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Table 7 Results from cognitive interviews in the CD study (N = 12)

From: Development and content validation of patient-reported outcomes tools for ulcerative colitis and Crohn’s disease in adults with moderate-to-severe disease

PRO-CD Diary item

Easy to answer

Symptoms easy to recalla

Accurate interpretation of question

Relevanceb

 ≥ 3

Relevanceb

 = 5

Abdominal pain

11

12

12

11

9

 Rate your abdominal pain

Stool frequency

12

10

12

10

8

 Enter number of bowel movements passed

Liquid/very soft stool frequency

12

11

12

11

9

 Enter number of liquid or very soft stools

Rectal bleeding

12

11

12

8

8

 Enter number of bowel movements with blood

Rectal urgency

12

12

12

11

8

 Enter number of bowel movements with urgency

Worst abdominal pain

12

12

11

8c

7c

 Rate your worst abdominal pain

Nausea

11

12

12

7

6

 Rate your worst feeling of nausea

Vomiting

11

12

12

6d

6d

 Enter number of vomiting episodes

Bowel incontinence

12

12

10

7

6

 Enter number of incontinence episodes

General well-being

11

12

12

12

10

 Rate your general well-being

Worst rectal bleeding

11

12

12

8

6

 Rate your worst experience of rectal bleeding

  1. Data are number of participants
  2. CD, Crohn’s disease; PRO, patient-reported outcomes
  3. aRecollection of symptoms over the past 24 h
  4. bParticipants rated how relevant the items were on a 6-point scale (from 0 = not at all relevant to 5 = extremely relevant)
  5. cOnly 10 participants were asked about relevancy of this item
  6. dOnly 11 participants rated the relevancy of this item