ObjectiveWe constructed a real-world evidence evaluation system to provide reference for obtaining high-quality evidence in evidence-based medicine.MethodsThrough the investigation and analysis of the key factors influencing the real-world research evidence, combined with domestic and foreign literature and evaluation tools, we preliminarily constructed the indicators of the real-world evidence evaluation system, then consulted experts in related fields by the Delphi method, modified and determined the final evaluation indicators. ResultsThe indicators of the final real-world evidence evaluation system included 40 items. The recovery efficiencies of the two rounds of expert consultation were 88.2% and 100%; The expert coordination coefficients were 0.174 (P<0.001) and 0.189 (P<0.001). After the second round of consultation, the mean of Likert scale in the range of 3.73~4.93, and the coefficient of variation varied in the range of 0.05~0.21. ConclusionThe real-world evidence evaluation system constructed in this study has certain reliability and scientificity, which can provide a basis and help for the transformation of real-world research into high-quality evidence.
Objective To investigate the effect and prognosis of patients with ventricular septal rupture after myocardial infarction treated by surgical repair combining an occluder and a patch. Methods Clinical data of 42 patients with myocardial infarction complicated with ventricular septal rupture admitted to the First Affiliated Hospital of Zhengzhou University from January 2010 to September 2021 were retrospectively analyzed. According to the surgical methods, 27 patients were divided into a traditional group, including 17 males and 10 females, with an average age of 62.81±6.81 years, who were repaired by patch only, and 15 patients were divided into a modified group, including 11 males and 4 females, with an average age of 64.27±9.24 years, who were repaired by surgery combining an occluder and a patch. Perioperative and follow-up data of the two groups were compared and analyzed.Results There were statistical differences between the two groups in preoperative Killip grading, rate of intra-aortic balloon pump use, interval from myocardial infarction to operation, and the number of culprit artery (P<0.05). There was no statistical difference in other preoperative data, the cardiopulmonary bypass time, aortic cross-clamping time, postoperative hospital stay or in-hospital death rate between the two groups (P＞0.05). No residual shunt occurred in the modified group, and the difference was statistically significant compared with the traditional group (P=0.038). There was no statistical difference in other complications between the two groups (P＞0.05). The median follow-up time was 4 years. Two patients in the traditional group and one in the modified group died during follow-up. The follow-up cardiac function grading of patients in the modified group was statistically different from that in the traditional group (P=0.023). Conclusion The perioperative mortality of ventricular septal rupture after myocardial infarction is high, but the long-term effect is satisfactory. Surgical repair combining an occluder and a patch is a safe and effective treatment for ventricular septal rupture, which can effectively reduce postoperative residual shunt.