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Open Access 01-12-2019 | Spondylolisthesis | Research article

Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis

Authors: Ivar Magne Austevoll, Rolf Gjestad, Margreth Grotle, Tore Solberg, Jens Ivar Brox, Erland Hermansen, Frode Rekeland, Kari Indrekvam, Kjersti Storheim, Christian Hellum

Published in: BMC Musculoskeletal Disorders | Issue 1/2019

Abstract

Background

Assessment of outcomes for spinal surgeries is challenging, and an ideal measurement that reflects all aspects of importance for the patients does not exist. Oswestry Disability Index (ODI), EuroQol (EQ-5D) and Numeric Rating Scales (NRS) for leg pain and for back pain are commonly used patients reported outcome measurements (PROMs). Reporting the proportion of individuals with an outcome of clinical importance is recommended. Knowledge of the ability of PROMs to identify clearly improved patients is essential. The purpose of this study was to search cut-off criteria for PROMs that best reflect an improvement considered by the patients to be of clinical importance.

Methods

The Global Perceived Effect scale was utilized to evaluate a clinically important outcome 12 months after surgery. The cut-offs for the PROMs that most accurately distinguish those who reported ‘completely recovered’ or ‘much improved’ from those who reported ‘slightly improved’, unchanged’, ‘slightly worse’, ‘much worse’, or ‘worse than ever’ were estimated. For each PROM, we evaluated three candidate response parameters: the (raw) follow-up score, the (numerical) change score, and the percentage change score.

Results

We analysed 3859 patients with Lumbar Spinal Stenosis [(LSS); mean age 66; female gender 50%] and 617 patients with Lumbar Degenerative Spondylolisthesis [(LDS); mean age 67; 72% female gender]. The accuracy of identifying ‘completely recovered’ and ‘much better’ patients was generally high, but lower for EQ-5D than for the other PROMs. For all PROMs the accuracy was lower for the change score than for the follow-up score and the percentage change score, especially among patients with low and high PROM scores at baseline.

The optimal threshold for a clinically important outcome was ≤24 for ODI, ≥0.69 for EQ-5D, ≤3 for NRS leg pain, and ≤ 4 for NRS back pain, and, for the percentage change score, ≥30% for ODI, ≥40% for NRS leg pain, and ≥ 33% for NRS back pain. The estimated cut-offs were similar for LSS and for LDS.

Conclusion

For estimating a ‘success’ rate assessed by a PROM, we recommend using the follow-up score or the percentage change score. These scores reflected a clinically important outcome better than the change score.

Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A randomized, controlled trial of fusion surgery for lumbar spinal stenosis. NEJM. 2016;374:1413–23. https://doi.org/10.1056/NEJMoa1513721.CrossRefPubMed

Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis. NEJM. 2016;374:1424–34. https://doi.org/10.1056/NEJMoa1508788.CrossRefPubMed

Watters WC 3rd, Baisden J, Gilbert TJ, Kreiner S, Resnick DK, Bono CM, Ghiselli G, Heggeness MH, Mazanec DJ, O'Neill C, Reitman CA, Shaffer WO, Summers JT, Toton JF. Degenerative lumbar spinal stenosis: an evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis. Spine J. 2008;8:305–10. https://doi.org/10.1016/j.spinee.2007.10.033.CrossRefPubMed

Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. NEJM. 2007;356:2257–70. https://doi.org/10.1056/NEJMoa070302.CrossRefPubMed

Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H. Surgical versus nonsurgical therapy for lumbar spinal stenosis. NEJM. 2008;358:794–810. https://doi.org/10.1056/NEJMoa0707136.CrossRefPubMed

Austevoll IM, Gjestad R, Brox JI, Solberg TK, Storheim K, Rekeland F, Hermansen E, Indrekvam K, Hellum C. The effectiveness of decompression alone compared with additional fusion for lumbar spinal stenosis with degenerative spondylolisthesis: a pragmatic comparative non-inferiority observational study from the Norwegian registry for Spine surgery. ESJ. 2017;26:404–13. https://doi.org/10.1007/s00586-016-4683-1.CrossRef

Forsth P, Michaelsson K, Sanden B (2013) Does fusion improve the outcome after decompressive surgery for lumbar spinal stenosis?: A two-year follow-up study involving 5390 patients. Bone Joint J 95-B:960–965. doi: 95-B/7/960 [pii];https://doi.org/10.1302/0301-620X.95B7.30776 [doi].

Hellum CF, − Johnsen LG FAU - Storheim K, Storheim KF, − Nygaard OP FAU - Brox JI, − Brox JI FAU - Rossvoll I, Rossvoll IF, Ro MF, Sandvik LF, Grundnes O (2011)Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ 19;342:d2786. doi: 101136/bmjd2786:BMJ.

Hermansen E, Austevoll IM, Romild UK, Rekeland F, Solberg T, Storheim K, Grundnes O, Aaen J, Brox JI, Hellum C, Indrekvam K. Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the spinal stenosis trial (SST) (part of the NORDSTEN study). BMC musculoskel Disord. 2017;18:121. https://doi.org/10.1186/s12891-017-1491-7.CrossRef

10.

Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, Nygaard OP. Comparing cost-effectiveness of X-stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine. 2015;40:514–20. https://doi.org/10.1097/brs.0000000000000798.CrossRefPubMed

11.

Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomised trials. BMJ (Clinical research ed). 1998;316:690–3.CrossRef

12.

Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105–21. https://doi.org/10.1016/j.jpain.2007.09.005.CrossRefPubMed

13.

Katz NP, Paillard FC, Ekman E. Determining the clinical importance of treatment benefits for interventions for painful orthopedic conditions. J Orthop Surg. 2015;10:24. https://doi.org/10.1186/s13018-014-0144-x.CrossRef

14.

Stratford PW, Binkley JM, Riddle DL, Guyatt GH. Sensitivity to change of the Roland-Morris Back pain questionnaire: part 1. Phys Ther. 1998;78:1186–96.CrossRef

15.

Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407–15.CrossRef

16.

van Kampen DA, Willems WJ, van Beers LW, Castelein RM, Scholtes VA, Terwee CB. Determination and comparison of the smallest detectable change (SDC) and the minimal important change (MIC) of four-shoulder patient-reported outcome measures (PROMs). JOrthop Surg Res. 2013;8:40. https://doi.org/10.1186/1749-799x-8-40.CrossRef

17.

Glassman SD, Copay AG, Berven SH, Polly DW, Subach BR, Carreon LY. Defining substantial clinical benefit following lumbar spine arthrodesis. J Bone Joint Surg Am volume. 2008;90:1839–47. https://doi.org/10.2106/jbjs.g.01095.CrossRef

18.

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

19.

van Hooff ML, Mannion AF, Staub LP, Ostelo RW, Fairbank JC. 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. 2016;16:1221–30. https://doi.org/10.1016/j.spinee.2016.06.010.CrossRefPubMed

20.

Gatchel RJ, Mayer TG. Testing minimal clinically important difference: consensus or conundrum? Spine J. 2010;10:321–7. https://doi.org/10.1016/j.spinee.2009.10.015.CrossRefPubMed

21.

Terwee CB, Roorda LD, Dekker J, Bierma-Zeinstra SM, Peat G, Jordan KP, Croft P, de Vet HCW. Mind the MIC: large variation among populations and methods. J Clin Epidemiol. 2010;63:524–34. https://doi.org/10.1016/j.jclinepi.2009.08.010.CrossRef

22.

Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: a closer look at the minimal clinically important difference (MCID). J Man Manip Ther20. 2012:160–6. https://doi.org/10.1179/2042618612y.0000000001.

23.

Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ (2010) Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol 63:760–766. doi: S0895–4356(09)00304–7 [pii];https://doi.org/10.1016/j.jclinepi.2009.09.009 [doi].

24.

Ostelo RW, de Vet HC. Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol. 2005;19:593–607. https://doi.org/10.1016/j.berh.2005.03.003.CrossRefPubMed

25.

Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry disability index, medical outcomes study questionnaire short form 36, and pain scales. Spine J. 2008;8:968–74. https://doi.org/10.1016/j.spinee.2007.11.006.CrossRefPubMed

26.

de Vet HC, Foumani M, Scholten MA, Jacobs WC, Stiggelbout AM, Knol DL, Peul WC. Minimally important change values of a measurement instrument depend more on baseline values than on the type of intervention. J Clinical Epidemiol. 2015;68:518–24. https://doi.org/10.1016/j.jclinepi.2014.07.008.CrossRef

27.

Solberg T, Johnsen LG, Nygaard OP, Grotle M. Can we define success criteria for lumbar disc surgery? estimates for a substantial amount of improvement in core outcome measures Acta Orthop. 2013;84:196–201. https://doi.org/10.3109/17453674.2013.786634.CrossRefPubMed

28.

Mannion AF, Fekete TF, Wertli MM, Mattle M, Nauer S, Kleinstuck FS, Jeszenszky D, Haschtmann D, Becker HJ, Porchet F. Could less be more when assessing patient-rated outcome in spinal stenosis? Spine. 2015;40:710–8. https://doi.org/10.1097/brs.0000000000000751.CrossRefPubMed

29.

McLeod LD, Coon CD, Martin SA, Fehnel SE, Hays RD. Interpreting patient-reported outcome results: US FDA guidance and emerging methods. Expert Rev Pharmacoecon Outcomes Res. 2011;11:163–9. https://doi.org/10.1586/erp.11.12.CrossRefPubMedPubMedCentral

30.

Baker DJ, Pynsent PB, J F (1989) The Oswestry disability index revisited: its reliability, repeatability and validity, and a comparison with the St Thomas’s disability index. Roland MO, Jenner JR, eds New approaches to rehabilitation and education Manchester: Manchester University Press:174–186.

31.

Fairbank JC, Pynsent PB. The Oswestry disability index. Spine. 2000;25:2940–52 discussion 2952.CrossRef

32.

Grotle M, Brox JI, Vollestad NK. Cross-cultural adaptation of the Norwegian versions of the Roland-Morris disability questionnaire and the Oswestry disability index. J Rehabil Med. 2003;35:241–7.CrossRef

33.

Watters WC, 3rd, Bono CM, Gilbert TJ, Kreiner DS, Mazanec DJ, Shaffer WO, Baisden J, Easa JE, Fernand R, Ghiselli G, Heggeness MH, Mendel RC, O'Neill C, Reitman CA, Resnick DK, Summers JT, Timmons RB, Toton JF, North American Spine S (2009) An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis. Spine J 9:609–614. doi: https://doi.org/10.1016/j.spinee.2009.03.016.

34.

Dolan P, Gudex C, Kind P, Williams A. The time trade-off method: results from a general population study. Health Econ. 1996;5:141–54. https://doi.org/10.1002/(sici)1099-1050(199603)5:2<141::aid-hec189>3.0.co;2-n.CrossRefPubMed

35.

Parai C, Hagg O, Lind B, Brisby H. The value of patient global assessment in lumbar spine surgery: an evaluation based on more than 90,000 patients. ESJ. 2018;27:554–63. https://doi.org/10.1007/s00586-017-5331-0.CrossRef

36.

Altman DG, Bland JM. Diagnostic tests 3: receiver operating characteristics plots. BMJ (Clinical research ed). 1994;309:188.CrossRef

37.

Tape TG (2006 Dec 18) Interpreting diagnostic tests. http://gim.unmc.edu/dxtests/ROC3.htm.

38.

Solberg TK, Sorlie A, Sjaavik K, Nygaard OP, Ingebrigtsen T. Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? Acta Orthop. 2011;82:56–63. https://doi.org/10.3109/17453674.2010.548024 [doi].CrossRefPubMedPubMedCentral

39.

Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods. 2002;7:147–77.CrossRef

40.

Carreon LY, Bratcher KR, Canan CE, Burke LO, Djurasovic M, Glassman SD. Differentiating minimum clinically important difference for primary and revision lumbar fusion surgeries. J Neurosurg Spine. 2013;18:102–6. https://doi.org/10.3171/2012.10.spine12727.CrossRefPubMed

41.

de Vet HC, Ostelo RW, Terwee CB, van der Roer N, Knol DL, Beckerman H, Boers M, Bouter LM. Minimally important change determined by a visual method integrating an anchor-based and a distribution-based approach. Qual Life Res. 2007;16:131–42. https://doi.org/10.1007/s11136-006-9109-9.CrossRefPubMed

42.

Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33:90–4. https://doi.org/10.1097/BRS.0b013e31815e3a10.CrossRefPubMed

43.

Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clinic Proc. 2002;77:371–83. https://doi.org/10.1016/s0025-6196(11)61793-x.CrossRef

44.

Katz N, Paillard FC, Van Inwegen R. A review of the use of the number needed to treat to evaluate the efficacy of analgesics. J Pain. 2015;16:116–23. https://doi.org/10.1016/j.jpain.2014.08.005.CrossRefPubMed

45.

van Hooff ML, Jacobs WC, Willems PC, Wouters MW, de Kleuver M, Peul WC, Ostelo RW, Fritzell P. Evidence and practice in spine registries. Acta Orthop. 2015;86:534–44. https://doi.org/10.3109/17453674.2015.1043174.CrossRefPubMedPubMedCentral

46.

Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders: summary and general recommendations. Spine. 2000;25:3100–3.CrossRef

47.

Hudak PL, Wright JG. The characteristics of patient satisfaction measures. Spine. 2000;25:3167–77.CrossRef

48.

Grovle L, Haugen AJ, Hasvik E, Natvig B, Brox JI, Grotle M. Patients' ratings of global perceived change during 2 years were strongly influenced by the current health status. J Clin Epidemiol. 2014;67:508–15. https://doi.org/10.1016/j.jclinepi.2013.12.001.CrossRefPubMed

49.

Glassman SD, Carreon LY. Thresholds for health-related quality of life measures: reality testing. Spine J. 2010;10:328–9. https://doi.org/10.1016/j.spinee.2009.12.026.CrossRefPubMed

50.

Malmivaara A, Slatis P, Heliovaara M, Sainio P, Kinnunen H, Kankare J, Dalin-Hirvonen N, Seitsalo S, Herno A, Kortekangas P, Niinimaki T, Ronty H, Tallroth K, Turunen V, Knekt P, Harkanen T, Hurri H. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial Spine. 2007;32:1–8. https://doi.org/10.1097/01.brs.0000251014.81875.6d.CrossRefPubMed

51.

Barrett B, Brown D, Mundt M, Brown R. Sufficiently important difference: expanding the framework of clinical significance. Med Decis Mak. 2005;25:250–61. https://doi.org/10.1177/0272989x05276863.CrossRef

52.

Ferreira ML, Herbert RD, Ferreira PH, Latimer J, Ostelo RW, Nascimento DP, Smeets RJ. A critical review of methods used to determine the smallest worthwhile effect of interventions for low back pain. J Clin Epidemiol. 2012;65:253–61. https://doi.org/10.1016/j.jclinepi.2011.06.018.CrossRefPubMed

Title: Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis
Authors: Ivar Magne Austevoll
Rolf Gjestad
Margreth Grotle
Tore Solberg
Jens Ivar Brox
Erland Hermansen
Frode Rekeland
Kari Indrekvam
Kjersti Storheim
Christian Hellum
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Spondylolisthesis
Leg Pain
Leg Pain
Back Pain
Back Pain
Spinal Stenosis
Back Pain
Published in: BMC Musculoskeletal Disorders / Issue 1/2019
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/s12891-018-2386-y

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis

Abstract

Background

Methods

Results

Conclusion

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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