Kamauu Allise, Agbor Stephen, Kamauu Aaron
Anolinx LLC, Salt Lake City, Utah, USA.
Stud Health Technol Inform. 2013;192:1167.
Clinical trial eligibility criteria define the target patient population for research studies. We assessed the eligibility criteria from 40 different protocols for Type II Diabetes Mellitus and depression (20 protocols each), to determine the extent to which protocol eligibility criteria were similar at three levels (test, test-value, and test-value-time clause). This was done to determine criteria that could be standardized to aid in identification of eligible patients from electronic health records. It was found that Type II Diabetes Mellitus had 36.9% similar and depression protocols had 53.1% similar at the test-value-clause level. This study demonstrates the need for more standardization of study protocol criteria as well as the associated query definitions to be run against the electronic healthcare data. Standardizing criteria based on the similar eligibility criteria between protocols will aid in patient recruitment by being able to reuse criteria and minimizing the time and money it takes to recruit patients.
临床试验入选标准定义了研究的目标患者群体。我们评估了40项不同的II型糖尿病和抑郁症研究方案（各20项）的入选标准，以确定方案入选标准在三个层面（测试、测试值和测试值-时间条款）的相似程度。这样做是为了确定可以标准化的标准，以帮助从电子健康记录中识别符合条件的患者。结果发现，在测试值-条款层面，II型糖尿病方案有36.9%的相似性，抑郁症方案有53.1%的相似性。这项研究表明，需要对研究方案标准以及针对电子医疗数据运行的相关查询定义进行更多标准化。根据方案之间相似的入选标准进行标准化，将有助于通过重用标准以及最大限度地减少招募患者所需的时间和资金来招募患者。
