Abstract' Content and GPs' Confidence in the Conclusion (ACOPI)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: Residents in Primary Care and General Practitioners (GP). They will be recruited among residents from the Primary Care department of the Paris Descartes University, members of the French Association of Young Researchers in General Practice (FayrGP), 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, on a secure website.
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. |
- 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"
- 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"
| Estimated Enrollment: | 350 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2012 |
| 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 |
Inclusion Criteria:
- General practitioners
- residents in General Practice
Exclusion Criteria:
- no one
Contacts and Locations| Contact: Celine Buffel du Vaure | celine.buffelduvaure@gmail.com | |
| Contact: Isabelle Boutron | isabelle.boutron@htd.aphp.fr |
| France | |
| Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu | Recruiting |
| Paris, France, 75004 | |
| Principal Investigator: Celine Buffel du Vaure | |
| Principal Investigator: Isabelle Boutron | |
| Sub-Investigator: Philippe Ravaud | |
| Sub-Investigator: Serge Gilberg | |
| Principal Investigator: | Celine Buffel du Vaure | Hotel Dieu Hospital |
More Information
No publications provided
| 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 13, 2012 |
| 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 May 16, 2013