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Open Access 01-08-2017 | Review

Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures

Authors: Sayf S. A. Faraj, Miranda L. van Hooff, Roderick M. Holewijn, David W. Polly Jr., Tsjitske M. Haanstra, Marinus de Kleuver

Published in: European Spine Journal | Issue 8/2017

Abstract

Purpose

Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD.

Methods

Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO’s International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated.

Results

The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD.

Conclusions

Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.

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Pellisé F, Vila-Casademunt A, Ferrer M et al (2015) Impact on health related quality of life of adult spinal deformity (ASD) compared with other chronic conditions. Eur Spine J 24:3–11. doi:10.1007/s00586-014-3542-1 CrossRefPubMed

Robin GC, Span Y, Steinberg R et al (1982) Scoliosis in the elderly: a follow-up study. Spine (Phila Pa 1976) 7:355–359. doi:10.1097/00007632-198207000-00005 CrossRef

Carter OD, Haynes SG (1987) Prevalence rates for scoliosis in US adults: results from the first National Health and Nutrition Examination Survey. Int J Epidemiol 16:537–544CrossRefPubMed

Schwab F, Dubey A, Gamez L et al (2005) Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976) 30:1082–1085. doi:10.1097/01.brs.0000160842.43482.cd CrossRef

United States Census Bureau 2014. Available at: http://www.census.gov/topics/population/age-and-sex.html. Accessed Dec 31, 2015

The Nationwide Inpatient Sample, US (2014) Available at: http://hcup-us.ahrq.gov/nisoverview.jsp. Accessed Sep 11, 2016

Healthcare Costs, Utilization Project. U.S. Department of Health and Human Services. Available at: http://hcupnet.ahrq.gov; 2013. Accessed July 28, 2016

Terran J, McHugh B, Fischer C et al (2014) Surgical treatment for adult spinal deformity: projected cost effectiveness at 5-year follow-up. Ochsner J 14:14–22PubMedPubMedCentral

Porter M (2010) What is value in health care? N Engl J Med. doi:10.1056/NEJMp1415160 PubMed

10.

Harwood JL, Butler CA, Page AE (2016) Patient-centered care and population health: establishing their role in the orthopaedic practice. J Bone Joint Surg Am 98:e40. doi:10.2106/JBJS.15.00752 CrossRefPubMed

11.

Kerr EA, Hayward RA (2013) Patient-centered performance management. JAMA 310:137. doi:10.1001/jama.2013.6828 CrossRefPubMedPubMedCentral

12.

van Hooff ML, Jacobs WCH, Willems PC et al (2015) Evidence and practice in spine registries. Acta Orthop 86:534–544. doi:10.3109/17453674.2015.1043174 CrossRefPubMedPubMedCentral

13.

Williamson P, Altman D, Blazeby J et al (2012) Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy 17:1–2. doi:10.1258/jhsrp.2011.011131 CrossRefPubMed

14.

Clarke M (2007) Standardising outcomes for clinical trials and systematic reviews. Trials 8:39. doi:10.1186/1745-6215-8-39 CrossRefPubMedPubMedCentral

15.

Bilimoria KY, Cella D, Butt Z (2014) Current challenges in using patient-reported outcomes for surgical care and performance measurement. JAMA Surg 149:505. doi:10.1001/jamasurg.2013.5285 CrossRefPubMed

16.

Cutler HS, Guzman JZ, Al Maaieh M et al (2015) patient reported outcomes in adult spinal deformity surgery: a bibliometric analysis. Spine Deform 3:312–317. doi:10.1016/j.jspd.2014.12.004 CrossRefPubMed

17.

Guzman JZ, Cutler HS, Connolly J et al (2016) Patient-reported outcome instruments in spine surgery. Spine (Phila Pa 1976) 41:429–437. doi:10.1097/BRS.0000000000001211 CrossRef

18.

Pezold ML, Pusic AL, Cohen WA et al (2016) Defining a research agenda for patient-reported outcomes in surgery. JAMA Surg. doi:10.1001/jamasurg.2016.1640 PubMedPubMedCentral

19.

Porter ME, Larsson S, Lee TH (2016) Standardizing patient outcomes measurement. N Engl J Med 374:504–506. doi:10.1056/NEJMp1511701 CrossRefPubMed

20.

Selby JV, Beal AC, Frank L (2012) The patient-centered outcomes research institute (PCORI) national priorities for research and initial research agenda. JAMA 307:1583. doi:10.1001/jama.2012.500 CrossRefPubMed

21.

Oner FC, Jacobs WCH, Lehr AM et al (2016) Toward the development of a universal outcome instrument for spine trauma: a systematic review and content comparison of outcome measures used in spine trauma research using the ICF as reference. Spine (Phila Pa 1976) 41:358–367. doi:10.1097/BRS.0000000000001207 CrossRef

22.

Boonen A, Braun J, van der Horst Bruinsma IE et al (2010) ASAS/WHO ICF Core Sets for ankylosing spondylitis (AS): how to classify the impact of AS on functioning and health. Ann Rheum Dis 69:102–107. doi:10.1136/ard.2008.104117 CrossRefPubMed

23.

Cieza A, Stucki G, Weigl M et al (2004) ICF core sets for low back pain. J Rehabil Med 36:69–74. doi:10.1080/16501960410016037 CrossRef

24.

Stoll T, Brach M, Huber EO et al (2005) ICF core set for patients with musculoskeletal conditions in the acute hospital. Disabil Rehabil 27:381–387. doi:10.1080/09638280400013990 CrossRef

25.

Selb M, Escorpizo R, Kostanjsek N et al (2015) A guide on how to develop an international classification of functioning, disability and health core set. Eur J Phys Rehabil Med 51:105–117PubMed

26.

Spence RT, Mueller JL, Chang DC (2016) A novel approach to global benchmarking of risk-adjusted surgical outcomes: beyond perioperative mortality rate. JAMA Surg 151:501–502. doi:10.1001/jamasurg.2016.0091 CrossRefPubMed

27.

Moher D, Liberati A, Tetzlaff J et al (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339:b2535CrossRefPubMedPubMedCentral

28.

Williamson PR, Altman DG, Blazeby JM et al (2012) Developing core outcome sets for clinical trials: issues to consider. Trials 13:132. doi:10.1186/1745-6215-13-132 CrossRefPubMedPubMedCentral

29.

U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research (2006) Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 4:79. doi:10.1186/1477-7525-4-79 CrossRefPubMedCentral

30.

WHO International Classification of Functioning, Health and Disability (ICF) Web Browser. http://apps.who.int/classifications/icfbrowser/. Accessed 29 Dec 2015

31.

Cieza A, Geyh S, Chatterji S et al (2005) ICF linking rules: an update based on lessons learned. J Rehabil Med 37:212–218. doi:10.1080/16501970510040263 CrossRefPubMed

32.

Cieza A, Brockow T, Ewert T et al (2002) Linking health-status measurements to the international classification of functioning, disability and health. J Rehabil Med 34:205–210. doi:10.1080/165019702760279189 CrossRefPubMed

33.

Terwee CB, Bot SDM, de Boer MR et al (2007) Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol 60:34–42. doi:10.1016/j.jclinepi.2006.03.012 CrossRefPubMed

34.

Bridwell KH, Cats-Baril W, Harrast J et al (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. doi:10.1097/01.brs.0000153393.82368.6b CrossRef

35.

Berven S, Deviren V, Demir-Deviren S et al (2003) Studies in the modified Scoliosis Research Society Outcomes Instrument in adults: validation, reliability, and discriminatory capacity. Spine (Phila Pa 1976) 28:2164–2169. doi:10.1097/01.BRS.0000084666.53553.D6 (discussion 2169) CrossRef

36.

Liu S, Schwab F, Smith JS et al (2014) Likelihood of reaching minimal clinically important difference in adult spinal deformity: a comparison of operative and nonoperative treatment. Ochsner J 14:67–77PubMedPubMedCentral

37.

Ailon T, Smith JS, Shaffrey CI et al (2015) Degenerative spinal deformity. Neurosurgery 77:S75–S91. doi:10.1227/NEU.0000000000000938 CrossRefPubMed

38.

Smith JS, Fu K-M, Urban P, Shaffrey CI (2008) Neurological symptoms and deficits in adults with scoliosis who present to a surgical clinic: incidence and association with the choice of operative versus nonoperative management: clinical article. J Neurosurg Spine 9:326–331. doi:10.3171/SPI.2008.9.10.326 CrossRefPubMed

39.

Silva FE, Lenke LG (2010) Adult degenerative scoliosis: evaluation and management. Neurosurg Focus 28:E1. doi:10.3171/2010.1.FOCUS09271 CrossRefPubMed

40.

Kleinstueck FS, Fekete TF, Jeszenszky D et al (2016) Adult degenerative scoliosis: comparison of patient-rated outcome after three different surgical treatments. Eur Spine J 25:2649–2656. doi:10.1007/s00586-014-3484-7 CrossRefPubMed

41.

Mannion AF, Elfering A, Staerkle R et al (2005) Outcome assessment in low back pain: how low can you go? Eur Spine J 14:1014–1026. doi:10.1007/s00586-005-0911-9 CrossRefPubMed

42.

Mannion AF, Vila-Casademunt A, Domingo-Sàbat M et al (2016) The core outcome measures index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity. Eur Spine J 25:2638–2648. doi:10.1007/s00586-015-4292-4 CrossRefPubMed

43.

Pehrsson K, Danielsson A, Nachemson A (2001) Pulmonary function in adolescent idiopathic scoliosis: a 25 year follow up after surgery or start of brace treatment. Thorax 56:388–393. doi:10.1136/thorax.56.5.388 CrossRefPubMedPubMedCentral

44.

Lenke LG, Fehlings MG, Shaffrey CI et al (2016) Neurologic outcomes of complex adult spinal deformity surgery: results of the prospective, multicenter Scoli-RISK-1 study. Spine (Phila Pa 1976) 41:204–212. doi:10.1097/BRS.0000000000001338 CrossRef

45.

Lehman RA, Kang DG, Lenke LG et al (2015) Pulmonary function following adult spinal deformity surgery: minimum two-year follow-up. J Bone Jt Surg 97:32–39. doi:10.2106/JBJS.N.00408 CrossRef

46.

Fairbank JC, Couper J, Davies JB, O’Brien JP (1980) The Oswestry low back pain disability questionnaire. Physiotherapy 66:271–273PubMed

47.

Fairbank JC, Pynsent PB (2000) The Oswestry Disability Index. Spine (Phila Pa 1976) 25:2940–2952 (discussion 2952) CrossRef

48.

Lai S-M, Burton DC, Asher MA, Carlson BB (2011) Converting SRS-24, SRS-23, and SRS-22 to SRS-22r. Spine (Phila Pa 1976) 36:E1525–E1533. doi:10.1097/BRS.0b013e3182118adf CrossRef

49.

Alanay A, Cil A, Berk H et al (2005) Reliability and validity of adapted Turkish version of Scoliosis Research Society-22 (SRS-22) questionnaire. Spine (Phila Pa 1976) 30:2464–2468. doi:10.1097/01.brs.0000184366.71761.84 CrossRef

50.

Asher M, Min Lai S, Burton D, Manna B (2003) The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis. Spine (Phila Pa 1976) 28:63–69. doi:10.1097/01.BRS.0000047634.95839.67 CrossRef

51.

Climent JM, Bago J, Ey A et al (2005) Validity of the spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. Spine (Phila Pa 1976) 30:705–709. doi:10.1097/01.brs.0000155408.76606.8f CrossRef

52.

Smith JS, Shaffrey CI, Berven S et al (2009) Improvement of back pain with operative and nonoperative treatment in adults with scoliosis. Neurosurgery 65:84–86. doi:10.1227/01.NEU.0000347005.35282.6C

53.

Weiss HR, Moramarco M (2013) Scoliosis—treatment indications according to current evidence. OA Musculoskelet Med 1(1):1. doi:10.13172/2052-9287-1-1-347

54.

Agabegi SS, Kazemi N, Sturm PF, Mehlman CT (2015) Natural history of adolescent idiopathic scoliosis in skeletally mature patients: a critical review abstract. J Am Acad Orthop Surg. doi:10.5435/JAAOS-D-14-00037 PubMed

Title: Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures
Authors: Sayf S. A. Faraj
Miranda L. van Hooff
Roderick M. Holewijn
David W. Polly Jr.
Tsjitske M. Haanstra
Marinus de Kleuver
Publication date: 01-08-2017
Publisher: Springer Berlin Heidelberg
Published in: European Spine Journal / Issue 8/2017
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI: https://doi.org/10.1007/s00586-017-5125-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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