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Abstract' Content and GPs' Confidence in the Conclusion (ACOPI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celine Buffel du Vaure, Hotel Dieu Hospital
ClinicalTrials.gov Identifier:
NCT01679873
First received: July 30, 2012
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

Objective: The aim of this study is to assess the impact of reporting, in abstracts of randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs) of the authors on General Practitioners' confidence in the abstracts' conclusions.

Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP). They will be recruited among residents from the Primary Care department of the Paris Descartes University and among a GP network who agreed to participate to research studies.

The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants will be blind of the hypothesis and of the randomization. Allocation concealment will be provided because only the statistician will have access to the randomization list.

Methods: Three interventions will be assessed corresponding to three different types of abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors, 2) abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs of authors.

A sample of abstracts will be selected from published randomized trials, testing superiority, assessing pharmacological treatment, in the field of Primary Care and General Practice and having a conclusion in favor of the beneficial effect of experimental treatment in terms of tolerance and / or efficacy. They will then be standardized and modified to obtain three types of abstracts: 1) with funding sources, 2) with funding sources and COIs and 3) without either source of funding or COIs.

Participants will be asked to assess one abstract of their randomization arm. Outcome: The primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be the quality perception of the study and the interpretation of the benefit of experimental treatment. Responses will be ranged by a 10-point numeric scale.

Potential interests: This study takes place in the field of Primary Care. We believe that better understandings of impact of funding sources and conflicts of interests are necessary to allow more transparency in medical research and in his translation into medical practice.

Sample size expected: 354 participants.


Condition Intervention
The Study Will Focus on no Specific Conditions
Other: Assess one type of abstract in the randomized arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Impact of Reporting Funding Sources and Conflicts of Interest in RCTs' Abstracts on General Practitioners' Confidence: a 3-arms Randomized Controlled Trial.

Further study details as provided by Hotel Dieu Hospital:

Primary Outcome Measures:
  • GPS' confidence on the conclusion of the abstract [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    measure on a numeric scale frome 0 to 10 where 0 is "no confidence" and 10 is "full confidence"


Secondary Outcome Measures:
  • GPs' quality perception of the study [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    measure on a numeric scale from 0 to 10 where 0 is "poor quality" and 10 is "excellent quality"

  • GPs' interpretation of the benefit of experimental treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    measure on a numéric scale from 0 to 10 wher 0 is "not beneficial" and 10 is "very beneficial"


Enrollment: 354
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
Assess abstract not reporting funding sources or conflicts of interest
Other: Assess one type of abstract in the randomized arm
Participants will be asked to assess only one abstract in his arm of randomization. Three reminders will be made
Experimental: Funding sources
Assess one type of abstract in the randomized arm. Assess abstract reporting funding sources only.
Other: Assess one type of abstract in the randomized arm
Participants will be asked to assess only one abstract in his arm of randomization. Three reminders will be made
Experimental: Funding sources/Conflicts of Interests
Assess one type of abstract in the randomized arm. Assess abstract reporting funding sources and conflicts of interest
Other: Assess one type of abstract in the randomized arm
Participants will be asked to assess only one abstract in his arm of randomization. Three reminders will be made

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General practitioners

Exclusion Criteria:

  • no one
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679873

Locations
France
Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu
Paris, France, 75004
Sponsors and Collaborators
Hotel Dieu Hospital
Investigators
Principal Investigator: Celine Buffel du Vaure Hotel Dieu Hospital
  More Information

No publications provided by Hotel Dieu Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celine Buffel du Vaure, Resident, Hotel Dieu Hospital
ClinicalTrials.gov Identifier: NCT01679873     History of Changes
Other Study ID Numbers: CBV-001-HD
Study First Received: July 30, 2012
Last Updated: December 20, 2013
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Hotel Dieu Hospital:
confidence
funding sources
conflicts of interests
general practitioner

ClinicalTrials.gov processed this record on November 20, 2014