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 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 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 Disposable Patterned Electroceutical Dressing (PED-10) Is Safe for Treatment of Open Clinical Chronic Wounds(Mary Ann Liebert, 2019-04-01) Roy, Sashwati; Prakash, Shaurya; Mathew-Steiner, Shomita S.; Das Ghatak, Piya; Lochab, Varun; Jones, Travis H.; Mohana Sundaram, Prashanth; Gordillo, Gayle M.; Subramaniam, Vish V.; Sen, Chandan K.; Surgery, School of MedicineObjective: To evaluate if patterned electroceutical dressing (PED) is safe for human chronic wounds treatment as reported by wound care providers. Approach: This work reports a pilot feasibility study with the primary objective to determine physically observable effects of PED application on host tissue response from a safety evaluation point of view. For this pilot study, patients receiving a lower extremity amputation with at least one open wound on the part to be amputated were enrolled. Patients were identified through the Ohio State University Wexner Medical Center (OSUWMC) based on inclusion and exclusion criteria through prescreening through the Comprehensive Wound Center's (CWC) Limb Preservation Program and wound physicians and/or providers at OSUWMC. Wounds were treated with the PED before amputation surgery. Results: The intent of the study was to identify if PED was safe for clinical application based on visual observations of adverse or lack of adverse events on skin and wound tissue. The pilot testing performed on a small cohort (N = 8) of patients showed that with engineered voltage regulation of current flow to the open wound, the PED can be used with little to no visually observable adverse effects on chronic human skin wounds. Innovation: The PED was developed as a second-generation tunable electroceutical wound care dressing, which could potentially be used to treat wounds with deeper infections compared with current state of the art that treats wounds with treatment zone limited to the surface near topical application. Conclusion: Technology advances in design and fabrication of electroceutical dressings were leveraged to develop a tunable laboratory prototype that could be used as a disposable low-cost electroceutical wound care dressing on chronic wounds. Design revisions of PED-1 (1 kΩ ballast resistor) circumvented previously observed adverse effects on the skin in the vicinity of an open wound. PED-10 (including a 10 kΩ ballast resistor) was well tolerated in the small cohort of patients (N = 8) on whom it was tested, and the observations reported here warrant a larger study to determine the clinical impact on human wound healing and infection control.Item Early solicited adverse events following the BNT162b2 mRNA vaccination, a population survey from Saudi Arabia(Elsevier, 2021-10-11) Almohaya, Abdulellah M.; Qari, Farah; Zubaidi, Ghuzlan A.; Alnajim, Noura; Moustafa, Khadeeja; Alshabi, Malak M.; Alsubaie, Faleh M.; Almutairi, Ibrahim; Alwazna, Qusai; Al-Tawfiq, Jaffar A.; Barry, Mazin; Medicine, School of MedicinePost rollout safety for the coronavirus disease vaccines is crucial and recommended. To explore the early solicited adverse events (AE) following BNT162b2 mRNA vaccination in Saudi Arabia, we distributed an online survey to adults vaccinated with BNT162b2 over the first week of June 2021, to collect data on first (V1), second doses (V2), symptoms, severity, and outcome after an informed consent was obtained. We recruited 3639 BNT162b2 vaccinated individuals, of which one-third had received two doses, 63.3% were female, 77% were healthy, and 89% had 18–55 years of age, while only 9.8% had a history of allergy. Overall, 50.3% had any AEs after any dose, especially those younger than 55 years of age, female, history of comorbidity, and when adjusted for age and gender, lung or cardiovascular diseases. Overall, the most common AE were pain at the injection site (44%), tiredness (39%), or body ache (31%). Compared to V1, a higher rate of post-V2 systemic AE (36% vs. 51%). Most AEs started very early (within 3 days), and rarely delayed in recovery (>2 weeks). Anti-pyretic was the most commonly used (51.7%), a third of which was unnecessary. Only 1.7% required hospital admission. By multivariate analysis, predictors for admission were the presence of lung or immunocompromising diseases. In conclusion, common AEs after BNT162b2 in the real world were generally mild, self-limiting, higher after the second dose, and largely mimicking that reported in clinical trials. The causality of these AE and the persistence of post-vaccination symptoms needs to be investigated further.Item Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial(Elsevier, 2020-07) Pohl, Heiko; Grimm, Ian S.; Moyer, Matthew T.; Hasan, Muhammad K.; Pleskow, Douglas; Elmunzer, B. Joseph; Khashab, Mouen A.; Sanaei, Omid; Al-Kawas, Firas H.; Gordon, Stuart R.; Mathew, Abraham; Levenick, John M.; Aslanian, Harry R.; Antaki, Fadi; von Renteln, Daniel; Crockett, Seth D.; Rastogi, Amit; Gill, Jeffrey A.; Law, Ryan J.; Elias, Pooja A.; Pellise, Maria; Mackenzie, Todd A.; Rex, Douglas K.; Medicine, School of MedicineBackground & aims: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. Methods: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. Results: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). Conclusions: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference.