0000000000001210
发表时间：
2016-02
期刊：
Spine
影响因子：
3
作者：
Schwieger T;Campo S;Weinstein SL;Dolan LA;Ashida S;Steuber KR
通讯作者：
Steuber KR

More severe thoracic idiopathic scoliosis is associated with a greater three-dimensional loss of thoracic kyphosis.

更严重的胸椎特发性脊柱侧凸与更大的胸椎后凸三维损失相关。

DOI：
10.1007/s43390-020-00149-7
发表时间：
2020
期刊：
Spine deformity
影响因子：
1.6
作者：
Sullivan,ThomasBarrett;Bastrom,TraceyP;Bartley,CarrieE;Dolan,LoriA;Weinstein,StuartL;Newton,PeterO
通讯作者：
Newton,PeterO

Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

青少年特发性脊柱侧凸试验 (BrAIST) 中支具的设计。