隨機控制臨床試驗：比較具有「病人專一性」及「非專一性」
之臨床警示系統用於降低顯影劑誘發腎病變
蔡宗佑1,2、王世亨3、李友專4
1亞東紀念醫院 泌尿科；2國立陽明大學 生物醫學資訊研究所；
3台灣大學流病及預醫研究所；4台北醫學大學醫學科技學院
Patient-specific versus non-patient-specific alerts in decision support system to prevent contrast-induced nephropathy: A randomized controlled trial
Chung-You Tsai1,2, Shi-Heng Wang3, Yu-Chuan Li4
1 2. Division of Urology, Department of Surgery, Far Eastern Memorial Hospital, Taiwan; 2Institute of Biomedical Informatics, National Yang-Ming University; 3Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University; 4College of Medicine Science and Technology (CoMST), Taipei Medical University, Taiwan
Purpose: Physicians ordering contrast imaging should identify patient risks and prevent contrast-induced nephropathy (CIN). Our aim is to determine whether patient-specific or non-patient-specific alerts in clinical decision support system triggers higher compliance with guidelines to prevent CIN.
Materials and Methods: A 3-arm cluster randomized controlled trial was conducted in two university hospitals using the same computerized physician order entry. Eligible physicians were randomized to receive patient-specific alerts, non-patient-specific alerts or no intervention (groups 1-3 respectively). Patient-specific alerts automatically prompted only when CIN risk was encountered and provides patient-specific data to physicians, while non-patient-specific alerts always prompted regardless of risk without providing patient-specific data. CIN risk was stratified as high-risk, low-risk and minimal-risk according to patient’s renal function. Contrast imaging order-cancellation rate was measured as primary outcome.
Results: Orders for 5372 patients from 99 physicians were analyzed. Renal function and risk distributions of patients were not statistically different among groups. Order-cancellation rates were 32.1%, 14.3%, 1.7% for high risk patients, and 7.2%, 3.0%, 1.3% for low risk patients in groups 1-3, respectively. Using generalized linear model, significant order-cancellation factors in at-risk patients were non-patient-specific alert (p=0.04), patient-specific alert (p<0.0001), high CIN risk (p=0.003), and physicians with low contrast imaging ordering volume (p<0.0001). Order-cancellation effects were compared and measured by odds ratio (OR). For high risk patients, patient-specific versus non-patient-specific alerts OR was significant at 2.73 (95%CI 1.09-6.84), while patient-specific vs. control OR=28.32 (95%CI 3.21-249.65), and non-patient-specific vs. control OR=9.17 (95%CI 0.96-87.55).
Conclusions: Patient-specific alert significantly outperformed non-patient-specific alert in physician compliance with guidelines.