دورية أكاديمية
أعرض في EDS

Perceptions of safety monitoring in CF clinical studies and potential impact on future study participation.

التفاصيل البيبلوغرافية
العنوان: Perceptions of safety monitoring in CF clinical studies and potential impact on future study participation.
المؤلفون: Kern-Goldberger AS; Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA., Hill-Ricciuti AC; Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA., Zhou JJ; Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA., Savant AP; Division of Pulmonary and Sleep Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL 60611, USA., Rugg L; Division of Pulmonary and Sleep Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL 60611, USA., Dozor AJ; Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine, New York Medical College and Westchester Medical Center, Valhalla, NY 10595, USA., Welter J; Division of Pediatric Pulmonology, Allergy, Immunology, and Sleep Medicine, New York Medical College and Westchester Medical Center, Valhalla, NY 10595, USA., Saiman L; Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA., Quittell LM; Department of Pediatrics, Columbia University Irving Medical Center, New York, NY 10032, USA. Electronic address: lmq1@cumc.columbia.edu.
المصدر: Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society [J Cyst Fibros] 2019 Jul; Vol. 18 (4), pp. 530-535.
نوع المنشور: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 101128966 Publication Model: Print Cited Medium: Internet ISSN: 1873-5010 (Electronic) Linking ISSN: 15691993 NLM ISO Abbreviation: J Cyst Fibros Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Amsterdam ; New York : Elsevier, c2002-
مواضيع طبية MeSH: Attitude* , Biomedical Research* , Cystic Fibrosis*, Patient Participation/*psychology , Patient Participation/*trends , Patient Safety/*standards, Adolescent ; Cross-Sectional Studies ; Female ; Forecasting ; Humans ; Male ; Young Adult
مستخلص: Background: Individuals with CF and their parents cite safety concerns as barriers to participating in clinical studies. We assessed whether a brochure/infographic describing patient safety monitoring processes could reduce knowledge and attitude barriers regarding safety monitoring. We also identified factors associated with likely participation in future CF studies.
Methods: Respondents from three CF centers in the U.S. were randomly assigned to receive the safety monitoring brochure/infographic or an unrelated brochure. Fifty parents of children with CF <16, 50 adolescents with CF 16-21, and 50 adults with CF ≥22 years old were recruited to complete the study survey. Factors associated with survey responses and with reported likelihood of participating in future studies were assessed.
Results: Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI 95 1.01-5.28), but not in drug studies. Non-Hispanic respondents reported greater likelihood of participating in a future drug study than Hispanic respondents (aOR 3.18, CI 95 1.30-7.74). Adults with CF (aOR 2.62, CI 95 1.05-6.51) and parents (aOR 4.49, CI 95 1.66-12.15) were more likely than adolescents to report they would ask their care team about clinical trials. Confidence in safety monitoring was associated with reported likelihood of future participation in drug studies.
Conclusions: Potential future participation in CF drug and/or non-drug studies was associated with respondent age and ethnicity, receiving the safety monitoring brochure/infographic, and confidence in safety monitoring. Our findings underscore the need for education about safety monitoring, with targeted approaches for the Hispanic CF population and adolescents.
(Copyright © 2019 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.)
التعليقات: Comment in: J Cyst Fibros. 2019 Jul;18(4):445-446. (PMID: 31230796)
فهرسة مساهمة: Keywords: Clinical trials, minority recruitment; Cystic fibrosis (CF); Education; Patient safety
تواريخ الأحداث: Date Created: 20190602 Date Completed: 20200917 Latest Revision: 20200917
رمز التحديث: 20240829
DOI: 10.1016/j.jcf.2019.05.001
PMID: 31151855
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-5010
DOI:10.1016/j.jcf.2019.05.001