Contact information
Type
Scientific
Primary contact
Dr Isabelle Boutron
ORCID ID
Contact details
Département d'Epidémiologie Biostatistique et Recherche Clinique
INSERM U738
Groupe Hospitalier Bichat-Claude Bernard
46 rue Henri Huchard
Paris
75018
France
isabelle.boutron@bch.ap-hop-paris.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CILS
Study hypothesis
Assessing the quality of reports of Randomised Controlled Trials (RCTs) is particularly important for clinicians critical appraisal of the healthcare literature and for systematic reviewers. In fact, evidence suggests that inadequate reporting is associated with biased treatment effect estimates. Quality assessment is often achieved by use of checklists or scales. In the field of Non Pharmacological Treatment (NPT), a checklist - the checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) - was developed to assess the quality of RCTs included in meta-analysis. However, reproducibility issues have been raised because these checklists use items inconsistently defined and not well understood by reviewers such as blinding, dropout and withdrawals or an intention-to-treat analysis. To improve the understanding of the CLEAR NPT, we developed an Internet-based Computer Learning System (ICLS). To evaluate the impact of the ICLS on proper coding with the CLEAR NPT, we carried out an RCT comparing ICLS to no specific training.
The aim of this study was to develop and evaluate a pedagogical tool to enhance the understanding of a checklist that evaluates reports of Non Pharmacological Trials (CLEAR NPT).
Ethics approval
No ethical approval required as no patients were tested for this trial.
Study design
Randomised controlled trial comparing two groups of participants
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Condition
Improving the understanding of a quality checklist
Intervention
We developed an Internet-based Computer Learning System (ICLS). This pedagogical tool used many examples from published randomised controlled trials to demonstrate the main coding difficulties encountered when using this checklist.
Randomised participants received either a specific web-based training with the ICLS (intervention group) or no specific training.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome was the rate of correct answers compared to a criterion standard for coding a report of randomised controlled trials with the CLEAR NPT.
Secondary outcome measures
Secondary outcomes were the rate of correct answers for each item and a qualitative assessment of the ICLS by the survey participants completed after fulfilling the training program.
Overall trial start date
01/04/2006
Overall trial end date
01/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Members from three different categories of participants were invited by e-mail to participate in the randomised controlled trial:
1. Members of Health Technology Assessment international (HTAi) (n = 430)
2. Directors of Evidence-based Practice Centers (EPC) (n = 13) who develop systematic reviews and technology assessments on topics relevant to clinical, social science/behavioural, economic, and other healthcare organisation and delivery issues
3. Corresponding authors of meta-analyses of NPT published between 1st January 2004, and 3rd March 2006 (n = 100)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
78
Participant exclusion criteria
Participants not completing inclusion criterias
Recruitment start date
01/04/2006
Recruitment end date
01/07/2006
Locations
Countries of recruitment
France
Trial participating centre
Département d'Epidémiologie Biostatistique et Recherche Clinique
Paris
75018
France
Sponsor information
Organisation
National Academy of Medicine (Académie Nationale de Médecine) (France)
Sponsor details
16 rue Bonaparte
Paris
75272
France
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
This work was supported by a grant from the National Academy of Medicine (Académie Nationale de Médecine) (France).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Results
Fourcade L, Boutron I, Moher D, Ronceray L, Baron G, Ravaud P, Development and evaluation of a pedagogical tool to improve understanding of a quality checklist: a randomised controlled trial., PLoS Clin Trials, 2007, 2, 5, e22, doi: 10.1371/journal.pctr.0020022.