Introduction and background
Stage 1 Literature review
Rationale
Methods
Results
Stage 2 - Interviews with therapeutic area experts
Rationale
Methods
Results
Stage 3 - Focus groups
Rationale
Methods
Inclusion/exclusion criteria for the focus groups
Procedures
Analytic approach
Concept of Sleep Disturbance | FG 1 (n = 9) | FG 2 (n = 8) | FG 3 (n = 8) | FG 4 (n = 5) | FG 5 (n = 4) |
---|---|---|---|---|---|
Trouble falling asleep
| X | X | X | X | X |
Wake after sleep onset
| X | X | X | X | X |
Tossing and turning
| X | X | X | X | X |
Waking up due to discomfort
| X | X | X | X | X |
Restfulness of sleep
| X | X | X | X | X |
Trouble staying asleep
| X | X | X | X | |
Unrested
| X | X | X | X | |
Never fully asleep
| X | X | X | ||
Time to fall asleep
| X | X | X | ||
Length of sleep
| X | X | X | ||
Cyclical sleep
| X | X | X | ||
Level of Energy
| X | X | X | ||
Unrefreshed
| X | X |
Results
Demographic characteristics - mean (SD); Range | Focus group (n = 34) | Cognitive interview (n = 15) |
---|---|---|
Age (years) | 47.8 (11.9); 22-70 | 51.4 (10.1); 27-64 |
Gender (n, % female) | 30 (88.2%) | 14 (93.3%) |
Ethnicity (n, % Hispanic or Latino) | 8 (23.5%) | 0 (0%) |
Race* (n, %) | ||
White | 25 (73.5%) | 11 (73.3%) |
Black or African American | 1 (2.9%) | 3 (20.0%) |
Asian | 2 (5.8%) | 1 (6.7%) |
Native Hawaiian or other Pacific Islander | 4 (11.7%) | 0 (0%) |
American Indian or Alaska Native | 1 (2.9%) | 0 (0%) |
Other1 | 6 (17.6%) | 0 (0%) |
Employment Status* (n, %)
| ||
Employed, full-time | 7 (20.5%) | 4 (26.7%) |
Employed, part-time | 9 (26.4%) | 1 (6.7%) |
Homemaker | 2 (5.8%) | 1 (6.7) |
Student2 | 1 (2.9%) | 0 (0%) |
Unemployed | 7 (20.5%) | 3 (20.0%) |
Retired | 3 (8.8%) | 2 (13.3%) |
Disabled | 9 (26.4%) | 6 (40.0%) |
Other2 | 2 (2.8%) | 0 (0%) |
Unemployed or Disabled due to Fibromyalgia (n, %)
| ||
Yes3 | 10 (62.5) | 7 (77.8%) |
No4 | 6 (37.5%) | 2 (22.2%) |
Sleep characteristic - mean (SD); range | Focus group (n = 34) | Cognitive interview (n = 15) |
---|---|---|
Sleep disturbance in the past week
| 6.4 (1.9); | 7.4 (1.4); |
(“0 “no sleep disturbance” to 10 “worst possible”) | (1, 10) | (6, 10) |
Pain in the past week
| 6.9 (1.8); | 7.3 (1.7); |
(“0” no pain to “10” worst possible pain) | (2, 10) | (3, 10) |
Tiredness in the past week
| 7.4 (1.8); | 7.6 (1.7); |
(0”not tired to “10” extremely tired) | (2, 10) | (4, 10) |
Time taken to fall asleep last night (in minutes)
| 74.5 (69.4); | 118.7 (147.4); |
(5, 240) | (5, 600) | |
Time spent sleeping last night (in minutes)
| 324.0 (76.8); | 224 (122.7); |
(180, 510) | (0, 510) | |
Number of times awoken last night, (mean, sd)
| 2.5 (1.5); | 3.3 (2.1); |
(0, 5) | (0, 6) | |
Time spent awake after falling asleep last night (in minutes)
| 71.4 (166.2); | 154 (127.9); |
(0, 960) | (0, 390) | |
Quality of sleep
| 5.1 (2.3); | 2.7 (2.3); |
(“0” very poor to “10” excellent) | (0, 10) | (0, 6) |
Stage 4: Conceptual framework and instrument development
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 |