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Impact of a Limitation Section on the Meta-analysis Results' Interpretation (ILMARI)

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ClinicalTrials.gov Identifier: NCT01848600
Recruitment Status : Withdrawn (Lack of funding)
First Posted : May 7, 2013
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Objective: The investigators aim to evaluate the impact of a " limitations " section in systematic review's abstract on results' interpretation by readers.

Design: Randomized ratio 1:1 controlled trial with two parallel arms. Participants will be invited to participate in an online survey.

Participants: Eligible participants are corresponding authors of randomized controlled trial published between 2010 and 2012 and referenced in pubmed 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 published in the journal Annals of Internal Medicine between 2006 and 2011.

Selected abstract will be standardised and the treatment's name hidden. The two groups of abstract will be presented as follow: 1) abstract with " limitations " section and 2) abstract without " limitations " section: the " limitations " section of the original abstract will be deleted.

Selected participants are invited by e-mail to answer the survey. After reading one abstract from his group a randomization they are invited two answer 5 questions about their interpretation of the meta-analysis's results.


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

Detailed Description:

OBJECTIVE The aim of the study is to evaluate the impact of a " limitations " section in systematic review's abstract on results' interpretation by readers.

STUDY DESIGN The study is a randomized controlled trial with two parallel arms. The study follows the CONSORT 2010 statements Participant will be invited to participate in an on-line survey with a secured web site. Participants, after a characteristic description will be randomized in one of the two arms: 1) abstract with a " limitations " section 2) abstract without a " limitations " section.

ELIGIBILITY Eligible participants are corresponding authors of randomized trials published between 2010 and 2012 and referenced in pubmed core set journal

INTERVENTION We will evaluate the impact of the presence of a " limitations " section in abstract of systematic review with meta-analysis.

SELECTION OF ABSTRACTS We will retrieve all systematic review with meta-analysis published in the journals Annals of Internal Medicine between the years 2006 and 2012, about health care intervention with a conclusion in favor the experimental treatment or intervention. We exclude updates, diagnostical, genetical, epidemiological or economical evaluation and multiple or indirect comparisons.

MODIFICATION OF ABSTRACTS All selected abstracts will be standardised. Treatment name will be replaced with "experimental treatment A", control treatment will be replaced by "control treatment B" if necessary in the title and in the abstract.

The two groups of abstract will be presented as follow:

  1. Abstract with " limitations " section
  2. Abstract without " limitations " section: the " limitations " section of the original abstract will be deleted.

OUTCOMES PRIMARY OUTCOME The primary outcome will be, the readers' recommendation of the experimental treatment A

SECONDARY OUTCOMES Secondary outcomes will evaluate the interpretation of the results of the meta-analysis. The readers will answers the following questions, with the choice of answers based on a 10-point Likert scale

  1. How would you rate the quality of the systematic review?
  2. How confident are you in the results of this systematic review?
  3. Do you consider that the experimental treatment A is a proven effective treatment?
  4. How confident are you in the validity of the conclusion that the authors draw? NUMBER OF PARTICIPANT A power analysis was conducted to estimate the number of subject (participants) needed to achieve a power of 0.9 and an alpha value of 0.05 to discern a different of effect size of 0.4 between the two versions of abstract. This resulted in an estimate to the need of recruit a minimum of 133 participants in each arm, either a total of 266 participants STATISTICAL ANALYSIS We will analyze data with R project software, in intention to treat. Data for quantitative variables are expressed with medians and interquartile (IQR) ranges. Qualitative variables are expressed with frequencies and percentages and missing data Primary analysis will compare means of the primary outcome between the 2 groups with a Student t test.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Impact of a Limitation Section on the Meta-analysis Results' Interpretation: a Randomized Controlled Trial
Study Start Date : April 2013
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: abstract without limitation section
the experimental arm is abstract without the limitation section
Behavioral: interpretation of the abstract
the intervention consist to interpret the results of the meta-analysis after reading the abstract.

abstract with limitation section
the control arm is abstract with the original limitation section
Behavioral: interpretation of the abstract
the intervention consist to interpret the results of the meta-analysis after reading the abstract.




Primary Outcome Measures :
  1. confidence in the results [ Time Frame: 1 month ]
    we ask participants: "how confident are you in the results of this systematic review?"


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

    We ask participants:

    " how would you rate the quality of the systematic review?" "how confident are you in the validity of the conclusion of the systematic review?" "how confident are you that intervention A is more beneficial than comparative intervention?" "how confident are you that the results of this systematic review could be apply in clinical practice?"




Information from the National Library of Medicine

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

Inclusion Criteria:

  • abstract of meta-analysis published in the journal "Annals of Internal Medicine" between 2006 and 2012, about health care intervention with a conclusion in favour the experimental treatment

Exclusion Criteria:

  • updates of previously published systematic reviews,
  • systematic review if diagnostic test accuracy, prognosis, epidemiologic, economics evaluation
  • indirect comparison meta-analysis.

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): NCT01848600


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Amélie YAVCHITZ, MD Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01848600     History of Changes
Other Study ID Numbers: RAV003
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: January 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
limitation
quality
bias
meta-analysis
interpretation
abstract