Section of Musculoskeletal Disease, University of Leeds, Leeds, UK.
Osteoarthritis Cartilage. 2011 May;19(5):606-10. doi: 10.1016/j.joca.2011.02.018. Epub 2011 Mar 23.
The Osteoarthritis Research Society International initiated a number of working groups to address a call from the US Food and Drug Administration (FDA) on updating draft guidance on conduct of osteoarthritis (OA) clinical trials. The development of disease-modifying osteoarthritis drugs (DMOADs) remains challenging. The Assessment of Structural Change (ASC) Working Group aimed to provide a state-of-the-art critical update on imaging tools for OA clinical trials.
The Group focussed on the performance metrics of conventional radiographs (CR) and magnetic resonance imaging (MRI), performing systematic literature reviews for these modalities. After acquiring these reviews, summary and research recommendations were developed through a consensus process.
For CR, there is some evidence for construct and predictive validity, with good evidence for reliability and responsiveness of metric measurement of joint space width (JSW). Trials off at least 1 and probably 2 years duration will be required. Although there is much less evidence for hip JSW, it may provide greater responsiveness than knee JSW. For MRI cartilage morphometry in knee OA, there is some evidence for construct and predictive validity, with good evidence for reliability and responsiveness. The responsiveness of semi-quantitative MRI assessment of cartilage morphology, bone marrow lesions and synovitis was also good in knee OA.
Radiographic JSW is still a recommended option for trials of structure modification, with the understanding that the construct represents a number of pathologies and trial duration may be long. MRI is now recommended for clinical trials in terms of cartilage morphology assessment. It is important to study all the joint tissues of the OA joint and the literature is growing on MRI quantification (and its responsiveness) of non-cartilage features. The research recommendations provided will focus researchers on important issues such as determining how structural change within the relatively short duration of a trial reflects long-term change in patient-centred outcomes.
国际骨关节炎研究协会（Osteoarthritis Research Society International）成立了多个工作组，以回应美国食品和药物管理局（FDA）关于更新骨关节炎（OA）临床试验指南的呼吁。开发治疗骨关节炎的药物（DMOAD）仍然具有挑战性。结构改变评估（ASC）工作组旨在提供有关 OA 临床试验成像工具的最新技术更新。
该小组专注于常规射线照相（CR）和磁共振成像（MRI）的性能指标，对这些模式进行了系统的文献回顾。在获得这些综述后，通过共识过程制定了总结和研究建议。
对于 CR，有一些关于结构和预测有效性的证据，并且关节间隙宽度（JSW）测量的可靠性和反应性有很好的证据。至少需要 1 年甚至 2 年的试验时间。尽管髋关节 JSW 的证据较少，但它可能比膝关节 JSW 更具反应性。对于膝关节 OA 的 MRI 软骨形态计量学，有一些关于结构和预测有效性的证据，并且具有良好的可靠性和反应性。膝关节 OA 中半定量 MRI 评估软骨形态、骨髓病变和滑膜炎的反应性也很好。
对于结构改变的试验，放射学 JSW 仍然是一种推荐的选择，需要了解结构代表多种病理学，并且试验持续时间可能很长。现在推荐 MRI 用于评估软骨形态的临床试验。研究所有 OA 关节的关节组织以及关于 MRI 定量（及其反应性）的非软骨特征的文献增长非常重要。提供的研究建议将使研究人员专注于一些重要问题，例如确定试验期间相对较短的结构变化如何反映患者为中心的长期结果的变化。
