Stephen McKenna & Jeanette Wilburn

Galen Research, Manchester

Karen Kemp & Simon Campbell

Manchester Royal Infirmary, CMFT

Crohn’s Life Impact Questionnaire (CLIQ)

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

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

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

Objective

Employment-related needs

Function Needs fulfilled

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

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

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

Scoring

QoL Scale

• “True” response scored 1, “Not true” scored 0

• Item scores summed to give total score

• High score indicates poor QoL

0

5

10

15

20

25

Me

an Q

oL

Self-perceived CD severity

Mild

Moderate

Severe

Very Severe

Validity: QoL scores by self-perceived CD severity (p<.01)

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

my world!!”

“I feel like I wrote this questionnaire, I no longer feel

alone”

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

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

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