Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review.

BACKGROUND: Working with patients through meaningful patient engagement (PE) and incorporating patient experience data (PXD) is increasingly important in medicines and medical device development. However, PE in the planning, organization, generation, and interpretation of PXD within regulatory and health technology assessment (HTA) decision-making processes remains challenging. We conducted a global review of the PE and PXD landscape to identify evolving resources by geography to support and highlight the potential of integration of PE and PXD in regulatory assessment and HTA. METHODS: A review of literature/public information was conducted (August 2021-January 2023), led by a multistakeholder group comprising those with lived or professional experience of PE and PXD, to identify relevant regulatory and HTA initiatives and resources reviewed and categorized by geography and focus area. RESULTS: Overall, 53 relevant initiatives/resources were identified (global, 14; North America, 11; Europe, 11; Asia, nine; UK, six; Latin America, one; Africa, one). Most focused either on PE (49%) or PXD (28%); few (11%) mentioned both PE and PXD (as largely separate activities) or demonstrated an integration of PE and PXD (11%). CONCLUSIONS: Our analysis demonstrates increasing interest in PE, PXD, and guidance on their use individually in decision-making. However, more work is needed to offer guidance on maximizing the value of patient input into decisions by combining both PE and PXD into regulatory and HTA processes; the necessity of integrating PE in the design and interpretation of PXD programs should be highlighted. A co-created framework to achieve this integration is part of a future project.

International Medical Graduates in Nephrology: A Guide for Trainees and Programs.

A significant portion of the nephrology workforce has traditionally consisted of non-United States (US) citizen international medical graduates and international research trainees. Although international medical graduates are offered opportunities for training and professional growth that are beyond those available in their countries of origin, they typically encounter barriers to transition from training to practice and early-stage career development. In this article, we describe the exchange visitor and temporary worker visas granted to foreign trainees in the United States, focusing on the transition from training to nephrology practice and/or research. While we provide general recommendations on how to navigate this tedious and unpredictable process for both programs and trainees, consultation with immigration attorneys is indispensable for a successful outcome. Trainees are therefore encouraged to seek continuous support from their programs/sponsors and assistance from immigration representatives at their training institutions. We provide a positive message to emphasize that there are many pathways to arrive at the desired post-training destination.