Association of Clopidogrel with Interstitial Lung Disease: Gaining Insight Through the Japanese Pharmacovigilance Database.

Background: The P2Y12 receptor inhibitors clopidogrel and prasugrel are widely used. Clopidogrel and prasugrel have different metabolic pathways, but whether their adverse event (AE) profiles differ significantly is unclear. Objective: This study aimed to compare the possible AEs induced by clopidogrel and prasugrel and to assess the rank-order of their AEs submitted to a spontaneous reporting database. Materials and Methods: Data were extracted from the Japanese Adverse Drug Event Report database (JADER). Reports of AEs associated with clopidogrel and prasugrel were analyzed to calculate the reporting odds ratios (RORs) and 95% confidence intervals (CIs). Results: Based on 5869 reports for clopidogrel (69.6%, men) and 513 reports for prasugrel (74.1%, men), 703 and 135 different AEs were identified, respectively. Bleeding complications including hemorrhage were commonly reported for both clopidogrel and prasugrel. As for AEs related to clopidogrel, unexpected AEs such as interstitial lung disease (227 reports; ROR, 1.77; 95% CI, 1.49-2.10), abnormal hepatic function (137 reports; ROR, 1.27; 95% CI, 1.07-1.51), and hepatocellular injury (96 reports; ROR, 120.0; 95% CI, 94.9-151.8) ranked at relatively high positions based on the number of occurrences, unlike prasugrel. Conclusion: This analysis of the national pharmacovigilance database highlights distinct AE profiles for clopidogrel and prasugrel. Unexpected AEs associated with clopidogrel were identified, providing valuable insights for clinical monitoring and patient safety.

Association Between COVID-19 and Diabetes Management Indices in Japanese Type 2 Diabetes Mellitus Patients: A Single-Center, Retrospective Study.

Purpose: The aim of the study was to determine the association between coronavirus disease 2019 (COVID-19) infection and diabetes management indices in patients with type 2 diabetes mellitus. Patients and Methods: A single-center, retrospective, observational study of patients with type 2 diabetes mellitus at Kenwakai Hospital (Nagano, Japan) was conducted. Data of 95 patients (mean age, 72 ± 12 years; men, 67.4%) who visited between March 1, 2019 and February 28, 2022 were obtained from the hospital's electronic information system. COVID-19 was diagnosed by a chemiluminescent enzyme immunoassay (CLEIA). Results: There was no association between COVID-19 infection and age, sex, hemodialysis treatment status, or the Charlson Comorbidity Index. After adjustment for possible confounding factors, the incidence of COVID-19 infection was significantly correlated with HbA1c ≥7.0% (odds ratio [OR], 5.51; 95% confidence interval [CI], 1.30-23.26). Conclusion: The results suggest an association between high HbA1c levels and COVID-19 infection in patients with type 2 diabetes mellitus. Appropriate management of diabetes mellitus, focusing on HbA1c levels, may help prevent COVID-19 infection and severe disease after infection.

Association between respiratory and heart rate fluctuations and death occurrence in dying cancer patients: continuous measurement with a non-wearable monitor.

BACKGROUND: The present study aimed to explore the association between impending death and continual changes in respiratory and heart rates measured using a non-wearable monitor every minute for the final 2 weeks of life in dying cancer patients. METHODS: In this longitudinal study, we enrolled patients in a palliative care unit and continuously measured their respiratory and heart rates via a monitor and additionally captured their other vital signs and clinical status from medical records. RESULT: A dataset was created comprising every 24-h data collected from every-minute raw data, including information from 240 days prior to death from 24 patients (345,600 data); each patient's data were measured for 3-14 days until death. After confirming the associations between the respiratory and heat rate values on the day of death (n = 24) or other days (2-14 days before death, n = 216) and the mean, maximum, minimum, and variance of respiratory and heart rates every 24 h by univariate analyses, we conducted a repeated-measures logistic regression analysis using a generalized estimating equation. Finally, the maximum respiratory rate and mean heart rate were significantly associated with death occurring within the following 3 days (0-24 h, 0-48 h, and 0-72 h), except for the maximum respiratory rate that occurs within 0-24 h. CONCLUSION: The maximum respiratory rate and mean heart rate measured every minute using a monitor can warn family caregivers and care staff, with the support of palliative care professionals, of imminent death among dying patients at home or other facilities.

The change over time of vital signs with consideration for opioid use in the last 2 weeks of life among cancer patients in a palliative care unit: Continuous measurement of vital signs using a non-wearable monitor.

OBJECTIVES: The aim of this study was to examine the following by using a non-wearable monitor: (ⅰ) the trajectory of vital signs (VS) in the last 2 weeks of life among cancer patients, and (ⅱ) the difference in change over time of VS between cancer patients with and without opioid use. METHODS: We conducted a longitudinal study involving cancer patients in a palliative care unit (PCU) from April 2018 to October 2019. VS were collected continuously using a non-wearable monitor, and we calculated the means of respiratory rate (RR) and heart rate (HR) per hour, and counts of apnea per hour as outcome variables. Explanatory variables were time (subtracting time of death from measurement time of VS, divided by 36) and opioid use. Mean difference (MD) of time represented the slope per hour of VS values. First, we analyzed the associations between VS per hour and time using a linear mixed model (LMM) with random intercepts and slope over time. Second, we analyzed the associations between VS and interaction term between time and opioid use. RESULTS: We analyzed 26 cancer patients. RR (MD: 0.27 beats/min [95% CI: 0.27-0.28]), HR (MD: 1.51 beats/min [95% CI: 1.50-1.52]), and apnea (MD: 0.71 count/hour [95% CI: 0.70-0.72]) significantly increased hourly. In addition, RR was significantly associated with interaction term (MD: -1.59 beats/min [95% CI: -3.11 to -0.07]), which indicates that there is a difference in the slope of RR between opioid users and non-users. CONCLUSIONS: We have successfully described the trajectory of VS in high-resolution under conditions of a natural end of life in PCU.

Healthcare professionals' competence in digitalisation: A systematic review.

AIMS AND OBJECTIVES: To identify key areas of competence for digitalisation in healthcare settings, describe healthcare professionals' competencies in these areas and identify factors related to their competence. BACKGROUND: Digitalisation requires changes in healthcare practices, policies and actions to revise job expectations and workflows. The aspects of patient safety and integration of digitalisation into the professional context necessitate an assessment of healthcare professionals' competencies in digitalisation. DESIGN: Systematic review. METHODS: A systematic review was conducted following Center of Reviews and Dissemination guidelines, including application of a PRISMA statement. Four databases-CINAHL (EBSCO), MEDLINE (Ovid), Web of Science and Academic Search Premiere (EBSCO)-were searched for relevant original peer-reviewed studies published between 2012-2017. Twelve were chosen for final analysis: five quantitative studies and seven qualitative studies, which were, respectively, subjected to narrative and thematic synthesis. RESULTS: Key competence areas regarding digitalisation from a healthcare perspective identified encompass knowledge of digital technology and the digital skills required to provide good patient care, including associated social and communication skills, and ethical considerations of digitalisation in patient care. Healthcare professionals need the motivation and willingness to acquire experience of digitalisation in their professional context. Collegial and organisational support appear to be essential factors for building positive experiences of digitalisation for healthcare professionals. CONCLUSION: Healthcare organisations should both pay attention to the social environment of a workplace and create a positive atmosphere if they want to improve the response to digitalisation. The successful implementation of new technology requires organisational and collegial support. RELEVANCE TO CLINICAL PRACTICE: Recommendations for clinical practice include the following: development of competence in digitalisation by healthcare professionals when using technological equipment to minimise errors; provision of sufficient resources, equipment and room for technology usage; and provision of regular education that considers the participants' competencies.

Potential underreporting of medication errors in a psychiatric general hospital in Japan.

The purpose of this study was to explore a pattern of underreporting within a psychiatric general hospital in Japan. All the medication errors reported online in 2010 were analysed. This research was approved by the university and the study hospital. There were 651 incidents related to medication errors. Medication error rate per 1000 patient days was 2.14 (range: 0.45-6.05). Medication error rates between two acute care wards with comparable case and staff mix differed. A low proportion of intercepted near-misses and low medication error rates around mealtime in acute care 1 were suggestive of under-reporting. Two dementia care wards with low medication error rates had no report of intercepted errors, which was also suggestive of underreporting. Ward-specific medication error rates and patterns are useful to identify wards with potential underreporting of medication error within the hospital.

Pattern of underreporting falls in a general psychiatric hospital in Japan.

PURPOSE: To examine the pattern of underreporting of fall incidents in a general psychiatric hospital in Japan. DESIGN AND METHODS: All fall incidents were analyzed and stratified by ward. FINDINGS: A discrepancy in fall rates was found in acute psychiatric and dementia wards. The following indicators were suggestive of underreporting: "zero fall/1,000 patient-days," "proportion of falls without injury," and "proportion of falls identified as occurring in the bedroom as a fall location during certain time periods." PRACTICE IMPLICATIONS: Ward-specific fall rates, with further stratifications by time and location of the fall, were useful for identifying a pattern of underreporting.