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犬猫临床试验报告质量:更新。

Quality of reporting of clinical trials in dogs and cats: An update.

机构信息

Department of Population Medicine, Ontario Veterinary College, University of Guelph, Guelph, Ontario, Canada.

Department of Public Health, College of Health and Human Sciences, Purdue University, West Lafayette, Indiana, USA.

出版信息

J Vet Intern Med. 2021 Jul;35(4):1957-1971. doi: 10.1111/jvim.16204. Epub 2021 Jun 28.

DOI:10.1111/jvim.16204
PMID:34184331
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8295703/
Abstract

BACKGROUND

Comprehensive reporting of clinical trials is essential to allow the trial reader to evaluate the methodological rigor of the trial and interpret the results. Since publication of the updated Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting of parallel clinical trials in humans, extensions for reporting of abstracts and crossover trials have been published.

OBJECTIVES

To describe the types of trials using dogs and cats published from 2015 to 2020 and to evaluate the quality of reporting of a sample of recently published parallel and crossover trials.

ANIMALS

None.

METHODS

A comprehensive search was conducted to identify parallel or crossover design clinical trials using dogs and cats published from January 1, 2015 onwards. Quality of reporting was evaluated on a subset of trials published during 2019. The reporting of items recommended in the CONSORT reporting guidelines for abstracts, parallel trials, and crossover trials was evaluated independently by 2 reviewers using standardized forms created for this study. Disagreements among reviewers were resolved by consensus. Results were tabulated descriptively.

RESULTS

The frequency of reporting of trial features varied from low to high. There remain deficiencies in the quality of reporting of key methodological features and information needed to evaluate and interpret trial results.

CONCLUSIONS AND CLINICAL IMPORTANCE

There is still a need for authors, peer-reviewers, and editors to follow reporting guidelines such as CONSORT to maximize the value of clinical trials and to increase confidence in the validity of the trial results.

摘要

背景

临床试验的全面报告对于允许试验读者评估试验的方法严谨性并解释结果至关重要。自人类平行临床试验报告的更新《统一报告标准》(CONSORT)指南发布以来,已经发布了用于报告摘要和交叉试验的扩展内容。

目的

描述 2015 年至 2020 年期间使用犬和猫进行的临床试验类型,并评估最近发表的平行和交叉试验样本的报告质量。

动物

无。

方法

全面搜索了 2015 年 1 月 1 日以后发表的使用犬和猫的平行或交叉设计临床试验。使用为这项研究专门制定的标准化表格,由 2 名评审员对 2019 年发表的试验子集进行报告质量评估。使用 CONSORT 报告指南评估摘要、平行试验和交叉试验推荐项目的报告情况。评审员之间的分歧通过协商解决。结果以描述性表格形式列出。

结果

试验特征的报告频率从低到高不等。在报告关键方法学特征和评估和解释试验结果所需的信息方面,报告质量仍存在不足。

结论和临床意义

作者、同行评审员和编辑仍然需要遵循报告指南,如 CONSORT,以最大限度地提高临床试验的价值,并提高对试验结果有效性的信心。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b3c/8295703/a2f45f7063ee/JVIM-35-1957-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b3c/8295703/a2f45f7063ee/JVIM-35-1957-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b3c/8295703/a2f45f7063ee/JVIM-35-1957-g001.jpg

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