The safety of tai chi: A meta-analysis of adverse events in randomized controlled trials

ObjectivesTo review current publications to examine safety of tai chi (TC).DesignCochrane Library, EBSCO host and MEDLINE/PubMed were searched for randomized controlled trials (RCTs) including TC as the core intervention and reporting adverse events (AEs). Data were extracted considering active vs. inactive control group comparisons and presence of an AE monitoring protocol. Meta-analyses were conducted for overall results as well as control group and reporting specific conditions.ResultsIn 256 RCTs of TC, 24 met eligibility criteria (1794 participants) and were assessed using the Cochrane Risk of Bias tool. The frequency of non-serious, serious and intervention-related AEs were not found to be significantly different between TC and inactive or active control conditions. In studies with an AE monitoring protocol, more non-serious adverse events (RD = 0.05; 95% CI: 0.00, 0.10; P = 0.05) were reported for TC compared to inactive interventions. Given the higher overall AE risks related to studies of participants with heart failure, additional analyses examined this set separately. More serious AEs were found for inactive interventions compared with TC in studies with heart failure participants (RD = −0.11; 95% CI: −0.20, −0.03; P = 0.01).ConclusionFindings indicate that TC does not result in more AEs than active and inactive control conditions, and produces fewer AEs than inactive control conditions for heart failure patients.     

Efficacy and adverse events of high-frequency oscillatory ventilation in adult patients with acute respiratory distress syndrome: a meta-analysis

Introduction

Theoretically, high-frequency oscillatory ventilation (HFOV) achieves all goals of a lung-protective ventilatory mode and seems ideal for the treatment of adult patients with acute respiratory distress syndrome (ARDS). However, its effects on mortality and adverse clinical outcomes remain uncertain given the paucity of high-quality studies in this area. This meta-analysis was performed to evaluate the efficacy and adverse events of HFOV in adults with ARDS.

Methods

We searched PubMed, EMBASE and Cochrane Central Register of Controlled Trials through February 2014 to retrieve randomized controlled trials of HFOV in adult ARDS patients. Two independent reviewers extracted data on study methods, clinical and physiological outcomes and adverse events. The primary outcome was 30-day or hospital mortality. Risk of bias was evaluated with the Cochrane Collaboration’s tool. Mortality, oxygenation and adverse effects of HFOV were compared to those of conventional mechanical ventilation. A random-effects model was applied for meta-analysis.

Results

A total of five trials randomly assigning 1,580 patients met inclusion criteria. Pooled data showed that HFOV significantly improved oxygenation on day one of therapy (four studies; 24% higher; 95% confidence interval (CI) 11 to 40%; P <0.01). However, HFOV did not reduce mortality risk (five studies; risk ratio (RR) 1.04; 95% CI 0.83 to 1.31; P = 0.71) and two early terminated studies suggested a harmful effect of HFOV in ARDS (two studies; RR 1.33; 95% CI 1.09 to 1.62; P <0.01). Safety profiles showed that HFOV was associated with a trend toward increased risk of barotrauma (five studies; RR 1.19; 95% CI 0.83 to 1.72; P = 0.34) and unfavorable hemodynamics (five studies; RR 1.16; 95% CI 0.97 to 1.39; P = 0.12).

Conclusions

HFOV improved oxygenation in adult patients with ARDS; however, it did not confer a survival benefit and might cause harm in the era of lung-protective ventilation strategy. The evidence suggests that HFOV should not be a routine practice in ARDS and further studies specifically selecting patients for this ventilator mode should be pursued.     

Growth-differentiation factor-15 predicts adverse cardiac events in patients with acute coronary syndrome: A meta-analysis

BackgroundWe aimed to analyse the association between high-level growth-differentiation factor-15 (GDF-15) and mortality, recurrent MI and heart failure compared to low-level GDF-15 in patients with acute coronary syndrome (ACS).MethodsPubMed and EMBASE were searched from their commencement to December 2017 for qualified studies that evaluated the associations between GDF-15 and ACS. Risk ratios were synthesized with random effect meta-analysis. Publication bias and sensitivity analyses were also conducted.ResultsA total of thirteen studies and 43,547 participants were analyzed systematically in our meta-analysis. Our study showed a significant association between GDF-15 values and mortality (p = 0.000, RR = 6.75, 95% CI = 5.81–7.84) and recurrent MI (p = 0.000, RR = 1.95, 95% CI = 1.72–2.21) in the overall analyses. Subgroup analyses revealed similar results. However, there was evidence of heterogeneity in the study of heart failure, whose overall RR was 6.66, with an I² of 87.3%.ConclusionThere was a significant association between high-level GDF-15 and mortality, recurrent MI in patients with ACS. We need more data to research the risk stratification of heart failure in ACS patients in the future.     

Managing immune-related adverse events to ipilimumab: a nurse's guide

Ipilimumab is a U.S. Food and Drug Administration-approved novel T-cell potentiator that improves survival in metastatic melanoma. Ipilimumab blocks cytotoxic T-lymphocyte antigen-4, a negative regulator of the immune response, thus promoting T-cell activation and prolonging a patient's antitumor response. However, that action may produce a mechanism-related spectrum of immune-related adverse events (irAEs), which can become severe and life-threatening if left unrecognized and untreated. This article describes the clinical properties of ipilimumab, specifically in regard to its unique profile of irAEs. Guidelines to manage irAEs are reviewed with a particular emphasis on the contribution of nurses to patient care and education. The nurse's role in facilitating communication among the oncology team, primary practice team, patients, and caregivers is fundamental to early recognition and effective management of irAEs so that patients can continue on therapy. As a regular, ongoing presence in patient care, the oncology nurse is well placed to deliver information, assess patients' understanding of that information, and support them through their cancer experience. Checklists of irAE symptoms may be useful for patients and nurses alike. In addition, education on ipilimumab's mechanism of action and how it contributes to irAEs should form an integral part of the patient treatment plan.     

Best-practice protocols: preventing adverse drug events

Analysis of Stanford's electronic Patient Safety Net revealed a pattern of unrecognized, widespread, low-frequency I.V.-PCA adverse events. A performance improvement-failure modes and effects analysis identified causes, and a multidisciplinary team developed solutions.     

Granulocyte colony-stimulating factor administration: adverse events

Recombinant human granulocyte colony-stimulating factor (G-CSF) has been in clinical use for approximately 2 decades. In healthy donors, it has been used to mobilize peripheral blood progenitor cells for hematopoietic stem cell transplantation and granulocytes for apheresis collection. In patients, it has been used to decrease the duration of neutropenia after chemotherapy and to offset the neutropenia due to myelodysplasia, acquired immunodeficiency syndrome, and genetic disorders of granulocyte production. As the number of uses of G-CSF in clinical practice grows, more side effects of this generally safe pharmaceutical agent are being recognized. Our objective in this article is to provide an in-depth review of the reported adverse events associated with the use of G-CSF.     

Screening for adverse events

Abstract: Adverse events (AEs) in medical patients are common, costly, and often preventable. Development of quality improvement programs to decrease the number and impact of AEs demands effective methods for screening for AEs on a routine basis. Here we describe the impact, types, and potential causes of AEs and review various techniques for identifying AEs. We evaluate the use of generic screening criteria in detail and describe a recent study of the sensitivity and specificity of individual generic screening criteria and combinations of these criteria. In general, the most sensitive screens were the least specific and no small sub-set of screens identified a large percentage of adverse events. Combinations of screens that were limited to administrative data were the least expensive, but none were particularly sensitive, although in practice they might be effective since routine screening is currently rarely done. As computer systems increase in sophistication sensitivity will improve. We also discuss recent studies that suggest that programs that screen for and identify AEs can be useful in reducing AE rates. While tools for identifying AEs have strengths and weaknesses, they can play an important role in organizations' quality improvement portfolios.     

Vinorelbine-related cardiac events: a meta-analysis of randomized clinical trials

Several cases of cardiac adverse reactions related to vinorelbine (VNR) have been reported in the literature. In order to quantify the incidence of these cardiac events, we performed a meta-analysis of clinical trials comparing VNR with other chemotherapeutic agents in the treatment of various malignancies. Randomized clinical trials comparing VNR with other drugs in the treatment of cancer were searched in Medline, Embase, Evidence-based Medicine Reviews databases and the Cochrane library from 1987 to 2002. Outcomes of interest were severe cardiac events, toxic deaths and cardiac event-related deaths reported in each publication. We found 19 trials, involving 2441 patients treated by VNR and 2050 control patients. The incidence of cardiac events with VNR was 1.19% [95% confidence interval (CI) (0.75; 1.67)]. There was no difference in the risk of cardiac events between VNR and other drugs [odds ratio: 0.92, 95% CI (0.54; 1.55)]. The risk of VNR cardiac events was similar to vindesine (VDS) and other cardiotoxic drugs [fluorouracil, anthracyclines, gemcitabine (GEM) em leader ]. Even if it did not reach statistical significance because of a few number of cases, the risk was lower in trials excluding patients with cardiac history, and seemed to be higher in trials including patients with pre-existing cardiac diseases. Vinorelbine-related cardiac events concern about 1% of treated patients in clinical trials. However, the risk associated with VNR seems to be similar to that of other chemotherapeutic agents in the same indications.     

Investigating adverse events in long-term care facilities: a systematized review

Objective: This systematized review aimed to synthesize the results of empirical studies focused on the types and factors of adverse events(AEs) that contribute to them in long-term care(LTC) settings. Methods: The search was conducted in Pro Quest, Scopus, and Pub Med in January 2021 and resulted in 1057 records. The content analysis method was used in the data analysis. Results: In all, 35 studies were identified as relevant for the review. The analysis revealed 133 different types of AEs and ...     

Risk factors for adverse drug events: a 10-year analysis

BACKGROUND: Many adverse drug events (ADEs) are the result of known pharmacologic properties, and some result from medication errors. However, some are the result of patient-specific risk factors. OBJECTIVE: To identify inpatient risk factors for ADEs. METHODS: Conditional logistic regression was used to analyze all pharmacist-verified ADEs by therapeutic class of drugs and severity during a 10-year study period. All inpatients > or = 18 years of age from a 520-bed tertiary teaching hospital were included. Each case patient was matched with up to 16 control patients. Odds ratios for patient factors associated with ADEs were calculated from different therapeutic classes of drugs. RESULTS: Odds ratios for numerous risk factors were identified for 4376 ADEs and were found to vary depending on therapeutic classification. The risk factors for the different classifications were grouped by (1) patient characteristics--female (OR 1.5-1.7), age (0.7-0.9), weight (1.2-1.4), creatinine clearance (0.8-4.7), and number of comorbidities (1.1-12.6); (2) drug administration--dosage (1.2-3.7), administration route (1.4-149.9), and number of concomitant drugs (1.2-2.4); and (3) patient type--service (1.2-4.9), nursing division (1.5-3.8), and diagnosis-related group (1.5-5.7). CONCLUSIONS: Some risk factors are consistent for all ADEs and across multiple therapeutic classes of drugs, while others are class specific. High-risk agents should be closely monitored based on patient characteristics (gender, age, weight, creatinine clearance, number of comorbidities) and drug administration (dosage, administration route, number of concomitant drugs).     

信息技术在护理不良事件管理中的应用进展

<正>随着社会和科技的进步,信息技术迅猛发展,被广泛应用于政治、经济、文化和个人生活等各个领域,发挥着越来越重要的作用。信息技术具有高效、方便、快捷的特点,能够简化工作流程,提高工作效率,保障信息共享,被广泛应用于医疗护理领域~([1-2])。近年来,医疗安全越来越引起人们的广泛关注。不良事件发生率高、后果严重,全球每年约21万~44万患     

Patient-reported adverse events under asthma therapy: a community pharmacy-based survey

The characteristics of patients who report adverse events (AEs) attributed to asthma therapy have been little investigated. Asthma patients aged 18-50 years were surveyed in pharmacies. Patients completed a questionnaire linked to computerized records of dispensed medications. Patients reported all AEs that they attributed to asthma therapy. The correlates of reporting 2+ AEs were identified. Almost 59% of the 1,351 patients (mean age: 37, 56% females) attributed AEs to asthma therapy, and 35% at least two. Most common AEs included tiredness (21.8%) and palpitations (21.1%). Poor asthma control and perception of asthma as a handicap were the major correlates of reporting 2+ AEs (odds ratio (OR)=2.5, 95% confidence interval (CI)=[1.7-3.7] and OR=1.9, 95% CI=[1.4-2.5]). Other significant correlates included age >30 years, female gender, and receiving psychotropic therapy. Inadequate control may partly account for AEs attributed by patients to asthma therapy. Improving patients' education may help to improve acceptability of asthma therapy.     

Multiple adverse events with a dual chamber pacemaker

The aim of the study was to evaluate our experience with Physiocor 400T, a dual chamber unipolar pacemaker manufactured by Sorin Biomedica. Between March 1993 and December 1994, 63 units of that model were implanted at our center. Patients were followed for 46 +/- 16 months. By the end of follow-up, 15 patients had died, 1 patient was lost to follow-up, and two units had been replaced for unrelated reasons. During follow-up the following phenomena had been observed: (1) Spontaneous backup reversion (VOO, 80 ppm) in 6 (9.5%) of 63 patients. In three patients this phenomenon was accompanied by concomitant ineffective pacing artifacts at 130 beats/min with very low pulse widths. (2) Unexpected battery depletion (EOL) occurred in 3 (5%) of 63 patients; two of the three occurred within weeks of routine evaluation that confirmed normal battery status. (3) Early elective replacement time (ERT) unpreceded by a gradual drop in magnet rate in 2 (3.2%) of 63 patients. (4) Total loss of telemetry without change in pacing mode in 1 (1.6%) of 63 patients. The estimated event-free 5-year survival of this model was 46%. In conclusion, 12 (19%) of 63 patients had adverse events with Physiocor 400T pacemakers. The potential risk of asynchronous pacing for prolonged periods and the risk of unexpected EOL warrants consideration of elective replacement of all remaining units.     

Vaccine adverse events: separating myth from reality

Vaccines have turned many childhood diseases into distant memories in industrialized countries. However, questions have been raised about the safety of some vaccines because of rare but serious adverse effects that have been attributed to them. Pain, swelling, and redness at the injection site are common local reactions to vaccines. Fever and irritability may occur after some immunizations. Currently, no substantial evidence links measles-mumps-rubella vaccine to autism, or hepatitis B vaccine to multiple sclerosis. Thimerosal is being eliminated from routine childhood vaccines because of concerns that multiple immunizations with vaccines containing this preservative could exceed recommended mercury exposures. Family physicians should be knowledgeable about vaccines so that they can inform their patients of the benefits of immunization and any proven risks. If immunization rates fall, the incidence of vaccine-preventable illnesses may rise.     

Preventing adverse healthcare events: lessons from abroad

John Tingle discusses a patient safety report from Minnesota, USA which contains some important lessons for maintaining and developing a safe and proper healthcare treatment environment.