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.
ObjectiveTo systematically evaluate the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors on the risk of cardiovascular events in type 2 diabetes mellitus (T2DM) patients. MethodsDatabases such as the Cochrane Library, PubMed, Elsevier ScienceDirect and EMbase were searched to collect randomized controlled trials (RCTs) about DPP-4 inhibitors for T2DM patients from inception to February 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed using RevMan5.2 software. ResultsA total of 20 RCTs involving 10 402 patients were included. The results of meta-analysis showed that:there were no significant differences between the DPP-4 inhibitors group and the control group in the cardiovascular adverse events (RR=0.86, 95%CI 0.62 to 1.20, P=0.38) and acute coronary syndrome (RR=0.66, 95%CI 0.37 to 1.17, P=0.15). Subgroup analyses by type of liptins and durations showed there were lower risks of adverse cardiovascular events in the DPP-4 inhibitors group of the sitagliptin subgroup (RR=0.49, 95%CI 0.29 to 0.82, P=0.007) and the duration of ≥52 weeks subgroup (RR=0.62, 95%CI 0.39 to 0.97, P=0.04). No significant difference was found between the two groups in hypertension events (RR=1.09, 95%CI 0.84 to 1.40, P=0.52). ConclusionThe DPP-4 inhibitors are relatively safe. In the long-term treatment of T2DM, the sitagliptin could not only effectively control the level of blood sugar but also might obtain benefits in cardiovascular aspects.
ObjectiveTo investigate the impact of clopidogrel resistance on the long-term prognosis in the elderly with acute coronary syndrome (ACS), as clopidogrel is widely used for secondary prevention in the patients with ACS, while studies on the relationship between clopidogrel resistance and long-term outcome in the elderly with ACS are limited. MethodsThree hundred elderly patients with ACS, aged from 70 to 95, with on average age of (81.3±6.4) years old, receiving clopidogrel (75 mg, once a day) over one month between January 2009 and December 2010 were followed up for major adverse cardiac events (MACE, including cardiac death, non-fatal re-myocardial infarction, angina, ischemia stroke/TIA, acute thrombosis and hemorrhage). Platelet aggregation was measured by light transmission aggregometry using adenosine diphosphate as a stimulus. According to the variation of platelet aggregation, the patients were divided into clopidogrel resistance group (<10%) and non-lopidogrel resistance group (≥10%). The median follow-up was 2 years. A Cox hazard proportional model was used to estimate time to outcome associated with clopidogrel resistance and MACE. ResultsThe incidence of clopidogrel resistance was 24.0% in our study population. Patients with diabetes, renal insufficiency, or a higher body mass index tended to have clopidogrel resistance. Compared with those patients without clopidogrel resistance, there was significantly increased MACE in patients with clopidogrel resistance (37.5%, 22.8%; P=0.032). Additionally, Cox hazard proportional model analysis demonstrated that clopidogrel resistance was an independently risk factor for MACE[HR=2.34, 95% CI (1.07, 4.57), P=0.016]. ConclusionDiabetes, renal insufficiency and high body max index are associated with clopidogrel resistance, which can predict the increased risk of MACE in elderly patients with ACS.
Objective To identify clinical risk factors for early major adverse cardiovascular events (MACEs) following surgical correction of supravalvar aortic stenosis (SVAS). Methods Patients who underwent SVAS surgical correction between 2002 and 2019 in Beijing and Yunnan Fuwai Cardiovascular Hospitals were included. The patients were divided into a MACEs group and a non-MACEs group based on whether MACEs concurring during postoperative hospitalization or within 30 days following surgical correction for SVAS. Their preoperative, intraoperative, and postoperative clinical data were collected for multivariate logistic regression. Results This study included 302 patients. There were 199 males and 103 females, with a median age of 63.0 (29.2, 131.2) months. The incidence of early postoperative MACEs was 7.0% (21/302). The multivariate logistic regression model identified independent risk factors for early postoperative MACEs, including ICU duration (OR=1.01, 95%CI 1.00-1.01, P=0.032), intraoperative cardiopulmonary bypass (CPB) time (OR=1.02, 95%CI 1.01-1.04, P=0.014), aortic annulus diameter (OR=0.65, 95%CI 0.43-0.97, P=0.035), aortic sinus inner diameter (OR=0.75, 95%CI 0.57-0.98, P=0.037), and diameter of the stenosis (OR=0.56, 95%CI 0.35-0.90, P=0.016). Conclusion The independent risk factors for early postoperative MACEs include ICU duration, intraoperative CPB time, aortic annulus diameter, aortic sinus inner diameter, and diameter of the stenosis. Early identification of high-risk populations for MACEs is beneficial for the development of clinical treatment strategies.
ObjectiveTo explore the application and effect of root cause analysis (RCA) in the management of adverse nursing events. MethodsNursing staff members were trained to establish the team of root cause analysis. They collected related materials of adverse nursing events in the infusion room of the Department of Pediatrics, found out the proximal causes and root causes, developed and implemented the corrective measures. RCA was carried out between January 2013 and December 2014. The efficacy was evaluated and the adverse events rate was compared before and after the practice. ResultsAfter the performance of RCA, the reporting rate of adverse events increased, the rate of adverse events decreased, and the reporting rate of potential safety problems also increased. All those changes were significant (P<0.01). ConclusionRoot cause analysis can decrease the rate of adverse nursing events, raise the reporting rate of adverse events. It is an effective guarantee to improve the nursing safety management.
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.
ObjectiveTo summarize the research progress of relationship between distal landing zone geometric and outcomes of endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysm. MethodsThe domestic and foreign literature on the accumulation of the impact of proximal and distal landing zone geometric morphology on clinical outcomes, the evaluation methods for related complications of proximal and distal landing zones, preventive measures for adverse outcomes related to the geometric morphology of the distal landing zone, and the pathophysiological mechanisms of complications related to the distal landing zone were retrieved to make an review. ResultsThe irregular geometric morphology of the proximal landing zone was closely associated with adverse events following EVAR. The morphology of the distal landing zone was actually more complex than that of the proximal zone, and the measurement methods for its parameters were also more complicated. Common methods used in the literature for studying landing zones included the centerline distance method, the minimum distance method, and the landing area method. Primary preventive measures for adverse outcomes related to the geometry of the distal landing zone included increasing radial support force and contact area, using endostaples, and extending the landing zone. In addition to anatomical factors, the distal landing zone was also influenced by various pathophysiological factors. ConclusionsThe morphology and related pathological changes of the distal landing zone significantly impact the clinical outcomes following EVAR for abdominal aortic aneurysm. However, current research on the distal landing zone is limited. Future studies should focus on developing new technologies and methods to improve the evaluation and management of the distal landing zone, thereby reducing the complications after EVAR, enhancing the success rate of the surgery, and improving patient survival quality.
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.
Objective To explore the predictive value of Composite Congestion Score (CCS) in predicting adverse events within 180 days in patients with acute heart failure (AHF) in emergency intensive care unit (EICU). Methods The patients with AHF who were admitted to EICU of Zigong Fourth People’s Hospital between January 1, 2018 and December 31, 2020 were included consecutively. The patients were followed up for 180 days, and were divided into poor prognosis group and good prognosis group according to whether there were adverse events. Logistic regression equation was used to screen independent risk factors for predicting adverse events in patients with AHF within 180 days after leaving EICU. To compare the discrimination, calibration and clinical usefulness of independent risk factors at EICU discharge and the Acute Physiology and Chronic Health Assessment SystemⅡ (APACHEⅡ) score at EICU admission to predict the occurrence of adverse events of AHF. Results A total of 71 patients were included, including 32 patients with good prognosis and 39 patients with poor prognosis. Except for age, APACHEⅡscore at EICU admission and CCS score at EICU discharge (P<0.05), there was no significant difference in other indicators between the two groups (P>0.05). Logistic regression analysis showed that CCS score at EICU discharge [odds ratio (OR)=2.806, 95% confidence interval (CI) (1.428, 5.512), P=0.003], age [OR=1.086, 95%CI (1.017, 1.159), P=0.013] were independent risk factors for predicting death or returning to hospital within 180 days. Among them, the CCS score at EICU discharge combining with age had a positive improvement ability compared with the CCS score at EICU discharge, the age, and the APACHE Ⅱ score at EICU admission. The calibration curves of the four scoring methods for predicting adverse events within 180 days showed that the CCS score at EICU discharge had the highest calibration and the calibration of age was the lowest. The decision curve showed that the clinical usefulness of age, the CCS score at EICU discharge and the CCS score at EICU discharge combining with age was better than the APACHE Ⅱ score at EICU admission. Conclusions The CCS score of patients with AHF at EICU discharge is closely related to adverse events within 180 days. The CCS score is designed based on clinical variables, simple and practical. The combination of age and the CCS score at EICU discharge will further enhance its clinical application value.