Objective To analyze the complaint characteristics of emergency department of women and children’s specialized hospital, and to provide a basis for improving medical service quality, enhancing hospital management, increasing satisfaction, and reducing complaint rates in specialized hospitals. Methods Using the Healthcare Complaint Analysis Tool classification framework, a retrospective analysis was conducted on complaints from the Emergency Department of West China Second University Hospital of Sichuan University. Results The total number of complaints from 2020 to 2022 was 525, and the number of complaints had been increasing year by year. There were 196 complaints against personnel and 329 complaints against regions. There were 320 complaints related to management issues (61.0%), 143 complaints related to doctor-patient relationship issues (27.2%), and 62 complaints related to clinical issues (11.8%). The complained areas were mainly fever clinics (193 cases), and the complained personnel were mainly nurses (82 cases). Conclusion The emergency department of women and children’s specialized hospitals is different from comprehensive hospitals, and active optimization should be carried out to address the main issues. While continuously improving the level of medical technology, it is also necessary to strengthen information technology construction, optimize medical procedures, improve environmental facilities, and provide psychological support for patients and their caregivers.
Objective To assess the effectiveness and safety of tongxinluo capsule for coronary heart disease. Methods Both the randomized controlled trials (RCTs) and quasi-RCTs of tongxinluo capsule for coronary heart disease were collected through searching on computer from the following databases, The Cochrane Library (Issue 4, 2010), PubMed (2000 to April 2010), WanFang Data (1996 to April 2010), CNKI (1994 to April 2010) and VIP (1989 to April 2010). The trials selection based on inclusion and exclusion criteria, data extraction, cross check and quality assessment were conducted by two reviewers independently, and meta-analysis was performed with RevMan 5.0 software. Results A total of 13 studies involving 1 496 participants were included. The results of meta-analyses showed that: compared with the nitrate esters group, the tongxinluo capsule group had a better curative effect on the coronary heart disease than isosorbide dinitrate (RR=0.50, 95%CI 0.36 to 0.70) and isosorbide mononitrate (RR=0.19, 95%CI 0.12 to 0.30); there was significant difference in the total curative effect between the two groups (RR=0.34, 95%CI 0.26 to 0.44, Plt;0.000 01); the tongxinluo capsule was also better in improving the ECG than isosorbide dinitrate (RR=0.55, 95%CI 0.46 to 0.66) and isosorbide mononitrate (RR=0.58, 95%CI 0.48 to 0.70); there was significant difference in the total ECG improvement between the two groups (RR=0.56, 95%CI 0.49 to 0.64, Plt;0.000 01); the tongxinluo capsule group had a lower incidence rate of adverse reaction than the nitrate esters group with a significant difference (RR=0.33, 95%CI 0.20 to 0.53, Plt;0.000 01). Conclusion The present evidence indicates that tongxinluo capsule is not inferior to isosorbide dinitrate or isosorbide mononitrate in improving the curative effect and ECG, and it has fewer adverse reactions. More well-designed and large scale multi-centered RCTs are required with longer follow-up time to confirm this conclusion.
Objective To observe the result of reconstructing quadriceps femoris function in the paraplegia rats by using the 7th cervical nerve root (C7) transposition with autologous and allogeneic neural transplantation. Methods Twenty16-week-old SPF male Wistar rats were adopted to prepare frozen sciatic nerve. Thirty-six Wistar rats were divided into 2 groups (group A and group B, n=18). The left paraplegia model was establ ished with left spinal cord hemisection by the micro scissors under the operation microscope. After the model establ ishment, the homolateral autologous sciatic nerve was bridged with the femoral nerve root by the translocation of C7 in group A, while the allogeneic sciatic nerve was bridged with the femoral nerve root by the translocation of C7 in group B. At 16 weeks and 24 weeks after operation, 9 rats in each group were selected for the neuroelectric-physiological test and then the histomorphology of the nerves was observed under the microscope and the electron microscope. The fresh weight recovery rate of quadriceps femoris was calculated. Results At 16 and 24 weeks after operation, the nerve action-evoked potential (NAP) was (1.14 ± 0.07) mV and (1.21 ± 0.07) mV in group A, and (0.87 ± 0.06) mV and (0.99 ± 0.05) mV in group B; the nerve conduction velocity (NCV) was (17.34 ± 2.15) m/s and (19.00 ± 3.02) m/s in group A, and (11.23 ± 1.45) m/s and (12.54 ± 1.59) m/s in group B, respectively, indicating significant differences (P lt; 0.05) between 2 groups. At 16 and 24 weeks after operation, HE staining and Bielschowsky staining showed that group A had a large number of nerve fiber regeneration, with a regular arrange of axons; while group B had l ittle nerve fiber regeneration with a scattered arrange of axons. At 24 weeks after operation, images in TEM showed a large number of regeneration myel inated nerve fibers and a small number of unmyel inated nerve fibers through the transplanted nerve in two groups. At 16 weeks after operation, the number of myel inated nerve fibers in group A and group B was (438 ± 79) and (196 ± 31) / vision, the areas of myel inated nerve fiberswere (5 596.00 ± 583.94) and (4 022.63 ± 615.75) μm2 / vision; after 24 weeks, the number of myel inated nerve fibers in groups A and B were (642 ± 64) and (321 ± 75)/vision, the areas of myel inated nerve fibers were (6 689.50 ± 1 142.10) and ( 4 733.00 ± 982.22) μm2/vision, indicating significant differences between two groups (P lt; 0.05). There was no statistically significant difference (P gt; 0.05) in the wet weight recovery rate of quadriceps between group A and group B at 16 weeks (87.96% ± 4.93% vs. 86.47% ± 7.47%) and at 24 weeks after operation (90.10% ± 4.22% vs. 87.66% ± 3.14%). Conclusion C7 transposition combined with autograft and allograft of sciatic nerve can reconstruct the partial function of the quadriceps femoris in paraplegia rats. The effect of graft is better than that of graft obviously.
Objective To evaluate the efficacy and safety of Shen Song Yang Xin Capsule for cardiac arrhythmia. Methods Randomized controlled trials (RCTs) were searched from the following electronic databases: WanFang, CNKI, CBM, VIP, PubMed, and The Cochrane Library. Quality assessment and data extraction were conducted by two reviewers independently. Disagreement was resolved through discussion. All data were analyzed by using RevMan 5.0 software. Results Thirteen studies involving 1896 participants were included. The results of meta-analyses showed that compared with the control group, a) efficacy: Shen Song Yang Xin Capsule was superior to mexiletine (OR=2.96, 95%CI 1.79 to 4.87), and propafenone (OR=2.41, 95%CI 1.60 to 3.62), but was not superior to miodarone (OR=1.25, 95%CI 0.88 to 1.71); b) safety: Shen Song Yang Xin Capsule was superior to propafenone and miodarone in reducing the incidence of cardiac arrhythmia (OR=0.06, 95%CI 0.01 to 0.35; OR=0.05, 95%CI 0.02 to 0.17), but no significant difference was found between the two groups in incidence of gastrointestinal adverse reactions. Conclusion Based on the current studies, Shen Song Yang Xin Capsule is not inferior to the commonly-used anti-arrhythmic medicine at present. It has lower incidence of cardiac arrhythmia, and has no significant difference in the incidence of gastrointestinal adverse reactions compared with western drugs. For the quality restrictions of the included studies, more double blind RCTs with high quality are required to further assess the effects.
Research of generating real-world evidence using real world data has attracted considerable attention globally. Outcome research of treatment based on existing health and medical data or registries has become one of the most important topics. However, there exists certain confusions in this line of research on how to design and implement appropriate statistical analysis. Therefore, in the fourth chapter of the series technical guidance to develop real world evidence by China REal world data and studies Alliance (ChinaREAL), we aim to provide an guidance on statistical analysis in the study to assess therapeutic outcomes based on existing health and medical data or registries.In this chapter, we first emphasize the significance of pre-specified statistical analysis plan, recommending key components of the statistical analysis plan. We then summarize the issue of sample size calculation in this content and clarify the interpretation of statistical p-value. Secondly, we recommend procedures to be considered to tackle the issue related to the selection bias, information bias and most importantly, confounding bias. We discuss the multivariable regression analysis as well as the popular causal inference models. We also suggest that careful consideration should be made to deal with missing data in real-world databases. Finally, we list core content of the statistical report.