Systematic Review With MetaanalysisILMARINCT01848600
Impact of a Limitation Section on the Meta-analysis Results' Interpretation
A study testing interpretation of the abstract in people with Systematic Review With Metaanalysis, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systematic Review With Metaanalysis
- What is being tested?
- interpretation of the abstract
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- updates of previously published systematic reviews,
- systematic review if diagnostic test accuracy, prognosis, epidemiologic, economics evaluation
- indirect comparison meta-analysis.
About this study
Official title: Impact of a Limitation Section on the Meta-analysis Results' Interpretation: a Randomized Controlled Trial
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.
Read more
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.
Read the 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:
- Abstract with " limitations " section
- 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
- How would you rate the quality of the systematic review?
- How confident are you in the results of this systematic review?
- Do you consider that the experimental treatment A is a proven effective treatment?
- 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.
- Conditions
- Systematic Review With Metaanalysis
- Being tested
- interpretation of the abstract
- Keywords
- limitation, quality, bias, meta-analysis, interpretation, abstract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpretation of the abstractBehavioural
the intervention consist to interpret the results of the meta-analysis after reading the abstract.
| Study group | Role | What they receive |
|---|---|---|
| abstract without limitation section | Experimental | the experimental arm is abstract without the limitation section Receives: Behavioral: interpretation of the abstract |
| abstract with limitation section | Other | the control arm is abstract with the original limitation section Receives: Behavioral: interpretation of the abstract |
What is being measured
The primary outcome is the main question the study is designed to answer.
confidence in the results
we ask participants: "how confident are you in the results of this systematic review?"
Measured: 1 month
Secondary outcomes (1)
interpretation of the quality of the systematic review
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?"
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systematic Review With MetaanalysisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amélie YAVCHITZ, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848600
- Sponsor's protocol ID
- RAV003
- Acronym
- ILMARI
- Status last verified
- Jan 2013
- First submitted
- 25 Feb 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Limitation Section on the Meta-analysis Results' Interpretation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01848600
- Acronym / sponsor ID
- ILMARI / RAV003
- Conditions
- Systematic Review With Metaanalysis
- Keywords
- limitation, quality, bias, meta-analysis, interpretation, abstract
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Abstract with " limitations " section
- 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
- How would you rate the quality of the systematic review?
- How confident are you in the results of this systematic review?
- Do you consider that the experimental treatment A is a proven effective treatment?
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abstract without limitation section | Experimental | Behavioral: interpretation of the abstractthe experimental arm is abstract without the limitation section |
| abstract with limitation section | Other | Behavioral: interpretation of the abstractthe control arm is abstract with the original limitation section |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- updates of previously published systematic reviews,
- systematic review if diagnostic test accuracy, prognosis, epidemiologic, economics evaluation
- indirect comparison meta-analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interpretation of the abstractthe intervention consist to interpret the results of the meta-analysis after reading the abstract. | Behavioural | abstract with limitation section, abstract without limitation section |
Primary outcome
confidence in the results
Time frame: 1 month
we ask participants: "how confident are you in the results of this systematic review?"
1 secondary outcome
interpretation of the quality of the systematic review
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amélie YAVCHITZ, MD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Questions about this trial
What is this clinical trial studying?
A study testing interpretation of the abstract in people with Systematic Review With Metaanalysis, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
confidence in the results (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.