Abstract' Content and GPs' Confidence in the Conclusion

NCT01679873 | Completed

• 1 other identifier: CBV-001-HD
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

The Study Will Focus on no Specific Conditions

Keywords

confidence; funding sources; conflicts of interests; general practitioner

Outcome Measures

Primary Outcomes (1)

• GPS' confidence on the conclusion of the abstract

  measure on a numeric scale frome 0 to 10 where 0 is "no confidence" and 10 is "full confidence"

  30 days

Secondary Outcomes (2)

• GPs' quality perception of the study

  30 days

• GPs' interpretation of the benefit of experimental treatment

  30 days

Study Arms (3)

Control group

PLACEBO COMPARATOR

Assess abstract not reporting funding sources or conflicts of interest

Other: Assess one type of abstract in the randomized arm

Funding sources

EXPERIMENTAL

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

Funding sources/Conflicts of Interests

EXPERIMENTAL

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

Interventions

Assess one type of abstract in the randomized arm OTHER

Participants will be asked to assess only one abstract in his arm of randomization. Three reminders will be made

Control group; Funding sources; Funding sources/Conflicts of Interests

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• General practitioners

You may not qualify if:

• no one

Sponsors & Collaborators

• Hotel Dieu Hospital: lead

Study Sites (1)

Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu

Paris, France, 75004, France

Location

Related Publications (1)

• Buffel du Vaure C, Boutron I, Perrodeau E, Ravaud P. Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners' confidence in conclusions, a three-arm randomized controlled trial. BMC Med. 2014 Apr 28;12:69. doi: 10.1186/1741-7015-12-69.

  PMID: 24779384 DERIVED

Study Officials

• Celine Buffel du Vaure

  Hotel Dieu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: September 6, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 23, 2013

Record last verified: 2013-12

Locations

FR (1)