目的:欧洲牙髓学会(ESE)正在制定S3级临床实践指南,以治疗牙髓和根尖疾病。为了支持稳健的系统文献综述,必须首先确定具有最短随访时间的适当结果指标(OMs)。因此,本项目旨在通过基于共识的标准方法学,确定合适的OMs,以评估牙髓炎和根尖周炎牙髓治疗的有效性,用于制定ESES3级指南.
方法:经过文献检索,相关OMs列表由治疗牙髓炎的指南制定组(GDG)(工作组[WG]1)确定,根尖周炎的非手术治疗(WG2),根尖周炎的手术治疗(WG3)和根尖周炎的再生治疗(WG4)。与每个WG相关的OMs由GDG的43名成员使用9点Likert量表对患者的重要性进行排名。包括7-9分(关键重要性)超过70%的项目和少于30%成员的1-3分(有限重要性)的项目,而1-3分超过70%的项目和7-9分低于30%的项目被排除。几个在线Delphi会议建立了一个编辑的列表,其中只有重要的OMs。排名的OMs由GDG讨论并协调产生“最关键”,\'关键\'和\'重要\'度量。在建立了最终排名的措施之后,与每个OM相关的最小和最大随访时间由指南指导组定义.
结果:Delphi调查进行了两轮。在所有四个工作组中,患者报告的结果测量(PROM)“牙齿存活率”被评为“最关键的测量”,而包括“疼痛”和“需要药物”在内的其他PROM被认为是“严重的”,除了临床医生报告的结果测量(CROM),\'射线照相评估\'。包括“需要进一步干预”和“口腔健康相关生活质量”(OHRQoL)的PROM,但作为\'重要\'而不是\'关键\'措施。在WG1中定义为关键的“活力测试”的WG与在WG4中定义为“关键”的“根的长度和宽度增加”之间发生了差异。认为有必要对所有OMs进行至少1年和“尽可能长”的最长期限,除了“痛苦”,\'肿胀\',\'药物\'和\'OHRQoL\',接受较短的随访。
结论:GDG共识过程将PROM“牙齿存活”确立为“最关键”。确定的OMs和随访时间将应用于所有委托的系统评价,这些评价将在制定ESES3级临床实践指南时为后续过程提供信息。
OBJECTIVE: The European Society of Endodontology (ESE) is in the process of developing S3-level clinical practice
guidelines for the treatment of pulpal and apical disease. In order to support robust systematic literature reviews, appropriate outcome measures (OMs) with minimum follow-up times must first be identified. Hence, the current project aimed to identify the appropriate OMs with minimum/maximum follow-up time to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of ESE S3-level guidelines through a standard
consensus-based methodology.
METHODS: After a literature search, lists of relevant OMs were identified by the
guideline development group (GDG) for the treatment of pulpitis (working group [WG] 1), the non-surgical treatment of apical periodontitis (WG 2), the surgical treatment of apical periodontitis (WG 3) and the regenerative treatment of apical periodontitis (WG 4). OMs relevant to each WG were ranked by the 43 members of the GDG in their importance to the patient using a 9-point Likert scale. Items with a score of 7-9 (critical importance) by more than 70% and items with a score of 1-3 (limited importance) by less than 30% of members were included, whereas the items with a score of 1-3 by more than 70% and items with a score of 7-9 by less than 30% were excluded. Several online Delphi meetings established an edited list of only important OMs. The ranked OMs were discussed by the GDG and harmonized to produce \'most critical\', \'critical\' and \'important\' measures. After establishing the final ranked measures, the minimum and maximum length of follow-up related to each OM was defined by the
guideline steering group.
RESULTS: The Delphi survey took place over two rounds. The patient-reported outcome measure (PROM) \'tooth survival\' was rated the \'most critical measure\' in all four WGs, while other PROMs including \'pain\' and \'need for medication\' were considered \'critical\', alongside the clinician-reported outcome measures (CROM), \'radiographic assessment\'. The PROMs \'The need for further intervention\' and \'oral-health-related-quality-of-life\' (OHRQoL) were included, but as \'important\' not \'critical\' measures. Differences occurred between WGs with \'vitality testing\' defined as critical in WG1 and \'increased length and width of the root\' defined as \'critical\' in WG4. A minimum of 1-year and maximum of \'as long as possible\' for all OMs were deemed necessary, except \'pain\', \'swelling\', \'medication\' and \'OHRQoL\', where shorter follow-up was accepted.
CONCLUSIONS: The GDG
consensus process established the PROM \"tooth survival\" as the \"most-critical\". The identified OMs and length of follow-up will be applied to all the commissioned systematic reviews that will inform the subsequent process when developing the ESE S3-level clinical practice guidelines.