Impact of Adding a Limitation Section in Abstract of Systematic Review (ILMARI2)

May 13, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Adding a Limitation Section in Abstract of Systematic Review on Interpretation by Readers: a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • corresponding authors of clinical trail indexed in pubmed with email address available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (score from 0, not at all confident, to 10, very confident )
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confidence With the Validity of the Conclusions
Time Frame: 1 month

We ask participants:

- "How confident are you in the validity of the conclusions of this study?"

with the choice of answer based on a 10 points Likert scale from 0, not at all confident, to 10, very confident
1 month
Beneficial Effect of the Experimental Intervention
Time Frame: 1 month

We ask participants:

- "How confident are you that the intervention "A" could be of benefit to patients?"

with the choice of answer based on a 10 points Likert scale from 0, not at all confident, to 10, very confident
1 month
Influence of Results on Clinical Practice
Time Frame: 1 month

We ask participants:

"How confident are you that the results of this study could influence your clinical practice?" with the choice of answer based on a 10 points Likert scale from 0, not at all confident, to 10, very confident
1 month
The Rigor of the Systematic Review
Time Frame: 1 month

We ask participants:

"Do you think that this systematic review was conducted rigorously?" with the choice of answer based on a 10 points Likert scale from 0, not at all confident, to 10, very confident
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Amelie YAVCHITZ, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimated)

May 8, 2013

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RAV006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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