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P091. Development of a patient-reported outcome measure for Crohn's disease

J. Wilburn1, S.P. McKenna1, J. Twiss1, M. Ben-L'amri1, K. Kemp2, S. Campbell2, 1Galen Research Ltd, Manchester Science Park, Manchester, United Kingdom, 2Central Manchester University Hospitals NHS Foundation Trust, Gastroenterology, Manchester, United Kingdom

Background

Research into Crohn's Disease (CD) has relied on dated generic measures that miss impacts of the disease important to the patient and that have proved unhelpful in clinical studies. The current study is designed to develop the first CD-specific Patient-Reported Outcome Measure (PROM).

Methods

Content for the measure was generated by qualitative interviews with CD patients. Face and content validity were assessed by cognitive debriefing interviews with patients. A postal survey was then conducted to identify valid, reliable unidimensional scales.

Results

Nearly 3,000 statements describing the impact of CD were generated from 30 qualitative interviews. Three different types of outcome were identified; symptoms, activity limitations and quality of life impairment. The draft measure was assessed by 15 CD patients who found it relevant and comprehensible. Eleven items were deleted and 5 others changed. The new draft was then included in the validation survey together with the Nottingham Health Profile (NHP) and the Unidimensional Fatigue Impact Scale (U-FIS).

The questionnaire was completed by 273 CD patients (34.4% male; aged 16–79 (mean: 43.9 SD 15.1) years). 104 of these respondents completed a second questionnaire two weeks later to determine reproducibility. 56.4% of the sample was married or living as married and 53.0% were employed full or part time. Half reported their overall health to be fair or poor and 88.8% reported their severity of CD as mild or moderate. Duration of CD ranged from 2 months to 60 years with 86.8% currently receiving treatment. Analyses of the survey data allowed the identification of unidimensional scales through the application of Item Response Theory (Rasch analysis). They also confirmed the scales' internal consistency, reproducibility and construct validity.

Conclusion

The new scale, now called the Crohn's Life Impact Questionnaire (CLIQ), is the first scientifically rigorous PROM specific to CD. It is well accepted by patients, easy to use and should prove valuable for assessing CD treatment in clinical trials and practice and for clinical audit.