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[Performance evaluation of a tool for institutional protocol quality assurance].

BACKGROUND
Few data are available on the quality of the protocols promoted by the University Hospital Centers (CHU) in France, and there is no standardised method for evaluating protocol quality. The Clinical Research Centre (CIC) of Nancy developed a checklist-based tool aimed at evaluating the quality of institutional protocols.


OBJECTIVE
The objective of this study was to evaluate the performance of this tool for assessing the quality of the protocols promoted by the CHU.


METHODS
A prospective parallel-group study design, controlled with cluster randomisation, was used. The checklist was applied within the Directions of Clinical Research (DRC) for 4 months. Sixty four protocols were analysed.


RESULTS
Before intervention there was no significant difference in quality scores between the two groups. Compared with baseline, there was a significant improvement of the methodological and regulation median score (81.7 +/- 13.7 vs 90.4 +/- 9.2) only in the intervention group (p = 0.040). Changes in the two groups over time were not significantly different from each other using analysis of variance (p = 0.501).


CONCLUSION
In an observation limited to 12 CHU in France, the quality of the promoted protocols was judged as suboptimal and able to be improved. Initiation of quality assurance tools, such as the one used in this study, was associated with some spontaneous improvement, but did not improve the result significantly.