[Evaluation of quality-control management for pediatric fulminant myocarditis]

Objective: To explore the efficacy of the implementation of quality control (QC) program for children with fulminant myocarditis (FM) on improving the survival rate, reducing mortality and complication rates, and to evaluate the feasibility of the QC protocol. Methods: A retrospective cohort study was conducted. A Clinical Medical Quality Control Scoring Scale for Pediatric Fulminant Myocarditis (the QC Scale) was implemented since January 2021. Clinical data and the QC Scale data of 187 children with FM admitted to 8 tertiary hospitals capable of pediatric extracorporeal membrane oxygenation (ECMO) treatment over 6 years were collected, including the pre-QC group (January 2018 to December 2020) and the post-QC group (January 2021 to December 2023). Independent-samples t-test, Mann-Whitney U test, Chi-square test or Fisher's exact test were used for intergroup comparisons; and multivariate Logistic regression was performed for risk factor analysis. The clinical characteristics of pediatric FM and the feasibility and clinical efficacy of the QC protocol were evaluated. Results: A total of 187 children with FM were enrolled, including 82 cases in the pre-QC period and 105 cases in the post-QC period. The age was (8±4) years, and the weight was (28±14) kg. There were 104 female cases (55.5%) and 83 male cases (44.5%). A total of 156 children survived and 31 died, with an overall in-hospital mortality rate of 16.6% (31/187). The completion rates of electrocardiogram or cardiac monitoring and echocardiography or non-invasive hemodynamic monitoring within 30 min after admission were 98.7% (81/82) and 92.6% (72/82) in the pre-QC group, compared with 96.2% (101/105) and 90.5% (95/105) in the post-QC group. The post-QC group showed significantly higher completion rates of blood lactate measurement and Glasgow Coma Scale assessment within 60 min of admission than the pre-QC group (86.5% (71/82) vs. 98.1% (103/105), 62.2% (51/82) vs. 81.9% (86/105), χ²=9.43, 8.72; P=0.002, 0.003). The pre-QC completion rates of reaching blood lactate ≤5 mmol/L, central venous oxygen saturation ≥65%, and urine output≥1 ml/(kg·h) at 12 h after treatment were 82.1%(46/56), 72.1%(31/43) and 72.7%(48/66), respectively, compared with 81.1%(77/95), 69.1%(47/68) and 80.9%(76/94) in the post-QC group. The time from admission to ECMO initiation was shorter in the post-QC group than in the pre-QC group ((11±17) vs. (7±10) h, t=2.09, P=0.037). The mortality rates were 22.0% (18/82) in the pre-QC group and 12.4% (13/105) in the post-QC group. Compared with the pre-QC group, the post-QC group presented decreased rates of pre-ECMO cardiopulmonary resuscitation, cerebral injury and severe renal injury (51.2% (42/82) vs. 28.6% (30/105), 19.5% (16/82) vs. 8.6% (9/105), 19.5% (16/82) vs. 8.6% (9/105); χ²=9.97, 4.76, 4.76, all P<0.05). Conclusions: The implementation of the QC protocol for pediatric FM improves the ability of organ injury identification and standardized treatment, facilitates timely ECMO initiation, reduces the occurrence of cardiac arrest and major complications, and is of great significance for improving long-term quality of life. The pilot hospitals achieves high completion rates of QC indicators, indicating good feasibility of the protocol.