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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...

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Autores principales: Mihaela Micheu, Miruna, Udrea, Oana-Maria, Octavia Popa, Mihaela, Rusu, Iulia, Gheorghe-Fronea, Oana, Scafa-Udriste, Alexandru, Dorobantu, Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Carol Davila University Press 2018
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.
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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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