Table 7 Representative quotations from the cognitive debriefing phase related to PROMIS SRI SF 8a (Sleep-Related Impairment) and PROMIS SD SF 8b (Sleep Disturbance)
US Participants | EU Participants | |
|---|---|---|
Overall assessments of the PROMIS scales | “They fit night sweats and menopause. I mean they are very good.” –Dallas-7 “They were easy to understand.” –Dallas-6 | “I really love [the] form[s], as it is clear. It is well-defined. It is comprehensible.” –France-6 “I did not find any great difficulty [recalling the past 7 days]. At first, you have to put yourself back into the situation and look back at the 7 past days. It simply requires a few seconds to remember.” –France-2 |
PROMIS response choices | “I really like [the response options] because it gives you quite a bit to choose from … you’re not limited to just ‘not at all’ and ‘very much’.” –Dallas-7 | “There are five possible answers and women can find themselves somewhere on that scale. I really liked that.” –France-6 |
Differentiating the two PROMIS scales | “They cover two different areas. The actual side of the sleeping quality of sleep [SF 8b] and then the consequences after a bad night [SF 8a].” –Dallas-1 | “I would say both [should be included in a trial] because that one [SF 8b] asks you about the sleep cycle, going to sleep, staying asleep, falling asleep, and that one [SF 8a] is how did you feel that day after it all happened.” –UK-2 |
PROMIS SRI SF 8a (Sleep-Related Impairment) | “Some things you don’t think about, you just move through it … so when you look at it on paper and I think about it … it’s kind of scary … that you’re functioning at a deficit almost.” –Chicago-7 | “For me, [PROMIS SRI SF 8a is] a fair reflection looking back on it, how [hot flashes and night sweats] affect me.” –UK-5 “Sometimes the link with hot flashes is not obvious. I was sleepy during the daytime. Everyone can get drowsy during the day, without it meaning that it is necessarily linked to the hot flashes.” –France-4 |
PROMIS SD SF 8b (Sleep Disturbance) | “It’s trouble staying asleep I put ‘often’ … that’s probably for me the most difficult thing.” –Chicago-2 “So you won’t have trouble falling asleep. It’s the maintaining of how you [sleep]…it’s the falling part that I have some reservations about because I can fall asleep. It’s just I’m losing the sleep with the flashes.” –Dallas-8 | “The questions were well targeted, so I was able to answer them without any problem.” –France-6 “Probably sleep was restless, trouble sleeping [would change the most with a treatment]. If I manage to just go back to sleep, I still feel okay, but if it has been a night where I have woken up a lot, and it has taken a while to go back to sleep, I have probably not had enough then, so I am still tired.” –UK-1 |