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BMJ Open Quality Jun 2024Intravenous medication errors continue to significantly impact patient safety and outcomes. This study sought to clarify the complexity and risks of the intravenous...
OBJECTIVES
Intravenous medication errors continue to significantly impact patient safety and outcomes. This study sought to clarify the complexity and risks of the intravenous administration process.
DESIGN
A qualitative focus group interview study.
SETTING
Focused interviews were conducted using process mapping with frontline nurses responsible for medication administration in September 2020.
PARTICIPANTS
Front line experiened nurses from a Japanese tertiary teaching hospital.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary outcome measure was to identify the mental models frontline nurses used during intravenous medication administration, which influence their interactions with patients, and secondarily, to examine the medication process gaps between the mental models nurses perceive and the actual defined medication administration process.
RESULTS
We found gaps between the perceived clinical administration process and the real process challenges with an emphasis on the importance of verifying to see if the drug was ordered for the patient immediately before its administration.
CONCLUSIONS
This novel and applied improvement approach can help nurses and managers better understand the process vulnerability of the infusion process and develop a deeper understanding of the administration steps useful for reliably improving the safety of intravenous medications.
Topics: Humans; Qualitative Research; Medication Errors; Focus Groups; Patient Safety; Infusions, Intravenous; Perception; Female; Administration, Intravenous; Adult; Nursing Staff, Hospital; Male; Japan; Interviews as Topic; Attitude of Health Personnel
PubMed: 38942437
DOI: 10.1136/bmjoq-2024-002809 -
International Journal of Infectious... Jun 2024To identify highest-risk subgroups for COVID-19 and Long COVID(LC), particularly in contexts of influenza and cardiovascular disease(CVD).
OBJECTIVE
To identify highest-risk subgroups for COVID-19 and Long COVID(LC), particularly in contexts of influenza and cardiovascular disease(CVD).
METHODS
Using national, linked electronic health records for England(NHS England Secure Data Environment via CVD-COVID-UK/COVID-IMPACT Consortium), we studied individuals(of all ages) with COVID-19 and LC (2020-2023). We compared all-cause hospitalisation and mortality by prior CVD, high CV risk, vaccination status(COVID-19/influenza), and CVD drugs, investigating impact of vaccination and CVD prevention using population preventable fractions.
RESULTS
Hospitalisation and mortality were 15.3% and 2.0% among 17,373,850 individuals with COVID-19(LC rate 1.3%), and 16.8% and 1.4% among 301,115 with LC. Adjusted risk of mortality and hospitalisation were reduced with COVID-19 vaccination≥2 doses(COVID-19:HR 0.36 and 0.69; LC:0.44 and 0.90). With influenza vaccination, mortality was reduced, but not hospitalisation(COVID-19:0.86 and 1.01, and LC:0.72 and 1.05). Mortality and hospitalisation were reduced by CVD prevention in those with CVD, e.g. anticoagulants- COVID:19:0.69 and 0.92; LC:0.59 and 0.88; lipid lowering- COVID-19:0.69 and 0.86; LC:0.68 and 0.90. COVID-19 vaccination averted 245044 of 321383 and 7586 of 8738 preventable deaths after COVID-19 and LC, respectively.
INTERPRETATION
Prior CVD and high CV risk are associated with increased hospitalisation and mortality in COVID-19 and LC. Targeted COVID-19 vaccination and CVD prevention are priority interventions.
FUNDING
NIHR. HDR UK.
PubMed: 38942167
DOI: 10.1016/j.ijid.2024.107155 -
Ecotoxicology and Environmental Safety Jun 2024Following ion-adsorption rare earth mining, the residual tailings experience considerable heavy metal contamination and gradually evolve into a pollution source....
Following ion-adsorption rare earth mining, the residual tailings experience considerable heavy metal contamination and gradually evolve into a pollution source. Therefore, the leaching characteristics and environmental impact of heavy metals in ion-adsorption rare earth tailings require immediate and thorough investigation. This study adopted batch and column experiments to investigate the leaching behaviour of heavy metals in tailings and assess the impact of tailings on paddy soil, thereby providing a scientific basis for environmental protection in mining areas. The results showed that Mn, Zn, and Pb contents were 431.67, 155.05, and 264.33 mg·kg, respectively, which were several times higher than their respective background values, thereby indicating significant heavy metal contamination in the tailings. The batch leaching experiment indicated that Mn and Pb were priority control heavy metals. Heavy metals were divided into fast and slow leaching stages. The Mn and Pb leaching concentrations far exceeded environmental limits. The DoseResp model perfectly fitted the leaching of all heavy metals from the tailings (R > 0.99). In conjunction with the findings of the column experiment and correlation analysis, the chemical form, rainfall pH, ammonia nitrogen, and mineral properties were identified as the primary factors controlling heavy metal release from tailings. Rainfall primarily caused heavy metal migration in the acid-extraction form from the tailings. The tailing leachate not only introduced heavy metals into the paddy soil but also caused the transformation of the chemical form of heavy metals in the paddy soil, further exacerbating the environmental risk posed by heavy metals. The study findings are significant for environmental conservation in mining areas and implementing environmentally friendly practices in rare earth mining.
PubMed: 38941660
DOI: 10.1016/j.ecoenv.2024.116642 -
Colloids and Surfaces. B, Biointerfaces Jun 2024In cancer research, circulating tumor cells (CTCs) were identified as the main drivers of metastasis. They are vital for early detection and prevention of metastasis...
In cancer research, circulating tumor cells (CTCs) were identified as the main drivers of metastasis. They are vital for early detection and prevention of metastasis during cancer treatment. Even though continuous progress in research offers more and more tools to combat cancer, we still lack a proper arsenal of therapeutics. Especially in tumors with close to no targeting options, like triple-negative breast cancer, early detection is often the main difference between successful and failed therapy. When such tumors are detected too late, they may have already produced plenty of CTCs, likely causing metastasis, which is the primary reason for tumor-associated deaths. Detecting those CTCs early on could substantially impact therapy outcomes and the 5-year survival rate. In our study, we developed and evaluated a reliable and affordable CTC screening method based on flow cytometry and 5-aminolevulinic acid (5-ALA) staining. We successfully established a circulation model for 5-ALA and CTCs research and demonstrated that the method can detect an average of 11 ± 3.3 CTCs out of 10,000 peripheral blood mononuclear cells, representing as low as approximately 0.1 % with a reasonable number of false positive events. Additionally, we present initial results on a theranostic approach using 5-ALA converted to protoporphyrin IX. The outcomes of this study might contribute significantly to the further development of CTC detection and the overall detection and treatment of cancer.
PubMed: 38941652
DOI: 10.1016/j.colsurfb.2024.114059 -
Medicine Jun 2024There has been significant interest in the changes in menstrual cycles following coronavirus disease 2019 (COVID-19) infection or vaccination. This study aimed to...
There has been significant interest in the changes in menstrual cycles following coronavirus disease 2019 (COVID-19) infection or vaccination. This study aimed to investigate the evidence for such changes and their potential risk factors. We used a descriptive study design and gathered data by sharing an online survey questionnaire on social media platforms. The questionnaire included questions regarding sociodemographic factors, menstrual cycle changes, and COVID-19 anxiety. The study population comprised women aged 18 to 49 years from Izmir. All data analyses were performed using Statistical Package for the Social Sciences 21.0. The risk factors influencing menstrual irregularities were determined after the COVID binary logistic regression analysis, including univariate and multivariate models. Among the 465 participants, those with an associate's degree had a significantly higher risk of menstrual irregularities than those with a high school diploma (P = .012). Anxiety scores emerged as a significant risk factor for menstrual cycle irregularities (P = .026). However, neither COVID-19 infection nor vaccination resulted in significant changes in the menstrual cycle characteristics (P > .05). Other sociodemographic variables, such as age, body mass index, and smoking, were not significantly associated with menstrual cycle changes(P > .05). The study findings suggest that educational level and anxiety may play a role in menstrual irregularities, whereas COVID-19 infection or vaccination itself may not directly affect menstrual cycle.
Topics: Humans; Female; COVID-19; Adult; Risk Factors; Anxiety; Middle Aged; Young Adult; Adolescent; COVID-19 Vaccines; Menstruation Disturbances; SARS-CoV-2; Surveys and Questionnaires; Vaccination; Educational Status
PubMed: 38941384
DOI: 10.1097/MD.0000000000038771 -
PloS One 2024Frequent use of pain relief medications among patients with migraine can result in disease worsening and medication-overuse headache (MOH), a painful and debilitating...
Frequent use of pain relief medications among patients with migraine can result in disease worsening and medication-overuse headache (MOH), a painful and debilitating condition. We sought to conduct a cross-sectional survey among adult patients diagnosed with migraine to determine: 1) their awareness of MOH, and 2) their knowledge of the condition and its prevention, and 3) the association of these factors with actual use of pain relief medications. We recruited and interviewed 200 English-speaking adults with migraine who had a clinic visit with a neurologist or primary care provider within the past month. Patients were identified via an electronic health record query. Almost 40% of participants had never heard of the term 'medication-overuse headache.' In bivariate analyses, participants who were Black or Hispanic and those with limited health literacy were less likely to have heard of MOH. Participants scored an average of 2.1 (range: 0-3) on a MOH knowledge measure; older participants, those with limited health literacy, lower education, and little or no migraine-related disability demonstrated less knowledge. Almost a third (31.5%) of patients reported overusing pain relief medication and were at risk for MOH. Overuse was not significantly associated with MOH awareness, knowledge, or sociodemographic factors, but was related to greater migraine-related disability. Our findings suggest that patient awareness and knowledge of MOH is suboptimal, particularly among older adults, racial and ethnic minority groups, and those with limited health literacy. Interventions are needed to prevent MOH and better inform patients about risks associated with frequent use of pain relief medications.
Topics: Humans; Male; Female; Adult; Migraine Disorders; Middle Aged; Health Knowledge, Attitudes, Practice; Headache Disorders, Secondary; Cross-Sectional Studies; Health Literacy; Analgesics; Aged; Young Adult; Awareness
PubMed: 38941310
DOI: 10.1371/journal.pone.0306264 -
JMIR Research Protocols Jun 2024Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months).
OBJECTIVE
This study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes.
METHODS
We are conducting a pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if they have type 1 or 2 DM, can read in English, are aged 18-75 years, have a current patient portal account, and have reliable access to a mobile device with internet access. We exclude patients with medical conditions that prevent them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among 4 DM preventive care services (diabetes eye examination, pneumococcal vaccination, hemoglobin A, and urine microalbumin) at 12 months after randomization. Secondary outcomes will include diabetes self-efficacy, confidence managing diabetes in general, understanding of diabetes preventive care, diabetes distress, patient portal satisfaction, and patient-initiated orders at baseline, 3 months, 6 months, and 12 months after randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at the 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used.
RESULTS
This study is ongoing. Recruitment was closed in February 2022; a total of 433 patients were randomized. Of those randomized, most (n=288, 66.5%) were non-Hispanic White, 33.5% (n=145) were racial or ethnic minorities, 33.9% (n=147) were aged 65 years or older, and 30.7% (n=133) indicated limited health literacy.
CONCLUSIONS
The study directly tests the hypothesis that a patient portal intervention-alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care-will reduce diabetes care gaps compared with usual care. The insights gained from this study may have broad implications for developing future interventions to address various care gaps, such as gaps in cancer screening, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04894903; https://classic.clinicaltrials.gov/ct2/show/NCT04894903.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/56123.
Topics: Humans; Patient Portals; Adult; Middle Aged; Female; Male; Aged; Adolescent; Diabetes Mellitus; Young Adult; Pragmatic Clinical Trials as Topic
PubMed: 38941148
DOI: 10.2196/56123 -
JMIR Research Protocols Jun 2024Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have...
BACKGROUND
Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.
OBJECTIVE
This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.
METHODS
This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.
RESULTS
The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.
CONCLUSIONS
Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.
TRIAL REGISTRATION
PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/51614.
Topics: Humans; Randomized Controlled Trials as Topic; Artificial Intelligence; Algorithms; Systematic Reviews as Topic; Patient Harm; Equipment and Supplies; Research Design
PubMed: 38941147
DOI: 10.2196/51614 -
JAMA Network Open Jun 2024The efficacy of a semirecumbent position (SRP) in reducing postoperative hypoxemia during anesthesia emergence is unclear despite its widespread use. (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
The efficacy of a semirecumbent position (SRP) in reducing postoperative hypoxemia during anesthesia emergence is unclear despite its widespread use.
OBJECTIVE
To determine the differences in postoperative hypoxemia between patients in an SRP and a supine position.
DESIGN, SETTING, AND PARTICIPANTS
This randomized clinical trial was performed at a tertiary hospital in China between March 20, 2021, and May 10, 2022. Patients scheduled to undergo laparoscopic upper abdominal surgery under general anesthesia were enrolled. Study recruitment and follow-up are complete.
INTERVENTIONS
Patients were randomized to 1 of the following positions at the end of the operation until leaving the postanesthesia care unit: supine (group S), 15° SRP (group F), or 30° SRP (group T).
MAIN OUTCOMES AND MEASURES
The primary outcome was the incidence of postoperative hypoxemia in the postanesthesia care unit. Severe hypoxemia was also evaluated.
RESULTS
Out of 700 patients (364 men [52.0%]; mean [SD] age, 47.8 [11.3] years), 233 were randomized to group S (126 men [54.1%]; mean [SD] age, 48.2 [10.9] years), 233 to group F (122 men [52.4%]; mean [SD] age, 48.1 [10.9] years), and 234 to group T (118 women [50.4%]; mean [SD] age, 47.2 [12.1] years). Postoperative hypoxemia differed significantly among the 3 groups (group S, 109 of 233 [46.8%]; group F, 105 of 233 [45.1%]; group T, 76 of 234 [32.5%]; P = .002). This difference was statistically significant for groups T vs S (risk ratio [RR], 0.69 [95% CI, 0.55-0.87]; P = .002) and groups T vs F (RR, 0.72 [95% CI, 0.57-0.91]; P = .007), but not for groups F vs S (RR, 0.96 [95% CI, 0.79-1.17]; P = .78). Severe hypoxemia also differed among the 3 groups (group S, 61 of 233 [26.2%]; group F, 53 of 233 [22.7%]; group T, 36 of 234 [15.4%]; P = .01). This difference was statistically significant for groups T vs S (RR, 0.59 [95% CI, 0.41-0.85]; P = .005).
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial of SRP during anesthesia recovery in patients undergoing laparoscopic upper abdominal surgery, postoperative hypoxemia was significantly reduced in group T compared with group F or group S.
TRIAL REGISTRATION
Chinese Clinical Trial Registry Identifier: ChiCTR2100045087.
Topics: Humans; Male; Female; Middle Aged; Hypoxia; Postoperative Complications; Patient Positioning; Adult; Anesthesia Recovery Period; Anesthesia, General; China; Laparoscopy; Supine Position; Abdomen
PubMed: 38941098
DOI: 10.1001/jamanetworkopen.2024.16797 -
Medeniyet Medical Journal Jun 2024
PubMed: 38940532
DOI: 10.4274/MMJ.galenos.2024.66281