Skip to main content

Advertisement

SpringerLink
Log in

The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity

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

Abstract

Introduction

The Core Outcome Measures Index for the back (COMI-back) is a very brief instrument for assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability). However, it might be expected to be less responsive than a disease-specific instrument when evaluating specific pathologies. In patients with adult spinal deformity, we compared the performance of COMI-back with the widely accepted SRS-22 questionnaire.

Methods

At baseline and 12 months after non-operative (N = 121) and surgical (N = 83) treatment, patients (175 F, 29 M) completed the following: COMI-back, SRS-22, Oswestry Disability Index (ODI) and SF-36 PCS. At 12 months' follow-up, patients also indicated on a 15-point Global Rating of Change Scale (GRCS) how their back problem had changed relative to 1 year ago. Construct validity for the COMI-back was assessed by the correlation between its scores and those of the comparator instruments; responsiveness was assessed with receiver operating characteristics (ROC) analysis of COMI-back change scores versus the criterion ‘treatment success’ (dichotomized GRCS).

Results

Baseline values for the COMI-back showed significant (p < 0.0001) correlations with SRS-22 (r = −0.85), ODI (r = 0.83), and SF-36 PCS (r = −0.82) scores; significantly worse scores for all measures were recorded in the surgical group. The correlation between the change scores (baseline to 12 months) for COMI and SRS-22 was 0.74, and between each of these change scores and the external criterion of treatment success were: COMI-back, r = 0.58; SRS-22, r = −0.58 (each p < 0.0001). The ROC areas under the curve for the COMI-back and SRS-22 change scores were 0.79 and 0.82, respectively.

Conclusion

Both baseline and change scores for the COMI-back correlated strongly with those of the SRS-22, and differed significantly in surgical and non-operative patients, suggesting good construct validity. With the “change in the back problem” serving as external criterion, COMI-back showed similar external responsiveness to SRS-22. The COMI-back was well able to detect important change. Coupled with its brevity, which minimizes patient burden, these favourable psychometric properties suggest the COMI-back is a suitable instrument for use in registries and can serve as a valid instrument in clinical studies emerging from such data pools.

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

Similar content being viewed by others

References

  1. 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  CAS  PubMed  Google Scholar 

  2. Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, Costa LO, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CW, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Ostelo RW (2015) Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. doi:10.1007/s00586-015-3892-3

    Google Scholar 

  3. 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 

  4. 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 

  5. 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  PubMed Central  Google Scholar 

  6. Mannion AF, Boneschi M, Teli M, Luca A, Zaina F, Negrini S, Schulz PJ (2012) Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index. Eur Spine J 21:S737–S749

    Article  PubMed  Google Scholar 

  7. Genevay S, Cedraschi C, Marty M, Rozenberg S, De Goumoens P, Faundez A, Balague F, Porchet F, Mannion AF (2011) Reliability and validity of the cross-culturally adapted French version of the Core Outcome Measures Index (COMI) in patients with low back pain. Eur Spine J 21:130–137

    Article  PubMed  PubMed Central  Google Scholar 

  8. Damasceno LH, Rocha PA, Barbosa ES, Barros CA, Canto FT, Defino HL, Mannion AF (2011) Cross-cultural adaptation and assessment of the reliability and validity of the Core Outcome Measures Index (COMI) for the Brazilian-Portuguese language. Eur Spine J 21:1273–1282

    Article  PubMed  PubMed Central  Google Scholar 

  9. Miekisiak G, Kollataj M, Dobrogowski J, Kloc W, Libionka W, Banach M, Latka D, Sobolewski T, Sulewski A, Nowakowski A, Kiwic G, Pala A, Potaczek T (2012) Cross-cultural adaptation and validation of the Polish version of the Core Outcome Measures Index for low back pain. Eur Spine J 22:995–1001. doi:10.1007/s00586-012-2607-2

    Article  PubMed  PubMed Central  Google Scholar 

  10. Storheim K, Brox JI, Lochting I, Werner EL, Grotle M (2012) Cross-cultural adaptation and validation of the Norwegian version of the Core Outcome Measures Index for low back pain. Eur Spine J 21:2539–2549. doi:10.1007/s00586-012-2393-x

    Article  PubMed  PubMed Central  Google Scholar 

  11. Qiao J, Zhu F, Zhu Z, Xu L, Wang B, Yu Y, Qian BP, Ding Y, Qiu Y (2013) Validation of the simplified Chinese version of the Core Outcome Measures Index (COMI). Eur Spine J 22:2821–2826. doi:10.1007/s00586-013-2761-1

    Article  PubMed  PubMed Central  Google Scholar 

  12. Monticone M, Ferrante S, Maggioni S, Grenat G, Checchia GA, Testa M, Teli MG, Mannion AF (2014) Reliability, validity and responsiveness of the cross-culturally adapted Italian version of the Core Outcome Measures Index (COMI) for the neck. Eur Spine J 23:863–872. doi:10.1007/s00586-013-3092-y

    Article  PubMed  Google Scholar 

  13. Genevay S, Marty M, Courvoisier DS, Foltz V, Mahieu G, Demoulin C, Fontana AG, Norberg M, de Goumoens P, Cedraschi C, Rozenberg S, Section Rachisde la Societe Francaise de R (2014) Validity of the French version of the Core Outcome Measures Index for low back pain patients: a prospective cohort study. Eur Spine J 23:2097–2104. doi:10.1007/s00586-014-3325-8

    Article  PubMed  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  15. 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  PubMed Central  Google Scholar 

  16. 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 18(Suppl 3):312–320

    Article  PubMed  PubMed Central  Google Scholar 

  17. Neukamp M, Perler G, Pigott T, Munting E, Aebi M, Roder C (2013) Spine Tango annual report 2012. Eur Spine J 22(Suppl 5):767–786. doi:10.1007/s00586-013-2943-x

    Article  PubMed  PubMed Central  Google Scholar 

  18. Deyo RA, Diehr P, Patrick DL (1991) Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation. Controll Clin Trials 12(Suppl):142–158

    Article  Google Scholar 

  19. Kirschner Guyatt A (1985) A methodological framework for assessing health indices. J Chron Dis 38:27–36

    Article  Google Scholar 

  20. Mannion AF, Fekete TF, Wertli MM, Mattle M, Nauer S, Kleinstuck FS, Jeszenszky D, Haschtmann D, Becker HJ, Porchet F (2015) Could less be more when assessing patient-rated outcome in spinal stenosis? Spine (Phila Pa 1976) 40:710–718. doi:10.1097/BRS.0000000000000751

    Article  Google Scholar 

  21. Haher TR, Gorup JM, Shin TM, Homel P, Merola AA, Grogan DP, Pugh L, Lowe TG, Murray M (1999) Results of the Scoliosis Research Society instrument for evaluation of surgical outcome in adolescent idiopathic scoliosis. A multicenter study of 244 patients. Spine (Phila Pa 1976) 24:1435–1440

    Article  CAS  Google Scholar 

  22. Asher MA, Min Lai S, Burton DC (2000) Further development and validation of the Scoliosis Research Society (SRS) outcomes instrument. Spine (Phila Pa 1976) 25:2381–2386

    Article  CAS  Google Scholar 

  23. Asher MA, Lai SM, Glattes RC, Burton DC, Alanay A, Bago J (2006) Refinement of the SRS-22 health-related quality of life questionnaire function domain. Spine (Phila Pa 1976) 31:593–597. doi:10.1097/01.brs.0000201331.50597.ea

    Article  Google Scholar 

  24. Bridwell KH, Cats-Baril W, Harrast J, Berven S, Glassman S, Farcy JP, Horton WC, Lenke LG, Baldus C, Radake T (2005) The validity of the SRS-22 instrument in an adult spinal deformity population compared with the Oswestry and SF-12: a study of response distribution, concurrent validity, internal consistency, and reliability. Spine (Phila Pa 1976) 30:455–461

    Article  Google Scholar 

  25. Bago J, Climent JM, Ey A, Perez-Grueso FJ, Izquierdo E (2004) The Spanish version of the SRS-22 patient questionnaire for idiopathic scoliosis: transcultural adaptation and reliability analysis. Spine (Phila Pa 1976) 29:1676–1680

    Article  Google Scholar 

  26. Pellise F, Vila-Casademunt A, Ferrer M, Domingo-Sabat M, Bago J, Perez-Grueso FJ, Alanay A, Mannion AF, Acaroglu E (2015) Impact on health related quality of life of adult spinal deformity (ASD) compared with other chronic conditions. Eur Spine J 24:3–11. doi:10.1007/s00586-014-3542-1

    Article  PubMed  Google Scholar 

  27. Genevay S, Cedraschi C, Marty M, Rozenberg S, de Goumoens P, Faundez A, Balague F, Porchet F, Mannion A (2009) Reliability and validity of the cross-culturally adapted French version of the Core Outcome Measures Index (COMI). Eur Spine J 18:S478

    Google Scholar 

  28. Fairbank JC, Couper J, Davies JB, O’Brien JP (1980) The Oswestry low back pain questionnaire. Physiotherapy 66:271–273

    CAS  PubMed  Google Scholar 

  29. Ware JE (2000) SF-36 health survey update. Spine 25:3130–3139

    Article  PubMed  Google Scholar 

  30. Juniper EF, Guyatt GH, Willan A, Griffith LE (1994) Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 47:81–87. doi:10.1016/0895-4356(94)90036-1

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

    Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  34. Husted JA, Cook RJ, Farewell VT, Gladman DD (2000) Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol 53:459–468. doi:10.1016/S0895-4356(99)00206-1

    Article  CAS  PubMed  Google Scholar 

  35. DeLong ER, DeLong DM, Clarke-Pearson DL (1988) Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics 44:837–845

    Article  CAS  PubMed  Google Scholar 

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

    Article  Google Scholar 

  37. Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I (2002) Increasing response rates to postal questionnaires: systematic review. BMJ 324:1183

    Article  PubMed  PubMed Central  Google Scholar 

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

    Article  PubMed  PubMed Central  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

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

    CAS  PubMed  Google Scholar 

  41. Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK (2014) Focus article: report of the NIH task force on research standards for chronic low back pain. Eur Spine J 23:2028–2045. doi:10.1007/s00586-014-3540-3

    Article  PubMed  Google Scholar 

  42. Klemencsics I, Lazary A, Valasek T, Szoverfi Z, Bozsodi A, Eltes P, Fekete TF, Varga PP (2015) Cross-cultural adaptation and validation of the Hungarian version of the Core Outcome Measures Index for the back (COMI Back). Eur Spine J. doi:10.1007/s00586-014-3750-8

    PubMed  Google Scholar 

  43. 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  PubMed Central  Google Scholar 

  44. Bess S, Boachie-Adjei O, Burton D, Cunningham M, Shaffrey C, Shelokov A, Hostin R, Schwab F, Wood K, Akbarnia B (2009) Pain and disability determine treatment modality for older patients with adult scoliosis, while deformity guides treatment for younger patients. Spine (Phila Pa 1976) 34:2186–2190. doi:10.1097/BRS.0b013e3181b05146

    Article  Google Scholar 

  45. Abbott JH, Schmitt JS (2014) The Patient-specific functional scale was valid for group-level change comparisons and between-group discrimination. J Clin Epidemiol 67:681–688. doi:10.1016/j.jclinepi.2013.11.002

    Article  PubMed  Google Scholar 

  46. Balague F, Mannion AF, Pellise F, Cedraschi C (2007) Clinical update: low back pain. Lancet 369:726–728

    Article  PubMed  Google Scholar 

  47. Weiner BK (2003) Letter Re: Walsh TL, Hanscom B, Lurie JD, et al. 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 2003;28:607–15. Spine 28:2304–2305

    Article  PubMed  Google Scholar 

  48. 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  CAS  PubMed  Google Scholar 

  49. Campbell H, Rivero-Arias O, Johnston K, Gray A, Fairbank J, Frost H (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 31:815–822

    Article  PubMed  Google Scholar 

  50. George SZ, Hirsch AT (2005) Distinguishing patient satisfaction with treatment delivery from treatment effect: a preliminary investigation of patient satisfaction with symptoms after physical therapy treatment of low back pain. Arch Phys Med Rehabil 86:1338–1344

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

This study was partially supported by a Depuy Synthes Research grant and by the Schulthess Klinik Research Fund. We are grateful to Montse Ferrer for her assistance and advice.

Author information

Authors and Affiliations

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

    A. F. Mannion, S. Wunderlin & F. S. Kleinstück

  2. Spine Research Unit, Vall d’Hebron Institute of Research, Barcelona, Spain

    A. Vila-Casademunt & M. Domingo-Sàbat

  3. Spine Surgery Unit, Hospital Vall d’Hebron, Barcelona, Spain

    F. Pellisé & J. Bago

  4. Spine Surgery Unit, Ankara Spine Center, Ankara, Turkey

    E. Acaroglu

  5. Spine Surgery Unit, Acibadem Maslak Hospital, Istanbul, Turkey

    A. Alanay

  6. Spine Surgery Unit, Hospital Universitario La Paz, Madrid, Spain

    F. S. Pérez-Grueso

  7. Spine Surgery Unit, Pellegrin Hospital, Bordeaux University Hospital, Bordeaux, France

    I. Obeid

Authors
  1. A. F. Mannion
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. A. Vila-Casademunt
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. M. Domingo-Sàbat
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. S. Wunderlin
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. F. Pellisé
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. J. Bago
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. E. Acaroglu
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. A. Alanay
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. F. S. Pérez-Grueso
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. I. Obeid
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. F. S. Kleinstück
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

European Spine Study Group (ESSG)

Corresponding author

Correspondence to A. F. Mannion.

Ethics declarations

Conflict of interest statement

None of the authors has any potential conflict of interest.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Mannion, A.F., Vila-Casademunt, A., Domingo-Sàbat, M. et al. The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity. Eur Spine J 25, 2638–2648 (2016). https://doi.org/10.1007/s00586-015-4292-4

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00586-015-4292-4

Keywords

Search

Navigation