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Abstract' Content and GPs' Confidence in the Conclusion

NCT01679873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2013-12-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hotel Dieu Hospital

    lead OTHER

Principal Investigators

  • Celine Buffel du Vaure · Hotel Dieu Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01679873 on ClinicalTrials.gov