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制定牙周试验的核心结局集。

Developing a core outcome set for periodontal trials.

机构信息

Dundee Dental School & Hospital, University of Dundee, Dundee, United Kingdom.

Newcastle University School of Dental Sciences, Newcastle upon Tyne, United Kingdom.

出版信息

PLoS One. 2021 Jul 22;16(7):e0254123. doi: 10.1371/journal.pone.0254123. eCollection 2021.

DOI:10.1371/journal.pone.0254123
PMID:34292965
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8297801/
Abstract

BACKGROUND

There is no agreement which outcomes should be measured when investigating interventions for periodontal diseases. It is difficult to compare or combine studies with different outcomes; resulting in research wastage and uncertainty for patients and healthcare professionals.

OBJECTIVE

Develop a core outcome set (COS) relevant to key stakeholders for use in effectiveness trials investigating prevention and management of periodontal diseases.

METHODS

Mixed method study involving literature review; online Delphi Study; and face-to-face consensus meeting.

PARTICIPANTS

Key stakeholders: patients, dentists, hygienist/therapists, periodontists, researchers.

RESULTS

The literature review identified 37 unique outcomes. Delphi round 1: 20 patients and 51 dental professional and researchers prioritised 25 and suggested an additional 11 outcomes. Delphi round 2: from the resulting 36 outcomes, 13 patients and 39 dental professionals and researchers prioritised 22 outcomes. A face-to-face consensus meeting was hosted in Dundee, Scotland by an independent chair. Eight patients and six dental professional and researchers participated. The final COS contains: Probing depths, Quality of life, Quantified levels of gingivitis, Quantified levels of plaque, Tooth loss.

CONCLUSIONS

Implementation of this COS will ensure the results of future effectiveness trials for periodontal diseases are more relevant to patients and dental professionals, reducing research wastage. This could reduce uncertainty for patients and dental professionals by ensuring the evidence used to inform their choices is meaningful to them. It could also strengthen the quality and certainty of the evidence about the relative effectiveness of interventions.

REGISTRATION

COMET Database: http://www.comet-initiative.org/studies/details/265?result=true.

摘要

背景

在研究牙周病干预措施时,尚无关于应测量哪些结果的共识。比较或合并具有不同结果的研究非常困难,导致研究资源浪费,并给患者和医疗保健专业人员带来不确定性。

目的

为牙周病预防和管理的有效性试验制定与主要利益相关者相关的核心结局集(COS)。

方法

混合方法研究,包括文献回顾、在线 Delphi 研究和面对面共识会议。

参与者

主要利益相关者:患者、牙医、口腔保健师/治疗师、牙周病学家、研究人员。

结果

文献回顾确定了 37 个独特的结果。Delphi 研究第 1 轮:20 名患者和 51 名牙科专业人员和研究人员优先考虑了 25 个结果,并提出了另外 11 个结果。Delphi 研究第 2 轮:在 36 个结果中,13 名患者和 39 名牙科专业人员和研究人员优先考虑了 22 个结果。在苏格兰邓迪,由独立主席主持了一次面对面的共识会议。八名患者和六名牙科专业人员和研究人员参加了会议。最终的 COS 包含:探诊深度、生活质量、牙龈炎量化水平、牙菌斑量化水平、牙齿丧失。

结论

实施本 COS 将确保未来牙周病有效性试验的结果更符合患者和牙科专业人员的需求,减少研究资源浪费。这可以通过确保用于为他们的选择提供信息的证据对他们有意义,从而减少患者和牙科专业人员的不确定性。它还可以增强关于干预措施相对有效性的证据的质量和确定性。

登记

COMET 数据库:http://www.comet-initiative.org/studies/details/265?result=true。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f145/8297801/fc1cfa052274/pone.0254123.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f145/8297801/0c19209510b9/pone.0254123.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f145/8297801/fc1cfa052274/pone.0254123.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f145/8297801/0c19209510b9/pone.0254123.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f145/8297801/fc1cfa052274/pone.0254123.g002.jpg

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