- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01848600
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.
연구 개요
상세 설명
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.
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
다른: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
confidence in the results
기간: 1 month
|
we ask participants: "how confident are you in the results of this systematic review?"
|
1 month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
interpretation of the quality of the systematic review
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Amélie YAVCHITZ, MD, Institut National de la Santé Et de la Recherche Médicale, France
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
interpretation of the abstract에 대한 임상 시험
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