Assessing patients’ satisfaction with anti-TNFα treatment in Crohn’s disease: qualitative steps of the development of a new questionnaire

Figures & data

Table 1 Patient characteristics: exploratory and comprehension test interviews

Patients’ characteristics	Exploratory interviews n = 13	Comprehension tests n = 12
Gender (N)
Male	4	7
Female	9	5
Age
Median (minimum-maximum) (years)	29 (21–74)	43 (25–62)
18–25 years (N)	4	1
26–40 years (N)	5	4
≥41 years (N)	4	7
Familial status (N)
Living with partner	13	8
Living alone	0	3
Widowed	0	1
Level of education (N)
General certificate of secondary education	3	5
A-levels	3	1
Undergraduate degree or national vocational qualification	1	4
Graduate degree or 4-year degree	6	2
Professional status (N)
Working full-time	7	5
Working part-time	2	3
Unemployed	0	1
Student	0	1
Housewife or househusband	2	0
Retired	2	2
Disease duration (years)
Median (minimum-maximum)	6 (3–24)	42 (6–21)
Anoperineal form (N)	6	5
Surgery related to Crohn’s disease (N)	5	6
Current treatment (N)
5-amino salicylic acid	2	1
Corticosteroids	3	3
Immunosuppressant agents	9	1
Anti-TNFα
Infliximab	8	4
Switch infliximab to adalimumab	5	6

Table 2 Pilot questionnaire version item content (concepts and detailed concepts measured by dimension)^a

Dimensions (no. items)	Item content
Efficacy (19 items)	Psychological well-being
	Physical well-being
	Speed of improvement
	Health state stabilization
	Overall well-being (2 items)
	Crohn’s attacks (4 items: frequency, intensity, efficacy, speed of efficacy)
	Diarrhea
	Abdominal pain
	Incontrollable need to defecate
	Anal pain
	Anal leakage
	Diet
	Protection against symptoms
	Protection against surgery
	Comparison to expectations
Side-effects (6 items)	Information
	Bother
	Worries
	Pregnancy
	Comparison to expectations
	Acceptability
Convenience and constraints (16 items)	Mode of administration (7 items): type, practical, constraining, unpleasant, reassuring, worrisome, easy
	Organization constraints (7 items): travel, medical appointments, time, costs, conservation, work, children
	Comparison to expectations
	Acceptability
Overall impact (8 items)	Impact on mood
	Impact on energy
	Impact on physical status
	Impact on emotions in relationships
	Impact on professional life
	Impact on family life
	Impact on social life
	Overall impact on life
Satisfaction (12 items)	Efficacy on Crohn’s attacks
	Side-effects
	Organization constraints
	Mood
	Energy
	Physical status
	Emotions in relationships
	Family life
	Professional life
	Social life
	Motivation to continue taking treatment
	Overall evaluation
Expectations (1 item)	Expectations toward new treatment

Notes:

a Item content presented in this table was translated into English, but did not follow a linguistic validation process at this stage.