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 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.
Lung cancer is the leading cause of cancer-related deaths worldwide. Although improvement has been achieved in platinum-based chemotherapy and tyrosine kinase inhibitors-based molecular targeted therapy, they still have limitations. Immunotherapy has recently emerged as a very effective new treatment, and there is now growing enthusiasm in cancer immunotherapy worldwide. We summarized the effects of immune checkpoint inhibitors in clinical trials, and the current status and progress of anti programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) agents in lung cancer treatment. Attention has been paid to finding out the factors which influence the therapeutic effect of anti-PD-1/PD-L1 therapy and reducing the occurrence of adverse events.
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 While reporting of adverse drug reactions (ADR) and adverse drug events (AE) following Chinese medicine injection (CMI) is becoming more common, the reporting quality is of concern. Methods A checklist about the reporting quality of ADR/AE was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (CJN) (1994-2009) and Chinese Science and Technological Journal Net (VIP) (1989-2009) were searched for target literature. Results Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were 7 reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned ‘adverse effect,’ ‘safety’ or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, while 128 cases (56.89%) in Type II papers and Fourteen (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CMI procedure, such as the drug company, product serial number, or the drug’s validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported. Conclusion and recommendations The current reporting format of ADR/AE in clinical CMIs is not standardized. Much fundamental information of ADR/AE following CMI is therefore missing. A standard reporting format for ADR should be developed, and should include the following: 1) a title mentioning adverse effects and safety; 2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; 3) demographic characteristic of the patients (gender, age, etc.); 4) clinical characteristics of patients (disease, syndrome, etc); 5) allergic history of patients; 6) diagnosis and syndrome based on Chinese medicine theory; 7) detailed information about the Chinese materia medica intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); 8) concomitant drug use; 9) time and symptoms of ADR/AE; 10) type and grading of ADR/AE; 11) physiological systems affected by ADR/AE; 12) specific treatment and prognosis for ADR/AE; 13) evidence of the cause and effect of ADR/AE; 14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.
Objective To evaluate the prognostic value of several indexes of laboratory and ultrasonic cardiogram for adverse events in 3 months following the diagnosis of acute non-high-risk pulmonary embolism. Methods A total of 266 cases of acute non-high-risk pulmonary embolism patients diagnosed and treated in Beijing Anzhen Hospital during 2016 to 2017 were retrospectively analyzed. The patients were divided into a bad event group and a control group according to whether there was a bad event happened in 3 months following the diagnosis. The general data, indexes of laboratory and ultrasonic cardiogram were compared. Univariate and multivariate COX regression analysis were conducted to explore independent risk factors for 3 months’ poor prognosis. Results The bad outcome group had a significantly higher value of the proportion of suffering from connective disease and active cancer, C-reaction protein, monocyte/lymphocyte ratio (MLR) and urea while a significantly lower level of red blood cell count and hemoglobin compared with the control group (all P<0.05). Univariate and multivariate COX regression analysis showed that both the MLR (hazard ratio 14.59, 95% confidence interval 1.48 - 143.69, P=0.02) and suffering from connective disease (hazard ratio 5.85, 95% confidence interval 1.11 - 30.81, P=0.04) remain significantly different between the bad events group and the control group. Conclusion MLR at the admission may be related to the 3 months death of acute non-high-risk pulmonary embolism.
In December 2019, an outbreak of pneumonia associated with the coronavirus disease 2019 (COVID-19) occurred in Wuhan, China. The lung imaging finding is like that of the lung cancer immune checkpoint inhibitors (ICI) associated pneumonia. Therefore, we speculated that they may have similar pathogenesis and treatment strategies, which is reviewed in this article in order to provide some reference to timely and effectively reduce the fatality rate of COVID-19.
ObjectiveTo evaluate the value of myocardial perfusion change before and after coronary artery bypass grafting (CABG) in predicting postoperative major adverse cardiovascular events (MACE).MethodsA total of 70 CABG patients who received CABG completed by the same operator from January to November 2017 were selected, including 45 males and 25 females with an average age of 64.83±9.09 years. The patients were divided into two groups according to whether the patients had MACE after 1 year of the surgery, including a non-MACE group (group A, n=60) and a MACE group (group B, n=10). The clinical data of patients were compared.ResultsThere were statistical difference in the myocardial contrast echocardiography (MCE) score in the group A before and after surgery (P<0.05), and there were statistically significant differences in the left ventricular size and left ventricular ejection fraction (LVEF) value before and 1 year after surgery (P<0.001), but no statistically significant difference in the size of left atrium (P=0.075). There was no significant difference in the preoperative and postoperative MCE score, and preoperative and postoperative 1-year cardiac ultrasound score in the group B (P>0.05).ConclusionThe change of myocardial perfusion after CABG surgery is associated with postoperative MACE. The evaluation of myocardial perfusion before and after CABG surgery is of great significance for the prognosis evaluation of patients.