Browsing by Subject "Safety"
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Item A health research agenda guided by migratory and seasonal farmworkers and the providers who serve them(Patient-Centered Outcomes Research Institute (PCORI), 2018-11) Holmes, Cheryl; Levy, Michelle; Mariscal, E. SusanaThis document shares the results of an almost two-year process to create a health research agenda specific to migratory and seasonal farmworkers. The purpose was to better understand what health outcomes are important to farmworkers in two Midwestern states and identify research and information gaps. A key strategy in accomplishing this work was not only to engage farmworkers in addition to providers, researchers and various other administrators but to do so in an active, direct and frequent manner, thus highlighting and elevating their voices and perspectives. This document is organized in that spirit.Item Acceptance or Rejection of the COVID-19 Vaccine: A Study on Iranian People's Opinions toward the COVID-19 Vaccine(MDPI, 2022-04-23) Nakhostin-Ansari, Amin; Zimet, Gregory D.; Khonji, Mohammad Saeid; Aghajani, Faezeh; Teymourzadeh, Azin; Kazerooni, Amir Ali Rastegar; Pirayandeh, Pendar; Aghajani, Reyhaneh; Safari, Sepideh; Khalaj, Kamand; Memari, Amir Hossein; Pediatrics, School of MedicineWe aimed to assess the Iranian people’s attitude and confidence in the COVID-19 vaccine, their concerns about the safety of vaccines, and their reasons for accepting or rejecting the COVID-19 vaccine. We conducted a web-based cross-sectional study with a mixed qualitative−quantitative approach from December 2020 to February 2021. Our questionnaire consisted of a COVID-19 vaccine attitude questionnaire, a COVID-19 vaccine confidence inventory, a modified vaccine safety scale, and questions about participants’ decision to accept or refuse the COVID-19 vaccine, and their explanations for their decisions. The research included 1928 people with an average age of 34.88 years with 1236 (64.1%) being female. A total of 1330 participants desired to have the COVID-19 vaccine (69%). Female gender, lower educational levels, following COVID-19 news through sources other than websites and social media, not following COVID-19 news, and loss of a first-degree relative due to COVID-19 were all associated with a more negative attitude toward the COVID-19 vaccine (p < 0.01). To conclude, the acceptance rate of the COVID-19 vaccine among Iranians is comparable to the international average; however, it is still unfavorable. There are serious challenges to the vaccination program in Iran, such as older adults’ lower intention to undergo the COVID-19 vaccine and misinformation.Item Adeno-associated virus-based gene therapy for hemophilia-addressing the gaps(Elsevier, 2024-12-31) Miesbach, Wolfgang; Batty, Paul; Chowdary, Pratima; Fong, Sylvia; Kaczmarek, Radoslaw; Leebeek, Frank W. G.; Long, Brian; Mahlangu, Johnny; Makris, Mike; Pierce, Glenn F.; Pipe, Steven W.; Srivastava, Alok; Voorberg, Jan; Peyvandi, Flora; Pediatrics, School of MedicineAdeno-associated virus-based gene therapy for hemophilia has emerged as a revolutionary treatment option, offering potential correction of clotting factor deficiency through a single intravenous infusion of functional genes directed to hepatocytes. With 3 gene therapies recently approved, this approach shows promise in transforming the lives of individuals with hemophilia. However, the complexity of gene therapy and the lack of standardization of methods in different components of this therapy can lead to unique challenges for clinical implementation. This manuscript follows literature reviews and structured discussions by the International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Working Group on Gene Therapy that identified specific areas requiring standardization of methods, including viral vector production, liver function assessment, quantification of factor (F)VIII and FIX expression levels, assessment of antiadeno-associated viral antibodies, and genomic integration detection methods. Standardization strategies aim to achieve consistent vector quality, effective patient selection, and uniform assessment methods by implementing advanced laboratory techniques and standardized protocols. Standardizing these parameters is essential for improving the understanding of short-term and long-term safety and efficacy of gene therapy in hemophilia. This effort aims to enhance the predictability of individual responses, address variability in outcomes, and ultimately provide more effective, safer, and personalized treatment options for individuals with hemophilia.Item Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections(Wolters Kluwer, 2021) Smith, Michael J.; Boutzoukas, Angelique; Autmizguine, Julie; Hudak, Mark L.; Zinkhan, Erin; Bloom, Barry T.; Heresi, Gloria; Lavery, Adrian P.; Courtney, Sherry E.; Sokol, Gregory M.; Cotten, C. Michael; Bliss, Joseph M.; Mendley, Susan; Bendel, Catherine; Dammann, Christiane E. L.; Weitkamp, Jörn-Hendrik; Saxonhouse, Matthew A.; Mundakel, Gratias T.; Debski, Julie; Sharma, Gaurav; Erinjeri, Jinson; Gao, Jamie; Benjamin, Daniel K., Jr.; Hornik, Christoph P.; Smith, P. Brian; Cohen-Wolkowiez, Michael; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee; Pediatrics, School of MedicineBackground: In premature infants, complicated intraabdominal infections (cIAIs) are a leading cause of morbidity and mortality. Although universally prescribed, the safety and effectiveness of commonly used antibiotic regimens have not been established in this population. Methods: Infants ≤33 weeks gestational age and <121 days postnatal age with cIAI were randomized to ≤10 days of ampicillin, gentamicin, and metronidazole (group 1); ampicillin, gentamicin, and clindamycin (group 2); or piperacillin-tazobactam and gentamicin (group 3) at doses stratified by postmenstrual age. Due to slow enrollment, a protocol amendment allowed eligible infants already receiving study regimens to enroll without randomization. The primary outcome was mortality within 30 days of study drug completion. Secondary outcomes included adverse events, outcomes of special interest, and therapeutic success (absence of death, negative cultures, and clinical cure score >4) 30 days after study drug completion. Results: One hundred eighty infants [128 randomized (R), 52 nonrandomized (NR)] were enrolled: 63 in group 1 (45 R, 18 NR), 47 in group 2 (41 R, 6 NR), and 70 in group 3 (42 R, 28 NR). Thirty-day mortality was 8%, 7%, and 9% in groups 1, 2, and 3, respectively. There were no differences in safety outcomes between antibiotic regimens. After adjusting for treatment group and gestational age, mortality rates through end of follow-up were 4.22 [95% confidence interval (CI): 1.39-12.13], 4.53 (95% CI: 1.21-15.50), and 4.07 (95% CI: 1.22-12.70) for groups 1, 2, and 3, respectively. Conclusions: Each of the antibiotic regimens are safe in premature infants with cIAI.Item Author's Response JSLS 2006;10:141–144(Society of Laparoscopic & Robotic Surgeons, 2006) Sundaram, Chandru P.; Urology, School of MedicineItem Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis(Taylor & Francis, 2021) Nikolaou, Andreas; Ambavane, Apoorva; Shah, Anshul; Ma, Wenkang; Tosh, Jon; Kapetanakis, Venediktos; Willson, Jenny; Wang, Feng; Hogea, Cosmina; Gorsh, Boris; Gutierrez, Ben; Sapra, Sandhya; Suvannasankha, Attaya; Samyshkin, Yevgeniy; Medicine, School of MedicineBackground: Patients with relapsed/refractory multiple myeloma (RRMM) require several lines of therapy, with typically shorter remission duration with each additional line. Research design and methods: The cost-effectiveness of belantamab mafodotin (belamaf; DREAMM-2; NCT03525678) was compared with selinexor plus dexamethasone (SEL+DEX; STORM Part 2; NCT02336815) among patients with RRMM who have received at least four prior therapies. The base case used a US commercial payer's perspective over a 10-year time horizon. Efficacy data were based on parametric survival analysis of DREAMM-2 and matching-adjusted indirect treatment comparison between DREAMM-2 and STORM Part 2, which assessed relative treatment effects between belamaf and SEL+DEX. Cost inputs included drug treatment, concomitant medications, adverse event management, subsequent treatments, and disease management. Results: Belamaf decreased total treatment costs per patient by $14,267 and increased patient life years by 0.74 and quality-adjusted life years (QALYs) by 0.49 versus SEL+DEX. Patients receiving belamaf accrued 0.12 fewer progression-free life years versus patients on SEL+DEX. Conclusions: From a US commercial payer's perspective, belamaf had lower costs, and increased QALYs and life-year gain, compared with SEL+DEX. Belamaf is therefore likely to be a cost-effective treatment option for patients with RRMM who have received four or more prior lines of therapy.Item Business travel, risk, and safety of female university faculty and staff(Taylor and Francis, 2020-09-29) Mirehie, Mona; Liu-Lastres, Bingjie; Cecil, A.; Jain, N.Women constitute a significant portion of the total business travel market in the U.S. This study aimed to explore travel risk and safety issues among women in higher education who regularly travel for work. Three focus groups were conducted with female faculty and staff at a major public university in the U.S. Results of an inductive-deductive analysis indicated three major themes, namely, risk perception, risk treatment, and risk adoption. Findings provide insights into how female higher education employees perceive risk and safety during business trips, and their travel behaviour that include actions taken to mitigate the potential risks or time-to-time risky decisions about travel arrangements. Further, recommendations are made for enhancement of travel policies at the institutional level to ensure safety of female employees.Item A Case Study of Safe and Cost-Effective Hospital HVAC Strategies(2022-08-02) Caesar, Jeffrey; Ray, Matthew Veto; Koo, Dan; Dalir, HamidThe pressures of healthcare facilities to keep patients safe while also maintaining financial viability have been felt in recent years amongst industry leaders. The impacts COVID has had on patient safety and planning has in any way fast-tracked patient safety progress, but certainly at a financial cost. As hospital leaders and facility leaders attempt to grapple with these realities, a facility's operating strategy that addresses both safety and cost should be employed. The below study aims to solve two issues facing hospital facility leadership in regards to the facilities’ HVAC system. The first issue is how to decrease energy consumption and operating expenses in light of industry pressures to improve the financial outlook and secondly, how to increase patient safety as a direct result of COVID-19 realities. Increasing safety and ultimately flexibility can many times increase costs, so utilizing the most appropriate and tested techniques that follow patient safety protocols will be necessary. The importance of this study cannot be understated. As with any healthcare system, improving patient outcomes are at the heart of the industry and especially in light of our recent pandemic. The fundamental question as to how facilities can keep patients safer while simultaneously reducing energy consumption is a tough question to answer, but manageable due to both recent industry experience and up-to-date research on the topic. The methodology will be to conduct a straightforward cost benefit analysis that takes into account both patient safety and energy consumption. The first step will be to gather baseline data for Lutheran Hospital’s HVAC system to gauge current system performance vs. benchmarked performance. Next, the data will inform us as to what strategies to implement to both curb costs and increase patient safety. The third step will be to implement those strategies where possible and measure their benefits. Lastly, a conclusion will be made as to what long-term solutions will be most useful to both this hospital and the other hospitals within Lutheran Health Network.Item Clinicians' use of Health Information Exchange technologies for medication reconciliation in the U.S. Department of Veterans Affairs: a qualitative analysis(Springer Nature, 2024-10-08) Snyder, Margie E.; Nguyen, Khoa A.; Patel, Himalaya; Sanchez, Steven L.; Traylor, Morgan; Robinson, Michelle J.; Damush, Teresa M.; Taber, Peter; Mixon, Amanda S.; Fan, Vincent S.; Savoy, April; Dismore, Rachel A.; Porter, Brian W.; Boockvar, Kenneth S.; Haggstrom, David A.; Locke, Emily R.; Gibson, Bryan S.; Byerly, Susan H.; Weiner, Michael; Russ-Jara, Alissa L.; Medicine, School of MedicineBackground: Medication reconciliation is essential for optimizing medication use. In part to promote effective medication reconciliation, the Department of Veterans Affairs (VA) invested substantial resources in health information exchange (HIE) technologies. The objectives of this qualitative study were to characterize VA clinicians' use of HIE tools for medication reconciliation in their clinical practice and to identify facilitators and barriers. Methods: We recruited inpatient and outpatient prescribers (physicians, nurse practitioners, physician assistants) and pharmacists at four geographically distinct VA medical centers for observations and interviews. Participants were observed as they interacted with HIE or medication reconciliation tools during routine work. Participants were interviewed about clinical decision-making pertaining to medication reconciliation and use of HIE tools, and about barriers and facilitators to use of the tools. Qualitative data were analyzed via inductive and deductive approaches using a priori codes. Results: A total of 63 clinicians participated. Over half (58%) were female, and the mean duration of VA clinical experience was 7 (range 0-32) years. Underlying motivators for clinicians seeking data external to their VA medical center were having new patients, current patients receiving care from an external institution, and clinicians' concerns about possible medication discrepancies among institutions. Facilitators for using HIE software were clinicians' familiarity with the HIE software, clinicians' belief that medication information would be available within HIE, and their confidence in the ability to find HIE medication-related data of interest quickly. Six overarching barriers to HIE software use for medication coordination included visual clutter and information overload within the HIE display; challenges with HIE interface navigation; lack of integration between HIE and other electronic health record interfaces, necessitating multiple logins and application switching; concerns with the dependability of HIE medication information; unfamiliarity with HIE tools; and a lack of HIE data from non-VA facilities. Conclusions: This study is believed to be the first to qualitatively characterize clinicians' HIE use with respect to medication reconciliation. Results inform recommendations to optimize HIE use for medication management activities. We expect that healthcare organizations and software vendors will be able to apply the findings to develop more effective and usable HIE information displays.Item Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis(Oxford University Press, 2025) Regueiro, Miguel; Siegmund, Britta; Horst, Sara; Moslin, Ryan; Charles, Lorna; Petersen, AnnKatrin; Tatosian, Daniel; Wu, Hsiuanlin; Lawlor, Garrett; Fischer, Monika; D’Haens, Geert; Colombel, Jean-Frederic; Medicine, School of MedicineBackground: Ozanimod, approved for the treatment of moderately to severely active ulcerative colitis (UC) and relapsing multiple sclerosis (RMS), is a weak in vitro monoamine oxidase B (MAO-B) inhibitor. MAO-B inhibitors can cause serotonin accumulation with concomitant use of selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs). We evaluated the incidence of treatment-emergent adverse events (TEAEs) potentially associated with serotonin accumulation during ozanimod and concomitant SSRI/SNRI use in this post hoc analysis of pooled UC studies and the open-label extension RMS DAYBREAK. Methods: Data for ozanimod 0.92 mg from pooled UC studies (n = 1158; cutoff: January 10, 2022) and RMS DAYBREAK (n = 2257; cutoff: February 1, 2022) were analyzed. Concomitant SSRI/SNRI use was allowed in the UC (n = 67) and RMS (n = 274) studies. A narrow Medical Dictionary for Regulatory Activities search ("serotonin syndrome," "neuroleptic malignant syndrome," and "malignant hyperthermia") and a broad search including terms potentially associated with serotonin accumulation were conducted. The percentages of patients with TEAEs in both searches were analyzed by concomitant SSRI/SNRI use when the TEAE occurred. Results: No patients had TEAEs matching the narrow search criteria. No differences were observed in the percentages of patients with ≥1 TEAE matching the broad search regardless of SSRI/SNRI use in UC (with: 25.4% [n = 17 of 67]; without: 15.0% [n = 164 of 1091]) and RMS (with: 12.4% [n = 34 of 274]; without: 15.6% [n = 310 of 1982]) studies. Conclusions: No evidence of increased TEAEs potentially associated with serotonin accumulation was observed with concurrent use of ozanimod and SSRIs/SNRIs.