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Establishing a Core Outcome Set for Endodontic Treatment modalities

2022; Wiley; Volume: 55; Issue: 7 Linguagem: Inglês

10.1111/iej.13749

1365-2591

Ikhlas El Karim, Henry F. Duncan, Siobhan Cushley, Venkateshbabu Nagendrababu, Lise‐Lotte Kirkevang, Casper Kruse, B. S. Chong, Pratik Shah, Mark Lappin, Conor McLister, Fionnuala T. Lundy, Mike Clarke,

Spine and Intervertebral Disc Pathology

The primary goal of endodontic treatment is the prevention or treatment of apical periodontitis (Kirkevang & Vaeth, 2019). The achievement of this goal is evaluated as an outcome through a process involving a combination of detailed patient history together with clinical and radiological examination. An outcome is a clinical measure used to make judgements not only about the efficacy or effectiveness of treatment but also to represent the suffering or loss of health experienced by an individual because of the disease process (Boers et al., 2014). Assessment of the outcome of endodontic treatment has evolved from primarily disease-based criteria to include patient-centred values, which emphasize survival and function even in the presence of inflammatory periapical disease (Chugal et al., 2017). Notably, endodontic treatment outcomes previously reported in many systematic reviews are demonstrated to have multiple limitations, with concerns highlighted over the use of only clinician-reported outcome measures, a lack of standardization between studies or the relevance of the outcome measures selected (Cushley et al., 2019, 2021; Wu et al., 2009). Variability, lack of consensus and reporting bias in describing outcomes are major concerns in the currently available clinical research that is necessary to underpin guideline development and ultimately direct patient care. These issues, however, can be addressed through the development of a core outcome set (COS). A COS is defined as an agreed, standardized set of outcomes that should be included, measured and reported as a minimum in all trials and on outcome studies in a particular field (Williamson et al., 2012). A COS increases the likelihood that important outcomes are measured, improves evidence synthesis by reducing heterogeneity between studies and reduces outcome-reporting bias to enhance the validity of studies (Clarke, 2008). In Dentistry, COS has been or being developed for various dental treatments, including management of traumatic dental injuries (Kenny et al., 2018), periodontal treatment (Lamont et al., 2017) and orthodontic treatment (Tsichlaki et al., 2020). As part of the European Society of Endodontology S3-level clinical practice guidelines development process (Duncan et al., 2021a) a focused, but abbreviated COS development process was completed (Duncan et al., 2021b). The ESE S3-level outcome measure project was limited in its consensus to the 10-member guideline steering group and was not representative of all stakeholders, particularly patients. Similarly, literature-based synthesis of outcomes in nonsurgical root canal treatment, nonsurgical retreatment, and apexification procedures were recently reported, but the process did not involve relevant stakeholders including patients or consensus development (Azarpazhooh et al., 2022). However, Endodontology is a broad subject which also includes vital pulp treatment, surgical endodontics, and revitalization procedures. In order to address shortcomings and develop a definitive COS, a group of experts across the globe have collaborated to develop a COS for all endodontic treatment modalities using a standard and approved methodology in line with the Core Outcome Set-STAndards for Development (COS-STAD) and Core Outcome Set–STAndards for Reporting the (COS-STAR) recommendations (Kirkham et al., 2016, 2017). The lack of agreed outcomes for endodontic treatment modalities prevents standardized reporting of clinical trials and outcome studies and thereby, negatively impacts on evidence synthesis and may eventually affect patient care. COSET is designed for use in both research and clinical practice, including any healthcare setting in which endodontic treatment of adults with pulpal and periapical disease is carried out. This COSET will develop COS for vital pulp treatment, nonsurgical root canal treatment, surgical endodontics and revitalization procedures. An a priori protocol for the development of COSET project was published (El Karim et al., 2021) and registered in COMET (https://comet-initiative.org/Studies/Details/1879). Ethical approval for this project was obtained from Queens University Belfast Faculty Research Ethics Committee (REC Reference Number: MHLS 21_28) and from Office of Research Ethics Committee Northern Ireland (REC reference: 21/NI/0078). The project will be carried out in two phases as follows: Phase 1: A structured scoping review of the literature will be performed to identify all outcomes reported in endodontic treatment outcome studies. The COSET has been divided into four major categories: vital pulp treatment, nonsurgical root canal treatment, surgical endodontics and revitalization procedures. The project leader (IEK) developed four reviews groups, to perform scoping reviews in: vital pulp treatment (SC, HD, IEK), nonsurgical root canal treatment (L-LK, CK), surgical endodontics (BSC, PKS) and revitalization procedures (ML, CMcL, HD). Outcomes identified for each treatment modality will be grouped into five cores areas: survival, clinical/physiological changes, life impact, resource use and adverse events (Dodd et al., 2018). Within each core area, disease and treatment specific outcome domains will be collated and put forward for later rating and grading of their importance via the consensus process described below. Phase 2: Consensus process using Delphi methodology and semi-structured interviews lead by (NV, MC) to agree the most important outcomes. With adequate representation from each group, patients, general dental practitioners, endodontists, policy makers (commissioners), students, industry representatives and researchers will contribute to the consensus process. It is critical that this project includes patients (Williamson et al., 2017). Patient contributions to help identify outcomes have not previously been considered (Sanderson et al., 2010), and patient-reported outcomes are often ignored in endodontic research (Duncan et al., 2021b). Patient representatives will be identified from those participating in clinical trial for endodontic treatment. Endodontists, general dental practitioners, students, policy makers and researchers will be identified and contacted through their employers or professional bodies. The geographical distribution of participants will be considered to ensure adequate international representation. During the process of COS development, it is important to select appropriate outcome measurement instruments (OMIs) and the appropriate time points at which the outcomes should be measured. Therefore, to select appropriate OMIs for COSET, guidelines for section of OMIs described by Prinsen et al. (2016) will be followed. The process involves identifying the outcomes and the measurement instrument through review of the literature and this will be carried out in Phase 1 as described above. The second step is to assess the quality of the OMIs, by means of the evaluation of the measurement properties of the instrument, such as reliability, validity, variability, and feasibility of use. Following this, OMIs with, high quality evidence for good content validity, internal consistency and feasibility will be forwarded for consideration in a consensus process described in Phase 2 and to obtain final agreement on the selected OMIs to be included in the COSET. Development and implementation of a COS for endodontic treatment will ensure standardized use of outcomes in research and clinical practice. Using standardized methodology for COS development, this project will provide for the first-time consensus on the COS required for different endodontic treatment modalities. Inclusion of patients and other key stakeholders is crucial and has not been reported in previous dental COS studies, which is a strength of this project and ensures a focus on treatment outcomes that are relevant with good external validity. The results of this project will be shared with participants and stakeholders including publication in peer-reviewed international journals. To increase uptake in the profession, the COS will also be actively shared with clinical guideline developers, research funders, dental and Endodontology journal editors. The authors have stated explicitly that there are no conflicts of interest in connection with this article. All the authors have made substantial contributions to the manuscript. All the authors have read and approved the final version of the manuscript. Ethical approval was not necessary, as this article is not a research study that involved any human or animal experiments.