Abstract：
OBJECTIVE: 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).
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.
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.
摘要：
目的：缺乏一致报告的结果限制了循证种植牙科和护理质量的进展。该计划的目的是开发一个核心结果集（COS）和植入物牙科临床试验（ID-COSM）的测量。
方法：这项在有效性试验（COMET）注册的国际核心结果措施包括24个月内的六个步骤：（i）对过去10年报告的结果进行系统回顾；（ii）国际患者焦点小组；（iii）与广泛的利益相关者（护理提供者，临床研究人员，方法学家,患者和行业代表）；（iv）专家组讨论使用理论框架组织领域的结果并确定COSs；（v）确定有效的测量系统以捕获不同领域，以及（vi）最终共识和正式批准，涉及专家和患者。根据类风湿关节炎临床试验中的结果测量和COMET手册，从最佳实践方法对方法进行了修改。
结果：系统评价和患者焦点组确定了754项（分别为665+89项）相关结局指标。在消除冗余和重复之后,111在Delphi项目中进行了正式评估。通过应用预先指定的过滤器，德尔菲过程确定了22个基本结果。在汇总相同特征的替代评估后，这些减少到13。专家委员会将其分为四个核心成果领域：（i）病理生理学，（ii）植入物/假体寿命，(iii)对生命的影响和(iv)获得护理的机会。在每个领域,确定了核心结局以反映治疗的益处和危害.强制性结果领域包括手术发病率和并发症的评估，种植体周围组织健康状况，干预相关不良事件，无并发症生存率和患者总体满意度和舒适度。在特定情况下被视为强制性的结果包括功能(咀嚼，演讲,美学和假牙固位)，生活质量,治疗和维护的努力和成本效益。确定了专门的COSs用于骨骼和软组织增强程序。测量仪器的有效性从国际共识（种植体周围组织健康状况）到早期识别重要结果（由焦点小组确定的患者报告结果）。
结论：ID-COSM计划就植入牙科和/或软组织/骨增强的临床试验的一组核心强制性结果达成共识。在未来的协议中采用并通过目前正在进行的试验报告各自领域将有助于改善循证植入物牙科和护理质量。
方法：这项在有效性试验（COMET）注册的国际核心结果措施包括24个月内的六个步骤：（i）对过去10年报告的结果进行系统回顾；（ii）国际患者焦点小组；（iii）与广泛的利益相关者（护理提供者，临床研究人员，方法学家,患者和行业代表）；（iv）专家组讨论使用理论框架组织领域的结果并确定COSs；（v）确定有效的测量系统以捕获不同领域，以及（vi）最终共识和正式批准，涉及专家和患者。根据类风湿关节炎临床试验中的结果测量和COMET手册，从最佳实践方法对方法进行了修改。
结果：系统评价和患者焦点组确定了754项（分别为665+89项）相关结局指标。在消除冗余和重复之后,111在Delphi项目中进行了正式评估。通过应用预先指定的过滤器，德尔菲过程确定了22个基本结果。在汇总相同特征的替代评估后，这些减少到13。专家委员会将其分为四个核心成果领域：（i）病理生理学，（ii）植入物/假体寿命，(iii)对生命的影响和(iv)获得护理的机会。在每个领域,确定了核心结局以反映治疗的益处和危害.强制性结果领域包括手术发病率和并发症的评估，种植体周围组织健康状况，干预相关不良事件，无并发症生存率和患者总体满意度和舒适度。在特定情况下被视为强制性的结果包括功能(咀嚼，演讲,美学和假牙固位)，生活质量,治疗和维护的努力和成本效益。确定了专门的COSs用于骨骼和软组织增强程序。测量仪器的有效性从国际共识（种植体周围组织健康状况）到早期识别重要结果（由焦点小组确定的患者报告结果）。
结论：ID-COSM计划就植入牙科和/或软组织/骨增强的临床试验的一组核心强制性结果达成共识。在未来的协议中采用并通过目前正在进行的试验报告各自领域将有助于改善循证植入物牙科和护理质量。
