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从临床实践指南制定到试验注册:炎症性肠病研究流程的系统调查

From clinical practice guideline development to trial registration: A systematic investigation of research pipeline for inflammatory bowel disease.

作者信息

Meyer Chase, Bowers Aaron, Heavener Trace E, Checketts Jake X, Vassar Matt

机构信息

Center for Health Sciences, Oklahoma State University, 1111 W 17th Street, Tulsa, OK, 74107, USA.

Department of Internal Medicine, Baylor Scott and White Medical Center-Temple, 2401 South 31st Street, Temple, TX, 76508, USA.

出版信息

Indian J Gastroenterol. 2019 Jun;38(3):247-262. doi: 10.1007/s12664-019-00965-4. Epub 2019 Jul 3.

Abstract

BACKGROUND

Clinical practice guidelines help practitioners manage patients in an effective and systematic way, and they assist in making evidence-based decisions related to diagnosis and treatment. Each recommendation is ranked based on evidence. The goal of this study is to determine gaps in research for inflammatory bowel diseases (IBD) by using the low-level evidence recommendations.

METHODS

We extracted low-level evidence recommendations set forth by the American College of Gastroenterology in IBD, ulcerative colitis (UC), and Crohn's disease. ClinicalTrials.gov , the World Health Organization's International Clinical Trials Registry Platform and PubMed were then used to locate studies relevant to the recommendations.

RESULTS

There were 30 low-level evidence recommendations, and 23 had recent or ongoing studies addressing them. We screened 2938 trials and 4321 published articles, 221 of which addressed low-quality recommendations. There were five recommendations that received the majority of research attention (143/221, 65%).

CONCLUSION

This study used clinical practice guidelines to help determine areas of needed research in IBD, UC, and Crohn's disease. By searching trial registries and articles indexed on PubMed, we identified the extent to which studies were being conducted to address research gaps. Of the gaps identified, five recommendations received most of the attention. While most of the significant gaps had some recent or ongoing research, our study found several areas where investigation is still needed. Clinical practice guidelines are an effective method to prioritize future research.

摘要

背景

临床实践指南有助于从业者以有效且系统的方式管理患者,并协助做出与诊断和治疗相关的循证决策。每项建议都基于证据进行排名。本研究的目的是通过使用低级别证据建议来确定炎症性肠病(IBD)研究中的差距。

方法

我们提取了美国胃肠病学会在IBD、溃疡性结肠炎(UC)和克罗恩病中提出的低级别证据建议。然后使用ClinicalTrials.gov、世界卫生组织国际临床试验注册平台和PubMed来查找与这些建议相关的研究。

结果

共有30条低级别证据建议,其中23条有近期或正在进行的研究涉及。我们筛选了2938项试验和4321篇已发表文章,其中221篇涉及低质量建议。有五条建议得到了大部分研究关注(143/221,65%)。

结论

本研究使用临床实践指南来帮助确定IBD、UC和克罗恩病中需要研究的领域。通过搜索试验注册库和PubMed上索引的文章,我们确定了针对研究差距开展研究的程度。在确定的差距中,五条建议得到了大部分关注。虽然大多数重大差距有一些近期或正在进行的研究,但我们的研究发现仍有几个领域需要进行调查。临床实践指南是确定未来研究重点的有效方法。

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