Systematic ReviewILMARI2NCT01848782
Impact of Adding a Limitation Section in Abstract of Systematic Review
A study testing interpretation of the abstract of the systematic review in people with Systematic Review, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systematic Review
- What is being tested?
- interpretation of the abstract of the systematic review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- corresponding authors of clinical trail indexed in pubmed with email address available
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Systematic Review
- Being tested
- interpretation of the abstract of the systematic review
- Keywords
- abstract, meta-analysis, systematic review, interpretation, results, quality, bias, spin, limits, limitation, risk of bias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpretation of the abstract of the systematic reviewBehavioural
| Study group | Role | What they receive |
|---|---|---|
| abstract with limitation section added | Experimental | we add a limitation section in each selected abstract, the limitation section will focus on the quality of included studies. Receives: Behavioral: interpretation of the abstract of the systematic review |
| abstract without limitation section | Active comparator | 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. Receives: Behavioral: interpretation of the abstract of the systematic review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confidence in the Results of the Systematic Review
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 )
Measured: 1 month
Secondary outcomes (4)
Confidence With the Validity of the Conclusions
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
Measured: 1 month
Beneficial Effect of the Experimental Intervention
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
Measured: 1 month
Influence of Results on Clinical Practice
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
Measured: 1 month
The Rigor of the Systematic Review
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
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 posted8 May 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systematic ReviewStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amelie YAVCHITZ, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848782
- Sponsor's protocol ID
- RAV006
- Acronym
- ILMARI2
- Status last verified
- Apr 2013
- First submitted
- 3 May 2013
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Yavchitz A, Ravaud P, Hopewell S, Baron G, Boutron I. Impact of adding a limitations section to abstracts of systematic reviews on readers' interpretation: a randomized controlled trial. BMC Med Res Methodol. 2014 Nov 24;14:123. doi: 10.1186/1471-2288-14-123.
PubMed 25420433
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding a Limitation Section in Abstract of Systematic Review on Interpretation by Readers: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01848782
- Acronym / sponsor ID
- ILMARI2 / RAV006
- Conditions
- Systematic Review
- Keywords
- abstract, meta-analysis, systematic review, interpretation, results, quality, bias, spin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Posted 17 May 2024
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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abstract with limitation section added | Experimental | Behavioral: interpretation of the abstract of the systematic reviewwe add a limitation section in each selected abstract, the limitation section will focus on the quality of included studies. |
| abstract without limitation section | Active comparator | Behavioral: interpretation of the abstract of the systematic reviewWe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- corresponding authors of clinical trail indexed in pubmed with email address available
Key exclusion criteria (0 listed)
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 abstract of the systematic review | Behavioural | abstract with limitation section added, abstract without limitation section |
Primary outcome
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 )
4 secondary outcomes
Confidence With the Validity of the Conclusions
Time frame: 1 month
Beneficial Effect of the Experimental Intervention
Time frame: 1 month
Influence of Results on Clinical Practice
Time frame: 1 month
The Rigor of the Systematic Review
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25420433Yavchitz A, Ravaud P, Hopewell S, Baron G, Boutron I. Impact of adding a limitations section to abstracts of systematic reviews on readers' interpretation: a randomized controlled trial. BMC Med Res Methodol. 2014 Nov 24;14:123. doi: 10.1186/1471-2288-14-123.
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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.
Amelie YAVCHITZ, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interpretation of the abstract of the systematic review in people with Systematic Review, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 0 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: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of the Systematic Review (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848782, which also lists 1 linked publication.
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 17 May 2024.