A clinical trial alert tool to recruit large patient samples and assess selection bias in general practice research
A clinical trial alert tool to recruit large patient samples and assess selection bias in general practice research
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DOI：
10.1186/1471-2288-11-16
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发表时间：
2011-02-15
影响因子：
4
通讯作者：
Himmel, Wolfgang
中科院分区：
文献类型：
--
作者：
Heinemann, Stephanie;Thuering, Sabine;Himmel, Wolfgang
背景资料：许多研究项目在招募患者时面临问题，通常导致招募率低和未知的选择偏差，从而限制了它们对卫生服务研究的价值。本研究的目的是评估招聘的实践工作人员在25个参与一般的做法时，使用临床试验警报（CTA）tool.Methods：CTA工具开发的骨质疏松症患者的骨质疏松症和骨折的风险调查的表现。该工具使用来自电子病历（EPR）的数据来自动识别风险人群（净样本），应用资格标准，联系符合条件的患者，每个实践至少招募和调查200名患者。CTA干预的效果进行了评估的基础上的招聘效率和选择bias.Results：CTA工具确定了净样本16,067例患者（范围162至1,316每个实践），其中的实践工作人员审查5,161（32%）例合格。他们排除了3,248名患者，并联系了1,913名患者。其中，1，526例患者（每个诊所范围为4至202例）成功入组并接受了调查。这占净样本的9%，占所接触病人的80%。男性和老年患者在研究population.Conclusion：虽然招聘目标是遥不可及的大多数做法，在参与实践的实践工作人员成功地使用CTA工具来识别，文件和调查一个大的患者样本。该工具还帮助研究团队精确地确定了轻微的选择偏差。
Background: Many research projects in general practice face problems when recruiting patients, often resulting in low recruitment rates and an unknown selection bias, thus limiting their value for health services research. The objective of the study is to evaluate the recruitment performance of the practice staff in 25 participating general practices when using a clinical trial alert (CTA) tool.Methods: The CTA tool was developed for an osteoporosis survey of patients at risk for osteoporosis and fractures. The tool used data from electronic patient records (EPRs) to automatically identify the population at risk (net sample), to apply eligibility criteria, to contact eligible patients, to enrol and survey at least 200 patients per practice. The effects of the CTA intervention were evaluated on the basis of recruitment efficiency and selection bias.Results: The CTA tool identified a net sample of 16,067 patients (range 162 to 1,316 per practice), of which the practice staff reviewed 5,161 (32%) cases for eligibility. They excluded 3,248 patients and contacted 1,913 patients. Of these, 1,526 patients (range 4 to 202 per practice) were successfully enrolled and surveyed. This made up 9% of the net sample and 80% of the patients contacted. Men and older patients were underrepresented in the study population.Conclusion: Although the recruitment target was unreachable for most practices, the practice staff in the participating practices used the CTA tool successfully to identify, document and survey a large patient sample. The tool also helped the research team to precisely determine a slight selection bias.