The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions.
To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both randomised and non-randomised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting, internal validity (bias and confounding) and power, but also for external validity.
Design-A pilot version was first developed, based on epidemiological principles, reviews, and existing checklists for randomised studies.
Face and content validity were assessed by three experienced reviewers and reliability was determined using two raters assessing 10 randomised and 10 non-randomised studies.
Using different raters, the checklist was revised and tested for internal consistency (Kuder-Richardson 20), test-retest and inter-rater reliability (Spearman correlation coefficient and sign rank test ; K statistics), criterion validity, and respondent burden.
Main results-The performance of the checklist improved considerably after revision ofa pilot version.
The Quality Index had high internal consistency (KR-20 : 0.89) as did the subscales apart from external validity (KR-20 : 0.54).
Test-retest (r 0.88) and inter-rater (r 0.75) reliability of the Quality Index were good.
Reliability of the subscales varied from good (bias) to poor (external validity).
The Quality Index correlated highly with an existing, established instrument for assessing randomised studies (r 0.90). (...)
Mots-clés Pascal : Liste contrôle, Méthodologie, Qualité, Epidémiologie, Evaluation, Faisabilité, Randomisation, Etude en condition contrôlée
Mots-clés Pascal anglais : Checklist, Methodology, Quality, Epidemiology, Evaluation, Feasibility, Randomization, Controlled environment study
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0288591
Code Inist : 002B30A01A1. Création : 27/11/1998.