Division of Restorative Dentistry & Periodontology, Dublin Dental University Hospital, Trinity College Dublin, Dublin, Ireland.
Department of Preventive and Restorative Dentistry, College of Dental Medicine, University of Sharjah, Sharjah, UAE.
Int Endod J. 2021 Dec;54(12):2184-2194. doi: 10.1111/iej.13627. Epub 2021 Sep 22.
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.
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.
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.
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.
欧洲牙髓病学会（ESE）正在制定牙髓和根尖疾病治疗的 S3 级临床实践指南。为了支持强有力的系统文献综述，必须首先确定具有最小随访时间的适当的结局测量（OM）。因此，目前的项目旨在通过标准的共识方法，确定具有最小/最大随访时间的适当 OM，以评估牙髓炎和根尖周炎的根管治疗效果，用于 ESE S3 级指南的制定。
在文献检索后，由指南制定小组（GDG）为牙髓炎治疗（工作组 [WG] 1）、根尖周非手术治疗（WG 2）、根尖周手术治疗（WG 3）和根尖周再生治疗（WG 4）确定了相关 OM 的清单。GDG 的 43 名成员使用 9 分李克特量表对每个 WG 的 OM 对患者的重要性进行了排名。得分在 7-9（关键重要性）的项目超过 70%，得分在 1-3（有限重要性）的项目低于 30%的项目被纳入，而得分在 1-3 的项目超过 70%，得分在 7-9 的项目低于 30%的项目被排除。几次在线德尔菲会议确定了一份只有重要 OM 的编辑清单。GDG 讨论了排名的 OM，并将其协调为“最关键”、“关键”和“重要”的措施。在确定最终的排名措施后，指南指导小组定义了与每个 OM 相关的最小和最大随访时间。
德尔菲调查进行了两轮。在所有四个 WG 中，患者报告的结果测量（PROM）“牙齿存活”被评为“最关键的措施”，而其他 PROM，包括“疼痛”和“需要药物治疗”，以及临床医生报告的结果测量（CROM）“放射评估”被认为是“关键”。PROM“需要进一步干预”和“口腔健康相关生活质量”（OHRQoL）被包括在内，但作为“重要”而不是“关键”的措施。WG1 中的“活力测试”被定义为关键，WG4 中的“根的长度和宽度增加”被定义为“关键”，这在 WG 之间存在差异。所有 OM 都需要至少 1 年和最长“尽可能长”的随访时间，除了“疼痛”、“肿胀”、“药物治疗”和“OHRQoL”，这些 OM 的随访时间可以更短。
GDG 共识过程确定了 PROM“牙齿存活”为“最关键”。确定的 OM 和随访时间将应用于所有委托的系统评价，为随后制定 ESE S3 级临床实践指南的过程提供信息。
