Qualification from FDA for the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD)
The Adelphi Values Patient-Centered Outcomes team are proud to share the news that the FDA have qualified the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) as measures of the core symptoms of asthma in adults and adolescents. The FDA have highlighted that “these instruments have demonstrated adequate evidence of content validity and cross-sectional measurement properties”. Working closely with the Critical Path Institute’s (C-Path’s) Patient-Reported Outcome (PRO) Consortium (including 10 different pharmaceutical sponsors) and a number of expert clinicians, the Adelphi Values PCO team (led by Adam Gater) were involved in every step of the development, content validity testing and initial evaluation of measurement properties for the ADSD and ANSD which have supported this qualification. Congratulations to everybody that has been involved in this process and contributed to such a successful outcome. Further details are posted on the FDA website and the C-Path website.