CONSORT 合规性在再生牙髓治疗坏死性未成熟牙的随机临床试验中的应用：范围综述。
CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review.
机构信息
Division of Endodontics, Department of Restorative Dentistry, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil; Division of Endodontics, Dental School, Federal University of Amazonas, Manaus, Amazonas, Brazil.
Division of Endodontics, Department of Restorative Dentistry, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil.
出版信息
J Endod. 2021 Nov;47(11):1751-1766. doi: 10.1016/j.joen.2021.07.017. Epub 2021 Aug 3.
INTRODUCTION
This study aimed to investigate methodological quality of clinical trials in regenerative endodontics and its compliance with the CONSORT statement.
METHODS
An electronic search was performed in 8 electronic databases. Only clinical trials whose participants underwent regenerative endodontic treatment on necrotic permanent immature teeth were included. Quality assessment was performed using the Cochrane Collaboration's Risk of Bias Tool (RoB, version 2.0). Compliance of articles with the CONSORT guidelines was assessed by a tool with scales: 0 = no description, 1 = deficient, and 2 = adequate description, totaling a maximum score of 32 points. The Mann-Whitney and Kruskal-Wallis tests were used to compare the scores among journals, studies, country, income levels, and publication periods. Spearman correlation analyses were performed between CONSORT compliance scores and 2019 journal CiteScore values, publication year, and quality assessment.
RESULTS
Twenty studies were included. The average CONSORT compliance score was 20.95 (±6.19). The better reported items were the description of the interventions performed in the trials (100%), followed by the description of the number of patients analyzed, losses and exclusions (90%), and the hypothesis tested (85%). Within the 20 studies, 3 articles were classified as "low risk of bias," 8 studies were classified as "some concerns," and 9 studies were considered "high risk of bias." Studies carried out in countries with higher income levels presented higher CONSORT scores. Significant moderate correlations were found between the CONSORT score and the percentage of risk of bias in low-risk domains (r = 0.63; 95% CI, 0.31-0.94; P = .003) and the overall risk of bias categories (r = 0.76; 95% CI, 0.54-0.98; P = .001).
CONCLUSIONS
The adequacy of reporting based on the CONSORT checklist items of regenerative endodontic trials was low with a moderate to high risk of bias.
简介
本研究旨在调查再生牙髓治疗临床试验的方法学质量及其对 CONSORT 声明的依从性。
方法
在 8 个电子数据库中进行了电子检索。仅纳入接受再生牙髓治疗的坏死性恒牙未成熟牙的临床试验。使用 Cochrane 协作风险偏倚工具（RoB，版本 2.0）进行质量评估。使用带有量表的工具评估文章对 CONSORT 指南的依从性：0=无描述，1=不充分，2=充分描述，总分最高为 32 分。使用 Mann-Whitney 和 Kruskal-Wallis 检验比较期刊、研究、国家、收入水平和出版周期之间的评分。对 CONSORT 依从性评分与 2019 年期刊 CiteScore 值、出版年份和质量评估之间进行 Spearman 相关分析。
结果
纳入 20 项研究。平均 CONSORT 依从性评分为 20.95（±6.19）。报告较好的项目是试验中干预措施的描述（100%），其次是分析患者数量、损失和排除的描述（90%），以及检验的假设（85%）。在这 20 项研究中，有 3 篇文章被归类为“低偏倚风险”，8 项研究被归类为“存在一些关注”，9 项研究被归类为“高偏倚风险”。在收入水平较高的国家开展的研究呈现出更高的 CONSORT 评分。在低风险领域的偏倚风险百分比（r=0.63；95%置信区间，0.31-0.94；P=0.003）和整体偏倚类别（r=0.76；95%置信区间，0.54-0.98；P=0.001）之间，发现 CONSORT 评分与偏倚风险之间存在中度至高度显著的相关性。
结论
再生牙髓治疗临床试验基于 CONSORT 清单项目的报告充分性较低，存在中度至高度偏倚风险。
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