Impact of a Limitation Section on the Meta-analysis Results' Interpretation (ILMARI)
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.
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.
調査の概要
詳細な説明
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.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:abstract without limitation section
the experimental arm is abstract without the limitation section
|
the intervention consist to interpret the results of the meta-analysis after reading the abstract.
|
他の:abstract with limitation section
the control arm is abstract with the original limitation section
|
the intervention consist to interpret the results of the meta-analysis after reading the abstract.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
confidence in the results
時間枠:1 month
|
we ask participants: "how confident are you in the results of this systematic review?"
|
1 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
interpretation of the quality of the systematic review
時間枠: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?" |
1 month
|
協力者と研究者
捜査官
- 主任研究者:Amélie YAVCHITZ, MD、Institut National de la Santé Et de la Recherche Médicale, France
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
interpretation of the abstractの臨床試験
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