作者
Henry F. Duncan,B. S. Chong,Massimo Del Fabbro,I. El‐Karim,Kerstin M. Galler,Lise‐Lotte Kirkevang,Gabriel Krastl,Ove A. Peters,Juan J. Segura‐Egea,Moritz Kebschull
摘要
The clinical practice of Endodontics has seen substantial changes in the last two decades, with major technical innovations such as the operating microscope, cone beam computed tomography (CBCT), nickel titanium rotary/reciprocating instruments and novel treatment modalities such as regenerative endodontics. At this stage, an update for Clinical Practice Guidelines is the next step to promote best practice and improve outcomes. The European Society of Endodontology (ESE) is committed to the process of developing new S3-Level Clinical Practice Guidelines for the treatment of pulpal and apical diseases, which will benefit clinicians, patients and other relevant stakeholders. The ESE last published quality guidelines for endodontic treatment in 2006 (ESE 2006) and since then, the process of consensus and guideline writing has changed significantly. In the development of the highest quality S3-Level guidelines, a comprehensive systematic review of the literature prior to a formal guideline consultation process is essential, as is a central focus on outcomes relevant to the patient using the Grading of Recommendations, Assessment, Development and Evaluations framework (Guyatt et al. 2008, 2011). Within this process, after the review of the literature a formal guideline meeting will be organized and a representative guideline group will consider and vote on all sections of the guideline document including the clinical recommendations. This process has been employed in the recent European Federation of Periodontology S3-Level Guidelines for treatment of Stage I-III periodontitis (Sanz et al. 2020). From a methodological perspective, the ESE has traditionally created guidelines based on recommendations by an expert group (S1 level), rather than via an formal consensus process, with these S1-level recommendations taking the form of quality guidelines (ESE 2006) or position statements on a range of subjects including, revitalization (ESE 2016), antibiotics in Endodontics (ESE 2018a), external cervical resorption (ESE 2018b), management of deep caries and the exposed pulp (ESE 2019a), CBCT (ESE 2019b) and surgical extrusion, intentional replantation and tooth auto-transplantation (ESE 2021). The next level, second stage (S2e and S2k) guidelines are considered higher quality using formalized methodological techniques; however, it is acknowledged that although position statements are important, the development of highest level treatment guidelines (S3) requires a more structured, formalized and transparent process to ensure relevance of the outcomes and consistency of the findings (Nothacker et al. 2014). Since receiving ESE Board approval in November 2020, the ESE S3-level guideline project has developed a framework and a provisional 2-year timetable for the guideline development process. A steering group of 10 individuals, comprising two overarching guideline leads (H. Duncan and M. Kebschull) and eight working group leads, has been formed and has met online to discuss the project. All working group leads were selected as senior clinical academics with experience of working with evidence-based dentistry approaches. In order to ensure rigour and reduce bias, each working group has two leads from different jurisdictions and with no history of previous collaboration with each other. The steering group will work throughout the process with the assistance of a senior guideline methodologist (I. Kopp) on a range issues relating to methodological training, standardization, selection of appropriate outcome measures, study selection, review process and conflicts of interest (COI). Indeed, a formal assessment of COI is a key feature of the S3-process with each participant making a declaration of interest, which is then considered by the steering group as to whether it could be perceived as a COI by external stakeholders. If COIs are identified, participants remain included but may be asked to abstain from voting, or even from participating in group discussions. The four ESE S3 working groups (WG) will focus on systematic reviews of treatment outcomes relating to the principle endodontic diseases (pulpitis and apical periodontitis) as follows: It was considered after discussion that other topics such as restoration of the endodontically treated tooth, the treatment of vertical root fractures and the endodontic management of traumatized teeth are not within the remit of the treatment of pulpitis and apical periodontitis and will be considered separately in position statements or as a component of another ESE guideline process. After initial meetings of the steering group, a further 32 global experts were selected to lead the 13 proposed systematic reviews distributed between the four WGs. All selected reviewers were considered eligible if they fulfilled the following criteria: After agreeing to assist the ESE in this process, all reviewers attended an online methodological training session with a guideline methodologist (I. Kopp) in January 2021. The systematic reviewers and members of the steering group are currently involved in the selection by consensus of scientifically justified patient-centred outcome measures for use in the systematic review process described in this issue of the IEJ (Duncan et al. 2021) prior to writing PICOT questions for their reviews. Thereafter, the systematic review groups will be submitting protocols for a priori review registration and receiving feedback from the steering committee members on their proposals. After consistency of review questions and completeness is ensured, reviewers will be asked to proceed with their respective systematic reviews before submission to a rigorous peer review process. Subsequent to revision and successful acceptance of the commissioned systematic reviews the findings will be used to populate the guideline document for consideration and voting on the strength of recommendation at the guideline summit in late 2022. It is envisaged that the commissioned systematic reviews as well as the guideline document will be published in a special edition of the International Endodontic Journal at the culmination of the process. In summary, clinical guidelines contribute to an improvement in the quality of dental care for the general population by providing evidenced-based recommendations relevant to patients and clinicians, which later assist decision-making for treatment of specific diseases. It is important for the specialty of Endodontology for the profession to engage in high-quality guidelines to justify the treatments provided for patients. To that end, this involved process will continue until the release of the guidelines and associated systematic reviews in 2022/23.