Why carry out this study?

Participants in the LUMINA-1 trial confirmed the importance of symptoms measured by the Flares Diary (pain, swelling, redness, warmth, stiffness, decreased movement, and heterotopic ossification because of a flare-up) and found the items relevant to their personal experience with flare-ups.

This study aimed to investigate the content validity of the Flares Diary by gaining an in-depth understanding of the experience of FOP flare-ups in people with FOP and by debriefing the Flares Diary to assess the relevance, comprehensiveness, and understandability of the instrument.

What was learned from the study?

Participants were able to understand the Flares Diary and found the items all-encompassing.

This study (1) provides important insights into the burden of FOP symptoms and their impacts on daily living and (2) supports the use of the Flares Diary as an instrument for capturing symptoms and treatment effects experienced by people with FOP.