{"title":"Analysis of the CONKO-001 trial: Is the validity of the study sufficient to recommend adjuvant chemotherapy for pancreatic cancer?","authors":"Katrin Bauer, Doris Henne-Bruns, Giulia Manzini","doi":"10.3233/JRS-210015","DOIUrl":"10.3233/JRS-210015","url":null,"abstract":"<p><strong>Background: </strong>Since randomized controlled trials have indicated that adjuvant chemotherapy prolongs survival and reduces recurrence rates after surgical resection of pancreatic adenocarcinoma, a gemcitabine based chemotherapy has become part of the interdisciplinary treatment concept for pancreatic cancer in accordance to current guidelines.</p><p><strong>Objectives: </strong>The aim of this project was to analyse the validity of the CONKO-001 trial as a basis for the recommendation of adjuvant chemotherapy in many international guidelines.</p><p><strong>Methods: </strong>We analysed the validity of the CONKO-001 trial regarding study design, recruitment period, participating institutions, patient selection, randomisation, stratification, standardization of surgical treatment and histological examination, statistical methods and interpretation of results. We additionally analysed the study regarding the risk of bias using the RoB 2 Tool. Finally we reviewed the influence of the pharmaceutical industry and potential conflicts of interest.</p><p><strong>Results: </strong>We identified several shortcomings of the study concerning the study protocol, the participating clinics, the patient recruitment, the randomization pattern, the standardization of surgical treatment and histological examination, the statistical methods, the evaluation of the results and the influence of the pharmaceutical industry. According to the Cochrane RoB 2 Tool the study was judged to raise some concerns in three of the five risk domains for the outcome \"overall survival\".</p><p><strong>Conclusions: </strong>Based on our review, the results of the CONKO-001-study should be revisited and critically reviewed. The recommendation to include adjuvant chemotherapy with gemcitabine deserves a critical appraisal.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9328776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maria Luiza Rodrigues Dos Santos, Victória Brioso Tavares, Natália Silva da Costa, Marcos Valério Santos da Silva, João Simão de Melo-Neto
{"title":"Patient safety culture in a COVID-19 ICU compared to a clinical-surgical ICU in the Brazilian Eastern Amazon: A cross-sectional study.","authors":"Maria Luiza Rodrigues Dos Santos, Victória Brioso Tavares, Natália Silva da Costa, Marcos Valério Santos da Silva, João Simão de Melo-Neto","doi":"10.3233/JRS-210071","DOIUrl":"https://doi.org/10.3233/JRS-210071","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic highlighted the need for a new dynamic in the organization and practices of health services, as it required rapid restructuring to promote safe and harm-free assistance.</p><p><strong>Objective: </strong>To assess the dimensions of the patient safety culture (PSC) from the perspective of the health team professionals in clinical-surgical ICU (G1) compared to a COVID-19 ICU (G2).</p><p><strong>Methods: </strong>Cross-sectional, analytical, descriptive and inferential study, using the \"Hospital Survey on Patient Safety Culture\" questionnaire.</p><p><strong>Results: </strong>The domain \"Supervisor/Manager Expectations and Actions Promoting Patient Safety (PS)\" was a potential weakness for G1 (p = 0.003). G2 was most positive on improving PS, being informed about errors, considering PS as a top priority to management, and that the units work together to provide the best care (p > 0.05). G1 was most negative about the work culture with staff from other units, exchange of information across units, and shift changes (p > 0.05). The highest PS grade was related to greater communication, and a smaller frequency of events was reported only for G2 (p > 0.05).</p><p><strong>Conclusion: </strong>There must be a balance in terms of attention focused on PS between different ICUs in times of crisis, especially regarding the supervisors/managers actions.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10788247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A systematic review and meta-analysis for risk factor profiles in patients with resistant Acinetobacter baumannii infection relative to control patients.","authors":"Prity Rani Deshwal, Raisa Fathima, Muskan Aggarwal, Nalla Surender Reddy, Pramil Tiwari","doi":"10.3233/JRS-220037","DOIUrl":"10.3233/JRS-220037","url":null,"abstract":"<p><strong>Background: </strong>Acinetobacter baumannii is a major cause of nosocomial infections and high mortality rates. Evaluation of risk factors for such resistant infections may aid surveillance and diagnostic initiatives, as well as, can be crucial in early and appropriate antibiotic therapy.</p><p><strong>Objective: </strong>To identify the risk factors in patients with resistant A. baumannii infection with respect to controls.</p><p><strong>Methods: </strong>Prospective or retrospective cohort and case-control studies reporting the risk factors for resistant A. baumannii infection were collected through two data sources, MEDLINE/PubMed and OVID/Embase. Studies published in the English language were included while animal studies were excluded. The Newcastle-Ottawa Scale was used to assess the quality of studies. The odds ratio of developing antibiotic resistance in patients with A. baumannii infection was pooled using a random-effect model.</p><p><strong>Results: </strong>The results are based on 38 studies with 60878 participants (6394 cases and 54484 controls). A total of 28, 14, 25, and 11 risk factors were identified for multi-drug resistant (MDRAB), extensive-drug resistant (XDRAB), carbapenem-resistant (CRAB) and imipenem resistant A. baumannii infection (IRAB), respectively. In the MDRAB infection group, exposure to carbapenem (OR 5.51; 95% CI: 3.88-7.81) and tracheostomy (OR 5.01; 95% CI: 2.12-11.84) were identified with maximal pool odd's ratio. While previous use of amikacin (OR 4.94; 95% CI: 1.89-12.90) and exposure to carbapenem (OR 4.91; 95% CI: 2.65-9.10) were the foremost factors associated with developing CRAB infection. Further analysis revealed, mechanical ventilation (OR 7.21; 95% CI: 3.79-13.71) and ICU stay (OR 5.88; 95% CI: 3.27-10.57) as the most significant factors for XDRAB infection.</p><p><strong>Conclusion: </strong>The exposure of carbapenem, amikacin (previous) and mechanical ventilation were the most significant risk factors for multidrug, extensive-drug, and carbapenem resistance in patients with A. baumannii infection respectively. These findings may guide to control and prevent resistant infections by identifying the patients at higher risk of developing resistance.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9431758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Charalampos Milionis, Ioannis Ilias, Evaggelia Venaki, Eftychia Koukkou
{"title":"The metabolic effects of hormonal treatment in transgender males: Safety of the testosterone gender-affirming therapy.","authors":"Charalampos Milionis, Ioannis Ilias, Evaggelia Venaki, Eftychia Koukkou","doi":"10.3233/JRS-200087","DOIUrl":"https://doi.org/10.3233/JRS-200087","url":null,"abstract":"<p><strong>Background: </strong>Gender dysphoria is characterised by a sense of distress because of discordance between the self-perception of gender identity and the assigned sex. Hormonal treatment of transgender males uses testosterone to induce and preserve masculinisation.</p><p><strong>Objective: </strong>The study investigated the safety of testosterone therapy in transgender males.</p><p><strong>Methods: </strong>The present study used a retrospective file review of transgender male subjects who were treated with testosterone (initially transdermal testosterone gel and subsequently parenteral testosterone undecanoate) for at least 18 months and had subsequently achieved a serum testosterone level within the normal range of cisgender male counterparts. Changes in somatometric data and blood biomarkers were investigated.</p><p><strong>Results: </strong>The mean testosterone serum levels after approximately 18 months of treatment were about 545 ng/dL (SD ± 94 ng/dL). There was a statistically significant rise in body mass index (𝜒d = +1.23 kg/m2) with a reduction in blood glucose (𝜒d = -5.33 mg/dL) as well as statistically significant increases in aspartate transaminase (𝜒d = +4.3 U/L), haemoglobin (𝜒d = +1.72 g/dL), and haematocrit (𝜒d = +4.76%). In contrast, there were no significant changes in the lipidaemic profile of the subjects.</p><p><strong>Conclusions: </strong>Treatment with testosterone is routinely used for the promotion of virilising physical changes in transgender males. However, the likelihood of adverse effects of continuous treatment is still unclear. This study contributed to the notion that achieving testosterone levels within the target range is a prerequisite for the safety of the gender-affirming treatment.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10787190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Can Twitter posts serve as early indicators for potential safety signals? A retrospective analysis.","authors":"Revati Pathak, Daniel Catalan-Matamoros","doi":"10.3233/JRS-210024","DOIUrl":"https://doi.org/10.3233/JRS-210024","url":null,"abstract":"<p><strong>Background: </strong>As Twitter has gained significant popularity, tweets can serve as large pool of readily available data to estimate the adverse events (AEs) of medications.</p><p><strong>Objective: </strong>This study evaluated whether tweets were an early indicator for potential safety warnings. Additionally, the trend of AEs posted on Twitter was compared with AEs from the Yellow Card system in the United Kingdom.</p><p><strong>Methods: </strong>English Tweets for 35 drug-event pairs for the period 2017-2019, two years prior to the date of EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting, were collected. Both signal and non-signal AEs were manually identified and encoded using the MedDRA dictionary. AEs from Yellow Card were also gathered for the same period. Descriptive and inferential statistical analysis was conducted using Fisher's exact test to assess the distribution and proportion of AEs from the two data sources.</p><p><strong>Results: </strong>Of the total 61,661 English tweets, 1,411 had negative or neutral sentiment and mention of at least one AE. Tweets for 15 out of the 35 drugs (42.9%) contained AEs associated with the signals. On pooling data from Twitter and Yellow Card, 24 out of 35 drug-event pairs (68.6%) were identified prior to the respective PRAC meetings. Both data sources showed similar distribution of AEs based on seriousness, however, the distribution based on labelling was divergent.</p><p><strong>Conclusion: </strong>Twitter cannot be used in isolation for signal detection in current pharmacovigilance (PV) systems. However, it can be used in combination with traditional PV systems for early signal detection, as it can provide a holistic drug safety profile.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10839060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Impact of the COVID-19 pandemic on dispensing medicines in the community pharmacy.","authors":"Shafq Al-Azzawi, Dhafir Masheta","doi":"10.3233/JRS-220061","DOIUrl":"10.3233/JRS-220061","url":null,"abstract":"<p><strong>Background: </strong>The world has faced an unprecedented challenge since COVID-19 emerged as a pandemic, which has led to quarantine and disruptions in drug services. During the pandemic, drug use habits and availability changed, causing a shift in behaviors and, in turn, medicine misuse. In Iraq, this is a major problem because many medicines can be easily obtained.</p><p><strong>Objective: </strong>The study aims to describe the pattern of dispensing medications during the pandemic and to evaluate the biochemical and pathological consequences.</p><p><strong>Method: </strong>The analytical, observational, cross-sectional study was performed via a compiled questionnaire for 400 random pharmacists, and the analysis and interpretation of the biochemical changes and medical reports.</p><p><strong>Results: </strong>Results revealed that dispensing of medications since the COVID-19 outbreak has increased by 74%, and the demand for medicines seems higher than required in comparison to the periods before the pandemic, while 60% of the dispensed medicines were taken just in case needed. In addition, the availability of medicines decreased by 61%, and the dispensing of common medicines increased due to the belief in their prophylactic action. Several biochemical abnormalities and pathological consequences were recorded due to the irrational use of medicines, and the highest percentage (12%) was seen in hepatic and liver enzymatic dysfunction and 8% for the endocrine and hormonal abnormalities.</p><p><strong>Conclusion: </strong>It can be concluded that most of the dispensed medicines were not used on a therapeutic or scientific basis during the pandemic.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10036977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Winthrop Taylor, Lisa-Marie Whittaker, Trevon Fletcher, Anthony Collins, Ryan Grant, Maxine Gossell-Williams
{"title":"Awareness of inappropriate use related to antimicrobial resistance among medical doctors by country economic status: A systematic review.","authors":"Winthrop Taylor, Lisa-Marie Whittaker, Trevon Fletcher, Anthony Collins, Ryan Grant, Maxine Gossell-Williams","doi":"10.3233/JRS-220044","DOIUrl":"10.3233/JRS-220044","url":null,"abstract":"<p><strong>Background: </strong>Antimicrobial resistance (AMR) is promoted by inappropriate use and is a greater burden for low to middle income countries (LMIC) than high income countries (HIC).</p><p><strong>Objective: </strong>This systematic review aimed to compare the awareness of inappropriate use related to AMR among medical doctors from LMIC and HIC using published knowledge, attitude and practice (KAP) studies.</p><p><strong>Methods: </strong>Following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, sequential systematic literature search of PubMed and Web of Science databases for articles published since inception up to June 1, 2022 for KAP studies involving medical doctors. Using fifteen KAP items related to promoting AMR, data on proportion of participants responding affirmatively was extracted and reported using means, ranges and 95% confidence intervals (CI).</p><p><strong>Results: </strong>Forty-two studies met the inclusion criteria and involved 13,089 medical doctors from 11HIC and 21LMIC. All were cross-sectional studies, 71.4% involved non-probability sampling and 78.6% were of satisfactory quality. Knowledge items showed mean proportion of more medical doctors responding correctly. Similar affirmation trends were observed for attitude and prescribing practice items. Awareness appeared similar between medical doctors of the economic groups, except for a greater interest in training for LMIC (95.4%; 95%CI 93.0%, 97.9%) versus HIC (81.7%; 95%CI 65.6%, 97.9%). Countries with poor proportions were identified in both economic groups.</p><p><strong>Conclusion: </strong>For identified studies, trends suggest good awareness among medical doctors of the known inappropriate use and perceived threat of AMR, as well as prescribing practices to reduce the risk of AMR. Trends were similar across HIC and LMIC; however, countries with evidence of poor awareness exist in both economic groups.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10642794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mohammad S Alyahya, Salam Momani, Main Naser Alolayyan, Yousef S Khader
{"title":"Workplace policies and quality of working life (QoWL) during the COVID-19 pandemic in Jordanian hospitals.","authors":"Mohammad S Alyahya, Salam Momani, Main Naser Alolayyan, Yousef S Khader","doi":"10.3233/JRS-220039","DOIUrl":"https://doi.org/10.3233/JRS-220039","url":null,"abstract":"<p><strong>Background: </strong>Many healthcare organizations place a high value on quality of work-life (QoWL). The healthcare system's long-term sustainability and capability to offer high-quality services to patients depend on improving QoWL for their healthcare workers.</p><p><strong>Objective: </strong>The study aimed to explore the impact of Jordanian hospitals' workplace policies and measures in three main domains: (I) Infection prevention and control (IPC) measures, (II) Supply of personal protective equipment (PPE), and (III) COVID-19 precautionary measures on the QoWL among healthcare workers during the COVID-19 pandemic.</p><p><strong>Methods: </strong>A cross-sectional survey was conducted from May to June 2021 through an online self-reported questionnaire (Google Form) targeting hospital healthcare professionals working at Jordanian hospitals (public, private, military, and university). The study used a valid work-related quality of life (WRQoL) scale to study the QoWL.</p><p><strong>Results: </strong>A total of 484 HCWs in Jordanian hospitals participated in the study with a mean age of (34.8 ± 8.28 years). 57.6% of the respondents were females. 66.1% were married, with 61.6% having children at home. An average QoWL among healthcare workers in Jordanian hospitals during the pandemic was observed. The study results also showed a significant positive correlation between workplace policies (IPC measures, supply of PPE, and COVID-19 preventive measures) and the WRQoL among healthcare workers.</p><p><strong>Conclusion: </strong>Our findings highlighted the vital need for QoWL and psychological well-being support services for healthcare staff during pandemics. Improved IPC systems and other precautionary measures at the national and hospital management levels are required to help minimize the stress and fear that healthcare workers experience and lower the risk of COVID-19 and future pandemics.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10134502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vittorio Bolcato, Livio Pietro Tronconi, Anna Odone, Lorenzo Blandi
{"title":"Healthcare-acquired Sars-Cov-2 infection: A viable legal category?","authors":"Vittorio Bolcato, Livio Pietro Tronconi, Anna Odone, Lorenzo Blandi","doi":"10.3233/JRS-220062","DOIUrl":"https://doi.org/10.3233/JRS-220062","url":null,"abstract":"<p><p>In the context of the Sars-Cov-2 pandemic, according to the various periods of emergency and the rate of infections, hospitalized subjects also contracted the infection within the ward, sometimes with the development of disease (COVID-19) and sometimes with permanent damage. The authors wondered if Sars-Cov-2 infection should be considered on a par with other infections acquired in the healthcare setting. The non-diversified diffusion between the health and non-health sectors, the ubiquity of the virus and the high contagiousness, together with the factual inability to prevent it by the health structures, despite the adoption of entry control, practices of isolation of positive subjects, and staff surveillance, lead to consider COVID-19 in a different way, in order to otherwise burden health structures in the face of unmanageable risks, clearly also dependent on exogenous and uncontrollable factors. The guarantee of care safety must, in the pandemic, be able to compare with the real capacity for intervention according to the asset of the current health service, requesting State intervention with alternative instruments, such as una tantum compensation, for COVID-19 damage reparation occurred in the health sector.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10134504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Use of non-steroidal anti-inflammatory drugs in renal transplant patients: A retrospective study.","authors":"Kannan Sridharan, Shamik Shah","doi":"10.3233/JRS-220065","DOIUrl":"10.3233/JRS-220065","url":null,"abstract":"<p><strong>Background: </strong>Renal transplants are often prescribed non-steroidal anti-inflammatory drugs (NSAIDs) for analgesic purposes.</p><p><strong>Objective: </strong>Considering the dearth of data, we carried out the present study to evaluate the use of various NSAIDs and the incidence of acute kidney injury (AKI) in transplant patients.</p><p><strong>Methods: </strong>A retrospective study amongst renal transplant patients prescribed at least one dose of NSAID was carried between January and December 2020 at the Department of Nephrology, Salmaniya Medical Complex, Kingdom of Bahrain. The patients' demographic details, serum creatinine values, and drug-related details were obtained. The Kidney Disease Improving Global Outcomes (KDIGO) criteria were used for defining AKI.</p><p><strong>Results: </strong>Eighty-seven patients were included. Forty-three patients were prescribed diclofenac, 60 received ibuprofen, six received indomethacin, 10 were administered mefenamic acid, and 11 received naproxen. Due to multiple courses of NSAID prescription, a total of 70 prescriptions were identified for diclofenac, 80 for ibuprofen, six for indomethacin, 11 for mefenamic acid, and 16 for naproxen. No significant differences were observed in the absolute (p = 0.08) and percent changes in serum creatinine (p = 0.1) between the NSAIDs. Twenty-eight (15.2%) courses of NSAID therapy met the KDIGO criteria for AKI. Age (OR: 1.1, 95% CI: 1.007, 1.2; p = 0.02), concomitant everolimus (OR: 483, 95% CI: 4.3, 54407; p = 0.01), and mycophenolate + cyclosporine + azathioprine (OR: 63.4E+006, 95% CI: 203.2157 to 19.8E+012; p = 0.005) administration were observed with significant risk of NSAID-induced AKI.</p><p><strong>Conclusion: </strong>We observed possible NSAID-induced AKI to an extent of around 15.2% in our renal transplant patients. No significant differences were observed in the incidence of AKI between various NSAIDs and none of them had either graft failure or death.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9431759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}