Outcome measures to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of European Society of Endodontology S3-level clinical practice guidelines: A consensus-based development

摘要

AIMS 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. 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. 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.