How Participants Perceive Biomedical Research in Pulmonology (PROTOACCEPT2)

The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

Study Overview

• Status: Completed
• Conditions: Biomedical Research
• Intervention / Treatment: Other: Questionnaire

Detailed Description

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:

• how biomedical research is experienced / felt;
• if the information delivered to the patient (orally - information note) is clearly perceived.

Comparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13915
    • APHM - Hôpital Nord
  • Montpellier, France, 34295
    • CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.

Description

Inclusion Criteria:

• The patient presents with at least one of the following: (1) asthma, (2) chronic obstructive pulmonary disease, (3) bronchiectasis, (4) idiopathic pulmonary fibrosis, (5) pulmonary arterial hypertension, (6) sleep apnoea syndrome
• The patient is participating in a biomedical research protocol.

Exclusion Criteria:

• Patient under 18 years of age
• Patient judged incapable of filling out the questionnaire for linguistic or other reasons.
• The patient has already participated in the present study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The study population; The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol. Intervention: Questionnaire	Other: Questionnaire; The Questionnaire is provided in the links at the end of the declaration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The PROTOACCEPT2 questionnaire.	day 0 (transversal study)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Arnaud Bourdin, MD, PhD, University Hospitals of Montpellier

Publications and helpful links

Helpful Links

• PROTOACCEPT2 on the Open Science Framework (access to questionnaire)

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (ACTUAL): January 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Participation; Patient willingness
• Other Study ID Numbers: RECHMPL17_0447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Individual datasets will be made available at time of submission.

IPD Sharing Access Criteria

The conditions under which members of the public will be granted access to the uploaded files are:

• The user does not work for a private insurance company;
• The data will be used/examined in a not-for-profit manner;
• The data will not be used in an attempt to identify a patient or group of patients;
• The data will not be used in support of any kind of private insurance policy or health penalties;
• The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights;
• The user will state why they wish to access the data.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No