Condition category
Signs and Symptoms
Date applied
18/12/2006
Date assigned
21/02/2007
Last edited
09/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.academie-medecine.fr/index.cfm

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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17479163

Publication citations

  1. 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.

Additional files

Editorial Notes