Describing the first 2000 registrations to the Research Registry®: A study protocol

Alexander J. Fowler , Chris Limb , Daniyal J. Jafree , Riaz A. Agha
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引用次数: 1

Abstract

Background

In 2013, the Declaration of Helsinki was updated and required the registration of all research studies involving human participants. Prior registries focussed on the registration of clinical trials and systematic reviews, and we estimate that only 10% of observational research is registered in a publically accessible registry. The Research Registry® was established to provide a venue of registration for any study, prospectively or retrospectively, involving human participants. This protocol describes the analysis for the first 2000 registrations received to the Research Registry®.

Methods and analysis

Data for each registration to the Research Registry® (www.researchregistry.com), adapted from the World Health Organisation minimum data set, has been collected since the launch of the registry in 2015. A weekly curation process ensures that inappropriate registrations, such as duplicate studies or those not involving human participants, are removed from the registry. We will present the characteristics of the first 2000 registrations and how they have changed overtime. A quality score will be calculated for each registration by two independent teams, and inter-rater reliability will be calculated. Funding sources of work registered will also be presented. This process will also be performed for the systematic review portion of the registry (‘The Review Registry’), which will be considered separately.

Ethics and dissemination

Ethical approval is not required for this study as it involves no human participants. The findings will be presented at international conferences and published in a peer reviewed journal.

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描述研究注册中心®的前2000个注册:一项研究方案
2013年,《赫尔辛基宣言》进行了更新,并要求对所有涉及人类参与者的研究进行注册。先前的注册集中于临床试验和系统评价的注册,我们估计只有10%的观察性研究在可公开访问的注册中注册。研究注册中心®的建立是为了为任何涉及人类参与者的前瞻性或回顾性研究提供注册场所。本协议描述了收到Research Registry®的前2000个注册的分析。方法和分析自2015年注册中心启动以来,收集了研究注册中心®(www.researchregistry.com)每次注册的数据,这些数据改编自世界卫生组织的最低数据集。每周管理流程确保不适当的注册,例如重复的研究或不涉及人类参与者的研究,从注册表中删除。我们将介绍前2000个注册的特征以及它们是如何随时间变化的。每个注册将由两个独立的团队计算质量分数,并计算评分者之间的信度。还将介绍已登记工作的资金来源。该过程也将对注册表的系统审查部分(“审查注册表”)执行,这将被单独考虑。伦理和传播本研究不需要伦理批准,因为它不涉及人类参与者。研究结果将在国际会议上发表,并发表在同行评议的期刊上。
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期刊介绍: IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.
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