Assessing quality of life in Crohn’s disease: development and validation of the Crohn’s Life Impact Questionnaire (CLIQ)
Despite the significant impact of Crohn’s disease (CD) on patients’ physical and emotional well-being, no CD-specific patient-reported outcome (PRO) measure is available for determining the efficacy of interventions. The objective of the study was to develop and validate the Crohn’s Life Impact Scale (CLIQ), the first such measure.
Questionnaire content was derived from qualitative interviews with CD patients and face and content validity assessed by cognitive debriefing interviews (CDIs) with patients. A postal survey was conducted to identify the final scale, confirm its unidimensionality and determine reproducibility and construct validity. A subset of the respondents was sent a second questionnaire package 2 weeks after the first. The survey included the CLIQ, Nottingham Health Profile (NHP) and Unidimensional Fatigue Impact Scale (U-FIS).
Content analysis was conducted on the 30 interview transcripts and a draft scale produced. The CDIs indicated that the draft scale was relevant, clear and easy to use. The questionnaire package was completed by 273 CD patients (65.6 % male; aged 16–79 (mean 43.9; SD 15.1) years). Of these, 104 also completed the second package. Rasch analysis confirmed a 27-item unidimensional QoL scale (p < 0.05). Both internal consistency and test–retest reliability were high (0.91). Scores on the CLIQ were related to both physical and emotional impairments (NHP) and to fatigue (U-FIS).
The CLIQ, the first CD-specific PRO, is unidimensional and has excellent psychometric properties. It should prove to be a valuable tool for evaluating the impact of CD and its treatment from the patients’ perspective.
KeywordsCrohn’s disease Inflammatory bowel disease IBD Patient-reported outcome measure PRO Questionnaire Quality of life
The authors would like to thank all the patients who contributed to the development and validation of the CLIQ. The study was part funded by Crohn’s and Colitis UK, and we would like to thank them for their support. The authors acknowledge the support of The National Institute for Health Research/Wellcome Trust Clinical Research Facility at Central Manchester University Hospitals NHS Foundation Trust.
Conflict of interest
The study procedures were followed in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, and its later amendments. Participants at each stage gave written informed consent prior to inclusion in the study. There is no identifying information in the manuscript.
- 1.Crohn’s and Colitis UK. Crohn’s Disease information booklet. http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/Crohns%20Disease.pdf. Accessed 24 July 2013.
- 2.Nahon, S., Lahmek, P., Saas, C., Durance, C., Olympie, A., Lesgourgues, B., & Gendre, J. P. (2011). Socioeconomic and psychological factors associated with nonadherence to treatment in inflammatory bowel disease patients: Results of the ISSEO survey. Inflammatory Bowel Diseases, 17(6), 1270–1276.PubMedCrossRefGoogle Scholar
- 3.European Medicines Agency. (2006). Reflection paper on the regulatory guidance for the use of health-related quality of life measures in the evaluation of medicinal products. http://www.ema.europa.eu/ema/pages. Accessed September 3, 2013.
- 5.Abdovic, S., Mocic Pavic, A., Milosevic, M., Persic, M., Senecic-Cala, I., & Kolacek, S. (2013). The IMPACT-III (HR) questionnaire: a valid measure of health-related quality of life in Croatian children with inflammatory bowel disease. Journal of Crohn’s and Colitis, 7(11), 908–915.PubMedCrossRefGoogle Scholar
- 6.Achleitner, U., Coenen, M., Colombel, J. F., Peyrin-Biroulet, L., Sahakyan, N., & Cieza, A. (2012). Identification of areas of functioning and disability addressed in inflammatory bowel disease-specific patient reported outcome measures. Journal of Crohn’s and Colitis, 6(5), 507–517.PubMedCrossRefGoogle Scholar
- 7.Dür, M., Sadloňová, M., Haider, S., Binder, A., Stoffer, M., Coenen, M., et al. (2014). Health determining concepts important to people with Crohn’s disease and their coverage by patient-reported outcomes of health and wellbeing. Journal of Crohn’s and Colitis, 8(1), 45–55.PubMedCentralPubMedCrossRefGoogle Scholar
- 11.Zijlstra, M., De Bie, C., Breij, L., van Pieterson, M., van Staa, A., de Ridder, L., et al. (2013). Self-efficacy in adolescents with inflammatory bowel disease: A pilot study of the “IBD-yourself”, a disease-specific questionnaire. Journal of Crohn’s and Colitis, 7(9), e375–e385.PubMedCrossRefGoogle Scholar
- 14.van der Linden, W. J., & Hambleton, R. K. (Eds.). (1996). Handbook of modern item response theory. New York: Springer.Google Scholar
- 16.Bernklev, T., Moum, B., Moum, T., & Inflammatory Bowel South-Eastern Norway (IBSEN) Group of Gastroenterologists. (2002). Quality of life in patients with inflammatory bowel disease: Translation, data quality, scaling assumptions, validity, reliability and sensitivity to change of the Norwegian version of IBDQ. Scandinavian Journal of Gastroenterology, 37(10), 1164–1174.PubMedCrossRefGoogle Scholar
- 18.Watanabe, K., Funayama, Y., Fukushima, K., Shibata, C., Takahashi, K., Ogawa, H., et al. (2006). Assessment of the Japanese Inflammatory Bowel Disease Questionnaire in patients after ileal pouch anal anastomosis for ulcerative colitis. Journal of Gastroenterology, 41, 662–667.PubMedCrossRefGoogle Scholar
- 37.Linacre, J. M. (1994). Sample size and item calibration stability. Rasch Measurement Transactions, 7(4), 328.Google Scholar
- 38.Hunt, S. M., McEwen, J., & McKenna, S. P. (1986). Measuring health status. London: Croom Helm.Google Scholar
- 39.European Group for Quality of Life Assessment and Health Measurement. (1993). European guide to the Nottingham health profile. Brookwood: Brookwood Medical Publications.Google Scholar
- 42.van Langenberg, D. R., Della Gatta, P., Warmington, S. A., Kidgell, D. J., Gibson, P. R., & Russell, A. P. (2014). Objectively measured muscle fatigue in Crohn’s disease: correlation with self-reported fatigue and associated factors for clinical application. Journal of Crohn’s and Colitis, 8(2), 137–146.PubMedCrossRefGoogle Scholar
- 43.Rasch, G. (1960). Probabilistic models for some intelligence and attainment tests. Chicago: University of Chicago Press.Google Scholar
- 45.Andrich, D., Sheridan, B. S., & Luo, G. (2010). Rumm 2030: Rasch unidimensional measurement models [computer software]. Perth: RUMM Laboratory.Google Scholar
- 46.Holland, P. W., & Wainer, H. (Eds.). (1993). Differential item functioning. New Jersey: Lawrence Erlbaum Associates.Google Scholar
- 50.Nunally, J. C, Jr. (1978). Psychometric theory (2nd ed.). New York: McGraw-Hill.Google Scholar
- 51.Weiner, E., & Stewart, B. (1984). Assessing individuals. Boston: Little Brown.Google Scholar
- 54.Kappelman, M. D., Long, M. D., Martin, C., DeWalt, D. A., Kinneer, P. M., Chen, W., et al. (2014). Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases. Clinical Gastroenterology and Hepatology, 12(8), 1315.PubMedCentralPubMedCrossRefGoogle Scholar
- 56.Bowden, A., & Fox-Rushby, J. A. (2003). A systematic and critical review of the process of translation and adaptation of generic health-related quality of life measures in Africa, Asia, Eastern Europe, the Middle East, South America. Social Science and Medicine, 57, 1289–1306.PubMedCrossRefGoogle Scholar