Development and evaluation of a pedagogical tool to improve the understanding of a quality checklist: a randomised controlled trial

ISRCTN ISRCTN07698599
DOI https://doi.org/10.1186/ISRCTN07698599
Secondary identifying numbers N/A
Submission date
18/12/2006
Registration date
21/02/2007
Last edited
09/05/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Isabelle Boutron
Scientific

Département d'Epidémiologie Biostatistique et Recherche Clinique
INSERM U738
Groupe Hospitalier Bichat-Claude Bernard
46 rue Henri Huchard
Paris
75018
France

Email isabelle.boutron@bch.ap-hop-paris.fr

Study information

Study designRandomised controlled trial comparing two groups of participants
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeDiagnostic
Scientific title
Study acronymCILS
Study objectivesAssessing 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(s)No ethical approval required as no patients were tested for this trial.
Health condition(s) or problem(s) studiedImproving the understanding of a quality checklist
InterventionWe 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 typeOther
Primary outcome measureThe 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 measuresSecondary 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 study start date01/04/2006
Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants78
Key inclusion criteriaMembers 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)
Key exclusion criteriaParticipants not completing inclusion criterias
Date of first enrolment01/04/2006
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • France

Study participating centre

Département d'Epidémiologie Biostatistique et Recherche Clinique
Paris
75018
France

Sponsor information

National Academy of Medicine (Académie Nationale de Médecine) (France)
Research organisation

16 rue Bonaparte
Paris
75272
France

Website http://www.academie-medecine.fr/index.cfm
ROR logo "ROR" https://ror.org/01b266018

Funders

Funder type

Research organisation

This work was supported by a grant from the National Academy of Medicine (Académie Nationale de Médecine) (France).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 04/05/2007 Yes No