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  1. Article ; Online: Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial.

    Ward, Caleb E / Adelgais, Kathleen M / Holsti, Maija / Jacobsen, Kammy K / Simon, Harold K / Morris, Claudia R / Gonzalez, Victor M / Lerner, Gonzalo / Ghaffari, Kimia / VanBuren, John M / Lerner, E Brooke / Shah, Manish I

    Academic emergency medicine : official journal of the Society for Academic Emergency Medicine

    2024  

    Abstract: Background: Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose ... ...

    Abstract Background: Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial implements age-based, standardized midazolam dosing for pediatric seizures. The primary objective of this study was to determine public support for and concerns about the PediDOSE EFIC trial. The secondary objective was to assess how support for PediDOSE varied by demographics.
    Methods: We conducted a mixed-methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free-text response data regarding participant concerns.
    Results: Of 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non-Hispanic Black respondents were less likely than non-Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42-0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19-10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias.
    Conclusions: In communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non-Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials.
    Language English
    Publishing date 2024-03-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1329813-6
    ISSN 1553-2712 ; 1069-6563
    ISSN (online) 1553-2712
    ISSN 1069-6563
    DOI 10.1111/acem.14884
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 4479: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Enroller Experience and Parental Familiarity of Disease Influence Participation in a Pediatric Trial.

    Schunk, Jeff E / Jacobsen, Kammy K / Stephens, Dilon / Watson, Amy / Olsen, Cody S / Casper, T Charles / Glaser, Nicole S / Kuppermann, Nathan

    The western journal of emergency medicine

    2021  Volume 22, Issue 5, Page(s) 1176–1182

    Abstract: Introduction: Acquiring parental consent is critical to pediatric clinical research, especially in interventional trials. In this study we investigated demographic, clinical, and environmental factors associated with likelihood of parental permission ... ...

    Abstract Introduction: Acquiring parental consent is critical to pediatric clinical research, especially in interventional trials. In this study we investigated demographic, clinical, and environmental factors associated with likelihood of parental permission for enrollment in a study of therapies for diabetic ketoacidosis (DKA) in children.
    Methods: We analyzed data from patients and parents who were approached for enrollment in the Pediatric Emergency Care Applied Research Network (PECARN) Fluid Therapies Under Investigation in DKA (FLUID) trial at one major participating center. We determined the influence of various factors on patient enrollment, including gender, age, distance from home to hospital, insurance status, known vs new onset of diabetes, glycemic control (hemoglobin A1c), DKA severity, gender of the enroller, experience of the enroller, and time of enrollment. Patients whose parents consented to participate were compared to those who declined participation using bivariable and multivariable analyses controlling for the enroller.
    Results: A total of 250 patient/parent dyads were approached; 177 (71%) agreed to participate, and 73 (29%) declined. Parents of patients with previous episodes of DKA agreed to enroll more frequently than those with a first DKA episode (94.3% for patients with 1-2 previous DKA episodes, 92.3% for > 2 previous episodes, vs 64.9% for new onset diabetes and 63.2% previously diagnosed but no previous DKA). Participation was also more likely with more experienced enrollers (odds ratio [95% confidence interval] of participation for an enroller with more than two years' experience vs less than two years: 2.46 [1.53, 3.97]). After adjusting for demographic and clinical factors, significant associations between participation and both DKA history and enroller experience remained. Patient age, gender, distance of home from hospital, glycemic control, insurance status, and measures of DKA severity were not associated with likelihood of participation.
    Conclusion: Familiarity with the disease process (previously diagnosed diabetes and previous experience with DKA) and experience of the enroller favorably influenced the likelihood of parental permission for enrollment in a study of DKA in children.
    MeSH term(s) Adolescent ; Biomedical Research ; Child ; Clinical Trials as Topic ; Diabetes Mellitus, Type 1/complications ; Diabetic Ketoacidosis/epidemiology ; Diabetic Ketoacidosis/etiology ; Diabetic Ketoacidosis/therapy ; Female ; Fluid Therapy ; Humans ; Male ; Parental Consent/psychology ; Parents/psychology ; Surveys and Questionnaires
    Language English
    Publishing date 2021-09-02
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2375700-0
    ISSN 1936-9018 ; 1936-9018
    ISSN (online) 1936-9018
    ISSN 1936-9018
    DOI 10.5811/westjem.2021.4.54647
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Consequences of pediatric undertriage and overtriage in a statewide trauma system.

    Hewes, Hilary A / Christensen, Mathew / Taillac, Peter P / Mann, N Clay / Jacobsen, Kammy K / Fenton, Stephen J

    The journal of trauma and acute care surgery

    2017  Volume 83, Issue 4, Page(s) 662–667

    Abstract: Background: With increasing attention to the quality of health care delivery, evaluating trauma triage decisions in a large system of emergency care can help decision makers reduce mortality, morbidity, unnecessary transfers, and health care costs.: ... ...

    Abstract Background: With increasing attention to the quality of health care delivery, evaluating trauma triage decisions in a large system of emergency care can help decision makers reduce mortality, morbidity, unnecessary transfers, and health care costs.
    Objectives: To quantify the magnitude of pediatric traumatic injury undertriage (hospital mortality risk) and overtriage (early trauma center discharge after transfer) in a statewide trauma system.
    Methods: A statewide population-based evaluation of pediatric trauma outcomes and secondary triage (interfacility transfers) patterns from 2001 to 2013 among 45 hospitals in Utah's statewide trauma system.
    Results: The odds of pediatric transfer were 13 times lower (odds ratio, 13.15; p < 0.0001; 95% confidence interval, 11.0-15.7) in acute care hospitals meeting undertriage criteria than hospitals meeting overtriage criteria. Hospital triage practice was a stronger predictor of pediatric transfer than injury severity, injury diagnoses, age, and geographic distance. The likelihood of pediatric trauma mortality was more than twice higher in undertriage hospitals than overtriage hospitals (OR, 2.44; p < 0.0001; 95% confidence interval, 1.5-3.8). Among pediatric patients that survived the injury to transfer, 61% were discharged from the pediatric center in < 24 hours.
    Conclusion: Substantial opportunity exists in the state trauma system to improve pediatric trauma patient transfer practices to reduce pediatric trauma mortality, morbidity, and health care costs associated with unnecessary transfers.
    Level of evidence: Prognostic and epidemiological, level III.
    MeSH term(s) Adolescent ; Child ; Child, Preschool ; Decision Making ; Female ; Hospital Mortality ; Humans ; Infant ; Infant, Newborn ; Injury Severity Score ; Length of Stay/statistics & numerical data ; Male ; Registries ; Trauma Centers ; Triage/methods ; Utah/epidemiology ; Wounds and Injuries/mortality ; Wounds and Injuries/therapy
    Language English
    Publishing date 2017-06-19
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2651070-4
    ISSN 2163-0763 ; 2163-0755
    ISSN (online) 2163-0763
    ISSN 2163-0755
    DOI 10.1097/TA.0000000000001560
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 127: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

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