Criteria Associated With Patient Willingness to Participate in Biomedical Research (PROTOACCEPT)

Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study

The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).

Study Overview

• Status: Completed
• Conditions: Consulting in Pneumology Department, But Not for Oncology or Tobacology

Detailed Description

The secondary objectives of this study are:

• To compare patient acceptance rates for participation in a clinical research protocol before and after January 15, 2016.
• To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) before January 15, 2016.
• To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) after January 15, 2016.
• To describe the patient population seen during pneumology consultations.
• To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by a pharmaceutical laboratory.
• To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by an academic institution.
• Construct clusters (homogeneous groups) of patients seen during the pneumology consultations.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Boujan-sur-Libron, France, 34760
    • Polyclinique Saint-Privat
  • Marignane, France, 13700
    • Clinique de Marignane
  • Marseille, France, 13915
    • Aphm - Hopital Nord
  • Montpellier, France, 34295
    • Centre Hospitalier Universitaire de Montpellier

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: Non-Probability Sample

Study Population

The target population corresponds to patients with respiratory disease. This study will be proposed to all patients consulting (excluding oncology and tobacco) in the associated departments.

Description

Inclusion Criteria:

• The patient was informed about the study.
• The patient is scheduled for a consult in the pneumology department

Exclusion Criteria:

• The patient is under judicial protection or is an adult under any kind of guardianship
• The patient expresses opposition to the study
• It is impossible to correctly inform the patient about the study
• The patient cannot fluently read French
• The patient is pregnant
• The patient is breastfeeding
• The patient has cancer
• The patient is consulting in tabaccology

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptation or refusal to participate in a biomedical research study	Positive or negative response to the question "If a biomedical research protocole were proposed to you, would you accept to participate?"	Day 0 (cross-sectional study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The PROTOACCEPT questionnaire	The PROTOACCEPT questionnaire (see links below).	Day 0 (cross-sectional study)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug 13;21(1):72. doi: 10.1186/s12910-020-00509-y.
• Molinari N, Suehs C, Vachier I, Pahus L, Halimi L, Gamez AS, Chanez P, Bourdin A. Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials. Clin Trials. 2019 Aug;16(4):440-442. doi: 10.1177/1740774519840268. Epub 2019 Mar 29. No abstract available.

Helpful Links

• The PROTOACCEPT patient questionnaire
• PROTOACCEPT on the Open Science Framework

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2014
• Primary Completion (Actual): December 13, 2016
• Study Completion (Actual): December 13, 2016

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 9373; 2014-A01201-46 (Other Identifier: RCB number)

Drug and device information, study documents

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