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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interpretation of the abstract of the systematic review | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Beneficial Effect of the Experimental Intervention |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amelie YAVCHITZ, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25420433 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. interpretation of the abstract of the systematic review |
| FG001 | 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. interpretation of the abstract of the systematic review |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. interpretation of the abstract of the systematic review |
| BG001 | Abstract Without Limitation Section |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 ) | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. interpretation of the abstract of the systematic review |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Boutron | Assistance publique hopitaux de paris | +33 1 42 34 78 33 | isabelle.boutron@htd.aphp.fr |
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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 | 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 | 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 |
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. interpretation of the abstract of the systematic review |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Education qualification | Count of Participants | Participants |
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| Clinical experience | Count of Participants | Participants |
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| Reading reports of systematic reviews | Count of Participants | Participants |
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| No. of randomized trials involved in | Count of Participants | Participants |
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| Authored at least one systematic review | Count of Participants | Participants |
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| No. of systematic reviews peer-reviewed | Count of Participants | Participants |
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| Training in clinical epidemiology | Count of Participants | Participants |
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| Training in methods of randomized trials | Count of Participants | Participants |
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
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|
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
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|
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
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|
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | 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. interpretation of the abstract of the systematic review | 0 | 150 | 0 | 150 | 0 | 150 |
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