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Impact of Adding a Limitation Section in Abstract of Systematic Review (ILMARI 2)

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ClinicalTrials.gov Identifier: NCT01848782
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:

Objective: The investigators aim to evaluate the impact of a adding a " limitations " section in systematic review's abstract on result's interpretation by readers Design: randomized controlled trial with two parallel arms. Participants will be invited to participate in an online survey.

Participants: Eligible participants are corresponding authors of clinical trials published between 2010 and 2012 and referenced in Medline.

Intervention: The investigators will evaluate the impact of the presence of a " limitations " section in abstract of systematic review with meta- analysis. The investigators selected abstracts of meta-analysis from a sample.

Selected abstract will be standardised and the treatment's name hidden. Two groups of abstract will be presented as follow: 1) abstract without " limitations " section 2) abstract with " limitations " section. The " limitations " section will be written by authors and will briefly describe the risk of bias of included studies.

Selected participant are invited by e-mail to answer the survey. After reading one abstract from his/her group of randomisation they are invited to answer 5 questions about their interpretation of the results.


Condition or disease Intervention/treatment Phase
Systematic Review Behavioral: interpretation of the abstract of the systematic review Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Impact of Adding a Limitation Section in Abstract of Systematic Review on Interpretation by Readers: a Randomised Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: abstract with limitation section added
we add a limitation section in each selected abstract, the limitation section will focus on the quality of included studies.
 Behavioral: interpretation of the abstract of the systematic review
Active Comparator: abstract without limitation section
We selected 30 abstracts with a conclusion in favour the experimental treatment from a sample of systematic reviews that evaluate the effect of health care intervention.
 Behavioral: interpretation of the abstract of the systematic review


Outcome Measures
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Primary Outcome Measures :
  1. confidence in the results of the systematic review [ Time Frame: 1 month ]
    we ask participants: "how confident are you in the results of this study?", with the choice of answer based on a 10 points Likert scale


Secondary Outcome Measures :
  1. interpretation of the quality of the systematic review [ Time Frame: 1 month ]

    We ask participants:

    • "How confident are you in the validity of the conclusions of this study?"
    • "How confident are you that the intervention "A" could be of benefit to patients?"
    • "How confident are you that the results of this study could influence your clinical practice?"
    • "Do you think that this systematic review was conducted rigorously?"

    with the choice of answer based on a 10 points Likert scale



Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • corresponding authors of clinical trail indexed in pubmed with email address available
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01848782


Locations
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France
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Amelie YAVCHITZ, MD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01848782    
Other Study ID Numbers: RAV006
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: April 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
abstract
meta-analysis
systematic review
interpretation
results
quality
 bias
spin
limits
limitation
risk of bias