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The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.
Over time, clinical research has become a challenge both in terms of public health and in terms of scientific progress. Additionally, it has also become a financial challenge for institutions, especially in France where a significant part of their government funding is provided according to their ability to conduct quality clinical research. Pulmonology is a sector where clinical research is well established with strong incentives from several pharmaceutical companies and numerous academic research projects. Nevertheless, it is important to put the patient back at the centre of biomedical research.
A better knowledge of patient expectations, questions and misunderstandings would considerably improve treatment observance, clinical trial data quality, doctor-patient trust/relationship, and ultimately, the patient's health.
The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.
The secondary objectives are to determine:
Comparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol. Intervention: Questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | The Questionnaire is provided in the links at the end of the declaration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The PROTOACCEPT2 questionnaire. | day 0 (transversal study) |
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Inclusion Criteria:
Exclusion Criteria:
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The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud Bourdin, MD, PhD | University Hospitals of Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHM - Hôpital Nord | Marseille | 13915 | France | |||
| CHRU Montpellier - Hôpital Arnaud de Villeneuve |
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| Label | URL |
|---|---|
| PROTOACCEPT2 on the Open Science Framework (access to questionnaire) | View source |
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The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.
Data will be made available on a not-for-profit, free platform that allows access control: zenodo.
A link on osf.io/pxnhc will point towards the zenodo upload.
Individual datasets will be made available at time of submission.
The conditions under which members of the public will be granted access to the uploaded files are:
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Montpellier |
| 34295 |
| France |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |