INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

{"title":"Analysis of the nervous system and gastrointestinal adverse events associated with solifenacin in older adults using the US FDA adverse event reporting system.","authors":"Connie Nicholls,&nbsp;Te-Yuan Chyou,&nbsp;Prasad S Nishtala","doi":"10.3233/JRS-210054","DOIUrl":"https://doi.org/10.3233/JRS-210054","url":null,"abstract":"<p><strong>Background: </strong>Antimuscarinics are the backbone of the pharmacological management of overactive bladder. Still, concerns have been raised over the nervous system (NS) adverse drug events (AEs) due to their dissimilarities to muscarinic receptor-subtype affinities.</p><p><strong>Objective: </strong>This study aimed to identify the nervous system and gastrointestinal adverse drug events (ADEs) associated with solifenacin use in older adults (≥65 years).</p><p><strong>Methods: </strong>A case/non-case analysis was performed on the reports submitted to the FDA Adverse Event Reporting System (FAERS) between 01/01/2004 and 30/06/2020. Cases were reports for solifenacin with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes 'nervous system' or 'gastrointestinal' disorders. Non-cases were all other remaining reports for solifenacin. The case/non-cases was compared between solifenacin and other bladder antimuscarinics. Frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used to measure disproportionality. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, EBGM > 1, for ADEs with ≥4 reports.</p><p><strong>Results: </strong>107 MedDRA preferred terms (PTs) comprising 970 ADE reports were retrieved for nervous system disorders associated with solifenacin. For gastrointestinal disorders, 129 MedDRA PTs comprising 1817 ADE reports were retrieved. Statistically significant results were found for 'altered state of consciousness': ROR = 9.71 (2.13-44.35), PRR = 9.69 (2.12-44.2) and IC = 1.29 (0.93-1.66).</p><p><strong>Conclusions: </strong>The disproportionality reporting of 'altered state of consciousness', a previously unidentified ADE, was unexpected. Further monitoring of this ADE is needed to ensure patient safety, as this could be linked to poor balance and falls in older adults.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"34 1","pages":"63-73"},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10839516","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":"Making the most of a Morbidity and Mortality meeting.","authors":"Gabriella Quiney,&nbsp;Gianluca Colucci","doi":"10.3233/JRS-210077","DOIUrl":"https://doi.org/10.3233/JRS-210077","url":null,"abstract":"<p><strong>Background: </strong>Morbidity and Mortality meetings (M&Ms) are a fundamental element of surgical practice. However, there has been little investigation into best practices, to maximise education and improvement outcomes.</p><p><strong>Objective: </strong>Create a new, evidence-based M&M methodology, that facilitates standardised analysis of errors in a non-judgemental fashion, and highlights areas for improvement.</p><p><strong>Methods: </strong>A Quality Improvement (QI) methodology was used. This project encompassed a literature review and two sequential QI cycles. A literature review and initial survey highlighted best practice and identified areas for improvement. From this information, a new standardised format was created, which centred around a new modified Fishbone framework, incorporating the London Protocol methodology. The project then sequentially tested new formats, with feedback collected for every new format.</p><p><strong>Results: </strong>The literature review and surveys guided improvement of the M&M. The need for standardisation was highlighted. The new PowerPoint template and modified Fishbone ensured presentations and analysis were consistent and systematic. Participants reported that M&Ms were more engaging, interactive and structured, ensuring improved discussion of errors. The modified Fishbone framework reinforced a blame-free, system-focused analysis.</p><p><strong>Conclusion: </strong>M&Ms are a critical aspect of patient safety. This project utilised simple QI tools to encourage collaborative reflection, learning and improvement.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"34 2","pages":"145-154"},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9747841","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":"Gabapentin monotherapy for epilepsy: A review.","authors":"Liliya Eugenevna Ziganshina, Tatyana Abakumova, Charles H V Hoyle","doi":"10.3233/JRS-235001","DOIUrl":"10.3233/JRS-235001","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Epilepsy is one of the most common chronic neurological disorders, affecting more than 50 million people globally. In this review we summarised the evidence from randomised controlled trials of gabapentin used as monotherapy for the treatment of focal epilepsy, both newly diagnosed and drug-resistant, with or without secondary generalisation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To assess the effects of gabapentin monotherapy for people with epileptic focal seizures with and without secondary generalisation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 24 February 2020) on 25 February 2020. CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRA), and the specialised registers of Cochrane Review Groups including the Cochrane Epilepsy Group. We also searched several Russian databases, reference lists of relevant studies, ongoing trials registers, conference proceedings, and we contacted trial authors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We found five randomised controlled trials (3167 participants) comparing gabapentin to other antiepileptic drugs (AEDs) and differing doses of gabapentin as monotherapy for newly diagnosed focal epilepsy and drug- resistant focal epilepsy with or without secondary generalisation. Two review authors independently applied the inclusion criteria, assessed trial quality, risk of bias, and extracted data. We used the GRADE approach to assess the certainty of evidence and present seven patient-important outcomes in the \"Summary of findings\" tables. The quality of evidence was very low to moderate due to poor reporting quality, poor trial design, and other risks of bias, such as selective presentation of findings and potential heavy industry input. Better quality research may change our certainty in the effect estimates. None of the included trials reported on the number of people with 50% or greater reduction in seizures and time to withdrawal (retention time) in an extractable way. Gabapentin-treated participants were more likely to withdraw from treatment for any cause (285/539) than those treated with lamotrigine, oxcarbazepine, or topiramate pooled together (695/1317) (RR 1.13, 95% CI 1.02 to 1.25; 3 studies, 1856 participants; moderate-certainty evidence), but not carbamazepine. Fewer people treated with gabapentin withdrew from treatment owing to adverse events (190/525) than those treated with carbamazepine, oxcarbazepine, or topiramate (479/1238), (RR 0.79, 95% CI 0.69 to 0.91; 1763 participants, 3 studies; moderate-certainty evidence), but not lamotrigine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Gabapentin as monotherapy probably controlled seizures no better and no worse than comparator AEDs (lamotrigine, carbamazepine, oxcarbazepine, and","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"34 3","pages":"243-286"},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10664484","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":"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":"34 1","pages":"29-40"},"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}

{"title":"Free access to emergency oral contraceptives (EOCs) in the European Union: A regulatory vacuum to be filled.","authors":"Andrea Cioffi,&nbsp;Camilla Cecannecchia,&nbsp;Fernanda Cioffi,&nbsp;Raffaella Rinaldi,&nbsp;Giorgio Bolino","doi":"10.3233/JRS-220011","DOIUrl":"https://doi.org/10.3233/JRS-220011","url":null,"abstract":"<p><strong>Background: </strong>According to the World Health Organization (WHO), any woman in childbearing age who have decided not to take permanently an oral contraceptive but who are sexually active has the right to access emergency contraception (EC). Despite this, in many European countries there are no specific laws governing the criteria for access to emergency oral contraceptives (EOCs) for girls under 18, especially about the need for third party consent. This normative vacuum is dangerous as it risks creating confusion and entrusting the management of the fundamental right of self-determination to the discretion of others. Moreover, in European Union (EU) countries, there is an inequality in terms of access to contraceptive supplies, reimbursement criteria and the availability of information online.</p><p><strong>Objective: </strong>Our article compares the criteria for access to EOCs (Ulipristal Acetate-UPA and Levonorgestrel-LNG) in the various EU countries to highlight possible disparities and consequent inequalities.</p><p><strong>Methods: </strong>Government and ministerial websites, European agencies websites, and Contraceptive Use by Method 2019 (WHO) have been consulted.</p><p><strong>Results: </strong>There are some differences between the various European countries that could configure inequality in EU countries.</p><p><strong>Conclusions: </strong>It would be appropriate a definitive levelling of the legislation of the European Union on emergency contraception associated with massive information and awareness campaigns.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"34 1","pages":"75-80"},"PeriodicalIF":1.7,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9344461","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":"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,&nbsp;Victória Brioso Tavares,&nbsp;Natália Silva da Costa,&nbsp;Marcos Valério Santos da Silva,&nbsp;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":"34 1","pages":"5-19"},"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":"Can Twitter posts serve as early indicators for potential safety signals? A retrospective analysis.","authors":"Revati Pathak,&nbsp;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":"34 1","pages":"41-61"},"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":" ","pages":"295-311"},"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}

{"title":"The metabolic effects of hormonal treatment in transgender males: Safety of the testosterone gender-affirming therapy.","authors":"Charalampos Milionis,&nbsp;Ioannis Ilias,&nbsp;Evaggelia Venaki,&nbsp;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":"34 1","pages":"21-28"},"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":"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":" ","pages":"337-355"},"PeriodicalIF":0.9,"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}