199
Participants
Start Date
January 29, 2018
Primary Completion Date
May 29, 2020
Study Completion Date
May 29, 2020
Focus group interview
Focus group interviews will take place to discuss the key domains of COPD exacerbation which then will be used in the formation of the draft item set.
Draft item set
Items that form the draft item set will be subject to cognitive debriefing. Questions in the draft item set will collect information on whether the subjects with COPD have experienced that item during an exacerbation. Changes in this draft set will result in the formation of candidate item set.
Candidate item set
Item reduction will be done using candidate item set and the subjects will be asked to respond to the candidate items on a 4-point scale in terms of how that item changed with the onset of the last episode. Item reduction will take into account frequency and magnitude of items, floor and ceiling items and consistency between regions. The candidate item set will then be used for generation of CERT.
GSK Investigational Site, Chongqing
GSK Investigational Site, Hangzhou
GSK Investigational Site, Shenyang
Lead Sponsor
GlaxoSmithKline
INDUSTRY