背景:医疗保健中的循证决策依赖于将研究结果转化为日常临床实践。一个基本要求是,任何医疗干预的有效性都必须得到由此产生的有利治疗结果的支持。不幸的是,研究设计和评估结果指标的差异通常使综合二级研究分析和指南制定所需的现有研究证据具有挑战性.核心成果集(COS)定义为商定的标准化成果集,在特定主题的所有临床试验中,应至少进行测量和报告。COS的好处包括更少的异质性,减少报告偏差的风险,并确保所有试验都有助于促进荟萃分析;考虑到关键利益相关者的参与,这也增加了确定临床相关结局的机会.对COS评估牙髓治疗结果的必要性的认识导致了牙髓治疗模式(COSET)方案的核心结果集的发展。已注册(编号1879)在有效性试验中的核心结果指标(COMET)网站上。
目的:本范围审查的目的是:(1)确定评估外科牙髓手术的研究中评估的结果;(2)报告用于评估结果的评估方法;(3)并评估纳入研究中的选择性报告偏倚。获得的数据将用于为外科牙髓药的COS的开发提供信息。
方法:对电子数据库和灰色文献进行了结构化的文献检索,以确定有关骨周手术(PS)的系统评价,有意再植(IR)和牙齿/牙根切除(RR),在1990年1月至2020年12月期间发布。两名独立审稿人参与了文献选择,数据提取和对确定的研究的评估。干预的类型,测量的结果,报告的结果类型(临床医生或患者报告),使用标准化表格记录结局测量方法和随访期.
结果:26项系统评价,包括19项PS研究,我们选择了3项IR研究和4项RR研究纳入.PS和IR的结果指标包括疼痛,肿胀,流动性和压痛,与牙周/软组织愈合相关的结局(包括窦道),根周愈合,牙齿存活,生活影响(包括口腔健康相关的生活质量),资源使用和/或不利影响。对于RR,除了牙齿存活,牙髓并发症和不良反应,结果测量主要与牙周有关,包括口袋深度减少,附件增益,牙周病和牙周牙髓病变。PS的大多数结果指标,IR和RR进行临床评估,放射学和/或通过患者病史。特定工具,如评分量表(视觉模拟量表、言语评定量表,数值评定量表和其他量表)用于评估疼痛,肿胀和压痛,使用经过验证的问卷评估口腔健康相关生活质量.随访期的范围是可变的,取决于结果测量和干预类型。
结论:结果指标,PS的评估方法和随访期,对IR和RR进行了识别和分类,以帮助标准化未来研究的结果报告。未报告的其他结果指标,但可以在COSET共识过程中考虑,包括根端填充材料的损失,诊所就诊次数,与手术相关的牙科焦虑和粘膜牙龈美学相关的措施,比如疤痕,黑色三角形,根表面暴露和组织变色。
背景:COMET(编号:1879).
BACKGROUND: Evidence-informed decision-making in health care relies on the translation of research results to everyday clinical practice. A fundamental requirement is that the validity of any healthcare intervention must be supported by the resultant favourable treatment outcome. Unfortunately, differences in study design and the outcome measures evaluated often make it challenging to synthesize the available research evidence required for secondary research analysis and guideline development. Core outcome sets (COS) are defined as an agreed standardized set of outcomes, which should be measured and reported as a minimum in all clinical trials on a specific topic. The benefits of COS include less heterogeneity, a reduction in the risk of reporting bias and ensuring all trials contribute data to facilitate meta-analyses; given the engagement of key stakeholders, it also increases the chances that clinically relevant outcomes are identified. The recognition of the need for COS for assessing endodontic treatment outcomes leads to the development of Core Outcome Sets for Endodontic Treatment modalities (COSET) protocol, which is registered (No. 1879) on the Core Outcome Measures in Effectiveness Trials (COMET) website.
OBJECTIVE: The objectives of this scoping review are to: (1) identify the outcomes assessed in studies evaluating surgical endodontic procedures; (2) report on the method of assessment used to measure the outcomes; (3) and assess selective reporting bias in the included studies. The data obtained will be used to inform the development of COS for surgical endodontics.
METHODS: A structured literature search of electronic databases and the grey literature was conducted to identify systematic reviews on periradicular surgery (PS), intentional replantation (IR) and tooth/root resection (RR), published between January 1990 and December 2020. Two independent reviewers were involved in the literature selection, data extraction and the appraisal of the studies identified. The type of intervention, outcomes measured, type of outcomes reported (clinician- or patient-reported), outcome measurement method and follow-up period were recorded using a standardized form.
RESULTS: Twenty-six systematic reviews consisting of 19 studies for PS, three studies for IR and four studies for RR were selected for inclusion. Outcome measures identified for PS and IR included pain, swelling, mobility and tenderness, outcomes related to periodontal/soft tissue healing (including sinus tract), periradicular healing, tooth survival, life impact (including oral health-related quality of life), resource use and/or adverse effects. For RR, in addition to tooth survival, endodontic complications and adverse effects, the outcome measures were primarily periodontal-related, including pocket depth reduction, attachment gain, periodontal disease and periodontic-endodontic lesions. The majority of outcome measures for PS, IR and RR were assessed clinically, radiologically and/or via patient history. Specific tools such as rating scales (Visual Analog Scale, Verbal Rating Scale, Numerical Rating Scale and other scales) were used for the assessment of pain, swelling and tenderness, and validated questionnaires were used for the assessment of oral health-related quality of life. The range of follow-up periods was variable, dependent on the outcome measure and the type of intervention.
CONCLUSIONS: Outcome measures, method of assessment and follow-up periods for PS, IR and RR were identified and categorized to help standardize the reporting of outcomes for future research studies. Additional outcome measures that were not reported, but may be considered in the COSET consensus process, include loss of root-end filling material, number of clinic visits, surgery-related dental anxiety and mucogingival aesthetic-related measures, such as scarring, black triangles, root surface exposure and tissue discoloration.
BACKGROUND: COMET (No. 1879).