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法国骨科与创伤外科学会(SICOT)杂志 2017 年作者利益冲突披露率及其有效性分析:与 Transparence.sante.gouv.fr 数据库的对比研究。

What are the rates and validity of French authors' conflicts of interest disclosures in Orthopaedics & Traumatology: Surgery & Research? Analysis of the year 2017 with comparison versus the Transparence.sante.gouv.fr database.

机构信息

CNRS, SIGMA Clermont, ICCF, Université Clermont Auvergne, CHU de Clermont-Ferrand, 63000 Clermont-Ferrand, France.

Université Clermont Auvergne, CHU de Clermont-Ferrand, 63000 Clermont-Ferrand, France.

出版信息

Orthop Traumatol Surg Res. 2021 Dec;107(8):103080. doi: 10.1016/j.otsr.2021.103080. Epub 2021 Sep 27.

Abstract

INTRODUCTION

Authors are responsible for their own Disclosure of Interests in submitting to Orthopaedics & Traumatology: Surgery & Research (OTSR). Disclosure may be incomplete or false, by deliberate or unintended omission. Omission may impact the analysis of results or at least the reader's perception of it. The rate of validity of disclosure in OTSR is not known, and we therefore conducted a bibliometric study on articles published in 2017, in order to: 1) determine the proportion of articles in which authors disclose interests; and 2), when interests are disclosed, to assess their validity by comparison against the Transparence.gov.fr database.

HYPOTHESIS

Disclosure rates exceed 75%.

MATERIAL AND METHOD

We analyzed all articles published in OTSR in 2017, and extracted those with at least one French author. We also analyzed data from the Transparence.gouv.fr corporate declaration database, for comparison with the authors' own disclosures in each article. Significant interest was defined by a €1000 threshold, although higher thresholds (>€5000, >€10,000 and >€100,000) were also investigated.

RESULTS

In 2017, 337 articles were published in OTSR, 210 of which had at least 1 French author. Of these, 201 (95.7%) had at least 1 author with significant interest (>€1000) according to the Transparence data. In 189 of these 201 articles (94%), authors had failed to disclose at least 1 direct or indirect conflict of interest. This omission rate fell to 22/45 (48.9%) for more substantial interests, which were more faithfully disclosed. At the €1000 threshold, in only 8/201 articles (4%) did authors disclose all their interests with perfect validity, but this rate increased up to 25/45 (55.5%) at higher thresholds. At the €1000 threshold, 66 of the 201 articles cited the trade-name of interest, resulting in 54/66 (82%) correct disclosure of direct interest; this rate increased up to 25/26 (96%) at higher thresholds.

DISCUSSION

At a threshold of €1000, the rate of complete and valid disclosure was 4% and the rate of omission 94%. At higher thresholds, rates were better, with just 48.9% omission and, above all, 55.5% validity, even if these rates were lower than hypothesized (75%). Authors and editors need to take greater care. Disclosures were often made, but incompletely, and authors need reminding that they must disclose not only interests related to the article in question but also all interests that might directly or indirectly influence their interpretation of the results reported, allowing readers to make up their own minds.

LEVEL OF EVIDENCE

IV; systematic retrospective study.

摘要

引言

作者在向《骨科与创伤杂志:外科与研究》(OTSR)投稿时,有责任披露自身的利益关系。披露可能存在不完整或虚假的情况,这可能是故意或无意的遗漏。遗漏可能会影响结果的分析,或者至少会影响读者对结果的看法。OTSR 中披露利益关系的准确性率尚不清楚,因此我们对 2017 年发表的文章进行了文献计量学研究,目的是:1)确定作者披露利益关系的文章比例;2),当披露利益关系时,通过与 Transparence.gov.fr 数据库进行比较来评估其准确性。

假设

披露率超过 75%。

材料和方法

我们分析了 2017 年在 OTSR 上发表的所有文章,并提取了至少有一位法国作者的文章。我们还分析了 Transparence.gouv.fr 公司声明数据库中的数据,以便与每篇文章中作者自己的披露进行比较。有意义的利益被定义为 1000 欧元的门槛,尽管我们也研究了更高的门槛(>5000 欧元、>10000 欧元和>100000 欧元)。

结果

2017 年,OTSR 发表了 337 篇文章,其中 210 篇至少有 1 位法国作者。在这些文章中,根据 Transparence 数据,有 201 篇(95.7%)至少有 1 位作者有重大利益关系(>1000 欧元)。在这 201 篇文章中的 189 篇(94%)中,作者至少遗漏了 1 个直接或间接的利益冲突。对于更实质性的利益,这种遗漏率下降到 48.9%(45 篇中的 22 篇),因为这些利益更准确地披露了。在 1000 欧元的门槛下,只有 8/201 篇文章(4%)的作者准确地披露了他们所有的利益,但在更高的门槛下,这一比例上升到 25/45(55.5%)。在 1000 欧元的门槛下,201 篇文章中有 66 篇引用了利益相关者的商标名,导致直接利益的披露率为 54/66(82%);在更高的门槛下,这一比例上升到 25/26(96%)。

讨论

在 1000 欧元的门槛下,完整准确披露的比例为 4%,遗漏的比例为 94%。在更高的门槛下,这一比例更好,只有 48.9%的遗漏,最重要的是,55.5%的准确性,尽管这些比例低于假设(75%)。作者和编辑需要更加小心。披露虽然经常发生,但并不完整,作者需要提醒的是,他们不仅要披露与文章相关的利益,还要披露可能直接或间接影响他们对报告结果的解释的所有利益,以便让读者自己做出判断。

证据水平

IV;系统回顾性研究。

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