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A web-based system for patient registering and matching in a prospective and observational clinical study

机译:一个基于网络的系统,用于前瞻性和观察性临床研究中的患者注册和匹配

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According to the principle of clinical trial design, treatment and control group should be comparable. In an ongoing prospective observational study to evaluate the effect of CRT (Cardiac resynchronization therapy) for heart failure patients, it is desired that two groups of patients (CRT treatment group and Non-CRT treatment group) were matched into pairs when being registered, and only matched patients were followed up so as to reduce the overall costs. We developed a registering and matching system to meet this requirement. Heart Failure Patients'' data were collected from 44 centers by an internet-based system prospectively. 11 potential confounding variables, ranked from 2 to 3 levels, were included in this study. 5 variables were matched absolutely, while 6 others were matched by an “unbalance score”. Patients from each group respectively with the minimum difference were matched within a pre-defined threshold. The matching was done automatically by database system at every night. Unmatched patients who had been registered over 4 weeks were no longer eligible for matching. After 28 months, 478 patients were registered and 206 were matched. After matching, the balance of the covariates between two groups was improved. Alternatives of matching methods are also discussed.
机译:根据临床试验设计的原则,治疗组和对照组应具有可比性。在一项正在进行的前瞻性观察性研究中,以评估CRT(心脏再同步治疗)对心力衰竭患者的疗效,希望在注册时将两组患者(CRT治疗组和非CRT治疗组)配对,并且仅对匹配的患者进行随访,以降低总体成本。我们开发了一个注册和匹配系统来满足此要求。心衰患者的数据是前瞻性地通过基于Internet的系统从44个中心收集的。这项研究包括11个潜在的混淆变量,从2到3级进行排序。绝对匹配了5个变量,而其他6个变量具有“不平衡得分”。每组分别具有最小差异的患者在预定阈值内匹配。匹配是每晚由数据库系统自动完成的。已登记4周以上的不匹配患者不再符合匹配条件。 28个月后,登记了478例患者,匹配了206例。匹配后,两组之间的协变量平衡得到了改善。还讨论了匹配方法的替代方法。

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