Standardization of criteria for adolescent idiopathic scoliosis brace studies - SRS Committee on Bracing and Nonoperative Management
Standardization of criteria for adolescent idiopathic scoliosis brace studies - SRS Committee on Bracing and Nonoperative Management
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DOI：
10.1097/01.brs.0000178819.90239.d0
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发表时间：
2005-09-15
期刊：
影响因子：
3
通讯作者：
Thompson, GH
中科院分区：
文献类型：
--
作者：
Richards, BS;Bernstein, RM;Thompson, GH
研究设计。文献综述。目的。为未来青少年特发性脊柱侧凸支具研究建立一致的参数，以便进行有效和可靠的比较。背景数据摘要。目前的支具文献在纳入标准和支具有效性的定义方面缺乏一致性。方法。对总共 32 项支具治疗研究和当前青少年特发性脊柱侧凸提案中的支具进行了分析，以：(1) 确定最能识别最有进展风险的患者的纳入标准，(2) 确定支具有效性的最合适定义，以及 (3) 确定可提供有价值信息的其他变量。结果。早期的支具研究其纳入标准缺乏明确性。在最近的研究中，纳入标准已大大缩小，主要包括那些最有可能从使用支具中受益的曲线进展风险的患者。支具有效性通常由成熟时不同程度的曲线进展来定义。不太常见的是，它是根据成熟时的最终曲线大小来定义的，无论是否需要手术干预，或者是否需要更换另一个支架。结论。未来青少年特发性脊柱侧凸支具研究的最佳纳入标准包括：使用支具时年龄为 10 岁或以上、Risser 0-2、主弯角度 25-40、未接受过治疗，以及如果是女性，则为初潮前或初潮后不到 1 年。支具有效性的评估应包括：(1) 成熟时进展 = 6 度的患者百分比，(2) 成熟时曲线超过 45 度的患者百分比以及建议/进行手术的患者百分比，以及 (3) 成熟后 2 年随访以确定随后接受手术的患者百分比。所有患者，无论主观依从性报告如何，都应包含在结果中（治疗意向）。每项研究都应提供按曲线类型和大小分组分层的结果。
Study Design. Literature review.Objective. To establish consistent parameters for future adolescent idiopathic scoliosis bracing studies so that valid and reliable comparisons can be made.Summary of Background Data. Current bracing literature lacks consistency for both inclusion criteria and the definitions of brace effectiveness.Methods. A total of 32 brace treatment studies and the current bracing in adolescent idiopathic scoliosis proposal were analyzed to: (1) determine inclusion criteria that will best identify those patients most at risk for progression, (2) determine the most appropriate definitions for bracing effectiveness, and (3) identify additional variables that would provide valuable information.Results. Early brace studies lacked clarity in their inclusion criteria. In more recent studies, inclusion criteria have narrowed considerably to include primarily those patients most at risk for curve progression who may benefit from the use of a brace. Brace effectiveness was usually defined by various degrees of curve progression at maturity. Less frequently, it was defined by the resultant curve magnitude at maturity, whether or not surgical intervention was needed, or if there was change to another brace.Conclusions. Optimal inclusion criteria for future adolescent idiopathic scoliosis brace studies consist of: age is 10 years or older when brace is prescribed, Risser 0-2, primary curve angles 25-40, no prior treatment, and, if female, either premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness should include: (1) the percentage of patients who have = 6 degrees progression at maturity, (2) the percentage of patients with curves exceeding 45 at maturity and the percentage who have had surgery recommended/undertaken, and (3) 2-year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. All patients, regardless of subjective reports on compliance, should be included in the results (intent to treat). Every study should provide results stratified by curve type and size grouping.