Table 1.
Demographic and clinical characteristics of study samples used to establish the content validity of the ESD and EIS
| Demographic and clinical characteristics | Concept Elicitation (n = 45) | Cognitive Debriefing (n = 31) |
|---|---|---|
| Age | ||
| Mean (Range) | 33.9 (18–44) | 36.3 (21–45) |
| Country n (%) | ||
| United States | 15 (33.3) | 19 (61.3) |
| Germany | 15 (33.3) | 12 (38.7) |
| France | 15 (33.3) | N/A |
| Ethnic Background n (%)a | ||
| Caucasian or White | 10 (66.7) | 8 (42.1) |
| African American | 3 (20.0) | 9 (47.4) |
| Other | 2 (13.3) | 2 (10.5) |
| Education Level n (%) | ||
| High school diploma or GED | 4 (8.9) | 3 (9.7) |
| Some years of college | 8 (17.8) | 5 (16.1) |
| Certificate program | 7 (15.6) | 9 (29.0) |
| College or University degree | 1 (2.2) | 10 (32.3) |
| Graduate or professional degree | 25 (55.6) | 4 (12.9) |
| Experience of pain at screening n (%)b | ||
| No pain (0) | 0 (0.0) | 1 (3.2)d |
| Mild (1–4) | 16 (35.6) | 9 (29.0)d |
| Moderate (5–6) | 14 (31.1) | 8 (25.8) |
| Severe (7–10) | 15 (33.3) | 13 (41.9) |
| Mean (range) | 5.8 (3–10) | 5.9 (0–10) |
| Current treatment n (%)c | ||
| Painkillers | 22 (48.9) | 19 (61.3) |
| Oral contraceptives | 13 (28.9) | 11 (35.5) |
| Other hormonal contraceptives | 3 (6.7) | 5 (16.1) |
| GnRH analogue | 4 (8.9) | 5 (16.1) |
| Progestin | 3 (6.7) | 1 (3.2) |
| Other | 3 (6.7) | 1 (3.2) |
aData not available for European sample; therefore, percentages calculated based on US sample only (concept elicitation: n = 15, cognitive debriefing: n = 19)
bSelf-rated assessment of endometriosis-associated pain at its worst in the last 24 h (using a 0–10 NRS where 0 = no pain and 10 = pain as bad as you can imagine). Classifications of pain based on Serlin et al. (1995) [40]
cCounts not mutually exclusive
dOf note: Two patients from the US sample had NRS scores < 3