牙周试验的核心结局：核心结局集制定的研究方案
Core outcomes in periodontal trials: study protocol for core outcome set development.
作者信息
Lamont Thomas J, Clarkson Jan E, Ricketts David N J, Heasman Peter A, Ramsay Craig R
机构信息
Dundee Dental School, Park Place, University of Dundee, Dundee, UK.
School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.
出版信息
Trials. 2017 Sep 20;18(1):436. doi: 10.1186/s13063-017-2169-z.
BACKGROUND
There are a large number of clinical outcome measures used to assess the effectiveness of prevention and management strategies of periodontal diseases. This heterogeneity causes difficulties when trying to synthesise data for systematic reviews or clinical guidelines, reducing their impact. Core outcome sets are an agreed, standardised list of outcomes that should be measured and reported in all trials in specific clinical areas. We aim to develop a core outcome set for effectiveness trials investigating the prevention and management of periodontal disease in primary or secondary care.
METHODS
To identify existing outcomes we screened the Cochrane systematic reviews and their included studies on the prevention and management of periodontal diseases. The core outcome set will be defined by consensus of key stakeholders using an online e-Delphi process and face-to-face meeting. Key stakeholders involved in the development will include: patients, dentists, hygienists/therapists, specialists, clinical researchers and policy-makers. Stakeholders will be asked to prioritise outcomes and feedback will be provided in the next round(s). Stakeholders will have an opportunity to add outcomes found in the Cochrane review screening process at the end of the first round. If consensus is not reached after the second round we will provide feedback prior to a third round. Remaining outcomes will be discussed at a face-to-face meeting and agreement will be measured via defined consensus rules of outcome inclusion.
DISCUSSION
The inclusive consensus process should provide a core outcome set that is relevant to all key stakeholders. We will actively disseminate our findings to help improve clinical trials, systematic reviews and clinical guidelines with the ultimate aim of improving the prevention and management of periodontal diseases.
TRIAL REGISTRATION
COMET ( http://www.comet-initiative.org/studies/details/265?result=true ). Registered on August 2012.
背景
有大量临床结局指标用于评估牙周疾病预防和管理策略的有效性。这种异质性在试图为系统评价或临床指南综合数据时造成困难，降低了它们的影响力。核心结局集是在特定临床领域的所有试验中应测量和报告的一组商定的、标准化的结局指标。我们旨在为调查初级或二级保健中牙周疾病预防和管理的有效性试验制定一个核心结局集。
方法
为了识别现有的结局指标，我们筛选了Cochrane系统评价及其纳入的关于牙周疾病预防和管理的研究。核心结局集将通过在线电子德尔菲法和面对面会议，由关键利益相关者达成共识来确定。参与制定的关键利益相关者将包括：患者、牙医、口腔保健员/治疗师、专家、临床研究人员和政策制定者。将要求利益相关者对结局指标进行优先排序，并在下一轮提供反馈。利益相关者将有机会在第一轮结束时添加在Cochrane综述筛选过程中发现的结局指标。如果在第二轮后未达成共识，我们将在第三轮之前提供反馈。其余结局指标将在面对面会议上进行讨论，并通过定义的结局指标纳入共识规则来衡量是否达成一致。
讨论
包容性的共识过程应提供一个与所有关键利益相关者相关的核心结局集。我们将积极传播我们的研究结果，以帮助改进临床试验、系统评价和临床指南，最终目标是改善牙周疾病的预防和管理。
试验注册
COMET（http://www.comet-initiative.org/studies/details/265?result=true）。于2012年8月注册。
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