Introduction/Objective: The overall conclusions of a review often appear to depend on the quality of both the individual RCTs and the review process. Most systematic reviews rely substantially on the assessment of the methodological quality of the individual trials. The aim of this study is to obtain consensus among experts about a criteria list for quality assessment of randomized clinical trials. Consensus studies are typically designed to combine the knowledge and experience of experts with the limited amount of available evidence.

Methods: The invited participants were experts in the field of quality assessment of RCTs. The initial item pool contained all items from existing criteria lists. Subsequently we reduced the number of items by using the Delphi consensus technique. Each Delphi round comprised a questionnaire, analysis and feedback report. The responses of the participants remain anonymous. The feedback report included staff team decisions made on the basis of the analysis and their justification.

Results/Discussion: A total of 33 experts participated of whom 21 completed all questionnaires. The initial item pool of 206 items was reduced to nine items in three Delphi rounds. The resulting Delphi list and several aspects of the procedure will be presented at the congress.