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The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology
One of the challenges faced when conducting a clinical trial is the recruitment of the proposed number of participants. Accordingly, identifying barriers to patients’ enrollment and developing effective strategies to overcome them is mandatory. One of the main strategies employed to improve particip...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Carol Davila University Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6418342/ https://www.ncbi.nlm.nih.gov/pubmed/30894889 http://dx.doi.org/10.25122/jml-2018-0072 |
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author | Mihaela Micheu, Miruna Udrea, Oana-Maria Octavia Popa, Mihaela Rusu, Iulia Gheorghe-Fronea, Oana Scafa-Udriste, Alexandru Dorobantu, Maria |
author_facet | Mihaela Micheu, Miruna Udrea, Oana-Maria Octavia Popa, Mihaela Rusu, Iulia Gheorghe-Fronea, Oana Scafa-Udriste, Alexandru Dorobantu, Maria |
author_sort | Mihaela Micheu, Miruna |
collection | PubMed |
description | One of the challenges faced when conducting a clinical trial is the recruitment of the proposed number of participants. Accordingly, identifying barriers to patients’ enrollment and developing effective strategies to overcome them is mandatory. One of the main strategies employed to improve participation rate consists of designing the informed consent forms based on patients’ feedback. This survey aims to explore the attitude of patients admitted in a Romanian tertiary cardiology center to take part in biomarker-based clinical trials. This is a descriptive, prospective and longitudinal single-center study. Participants will be recruited until the planned sample size will be reached (n=333). The patients will be interviewed based on a semi-structured questionnaire which includes four sections: demographics (7 items), personal medical history (7 items), attitudes (9 items) and trust (4 items). Descriptive statistics will be used to illustrate patients’ demographics, medical history, attitudes toward biomarker-based clinical trials and trust in medical researchers. Logistic regression models will be employed to assess relations between patients’ attitudes, trust, and different socio-demographic variables. Data analysis will offer answers to key questions addressed by this survey: What amount of and in what form should information be disclosed? Who should make the invitation to participate? The information gained will facilitate tailoring informed consent forms to suit the needs of patients with various demographic, social and educational backgrounds. |
format | Online Article Text |
id | pubmed-6418342 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Carol Davila University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-64183422019-03-20 The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology Mihaela Micheu, Miruna Udrea, Oana-Maria Octavia Popa, Mihaela Rusu, Iulia Gheorghe-Fronea, Oana Scafa-Udriste, Alexandru Dorobantu, Maria J Med Life Original Article One of the challenges faced when conducting a clinical trial is the recruitment of the proposed number of participants. Accordingly, identifying barriers to patients’ enrollment and developing effective strategies to overcome them is mandatory. One of the main strategies employed to improve participation rate consists of designing the informed consent forms based on patients’ feedback. This survey aims to explore the attitude of patients admitted in a Romanian tertiary cardiology center to take part in biomarker-based clinical trials. This is a descriptive, prospective and longitudinal single-center study. Participants will be recruited until the planned sample size will be reached (n=333). The patients will be interviewed based on a semi-structured questionnaire which includes four sections: demographics (7 items), personal medical history (7 items), attitudes (9 items) and trust (4 items). Descriptive statistics will be used to illustrate patients’ demographics, medical history, attitudes toward biomarker-based clinical trials and trust in medical researchers. Logistic regression models will be employed to assess relations between patients’ attitudes, trust, and different socio-demographic variables. Data analysis will offer answers to key questions addressed by this survey: What amount of and in what form should information be disclosed? Who should make the invitation to participate? The information gained will facilitate tailoring informed consent forms to suit the needs of patients with various demographic, social and educational backgrounds. Carol Davila University Press 2018 /pmc/articles/PMC6418342/ /pubmed/30894889 http://dx.doi.org/10.25122/jml-2018-0072 Text en ©Carol Davila University Press This article is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use and redistribution provided that the original author and source are credited. |
spellingShingle | Original Article Mihaela Micheu, Miruna Udrea, Oana-Maria Octavia Popa, Mihaela Rusu, Iulia Gheorghe-Fronea, Oana Scafa-Udriste, Alexandru Dorobantu, Maria The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology |
title | The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology |
title_full | The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology |
title_fullStr | The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology |
title_full_unstemmed | The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology |
title_short | The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials – Survey Methodology |
title_sort | attitude of patients from a romanian tertiary cardiology center as regards participation in biomarker-based clinical trials – survey methodology |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6418342/ https://www.ncbi.nlm.nih.gov/pubmed/30894889 http://dx.doi.org/10.25122/jml-2018-0072 |
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