背景:开发一套标准化的主题特异性结果集(称为核心结果集(COS))对于解决研究结果报告中的异质性问题非常重要,以简化证据综合和临床决策。
目的:当前国际共识研究的目的是确定牙髓治疗核心结果集(COSET)中包含的“什么”结果。各种牙髓治疗的结果(非手术根管治疗,外科牙髓,考虑了对恒牙进行的重要牙髓治疗和振兴程序)。
方法:采用了COS开发和报告的标准验证方法。该过程涉及通过四个已发布的范围界定审查来确定现有结果。这使得能够通过半结构化患者访谈创建结果列表,e-Delphi进程和与一系列相关全球利益攸关方的共识会议。结果使用1-9李克特量表进行优先排序,结果评级为7-9被认为是关键的,4-6很重要,1-3不太重要。≥70%的结果为7-9,<15%的参与者为1-3,被认为达成了纳入COS的共识。第一轮未达成共识的结果被考虑在第二轮德尔菲轮和共识会议上进一步确定优先次序。通过在共识小组会议期间使用ZoomPoll功能进行投票,最终决定了要包含在COSET中的结果。
结果:总共95名参与者(包括患者)参与了COS的发展过程。共识小组建议,有强烈的共识,纳入COSET的所有治疗模式共有八个结果:疼痛;感染迹象(肿胀,窦道);进一步干预/恶化;敲击/触诊压痛;疾病进展/愈合的影像学证据;功能;牙齿存活;和患者满意度。还建议额外的治疗具体结果。
结论:COSET中包含的许多结果均为患者报告。所有这些都应包括在未来的结果研究中。
结论:COSET确定了对患者和临床医生重要的结果,并使用严格的方法学验证了这些结果。进一步的工作正在进行中,以确定“如何”和“何时”应测量这些结果。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: Many of the outcomes included in COSET are patient reported. All should be included in future outcomes studies.
CONCLUSIONS: 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.