Kairisto V, Kouri T, Virtanen A, Uusipaikka E, Koivula T
Department of Clinical Chemistry, University of Turku, Finland.
Scand J Clin Lab Invest Suppl. 1995;222:37-41. doi: 10.3109/00365519509088449.
Two approaches for deriving reference change limits from patient data are described. In the direct method, hospital database information is used for the selection of appropriate reference groups. If database information is not sufficient or reliable enough, but still most of the source data can be considered as health-related, an indirect method can be applied in the calculation of rough estimates for reference change limits. A computer program developed by us, GraphROC for Windows, includes both methods for the estimation of change limits from patient data. Time between specimen collections should be included as one classifying factor in the selection of source data. When only one previous result is available for comparison, change limits based on the reference sample group form the only available guide for clinical interpretation. However, when several previous results are available and the within-subject variances for the considered analyte are known to be heterogeneous between individuals, the clinical interpretation should rather be based on application of time series analysis.
本文描述了两种从患者数据中推导参考变化限值的方法。在直接法中，医院数据库信息用于选择合适的参考组。如果数据库信息不足或不够可靠，但大部分源数据仍可被视为与健康相关，则可采用间接法来计算参考变化限值的粗略估计值。我们开发的一个计算机程序，Windows版的GraphROC，包括了这两种从患者数据中估计变化限值的方法。在选择源数据时，标本采集之间的时间应作为一个分类因素包含在内。当只有一个先前结果可供比较时，基于参考样本组的变化限值是临床解释的唯一可用指南。然而，当有多个先前结果可用且已知所考虑分析物的个体内方差在个体之间存在异质性时，临床解释应更多地基于时间序列分析的应用。
