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Crohn’s Life Impact Questionnaire (CLIQ) 
Stephen McKenna & Jeanette Wilburn 
Galen Research, Manchester 
Karen Kemp & Sim...
Need for CLIQ 
• No PROM available specific to CD 
• No IBD PROM truly patient-based 
• No IBD PROM employs modern psychom...
Requirements for CLIQ 
• To have a coherent measurement model 
• Derive content directly from patients through 
unstructur...
Needs-based QoL model 
• Impact of disease related to inability to meet needs 
rather than functional limitations 
• Life ...
Employment-related needs 
Objective 
Function Needs fulfilled
Development 
Project conducted by Galen Research and MRI. 
Part-funded by CCUK who also provided some patients. 
• 30 qual...
Results 
• 27-item QoL scale identified 
• QoL scale proved to be unidimensional 
• Reproducible (test-retest correlations...
Sample QoL items 
There is not much fun in my life 
I feel dependent on others 
I rarely feel clean 
I worry about having ...
Scoring 
QoL Scale 
• “True” response scored 1, “Not true” scored 0 
• Item scores summed to give total score 
• High scor...
25 
20 
15 
10 
5 
0 
Mean QoL 
Self-perceived CD severity 
Mild 
Moderate 
Severe 
Very Severe 
Validity: QoL scores by s...
Rasch: Person-Item threshold distribution map
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 
m...
Potential uses of CLIQ 
• Routine clinical practice 
• Clinical studies and trials 
• Audit 
• Economic analysis 
• CLIQ a...
Dissemination 
• Posters presented at: 
• DDF (GUT) 
• ISOQOL (Qual Life Res) 
• ISPOR (Value Health) 
• ECCO (J Crohns Co...
Future plans 
• UC PROM 
• Paediatric CD 
• Paediatric UC 
• Intestinal Failure 
• CLIQ responsiveness study
Contact details 
Jeanette Wilburn 
jwilburn@galen-research.com 
Tel: 0161 226 4446
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Crohn’s Life Impact Questionnaire (CLIQ)

This presentation details the development of the Crohn’s Life Impact Questionnaire (CLIQ), which is a patient reported outcome measure specific to Crohn's Disease.

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Crohn’s Life Impact Questionnaire (CLIQ)

  1. 1. Crohn’s Life Impact Questionnaire (CLIQ) Stephen McKenna & Jeanette Wilburn Galen Research, Manchester Karen Kemp & Simon Campbell Manchester Royal Infirmary, CMFT
  2. 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. 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. 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. 5. Employment-related needs Objective Function Needs fulfilled
  6. 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. 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. 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. 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. 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. 11. Rasch: Person-Item threshold distribution map
  12. 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. 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. 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. 15. Future plans • UC PROM • Paediatric CD • Paediatric UC • Intestinal Failure • CLIQ responsiveness study
  16. 16. Contact details Jeanette Wilburn jwilburn@galen-research.com Tel: 0161 226 4446

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