Skip to main content

Advertisement

SpringerLink
Log in

Assessing quality of life in Crohn’s disease: development and validation of the Crohn’s Life Impact Questionnaire (CLIQ)

  • Published:
Quality of Life Research Aims and scope Submit manuscript

Abstract

Purpose

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.

Methods

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).

Results

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).

Conclusion

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

Similar content being viewed by others

References

  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.

    Article  PubMed  Google 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.

  4. Fehnel, S., DeMuro, C., McLeod, L., Coon, C., & Gnanasakthy, A. (2013). US FDA patient-reported outcome guidance: Great expectations and unintended consequences. Expert Review of Pharmacoeconomics and Outcomes Research, 13(4), 441–446.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google 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.

    Article  PubMed  Google 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.

    Article  PubMed Central  PubMed  Google Scholar 

  8. Huamán, J. W., Casellas, F., Borruel, N., Peláez, A., Torrejón, A., Castells, I., et al. (2010). Cutoff values of the Inflammatory Bowel Disease Questionnaire to predict a normal health related quality of life. Journal of Crohn’s and Colitis, 4(6), 637–641.

    Article  PubMed  Google Scholar 

  9. McDermott, E., Keegan, D., Byrne, K., Doherty, G. A., & Mulcahy, H. E. (2013). The Short Health Scale: A valid and reliable measure of health related quality of life in English speaking inflammatory bowel disease patients. Journal of Crohn’s and Colitis, 7(8), 616–621.

    Article  PubMed  Google Scholar 

  10. Werner, H., Landolt, M. A., Buehr, P., Koller, R., Nydegger, A., Spalinger, J., et al. (2014). Validation of the IMPACT-III quality of life questionnaire in Swiss children with inflammatory bowel disease. Journal of Crohn’s and Colitis, 8(7), 641–648.

    Article  PubMed  Google 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.

    Article  PubMed  Google Scholar 

  12. Guyatt, G., Mitchell, A., Irvine, E. J., Singer, J., Williams, N., Goodacre, R., & Tompkins, C. (1989). A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology, 96(3), 804–810.

    CAS  PubMed  Google Scholar 

  13. Ware, J. E, Jr, & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Medical Care, 30, 473–483.

    Article  PubMed  Google Scholar 

  14. van der Linden, W. J., & Hambleton, R. K. (Eds.). (1996). Handbook of modern item response theory. New York: Springer.

    Google Scholar 

  15. Irvine, E. J. (1999). Development and subsequent refinement of the inflammatory bowel disease questionnaire: a quality-of-life instrument for adult patients with inflammatory bowel disease. Journal of Pediatric Gastroenterology and Nutrition, 28(4), S23–S27.

    Article  CAS  PubMed  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.

    Article  CAS  PubMed  Google Scholar 

  17. Vlachonikolis, I. G., Pallis, A. G., & Mouzas, I. A. (2003). Improved validation of the Inflammatory Bowel Disease Questionnaire and development of a short form in Greek patients. The American Journal of Gastroenterology, 98, 1802–1812.

    Article  PubMed  Google 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.

    Article  PubMed  Google Scholar 

  19. Stjernman, H., Grännö, C., Bodemar, G., Järnerot, G., Ockander, L., Tysk, C., et al. (2006). Evaluation of the Inflammatory Bowel Disease Questionnaire in Swedish patients with Crohn’s disease. Scandinavian Journal of Gastroenterology, 41, 934–943.

    Article  PubMed  Google Scholar 

  20. Vidal, A., Gómez-Gil, E., Sans, M., Portella, M. J., Salamero, M., Piqué, J. M., & Panés, J. (2007). Psychometric properties of the original Inflammatory Bowel Disease Questionnaire, a Spanish version. Gastroenterología y Hepatología, 30, 212–218.

    Article  PubMed  Google Scholar 

  21. Devlen, J., Beusterien, K., Yen, L., Ahmed, A., Cheifetz, A. S., & Moss, A. C. (2014). The burden of inflammatory bowel disease: A patient-reported qualitative analysis and development of a conceptual model. Inflammatory Bowel Diseases, 20(3), 545–552.

    Article  PubMed Central  PubMed  Google Scholar 

  22. Wright, B. D. (1996). Comparing Rasch measurement and factor analysis. Structural Equation Modelling, 3, 3–24.

    Article  Google Scholar 

  23. Prieto, L., Alonso, J., & Lamarca, R. (2003). Classical test theory versus Rasch analysis for quality of life questionnaire reduction. Health and Quality of Life Outcomes, 1, 27.

    Article  PubMed Central  PubMed  Google Scholar 

  24. Waugh, R. F., & Chapman, E. S. (2005). An analysis of dimensionality using factor analysis (true-score theory) and Rasch measurement: What is the difference? Which method is better? Journal of Applied Measurement, 6, 80–99.

    PubMed  Google Scholar 

  25. Belvedere, S. L., & de Morton, N. A. (2010). Application of Rasch analysis in health care is increasing and is applied for variable reasons in mobility instruments. Journal of Clinical Epidemiology, 63(12), 1287–1297.

    Article  PubMed  Google Scholar 

  26. Siemons, L., Ten Klooster, P. M., Taal, E., Glas, C. A., & Van de Laar, M. A. (2012). Modern psychometrics applied in rheumatology—A systematic review. BMC Musculoskeletal Disorders, 13, 216.

    Article  PubMed Central  PubMed  Google Scholar 

  27. Doward, L. C., Meads, D. M., & Thorsen, H. (2004). Requirements for Quality of Life instruments in clinical research. Value in Health, 7(s1), S13–S16.

    Article  PubMed  Google Scholar 

  28. Doyal, L., & Gough, I. (1991). A theory of human need. Basingstoke: Macmillan.

    Book  Google Scholar 

  29. Hyde, M., Wiggins, R. D., Higgs, P., & Blane, D. B. (2003). A measure of quality of life in early old age: The theory, development and properties of a needs satisfaction model (CASP-19). Aging Mental Health, 7(3), 186–194.

    Article  CAS  PubMed  Google Scholar 

  30. Hornquist, J. O. (1982). The concept of quality of life. Scandinavian Journal of Social Medicine, 10(2), 57–61.

    CAS  PubMed  Google Scholar 

  31. Doward, L. C., McKenna, S. P., Meads, D. M., Twiss, J., & Eckert, B. J. (2009). The development of patient-reported outcome indices for multiple sclerosis (PRIMUS). Multiple Sclerosis, 15(9), 1092–1102.

    Article  CAS  PubMed  Google Scholar 

  32. Hunt, S. M., & McKenna, S. P. (1992). The QLDS: A scale for the measurement of quality of life in depression. Health Policy, 22, 307–319.

    Article  CAS  PubMed  Google Scholar 

  33. Whalley, D., McKenna, S. P., de Jong, Z., & van der Heijde, D. (1997). Quality of life in rheumatoid arthritis. British Journal of Rheumatology, 36(8), 884–888.

    Article  CAS  PubMed  Google Scholar 

  34. Keenan, A. M., McKenna, S. P., Doward, L. C., Conaghan, P. G., Emery, P., & Tennant, A. (2008). Development and validation of a needs-based quality of life instrument for osteoarthritis. Arthritis and Rheumatism, 59(6), 841–848.

    Article  PubMed  Google Scholar 

  35. Doward, L. C., Spoorenberg, A., Cook, S. A., Whalley, D., Helliwell, P. S., Kay, L. J., et al. (2003). Development of the ASQoL: A quality of life instrument specific to ankylosing spondylitis. Annals of the Rheumatic Diseases, 62(1), 20–26.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  36. McKenna, S. P., Doward, L. C., Whalley, D., Tennant, A., Emery, P., & Veale, D. J. (2004). Development of the PsAQoL: A quality of life instrument specific to psoriatic arthritis. Annals of the Rheumatic Diseases, 63(2), 162–169.

    Article  CAS  PubMed Central  PubMed  Google 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 

  40. Meads, D. M., Doward, L. C., McKenna, S. P., Fisk, J., Twiss, J., & Eckert, B. (2009). The development and validation of the Unidimensional Fatigue Impact Scale. Multiple Sclerosis, 15(10), 1228–1238.

    Article  CAS  PubMed  Google Scholar 

  41. van Langenberg, D. R., & Gibson, P. R. (2014). Factors associated with physical and cognitive fatigue in patients with Crohn’s disease: A cross-sectional and longitudinal study. Inflammatory Bowel Diseases, 20(1), 115–125.

    Article  PubMed  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.

    Article  PubMed  Google Scholar 

  43. Rasch, G. (1960). Probabilistic models for some intelligence and attainment tests. Chicago: University of Chicago Press.

    Google Scholar 

  44. Tennant, A., McKenna, S. P., & Hagell, P. (2004). Application of Rasch analysis in the development and application of quality of life instruments. Value in Health, 7(Suppl 1), S22–S26.

    Article  PubMed  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 

  47. Tennant, A., & Gonaghan, P. G. (2007). The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one should one look for in a Rasch paper? Arthritis and Rheumatism, 57, 1358–1362.

    Article  PubMed  Google Scholar 

  48. Balsamo, M., Giampaglia, G., & Saggino, A. (2014). Building a new Rasch-based self-report inventory of depression. Neuropsychiatric Disease and Treatment, 10, 153–165.

    Article  PubMed Central  PubMed  Google Scholar 

  49. Smith, E. V. (2002). Detecting and evaluating the impact of multidimensionality using item fit statistics and principal component analysis of residuals. Journal of Applied Measurement, 3(2), 205–231.

    PubMed  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 

  52. de Jong, Z., van der Heijde, D., McKenna, S. P., & Whalley, D. (1997). The reliability and construct validity of the RAQoL: A rheumatoid arthritis-specific quality of life instrument. British Journal of Rheumatology, 36(8), 878–883.

    Article  PubMed  Google Scholar 

  53. Kemp, K., Griffiths, J., & Lovell, K. (2012). Understanding the health and social care needs of people living with IBD: A meta-synthesis of the evidence. World Journal of Gastroenterology, 18(43), 6240–6249.

    Article  PubMed Central  PubMed  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.

    Article  PubMed Central  PubMed  Google Scholar 

  55. Kim, M., Han, H. R., & Phillips, L. (2003). Metric equivalence assessment in cross-cultural research: using an example of the Center for Epidemiological Studies-Depression Scale. Journal of Nursing Measurement, 11, 5–18.

    Article  PubMed  Google 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.

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

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

None.

Ethical standards

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.

Author information

Authors and Affiliations

  1. Galen Research Ltd, Enterprise House, Manchester Science Park, Lloyd Street North, Manchester, M15 6SE, UK

    Jeanette Wilburn, Stephen P. McKenna & James Twiss

  2. Department of Gastroenterology, Manchester Royal Infirmary, Manchester, M13 9WL, UK

    Karen Kemp & Simon Campbell

Authors
  1. Jeanette Wilburn
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Stephen P. McKenna
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. James Twiss
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Karen Kemp
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Simon Campbell
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jeanette Wilburn.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Wilburn, J., McKenna, S.P., Twiss, J. et al. Assessing quality of life in Crohn’s disease: development and validation of the Crohn’s Life Impact Questionnaire (CLIQ). Qual Life Res 24, 2279–2288 (2015). https://doi.org/10.1007/s11136-015-0947-1

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11136-015-0947-1

Keywords

Search

Navigation