Oral Medicine Department, Guy's and St. Thomas Hospital NHS Foundation Trust, King's College London, London, UK.
Department of Oral Diagnostic Sciences, Faculty of Dentistry, King AbdulAziz University, Jeddah, Saudi Arabia.
Trials. 2020 Aug 12;21(1):711. doi: 10.1186/s13063-020-04640-4.
BACKGROUND: A core outcome set (COS) represents the agreed minimum set of domains and measurement instruments that should be measured and reported in any clinical trial for a given condition. In BMS randomized controlled trials (RCTs), the outcomes identified in the existing literature regarding the efficacy of therapeutic interventions are numerous and diverse. Although the standardized IMMPACT core outcome domains has been developed for measurement of outcomes in chronic pain RCTs, no BMS-specific COS have been adopted and validated. With the evolving landscape of BMS management end points and the development of new therapies, a consensus on a COS for use in future BMS trials is paramount to reduce heterogeneity in outcome reporting. The aim of this study was to reach a consensus for adopting the standardized Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) outcome domains, and their tools of assessment, for burning mouth syndrome (BMS) clinical trials and clinical practice. METHODS: A BMS-specific COS will be developed using the method recommended by the Core Outcome Measures in Effective Trials (COMET) initiative (Registration: http://www.comet-initiative.org/studies/details/1357 ). Selection of questionnaire outcome measures was informed by the IMMPACT consensus and previous systematic review of RCTs in BMS conducted by the consortium. An international group of clinicians and researchers will be invited to participate in several rounds of a Delphi survey. A consensus meeting will be held with the objective of ratifying the outcomes for inclusion in the COS. A finalized COS explanatory document will be drafted, including all outcomes and measurements as determined by the Delphi rounds and consensus meeting. DISCUSSION: A COS for the management of BMS will improve the quality of future RCTs, reduce outcome reporting heterogeneity, and facilitate more vigorous data synthesis of management interventions for systematic reviews and meta-analysis. This would ensure enhanced quality evidence for clinical management of the condition.
背景:核心结局集(COS)代表了在特定疾病的任何临床试验中都应测量和报告的一组经过协商一致的最小域和测量工具。在 BMS 随机对照试验(RCT)中,针对治疗干预效果的现有文献中确定的结局数量众多且多种多样。虽然已经为慢性疼痛 RCT 制定了标准化的 IMMPACT 核心结局领域,但尚未采用和验证任何特定于 BMS 的 COS。随着 BMS 管理终点的不断发展和新疗法的开发,就未来 BMS 试验中使用的 COS 达成共识至关重要,这对于减少结局报告的异质性至关重要。本研究的目的是就采用标准化的临床试验方法、测量和疼痛评估倡议(IMMPACT)结局领域及其评估工具达成共识,以用于治疗口腔灼痛综合征(BMS)的临床试验和临床实践。
方法:将使用核心结局测量在有效试验(COMET)倡议建议的方法开发特定于 BMS 的 COS(注册:http://www.comet-initiative.org/studies/details/1357)。问卷结局测量的选择由 IMMPACT 共识和联盟之前对 BMS 的 RCT 进行的系统评价告知。将邀请国际临床医生和研究人员参加几轮 Delphi 调查。将举行一次共识会议,目的是批准纳入 COS 的结局。将起草一份最终的 COS 解释文件,其中包括 Delphi 轮次和共识会议确定的所有结局和测量。
讨论:BMS 管理的 COS 将提高未来 RCT 的质量,减少结局报告的异质性,并促进更有力的管理干预措施的数据综合,用于系统评价和荟萃分析。这将确保为该疾病的临床管理提供更优质的证据。
J Eur Acad Dermatol Venereol. 2021-9
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