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肾脏研究的数量和报告质量。

Quantity and Reporting Quality of Kidney Research.

机构信息

Division of Nephrology, Medizinische Klinik and Poliklinik IV, Klinikum der Universität München, Ludwig Maximilians University München, Munich, Germany.

Division of Nephrology, Medizinische Klinik and Poliklinik IV, Klinikum der Universität München, Ludwig Maximilians University München, Munich, Germany

出版信息

J Am Soc Nephrol. 2019 Jan;30(1):13-22. doi: 10.1681/ASN.2018050515. Epub 2018 Dec 13.

Abstract

BACKGROUND

In 2004, researchers reported that the number of nephrology clinical trials was low and that the reporting quality of such trials was suboptimal. Furthermore, the number or quality of preclinical kidney-related studies has not been systematically evaluated.

METHODS

We performed a systematic review of randomized clinical trials published in 1966-2017 (listed in the Cochrane Library) and preclinical studies published in 1945-2017 (listed in PubMed). For reporting quality analysis, we evaluated the final main paper of 118 clinical trial reports and 135 preclinical studies published in leading journals in 1996, 2006, and 2016 on the basis of criteria from the widely used CONSORT and ARRIVE guidelines.

RESULTS

The annual number of reports of clinical kidney-related trials more than doubled between 2004 and 2014 along with reports in other medical disciplines. Hypertension remains the dominant focus of study, but ongoing trials also center on CKD, ESRD, and AKI. The reporting quality analysis revealed improvements, but deficits in reporting of clinical trial design, mode of randomization, and intention-to-treat analysis remain. Annual numbers of kidney-related preclinical studies remained low between 1945 and 2017 compared with other disciplines. Reporting quality analysis of preclinical studies revealed substantial reporting deficits across all leading journals, with little improvement over the last 20 years, especially for group size calculations, defining primary versus secondary outcomes, and blinded analysis.

CONCLUSIONS

Nephrology studies keep increasing in number but still lag behind other medical disciplines, and the quality of data reporting in kidney research can be further improved.

摘要

背景

2004 年,研究人员报告称,肾脏病学临床试验的数量较少,且此类试验的报告质量并不理想。此外,肾相关的临床前研究的数量或质量尚未得到系统评估。

方法

我们对 1966 年至 2017 年(Cochrane 图书馆中列出)发表的随机临床试验和 1945 年至 2017 年(PubMed 中列出)发表的临床前研究进行了系统评价。对于报告质量分析,我们根据广泛使用的 CONSORT 和 ARRIVE 指南的标准,评估了 1996 年、2006 年和 2016 年在主要期刊上发表的 118 项临床试验报告和 135 项临床前研究的最终主要论文。

结果

2004 年至 2014 年,肾脏病相关临床试验报告的年数量增加了一倍以上,其他医学学科也有报告。高血压仍然是研究的主要焦点,但正在进行的试验也集中在 CKD、ESRD 和 AKI 上。报告质量分析显示有所改善,但临床试验设计、随机分组方式和意向治疗分析的报告仍存在缺陷。与其他学科相比,1945 年至 2017 年期间,肾相关临床前研究的年数量仍然较低。临床前研究报告质量分析显示,所有主要期刊均存在大量报告缺陷,过去 20 年来几乎没有改善,尤其是组大小计算、定义主要和次要结局以及盲法分析方面。

结论

肾脏病学研究的数量不断增加,但仍落后于其他医学学科,肾研究的数据报告质量可以进一步提高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b667/6317598/5ce32cbc53bb/ASN.2018050515absf1.jpg

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