Perceptions of safety monitoring in CF clinical studies and potential impact on future study participation
| Autor: | Alexandra Hill-Ricciuti, Lisa Saiman, Lynne M. Quittell, Allen J. Dozor, Larissa Rugg, Juyan J. Zhou, Adrienne P. Savant, Andrew S Kern-Goldberger, John Welter |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Pulmonary and Respiratory Medicine education.field_of_study Potential impact medicine.medical_specialty business.industry media_common.quotation_subject Population Ethnic group Clinical trial 03 medical and health sciences Patient safety 030104 developmental biology 0302 clinical medicine 030228 respiratory system Family medicine Perception Pediatrics Perinatology and Child Health Respondent Medicine education business Safety monitoring media_common |
| Zdroj: | Journal of Cystic Fibrosis. 18:530-535 |
| ISSN: | 1569-1993 |
| DOI: | 10.1016/j.jcf.2019.05.001 |
| Popis: | 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 Results Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI95 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, CI95 1.30–7.74). Adults with CF (aOR 2.62, CI95 1.05–6.51) and parents (aOR 4.49, CI95 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. |
| Databáze: | OpenAIRE |
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