Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra, Coimbra, Portugal.
Faculty of Medicine, Institute of Experimental Pathology, University of Coimbra, Coimbra, Portugal.
J Oral Rehabil. 2024 Jul;51(7):1303-1319. doi: 10.1111/joor.13692. Epub 2024 Apr 4.
The selection of appropriate outcomes in clinical trials and systematic reviews is a crucial factor in determining the results that are useful, reliable, and relevant for both patients and healthcare professionals. Clinicians and researchers have been encouraged to develop and apply core outcome sets (COS) to minimise the discrepancy between studies.
This systematic review is the first phase of the COS development project for clinical trials in temporomandibular disorders (COS-TMD). It aims to identify and synthesise the outcomes used in the randomised controlled trials (RCT) that evaluated the effectiveness of interventions used in TMD management.
An electronic search was performed in several databases: MEDLINE (via PubMed), Scopus, Web of Science, Cochrane Library and EMBASE. The eligibility criteria comprised RCT that applied any intervention to treat temporomandibular joint disorders or masticatory muscle disorders. The identified outcomes were categorised according to domains of the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT).
The electronic search resulted in 1606 studies. After removing duplicates and applying the eligibility criteria, 106 RCT were included. A total of 43 studies evaluated masticatory muscle disorders, 27 evaluated temporomandibular joint disorders, and 36 analysed mixed TMD.
The evaluation showed significant variability in the types of outcomes and their measurement instruments. In addition, some domains such as physical and emotional functioning, participant ratings of global improvement and adverse events have been neglected when determining the effectiveness of treatments for TMD.
临床试验和系统评价中选择适当的结局是确定对患者和医疗保健专业人员有用、可靠和相关结果的关键因素。临床医生和研究人员已被鼓励制定和应用核心结局集(COS),以最小化研究之间的差异。
这是颞下颌关节紊乱症(COS-TMD)临床试验核心结局集开发项目的第一阶段。它旨在确定和综合评估 TMD 管理中干预措施有效性的随机对照试验(RCT)中使用的结局。
在几个数据库中进行了电子搜索:MEDLINE(通过 PubMed)、Scopus、Web of Science、Cochrane 图书馆和 EMBASE。纳入标准包括应用任何干预措施治疗颞下颌关节紊乱或咀嚼肌疾病的 RCT。根据临床研究中方法、测量和疼痛评估倡议(IMMPACT)的领域对确定的结局进行分类。
电子搜索产生了 1606 项研究。去除重复项并应用纳入标准后,纳入了 106 项 RCT。共有 43 项研究评估了咀嚼肌疾病,27 项研究评估了颞下颌关节疾病,36 项研究分析了混合 TMD。
评估表明,在结局的类型及其测量工具方面存在显著的可变性。此外,在确定 TMD 治疗效果时,一些领域,如身体和情绪功能、参与者对整体改善的评价和不良事件,被忽视了。