Audigé Laurent, Bhandari Mohit, Hanson Beate, Kellam James
AO Clinical Investigation and Documentation, AO Foundation, Davos Platz, Switzerland.
J Orthop Trauma. 2005 Jul;19(6):401-6. doi: 10.1097/01.bot.0000155310.04886.37.
The fracture classification systems currently used most frequently were not developed or validated by rigorous scientific evaluation methods. This paper discusses the classification of fractures from an epidemiological and clinical decision-making perspective and proposes a standardized methodological concept for their development and scientific validation. Classification categories are clinically relevant entities that surgeons should be able to use for diagnosis with sufficient confidence to limit misclassification and associated treatment errors. The process of validation should assess the value of specific clinical information (eg, the use of radiographs or computed tomography scans) in increasing the probability of a correct diagnosis. A 3-phase validation concept is proposed where: 1) classification categories are defined and the classification process using specific diagnostic images is evaluated by experts in a series of agreement studies (reliability, accuracy, likelihood ratios); 2) a multicenter agreement study is conducted among a representative group of future users of the classification; and 3) the classification proposal is applied in the context of a prospective clinical study to assess its clinical usefulness.
目前最常使用的骨折分类系统并非通过严格的科学评估方法开发或验证。本文从流行病学和临床决策的角度讨论骨折分类，并提出一种用于其开发和科学验证的标准化方法概念。分类类别是临床相关实体，外科医生应能够有足够信心地将其用于诊断，以限制错误分类及相关治疗错误。验证过程应评估特定临床信息（如使用X光片或计算机断层扫描）在提高正确诊断概率方面的价值。本文提出了一个三阶段验证概念，即：1）定义分类类别，并通过一系列一致性研究（可靠性、准确性、似然比）由专家评估使用特定诊断图像的分类过程；2）在该分类的未来使用者代表群体中进行多中心一致性研究；3）在一项前瞻性临床研究中应用分类提案以评估其临床实用性。
