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medRxiv 预印本与同行评议期刊文章中报告的临床研究结果比较。

Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles.

机构信息

Yale School of Medicine, New Haven, Connecticut.

Department of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.

出版信息

JAMA Netw Open. 2022 Dec 1;5(12):e2245847. doi: 10.1001/jamanetworkopen.2022.45847.

Abstract

IMPORTANCE

Preprints have been widely adopted to enhance the timely dissemination of research across many scientific fields. Concerns remain that early, public access to preliminary medical research has the potential to propagate misleading or faulty research that has been conducted or interpreted in error.

OBJECTIVE

To evaluate the concordance among study characteristics, results, and interpretations described in preprints of clinical studies posted to medRxiv that are subsequently published in peer-reviewed journals (preprint-journal article pairs).

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study assessed all preprints describing clinical studies that were initially posted to medRxiv in September 2020 and subsequently published in a peer-reviewed journal as of September 15, 2022.

MAIN OUTCOMES AND MEASURES

For preprint-journal article pairs describing clinical trials, observational studies, and meta-analyses that measured health-related outcomes, the sample size, primary end points, corresponding results, and overarching conclusions were abstracted and compared. Sample size and results from primary end points were considered concordant if they had exact numerical equivalence.

RESULTS

Among 1399 preprints first posted on medRxiv in September 2020, a total of 1077 (77.0%) had been published as of September 15, 2022, a median of 6 months (IQR, 3-8 months) after preprint posting. Of the 547 preprint-journal article pairs describing clinical trials, observational studies, or meta-analyses, 293 (53.6%) were related to COVID-19. Of the 535 pairs reporting sample sizes in both sources, 462 (86.4%) were concordant; 43 (58.9%) of the 73 pairs with discordant sample sizes had larger samples in the journal publication. There were 534 pairs (97.6%) with concordant and 13 pairs (2.4%) with discordant primary end points. Of the 535 pairs with numerical results for the primary end points, 434 (81.1%) had concordant primary end point results; 66 of the 101 discordant pairs (65.3%) had effect estimates that were in the same direction and were statistically consistent. Overall, 526 pairs (96.2%) had concordant study interpretations, including 82 of the 101 pairs (81.2%) with discordant primary end point results.

CONCLUSIONS AND RELEVANCE

Most clinical studies posted as preprints on medRxiv and subsequently published in peer-reviewed journals had concordant study characteristics, results, and final interpretations. With more than three-fourths of preprints published in journals within 24 months, these results may suggest that many preprints report findings that are consistent with the final peer-reviewed publications.

摘要

重要性

预印本已被广泛采用,以加快许多科学领域的研究传播。人们仍然担心,早期公开获取初步医学研究有可能传播已经进行或错误解释的误导性或有缺陷的研究。

目的

评估在 medRxiv 上发布的后续在同行评审期刊上发表的临床研究预印本(预印本-期刊文章对)中描述的研究特征、结果和解释的一致性。

设计、设置和参与者:本横断面研究评估了所有在 2020 年 9 月首次发布在 medRxiv 上的描述临床研究的预印本,这些预印本截至 2022 年 9 月 15 日已在同行评审期刊上发表。

主要结果和措施

对于描述临床试验、观察性研究和测量健康相关结果的荟萃分析的预印本-期刊文章对,提取并比较了样本量、主要终点、相应结果和总体结论。如果主要终点的样本量具有确切的数值等同性,则认为它们是一致的。

结果

在 2020 年 9 月首次发布在 medRxiv 上的 1399 篇预印本中,截至 2022 年 9 月 15 日,共有 1077 篇(77.0%)已发表,在预印本发布后中位数为 6 个月(IQR,3-8 个月)。在 547 篇描述临床试验、观察性研究或荟萃分析的预印本-期刊文章对中,有 293 篇(53.6%)与 COVID-19 相关。在 535 对报告两个来源样本量的对中,有 462 对(86.4%)是一致的;在 73 对不一致的样本量中,有 43 对(58.9%)在期刊出版物中有更大的样本量。有 534 对(97.6%)具有一致的主要终点,有 13 对(2.4%)具有不一致的主要终点。在 535 对主要终点的数值结果中,有 434 对(81.1%)具有一致的主要终点结果;在 101 对不一致的对中,有 66 对(65.3%)的效应估计值方向相同且具有统计学一致性。总体而言,有 526 对(96.2%)具有一致的研究解释,包括 82 对(81.2%)具有不一致的主要终点结果。

结论和相关性

在 medRxiv 上发布的大多数临床研究预印本,随后在同行评审期刊上发表,具有一致的研究特征、结果和最终解释。超过四分之三的预印本在 24 个月内在期刊上发表,这些结果可能表明,许多预印本报告的发现与最终的同行评审出版物一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/910f/9856222/7e1248a41c97/jamanetwopen-e2245847-g001.jpg

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