Assessment of sleep in patients with fibromyalgia: qualitative development of the fibromyalgia sleep diary

Table 4 FMSD support

Concept	Hypothesized domain	Support from literature review¹	Support from Expert interviews²	Support from focus groups³	FMSD Item	Support from cognitive interviews (n = 15)⁴
Difficulty falling asleep, initiating	Falling asleep	✓	✓	✓	How difficult was it to fall asleep last night?	15/15
Restless sleep	Staying asleep	✓	✓	✓	How restless was your sleep last night?	15/15
Discomfort; difficulty getting comfortable	Falling asleep	✓	✓	✓	How difficult was it to get comfortable last night?	15/15
Difficulty staying asleep, maintaining	Staying asleep	✓	✓	✓	How difficult was it to stay asleep last night?	14/14
Soundness of sleep	Staying asleep	✓	✓	✓	How deep was your sleep last night?	15/15
Waking up, unrested sleep	Feeling upon awakening	✓	✓	✓	How rested were you when you woke up for the day?	15/15
Difficulty awakening and arising	Feeling upon awakening	✓	✓	✓	How difficult was it to begin your day?	15/15
Quantity of sleep	Sufficient sleep	✓	✓	✓	Did you have enough sleep last night?	15/15

¹Identified as important in existing research.
²Concept was endorsed by experts during the therapeutic area expert interviews.
³Concept was endorsed by patients in the focus group discussions.
⁴Patients understood the item meaning, understood response scale, and were able to select a response.

ISSN: 1477-7525