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 |
| Protocol serial number | N/A |
| Sponsor | National Academy of Medicine (Académie Nationale de Médecine) (France) |
| Funder | This work was supported by a grant from the National Academy of Medicine (Académie Nationale de Médecine) (France). |
- 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
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial comparing two groups of participants |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CILS |
| Study objectives | 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(s) | No ethical approval required as no patients were tested for this trial. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 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. |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 78 |
| Key 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) |
| Key exclusion criteria | Participants not completing inclusion criterias |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- France
Study participating centre
Département d'Epidémiologie Biostatistique et Recherche Clinique
Paris
75018
France
75018
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
