The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.
The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.
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DOI：
10.1186/1745-6215-14-426
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发表时间：
2013-12-11
期刊：
影响因子：
2.5
通讯作者：
Yokode M
中科院分区：
文献类型：
--
作者：
Sumi E;Teramukai S;Yamamoto K;Satoh M;Yamanaka K;Yokode M
许多临床试验在开始试验时都遇到了招募足够数量患者的困难。最近，已经开发了许多在临床数据仓库中搜索符合临床试验资格的患者的筛选系统。我们的目的是使用常规电子病历（EMR）估计符合条件的患者数量，并预测在开始试验之前招募足够患者的难度。本研究纳入了 2004 年 7 月至 2011 年 1 月期间在京都大学医院进行的研究者发起的临床试验。我们在 EMR 中搜索符合条件的患者，并通过将 EMR 中符合条件的患者数量除以目标样本量来计算符合条件的 EMR 患者指数。此外，我们将试验资格标准划分为 EMR 中相应的数据元素，以评估将试验资格标准中的临床表现映射到 EMR 中结构化数据元素的完整性。我们用斯皮尔曼等级相关系数评估了该指数与应计成就之间的相关性。 19 项试验中有 13 项没有达到最初的目标样本量。总体而言，55% 的试验资格标准已映射到 EMR 中的数据元素。应计成就与符合条件的 EMR 患者指数呈显着正相关（r = 0.67，95% 置信区间 (CI)，0.42 至 0.92）。接受者操作特征分析显示，合格的 EMR 患者指数截止值为 1.7，敏感性为 69.2%，特异性为 100.0%。我们的研究表明，符合条件的 EMR 患者指数仍处于探索阶段，但在规划临床试验时可能是可行性研究的有用组成部分。建立一个步骤来检查是否有足够数量的合格患者，使申办者和研究人员能够将其资源和精力集中在更可实现的试验上。
A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials.
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影响因子：
2.9
作者：
Yamamoto K;Sumi E;Yamazaki T;Asai K;Yamori M;Teramukai S;Bessho K;Yokode M;Fukushima M
通讯作者：
Fukushima M
影响因子：
2.5
作者：
McGregor, Joanna;Brooks, Caroline;Lloyd, Keith
通讯作者：
Lloyd, Keith
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2.2
作者：
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通讯作者：
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影响因子：
4.5
作者：
Tu SW;Peleg M;Carini S;Bobak M;Ross J;Rubin D;Sim I
通讯作者：
Sim I
影响因子：
2.7
作者：
Dugas, Martin;Lange, Matthias;Prokosch, Hans-Ulrich
通讯作者：
Prokosch, Hans-Ulrich