OBJECTIVES:  A patient-reported syndrome scale: Qi-deficiency syndrome (PRS-QDS) had been developed for efficacy assessment in Traditional Chinese Medicine (TCM) . This study aimed to evaluate the discriminant validity of the PRS-QDS. METHODS:  The patients with Qi-deficiency syndrome (QDS) and healthy subjects were recruited. All the subjects were divided into young, middle-aged and aged groups determined by age. Studies have found that there was a correlation between QDS and hemoglobin concentration (Hb), Hb was recorded for patients with anemia to analyse the relationship of QDS and Hb. All the patients with anemia were divided into two subgroups of mild and moderately severe anemia determined by Hb. T test was applied to compare the PRS-QDS scores between healthy subjects and patients with QDS.

RESULTS:  A total of 207 subjects [77 health (age: 51, 30 males) and 130 patients (age: 54, 46 males)] completed the PRS-QDS(ranging from 0-40, high score means less healthy). The total score of healthy people was 7.44±5.16, and the patients with QDS was 19.44±7.30. These total scores of young, middle-aged and aged subgroups for those patients were 19.60±5.86, 19.39±7.36, 19.42±7.67 compared to 8.91±5.15, 7.00±5.82, 4.47±3.12 for those healthy population respectively. The ten item scores of the patients with QDS were obviously higher than those of healthy population(P<0.001). The total score for the mild anemia subgroups was 14.36±7.89 compared to 23.00±7.07 for those moderately severe anemia. T test results showed that the ten item scores of the patients with mild anemia were clearly lower than those of moderately severe anemia. CONCLUSIONS:  The results expected differences in the PRS-QDS scores by the degree of anemia and known groups showed a good discriminant validity of the PRS-QDS. The evaluation of efficacy assessment for the PRS-QDS will be needed in the futher research.