School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
Division of Restorative Dentistry & Periodontology, Dublin Dental University Hospital, Trinity College Dublin, University of Dublin, Dublin, Ireland.
Int Endod J. 2024 Mar;57(3):270-280. doi: 10.1111/iej.14008. Epub 2023 Dec 27.
Development of a standardized set of topic-specific outcomes known as a Core Outcome Set (COS) is important to address issues of heterogeneity in reporting research findings in order to streamline evidence synthesis and clinical decision making.
The aim of the current international consensus study is to identify "what" outcomes to include in the Core Outcome Set for Endodontic Treatments (COSET). Outcomes of various endodontic treatments (non-surgical root canal treatment, surgical endodontics, vital pulp treatment and revitalization procedures) performed on permanent teeth were considered.
A standard validated methodology for COS development and reporting was adopted. The process involved identification of existing outcomes through four published scoping reviews. This enabled creation of a list of outcomes to be prioritized via semi-structured patient interviews, e-Delphi process and a consensus meeting with a range of relevant global stakeholders. Outcomes were prioritized using a 1-9 Likert scale, with outcomes rated 7-9 considered critical, 4-6 are important and 1-3 are less important. Outcomes rated 7-9 by ≥70% and 1-3 by <15% of participants were considered to achieve consensus for inclusion in the COS. The outcomes that did not achieve consensus in the first round were considered for further prioritization in the second Delphi round and consensus meeting. Final decisions about the outcomes to include in COSET were made by voting during the consensus panel meeting using the Zoom Poll function.
A total of 95 participants including patients contributed to the COS development process. The consensus panel recommended, with strong consensus, eight outcomes shared across all treatment modalities for inclusion in COSET: pain; signs of infection (swelling, sinus tract); further intervention/exacerbation; tenderness to percussion/palpation; radiographic evidence of disease progression/healing; function; tooth survival; and patient satisfaction. Additional treatment specific outcomes were also recommended.
Many of the outcomes included in COSET are patient reported. All should be included in future outcomes studies.
COSET identified outcomes that are important for patients and clinicians and validated these using a rigorous methodology. Further work is ongoing to determine "how" and "when" these outcomes should be measured.
制定一套标准化的特定主题结局,即核心结局集(COS),对于解决报告研究结果的异质性问题非常重要,以便简化证据综合和临床决策。
本国际共识研究的目的是确定纳入牙髓治疗核心结局集(COSET)的“哪些”结局。考虑了各种牙髓治疗(非手术根管治疗、手术牙髓学、活髓治疗和再生活跃程序)在恒牙上的结局。
采用了一种用于 COS 开发和报告的标准验证方法。该过程通过四项已发表的范围综述确定了现有结局,从而创建了一个通过半结构化患者访谈、电子德尔菲法和具有广泛相关全球利益相关者的共识会议来确定优先级的结局清单。使用 1-9 级 Likert 量表对结局进行优先级排序,评分 7-9 的结局被认为是关键的,4-6 是重要的,1-3 是不太重要的。如果≥70%的参与者对结局评分 7-9,且<15%的参与者评分 1-3,则认为该结局达到纳入 COS 的共识。在第一轮未达成共识的结局将在第二轮德尔菲法和共识会议中进一步进行优先级排序。在共识小组会议期间,使用 Zoom Poll 功能投票来对纳入 COSET 的结局做出最终决定。
共有 95 名参与者,包括患者,参与了 COS 的开发过程。共识小组强烈一致地推荐了纳入 COSET 的八项在所有治疗方式中都共享的结局:疼痛;感染迹象(肿胀、窦道);进一步干预/恶化;叩诊/触诊压痛;疾病进展/愈合的放射学证据;功能;牙齿存活;和患者满意度。还推荐了其他特定于治疗的结局。
COSET 纳入的许多结局都是患者报告的。所有这些结局都应该纳入未来的结局研究中。
COSET 确定了对患者和临床医生都很重要的结局,并使用严格的方法对其进行了验证。进一步的工作正在进行中,以确定应该如何以及何时测量这些结局。