Skip to main content
SpringerLink
Log in

Cross-cultural adaptation, validation and establishment of the minimal clinically important change score of the European Portuguese core outcome measures index in patients with lumbar degenerative spine disease

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

Abstract

Purpose

The core outcome measures index (COMI) for the back is a questionnaire that evaluates five domains and has been translated into several languages and validated for different populations. We aimed to translate, cross-culturally adapt and validate it in European Portuguese for use in patients with degenerative lumbar disease. Additionally, we aimed to establish the minimal clinically important change score (MCIC).

Methods

The translation and cultural adaptation were done according to published guidelines. Patients awaiting surgery at a neurosurgical center completed the COMI, Oswestry Disability Index (ODI), EQ-5D questionnaires and a pain visual analog scale (VAS). To evaluate COMI’s reproducibility, patients completed the questionnaire twice within two weeks, preoperatively, in addition to answering a transition question. The MCIC was determined by analysis of postoperative changes in total COMI score, using the anchor method, with a question ascertaining surgical outcome as perceived by the patient.

Results

The first set of questionnaires was answered by 108 patients and the second, by 98 patients. COMI's construct validity was confirmed by demonstrating the hypothesized correlation between each domain’s score (Spearman Rho > 0.4) and the corresponding questionnaire score (ODI, EQ-5D and VAS) and through adequate correlation (Spearman > 0.6) between COMI's total score and ODI and EQ-5D total scores. Intraclass correlation coefficients between each domain and COMI’s total score were > 0.8. The MCIC was calculated as 2.1.

Conclusion

The cross-culturally adapted COMI questionnaire is a valid clinical assessment tool for European Portuguese-speaking patients with degenerative lumbar disease, with an MCIC of 2.1 points.

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. McCormick JD, Werner BC, Shimer AL (2013) Patient-reported outcome measures in spine surgery. J Am Acad Orthop Surg 21:99–107

    Article  PubMed  Google Scholar 

  2. Nayak NR, Coats JM, Abdullah KG, Stein SC, Malhotra NR (2015) Tracking patient-reported outcomes in spinal disorders. Surg Neurol Int 6(19):S490–S499. https://doi.org/10.4103/2152-7806.166892

    Article  PubMed  PubMed Central  Google Scholar 

  3. 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 Phila Pa (1976) 31(12):1372–1379. https://doi.org/10.1097/01.brs.0000218477.53318.bc

    Article  PubMed  Google Scholar 

  4. 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 1: the core outcome measures index in clinical practice. Eur Spine J 18(3):367–373. https://doi.org/10.1007/s00586-009-0942-8

    Article  PubMed  PubMed Central  Google Scholar 

  5. Damasceno LH, Rocha PA, Barbosa ES, Barros CA, Canto FT, Defino HL, Mannion AF (2012) 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(7):1273–1282. https://doi.org/10.1007/s00586-011-2100-3

    Article  CAS  PubMed  Google Scholar 

  6. Silva AS (2008) Integrando a variação social e métodos quantitativos na investigação sobre linguagem e cognição: para uma sociolinguística cognitiva do português europeu e brasileiro. Rev Est Ling 16(1):49–81. https://doi.org/10.17851/2237-2083.16.1.49-81

    Article  Google Scholar 

  7. Feldman-Bianco B (2001) Brazilians in Portugal, Portuguese in Brazil: constructions of sameness and difference. Identities Glob Stud Cult Power 8(4):607–650. https://doi.org/10.1080/1070289X.2001.9962710

    Article  Google Scholar 

  8. 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(1):34–42. https://doi.org/10.1016/j.jclinepi.2006.03.012

    Article  PubMed  Google Scholar 

  9. Martins NS (2002) Adaptação Cultural e Linguística do Owestry Low Back Pain Disability Índex – ODI 2.0 [Monografia]. Coimbra: Escola Superior de Tecnologia da Saúde de Coimbra

  10. Ferreira PL, Ferreira LN, Pereira LN (2013) Contributos para a Validação da Versão Portuguesa do EQ-5D [Contribution for the validation of the Portuguese version of EQ-5D]. Acta Med Port 26(6):664–675

    Article  PubMed  Google Scholar 

  11. Ferreira PL, Antunes P, Ferreira LN, Pereira LN, Ramos-Goñi JM (2019) A hybrid modelling approach for eliciting health state preferences: the Portuguese EQ-5D-5L value set. Quality life Res Int J quality life Asp Treat care Rehabilit 28(12):3163–3175. https://doi.org/10.1007/s11136-019-02226-5

    Article  Google Scholar 

  12. Pochon L, Kleinstück FS, Porchet F, Mannion AF (2016) Influence of gender on patient-oriented outcomes in spine surgery. Eur Spine J 25(1):235–246. https://doi.org/10.1007/s00586-015-4062-3

    Article  CAS  PubMed  Google Scholar 

  13. Beaton DE, Bombardier C, Guillemin F, Ferraz MB (2000) Guidelines for the process of cross-cultural adaptation of self-report measures. Spine Phila Pa (1976) 25(24):3186–3191

    Article  CAS  PubMed  Google Scholar 

  14. Kim HJ, Yeom JS, Nam Y, Lee NK, Heo YW, Lee SY, Park J, Chang BS, Lee CK, Chun HJ, Mannion AF (2018) Validation and cross-cultural adaptation of the Korean version of the core outcome measures index in patients with degenerative lumbar disease. Eur Spine J 27(11):2804–2813. https://doi.org/10.1007/s00586-018-5759-x

    Article  PubMed  Google Scholar 

  15. Matsudaira K, Oka H, Oshima Y, Chikuda H, Taniguchi Y, Matsubayashi Y, Kawaguchi M, Sato E, Murano H, Laurent T, Tanaka S, Mannion AF (2018) Development of the Japanese core outcome measures index (comi): cross-cultural adaptation and psychometric validation. BMC Musculoskelet Disord 19(1):71. https://doi.org/10.1186/s12891-018-1986-x

    Article  PubMed  PubMed Central  Google Scholar 

  16. Mannion AF, Porchet F, Kleinstück 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(3):374–379. https://doi.org/10.1007/s00586-009-0931-y

    Article  PubMed  PubMed Central  Google Scholar 

  17. Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D (2016) Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol 34(6):557–565. https://doi.org/10.1200/JCO.2015.63.0830

    Article  CAS  PubMed  Google Scholar 

  18. Nguyen H, Butow P, Dhillon H, Sundaresan P (2021) A review of the barriers to using patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) in routine cancer care. J Med Radiat Sci 68(2):186–195. https://doi.org/10.1002/jmrs.421

    Article  PubMed  Google Scholar 

  19. Abdeldaiem A, Saweeres ESB, Shehab-Eldien AA, Mannion AF, Rehan Youssef A (2020) Cross-cultural adaptation and validation of the Arabic version of the core outcome measures index for the back (COMI-back) in patients with non-specific low back pain. Eur Spine J 29(10):2413–2430. https://doi.org/10.1007/s00586-020-06530-4

    Article  PubMed  Google Scholar 

  20. 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 (2013) Cross-cultural adaptation and validation of the Polish version of the core outcome measures index for low back pain. Eur Spine J 22(5):995–1001. https://doi.org/10.1007/s00586-012-2607-2

    Article  PubMed  Google Scholar 

  21. Klemencsics I, Lazary A, Valasek T, Szoverfi Z, Bozsodi A, Eltes P, Fekete TF, Varga PP (2016) Cross-cultural adaptation and validation of the Hungarian version of the core outcome measures index for the back (COMI Back). Eur Spine J 25(1):257–264. https://doi.org/10.1007/s00586-014-3750-8

    Article  PubMed  Google Scholar 

  22. OECD/European Observatory on Health Systems and Policies (2021) Portugal: Country Health Profile 2021, State of Health in the EU, OECD Publishing, Paris/European Observatory on Health Systems and Policies, Brussels https://health.ec.europa.eu/system/files/2021-12/2021_chp_pt_english.pdf.

Download references

Acknowledgements

We would like to thank the translators involved in the cross-cultural adaptation and the office clerk at our institution for the important contribution to this work.

Author information

Authors and Affiliations

  1. Neurosurgery Department, Centro Hospitalar Universitário São João, Alameda Prof Hernâni Monteiro, 4200-319, Porto, Portugal

    Pedro Valente Aguiar, Pedro Santos Silva, Diana Lucas, Rui Vaz & Paulo Pereira

  2. Faculty of Medicine, Porto University, Porto, Portugal

    Pedro Valente Aguiar, Pedro Santos Silva, Diana Lucas, Rui Vaz & Paulo Pereira

  3. Neurosciences Centre, Hospital da CUF, Porto, Portugal

    Rui Vaz & Paulo Pereira

  4. Department of Teaching, Research and Development, Spine Division, Schulthess Klinik, Zurich, Switzerland

    Anne F. Mannion

Authors
  1. Pedro Valente Aguiar
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Pedro Santos Silva
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Diana Lucas
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Rui Vaz
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Paulo Pereira
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Anne F. Mannion
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Pedro Valente Aguiar.

Ethics declarations

Conflict of interest

There are no conflicts of interest for this manuscript.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PDF 435 KB)

Supplementary file2 (PDF 417 KB)

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Valente Aguiar, P., Santos Silva, P., Lucas, D. et al. Cross-cultural adaptation, validation and establishment of the minimal clinically important change score of the European Portuguese core outcome measures index in patients with lumbar degenerative spine disease. Eur Spine J 33, 394–400 (2024). https://doi.org/10.1007/s00586-023-08093-6

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00586-023-08093-6

Keywords

Search

Navigation