| ObjectiveTo Develop a excellent scale (DKDPRO) on the basis of revision of the the Diabetic Nephropathy PRO Scale (DNPRO) through Classic Test Theory, so that to improve the evaluation for DKD patient’s condition and the TCM therapeutic effect.MethodsWith reference to the PRO scale revised principle, the appearance of the DNPRO was modified firstly, forming a new scale called DKDPRO-1. The fe asibility, reliability, validity as well as responsibility of DKDPRO-1 was tested through experts consultation and clinical survey. Reliability included internal consistency reliability, split-half reliability and tes t-retest reliability. Validity included content validity, criterion-relate d validity and construct validity. To screen items of DKDPRO-1 and develo p a excellent scale,6 types of statistical methods, including Delphi metho d, dispersion degree, item distributing, Cronbach’s a, t test, correlati on analysis, was applied. Response scales was tested by investigating 50 individuals including patients and healthy persons.ResultsAfter the core working group discussion, the appearance of the scale and the expression of some items were more concise and beautiful.For Feasibility analysis, the completion time of the scale was 16.9+5.1 minutes, with satisfying acceptance rate and completion rare of 88.8%,92.5-100%, respectively.Reliability evaluation:With respect to the internal consistency reliability, the Cronbach’s a coefficients of the DKDPRO-1 and its three domians(physiological field, psychological field and social field)were 0.886,0.853,0.873,0.674, respectively. The split-half reliability coefficients of DKDPRO-1 and its three domains were 0.849,0.794, 0.899,0.766, respectively. There was no significant difference (P＞ 0.05)between test-retest among 20 DKD patients according to the paired t test. The total scale’s test-retest correlation coefficient was 0.933, and its three domians’test-retest correlation coefficient were 0.902,0.960, 0.965(P＜0.001), respectively. Validity assessment:About content validity, the CVI of experts consultation is 0.91. The criterion-related validity correlation coefficients between DKDPRO-1 and SF-36 and their corresponding field were 0.213,0.274,0.487,0.493, respectively. To construct validity, except items 13,25,36,48, correlation coefficients between other items and field they belong to were bigger than that with other fields. The KMO was 0.543 and the result of Bartlett Test of sphericity was P<0.001. Seventeen factors’cumulative% was 74.661%. Responsibility evaluation:The scores were significantly different between DKD patients in stage Vand DM patients without renal damage (P<0.05), with similar outcome between DKD patients in stage Ⅲ-Ⅴ and healthy subjects (P<0.05), showing that the scale was able to distinguish the subjects.Seven items (3,4,6,18,34,36,38), with poor performance, were deleted by applying Delphi technique and the other five methods.The expression of three items(17,50,51) were revised according to clinical investigation. In addition, we were going to increase three items:urine with bubble, dry stool and confidence for treatment in the second round of experts consultation. Response scales assessment:The means of the adverbs used in the scales were closed to 2.5,5.0,7.5, respectively, and the medians were among 2 to 3,4.5 to 4.5,7.0 to 8.0, respectively.ConcIusionThe feasibility, internal consistency reliability, split-half reliabil ity, test-retest reliability, content validity and responsibility of DKDPR 0-1 were good.However, its criterion-related validity,construct validity a s well as respond scales need to be improved. It is necessary to conduct a multicenter study to verify the performance of DKDPRO-2. |
