A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing.
A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing.
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DOI：
10.1016/j.jclinepi.2021.03.021
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发表时间：
2021-09
影响因子：
7.2
通讯作者：
Taljaard M
中科院分区：
文献类型：
--
作者：
Nicholls SG;Carroll K;Hey SP;Zwarenstein M;Zhang JZ;Nix HP;Brehaut JC;McKenzie JE;McDonald S;Weijer C;Fergusson DA;Taljaard M
我们建立了一个大型的试验数据库，作为未来方法和伦理分析的资源。在这里，我们使用元数据来描述广泛的景观务实的试验，包括研究领域，识别为务实，试验登记数据和入组的质量。通过经验证的检索过滤器识别试验，如果是2014年1月至2019年4月发表的健康相关随机试验的主要报告，则纳入试验。数据整理自MEDLINE、Web of Science、ClinicalTrials.gov和全文。从13，065条记录中确定了4337项合格试验，其中1988项在ClinicalTrials.gov注册。研究领域多种多样，最常见的是普通和内科;公共，环境和职业健康;以及医疗保健科学和服务。“务实”一词很少用于标题或摘要。ClinicalTrials.gov中的几个域名的数据质量存在问题。我们估计，五分之一的试验至少欠15%。有必要改进实用性试验的报告和试验登记数据的质量。尽管要求更精简的招募方法，但在务实的RCT中，应计制仍然是一个挑战。在未来的伦理分析中应反映出实用主义试验的多样性。
We established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment. Trials were identified by a validated search filter and included if a primary report of a health-related randomized trial published January 2014-April 2019. Data were collated from MEDLINE, Web of Science, ClinicalTrials.gov, and full text. 4337 eligible trials were identified from 13,065 records, of which 1988 were registered in ClinicalTrials.gov. Research areas were diverse, with the most common being general and internal medicine; public, environmental and occupational health; and health care sciences and services. The term “pragmatic” was seldom used in titles or abstracts. Several domains in ClinicalTrials.gov had questionable data quality. We estimated that one-fifth of trials under-accrued by at least 15%. There is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches. The diversity of pragmatic trials should be reflected in future ethical analyses.
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DOI：
10.1136/bmj.f6104
发表时间：
2013-10-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Jones CW;Handler L;Crowell KE;Keil LG;Weaver MA;Platts-Mills TF
通讯作者：
Platts-Mills TF
影响因子：
2.8
作者：
Clifford TJ;Barrowman NJ;Moher D
通讯作者：
Moher D
影响因子：
4
作者：
Khamis AM;Bou-Karroum L;Hakoum MB;Al-Gibbawi M;Habib JR;El-Jardali F;Akl EA
通讯作者：
Akl EA
影响因子：
2.7
作者：
Kim, Scott Y. H.;Flory, James;Relton, Clare
通讯作者：
Relton, Clare
影响因子：
158.5
作者：
Kim, Scott Y. H.;Miller, Franklin G.
通讯作者：
Miller, Franklin G.