Pub Date : 2026-01-23DOI: 10.1097/PTS.0000000000001472
Kerri Kuntz, Matthew T Nare, April Assee, Damon Pabst, Sarah Dierking, Jennifer McDonnell, Sarah Fouquet
Purpose: This quality improvement study aimed to address challenges in medication storage and accessibility in an acute pediatric care setting. By examining current processes, improvement opportunities were identified to enhance medication availability and reduce errors by introducing new locked medication storage boxes for multiuse, patient-specific medications.
Methods: This quality improvement study was conducted in a 38-bed medical-surgical unit at a large Midwestern pediatric hospital. The study consisted of 3 phases: preintervention, simulation, and postintervention. Preintervention included near miss frequency counts, bedside medication audits, time observation audits, and a knowledge survey. The simulation phase involved in-situ simulations over 2 shifts with ten nurses (n=10), measuring success rates, task completion times, workload, and task difficulty and confidence ratings. Postintervention activities repeated the initial measures collected during the preintervention phase.
Results: Participants showed a higher task success rate (94.6%) for the work-as-imagined procedure compared with a work-as-done (60%) and intervention (89%) processes. Overall, the intervention process decreased perceived workload according to the unweighted NASA-Task Load Index (NASA-TLX) scores and decreased task time compared with the work-as-imagined storage process. Confidence in task completion was highest for work-as-imagined, with a slight decrease in difficulty for the intervention or work-as-done.
Conclusions: This study underscores the importance of identifying and addressing gaps between organizational policies or standard operating procedures and actual practices while engaging frontline staff. The implementation of new medication lockboxes significantly improved the medication storage process, demonstrating the effectiveness of quality improvements methods in enhancing both safety and efficiency. These findings highlight the value of a collaborative, systems-based approach in driving meaningful improvements in health care settings, ultimately contributing to better patient outcomes and operational efficiency.
目的:本质量改进研究旨在解决急性儿科护理环境中药物储存和可及性的挑战。通过检查当前的流程,确定了改进的机会,以提高药物的可用性,并通过引入新的锁着的药物储存箱来减少错误,以储存多用途的、针对患者的药物。方法:本质量改进研究在中西部一家大型儿科医院的38个床位的内科外科单位进行。研究分为三个阶段:干预前、模拟和干预后。预防干预包括近错过频率计数、床边用药审计、时间观察审计和知识调查。模拟阶段包括10名护士(n=10)在2个班次的现场模拟,测量成功率、任务完成时间、工作量、任务难度和信心评级。干预后的活动重复了干预前阶段收集的初始措施。结果:与已完成工作(60%)和干预(89%)过程相比,参与者在想象工作过程中表现出更高的任务成功率(94.6%)。总体而言,根据未加权NASA-Task Load Index (NASA-TLX)得分,干预过程减少了感知工作量,与想象工作存储过程相比,干预过程减少了任务时间。对完成任务的信心在想象工作中是最高的,干预或完成工作的难度略有降低。结论:本研究强调了识别和解决组织政策或标准操作程序与实际做法之间差距的重要性,同时吸引一线员工。新型药物锁盒的实施显著改善了药物储存过程,证明了质量改进方法在提高安全性和效率方面的有效性。这些发现突出了协作、基于系统的方法在推动卫生保健环境有意义的改进方面的价值,最终有助于改善患者的治疗效果和运营效率。
{"title":"Redesigning From Work-as-imagined to Work-as-done: A Systems Safety Approach to Bedside Medication Storage.","authors":"Kerri Kuntz, Matthew T Nare, April Assee, Damon Pabst, Sarah Dierking, Jennifer McDonnell, Sarah Fouquet","doi":"10.1097/PTS.0000000000001472","DOIUrl":"10.1097/PTS.0000000000001472","url":null,"abstract":"<p><strong>Purpose: </strong>This quality improvement study aimed to address challenges in medication storage and accessibility in an acute pediatric care setting. By examining current processes, improvement opportunities were identified to enhance medication availability and reduce errors by introducing new locked medication storage boxes for multiuse, patient-specific medications.</p><p><strong>Methods: </strong>This quality improvement study was conducted in a 38-bed medical-surgical unit at a large Midwestern pediatric hospital. The study consisted of 3 phases: preintervention, simulation, and postintervention. Preintervention included near miss frequency counts, bedside medication audits, time observation audits, and a knowledge survey. The simulation phase involved in-situ simulations over 2 shifts with ten nurses (n=10), measuring success rates, task completion times, workload, and task difficulty and confidence ratings. Postintervention activities repeated the initial measures collected during the preintervention phase.</p><p><strong>Results: </strong>Participants showed a higher task success rate (94.6%) for the work-as-imagined procedure compared with a work-as-done (60%) and intervention (89%) processes. Overall, the intervention process decreased perceived workload according to the unweighted NASA-Task Load Index (NASA-TLX) scores and decreased task time compared with the work-as-imagined storage process. Confidence in task completion was highest for work-as-imagined, with a slight decrease in difficulty for the intervention or work-as-done.</p><p><strong>Conclusions: </strong>This study underscores the importance of identifying and addressing gaps between organizational policies or standard operating procedures and actual practices while engaging frontline staff. The implementation of new medication lockboxes significantly improved the medication storage process, demonstrating the effectiveness of quality improvements methods in enhancing both safety and efficiency. These findings highlight the value of a collaborative, systems-based approach in driving meaningful improvements in health care settings, ultimately contributing to better patient outcomes and operational efficiency.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146031234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-23DOI: 10.1097/PTS.0000000000001460
Kawtar Zouaidi, Jan Yeager, Sayali Tungare, Suhasini Bangar, Janelle Urata, Alfa-Ibrahim Yansane, Jungsoo Kim, Emily Sedlock, Krishna K Kookal, Yan Xiao, Oluwabunmi Tokede, Heiko Spallek, Amy Franklin, Gregory Olson, Joel White, Elsbeth Kalenderian, Muhammad F Walji
Background: The OWLL (Open-Wide Learning Lab) intervention was developed using Human-Centered Design to improve the quality and safety of pediatric dental sedation. The intervention includes a patient-facing informational sedation brochure and video, and an enhanced set of clinical sedation records. Here, we report on the process evaluation 6 months after implementation in daily clinical practice.
Methods: This study was conducted at the outpatient pediatric dental clinics of 2 large US academic dental institutions. We used a mixed-methods design to assess the fidelity, acceptability, appropriateness, and feasibility of the OWLL intervention. Quantitative data were gathered through chart reviews, while qualitative data were collected through surveys and interviews with providers and patients.
Results: During implementation, the intervention was used for 81 pediatric sedation patients across sites. Overall, the intervention was well-received by both clinicians and patients. Chart reviews indicated that sedation records were consistently utilized, though occasional gaps in data completeness were observed. Providers welcomed the intervention, finding it compatible with their daily routines and easy to use. However, some challenges were reported, primarily related to time constraints and the need to adjust clinical encounters for effective intervention integration. Parents appreciated the sedation brochure and video, describing them as a valuable and positive addition to the care process.
Conclusion: The findings suggest that the intervention was used and is a welcomed addition, with the potential for broader application in clinical settings to further improve patient care. Future efforts should examine the intervention's impact on patient safety outcomes across diverse clinical settings.
{"title":"Implementation and Evaluation of the OWLL Intervention to Improve the Quality and Safety of Pediatric Dental Sedation: A Mixed-Methods Approach.","authors":"Kawtar Zouaidi, Jan Yeager, Sayali Tungare, Suhasini Bangar, Janelle Urata, Alfa-Ibrahim Yansane, Jungsoo Kim, Emily Sedlock, Krishna K Kookal, Yan Xiao, Oluwabunmi Tokede, Heiko Spallek, Amy Franklin, Gregory Olson, Joel White, Elsbeth Kalenderian, Muhammad F Walji","doi":"10.1097/PTS.0000000000001460","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001460","url":null,"abstract":"<p><strong>Background: </strong>The OWLL (Open-Wide Learning Lab) intervention was developed using Human-Centered Design to improve the quality and safety of pediatric dental sedation. The intervention includes a patient-facing informational sedation brochure and video, and an enhanced set of clinical sedation records. Here, we report on the process evaluation 6 months after implementation in daily clinical practice.</p><p><strong>Methods: </strong>This study was conducted at the outpatient pediatric dental clinics of 2 large US academic dental institutions. We used a mixed-methods design to assess the fidelity, acceptability, appropriateness, and feasibility of the OWLL intervention. Quantitative data were gathered through chart reviews, while qualitative data were collected through surveys and interviews with providers and patients.</p><p><strong>Results: </strong>During implementation, the intervention was used for 81 pediatric sedation patients across sites. Overall, the intervention was well-received by both clinicians and patients. Chart reviews indicated that sedation records were consistently utilized, though occasional gaps in data completeness were observed. Providers welcomed the intervention, finding it compatible with their daily routines and easy to use. However, some challenges were reported, primarily related to time constraints and the need to adjust clinical encounters for effective intervention integration. Parents appreciated the sedation brochure and video, describing them as a valuable and positive addition to the care process.</p><p><strong>Conclusion: </strong>The findings suggest that the intervention was used and is a welcomed addition, with the potential for broader application in clinical settings to further improve patient care. Future efforts should examine the intervention's impact on patient safety outcomes across diverse clinical settings.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146031227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-22DOI: 10.1097/PTS.0000000000001466
Joseph D Forrester, William J Gostic, Ashley Peterson, Britomar Gomez, Dominique Watt, Sara Singer, Samuel H Wald, Brian T Bateman, Mary T Hawn
{"title":"Tips for Success: Developing a Video-based Multidisciplinary Review Rounds of Critical Events in the Operating Room.","authors":"Joseph D Forrester, William J Gostic, Ashley Peterson, Britomar Gomez, Dominique Watt, Sara Singer, Samuel H Wald, Brian T Bateman, Mary T Hawn","doi":"10.1097/PTS.0000000000001466","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001466","url":null,"abstract":"","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146013027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-21DOI: 10.1097/PTS.0000000000001462
Chih-Hsuan Huang, Hsin-Hung Wu, Yii-Ching Lee, Li Li
Objectives: Emotional exhaustion among ICU professionals poses a significant threat to both health care quality and staff well-being. While patient safety culture (PSC) is recognized as a potential buffer, its longitudinal impact on emotional exhaustion remains underexplored, particularly within high-intensity clinical environments like ICUs. This study investigates how ICU professionals' perceptions of PSC influence the progression of emotional exhaustion over a 5-year period, highlighting shifts in organizational and psychological predictors.
Methods: A 5-year longitudinal survey (2020-2024) was conducted in a regional teaching hospital in Taiwan. A total of 1213 valid responses were collected from ICU physicians and nurses using the Chinese version of the Safety Attitudes Questionnaire (CSAQ), which includes 6 PSC dimensions and an emotional exhaustion scale. Stepwise multiple regression was used annually to identify significant predictors of emotional exhaustion.
Results: Findings revealed a temporal shift in the predictors of emotional exhaustion. In 2020, organizational support factors-job satisfaction (β=-0.523, p<0.001) and perceptions of management (β=-0.443, p<0.001)-were significant negative predictors, while safety climate showed a counterintuitive positive association (β=0.264, p=0.004). From 2021 to 2024, stress recognition emerged as the most consistent protective factor (β range=-0.366 to -0.537, p<0.001). Interestingly, teamwork climate, often considered beneficial, was positively associated with emotional exhaustion in later years, suggesting added interpersonal burdens in collaborative ICU settings.
Conclusions: Emotional exhaustion in ICU professionals is shaped by dynamic interactions between organizational structures and individual-level coping resources. Early burnout prevention should focus on institutional support, while long-term strategies should promote stress awareness and carefully manage team-based expectations. These findings provide health care leaders with actionable insights to design adaptive, stage-specific interventions to sustain psychological resilience in high-stress clinical environments.
{"title":"Patient Safety Culture and Emotional Exhaustion Among ICU Professionals: A Five-year Longitudinal Study.","authors":"Chih-Hsuan Huang, Hsin-Hung Wu, Yii-Ching Lee, Li Li","doi":"10.1097/PTS.0000000000001462","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001462","url":null,"abstract":"<p><strong>Objectives: </strong>Emotional exhaustion among ICU professionals poses a significant threat to both health care quality and staff well-being. While patient safety culture (PSC) is recognized as a potential buffer, its longitudinal impact on emotional exhaustion remains underexplored, particularly within high-intensity clinical environments like ICUs. This study investigates how ICU professionals' perceptions of PSC influence the progression of emotional exhaustion over a 5-year period, highlighting shifts in organizational and psychological predictors.</p><p><strong>Methods: </strong>A 5-year longitudinal survey (2020-2024) was conducted in a regional teaching hospital in Taiwan. A total of 1213 valid responses were collected from ICU physicians and nurses using the Chinese version of the Safety Attitudes Questionnaire (CSAQ), which includes 6 PSC dimensions and an emotional exhaustion scale. Stepwise multiple regression was used annually to identify significant predictors of emotional exhaustion.</p><p><strong>Results: </strong>Findings revealed a temporal shift in the predictors of emotional exhaustion. In 2020, organizational support factors-job satisfaction (β=-0.523, p<0.001) and perceptions of management (β=-0.443, p<0.001)-were significant negative predictors, while safety climate showed a counterintuitive positive association (β=0.264, p=0.004). From 2021 to 2024, stress recognition emerged as the most consistent protective factor (β range=-0.366 to -0.537, p<0.001). Interestingly, teamwork climate, often considered beneficial, was positively associated with emotional exhaustion in later years, suggesting added interpersonal burdens in collaborative ICU settings.</p><p><strong>Conclusions: </strong>Emotional exhaustion in ICU professionals is shaped by dynamic interactions between organizational structures and individual-level coping resources. Early burnout prevention should focus on institutional support, while long-term strategies should promote stress awareness and carefully manage team-based expectations. These findings provide health care leaders with actionable insights to design adaptive, stage-specific interventions to sustain psychological resilience in high-stress clinical environments.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146013047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-21DOI: 10.1097/PTS.0000000000001461
Muaz Gülşen, Hatice Özsoy, Askeri Çankaya
Background: Surgical outcomes depend not only on clinical expertise but also on environmental factors, among which operating room noise is an important yet often underestimated risk factor. Rather than providing an extensive background, this study focuses on mapping how operating room noise and patient outcomes have been conceptualized in the scientific literature using bibliometric scientific mapping methods to identify intellectual structures, thematic trends, and research gaps.
Method: This retrospective descriptive study analyzed 54 original research articles identified through a predefined and structured bibliometric search of the Web of Science Core Collection conducted on April 25, 2025. Search terms included combinations of "operating room," "noise," and "patient." Bibliometric analyses were performed using VOSviewer and the Bibliometrix R package, examining publication trends, citation patterns, keyword co-occurrences, and collaboration networks.
Results: The earliest publication was identified in 1986, with 41.51% of articles published in the last 5 years and a marked increase after 2020. The analyzed studies were published in 43 journals and authored by 247 researchers, with a mean of 4.74 authors and 18.72 citations per article. The United States was the most productive and most cited country. Core themes centered on "noise," "patient safety," and "communication," while recent trends highlighted "auditory alarms," "staff stress," and "surgeon workload." Author productivity followed Lotka law, and institutional contributions were concentrated in Vanderbilt University and the University of Neuchâtel.
Conclusion: The findings demonstrate increasing academic attention to operating room noise and its relationship with patient outcomes; however, the literature remains fragmented, predominantly observational, and largely single-centered. This bibliometric mapping highlights the need for multicenter, experimental, and interdisciplinary research designs, as well as clearer outcome definitions, to better capture the clinical, psychosocial, and organizational pathways through which operating room noise may influence patient safety and perioperative care quality.
背景:手术结果不仅取决于临床专业知识,还与环境因素有关,其中手术室噪音是一个重要但常被低估的危险因素。本研究没有提供一个广泛的背景,而是着重于绘制手术室噪音和患者结果如何在科学文献中被概念化,使用文献计量学科学制图方法来识别知识结构、主题趋势和研究差距。方法:本回顾性描述性研究分析了54篇原创研究文章,这些文章是通过对Web of Science核心馆藏进行的预定义和结构化的文献计量学检索确定的,检索时间为2025年4月25日。搜索词包括“手术室”、“噪音”和“病人”的组合。使用VOSviewer和Bibliometrix R软件包进行文献计量分析,检查出版趋势、引用模式、关键词共现和合作网络。结果:最早发表于1986年,近5年发表的文章占41.51%,2020年以后显著增加。被分析的研究发表在43种期刊上,由247名研究人员撰写,平均有4.74名作者,每篇文章被引用18.72次。美国是生产率最高、被引用次数最多的国家。核心主题集中在“噪音”、“患者安全”和“沟通”上,而最近的趋势则强调了“听觉警报”、“工作人员压力”和“外科医生工作量”。作者生产力遵循洛特卡定律,机构贡献集中在范德比尔特大学和neuch大学。结论:研究结果表明,学术界越来越关注手术室噪音及其与患者预后的关系;然而,文献仍然是碎片化的,主要是观察性的,而且主要是单一中心的。这一文献计量测绘强调了多中心、实验和跨学科研究设计的必要性,以及更清晰的结果定义,以更好地捕捉手术室噪音可能影响患者安全和围手术期护理质量的临床、社会心理和组织途径。
{"title":"The Unheard Threat: Scientific Mapping of Studies Investigating the Impact of Operating Room Noise on Patient Outcomes.","authors":"Muaz Gülşen, Hatice Özsoy, Askeri Çankaya","doi":"10.1097/PTS.0000000000001461","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001461","url":null,"abstract":"<p><strong>Background: </strong>Surgical outcomes depend not only on clinical expertise but also on environmental factors, among which operating room noise is an important yet often underestimated risk factor. Rather than providing an extensive background, this study focuses on mapping how operating room noise and patient outcomes have been conceptualized in the scientific literature using bibliometric scientific mapping methods to identify intellectual structures, thematic trends, and research gaps.</p><p><strong>Method: </strong>This retrospective descriptive study analyzed 54 original research articles identified through a predefined and structured bibliometric search of the Web of Science Core Collection conducted on April 25, 2025. Search terms included combinations of \"operating room,\" \"noise,\" and \"patient.\" Bibliometric analyses were performed using VOSviewer and the Bibliometrix R package, examining publication trends, citation patterns, keyword co-occurrences, and collaboration networks.</p><p><strong>Results: </strong>The earliest publication was identified in 1986, with 41.51% of articles published in the last 5 years and a marked increase after 2020. The analyzed studies were published in 43 journals and authored by 247 researchers, with a mean of 4.74 authors and 18.72 citations per article. The United States was the most productive and most cited country. Core themes centered on \"noise,\" \"patient safety,\" and \"communication,\" while recent trends highlighted \"auditory alarms,\" \"staff stress,\" and \"surgeon workload.\" Author productivity followed Lotka law, and institutional contributions were concentrated in Vanderbilt University and the University of Neuchâtel.</p><p><strong>Conclusion: </strong>The findings demonstrate increasing academic attention to operating room noise and its relationship with patient outcomes; however, the literature remains fragmented, predominantly observational, and largely single-centered. This bibliometric mapping highlights the need for multicenter, experimental, and interdisciplinary research designs, as well as clearer outcome definitions, to better capture the clinical, psychosocial, and organizational pathways through which operating room noise may influence patient safety and perioperative care quality.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146013044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-16DOI: 10.1097/PTS.0000000000001468
Edna Marta Mendes da Silva, Juliana Dantas de Araújo Camargo, Sávio Ferreira Camargo, Camiliane Azevedo Ferreira, Marcelo Tafuri E Silva, Letícia Barbosa Teixeira, Érika Celi de Albuquerque Nunes, Jarlliany Aline da Silva Souza Tafuri, Dalila Rebeca Costa, Isadora Carvalho de Sousa, Ricardo Ney Cobucci
Objectives: Adverse drug events (ADEs) associated with subcutaneous (SC) medication use represent an escalating public health concern. However, data regarding the severity and associated risk factors of these events in Brazil remain limited, which impedes the development of effective safety interventions. This study aimed to characterize ADE reports linked to SC drug administration in Brazil from 2019 to 2024 and to identify sociodemographic and clinical predictors of severity.
Methods: A cross-sectional analysis was conducted utilizing 4954 ADE reports from the Brazilian VigiMed pharmacovigilance database. The variables assessed included patient demographics, reporter type, drug class, and event severity (eg, hospitalization, death). Associations were evaluated using χ2 tests, and multivariate logistic regression was used to identify independent predictors of severity.
Results: The majority of reports involved female patients (69.2%) and individuals aged 60 years or older (54.9%). Endocrine and metabolic agents were the most frequently implicated drug class (54.4%). Severe ADEs accounted for approximately one-third of all reports, with hospitalization (27.3%) and death (8.3%) being the most common outcomes. After adjustment, male sex [adjusted odds ratio (aOR) 1.31], age ≥60 years (aOR 1.48), reports from health care services (aOR 3.80), and nonspontaneous notifications (eg, clinical studies; aOR 1.52) were significantly associated with increased severity.
Conclusions: Subcutaneous medications in Brazil are associated with a considerable burden of severe ADEs, particularly among older adults and male patients. Strengthening pharmacovigilance systems, enhancing professional training, and implementing robust safety protocols are essential measures to mitigate harm and ensure safer SC drug administration.
{"title":"Predictors of Severity in Adverse Reactions to Subcutaneous Medications: A Nationwide Pharmacovigilance Study in Brazil (2019-2024).","authors":"Edna Marta Mendes da Silva, Juliana Dantas de Araújo Camargo, Sávio Ferreira Camargo, Camiliane Azevedo Ferreira, Marcelo Tafuri E Silva, Letícia Barbosa Teixeira, Érika Celi de Albuquerque Nunes, Jarlliany Aline da Silva Souza Tafuri, Dalila Rebeca Costa, Isadora Carvalho de Sousa, Ricardo Ney Cobucci","doi":"10.1097/PTS.0000000000001468","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001468","url":null,"abstract":"<p><strong>Objectives: </strong>Adverse drug events (ADEs) associated with subcutaneous (SC) medication use represent an escalating public health concern. However, data regarding the severity and associated risk factors of these events in Brazil remain limited, which impedes the development of effective safety interventions. This study aimed to characterize ADE reports linked to SC drug administration in Brazil from 2019 to 2024 and to identify sociodemographic and clinical predictors of severity.</p><p><strong>Methods: </strong>A cross-sectional analysis was conducted utilizing 4954 ADE reports from the Brazilian VigiMed pharmacovigilance database. The variables assessed included patient demographics, reporter type, drug class, and event severity (eg, hospitalization, death). Associations were evaluated using χ2 tests, and multivariate logistic regression was used to identify independent predictors of severity.</p><p><strong>Results: </strong>The majority of reports involved female patients (69.2%) and individuals aged 60 years or older (54.9%). Endocrine and metabolic agents were the most frequently implicated drug class (54.4%). Severe ADEs accounted for approximately one-third of all reports, with hospitalization (27.3%) and death (8.3%) being the most common outcomes. After adjustment, male sex [adjusted odds ratio (aOR) 1.31], age ≥60 years (aOR 1.48), reports from health care services (aOR 3.80), and nonspontaneous notifications (eg, clinical studies; aOR 1.52) were significantly associated with increased severity.</p><p><strong>Conclusions: </strong>Subcutaneous medications in Brazil are associated with a considerable burden of severe ADEs, particularly among older adults and male patients. Strengthening pharmacovigilance systems, enhancing professional training, and implementing robust safety protocols are essential measures to mitigate harm and ensure safer SC drug administration.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145991325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-13DOI: 10.1097/PTS.0000000000001459
Arzu Aslan Basli, Ayşe Gökce Işıklı, Serhat Hüseyin, Sevim Akbal
Objective: The aim of this study is to determine the frequency of opening of operating room doors during cardiovascular surgery operations, the number of personnel entering and exiting, and the reasons for these entries.
Materials and methods: This descriptive observational study was carried out in the cardiovascular surgery operating rooms of a university hospital. Using purposive sampling, 22 consecutive surgeries were observed, and data were collected with an "Intraoperative Observation Form." Descriptive statistics were used for analysis.
Results: The mean number of door openings per procedure was 74.18±41.54, corresponding to 16.92±7.33 openings per hour. Individuals opening the doors were support staff (27.8%), nurses (24.7%), perfusionists/others (18.9%), surgeons (15.6%), and anesthesiologists/anesthesia technicians (13.1%). The leading reason for entry was equipment retrieval (27.2%). Notably, 20.3% of entries were unrelated to the ongoing surgery.
Conclusion: Operating-room traffic is characterized by frequent door openings and substantial personnel movement, conditions that may degrade air quality and heighten the risk of surgical-site infection. Educational initiatives, improved equipment planning, and institutional policy development are recommended to reduce unnecessary traffic.
{"title":"Operating Room Traffic, Door Opening and Closing: A Clinical Observational Study.","authors":"Arzu Aslan Basli, Ayşe Gökce Işıklı, Serhat Hüseyin, Sevim Akbal","doi":"10.1097/PTS.0000000000001459","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001459","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study is to determine the frequency of opening of operating room doors during cardiovascular surgery operations, the number of personnel entering and exiting, and the reasons for these entries.</p><p><strong>Materials and methods: </strong>This descriptive observational study was carried out in the cardiovascular surgery operating rooms of a university hospital. Using purposive sampling, 22 consecutive surgeries were observed, and data were collected with an \"Intraoperative Observation Form.\" Descriptive statistics were used for analysis.</p><p><strong>Results: </strong>The mean number of door openings per procedure was 74.18±41.54, corresponding to 16.92±7.33 openings per hour. Individuals opening the doors were support staff (27.8%), nurses (24.7%), perfusionists/others (18.9%), surgeons (15.6%), and anesthesiologists/anesthesia technicians (13.1%). The leading reason for entry was equipment retrieval (27.2%). Notably, 20.3% of entries were unrelated to the ongoing surgery.</p><p><strong>Conclusion: </strong>Operating-room traffic is characterized by frequent door openings and substantial personnel movement, conditions that may degrade air quality and heighten the risk of surgical-site infection. Educational initiatives, improved equipment planning, and institutional policy development are recommended to reduce unnecessary traffic.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145960551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: To evaluate and consolidate evidence related to the management of lateral-prone surgical positioning from national and international sources, aiming to provide an evidence-based foundation for clinical practice.
Methods: Using the "6S" evidence model, a comprehensive search was conducted in Chinese and English databases, guideline websites, and professional society websites. We included all relevant evidence concerning the management of lateral-prone surgical positioning: clinical practice guidelines, systematic reviews, evidence summaries, clinical decisions, expert consensus, and randomized clinical trials. Search records were included from the establishment of each database up to June 30, 2024. Two researchers with expertise in evidence-based nursing independently screened and assessed the quality of the search results.
Results: Nine documents, consisting of 7 guidelines and 2 expert consensus documents, were included. In total, 28 pieces of evidence related to the management of lateral-prone surgical positioning were summarized. These address 6 key areas: prepositioning assessment, preparation of appropriate positioning equipment and supplies, teamwork, positioning, postpositioning checks, and intraoperative considerations.
Conclusion: This study synthesizes the best evidence available related to the management of lateral-prone surgical positioning, thus providing an evidence-based foundation for surgical teams. Health care professionals should apply this evidence selectively, considering clinical contexts and physician preferences.
{"title":"Summary of Best Evidence for Lateral-Prone Surgical Position Management.","authors":"Jingjing Zhou, Xiaoping Chen, Jianhui Huang, Mengxiao Jiang","doi":"10.1097/PTS.0000000000001448","DOIUrl":"https://doi.org/10.1097/PTS.0000000000001448","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate and consolidate evidence related to the management of lateral-prone surgical positioning from national and international sources, aiming to provide an evidence-based foundation for clinical practice.</p><p><strong>Methods: </strong>Using the \"6S\" evidence model, a comprehensive search was conducted in Chinese and English databases, guideline websites, and professional society websites. We included all relevant evidence concerning the management of lateral-prone surgical positioning: clinical practice guidelines, systematic reviews, evidence summaries, clinical decisions, expert consensus, and randomized clinical trials. Search records were included from the establishment of each database up to June 30, 2024. Two researchers with expertise in evidence-based nursing independently screened and assessed the quality of the search results.</p><p><strong>Results: </strong>Nine documents, consisting of 7 guidelines and 2 expert consensus documents, were included. In total, 28 pieces of evidence related to the management of lateral-prone surgical positioning were summarized. These address 6 key areas: prepositioning assessment, preparation of appropriate positioning equipment and supplies, teamwork, positioning, postpositioning checks, and intraoperative considerations.</p><p><strong>Conclusion: </strong>This study synthesizes the best evidence available related to the management of lateral-prone surgical positioning, thus providing an evidence-based foundation for surgical teams. Health care professionals should apply this evidence selectively, considering clinical contexts and physician preferences.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145913435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-07-14DOI: 10.1097/PTS.0000000000001393
Pier Luigi Ingrassia, Alessandro Barelli, Enrico Benedetti, Silvia Bressan, Luca Carenzo, Fausto D'Agostino, Francesco DiMeco, Giovanni Esposito, Alessandro Perin, Alfonso Piro, Giovanni Scambia, Andrea Silenzi, Stefano Sironi, Antonio Ursone, Pierpaolo Sileri
Background: Simulation-based education is an essential tool in modern health care, enhancing technical, behavioral, and decision-making skills while improving patient safety and clinical outcomes. In Italy, health care simulation has developed over the past 2 decades, with multiple scientific societies and educational initiatives promoting its use. However, the absence of national data and standardized educational frameworks presents a barrier to its widespread adoption. Recognizing these challenges, the Italian Ministry of Health convened a panel of experts to establish a strategic framework for simulation in health care, aiming to standardize methodologies, promote quality assurance, and foster collaboration across institutions.
Methods: The panel, composed of experts in health care simulation, clinical practice, and risk management, conducted a series of telematic meetings from April 2022 to July 2022. A consensus-driven approach was adopted to review existing literature, identify key areas for development, and formulate practical recommendations.
Results: Key recommendations include: establishing a national registry of simulation programs, defining accreditation criteria for simulation-based education, standardizing professional competencies for simulation educators, integrating simulation into health care curricula and continuous professional development, developing national standards for simulation-based training in new technologies and clinical procedures, utilizing simulation in public health preparedness and emergency response planning, promoting research funding and inter-institutional collaborations.
Conclusion: This position paper provides a strategic roadmap for standardizing simulation-based education across the Italian health care system. By establishing national standards and fostering collaboration, simulation can significantly improve patient safety, care quality, and health care system resilience.
{"title":"A National Position Paper for the Strategic Development of Health Care Simulation in Italy.","authors":"Pier Luigi Ingrassia, Alessandro Barelli, Enrico Benedetti, Silvia Bressan, Luca Carenzo, Fausto D'Agostino, Francesco DiMeco, Giovanni Esposito, Alessandro Perin, Alfonso Piro, Giovanni Scambia, Andrea Silenzi, Stefano Sironi, Antonio Ursone, Pierpaolo Sileri","doi":"10.1097/PTS.0000000000001393","DOIUrl":"10.1097/PTS.0000000000001393","url":null,"abstract":"<p><strong>Background: </strong>Simulation-based education is an essential tool in modern health care, enhancing technical, behavioral, and decision-making skills while improving patient safety and clinical outcomes. In Italy, health care simulation has developed over the past 2 decades, with multiple scientific societies and educational initiatives promoting its use. However, the absence of national data and standardized educational frameworks presents a barrier to its widespread adoption. Recognizing these challenges, the Italian Ministry of Health convened a panel of experts to establish a strategic framework for simulation in health care, aiming to standardize methodologies, promote quality assurance, and foster collaboration across institutions.</p><p><strong>Methods: </strong>The panel, composed of experts in health care simulation, clinical practice, and risk management, conducted a series of telematic meetings from April 2022 to July 2022. A consensus-driven approach was adopted to review existing literature, identify key areas for development, and formulate practical recommendations.</p><p><strong>Results: </strong>Key recommendations include: establishing a national registry of simulation programs, defining accreditation criteria for simulation-based education, standardizing professional competencies for simulation educators, integrating simulation into health care curricula and continuous professional development, developing national standards for simulation-based training in new technologies and clinical procedures, utilizing simulation in public health preparedness and emergency response planning, promoting research funding and inter-institutional collaborations.</p><p><strong>Conclusion: </strong>This position paper provides a strategic roadmap for standardizing simulation-based education across the Italian health care system. By establishing national standards and fostering collaboration, simulation can significantly improve patient safety, care quality, and health care system resilience.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"78-85"},"PeriodicalIF":1.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144627425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}