ObjectiveTo explore the risk factors and countermeasures of the perfusionist-related near-miss event (NME) in cardiopulmonary bypass (CPB). MethodsThe clinical data of the patients who underwent cardiac surgery in the Department of Cardiovascular Surgery, Nanfang Hospital, Southern Medical University from March 2020 to July 2021 were retrospectively analyzed. According to whether NME occurred during the operation, the patients were divided into an NME group and a non-NME group. The clinical data of the two groups were compared, and the risk factors for NME were analyzed. ResultsA total of 702 patients were enrolled, including 424 males and 278 females with a median age of 56.0 years. There were 125 patients in the NME group and 577 patients in the non-NME group. The occurrence rate of NME was 17.81%. Univariate analysis showed that there were statistical differences between the two groups in the gender, body surface area, CPB time, European system for cardiac operative risk evaluation score, emergency surgery, type of surgery, night CPB initiation, modified ultrafiltration use, multi-device control, average operation time, et al. (all P<0.05). The above variables were dimensionality reduction processed by least absolute shrinkage and selection operator regression, and the λ of minimum mean square error of 10-fold cross validation was 0.014. The variables of the corresponding model were selected as follows: multi-device control, night CPB initiation, minimum hematocrit, modified ultrafiltration use, CPB time. The results of multivariate logistic regression showed that night CPB initiation [OR=9.658, 95%CI (4.735. 19.701), P<0.01] and CPB time [OR=1.003, 95%CI (1.001, 1.006), P=0.014] were independent risk factors for NME. ConclusionNight CPB initiation and CPB time are independent risk factors for NME during CPB, which should be recognized and early warned in clinical work.
ObjectiveZero-events studies frequently occur in systematic reviews of adverse events, which consist of an important source of evidence. We aimed to examine how evidence of zero-events studies was utilized in the meta-analyses of systematic reviews of adverse events.MethodsWe conducted a survey of systematic reviews published in two periods: January 1, 2015 to January 1, 2020 and January 1, 2008, to April 25, 2011. Databases were searched for systematic reviews that conducted at least one meta-analysis of any healthcare intervention and used adverse events as the exclusive outcome. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. We summarized the frequency of occurrence of zero-events studies in eligible systematic reviews and how these studies were dealt with in the meta-analyses of these systematic reviews.ResultsWe included 640 eligible systematic reviews. There were 406 (63.45%) systematic reviews involving zero-events studies in their meta-analyses, among which 389 (95.11%) involved single-arm-zero-events studies and 223 (54.93%) involved double-arm-zero-events studies. The majority (98.71%) of these systematic reviews incorporated single-arm-zero-events studies into the meta-analyses. On the other hand, the majority (76.23%) of them excluded double-arm-zero-events studies from the meta-analyses, of which the majority (87.06%) did not discuss the potential impact of excluding such studies. Systematic reviews published at present (2015-2020) tended to incorporate zero-events studies in meta-analyses than those published in the past (2008-2011), but the difference was not significant [proportion difference=–0.09, 95%CI (–0.21, 0.03), P=0.12].ConclusionSystematic review authors routinely treated studies with zero-events in both arms as "non-informative" carriers and excluded them from their reviews. Whether studies with no events are "informative" or not, largely depends on the methods and assumptions applied, thus sensitivity analyses using different methods should be considered in future meta-analyses.
Objective To construct a risk prediction score model for serious adverse event (SAE) after cardiac catheterization in patients with adult congenital heart disease (ACHD) and pulmonary hypertension (PH) and verify its predictive effect. Methods The patients with PH who underwent cardiac catheterization in Wuhan Asian Heart Hospital Affiliated to Wuhan University of Science and Technology from January 2018 to January 2022 were retrospectively collected. The patients were randomly divided into a model group and a validation group according to the order of admission. The model group was divided into a SAE group and a non-SAE group according to whether SAE occurred after the catheterization. The data of the two groups were compared, and the risk prediction score model was established according to the results of multivariate logistic regression analysis. The discrimination and calibration of the model were evaluated using the area under the receiver operating characteristic (ROC) curve and the Hosmer-Lemeshow test, respectively. Results A total of 758 patients were enrolled, including 240 (31.7%) males and 518 (68.3%) females, with a mean age of 43.1 (18.0-81.0) years. There were 530 patients in the model group (47 patients in the SAE group and 483 patients in the non-SAE group) and 228 patients in the validation group. Univariate analysis showed statistical differences in age, smoking history, valvular disease history, heart failure history, N-terminal pro-B-type natriuretic peptide, and other factors between the SAE and non-SAE groups (P<0.05). Multivariate analysis showed that age≥50 years, history of heart failure, moderate to severe congenital heart disease, moderate to severe PH, cardiac catheterization and treatment, surgical general anesthesia, and N-terminal pro-B-type natriuretic peptide≥126.65 pg/mL were risk factors for SAE after cardiac catheterization for ACHD-PH patients (P<0.05). The risk prediction score model had a total score of 0-139 points and patients who had a score>50 points were high-risk patients. Model validation results showed an area under the ROC curve of 0.937 (95%CI 0.897-0.976). Hosmer-Lemeshow goodness-of-fit test: χ2=3.847, P=0.797. Conclusion Age≥50 years, history of heart failure, moderate to severe congenital heart disease, moderate to severe PH, cardiac catheterization and treatment, general anesthesia for surgery, and N-terminal pro-B-type natriuretic peptide≥126.65 pg/mL were risk factors for SAE after cardiac catheterization for ACHD-PH patients. The risk prediction model based on these factors has a high predictive value and can be applied to the risk assessment of SAE after interventional therapy in ACHD-PH patients to help clinicians perform early intervention.
Endoscopic retrograde cholangiopancreatography (ERCP) is currently the first-line minimally invasive diagnosis and treatment of biliary and pancreatic diseases. With the increasing popularity of ERCP, ERCP-related adverse events which include post-ERCP pancreatitis, cholecystitis, cholangitis, bleeding, perforation, etc., have received more and more attention. In response to the controversy and problems in the management of these adverse events, the European Society of Gastrointestinal Endoscopy published the guidelines for ERCP-related adverse events in December 2019. The paper interprets the key points in the guideline to provide references for clinical practice.
ObjectiveTo compare the efficacy of three surgical approaches, including percutaneous transluminal angioplasty (PTA), PTA+bare metal stent (BMS), and Rotarex+PTA+drug coated balloon (DCB), in treating femoropopliteal artery lesions in arteriosclerosis obliterans (ASO), and to explore the prognostic factors of femoropopliteal artery lesions in ASO. MethodsA retrospective analysis was conducted on 314 patients with femoropopliteal artery lesions in ASO who were treated in the Department of Vascular and Thyroid Surgery in the First Affiliated Hospital of Xinjiang Medical University from March 2018 to March 2024. inverse probability of treatment weighting was used to balance the baseline characteristics of the three groups. The clinical examination, imaging examination, and ankle-brachial index (ABI) results of the three groups at 3 months, 12 months, and 24 months after surgery were compared. Log-rank test was used to compare the incidence of all-cause mortality (ACM) and major adverse limb events (MALEs) among the three groups, and Cox proportional hazards regression model was used to analyze the prognostic factors of femoropopliteal artery lesions in ASO. ResultsA total of 314 patients with ASO femoropopliteal artery lesions were enrolled, comprising 153 cases in the PTA group, 89 cases in the PTA+BMS group, and 72 cases in the Rotarex+PTA+DCB group. After inverse probability of treatment weighting based on propensity scores, baseline characteristics were balanced across all groups (all P>0.05). Postoperative follow-up results demonstrated the following patency rates: at 3 months, 58.4% (87/149) for the PTA group, 79.5% (66/83) for the PTA+BMS group, and 87.5% (63/72) for the Rotarex+PTA+DCB group; at 12 months, 78.0% (60/79), 68.3% (43/63), and 80.0% (44/55), respectively; and at 24 months, 98.1% (52/53), 89.7% (35/39), and 100.0% (43/43), respectively. The Rotarex+PTA+DCB group exhibited significantly superior patency rates, claudication distances, ankle-brachial index (ABI), and Rutherford classification compared to both the PTA and PTA+BMS groups at 3 months (P<0.05). Furthermore, the Rotarex+PTA+DCB group showed lower incidence of ACM/MALEs compared to the other two groups (χ2=18.70, P<0.001). Survival analysis revealed that the Rotarex+PTA+DCB group had significantly better survival outcomes compared to the PTA+BMS group (χ2=14.27, P<0.001) and the PTA group (χ2=3.92, P=0.016). Cox proportional hazards regression analysis identified elevated red cell distribution width (RDW) as an independent risk factor for ACM/MALEs following endovascular therapy in ASO patients, with a relative risk of 1.006 [95%CI (1.002, 1.011), P=0.006]. ConclusionsThe Rotarex+PTA+DCB demonstrate superior outcomes compared to both the PTA and PTA+BMS in terms of patency rate, claudication distance, ABI, and Rutherford classification at 3 months postoperatively, along with the better survival. Furthermore, elevated RDW may serve as a prognostic factor for adverse outcomes in patients with ASO femoropopliteal artery lesions.
ObjectiveTo explore the psychological process and needs of the second victims of medical adverse events after the occurrence of adverse events, so as to provide reference for the psychological intervention strategies of medical institutions for the second victims of medical adverse events.MethodsThe second victims of medical adverse events in the First People’s Hospital of Ziyang were selected from April to July 2019. Qualitative research method was used to conduct semi-structured in-depth interviews with the second victims. Colaizzi method was used to analyze the transcripts through reading and rereading, coding, and thematizing. ResultsA total of 22 second victims of medical adverse events were interviewed. The second victims of medical adverse events experienced negative emotional experience, and the desire to seek emotional support was urgent. The psychological process of the second victims of medical adverse events mainly involved five stages: fear, anxiety, depression, guilt and recovery. Emotional support hada positive effect on regression. Conversely, negative or lack of emotional support had a negative effect on regression. ConclusionsThe emotional experience of the second victims of medical adverse events is relatively staged, and the recovery and regression are greatly affected by internal and external factors. Hospital administrators should take active measures and establish an emotional support mechanism for adverse events in order to reduce psychosomatic injuries and improve medical quality and efficiency.
摘要:医院有效事前监测、管控医疗不良事件，是保障患者安全、提高医疗质量的管理措施之一。超大型医院对医疗不良事件管理的实战中，建立、实施医疗安全隐患事件关键监测指标、医疗安全隐患事件筛查程序指标，积极开展医疗不良事件后台监管工作，切断医疗安全隐患事件向医疗风险事件演变、医疗风险事件向医疗纠纷事件演变的环节，保障患者安全。Abstract: Effective supervision in advance to the medical adverse event, is one of measures which hospital adopt to guarantee patient safety and enhance medical quality. The actual combat of supervision to the medical adverse event in super sized hospital, set up and put in practice on the key target of supervising the medical adverse event and the key target of ridding procedure, remain in the background and work actively on supervision on the medical adverse event, shut off the road from the medical safety issue to the medical risk issue and the road from the medical risk issue to the medical dissension in order to guarantee the patient safety.
Objective To explore the emergence agitation resulting from postoperative indwelling urethral catheters in patients of thoracic surgery. Methods In this prospective cohort study, we recruited 140 patients who were scheduled for thoracic surgery under general anesthesia in West China Hospital from January through April 2014. These patients were divided into two groups including a control group and a trial group with 70 patients in each group. The patients in the control group had indwelled urethral catheter routinely. The catheter removed after the surgery at operation room in the trial group. Intraoperative urinary volume, emergence agitation (EA) occurrence, postoperative urinary retention, and urethral irritation were recorded. Results There was no statistical difference in postoperative urinary retention rate between the control group and the trial group (1.43% vs. 2.86%, P=0.230). However, the urethral irritation rate in the control group was significantly higher than that in the trial group (12.86% vs. 0.00%, P=0.012) . And there was a statistical difference in adverse event rate (2.86% vs. 0.00%, P=0.039) between the two groups. There was a significantly higher incidence of urethral irritation in male patients (20.51%, 8/39) than female patients (3.23%, 1/31, P=0.033).The rate of EA in the control group was significantly higher than that in the trial group (28.57% vs. 12.86%, P=0.010). There was a significantly higher EA rate in the patients who had urethral irritation by postoperative indwelling catheters compared with those without indwelling catheters (45.00% vs. 12.86%, P=0.043). Conclusion This study suggests that postoperative EA is a result from urethral irritation than local pain, and the EA rate can be decreased by removal of catheter before anaesthetic recovery.