Skip to main content

Advertisement

Log in

Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck

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

An Erratum to this article was published on 08 December 2011

Abstract

Purpose

Patient-orientated outcome questionnaires are essential to evaluate treatment success. To compare different treatments, hospitals, and surgeons, standardised questionnaires are required. The present study examined the validity and responsiveness of the Core Outcome Measurement Index for neck pain (COMI-neck), a short, multidimensional outcome instrument.

Methods

Questionnaires were completed by patients with degenerative problems of the cervical spine undergoing cervical disc arthroplasty before (N = 89) and 3 months after (N = 75) surgery. The questionnaires comprised the EuroQol-Five Dimension (EQ-5D), the North American Spine Society Cervical Spine Outcome Assessment Instrument (NASS-cervical) and the COMI-neck.

Results

The COMI and NASS-cervical scores displayed no notable floor or ceiling effects at any time point whereas for the EQ-5D, the highest or lowest values were reached in around 32.5% of patients at follow-up. With one exception (symptom-specific well-being), the individual COMI items and the COMI summary score correlated to the expected extent (R = 0.4–0.8) with the scores of the chosen reference questionnaires. The area under the curve (AUC) generated by ROC analysis was significantly higher for the COMI (0.96) than for any other instrument/subscale when self reported treatment outcome was used as the external criterion, dichotomised as “good” (operation helped a lot/helped) versus “poor” (operation helped only a little/didn’t help/made things worse). The COMI had a high effect size (standardised response mean; SRM) (2.34) for the good global outcome group and a low SRM for the poor outcome group (0.34). The EQ-5D and the NASS-cervical lacked this ability to differentiate between the two groups, showing less distinct SRMs for good and poor outcome groups.

Conclusions

This study provides evidence that the COMI-neck is a valid and responsive questionnaire in the population of patients examined. Further investigations should examine its applicability in other patient groups with less severe neck pain or undergoing other treatment modalities.

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

Access this article

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

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Fejer R, Kyvik K, Hartvigsen J (2006) The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J 15:834–848

    Article  PubMed  Google Scholar 

  2. Borghouts J, Koes B, Vondeling H, Bouter L (1999) Cost-of-illness of neck pain in The Netherlands in 1996. Pain 80:629–636

    Article  PubMed  CAS  Google Scholar 

  3. Bombardier C (2000) Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine (Phila Pa 1976) 25:3100–3103

    Article  CAS  Google Scholar 

  4. Strömqvist B (2002) Evidence-based lumbar spine surgery. The role of national registration. Acta Orthop Scand Suppl 73:34–39

    PubMed  Google Scholar 

  5. Block A, Ohnmeiss D, Guyer R, Rashbaum R, Hochschuler S (2001) The use of presurgical psychological screening to predict the outcome of spine surgery. Spine J 1:274–282

    Article  PubMed  CAS  Google Scholar 

  6. Carragee E (2001) Psychological screening in the surgical treatment of lumbar disc herniation. Clin J Pain 17:215–219

    Article  PubMed  CAS  Google Scholar 

  7. Junge A, Dvorak J, Ahrens S (1995) Predictors of bad and good outcomes of lumbar disc surgery. A prospective clinical study with recommendations for screening to avoid bad outcomes. Spine (Phila Pa 1976) 20:460–468

    Article  CAS  Google Scholar 

  8. Grob D, Porchet F, Kleinstück F, Lattig F, Jeszenszky D, Luca A, Mutter U, Mannion A (2010) A comparison of outcomes of cervical disc arthroplasty and fusion in everyday clinical practice: surgical and methodological aspects. Eur Spine J 19:297–306

    Article  PubMed  Google Scholar 

  9. Mannion A, Junge A, Elfering A, Dvorak J, Porchet F, Grob D (2009) Great expectations: really the novel predictor of outcome after spinal surgery? Spine (Phila Pa 1976) 34:1590–1599

    Article  Google Scholar 

  10. Ahn H, Bhandari M, Schemitsch E (2009) An evidence-based approach to the adoption of new technology. J Bone Joint Surg Am 91(Suppl 3):95–98

    Article  PubMed  Google Scholar 

  11. Anderson P, Sasso R, Rouleau J, Carlson C, Goffin J (2004) The Bryan Cervical Disc: wear properties and early clinical results. Spine J 4:303S–309S

    Article  PubMed  Google Scholar 

  12. Deyo R (1988) Measuring the functional status of patients with low back pain. Arch Phys Med Rehabil 69:1044–1053

    PubMed  CAS  Google Scholar 

  13. Bowling A (2005) Just one question: if one question works, why ask several? J Epidemiol Community Health 59:342–345

    Article  PubMed  Google Scholar 

  14. Deyo R, Battie M, Beurskens A, 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 (Phila Pa 1976) 23:2003–2013

    Article  CAS  Google Scholar 

  15. Mannion A, Elfering A, Staerkle R, Junge A, Grob D, Semmer N, 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 

  16. Ferrer M, Pellisé 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 (Phila Pa 1976) 31:1372–1379 discussion 1380

    Article  Google Scholar 

  17. Melloh M, Staub L, Aghayev E, Zweig T, Barz T, Theis J, 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 

  18. White P, Lewith G, Prescott P (2004) The core outcomes for neck pain: validation of a new outcome measure. Spine (Phila Pa 1976) 29:1923–1930

    Article  Google Scholar 

  19. Kirshner B, Guyatt G (1985) A methodological framework for assessing health indices. J Chronic Dis 38:27–36

    Article  PubMed  CAS  Google Scholar 

  20. Schluessmann E, Diel P, Aghayev E, Zweig T, Moulin P, Röder C, Group SR (2009) SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses. Eur Spine J 18:851–861

    Article  PubMed  CAS  Google Scholar 

  21. Deyo R, Centor R (1986) Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. J Chronic Dis 39:897–906

    Article  PubMed  CAS  Google Scholar 

  22. Beaton DE, Schemitsch E (2003) Measures of health-related quality of life and physical function. Clin Orthop Relat Res 90–105.

  23. Mannion A, 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 2. Minimal clinically important difference for improvement and deterioration as measured with the Core Outcome Measures Index. Eur Spine J 18(Suppl 3):374–379

    Article  PubMed  Google Scholar 

  24. Brooks R (2003) The measurement and valuation of health status using EQ-5D: a European perspective evidence from EuroQol BIOMED research programme. Kluwer, Dordrecht

    Google Scholar 

  25. Prieto L, Sacristán 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 

  26. AAOS/NASS/SRS/CSRS/ORA/ASIA/COSS outcomes data collection questionnaires (1998) Cervical spine—baseline questionnaire, March 1998, Version 2.0

  27. Stoll T, Huber E, Bachmann S, Baumeler H, Mariacher S, Rutz M, Schneider W, Spring H, Aeschlimann A, Stucki G, Steiner W (2004) Validity and sensitivity to change of the NASS questionnaire for patients with cervical spine disorders. Spine (Phila Pa 1976) 29:2851–2855

    Article  Google Scholar 

  28. Sangha O, Wildner M, Peters A (2000) Evaluation of the North American Spine Society Instrument for assessment of health status in patients with chronic backache. Z Orthop Ihre Grenzgeb 138:447–451

    Article  PubMed  CAS  Google Scholar 

  29. Daltroy L, Cats-Baril W, Katz J, Fossel A, Liang M (1996) The North American spine society lumbar spine outcome assessment Instrument: reliability and validity tests. Spine (Phila Pa 1976) 21:741–749

    Article  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  31. 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 

  32. Terwee C, Bot S, de Boer M, van der Windt D, Knol D, Dekker J, Bouter L, de Vet H (2007) Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 60:34–42

    Article  PubMed  Google Scholar 

  33. Streiner DL, Norman GR (1995) Health measurement scales: a practical guide to their development and use. Oxford University Press, Oxford

    Google Scholar 

  34. Beaton DE, Bombardier C, Katz JN, Wright JG (2001) A taxonomy for responsiveness. J Clin Epidemiol 54:1204–1217

    Article  PubMed  CAS  Google Scholar 

  35. Beurskens A, de Vet H, Köke A (1996) Responsiveness of functional status in low back pain: a comparison of different instruments. Pain 65:71–76

    Article  PubMed  CAS  Google Scholar 

  36. Cohen J (1988) Statistical power analysis for the behavioral sciences. Lawrence Earlbaum Associates, Hillsdale

    Google Scholar 

  37. Kazis L, Anderson J, Meenan R (1989) Effect sizes for interpreting changes in health status. Med Care 27:S178–S189

    Article  PubMed  CAS  Google Scholar 

  38. Zweig M, Campbell G (1993) Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine. Clin Chem 39:561–577

    PubMed  CAS  Google Scholar 

  39. Youden W (1950) Index for rating diagnostic tests. Cancer 3:32–35

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  Google Scholar 

  41. Fitzpatrick R, Davey C, Buxton MJ, Jones DR (1998) Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess 2:i–iv, 1–74

  42. Bolognese J, Schnitzer T, Ehrich E (2003) Response relationship of VAS and Likert scales in osteoarthritis efficacy measurement. Osteoarthr Cartil 11:499–507

    Article  PubMed  CAS  Google Scholar 

  43. Janssen MF, Birnie E, Haagsma JA, Bonsel GJ (2008) Comparing the standard EQ-5D three-level system with a five-level version. Value Health 11:275–284

    Article  PubMed  Google Scholar 

  44. Janssen MF, Birnie E, Bonsel GJ (2008) Quantification of the level descriptors for the standard EQ-5D three-level system and a five-level version according to two methods. Qual Life Res 17:463–473

    Article  PubMed  CAS  Google Scholar 

  45. Pickard AS, De Leon MC, Kohlmann T, Cella D, Rosenbloom S (2007) Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients. Med Care 45:259–263

    Article  PubMed  Google Scholar 

  46. Deyo R, Diehr P, Patrick D (1991) Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation. Control Clin Trials 12:142S–158S

    Article  PubMed  CAS  Google Scholar 

  47. Walsh TL, Hanscom B, Lurie JD, Weinstein JN (2003) Is a condition-specific instrument for patients with low back pain/leg symptoms really necessary? The responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36. Spine (Phila Pa 1976) 28:607–615

    Google Scholar 

  48. Fritzell P, Berg S, Borgström F, Tullberg T, Tropp H (2010) Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up. Eur Spine J

  49. Hyland M (1992) Selection of items and avoidance of bias in quality of life scales. Pharmacoeconomics 1:182–190

    Article  PubMed  CAS  Google Scholar 

  50. Guyatt GH, Feeny DH, Patrick DL (1993) Measuring health-related quality of life. Ann Intern Med 118:622–629

    PubMed  CAS  Google Scholar 

  51. Johnson JA, Coons SJ, Ergo A, Szava-Kovats G (1998) Valuation of EuroQOL (EQ-5D) health states in an adult US sample. Pharmacoeconomics 13:421–433

    Article  PubMed  CAS  Google Scholar 

  52. Bharmal M, Thomas J (2006) Comparing the EQ-5D and the SF-6D descriptive systems to assess their ceiling effects in the US general population. Value Health 9:262–271

    Article  PubMed  Google Scholar 

  53. Cunillera O, Tresserras R, Rajmil L, Vilagut G, Brugulat P, Herdman M, Mompart A, Medina A, Pardo Y, Alonso J, Brazier J, Ferrer M (2010) Discriminative capacity of the EQ-5D, SF-6D, and SF-12 as measures of health status in population health survey. Qual Life Res 19:853–864

    Article  PubMed  Google Scholar 

  54. Petrou S, Hockley C (2005) An investigation into the empirical validity of the EQ-5D and SF-6D based on hypothetical preferences in a general population. Health Econ 14:1169–1189

    Article  PubMed  Google Scholar 

  55. Tidermark J, Bergström G (2007) Responsiveness of the EuroQol (EQ-5D) and the Nottingham Health Profile (NHP) in elderly patients with femoral neck fractures. Qual Life Res 16:321–330

    Article  PubMed  Google Scholar 

  56. Bombardier C, Hayden J, Beaton DE (2001) Minimal clinically important difference. Low back pain: outcome measures. J Rheumatol 28:431–438

    PubMed  CAS  Google Scholar 

  57. Siepe CJ, Mayer HM (2009) Is the final outcome predictable following total lumbar disc replacement? Proceedings of the International Society for the Study of the Lumbar Spine, Miami, Florida, USA, 4–8 May 2009

  58. Campbell H, Rivero-Arias O, Johnston K, Gray A, Fairbank J, Frost H, Trial UMSS (2006) Responsiveness of objective, disease-specific, and generic outcome measures in patients with chronic low back pain: an assessment for improving, stable, and deteriorating patients. Spine (Phila Pa 1976) 31:815–822

    Article  Google Scholar 

  59. Stratford PW, Binkley JM, Riddle DL, Guyatt GH (1998) Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 1. Phys Ther 78:1186–1196

    PubMed  CAS  Google Scholar 

  60. MacKenzie CR, Charlson ME, DiGioia D, Kelley K (1986) Can the Sickness Impact Profile measure change? An example of scale assessment. J Chronic Dis 39:429–438

    Article  PubMed  CAS  Google Scholar 

  61. Stratford PW, Binkley J, Solomon P, Gill C, Finch E (1994) Assessing change over time in patients with low back pain. Phys Ther 74:528–533

    PubMed  CAS  Google Scholar 

Download references

Acknowledgments

We are grateful to Gordana Balaban, Dave O’Riordan, Julian Amacker, Kirsten Clift, and Sara Preziosa, for their excellent work collecting the COMI and Spine Tango Surgical Registry data.

Conflict of interest

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to A. F. Mannion.

Additional information

An erratum to this article can be found at http://dx.doi.org/10.1007/s00586-011-2107-9

Rights and permissions

Reprints and permissions

About this article

Cite this article

Fankhauser, C.D., Mutter, U., Aghayev, E. et al. Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck. Eur Spine J 21, 101–114 (2012). https://doi.org/10.1007/s00586-011-1921-4

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00586-011-1921-4

Keywords

Navigation