1.
Crohn’s Life Impact Questionnaire (CLIQ)
Stephen McKenna & Jeanette Wilburn
Galen Research, Manchester
Karen Kemp & Simon Campbell
Manchester Royal Infirmary, CMFT

2.
Need for CLIQ
• No PROM available specific to CD
• No IBD PROM truly patient-based
• No IBD PROM employs modern psychometric
methods
• To allow impact of CD to be compared to that of
different diseases

3.
Requirements for CLIQ
• To have a coherent measurement model
• Derive content directly from patients through
unstructured qualitative interviews
• Unidimensional scale(s) providing valid total scores
• Reproducible and valid
• Short, simple to administer and score

4.
Needs-based QoL model
• Impact of disease related to inability to meet needs
rather than functional limitations
• Life gains its quality from the ability and capacity of
individuals to satisfy their needs
• QoL is a unidimensional construct - providing an
index rather than a profile

5.
Employment-related needs
Objective
Function Needs fulfilled

6.
Development
Project conducted by Galen Research and MRI.
Part-funded by CCUK who also provided some patients.
• 30 qualitative interviews with CD patients
• Thematic content analysis of transcripts
• 15 cognitive interviews to confirm face and content
validity
• Test-retest validation survey with 273 CD patients
• Identification of final scales
• 15 interviews to re-confirm face and content validity

7.
Results
• 27-item QoL scale identified
• QoL scale proved to be unidimensional
• Reproducible (test-retest correlations = 0.91)
• High correlation between CLIQ QoL scores and
fatigue (U-FIS), 0.79
• 2-3 minutes to complete

8.
Sample QoL items
There is not much fun in my life
I feel dependent on others
I rarely feel clean
I worry about having an accident
I only feel comfortable at home

9.
Scoring
QoL Scale
• “True” response scored 1, “Not true” scored 0
• Item scores summed to give total score
• High score indicates poor QoL

10.
25
20
15
10
5
0
Mean QoL
Self-perceived CD severity
Mild
Moderate
Severe
Very Severe
Validity: QoL scores by self-perceived CD
severity (p<.01)

11.
Rasch: Person-Item threshold distribution map

12.
Patient quotes
“If I had to explain to my doctors what I was going
through I’d take it [the CLIQ] with me… welcome to
my world!!”
“I feel like I wrote this questionnaire, I no longer feel
alone”

13.
Potential uses of CLIQ
• Routine clinical practice
• Clinical studies and trials
• Audit
• Economic analysis
• CLIQ adds to growing battery of nQoL measures
linked by co-calibration

14.
Dissemination
• Posters presented at:
• DDF (GUT)
• ISOQOL (Qual Life Res)
• ISPOR (Value Health)
• ECCO (J Crohns Colitis)
• BIG (GUT)
• BSG (GUT)
• “Assessing quality of life in Crohn's Disease: Development and
validation of the Crohn's Life Impact Questionnaire (CLIQ)” -
Manuscript submitted to GUT

15.
Future plans
• UC PROM
• Paediatric CD
• Paediatric UC
• Intestinal Failure
• CLIQ responsiveness study

16.
Contact details
Jeanette Wilburn
jwilburn@galen-research.com
Tel: 0161 226 4446