OBJECTIVETo explore the value of electronic data capture (EDC) system in large-sample size studies on Kawasaki disease (KD).

METHODThe clinical data of 602 KD cases from 2007 to 2012 admitted to Shanghai Children's Hospital with EDC system connected with hospital information system (HIS) were retrospectively analyzed. Age, gender, acute symptoms, laboratory results, echocardiography, therapy were collected. The differences in parameters were compared between KD with and without coronary artery lesion (CAL). Furthermore, the difference between intravenous immunoglobulin (IVIG) resistant group and sensitive group were compared. Multi-factor logistic regression analyses were used to analyze the risk factors. The sensitivity and specificity of IVIG resistance parameters were detected with receiver operating characteristic curve (ROC) analysis.

RESULTThe male to female ratio of KD cases was 1.85: 1. The median age of KD cases was 2.0 years (one month to 11.7 years old); 20.1% cases (121/602) exhibited CAL. Compared with KD without CAL (n = 481), the incidence of bright red cracked lips (71.1% vs. 88.6%, P = 0.001), peeling of the skin of the toes (28.1% vs. 41.6%, P = 0.021) and perianal skin peeling (29.8% vs. 38.9%, P = 0.031) were statistically lower in KD with CAL (n = 121). The incidence of CAL in KD IVIG resistant group was significantly higher than KD IVIG sensitive group (34.6% (9/26) vs.21.3% (112/525), P = 0.05 ). Male ratio (80.8% vs. 63.4%, P = 0.05), time of IVIG ( (6 ± 2) vs. (8 ± 5) d, P = 0.009), erythrocyte sedimentation rate(ESR) ( (81 ± 2) vs. (66 ± 30) mm/1 h, P = 0.014), C-reactive protein ((107 ± 51) vs. (87 ± 52) mg/L, P = 0.017), blood platelet ( (599 ± 178) vs. (489 ± 182) ×10(9)/L, P = 0.003), hemoglobin ( (96 ± 13) vs. (102 ± 19) g/L, P = 0.032) and albumin ((34 ± 6) vs. (37 ± 6) g/L, P = 0.020) were significantly different between IVIG resistant group and sensitive group. Logistic regression analysis showed that alanine aminotransferase (ALT) ≥ 80 U/L was the independent risk factor of IVIG resistance (P = 0.012). C-reactive protein = 104 mg/L (sensitivity 61.5%, specificity 62.7%), ESR = 106 mm/1 h (sensitivity 26.9%, specificity 93.6%) and blood platelet = 187×10(9)/L (sensitivity 76.9%, specificity 53.1%) of KD in acute phase were predictive for IVIG resistance with receiver operate characteristic curve analysis.

CONCLUSIONEDC system can acquire KD clinical data quickly and accurately. It is helpful for multicenter retrospective analysis of KD.