Employing computers for the recruitment into clinical trials: a comprehensive systematic review.

Employing computers for the recruitment into clinical trials: a comprehensive systematic review.
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DOI:
10.2196/jmir.3446
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发表时间:
2014-07-01
影响因子:
7.4
通讯作者:
Prokosch HU
Prokosch HU
中科院分区:
医学2区
文献类型:
--
作者:
Köpcke F;Prokosch HU

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医学进步取决于临床试验中对新的诊断和治疗干预措施的评估。临床试验招募支持系统(CTRSS)旨在提高招募过程的有效性和效率。其目标是:(1)概述截至2013年底报告的所有CTRSS,(2)发现并描述设计上的相似之处,(3)对不同方法的原因进行理论化,以及(4)检查项目是否能够说明CTRSS的影响。我们检索了PubMed标题、摘要和关键词中与CTRSS研究相关的术语。根据临床背景、工作流集成、知识和数据源、推理算法和结果对查询结果进行分类。共发现了101篇关于79个不同系统的论文,大多数缺乏一个或多个类别的详细信息。有3种不同的CTRSS占主导地位:(1)基于现有临床数据,通常通过对关系数据库的结构化查询语言(SQL)查询,用于回顾性识别试验参与者的系统,(二)监测现有健康信息技术组件关键事件的出现的系统,其中事件的发生导致对患者进行全面的资格测试,或直接与研究人员沟通,以及(3)需要用户将患者数据输入界面以触发资格评估的独立系统。虽然在旧系统中,治疗医生需要为患者采取行动,但现在越来越流行直接向患者提供这种可能性。许多CTRSS的设计是为了适应临床护理提供者的现有基础设施或试验的特殊性。我们的结论是,CTRSS的成功更多地取决于其成功的工作流程集成比复杂的推理和数据处理算法。此外,一些最新的文献表明,可以预期招募患者的增加和招募效率的提高,尽管前者将取决于被取代的招募过程的错误率。最后,为了提高今后的专题技术支助和社会调查报告的质量,我们提出了一个应列入的项目清单。
Medical progress depends on the evaluation of new diagnostic and therapeutic interventions within clinical trials. Clinical trial recruitment support systems (CTRSS) aim to improve the recruitment process in terms of effectiveness and efficiency. The goals were to (1) create an overview of all CTRSS reported until the end of 2013, (2) find and describe similarities in design, (3) theorize on the reasons for different approaches, and (4) examine whether projects were able to illustrate the impact of CTRSS. We searched PubMed titles, abstracts, and keywords for terms related to CTRSS research. Query results were classified according to clinical context, workflow integration, knowledge and data sources, reasoning algorithm, and outcome. A total of 101 papers on 79 different systems were found. Most lacked details in one or more categories. There were 3 different CTRSS that dominated: (1) systems for the retrospective identification of trial participants based on existing clinical data, typically through Structured Query Language (SQL) queries on relational databases, (2) systems that monitored the appearance of a key event of an existing health information technology component in which the occurrence of the event caused a comprehensive eligibility test for a patient or was directly communicated to the researcher, and (3) independent systems that required a user to enter patient data into an interface to trigger an eligibility assessment. Although the treating physician was required to act for the patient in older systems, it is now becoming increasingly popular to offer this possibility directly to the patient. Many CTRSS are designed to fit the existing infrastructure of a clinical care provider or the particularities of a trial. We conclude that the success of a CTRSS depends more on its successful workflow integration than on sophisticated reasoning and data processing algorithms. Furthermore, some of the most recent literature suggest that an increase in recruited patients and improvements in recruitment efficiency can be expected, although the former will depend on the error rate of the recruitment process being replaced. Finally, to increase the quality of future CTRSS reports, we propose a checklist of items that should be included.
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