Ningen Dock Database-based Criteria for Assessing the Significance of Changes in Test Values of Individuals

抄録

Objective: The Japan Society of Ningen Dock does not provide any criteria for determining whether changes from previous test values are within the range of natural biological variation or indicate clinical improvement or deterioration. Thus, when test values are classified into the same category as previously, deciding the significance of changes in the values has been left to the discretion of examiners. This study utilized data collected from participants to investigate new indices that would allow us to objectively determine whether changes in test values were significant within the respective criteria categories.

Methods: Participants comprised individuals who had undergone comprehensive health checkups (Ningen Dock) at the Jikei University School of Medicine for 25 years. Their data were used to calculate the level-specific, within-individual coefficient of variation (CV_I), and the reference change value (RCV) based on this CV_I. We then investigated significant changes in test values according to the criteria categories. Differences due to sex and age were also evaluated.

Results: Level-specific CV_I was estimated from measurements of 20,262 individuals with stable health status over time. We calculated RCV based on CV_I estimated without considering sex and age, and then classified RCV according to the criteria categories.

Conclusions: RCV estimation allows an objective evaluation of the significance of changes in test values, which helps determine whether the values have improved or deteriorated based on scientific evidence. RCV is expected to be widely used for Ningen Dock and in future clinical practice.