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Outcome measures in chronic low back pain

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Abstract

The purpose of this prospective, single site cohort quasi-experimental study was to determine the responsiveness of the numerical rating scale (NRS), Roland–Morris disability questionnaire (RMDQ), Oswestry disability index (ODI), pain self-efficacy questionnaire (PSEQ) and the patient-specific functional scale (PSFS) in order to determine which would best measure clinically meaningful change in a chronic low back pain (LBP) population. Several patient-based outcome instruments are currently used to measure treatment effect in the chronic LBP population. However, there is a lack of consensus on what constitutes a “successful” outcome, how an important improvement/deterioration has been defined and which outcome measure(s) best captures the effectiveness of therapeutic interventions for the chronic LBP population. Sixty-three consecutive patients with chronic LBP referred to a back exercise and education class participated in this study; 48 of the 63 patients had complete data. Five questionnaires were administered initially and after the 5-week back class intervention. Also at 5 weeks, patients completed a global impression of change as a reflection of meaningful change in patient status. Score changes in the five different questionnaires were subjected to both distribution- and anchor-based methods: standard error of measurement (SEM) and receiver operating characteristic (ROC) curves to define clinical improvement. From these methods, the minimal clinically important difference (MCID) defined as the smallest difference that patients and clinicians perceive to be worthwhile is presented for each instrument. Based on the SEM, a point score change of 2.4 in the NRS, 5 in the RMDQ, 17 in the ODI, 11 on the PSEQ, and 1.4 on the PSFS corresponded to the MCID. Based on ROC curve analysis, a point score change of 4 points for both the NRS and RMDQ, 8 points for the ODI, 9 points for the PSEQ and 2 points for the PSFS corresponded to the MCID. The ROC analysis demonstrated that both the PSEQ and PSFS are responsive to clinically important change over time. The NRS was found to be least responsive. The exact value of the MCID is not a fixed value and is dependent on the assessment method used to calculate the score change. Based on ROC curve analysis the PSFS and PSEQ were more responsive than the other scales in measuring change in patients with chronic LBP following participation in a back class programme. However, due to the small sample size, the lack of observed worsening of symptoms over time, the single centre and intervention studied these results which need to be interpreted with caution.

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References

  1. Waddell G (2006) Preventing incapacity in people with musculoskeletal disorders. Br Med Bull 77–78:55–69

    Article  PubMed  Google Scholar 

  2. Turk DC, Dworkin RH, Revichi D et al (2008) Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain. Pain 137:276–285

    Article  PubMed  Google Scholar 

  3. Taylor W (2005) Musculoskeletal pain in adult New Zealand population: prevalence and impact. N Z Med J 118:1221

    Google Scholar 

  4. Lewis J, Hewitt J, Billington L et al (2005) A randomized control trial comparing two physiotherapy interventions for chronic low back pain. Spine 30:711–721

    Article  PubMed  Google Scholar 

  5. Heymans M, van Tulder M, Esmail R et al (2005) Back schools for nonspecific low back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine 30:2153–2163

    Article  CAS  PubMed  Google Scholar 

  6. NICE clinical guideline 88 (May 2009) Low back pain. Early management of persistent non-specific low back pain

  7. Underwood M, Morton V, Farrin A (2007) Do baseline characteristics predict response to treatment for low back pain? Secondary analysis of the UK BEAM dataset. Rheumatology 46(8):1297–1302

    Google Scholar 

  8. Turk DC (2002) Clinical effectiveness and cost-effectiveness of treatments for patients with chronic pain. Clin J Pain 18:355–365

    Article  PubMed  Google Scholar 

  9. O’Sullivan P (2005) Diagnosis and classification of chronic low back pain disorders: maladaptive movement and control impairments as underlying mechanism. Man Ther 10:116–121

    Article  Google Scholar 

  10. Wand BM, O’Connell NE (2008) Chronic non-specific low back pain—sub-groups or a single mechanism? BMC Musculoskelet Disord 9:11

    Article  PubMed  Google Scholar 

  11. Hurst H, Bolton J (2004) Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther 27:26–35

    Article  PubMed  Google Scholar 

  12. Beaton D, Tarasuk V, Katz J et al (2001) Are you better? A qualitative study into the meaning of being better and its implications for health status measurement. Arthritis Rheumatol 42(supplement):S274

    Google Scholar 

  13. Terwee C (2003) On assessing responsiveness of health-related quality of life instruments: guidelines for instrument evaluation. Qual Life Res 12:349–362

    Article  CAS  PubMed  Google Scholar 

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

    PubMed  Google Scholar 

  15. Jaeschke R, Singer J, Guyatt G (1989) Measurement of health status. Ascertaining the minimal clinical important difference. Control Clin Trials 10:407–415

    Article  CAS  PubMed  Google Scholar 

  16. Crosby R, Kolotkin R, Williams G (2003) Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 56:395–407

    Article  PubMed  Google Scholar 

  17. Fritz J, Irrgang J (2001) A comparison of a modified Oswestry low back pain disability questionnaire and the Quebec back pain disability scale. Phys Ther 81:776–788

    Google Scholar 

  18. Terwee C (2007) Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 60:34–42

    Article  PubMed  Google Scholar 

  19. Dworkin RH, Turk DC, Farrar JT (2005) Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 113:9–19

    Article  PubMed  Google Scholar 

  20. Lauridsen H, Hartvigsen J, Korsholm L et al (2007) Choice of external criteria in back pain research: Does it matter? Recommendations based on analysis of responsiveness. Pain 131:112–120

    Article  PubMed  Google Scholar 

  21. Ostelo R, Deyo R, Stratford P et al (2008) Interpreting change scores for pain and functional status in low back pain. Spine 33:90–94

    Article  PubMed  Google Scholar 

  22. 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

    Google Scholar 

  23. Fairbank J, Pynsent P (2000) The Oswestry disablility index. Spine 25:2940–2953

    Google Scholar 

  24. Nicholas M (1989) Self-efficacy and chronic pain. Paper presented at the annual conference of the British Psychological Society, St. Andrews

  25. Stratford P, Gill C, Westaway M et al (1995) Assessing disability and change on individual patients: a report of a patient specific measure. Physiother Can 47:258–263

    Article  Google Scholar 

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

    PubMed  Google Scholar 

  27. De Vet H, Terwee C, Knol D, Bouter L (2006) When to use agreement versus reliability measures. J Clin Epidemiol 59:1033–1039

    Article  PubMed  Google Scholar 

  28. Ostelo R, de Vet H (2005) Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol 19:593–607

    Article  PubMed  Google Scholar 

  29. 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  CAS  PubMed  Google Scholar 

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

    Article  CAS  PubMed  Google Scholar 

  31. Grotle M, Brox JL, Vallestad N (2004) Functional status and disability questionnaires: what do they assess? A systematic review of back-specific outcome questionnaires. Spine 30:130–140

    Google Scholar 

  32. Brouwer S, Kuijer W, Dijkstra P, Goeken L et al (2003) Reliability and stability of the Roland Morris questionnaire: intraclass correlation and limits of agreement. Disabil Rehabil 26:162–165

    Article  Google Scholar 

  33. Department of Health (2008) High quality care for all—NHS next stage review final report, section 4. Quality at the heart of everything we do, Crown Copyright, The Stationery Office, p 47. http://www.tsoshop.co.uk

  34. Wyrwich K, Tierney W, Wolinsky F (1999) Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 52:861–873

    Article  CAS  PubMed  Google Scholar 

  35. Childs J, Riva S, Fritz J (2005) Responsiveness of the numeric pain rating scale in patients with low back pain. Spine 30:1331–1334

    Article  PubMed  Google Scholar 

  36. Stratford P, Binkley J, Riddle D, Guyatt G (1998) Sensitivity to change of the Roland-Morris back pain questionnaire: Part 1. Phys Ther 78:1186–1196

    CAS  PubMed  Google Scholar 

  37. Wyrwich K (2004) Minimal important difference thresholds and the standard error of measurement: is there a connection? J Biopharm Stat 14:97–110

    Article  PubMed  Google Scholar 

  38. Farrar JT, Young J, LaMoreaux L et al (2001) Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 94:149–158

    Article  CAS  PubMed  Google Scholar 

  39. Salaffi F, Stancati A, Silvestri C, Ciapetti A, Grassi W (2004) Minimal critical important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain 8:165–172

    Article  Google Scholar 

  40. Baldwin ML, Butler RJ, Johnson WG et al (2007) Self-reported severity measures as predictors of return to work outcomes in occupational back pain. J Occup Rehabil 17:68

    Article  Google Scholar 

  41. Beurskens A, de Vet H, Koke A (1999) A patient specific approach for measuring functional status in low back pain. J Manipulative Physiol Ther 22:144–148

    Article  CAS  PubMed  Google Scholar 

  42. Pengel L, Refshauge K, Maher C (2004) Responsiveness of pain, disability, and physical impairment outcomes in patients with low back pain. Spine 29:879–883

    Article  PubMed  Google Scholar 

  43. Chatman A, Hyams S, Neel J et al (1997) The patient specific functional scale: measurement properties in patients with knee dysfunction. Phys Ther 77:820–829

    CAS  PubMed  Google Scholar 

  44. Hudak P, Wright J (2004) The characteristics of patient satisfaction measures. Spine 25:3167–3317

    Article  Google Scholar 

  45. Asghari A, Nicholas M (2001) Pain self-efficacy beliefs and pain behaviour. A prospective study. Pain 94:85–100

    Article  CAS  PubMed  Google Scholar 

  46. Nicholas M (2007) The Pain self efficacy questionnaire: taking pain into account. Eur J Pain 11:153–163

    Article  PubMed  Google Scholar 

  47. Williams A, Richardson P, Nicholas M, Pither C, Harding V, Ralphs J (1996) Inpatient versus outpatient pain management results of a chronic pain trial. Pain 66:13–22

    Article  CAS  PubMed  Google Scholar 

  48. Norman G, Stratford P, Regehr G (1997) Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. J Clin Epidemiol 50:869–879

    Article  CAS  PubMed  Google Scholar 

  49. Schmitt J, Di Fabio R (2005) The value of prospective and retrospective global change criterion measures. Arch Phys Med Rehabil 86:2270–2276

    Article  PubMed  Google Scholar 

  50. Von Korff M, Jensen P, Karoli P (2000) Assessing global pain severity by self-report in clinical and health services research. Spine 25:3140–3151

    Article  Google Scholar 

  51. De Vet H (2007) Reproducibility and responsiveness of evaluative outcome measures. Int J Technol Assess Health Care 17:479–487

    Google Scholar 

  52. Yelland J, Schluter P (2006) Defining worthwhile and desired responses to treatment of chronic low back pain. Pain Med 7:38–45

    Article  PubMed  Google Scholar 

  53. Walsh D, Kelly S, Johnson P et al (2003) Performance problems of patients with chronic low back pain and the measurement of patient-centered outcome. Spine 29:87–93

    Article  Google Scholar 

  54. Westaway M, Stratford P, Binkley J (1998) The patient specific functional scale: validation of its use in persons with neck dysfunction. J Sports Phys Ther 27:331–338

    CAS  Google Scholar 

  55. Jordan K, Dunn K, Lewis M et al (2006) A minimal clinically important difference was derived for the Roland-Morris disability questionnaire for low back pain. J Clin Epidemiol 59:45–52

    Article  PubMed  Google Scholar 

  56. Dworkin R, Turk D, Wyrwrich K, Beaton D et al (2008) Interpreting the clinical importance of treatment outcomes in chronic pain trials: IMMPACT recommendations. J Pain 9:105–121

    Article  PubMed  Google Scholar 

  57. Haywood K (2006) Patient reported outcome I: Measuring what matters in musculoskeletal care. Musculoskeletal Care 4:187–203

    Article  PubMed  Google Scholar 

  58. Greenhalgh J, Long A, Flynn (2005) The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory? Soc Sci Med 60:833–843

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Authors and Affiliations

  1. Guy’s and St Thomas’ NHS Trust, London, UK

    Elaine F. Maughan

  2. St George’s NHS Healthcare Trust, London, UK

    Jeremy S. Lewis

  3. St George’s University of London, London, UK

    Jeremy S. Lewis

  4. Therapy Department, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK

    Jeremy S. Lewis

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  1. Elaine F. Maughan
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  2. Jeremy S. Lewis
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Correspondence to Elaine F. Maughan.

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Maughan, E.F., Lewis, J.S. Outcome measures in chronic low back pain. Eur Spine J 19, 1484–1494 (2010). https://doi.org/10.1007/s00586-010-1353-6

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