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过去20年牙科植入物研究随机临床试验中行业支持与研究结果报告之间的关联。

Association between industry support and the reporting of study outcomes in randomized clinical trials of dental implant research from the past 20 years.

作者信息

Dini Caroline, Pereira Marta Maria Alves, Souza João Gabriel Silva, Shibli Jamil A, de Avila Erica Dorigatti, Barão Valentim Adelino R

机构信息

Department of Prosthodontics and Periodontology, Piracicaba Dental School, University of Campinas (UNICAMP), Piracicaba, Brazil.

Department of Dental Materials and Prosthodontics, School of Dentistry at Araraquara, São Paulo State University (UNESP), Araraquara, Brazil.

出版信息

Clin Implant Dent Relat Res. 2022 Feb;24(1):94-104. doi: 10.1111/cid.13065. Epub 2022 Jan 12.

DOI:10.1111/cid.13065
PMID:35019213
Abstract

BACKGROUND

Industry support is a significant funding source in implant dentistry research, not only to provide regulatory processes, but also to validate and promote products through randomized clinical trials (RCTs). However, industry funding should not affect scientific outcomes.

PURPOSE

The aim of this study was to investigate whether there is an association between industry support for RCTs in implant dentistry and a greater chance of the reporting of positive outcomes, and whether there are other funding tendencies.

MATERIALS AND METHODS

Randomized clinical trials from five implant dentistry journals were reviewed. Data were extracted, and descriptive and inferential statistical analyses (α = 0.05), including bivariate and multivariable logistic regression, and Spearman's correlation were performed.

RESULTS

Two hundred eleven RCTs were included. Industry-funded and -unfunded studies presented similar outcomes, in terms of positive and negative results (p ≥ 0.05). North American and European countries received more industry funding, as did high-income countries, which showed well-established collaboration with each other. Clinical Oral Implants Research and Clinical Implant Dentistry and Related Research published 83.6% of industry-funded articles. Industry-funded studies from middle-income countries established more international collaborations with high-income countries than did unfunded studies. Citation numbers were similar for funded and unfunded studies. The chance of RCTs being industry-funded was higher for high-income (odds ratio [OR] = 3.00; 95% confidence interval [CI], 0.99-9.32; p = 0.05) and North American articles (OR = 3.40; 95% CI, 1.37-8.42; p = 0.008) than in lower-middle-income and other continents, respectively. Higher industry funding was associated with specific topics such as "surgical procedures," "prosthodontics topics," and "implant macrodesign" (OR = 4.7; 95% CI, 1.45-15.20; p = 0.010) and with the increase in numbers of institutions (OR = 1.52; 95% CI, 1.16-2.0; p = 0.002).

CONCLUSION

The available evidence suggests no association between industry funding and greater chances of the reporting of positive outcomes in implant dentistry RCTs. A strong association was identified in industry trends concerning geographic origins, higher numbers of institutions, and specific research topics.

摘要

背景

行业支持是口腔种植学研究的重要资金来源,不仅用于提供监管流程,还通过随机临床试验(RCT)来验证和推广产品。然而,行业资金不应影响科学结果。

目的

本研究旨在调查口腔种植学RCT的行业支持与报告阳性结果的更大可能性之间是否存在关联,以及是否存在其他资金倾向。

材料与方法

对五本口腔种植学期刊上的随机临床试验进行综述。提取数据,并进行描述性和推断性统计分析(α = 0.05),包括双变量和多变量逻辑回归以及Spearman相关性分析。

结果

共纳入211项RCT。在阳性和阴性结果方面,有行业资助和无行业资助的研究呈现出相似的结果(p≥0.05)。北美和欧洲国家以及高收入国家获得了更多的行业资金,这些国家之间展现出了稳固的合作关系。《临床口腔种植研究》和《临床种植牙科学及相关研究》发表了83.6%的有行业资助的文章。与无资助的研究相比,中等收入国家有行业资助的研究与高收入国家建立了更多的国际合作。有资助和无资助的研究的被引次数相似。高收入(优势比[OR]=3.00;95%置信区间[CI],0.99 - 9.32;p = 0.05)和北美文章(OR = 3.40;95% CI,1.37 - 8.42;p = 0.008)的RCT获得行业资助的可能性分别高于中低收入国家和其他大洲文章。更高的行业资金与“外科手术”、“修复学主题”和“种植体宏观设计”等特定主题相关(OR = 4.7;95% CI,1.45 - 15.20;p = 0.010),也与机构数量的增加相关(OR = 1.52;95% CI,1.16 - 2.0;p = 0.002)。

结论

现有证据表明,在口腔种植学RCT中,行业资金与报告阳性结果的更大可能性之间没有关联。在行业趋势方面,已确定在地理来源、更多的机构数量和特定研究主题之间存在密切关联。

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