Multi‐stakeholder contribution to the identification of a core outcome set and measurements in implant dentistry (<scp>ID‐COSM</scp> initiative) using the Delphi methodology

Sanz, Mariano; Albornoz, A. Carrillo de; Martín, Conchita; Needleman, Ian; Tonetti, Maurizio S.

doi:10.1111/jcpe.13805

Cited by 9 publications

(9 citation statements)

References 39 publications

(24 reference statements)

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“…The panel took great care to avoid overlaps between the SRs or significant thematic omissions in order to ensure that they encompass the main interventions currently undertaken in the management of peri-implant diseases. followed (Derks et al, 2022;Needleman et al, 2023;Sanz et al, 2023;Tonetti et al, 2023), specifically the conclusions of the SR dealing with the outcome measures used in clinical studies (Derks et al, 2022). As expected, and since the report of the strongest outcome (dental implant/ implant-supported prosthesis survival) was not frequently found, surrogate parameters were selected, in parallel with the previous EFP guidelines on the treatment of periodontitis (Herrera et al, 2022;Sanz et al, 2020).…”

Section: Focused Questionsmentioning

confidence: 99%

Prevention and treatment of peri‐implant diseases—The EFP S3 level clinical practice guideline

Herrera

Berglundh

Schwarz

et al. 2023

J Clinic Periodontology

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103

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Background The recently published Clinical Practice Guidelines (CPGs) for the treatment of stages I–IV periodontitis provided evidence‐based recommendations for treating periodontitis patients, defined according to the 2018 classification. Peri‐implant diseases were also re‐defined in the 2018 classification. It is well established that both peri‐implant mucositis and peri‐implantitis are highly prevalent. In addition, peri‐implantitis is particularly challenging to manage and is accompanied by significant morbidity. Aim To develop an S3 level CPG for the prevention and treatment of peri‐implant diseases, focusing on the implementation of interdisciplinary approaches required to prevent the development of peri‐implant diseases or their recurrence, and to treat/rehabilitate patients with dental implants following the development of peri‐implant diseases. Materials and Methods This S3 level CPG was developed by the European Federation of Periodontology, following methodological guidance from the Association of Scientific Medical Societies in Germany and the Grading of Recommendations Assessment, Development and Evaluation process. A rigorous and transparent process included synthesis of relevant research in 13 specifically commissioned systematic reviews, evaluation of the quality and strength of evidence, formulation of specific recommendations, and a structured consensus process involving leading experts and a broad base of stakeholders. Results The S3 level CPG for the prevention and treatment of peri‐implant diseases culminated in the recommendation for implementation of various different interventions before, during and after implant placement/loading. Prevention of peri‐implant diseases should commence when dental implants are planned, surgically placed and prosthetically loaded. Once the implants are loaded and in function, a supportive peri‐implant care programme should be structured, including periodical assessment of peri‐implant tissue health. If peri‐implant mucositis or peri‐implantitis are detected, appropriate treatments for their management must be rendered. Conclusion The present S3 level CPG informs clinical practice, health systems, policymakers and, indirectly, the public on the available and most effective modalities to maintain healthy peri‐implant tissues, and to manage peri‐implant diseases, according to the available evidence at the time of publication.

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Section: Focused Questionsmentioning

confidence: 99%

Prevention and treatment of peri‐implant diseases—The EFP S3 level clinical practice guideline

Herrera

Berglundh

Schwarz

et al. 2023

J Clinic Periodontology

Self Cite

103

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“…The outcomes identified in the systematic reviews and the patient focus groups were incorporated into an exercise using the Delphi methodology for gathering information from experts and other stakeholders (clinical trials specialists, methodologists, clinicians, PWLE and industry representatives; Sanz et al, 2023). Questionnaires were developed using these outcomes, which were completed in two rounds and incorporated individual feedback, group judgement and a final discussion to achieve the consensus through a structured, unbiased assessment by multiple stakeholders.…”

Section: Methodsmentioning

confidence: 99%

Section: Delphi Projectmentioning

confidence: 99%

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Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID‐COSM) international consensus report

Tonetti

Sanz

Ávila‐Ortiz

et al. 2023

Clinical Oral Implants Res

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Aim Lack of consistently reported outcomes limits progress in evidence‐based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID‐COSM). Materials and Methods This Core Outcome Measures in Effectiveness Trials (COMET)‐registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. Results The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre‐specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri‐implant tissue health status, intervention‐related adverse events, complication‐free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft‐tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri‐implant tissue health status) to early identification of important outcomes (patient‐reported outcomes identified by the focus groups). Conclusions The ID‐COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence‐informed implant dentistry and quality of care.

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“…The finalized list of outcomes was then included in the first of three rounds of Delphi survey. This process is described in more detail in Sanz et al (2023). In brief, participants were sent detailed instructions by email on how to complete the surveys using the web 1.…”

Section: Participation Of Pwle In the Delphi Surveymentioning

confidence: 99%

Involving people with lived experience in developing a core outcome set for implant dentistry research. The Implant Dentistry‐Core Outcomes Sets and Measures (ID‐COSM) project

Needleman

Sanz

Albornoz

et al. 2023

J Clinic Periodontology

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Aims The aims of this project were to establish the outcomes for dental implant research that are important to people with lived experience (PWLE) and to achieve consensus with those developed by dental professionals (DPs) for a core outcome set (COS). This paper reports the process, outcomes and experiences of involving PWLE in developing a COS for dental implant research: the Implant Dentistry Core Outcome Sets and Measures project. Materials and Methods Overall methods were guided by the Core Outcome Set Measures in Effectiveness Trials (COMET) initiative. Initial outcome identification was achieved from focus groups with PWLE employing calibrated methods across two low‐middle‐income countries (China and Malaysia) and two high‐income countries (Spain and the United Kingdom). Following consolidation of the results, the outcomes were incorporated into a three‐stage Delphi process with PWLE participation. Finally, consensus between PWLE and DPs was achieved using a mixed live and recorded platform. The experiences of PWLE involvement in the process was also evaluated. Results Thirty‐one PWLE participated in four focus groups. Thirty‐four outcomes were suggested across the focus groups. Evaluation of the focus groups revealed a high level of satisfaction with the engagement process and some new learning. Seventeen PWLE contributed to the first 2 Delphi rounds and 7 to the third round. The final consensus included 17 PWLE (47%) and 19 DPs (53%). Out of the total of 11 final consensus outcomes considered essential by both PWLE and health professionals, 7 (64%) outcomes mapped across to ones that PWLE initially identified, broadening their definition. One outcome (PWLE effort required for treatment and maintenance) was entirely novel. Conclusions We conclude that engaging PWLE in COS development can be achieved across widely different communities. Furthermore, the process both broadened and enriched overall outcome consensus, yielding important and novel perspectives for health‐related research.

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Multi‐stakeholder contribution to the identification of a core outcome set and measurements in implant dentistry (ID‐COSM initiative) using the Delphi methodology

Cited by 9 publications

References 39 publications

Prevention and treatment of peri‐implant diseases—The EFP S3 level clinical practice guideline

Prevention and treatment of peri‐implant diseases—The EFP S3 level clinical practice guideline

Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID‐COSM) international consensus report

Involving people with lived experience in developing a core outcome set for implant dentistry research. The Implant Dentistry‐Core Outcomes Sets and Measures (ID‐COSM) project

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