Table 1.

Main considerations from the discussion group reports.

In relation to instruments
  Patients should know why they are completing an instrument — but this may present challenges in avoiding bias
  Recognize the importance of use within the population in which it was developed
  Trial instruments in appropriate normative populations
  Do not reinvent the wheel, but there are gaps in the literature, and new questionnaires need to be developed on occasions
  Instrument use in clinical trials should be as close as possible to routine clinical practice to enhance the ability to transfer findings to routine practice
  Personalized instruments may help with personalized medicine
  Instruments have to be understood by the responders
In relation to developmental methods
  Nominal group techniques need expert facilitators (for trust, confidentiality, and inclusion)
  Standards for facilitators exist and should be applied
  Patient partner involvement in nominal groups is feasible, important, and valuable
  Patient partner involvement helps with preparations for and running groups; seeding statements; recruitment
  Patients raising issues makes clinicians/researchers think more widely in clinical practice
  Translation of instruments in culture and language requires both forward and backward translation and cultural adaptation
  International collaboration at an early stage; avoid unnecessary duplication
  Reduce responder burden
  Mixed methods approaches are critical (i.e., both qualitative and quantitative approaches). Suggested that international collaborative research begin early in concept, domain analysis, and ultimate item bank generation for instrument development in order to optimize recourses, i.e., financial, time, effort, outputs