Abstract' Content and GPs' Confidence in the Conclusion (ACOPI)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01679873 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Last Update Posted : December 23, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
The Study Will Focus on no Specific Conditions | Other: Assess one type of abstract in the randomized arm | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 354 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
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. |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
---|---|
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 |
- GPS' confidence on the conclusion of the abstract [ Time Frame: 30 days ]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 ]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 ]measure on a numéric scale from 0 to 10 wher 0 is "not beneficial" and 10 is "very beneficial"

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- General practitioners
Exclusion Criteria:
- no one

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679873
France | |
Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu | |
Paris, France, 75004 |
Principal Investigator: | Celine Buffel du Vaure | Hotel Dieu Hospital |
Responsible Party: | Celine Buffel du Vaure, Resident, Hotel Dieu Hospital |
ClinicalTrials.gov Identifier: | NCT01679873 |
Other Study ID Numbers: |
CBV-001-HD |
First Posted: | September 6, 2012 Key Record Dates |
Last Update Posted: | December 23, 2013 |
Last Verified: | December 2013 |
confidence funding sources conflicts of interests general practitioner |