• Saskia M Tuijn, Huub van den Bergh, Paul Robben, and Frans Janssens.
• O&I, IGZ, Utrecht, The Netherlands.
• J Eval Clin Pract. 2014 Aug 1; 20 (4): 352361352-61.

Rationale, Aims And ObjectivesWe examined the effect of two interventions on both the reliability and validity of regulatory judgments: adjusting the regulatory instrument and attending a consensus meeting.MethodWe adjusted the regulatory instrument. With a randomized controlled trial (RCT) we examined the effect of the adjustments we made to the instrument. In the consensus meeting inspectors discussed cases and had to reach consensus about the order of the cases. We used a before and after case study to assess the effect of the consensus meeting. We compared the judgments assigned in the RCT with the unadjusted instrument with the judgments assigned with the unadjusted instrument after the consensus meeting. Moreover we explored the effect of increasing the number of inspectors per regulatory visit based on the estimates of the two interventions.ResultsThe consensus meeting improved the agreement between inspectors; the variance between inspectors was smallest (0.03) and the reliability coefficient was highest (0.59). Validity is assessed by examining the relation between the assigned judgments and the corporate standard and expressed by a correlation coefficient. This coefficient was highest after the consensus meeting (0.48). Adjustment of the instrument did not increase reliability and validity coefficients.ConclusionsParticipating in a consensus meeting improved reliability and validity. Increasing the number of inspectors resulted in both higher reliability and validity values. Organizing consensus meetings and increasing the number of inspectors per regulatory visit seem to be valuable interventions for improving regulatory judgments.© 2014 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

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