All training was conducted in Japanese, including provision of training material (patient videos, didactic modules, quizzes) developed in or translated into Japanese.
Integrating Local Cultural Norms into Training Processes and Performance Expectations: The study Sponsor, which had a multi-year relationship with our scientific team, requested a program to address the challenges of conducting training and quality control in this region. Specifically, it was important that the study be conducted in a standardized way that would allow for the comparison of data produced in this trial with data sets produced elsewhere. On the other hand, it was equally important that the Japanese investigators be engaged in a meaningful way that was appropriate to their cultural context.
Engaging Local Experts: Our core scientific team, based in New York, worked closely with our Japan-based colleagues who are part of our network of experts. This approach accomplished three key objectives:
1. Ensuring that material created or customized for this program was congruent with the cultural context of the study and the clinical reality faced by the investigators; for example, that the patient simulations presented were likely to be, in fact, encountered by the raters in their practice.
2. Creating a forum for an interactive and meaningful discussion during the training events; anchoring live-training events with a distinguished local expert who gave a keynote address and then facilitated questions and answers. This enabled all raters to participate more actively than when the content is presented in English or simply translated by non-clinicians.
3. Respecting the experience and seniority of the principal investigators who were better able to relate to a trainer who was one of their peers.
Data collected was comparable to other sets and valid in the setting in which it was collected: Our post-study analysis showed high inter-rater agreement on all study measures, as well as very good agreement on measure subscales that have been shown to have low reliability in international settings. Overall quality of the data collected matched or exceeded data collected in the US on similar studies conducted by this Sponsor. A related benefit reported to us by the Sponsor was the improvement in investigator site motivation for active participation in the study.