Skip to main navigation menu Skip to main content Skip to site footer

Original article

Vol. 146 No. 5152 (2016)

Feasibility, acceptability and construct validity of EQ-5D in systemic sclerosis

  • Roberta Gualtierotti
  • Francesca Ingegnoli
  • Luciana Scalone
  • Paolo Cortesi
  • Eleonora Bruschi
  • Maria Gerosa
  • Pier Luigi Meroni
Cite this as:
Swiss Med Wkly. 2016;146:w14394


BACKGROUND: Systemic sclerosis is a chronic disabling disease that is often associated with severe physical and psychological impairment. Nonetheless, health-related quality of life (HRQoL) in patients with systemic sclerosis is often left behind in clinical practice and research. One of the reasons for this lack of evaluation is the current use of tools, such as the short form-36 (SF-36) questionnaire, that are complete but complicated to use in everyday routine. Other self-reported outcome measures such as the health assessment questionnaire (HAQ) are simple, but specifically designed for physical disability.

STUDY AIMS AND METHODS: Our aim was to evaluate the feasibility, acceptability and construct validity of EQ-5D, a simple and quick self-assessment tool, and to compare its performance with SF-36 and HAQ. We investigated 119 consecutive patients with systemic sclerosis (94% female; age: median 63 years, interquartile range 53–70 years) at three different rheumatology centres. Acceptability was evaluated from comments made by the patients and feasibility on the basis of the number of patients needing assistance or not answering questions (missing data). Construct validity was based on both convergent and divergent validity between conceptually similar and dissimilar domains, respectively, of the compared instruments.

RESULTS: EQ-5D was well accepted by patients. The percentage of patients missing data in at least one EQ-5D domain was 2.5%. Spearman’s correlation coefficients between similar dimensions of EQ-5D vs SF-36 and vs HAQ were moderate (≥0.30) to strong (≥0.50); in contrast, correlation coefficients between less comparable dimensions were weak. As expected, the EQ-5D anxiety/depression domain did not correlate with any of the HAQ domains. The EQ-5D visual analogue scale (VAS) concordance with SF-36 general health domain and HAQ total score was strong (≥0.50 for both). Median value for the EQ-5D index (interquartile range) was 0.81 (0.75–0.86). The EQ-5D index had correlation coefficients >0.40 with all SF-36 domains and with all HAQ domains, HAQ total and HAQ VAS.

CONCLUSIONS: Our data demonstrate good acceptability, feasibility and construct validity of EQ-5D in patients with systemic sclerosis. We suggest the use of EQ-5D in systemic sclerosis patients as an HRQoL measure in clinical practice, in randomised clinical trials and/or in pharmacoeconomic evaluations.


  1. McMahan ZH, Hummers LK. Systemic sclerosis – challenges for clinical practice. Nat Rev Rheumatol. 2012;9(2):90–100. doi:
  2. Haythornthwaite JA, Heinberg LJ, McGuire L. Psychologic factors in scleroderma. Rheum Dis Clin North Am. 2003;29(2):427–39. doi:
  3. Malcarne VL, Greenbergs HL. Psychological adjustment to systemic sclerosis. Arthritis Care Res. 1996;9(1):51–9. doi:
  4. Ingegnoli F, Boracchi P, Ambrogi F, Gualtierotti R, Galbiati V, Meroni PL. Hand impairment in systemic sclerosis: association of different hand indices with organ involvement. Scand J Rheumatol. 2010;39(5):393–7. doi:
  5. Pellar RE, Tingey TM, Pope JE. Patient-Reported Outcome Measures in Systemic Sclerosis (Scleroderma). Rheum Dis Clin North Am. 2016;42(2):301–16. doi:
  6. Frantz C, Avouac J, Distler O, Amrouche F, Godard D, Kennedy AT, et al. Impaired quality of life in systemic sclerosis and patient perception of the disease: A large international survey. Semin Arthritis Rheum. 2016;46(1):115–23. doi:
  7. Racine M, Hudson M, Baron M, Nielson WR. Canadian Scleroderma Research G. The Impact of Pain and Itch on Functioning and Health-Related Quality of Life in Systemic Sclerosis: An Exploratory Study. J Pain Symptom Manage. 2016;52(1):43–53. doi:
  8. Almeida C, Almeida I, Vasconcelos C. Quality of life in systemic sclerosis. Autoimmun Rev. 2015;14(12):1087–96. doi:
  9. Thombs BD, van Lankveld W, Bassel M, Baron M, Buzza R, Haslam S, et al. Psychological health and well-being in systemic sclerosis: State of the science and consensus research agenda. Arthritis Care Res (Hoboken). 2010;62(8):1181–9. doi:
  10. Nguyen C, Ranque B, Baubet T, Bérezné A, Mestre-Stanislas C, Rannou F, et al.; Groupe Français de Recherche sur la Sclérodermie. Clinical, functional and health-related quality of life correlates of clinically significant symptoms of anxiety and depression in patients with systemic sclerosis: a cross-sectional survey. PLoS One. 2014;9(2):e90484. doi:
  11. Ingegnoli F, Galbiati V, Boracchi P, Comi D, Gualtierotti R, Zeni S, et al. Reliability and validity of the Italian version of the hand functional disability scale in patients with systemic sclerosis. Clin Rheumatol. 2008;27(6):743–9. doi:
  12. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993;118(8):622–9. doi:
  13. Dowie J. Decision validity should determine whether a generic or condition-specific HRQOL measure is used in health care decisions. Health Econ. 2002;11(1):1–8. doi:
  14. Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30(6):473–83. doi:
  15. Brooks R. EuroQol: the current state of play. Health Policy. 1996;37(1):53–72. doi:
  16. Olivieri I, Cortesi PA, de Portu S, Salvarani C, Cauli A, Lubrano E, et al.; PACE Working Group. Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study. Clin Exp Rheumatol. 2016;34(1):68–75.
  17. Ferreira PL, Gonçalves SP, Ferreira LN, Pereira LN, Antunes P, Gouveia N, et al. Assessing quality of life of self-reported rheumatic patients. Rheumatol Int. 2016;36(9):1265–74. doi:
  18. Wallman JK, Eriksson JK, Nilsson JA, Olofsson T, Kristensen LE, Neovius M, et al. Costs in Relation to Disability, Disease Activity, and Health-related Quality of Life in Rheumatoid Arthritis: Observational Data from Southern Sweden. J Rheumatol. 2016;43(7):1292–9. doi:
  19. Fattore G. Proposta di linee guida per la valutazione economica degli interventi sanitari in Italia. [A proposal for guidelines for the economic evaluation of health interventions in Italy.] PharmacoEconomics Italian Research Articles. 2009;11(2):83–93. doi:
  20. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23(2):137–45. doi:
  21. Masi AT. Preliminary criteria for the classification of systemic sclerosis (scleroderma). Subcommittee for scleroderma criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee. Arthritis Rheum. 1980;23(5):581–90. doi:
  22. van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis Rheum. 2013;65(11):2737–47. doi:
  23. Ingegnoli F, Gualtierotti R, Orenti A, Schioppo T, Marfia G, Campanella R, et al. Uniphasic Blanching of the Fingers, Abnormal Capillaroscopy in Nonsymptomatic Digits, and Autoantibodies: Expanding Options to Increase the Level of Suspicion of Connective Tissue Diseases beyond the Classification of Raynaud’s Phenomenon. J Immunol Res. 2015;2015:371960. doi:
  24. Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997;35(11):1095–108. doi:
  25. Khanna D, Furst DE, Clements PJ, Park GS, Hays RD, Yoon J, et al.; Relaxin Study Group; Scleroderma Clinical Trials Consortium. Responsiveness of the SF-36 and the Health Assessment Questionnaire Disability Index in a systemic sclerosis clinical trial. J Rheumatol. 2005;32(5):832–40.
  26. Hudson M, Thombs BD, Steele R, Panopalis P, Newton E, Baron M; Canadian Scleroderma Research Group. Health-related quality of life in systemic sclerosis: a systematic review. Arthritis Rheum. 2009;61(8):1112–20. doi:
  27. Callahan LF. The History of Patient-Reported Outcomes in Rheumatology. Rheum Dis Clin North Am. 2016;42(2):205–17. doi:
  28. Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998;51(11):1025–36. doi:
  29. Ware JE, Jr, Kosinski M, Bayliss MS, McHorney CA, Rogers WH, Raczek A. Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Med Care. 1995;33(4, Suppl):AS264–79.
  30. Poole JL, Steen VD. The use of the Health Assessment Questionnaire (HAQ) to determine physical disability in systemic sclerosis. Arthritis Care Res. 1991;4(1):27–31. doi:
  31. Scalone L, Cortesi PA, Ciampichini R, Belisari A, D’Angiolella LS, Cesana G, et al. Italian population-based values of EQ-5D health states. Value Health. 2013;16(5):814–22. doi:
  32. Scalone L, Cortesi PA, Ciampichini R, Cesana G, Mantovani LG. Health related quality of life norm data of the Italian general population: results using the EQ-5D-3L and EQ-5D-5L instruments. Epidemiology, Biostatistics and Public Health. 2015;12(3):e11457-1–15. doi:
  33. Cohen J. Statistical power analysis for the behavioural sciences. Hillside. NJ: Lawrence Earlbaum Associates. 1988.
  34. Fox-Rushby J, Selai C. What concepts does the EQ-5D measure? Intentions and interpretations. The measurement and valuation of health status using EQ-5D: A European Perspective: Springer; 2003. p. 167–82.
  35. Scalone L, Tomasetto C, Matteucci MC, Selleri P, Broccoli S, Pacelli B, et al. Assessing quality of life in children and adolescents: development and validation of the Italian version of the EQ-5D-Y. Ital J Public Health. 2011;8(4):331–41. doi:
  36. De Angelis R, Salaffi F, Grassi W. Health-related quality of life in primary Raynaud phenomenon. J Clin Rheumatol. 2008;14(4):206–10. doi:
  37. Stamuli E. Health outcomes in economic evaluation: who should value health? Br Med Bull. 2011;97(1):197–210. doi:
  38. Gualtierotti R, Scalone L, Ingegnoli F, Cortesi P, Lubatti C, Zeni S, et al. Health related quality of life assessment in patients with systemic sclerosis. Reumatismo. 2010;62(3):210–4. Italian.
  39. Cortesi PA, Mencacci C, Luigi F, Pirfo E, Berto P, Sturkenboom MC, et al. Compliance, persistence, costs and quality of life in young patients treated with antipsychotic drugs: results from the Cometa study. BMC pychiatry. 2013:13(98):2-16.
  40. Scalone L, Mantovani LG, Krol M, Rofail D, Ravera S, Bisconte MG, et al. Costs, quality of life, treatment satisfaction and compliance in patients with beta-thalassaemia major undergoing iron chelation therapy: the ITHACA study. Curr Med Res Opin. 2008;24(7):1905-17.
  41. Scalone L, Mantovani LG, Mannucci PM, Gringeri A; COCIS Study Investigators. Quality of life is associated to the orthopaedic status in haemophilic patients with inhibitors. Haemophilia. 2006;12(2):154-62.