Journal of Patient Safety最新文献

{"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":"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 χ 2 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":"341-348"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","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}

{"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":"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":"357-368"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","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}

{"title":"Reframing ED Boarding Through a Human Factors Sociotechnical Systems Lens.","authors":"Woosuk Seo, Raj M Ratwani, Jesse M Pines, Edward R Melnick","doi":"10.1097/PTS.0000000000001507","DOIUrl":"10.1097/PTS.0000000000001507","url":null,"abstract":"","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e164-e165"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147647207","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}

{"title":"Steroid Safety in Respiratory Primary Care: When \"Short Courses\" Cause Long-Term Harm.","authors":"Waseem Jerjes, Azeem Majeed","doi":"10.1097/PTS.0000000000001519","DOIUrl":"10.1097/PTS.0000000000001519","url":null,"abstract":"","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e166-e168"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147870188","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}

{"title":"AI Never Events: An Increasing Threat to Patient Safety, Medical Science Needs to Prepare for.","authors":"Sebastian Ocklenburg, Annakarina Mundorf","doi":"10.1097/PTS.0000000000001540","DOIUrl":"10.1097/PTS.0000000000001540","url":null,"abstract":"","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e175"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310296","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}

{"title":"Psychosocial Safety Is Patient Safety: Gender-Affirming Care as an Exemplar for Health Equity.","authors":"Hanna J Barton, Tara N Cohen, Falisha F Kanji, Victor Trasvina, Jennifer T Anger, Alan J Card","doi":"10.1097/PTS.0000000000001478","DOIUrl":"10.1097/PTS.0000000000001478","url":null,"abstract":"<p><strong>Objective: </strong>Traditional patient safety has predominantly focused on preventing direct physical harm, such as falls and infections, often neglecting a critical aspect of safety: psychosocial safety. Yet preventable psychosocial harm-including the affective experience of pain; emotional harm; or social harm that may involve reputational, relational, or economic injuries-represents a pervasive threat to patient well-being that warrants research efforts and practice changes commensurate with the scope of the problem. Minoritized populations, particularly transgender and gender nonconforming (TGGN) patients, face heightened risks of psychosocial harm due to systemic biases and discrimination within health care systems.</p><p><strong>Methods: </strong>In this article, we focus on the experiences of TGGN patients to illustrate the pervasive nature of psychosocial harm and the urgent need for patient-centered care, which, in the case of TGGN care, is gender-affirming care.</p><p><strong>Results: </strong>We identify the need for systemic solutions to address psychosocial safety, including inclusive policies, education, and engagement with TGGN communities. We recommend taking a human-centered design approach to health care that prioritizes the needs of minoritized populations and aims to eliminate structural stigma.</p><p><strong>Conclusion: </strong>By integrating psychosocial safety into the broader patient safety framework, health care systems can create more equitable and compassionate environments that promote the well-being of all patients. There is no patient safety without psychosocial safety, and there is no psychosocial safety without equity.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"377-381"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146229332","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}

{"title":"Caregiver and Patient Input for Quality and Safety (C-PIQS) Pilot Study: Patient-Initiated Safety Observations Using an m-Health Tool.","authors":"Anjana E Sharma, Lizette Avina, Amber Tran, John Boscardin, Melisa C Sosa, Maité Garcia, Samuel Solis, Urmimala Sarkar, Glenn Rosenbluth, Margaret Stafford, James D Harrison, Andrew Auerbach, Naomi S Bardach","doi":"10.1097/PTS.0000000000001482","DOIUrl":"10.1097/PTS.0000000000001482","url":null,"abstract":"<p><strong>Background: </strong>Safety reporting systems do not identify all adverse events affecting hospitalized patients. Patients and caregivers may identify inpatient safety events that health care staff miss.</p><p><strong>Objective: </strong>To assess the feasibility of a text message-enabled safety reporting tool among adult inpatients and caregivers at a public hospital.</p><p><strong>Design: </strong>Prospective, observational pilot study to gather patient or caregiver safety observations. We assessed feasibility through engagement with the tool, reporting rates, content analysis of observations by category, and comparison to staff-entered incident reports.</p><p><strong>Participants: </strong>English-speaking and Spanish-speaking adults and caregivers age 18+ admitted to an urban, public hospital.</p><p><strong>Intervention: </strong>Participants received a daily text message eliciting safety observations, with a link to an online reporting tool.</p><p><strong>Main measures: </strong>Number of safety observations/100 study-days, adjusted for patient sociodemographics, patient activation, and patient electronic health literacy.</p><p><strong>Results: </strong>Seventy-five patients and 6 caregivers participated in the study (participation rate: 50%). Of patients, 56% were Latinx and 19% Black/African American; 44% were Spanish-speaking. Of all participants, 50.6% (41/81) engaged with at least 1 text message. There were 64 total safety observations, 27 patient-entered and 37 by caregivers. In multivariable analysis, Spanish-speaking Latinx patients made 1.8 [0.04-3.5] observations/100 study-days; English-speaking Latinx patients 3.4 [0-10.2]; Black/African American patients 5.8 [1.5-10.2] and combined Asian/Multiracial/white/Other English-speaking patients 11.9 [5.9-17.9] ( P =0.006). The most common category was \"What Went Well\" (34%), followed by Other (27%). Only one observation overlapped with a staff-entered incident report.</p><p><strong>Conclusions: </strong>The tool feasibly gathered relevant patient-reported safety observations from admitted patients from marginalized populations. Our study found lower reporting rates among Spanish-preferring, Latinx, and Black/African American patients, despite known higher rates of adverse events for these groups. Tracking minoritized patient participation and addressing differential engagement in patient engagement safety initiatives can improve racial and ethnic equity in reporting rates and, ultimately, safety, and health outcomes.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"382-389"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12997656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147272331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Severity of Reported Potassium-Related Errors and Developing Safeguards to Improve Potassium Safety in Critical Care-a Modified Expert Panel Study.","authors":"Minna Kurttila, Susanna Saano, Raisa Laaksonen","doi":"10.1097/PTS.0000000000001481","DOIUrl":"10.1097/PTS.0000000000001481","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to describe high-risk medicine, potassium-related incidents, reported in intensive care units (ICUs) nationally, investigate the consensus of an expert panel's evaluations and the inter-rater reliability between the expert panel and the original data classifiers in evaluating the clinical severity of patient harm, and develop safeguards by the expert panel to improve potassium safety in ICUs.</p><p><strong>Methods: </strong>Potassium-related incidents over an 11-year period were examined retrospectively and a subsample of typical errors that had caused patient harm was selected for error severity evaluation and development of safeguards, employing a prospective modified nominal group technique with an expert panel. The consensus of evaluations was determined using averages and the inter-rater reliability by using Cohen kappa. In addition, an expert panel discussion was conducted to develop recommendations for consensus-based safeguards to improve potassium safety in ICUs.</p><p><strong>Results: </strong>Of the 440 reported potassium incidents, 34% were related to wrong concentration, and 24% to wrong medication. Twenty-six percent were reported to have caused consequences for patients. The expert panel achieved almost complete consensus on the evaluation of the clinical severity of the subsample of errors (89%, n=42/47). The inter-rater reliability between the expert panel and original data classifiers was low (κ=0.34). The expert panel suggested multilevel safeguards.</p><p><strong>Conclusions: </strong>Most potassium-related incidents were related to wrong concentration and medication. The consequences of potassium-related errors may be more serious than reported. The quality of harm categorisation needs improvement to provide more reliable information on medication errors to improve medication safety. The expert panel suggested multilevel safeguards to improve potassium safety in ICUs.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"390-399"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13492640/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147272416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing Inter-Rater Agreement Across Five Teams Applying the Global Trigger Tool to Review 200 Inpatient Medical Records.","authors":"Ingunn Fride Tvete, Ellen Tveter Deilkås, Linda Reiersølmoen Neef, Wenche Pedersen Patrono, Hanne Narbuvold, Marion Haugen","doi":"10.1097/PTS.0000000000001491","DOIUrl":"10.1097/PTS.0000000000001491","url":null,"abstract":"<p><strong>Objective: </strong>A national quality indicator for hospital adverse events (AEs) could be based on Global Trigger Tool (GTT) data, with its validity depending on consistent reproducibility within the same GTT team and across independent GTT teams. A few studies have examined the inter-rater agreement between 2 independent teams' ratings of the same medical records, but not across a larger number of teams, which was the objective of this study.</p><p><strong>Methods: </strong>Five trained and experienced GTT teams across Norway reviewed the same 200 randomly sampled records. The inter-rater agreement across the teams on the presence or absence of at least one AE was assessed, together with agreement on the number of AEs and AE severity level. Differences in the teams' ratings were evaluated using a generalized linear mixed model, with adjustment for relevant covariates, and tested with a nonparametric method.</p><p><strong>Results: </strong>The 5 teams agreed on AE occurrence in 57.5% of the records, giving moderate agreement (Fleiss' κ: 0.48; Gwet's AC1: 0.65). Records with agreement on AE occurrence were clinically more complex, with longer LOS, more diagnoses and procedures, and higher readmission rates than those with disagreement. Teams 4 and 5 identified the highest number of records with AEs, and the differences in the 5 teams' ratings were significant.</p><p><strong>Conclusions: </strong>We point to a need for strengthening reviewer calibration and training to obtain higher agreement across independent GTT teams. This is a prerequisite for applying GTT data in a national quality indicator for AEs in hospitals.</p>","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e143-e150"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13492648/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147595532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protecting Women's Health, Protecting Patient Safety: Tackling HPV Vaccine Mistrust in Pakistan.","authors":"Syeda Rashmeen, Bisma Nadeem, Neha Fatima Chaudhry","doi":"10.1097/PTS.0000000000001527","DOIUrl":"10.1097/PTS.0000000000001527","url":null,"abstract":"","PeriodicalId":48901,"journal":{"name":"Journal of Patient Safety","volume":" ","pages":"e173"},"PeriodicalIF":1.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148145292","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}