| Background Chronic kidney disease is a worldwide public health problem with increasing prevalence, low awareness rate, poor outcome and heavy economic burden. The early stage of CKD is asymptomatic and many patients diagnosed as end-stage renal disease in the first consultation of nephrologist. Previous studies showed that early diagnosis and intervention is benefit for delaying the progression and reducing the economic burden. However, screening strategy for CKD is still controversial. Microalbuminuria is the earliest marker of kidney damage. Persistent albuminuria is the criteria for CKD diagnosis. The time-window of current diagnose strategy for persistent albuminuria is 2 months. Long time-window limits its promotion in clinic trials and clinical works. Due to the fluctuation of albuminuria, the significance of single measurement is limited. Early intervention based on single test may lead to over-treatment and the waste of medical resource. Developing a reasonable, practical and cost-efficient screening strategy is essential while researches on this issue were quiet limited.Objectives To explore a feasible and cost-effective screening strategy for persistent albuminuria among high-risk population. MethodAltogether 157 clinical stable outpatients previously diagnosed with hypertension, diabetes and/or coronary heart disease were recruited. Each participant collected three first morning urine samples in three consecutive months labeled as D-1, M-2 and M-3. In the first month, a randomized spot sample in the first day afternoon and another first morning sample in the second day were collected which were labeled as R-spot and D-2. Five strategies were designed based on following sample selections(albuminuria positive as ACR≥3mg/mmol) – a) D1; b) R-spot; 3) D1 & R-spot; 4) D1 &D2; 5) D1 & Spot &D2(Test A). Golden standard was defined as D-1 & M-2 & M-3 all positive. Validity assessments and cost-effectiveness analysis based on Markov model had been developed.Results According to the golden standard, 82 of 157 patients had persistent albuminuria. D-1 strategy reached 100% sensitivity and 69.33% specificity. R-spot had the lowest specificity of 46.67%. Veracity of D1&Spot and D1&D2 were quite similar(sensitivity 96.34% vs 96.34%; specificity 76% vs 77.34%). D-1&D-2&R-Spot showed a relatively satisfied specificity of 81.3% and sensitivity of 93.9%.With the consideration of time-cost, D1& D2 was abandoned in cost-effectiveness analysis. Markov model was developed. After 120 cycles, the cumulated cost and utility were CNY6351.82 and 0.6987 QALYs in Test A; CNY7586.53 and 0.6979 QALYs in D1& R-spot; CNY9155.12 and 0.6976 QALYs in D1; CNY14109.69 and 0.6885 QALYs in R-spot. Test A was undominated. Compared with Test A, the incremental cost-utility ratio for D1& R-spot, D1 and R-spot were CNY-830786.14 /QALYs, CNY-1331437.19 /QALYs and CNY-402122.36/QALYs. When the willingness-to-pay threshold is CNY100000/QALY, D1& R-spot, D1 and R-spot were all no cost-utility.Conclusion To diagnose persistent albuminuria, the strategy of combination two first morning urine samples and one randomized spot urine sample in two consecutive days is quite accurate, time-saved and cost-efficient. |
PDF Full Text Request