Skip to main content
SpringerLink
Log in

Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index

  • Original Article
  • Published:
European Spine Journal Aims and scope Submit manuscript

Abstract

Patient-orientated outcome questionnaires are essential for the assessment of treatment success in spine care. Standardisation of the instruments used is necessary for comparison across studies and in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders and is the recommended outcome instrument in the Spine Society of Europe Spine Tango Registry; currently, no validated Italian version exists. A cross-cultural adaptation of the COMI into Italian was carried out using established guidelines. 96 outpatients with chronic back problems (>3 months) were recruited from five practices in Switzerland and Italy. They completed the newly translated COMI, the Roland Morris disability (RM), adjectival pain rating, WHO Quality of Life (WHOQoL), EuroQoL-5D, and EuroQoL-VAS scales. Reproducibility was assessed in a subgroup of 63 patients who returned a second questionnaire within 1 month and indicated no change in back status on a 5-point Likert-scale transition question. The COMI scores displayed no floor or ceiling effects. On re-test, the responses for each individual domain of the COMI were within one category in 100% patients for “function”, 92% for “symptom-specific well-being”, 100% for “general quality of life”, 90% for “social disability”, and 98% for “work disability”. The intraclass correlation coefficients (ICC2,1) for the COMI back and leg pain items were 0.78 and 0.82, respectively, and for the COMI summary index, 0.92 (95% CI 0.86–0.95); this compared well with 0.84 for RM, 0.87 for WHOQoL, 0.79 for EQ-5D, and 0.77 for EQ-VAS. The standard error of measurement (SEM) for COMI was 0.54 points, giving a ‘‘minimum detectable change’’ for the COMI of 1.5 points. The scores for most of the individual COMI domains and the COMI summary index correlated to the expected extent (0.4–0.8) with the corresponding full-length reference questionnaires (r = 0.45–0.72). The reproducibility of the Italian version of the COMI was comparable to that published for the German and Spanish versions. The COMI scores correlated in the expected manner with existing but considerably longer questionnaires suggesting adequate convergent validity for the COMI. The Italian COMI represents a practical, reliable, and valid tool for use with Italian-speaking patients and will be of value for international studies and surgical registries.

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

Similar content being viewed by others

References

  1. Andresen EM (2000) Criteria for assessing the tools of disability outcomes research. Arch Phys Med Rehabil 81:S15–S20

    Article  PubMed  CAS  Google Scholar 

  2. Beaton DE, Bombardier C, Guillemin F, Ferraz MB (2000) Guidelines for the process of cross-cultural adaptation of self-report measures. Spine 25:3186–3191

    Article  PubMed  CAS  Google Scholar 

  3. Beurskens AJHM, de Vet HCW, Köke AJA (1996) Responsiveness of functional status in low back pain: a comparison of different instruments. Pain 65:71–76

    Article  PubMed  CAS  Google Scholar 

  4. Bombardier C (2000) Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine 25:3100–3103

    Article  PubMed  CAS  Google Scholar 

  5. Brooks R (1996) EuroQol: the current state of play. Health Policy 37:53–72

    Article  PubMed  CAS  Google Scholar 

  6. Costa LO, Maher CG, Latimer J (2007) Self-report outcome measures for low back pain: searching for international cross-cultural adaptations. Spine 32:1028–1037

    Article  PubMed  Google Scholar 

  7. Davidson M, Keating JL (2002) A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther 82:8–24

    PubMed  Google Scholar 

  8. De Girolamo G, Rucci P, Scocco P, Becchi A, Coppa F, D’ Addario A, Darú E, De Leo D, Galassi L, Mangelli L, Marson C, Neri GLS (2000) Quality of life assessment: validation of the Italian version of the WHOQOL-Brief. Epidemiol Psichiatr Soc 9:45–55

    Article  PubMed  Google Scholar 

  9. Deyo RA, Battie M, Beurskens AJHM, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G (1998) Outcome measures for low back pain research. A proposal for standardized use. Spine 23:2003–2013

    Article  PubMed  CAS  Google Scholar 

  10. Ferrer M, Pellise F, Escudero O, Alvarez L, Pont A, Alonso J, Deyo R (2006) Validation of a minimum outcome core set in the evaluation of patients with back pain. Spine 31:1372–1379, discussion 1380

    Article  PubMed  Google Scholar 

  11. Guillemin F, Bombardier C, Beaton D (1993) Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol 46:1417–1432

    Article  PubMed  CAS  Google Scholar 

  12. Haefeli M, Elfering A (2006) Pain assessment. Eur Spine J 15(Suppl 1):S17–S24

    Article  PubMed  Google Scholar 

  13. Hagg O, Fritzell P, Nordwall A, Group SLSS (2003) The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J 12:12–20

    PubMed  CAS  Google Scholar 

  14. Hyland ME (2003) A brief guide to the selection of quality of life instrument. Health Qual Life Outcomes 1:24

    Article  PubMed  Google Scholar 

  15. Kessler JT, Melloh M, Zweig T, Aghayev E, Roder C (2010) Development of a documentation instrument for the conservative treatment of spinal disorders in the International Spine Registry, Spine Tango. Eur Spine J (in press)

  16. Mannion AF, Elfering A, Staerkle R, Junge A, Grob D, Semmer NK, Jacobshagen N, Dvorak J, Boos N (2005) Outcome assessment in low back pain: how low can you go? Eur Spine J 14:1014–1026

    Article  PubMed  Google Scholar 

  17. Mannion AF, Porchet F, Kleinstück F, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D (2009) The quality of spine surgery from the patient’s perspective: Part 1. The Core Outcome Measures Index (COMI) in clinical practice. Eur Spine J 18:367–373

    Article  PubMed  Google Scholar 

  18. Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D (2009) The quality of spine surgery from the patient’s perspective: Part 2. Minimal clinically important difference for improvement and deterioration as measured with the Core Outcome Measures Index. Eur Spine J 18:374–379

    Article  PubMed  Google Scholar 

  19. McHorney CA, Tarlov AR (1995) Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res 4:293–307

    Article  PubMed  CAS  Google Scholar 

  20. Melloh M, Staub L, Aghayev E, Zweig T, Barz T, Theis JC, Chavanne A, Grob D, Aebi M, Roeder C (2008) The international spine registry SPINE TANGO: status quo and first results. Eur Spine J 17:1201–1209

    Article  PubMed  Google Scholar 

  21. Nevill AM, Lane AM, Kilgour LJ, Bowes N, Whyte GP (2001) Stability of psychometric questionnaires. J Sports Sci 19:273–278

    Article  PubMed  CAS  Google Scholar 

  22. Norman GR, Sloan JA, Wyrwich KW (2003) Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 41:582–592

    PubMed  Google Scholar 

  23. Padua R, Padua L, Ceccarelli E, Romanini E, Zanoli G, Bondi R, Campi A (2002) Italian version of the Roland Disability Questionnaire, specific for low back pain: cross-cultural adaptation and validation. Eur Spine J 11:126–129

    Article  PubMed  CAS  Google Scholar 

  24. Prieto L, Sacristan JA (2004) What is the value of social values? The uselessness of assessing health-related quality of life through preference measures. BMC Med Res Methodol 4:10

    Article  PubMed  Google Scholar 

  25. Rabin R, de Charro F (2001) EQ-5D: a measure of health status from the EuroQol Group. Ann Med 33:337–343

    Article  PubMed  CAS  Google Scholar 

  26. Roder C, Chavanne A, Mannion AF, Grob D, Aebi M, El-Kerdi A (2005) SSE Spine Tango—content, workflow, set-up. http://www.eurospine.org-Spine Tango. A European spine registry. Eur Spine J 14:920–924

  27. Roland M, Morris R (1983) A study of the natural history of back pain. Part 1: Development of a reliable and sensitive measure of disability in low-back pain. Spine 8:141–144

    Article  PubMed  CAS  Google Scholar 

  28. Savoia E, Fantini MP, Pandolfi PP, Dallolio L, Collina N (2006) Assessing the construct validity of the Italian version of the EQ-5D: preliminary results from a cross-sectional study in North Italy. Health Qual Life Outcomes 4:47

    Article  PubMed  Google Scholar 

  29. Staerkle RF, Villiger P (2011) Simple questionnaire for assessing core outcomes in inguinal hernia repair. Br J Surg 98(1):148–155

    Google Scholar 

  30. Streiner DL, Norman GR (1995) Health Measurement Scales: a practical guide to their development and use. Oxford University Press, Oxford

    Google Scholar 

  31. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC (2007) Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 60:34–42

    Article  PubMed  Google Scholar 

  32. White P, Lewith G, Prescott P (2004) The core outcomes for neck pain: validation of a new outcome measure. Spine 29:1923–1930

    Article  PubMed  Google Scholar 

  33. WHOQOL (1998) The World Health Organisation WHOQOL-BREF Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med 46:1569–1585

    Article  Google Scholar 

  34. Zweig T, Mannion AF, Grob D, Melloh M, Munting E, Tuschel A, Aebi M, Roder C (2009) How to Tango: a manual for implementing Spine Tango. Eur Spine J 312(Suppl 3):312–320

    Article  Google Scholar 

Download references

Acknowledgments

The authors would like to thank Eurospine, the Spine Society of Europe, and the Schulthess Klinik, Zürich, for funding this work. We thank Elena Zaina for help with the translations, Gordana Balaban, Nik Maffiuletti, Mario Bizzini and Franco Impellizeri for their assistance in proof-reading the final Italian version, Vera Demalde for her help in collecting the data, and the secretaries of our clinical departments for assisting with questionnaire administration. We also thank the doctors who referred patients into the study: Maria Grazia Canepa, Nicola Keller, Guido Mariotti and Andrea Badaracco.

Conflict of interest

None.

Author information

Authors and Affiliations

  1. Spine Center Division, Department of Research and Development, Schulthess Klinik, Lengghalde 2, 8008, Zurich, Switzerland

    A. F. Mannion

  2. Institute of Communication and Health, Università della Svizzera Italiana, Lugano, Switzerland

    M. Boneschi & P. J. Schulz

  3. Department of Spinal Surgery, Galeazzi Orthopaedic Institute, Via Galeazzi 4, 20161, Milan, Italy

    M. Teli

  4. Spine Center Division, Schulthess Klinik, Lengghalde 2, 8008, Zurich, Switzerland

    A. Luca

  5. Italian Scientific Spine Institute (ISICO), Milan, Italy

    F. Zaina & S. Negrini

Authors
  1. A. F. Mannion
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M. Boneschi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. M. Teli
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. A. Luca
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. F. Zaina
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. S. Negrini
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. P. J. Schulz
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to A. F. Mannion.

 

 

figure a
figure b
figure c

Rights and permissions

Reprints and permissions

About this article

Cite this article

Mannion, A.F., Boneschi, M., Teli, M. et al. Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index. Eur Spine J 21 (Suppl 6), 737–749 (2012). https://doi.org/10.1007/s00586-011-1741-6

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00586-011-1741-6

Keywords

Search

Navigation