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A comparison between different outcome measures based on “meaningful important differences” in patients with lumbar spinal stenosis

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Abstract

Purpose

Patient-reported outcome measures (PROM) are used to measure treatment efficacy in clinical trials. The impact of the choice of a PROM and the cut-off values for ‘meaningful important differences’ (MID) on the study results in patients with lumbar spinal stenosis (LSS) is unclear.

Objective

The objective is to study the consequences of applying different PROMs and values for MID for pain and disability on the proportions of patients with improvement.

Design

Prospective multi-center cohort study.

Methods

Proportions of patients with improvement using established MID cut-off values were calculated and compared for PROMs for pain and disability.

Results

466 patients with LSS completed a baseline and 6-month follow-up assessment and were analyzed. Treatment modalities included surgery (65 %), epidural steroid injections (15 %), or conservative care (20 %). The prevalence of patients fulfilling the criteria for MID ranged from 40 to 70 % across all outcome measures and cut-offs. The agreement of the spinal stenosis outcome measure (SSM) symptom subscale with other pain scales, and the SSM function subscale with other function scales was fair to moderate (Cohen’s κ value between 0.24 and 0.5). Disagreement in the assessment of MID (MID reported by patients in one scale but not the other) was found in at least one-third of the patients.

Conclusion

The MID in outcome scores for this population varied from 40 to 70 %, depending on the measure or cut-off score used. Further, the disagreement between domain specific measures indicates that differences between studies may be also related to the choice of an outcome measures. An international consensus on the use and reporting of outcome measures in studies on lumbar spinal stenosis is needed.

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References

  1. Barrett B, Brown D, Mundt M, Brown R (2005) Sufficiently important difference: expanding the framework of clinical significance. Med Decis Making 25:250–261. doi:10.1177/0272989X05276863

    Article  PubMed  Google Scholar 

  2. Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN (1996) Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine (Phila Pa 1976) 21:796–803

    Article  CAS  Google Scholar 

  3. Cleland J, Whitman J, Houser J, Wainner R, Childs J (2012) Psychometric properties of selected tests in patients with lumbar spinal stenosis. The spine journal 12:921–931

    Article  PubMed  Google Scholar 

  4. Pratt RK, Fairbank JC, Virr A (2002) The reliability of the Shuttle Walking Test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis. Spine (Phila Pa 1976) 27:84–91

    Article  Google Scholar 

  5. Sekiguchi M, Wakita T, Otani K, Onishi Y, Fukuhara S, Kikuchi S, Konno S (2012) Development and validation of a symptom scale for lumbar spinal stenosis. Spine (Phila Pa 1976) 37:232–239. doi:10.1097/BRS.0b013e318216afb4

    Article  Google Scholar 

  6. EuroQol Group (1990) EuroQol—a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 16:199–208

    Article  Google Scholar 

  7. Steurer J, Nydegger A, Held U, Brunner F, Hodler J, Porchet F, Min K, Mannion AF, Michel B (2010) LumbSten: the lumbar spinal stenosis outcome study. BMC Musculoskelet Disord 11:254. doi:10.1186/1471-2474-11-254

    Article  PubMed  PubMed Central  Google Scholar 

  8. World Medical Assembly (WMA) (2006) WMA Declaration of Helsinki-Ethical principles for medical research involving human subjects. Adopted by the 18th WMA general assembly, Helsinki, Finland, June 1964 and amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. http://www.wma.net/en/30publications/30ethicsmanual/index.html

  9. Fokter SK, Yerby SA (2006) Patient-based outcomes for the operative treatment of degenerative lumbar spinal stenosis. Eur Spine J 15:1661–1669. doi:10.1007/s00586-005-0033-4

    Article  PubMed  Google Scholar 

  10. Thornes E, Grotle M (2008) Cross-cultural adaptation of the Norwegian version of the spinal stenosis measure. Eur Spine J 17:456–462. doi:10.1007/s00586-007-0576-7

    Article  PubMed  PubMed Central  Google Scholar 

  11. Wertli MM, Steurer J, Wildi LM, Held U (2014) Cross-cultural adaptation of the German version of the spinal stenosis measure. Eur Spine J 23:1309–1319. doi:10.1007/s00586-014-3245-7

    Article  PubMed  Google Scholar 

  12. Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA (1978) Studies with pain rating scales. Ann Rheum Dis 37:378–381. doi:10.1136/ard.37.4.378

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Kremer E, Atkinson JH, Ignelzi RJ (1981) Measurement of pain: patient preference does not confound pain measurement. Pain 10:241–248

    Article  CAS  PubMed  Google Scholar 

  14. Choinière M, Amsel R (1996) A visual analogue thermometer for measuring pain intensity. J Pain Symptom Manag 11:299–311

    Article  Google Scholar 

  15. Roland M, Morris R (1983) A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Philadelphia, Pa 1976) 8:141–144

    Article  CAS  Google Scholar 

  16. Exner V, Keel P (2000) Measuring disability of patients with low-back pain—validation of a German version of the Roland and Morris disability questionnaire. Schmerz 14:392–400

    Article  CAS  PubMed  Google Scholar 

  17. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC (2008) Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976) 33:90–94. doi:10.1097/BRS.0b013e31815e3a10

    Article  Google Scholar 

  18. Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Sullivan SD, Bauer Z, Bresnahan BW, Avins AL, Nedeljkovic SS, Nerenz DR, Standaert C, Kessler L, Akuthota V, Annaswamy T, Chen A, Diehn F, Firtch W, Gerges FJ, Gilligan C, Goldberg H, Kennedy DJ, Mandel S, Tyburski M, Sanders W, Sibell D, Smuck M, Wasan A, Won L, Jarvik JG (2014) A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med 371:11–21. doi:10.1056/NEJMoa1313265

    Article  PubMed  Google Scholar 

  19. Minamide A, Yoshida M, Yamada H, Nakagawa Y, Hashizume H, Iwasaki H, Tsutsui S (2015) Clinical outcomes after microendoscopic laminotomy for lumbar spinal stenosis: a 5-year follow-up study. Eur Spine J 24:396–403. doi:10.1007/s00586-014-3599-x

    Article  PubMed  Google Scholar 

  20. Roland M, Fairbank J (2000) The Roland–Morris disability questionnaire and the Oswestry disability questionnaire. Spine (Phila Pa 1976) 25:3115–3124

    Article  CAS  Google Scholar 

  21. Viera AJ, Garrett JM (2005) Understanding interobserver agreement: the kappa statistic. Fam Med 37:360–363

    PubMed  Google Scholar 

  22. Sim J, Wright CC (2005) The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther 85:257–268

    PubMed  Google Scholar 

  23. Vach W (2005) The dependence of Cohen’s kappa on the prevalence does not matter. J Clin Epidemiol 58:655–661. doi:10.1016/j.jclinepi.2004.02.021

    Article  PubMed  Google Scholar 

  24. Core Team R (2013) R: A language and environment for statistical computing. In: Core Team R (ed) R Foundation for statistical computing. R Core Team, Vienna

    Google Scholar 

  25. Parker SL, Adogwa O, Mendenhall SK, Shau DN, Anderson WN, Cheng JS, Devin CJ, McGirt MJ (2012) Determination of minimum clinically important difference (MCID) in pain, disability, and quality of life after revision fusion for symptomatic pseudoarthrosis. Spine J 12:1122–1128. doi:10.1016/j.spinee.2012.10.006

    Article  PubMed  Google Scholar 

  26. Munting E, Roder C, Sobottke R, Dietrich D, Aghayev E, Spine Tango C (2015) Patient outcomes after laminotomy, hemilaminectomy, laminectomy and laminectomy with instrumented fusion for spinal canal stenosis: a propensity score-based study from the Spine Tango registry. Eur Spine J 24:358–368. doi:10.1007/s00586-014-3349-0

    Article  PubMed  Google Scholar 

  27. Mannion AF, Fekete TF, Wertli MM, Mattle M, Nauer S, Kleinstuck FS, Jeszenszky D, Haschtmann D, Becker HJ, Porchet F, Lumbar Spinal Stenosis Outcome Study Group (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 

  28. Machado GC, Ferreira PH, Harris IA, Pinheiro MB, Koes BW, van Tulder M, Rzewuska M, Maher CG, Ferreira ML (2015) Effectiveness of surgery for lumbar spinal stenosis: a systematic review and meta-analysis. PLoS ONE 10:e0122800. doi:10.1371/journal.pone.0122800

    Article  PubMed  PubMed Central  Google Scholar 

  29. Pincus T, Santos R, Breen A, Burton AK, Underwood M, Multinational Musculoskeletal Inception Cohort Study Collaboration (2008) A review and proposal for a core set of factors for prospective cohorts in low back pain: a consensus statement. Arthritis Rheum 59:14–24. doi:10.1002/art.23251

    Article  PubMed  Google Scholar 

  30. Burgstaller JM, Porchet F, Steurer J, Wertli MM (2015) Arguments for the choice of surgical treatments in patients with lumbar spinal stenosis—a systematic appraisal of randomized controlled trials. BMC Musculoskelet Disord 16:96. doi:10.1186/s12891-015-0548-8

    Article  PubMed  PubMed Central  Google Scholar 

  31. Gum JL, Glassman SD, Carreon LY (2013) Clinically important deterioration in patients undergoing lumbar spine surgery: a choice of evaluation methods using the Oswestry Disability Index, 36-Item Short Form Health Survey, and pain scales: clinical article. J Neurosurg Spine 19:564–568. doi:10.3171/2013.8.spine12804

    Article  PubMed  Google Scholar 

  32. Lurie JD, Spratt KF, Blood EA, Tosteson TD, Tosteson AN, Weinstein JN (2011) Effects of viewing an evidence-based video decision aid on patients’ treatment preferences for spine surgery. Spine (Phila Pa 1976) 36:1501–1504. doi:10.1097/BRS.0b013e3182055c1e

    Article  Google Scholar 

  33. Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH (2014) Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 1:Cd001431. doi:10.1002/14651858.CD001431.pub4

    Google Scholar 

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Acknowledgments

We thank our research staff at all studies sites for their continuous meticulous work to include and follow-up with patients. In particular, we thank MM and GP for their efforts to assure high quality data intake and database handling.

Author information

Authors and Affiliations

  1. Horten Centre for Patient Oriented Research and Knowledge Transfer, Department of Internal Medicine, University of Zurich, Pestalozzistrasse 24, 8032, Zurich, Switzerland

    Maria M. Wertli, Franziska Christina Buletti, Ulrike Held, Jakob M. Burgstaller & Johann Steurer

  2. NYU Hospital for Joint Diseases, Occupational and Industrial Orthopaedic Center (OIOC), New York University, 63 Downing Street, New York, NY, 10014, USA

    Maria M. Wertli, Eva Rasmussen-Barr & Sherri Weiser

  3. Department of General Internal Medicine, Inselspital, Bern University Hospital, 3010, Bern, Switzerland

    Maria M. Wertli

  4. Institute of Environmental Medicine, Karolinska Institutet, Box 210, 17177, Stockholm, Sweden

    Eva Rasmussen-Barr

Authors
  1. Maria M. Wertli
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  2. Franziska Christina Buletti
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  3. Ulrike Held
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  4. Eva Rasmussen-Barr
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  5. Sherri Weiser
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  6. Jakob M. Burgstaller
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  7. Johann Steurer
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Corresponding author

Correspondence to Maria M. Wertli.

Ethics declarations

Funding sources and role of sponsors

The lumbar stenosis outcome study (LSOS) was funded by the Helmut Horten Foundation, OPO-Foundations, Symphasis Foundation, Baugarten Foundation, and the Pfizer-Foundation for geriatrics and research in geriatrics. The funders had no influence on the study design, on the data collection, data management, statistical analysis, the interpretation of the data, the content of the manuscript, and the decision to submit the paper for publication.

Conflict of interest

The authors declare no financial interests or affiliations with institutions, organizations, or companies relevant to the manuscript. All authors had full access to the data, interpreted the analysis and commented on the final manuscript.

Ethical statement

This cohort study was conducted in compliance with all international laws and regulations as well as any applicable guidelines. The study was approved by the independent Ethics Committee of the Canton Zurich (KEK-ZH-NR: 2010-0395/0). A study protocol was published: Steurer et al. [7].

Appendices

Appendix 1

See Fig. 3.

Fig. 3
figure 3

Study flow

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Appendix 2

See Table 6.

Table 6 Meaningful important difference (MID) for the SSM subscales
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Wertli, M.M., Buletti, F.C., Held, U. et al. A comparison between different outcome measures based on “meaningful important differences” in patients with lumbar spinal stenosis. Eur Spine J 26, 450–461 (2017). https://doi.org/10.1007/s00586-016-4587-0

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  • DOI: https://doi.org/10.1007/s00586-016-4587-0

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