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Table 1 Demographic and clinical characteristics of study samples used to establish the content validity of the ESD and EIS

From: Development and content validation of two new patient-reported outcome measures for endometriosis: the Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (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)
  1. aData not available for European sample; therefore, percentages calculated based on US sample only (concept elicitation: n = 15, cognitive debriefing: n = 19)
  2. 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]
  3. cCounts not mutually exclusive
  4. dOf note: Two patients from the US sample had NRS scores < 3