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What level of symptoms are patients with adult spinal deformity prepared to live with? A cross-sectional analysis of the 12-month follow-up data from 1043 patients

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Abstract

Introduction

Previous studies suggest that a meaningful and easily understood measure of treatment outcome may be the proportion of patients who are in a “patient acceptable symptom state” (PASS). We sought to quantify the score equivalent to PASS for different outcome instruments, in patients with adult spinal deformity (ASD).

Methods

We analysed the following 12-month questionnaire data from the European Spine Study Group (ESSG): Oswestry Disability Index (ODI; 0–100); Numeric Rating Scales (NRS; 0–10) for back/leg pain; Scoliosis Research Society (SRS) questionnaire; and an item “if you had to spend the rest of your life with the symptoms you have now, how would you feel about it?” (5-point scale, dichotomised with top 2 responses “somewhat satisfied/very satisfied” being considered PASS+, everything else PASS−). Receiver operating characteristics (ROC) analyses indicated the cut-off scores equivalent to PASS+.

Results

Out of 1043 patients (599 operative, 444 non-operative; 51 ± 19 years; 84% women), 42% reported being PASS+ at 12 months’ follow-up. The ROC areas under the curve were 0.71–0.84 (highest for SRS subscore), suggesting the questionnaire scores discriminated well between PASS+ and PASS−. The scores corresponding to PASS+ were > 3.5 for the SRS subscore (> 3.3–3.8 for SRS subdomains); ≤ 18 for ODI; and ≤ 3 for NRS pain. There were slight differences in cut-offs for subgroups of age, treatment type, aetiology, baseline symptoms, and sex.

Conclusion

Most interventions for ASD improve patients’ complaints but do not totally eliminate them. Reporting the percentage achieving a score equivalent to an “acceptable state” may represent a more stringent and discerning target for denoting treatment success in ASD.

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Notes

  1. The same data are not presented in detail for the non-operative patients, since many who were included in the database were not actively seeking treatment but were simply under observation or were presenting for routine follow-up from a previous surgery, more than 2 years prior to recruitment in ESSG. Overall, 12% (54/442) reported being in PASS for all of the three main outcome measures as well as the SRS subdomains at baseline.

References

  1. 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 24:1127–1142. https://doi.org/10.1007/s00586-015-3892-3

    Article  PubMed  Google Scholar 

  2. Schunemann HJ, Akl EA, Guyatt GH (2006) Interpreting the results of patient reported outcome measures in clinical trials: the clinician’s perspective. Health Qual Life Outcomes 4:62

    Article  Google Scholar 

  3. Carragee EJ (2010) The rise and fall of the “minimum clinically important difference”. Spine J 10:283–284. https://doi.org/10.1016/j.spinee.2010.02.013

    Article  PubMed  Google Scholar 

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

    Article  CAS  Google Scholar 

  5. Lauridsen HH, Hartvigsen J, Manniche C, Korsholm L, Grunnet-Nilsson N (2006) Responsiveness and minimal clinically important difference for pain and disability instruments in low back pain patients. BMC Musculoskelet Disord 7:82

    Article  Google Scholar 

  6. Glassman SD, Copay AG, Berven SH, Polly DW, Subach BR, Carreon LY (2008) Defining substantial clinical benefit following lumbar spine arthrodesis. J Bone Joint Surg Am 90:1839–1847

    Article  Google Scholar 

  7. Gatchel RJ, Lurie JD, Mayer TG (2010) Minimal clinically important difference. Spine (Phila Pa 1976) 35:1739–1743. https://doi.org/10.1097/brs.0b013e3181d3cfc9

    Article  Google Scholar 

  8. Hays RD, Woolley JM (2000) The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics 18:419–423

    Article  CAS  Google Scholar 

  9. Agarwalla A, Gowd AK, Liu JN, Puzzitiello RN, Cole BJ, Romeo AA, Verma NN, Forsythe B (2019) Predictive factors and the duration to pre-injury work status following biceps tenodesis. Arthroscopy 35:1026–1033. https://doi.org/10.1016/j.arthro.2018.10.144

    Article  PubMed  Google Scholar 

  10. Veron O, Tcherniatinsky E, Fayad F, Revel M, Poiraudeau S (2008) Chronic low back pain and functional restoring program: applicability of the Patient Acceptable Symptom State. Ann Readapt Med Phys 51:642–649. https://doi.org/10.1016/j.annrmp.2008.08.003

    Article  CAS  PubMed  Google Scholar 

  11. Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M (2005) Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis 64:34–37. https://doi.org/10.1136/ard.2004.023028ard.2004.023028

    Article  CAS  PubMed  Google Scholar 

  12. Fekete TF, Haschtmann D, Kleinstuck FS, Porchet F, Jeszenszky D, Mannion AF (2016) What level of pain are patients happy to live with after surgery for lumbar degenerative disorders? Spine J 16:S12–S18. https://doi.org/10.1016/j.spinee.2016.01.180

    Article  PubMed  Google Scholar 

  13. Impellizzeri FM, Mannion AF, Naal FD, Hersche O, Leunig M (2012) The early outcome of surgical treatment for femoroacetabular impingement: success depends on how you measure it. Osteoarthr Cartil 20:638–645. https://doi.org/10.1016/j.joca.2012.03.019

    Article  CAS  PubMed  Google Scholar 

  14. Mannion AF, Impellizzeri FM, Leunig M, Jeszenszky D, Becker H-J, Haschtmann D, Preiss S, Fekete FT (2018) Time to remove our rose-tinted spectacles: a candid appraisal of the relative success of surgery in over 4,500 patients with degenerative disorders of the lumbar spine, hip or knee. Eur Spine J 27:778–788

    Article  Google Scholar 

  15. 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 

  16. 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 

  17. 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. https://doi.org/10.1097/01.brs.0000201331.50597.ea00007632-200603010-00018

    Article  Google Scholar 

  18. 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 

  19. 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 

  20. Mannion AF, Elfering A, Bago J, Pellise F, Vila-Casademunt A, Richner-Wunderlin S, Domingo-Sabat M, Obeid I, Acaroglu E, Alanay A, Perez-Grueso FS, Baldus CR, Carreon LY, Bridwell KH, Glassman SD, Kleinstuck F, European Spine Study Group (2018) Factor analysis of the SRS-22 outcome assessment instrument in patients with adult spinal deformity. Eur Spine J 27:685–699. https://doi.org/10.1007/s00586-017-5279-0

    Article  CAS  PubMed  Google Scholar 

  21. 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. https://doi.org/10.1007/s00586-014-3542-1

    Article  PubMed  Google Scholar 

  22. 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  Google Scholar 

  23. 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  Google Scholar 

  24. van Hooff ML, Mannion AF, Staub LP, Ostelo RW, Fairbank JC (2016) Determination of the Oswestry Disability Index score equivalent to a “satisfactory symptom state” in patients undergoing surgery for degenerative disorders of the lumbar spine-a Spine Tango registry-based study. Spine J 16:1221–1230. https://doi.org/10.1016/j.spinee.2016.06.010

    Article  PubMed  Google Scholar 

  25. Altman DG, Bland JM (1994) Diagnostic tests 3: receiver operating characteristic plots. BMJ 309:188

    Article  CAS  Google Scholar 

  26. Guyatt GH, Norman GR, Juniper EF, Griffith LE (2002) A critical look at transition ratings. J Clin Epidemiol 55:900–908

    Article  Google Scholar 

  27. Crawford CH 3rd, Glassman SD, Bridwell KH, Carreon LY (2016) The substantial clinical benefit threshold for SRS-22R domains after surgical treatment of adult spinal deformity. Spine Deform 4:373–377. https://doi.org/10.1016/j.jspd.2016.05.001

    Article  PubMed  Google Scholar 

  28. Baldus C, Bridwell KH, Harrast J, Edwards C 2nd, Glassman S, Horton W, Lenke LG, Lowe T, Mardjetko S, Ondra S, Schwab F, Shaffrey C (2008) Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific? Spine (Phila Pa 1976) 33:2214–2218. https://doi.org/10.1097/brs.0b013e31817c0466

    Article  Google Scholar 

  29. Baldus C, Bridwell K, Harrast J, Shaffrey C, Ondra S, Lenke L, Schwab F, Mardjetko S, Glassman S, Edwards C 2nd, Lowe T, Horton W, Polly D Jr (2011) The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis. Spine (Phila Pa 1976) 36:1154–1162. https://doi.org/10.1097/brs.0b013e3181fc8f98

    Article  Google Scholar 

  30. Wright AA, Hensley CP, Gilbertson J, Leland JM 3rd, Jackson S (2015) Defining patient acceptable symptom state thresholds for commonly used patient reported outcomes measures in general orthopedic practice. Man Ther 20:814–819. https://doi.org/10.1016/j.math.2015.03.011

    Article  PubMed  Google Scholar 

  31. Tubach F, Dougados M, Falissard B, Baron G, Logeart I, Ravaud P (2006) Feeling good rather than feeling better matters more to patients. Arthritis Rheum 55:526–530. https://doi.org/10.1002/art.22110

    Article  PubMed  Google Scholar 

  32. van Hooff ML, Spruit M, O’Dowd JK, van Lankveld W, Fairbank JC, van Limbeek J (2014) Predictive factors for successful clinical outcome 1 year after an intensive combined physical and psychological programme for chronic low back pain. Eur Spine J 23:102–112. https://doi.org/10.1007/s00586-013-2844-z

    Article  PubMed  Google Scholar 

  33. Tonosu J, Takeshita K, Hara N, Matsudaira K, Kato S, Masuda K, Chikuda H (2012) The normative score and the cut-off value of the Oswestry Disability Index (ODI). Eur Spine J 21:1596–1602. https://doi.org/10.1007/s00586-012-2173-7

    Article  PubMed  PubMed Central  Google Scholar 

  34. Park SW, Shin YS, Kim HJ, Lee JH, Shin JS, Ha IH (2014) The dischargeable cut-off score of Oswestry Disability Index (ODI) in the inpatient care for low back pain with disability. Eur Spine J 23:2090–2096. https://doi.org/10.1007/s00586-014-3503-8

    Article  PubMed  Google Scholar 

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

    Article  Google Scholar 

  36. Witiw CD, Mansouri A, Mathieu F, Nassiri F, Badhiwala JH, Fessler RG (2018) Exploring the expectation-actuality discrepancy: a systematic review of the impact of preoperative expectations on satisfaction and patient reported outcomes in spinal surgery. Neurosurg Rev 41:19–30. https://doi.org/10.1007/s10143-016-0720-0

    Article  PubMed  Google Scholar 

  37. Chen PG, Daubs MD, Berven S, Raaen LB, Anderson AT, Asch SM, Nuckols TK, the Degenerative Lumbar Scoliosis Appropriateness Group (2015) Surgery for degenerative lumbar scoliosis: the development of appropriateness criteria. Spine (Phila Pa 1976). https://doi.org/10.1097/brs.0000000000001392

    Article  Google Scholar 

  38. Escobar A, Quintana JM, Arostegui I, Azkarate J, Guenaga JI, Arenaza JC, Garai I (2003) Development of explicit criteria for total knee replacement. Int J Technol Assess Health Care 19:57–70

    Article  Google Scholar 

  39. Quintana JM, Arostegui I, Azkarate J, Goenaga JI, Elexpe X, Letona J, Arcelay A (2000) Evaluation of explicit criteria for total hip joint replacement. J Clin Epidemiol 53:1200–1208

    Article  CAS  Google Scholar 

  40. Mannion AF, Pittet V, Steiger F, Vader JP, Becker HJ, Porchet F (2014) Development of appropriateness criteria for the surgical treatment of symptomatic lumbar degenerative spondylolisthesis (LDS). Eur Spine J 23:1903–1917. https://doi.org/10.1007/s00586-014-3284-0

    Article  CAS  PubMed  Google Scholar 

  41. Straus SE, Glasziou PP, Richardson S, Haynes RB (2018) Evidence-based medicine: how to practice and teach EBM. Elsevier, Amsterdam

    Google Scholar 

  42. Pham T, Tubach F (2009) Patient acceptable symptomatic state (PASS). Joint Bone Spine 76:321–323. https://doi.org/10.1016/j.jbspin.2009.03.008

    Article  PubMed  Google Scholar 

  43. Tubach F, Ravaud P, Martin-Mola E, Awada H, Bellamy N, Bombardier C, Felson DT, Hajjaj-Hassouni N, Hochberg M, Logeart I, Matucci-Cerinic M, van de Laar M, van der Heijde D, Dougados M (2012) Minimum clinically important improvement and patient acceptable symptom state in pain and function in rheumatoid arthritis, ankylosing spondylitis, chronic back pain, hand osteoarthritis, and hip and knee osteoarthritis: results from a prospective multinational study. Arthritis Care Res (Hoboken) 64:1699–1707. https://doi.org/10.1002/acr.21747

    Article  CAS  Google Scholar 

  44. Hobart J (2016) Measuring spinal surgical success: the proportion achieving acceptable symptoms: keep it simple but not simplistic. Spine J 16:S19–S20. https://doi.org/10.1016/j.spinee.2016.01.221

    Article  PubMed  Google Scholar 

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

    Google Scholar 

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Correspondence to A. F. Mannion.

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None of the authors have any conflict of interest in relation to the current work. The ESSG is partially funded by research grants from Depuy Synthes Spine and Medtronic.

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Mannion, A.F., Loibl, M., Bago, J. et al. What level of symptoms are patients with adult spinal deformity prepared to live with? A cross-sectional analysis of the 12-month follow-up data from 1043 patients. Eur Spine J 29, 1340–1352 (2020). https://doi.org/10.1007/s00586-020-06365-z

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