A novel approach to rater training and certification in multinational trials

Area of Science:

• Clinical Psychology
• Psychometric Assessment
• International Health Research

Background:

• International clinical trials face challenges in rater training due to language and cultural barriers.
• Effective rater calibration is crucial for maintaining study power and data integrity in global research.
• Poorly conducted interviews can significantly reduce the power of clinical studies.

Purpose of the Study:

• To evaluate the effectiveness of a two-step training and certification process for raters in multinational clinical trials.
• To assess improvements in both theoretical knowledge and applied clinical skills of raters.
• To validate a training model for enhancing rater performance across diverse linguistic and cultural settings.

Main Methods:

• A two-step certification process was implemented for 109 raters from 14 countries.
• Step 1 involved an online didactic tutorial on scoring conventions for the Hamilton Depression and Anxiety Rating Scales.
• Step 2 included applied clinical training in small, language-specific groups with expert observation and feedback, utilizing translators when necessary.

Main Results:

• Raters showed significant improvement in knowledge of scoring conventions, with test scores increasing from 14.59 to 17.83 (P<0.0001).
• Applied clinical skills significantly improved, as evidenced by an increase in the Rater Applied Performance Scale scores from 10.25 to 11.31 (P=0.003).
• The training model demonstrated efficacy in enhancing both knowledge and practical application of rating scales.

Conclusions:

• The applied training model is effective in improving raters' applied clinical skills in multinational trials.
• This training approach addresses language and cultural differences, crucial for global study success.
• Enhanced rater performance contributes to more reliable and powerful clinical trial outcomes.