IMMPACT recommendations for clinical trials: opportunities for the RDC/TMD
IMMPACT recommendations for clinical trials: opportunities for the RDC/TMD
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DOI：
10.1111/j.1365-2842.2010.02152.x
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发表时间：
2010-10-01
影响因子：
2.9
通讯作者：
Haythornthwaite, J. A.
中科院分区：
文献类型：
--
作者：
Haythornthwaite, J. A.
临床试验方法、测量和疼痛评估倡议（IMMPACT）对临床试验结果的核心领域和测量的建议补充了颞下颌关节紊乱病研究诊断标准（RDC/TMD）的平行工作。尽管根据TMD文献中建立的先例，用于量化临床表现的具体工具有适当的不同，但RDC/TMD的总体方法与IMMPACT建议一致。IMMPACT的建议，而针对临床试验，具有广泛的效用，所有的临床研究在TMD。未来的TMD研究应考虑纳入健康相关生活质量的测量和跟踪参与者的处置，以及跟踪治疗的不良事件和评估参与者对临床试验变化的总体评估。RDC/TMD方法提供了丰富的基础，在此基础上制定标准，量化多个领域治疗结果的临床意义，这是一个发展成熟的领域。轴II可能受益于概念化的转变，其中测量侧重于筛查抑郁症和躯体化，以一种新的，多维的方法，其中轴II域的测量和评估的症状严重程度的连续性。结合轴II的扩展，包括灾难性和睡眠障碍的措施，由此产生的方法可以提供一个强大的方法来评估与TMD不良结局相关的风险状况。
P>The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations for core domains and measures of outcome in clinical trials complement the parallel work completed on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The overall approach of the RDC/TMD is consistent with the IMMPACT recommendations, although the specific tools used to quantify clinical presentation are appropriately different based on the precedents established in the TMD literature. The IMMPACT recommendations, while directed at clinical trials, have broad utility for all clinical research in TMD. Future TMD studies should consider including a measure of health-related quality of life and tracking participant disposition, as well as tracking adverse events from treatment and assessing the participant's global assessment of change in clinical trials. The RDC/TMD methodology provides a rich basis upon which to develop standards for quantifying the clinical significance of treatment outcomes across multiple domains, an area ripe for development. Axis II may benefit from a shift in conceptualisation in which measurement focuses on screening for depression and somatisation to a new, dimensional approach in which Axis II domains are measured and evaluated on a continuum of symptom severity. Combined with the expansion of Axis II to include measures of catastrophising and sleep disturbance, the resulting approach may provide a powerful method for evaluating risk profiles associated with poor outcomes in TMD.