INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

Background: Delamanid (DLM) is a relatively new drug for drug-resistant tuberculosis (DR-TB) that has been used in Indonesia since 2019 despite its limited safety data. DLM is known to inhibit hERG potassium channel with the potential to cause QT prolongation which eventually leads to Torsades de pointes (TdP).

Objective: This study aims to analyse the changes of QTc interval in DR-TB patients on DLM regimen compared to shorter treatment regimens (STR).

Methods: A retrospective cohort was implemented on secondary data obtained from two participating hospitals. The QTc interval and the changes in QTc interval from baseline (ΔQTc) were assessed every 4 weeks for 24 weeks.

Results: The maximum increased of QTc interval and ΔQTc interval were smaller in the DLM group with mean difference of 18,6 (95%CI 0.3 to 37.5) and 31.6 milliseconds (95%CI 14.1 to 49.1) respectively. The proportion of QTc interval prolongation in DLM group were smaller than STR group (RR=0.62; 95%CI 0.42 to 0.93).

Conclusion: This study has shown that DLM regimens are less likely to increase QTc interval compared to STR. However, close monitoring of the risk of QT interval prolongation needs to be carried out upon the use of QT interval prolonging antituberculoid drugs.

Background: Organizational learning (OL) and interprofessional collaboration (IPC) are said to enhance medical safety in hospitals, but the relationship between these variables has not been quantitatively tested.

Objective: This study examines the mediating effects of IPC on the relationship between OL and safety climate (improvement, compliance, and patient/family involvement).

Methods: An anonymous self-reporting questionnaire was administered to 1,495 healthcare workers from November 2021 to January 2022. The questions regarded the hospital's safety climate, OL, and IPC. A mediation analysis using structural equation modeling was conducted to examine the mediating role of IPC on the relationship between OL and the three safety climates. The indirect effect was estimated using 2,000 bootstrap samples.

Results: Responses from 643 healthcare workers were analyzed. The direct effects of OL were 𝛽 = .74, 75 (p < .001) on improvement and involvement and 𝛽 = 0.1 (p > .05) on compliance. The indirect effects of IPC on improvement and involvement were 𝛽 = .14 (95%CI: .00 ∼ .06) and 𝛽 = .37 (95%CI: .04 ∼ .09), respectively.

Conclusion: This study determined the mechanisms that enhance a hospital's safety climate, demonstrating that IPC mediates the relationship between OL and improvement and patient/family involvement. However, OL and IPC are not related to compliance.

Background: Healthcare organizations are among high-risk organizations due to the nature of their work as well as structural, physical and technological complexities. Accordingly, it is important to use risk management and control programs in all departments of these organizations.

Objective: The present study was conducted for the first time to evaluate the risk management status of the operating room and laboratory departments of Hamadan hospitals in 2022.

Methods: In this descriptive-observational cross-sectional study, laboratory and operating room departments were selected as the research environment. To conduct this research, a valid and reliable questionnaire was used to collect data, and the data were analyzed using SPSS 22 statistical software.

Results: The findings of the present study showed that the overall mean score of risk management status for the laboratory and operating room departments was 2.66 ± 0.15 and 2.89 ± 0.13, respectively. Furthermore, there was no statistically significant difference in the mean scores of the research components based on work experience, education level, and gender.

Conclusion: It is suggested that the laboratory and operating room departments should focus more on adopting policies and solutions to improve the position of risk management, training and budget allocation for risk management.

Background: The global COVID-19 pandemic has forced people to obtain health products and services from home. Similar to other e-commerce, medicines are bought online and delivered using a courier service.

Objective: By being fully concerned to patient safety, this study aims to determine development strategies to increase intention in purchasing prescription drugs through e-pharmacy.

Methods: Two stages of measurement are employed in this study, namely confirmatory factor analyis using PLS-SEM and pairwise comparison using AHP method. To discover consumer perception in using e-pharmacy, the basic model of Theory of Planned Behavior (TPB) is employed with several extensions.

Results: The results of PLS-SEM express that Trust has a major role as an intervening variable to enhance the indirect effect of Subjective Norms and Perceived Values on Purchase Intention. In general, PLS-SEM structural model is declared "fit" (GFI = 0.93 ≥ 0.90; RMSEA = 0.045 ≤ 0.08; SRMR = 0.033 ≤ 0.05). Measurement model test proves that all selected indicators are valid to represent their related constructs (Loading Factor ≥ 0.50), and all selected constructs are reliable to build the whole path model (CR ≥ 0.7; AVE ≥ 05). Meanwhile, the results of AHP indicate that strengthening government policies and regulations is prioritized to increase consumer intention of purchasing prescription drugs through e-pharmacy, followed by protection of user confidential data in the second place. Those two eigenvectors are 0.236 and 0.185 respectively.

Conclusion: Future research is suggested to add perceived risk as latent variable in the study of consumer behavior for any high-risk products.

Background: The self-controlled case series (SCCS) is often used to monitor vaccine safety. The evaluation of intussusception after the rotavirus vaccine is complicated because the baseline rate varies with age. Time-varying baseline risk adjustments with data from unexposed cohorts are utilised. Self-controlled risk interval (SCRI), with a shorter observation period, can also mitigate the problem by studying a control period close to the risk period.

Objective: An Indian rotavirus vaccine has previously been studied using SCCS. The risk of intussusception in the high-risk windows (21 days after vaccination) was comparable to the background risk. The aim was to re-analyse data of an existing SCCS study using alternate statistical methods to examine vaccine safety.

Methods: We examined the mean age of intussusception in the vaccinated and the unvaccinated. We performed an SCRI analysis of the surveillance data from the SCCS study, limiting the observation period to 180 days. We analysed the time-to-intussusception from the last vaccination. Finally, we performed an SCCS analysis, excluding unvaccinated cases from the analysis.

Results: We found that the mean age of intussusception was significantly lower in the vaccinated (205 days) compared to the unvaccinated (223 days) (p-value 0.0026). The Incident Risk Ratio (IRR) on SCRI analysis was 1.62 (95% CI 1.07-2.44). There were significantly more intussusceptions in the first 30 days after vaccination compared to the next 30-day window. (92 vs 63 p-value = 0.009). We found that excluding unvaccinated infants from the SCCS analysis demonstrated significantly increased risk for the risk period 1-21 days after the 3rd dose (IRR 2.47, 95% CI 1.70-3.59). The risks of intussusception were missed in traditional SCCS analysis using unvaccinated infants as controls.

Conclusion: Traditional risk adjustments using data from unexposed cohorts in SCCS may not be appropriate for investigating the risk of intussusception where vaccination lowers the mean age of intussusception.

Background: Data about performance measures (PM) in patients with ST segment Elevation Myocardial Infarction (STEMI) in low- and middle-income countries is really scarce. One of the reasons is the lack of appropriate measures for these scenarios where coronary intervention is not the standard treatment.

Objective: This study aimed to develop a set of PM and quality markers for patients with STEMI in these countries.

Methods: Two investigators systematically reviewed existing guidelines and scientific literature to identify potential PM by referring to documents searched through PubMed from 2010 through 2019, using terms "Myocardial Infarction", "STEMI", "quality indicator", and "performance measure". A modified Delphi technique, involving multidisciplinary panel interview, was used. A 15-member multidisciplinary expert panel individually rated each potential indicator on a scale of 1 (lowest) to 5 (highest) during three rounds. All indicators that received a median score ≥4.5, in final round without significant disagreement were included as PM.

Results: Through the consensus-building process, 84 potential indicators were found, of which 10 were proposed as performance measures and 2 as quality metrics, as follows: Pre-Hospital Electrocardiogram; Patients with reperfusion therapy; Pre-hospital Reperfusion; Ischemic time less than 120 minutes; System delay time less than 90 minutes; In-hospital Mortality; Complete in-hospital Treatment; Complete in-hospital Treatment in patients with Heart Failure; 30 day-Re-admissions; 30 day-mortality; Patients with in-hospital stress test performed; and, Patients included in rehabilitation programs.

Conclusion: This document provides the official set of PM of attention in ST segment Elevation Myocardial Infarction of the Cuban Society of Cardiology and Cuban National Group of Cardiology.

Background: Neonatal resuscitation is one of the most critical and risky events that requires a high level of individual skill and team performance.

Objective: To evaluate the effect of training of resuscitation teams on the frequency and type of medical errors (ME) that result from neonatal resuscitation.

Methods: A prospective observational study was performed using a checklist to detect ME related to neonatal resuscitation.

Results: The rate of ME was 24.82%. There was a significant reduction in the percentage of errors from 17.28% in pre- pre-training phase to 7.54% in post post-training phase. Near miss MEs (98.77%) were significantly higher than adverse events. The active errors were significantly higher than latent errors, P < 0.001, and decreased from 39.19% during pre-training to 19.64% in the post-training phase. The commission ME s were significantly higher than the omission, P < 0.001. The latent errors percentage was 41.17% of the total errors and were not significantly reduced after training.

Conclusion: Training sessions reduced ME that occurred during resuscitation, however careful distinguishing and recognizing the type of MEs is important to plan for further reduction of errors. Special attention to latent errors is imperative as it needs a specific approach rather than just training.

Background: Patients undergoing dialysis pose therapeutic challenges in terms of polypharmacy, administration of potentially inappropriate drugs, and drugs with the potential risk of toxicity.

Objective: This study evaluated the use of drugs, potentially inappropriate medicines (PIM), drugs with risk of Torsades de Pointes (TdP), and the complexity of the prescribed regimen using the medication regimen complexity index scale in patients undergoing hemodialysis.

Methods: A retrospective cohort study was carried out amongst patients receiving hemodialysis. Drugs were classified into one of four classes: (i) drugs used in managing renal complications, (ii) cardiovascular drugs, (iii) anti-diabetic drugs, (iv) drugs for symptomatic management, and (v) others. Drugs were considered as PIM according to the Can-SOLVE CKD working group from a network of Canadian nephrology health professionals. The study adhered to the CredibleMeds classification of drugs with known, possible, and conditional risk of TdP and the complexity of prescribed medicines was evaluated based on the pre-validated medication regimen complexity index scale based on form/route, frequency of dosing, and requirement of special instructions.

Results: Sixty-three participants were included in the study (49 males and 14 females) with the median (range) age of 45 (21-66) years. Cardiovascular drugs followed by drugs used for managing renal complications were the most common classes administered. Notably, 12 (19.1%) patients received one of the non-steroidal anti-inflammatory drugs, 21 (33.3%) received a proton pump inhibitor, three (4.8%) received pregabalin, two (3.2%) received opioid drugs, and one (1.6%) was administered celecoxib. Atorvastatin, furosemide, omeprazole, and allopurinol were the most common PIM drugs administered to the study participants followed by others. Drugs used for symptomatic management had significantly more PIM compared to other classes (p < 0.0001). Six (9.5%) patients received drugs with known TdP risk, one with possible TdP risk, and 61 with conditional risk. Median (range) medical regimen complexity index score was 26.5 (2-62.5).

Conclusion: A huge burden of drug therapy was observed in the hemodialysis patients in terms of higher proportions of PIM, complex medical regimen, and prescription of drugs with risk of TdP. Implementation of clinical decision support tools enhancing rational prescription and identification of drugs with TdP risk, introducing antimicrobial stewardship, and stepwise deprescription of the drugs with the least benefit-risk ratio are warranted.