Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity

Spinal Deformity Clinical Trial

— HEO  

Official title:

Cost Effectiveness of Nonoperative Management for Adult Spinal Deformity Associated With Low Grade Scoliosis: A Prospective Pilot Study to Evaluate Disease Burden and Longitudinal Study Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880164
• Other study ID #: 2108
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: April 4, 2017
• Start date: June 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: International Spine Study Group Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.

Description:

1. Identify disease burden associated with adult spinal deformity (ASD) using quality adjusted life year (QALY) analysis.

2. Identify disease burden of specific demographic and radiographic features associated with ASD.

3. Compare disease burden of ASD to other musculoskeletal and non-musculoskeletal diseases.

4. Identify efficacy of specific nonoperative treatment modalities to treat ASD and identify specific clinical and radiographic features of ASD responsive to nonoperative treatment modalities.

5. Compare QALY and ICER values for different ASD nonoperative treatment modalities to previously established QALY and ICER for values for operative and nonoperative treatment modalities for degenerative hip and knee disease, coronary artery disease, insulin dependent diabetes, and hypertension.

6. Evaluate the cost and work hours associated with data collection and minimum 85% patient follow up.

7. Evaluate patient characteristics associated with poor patient compliance for study follow up including demographic, radiographic and HRQOL values and for reasons for cross-over to operative treatment for ASD.

8. Establish standardized data collection methodology for economic based outcome studies based upon patient demographics and HRQOL values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 40-75 years of age at the time of enrollment.

2. ODI =30

3. Adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the Cobb angle technique

4. Sagittal plane deformity by SRS Schwab classification with at least one modifier ++ or two modifiers + and associated coronal cobb of at least 10 degrees

Exclusion Criteria:

1. Adult degenerative or idiopathic scoliosis with a curvature of the spine measuring <10 degrees or >40 degrees

2. Diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.)

3. Cardiopulmonary disease or comorbidities that preclude surgical intervention

4. Patient not deemed surgical candidate by treating surgeon

5. Patient unwilling to commit to monthly phone interviews or completion of necessary questionnaires or inability to return for defined follow up time points. Patients unwilling to comply with study protocol will not be offered enrollment into the study, regardless of meeting inclusion criteria.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Rocky Mountain Scoliosis and Spine	Denver	Colorado
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Norton Leatherman Spine Center	Louisville	Kentucky
United States	Hospital for Special Surgery	New York	New York
United States	NYU Hospital for Joint Diseases	New York	New York
United States	Oregon Health Sciences University	Portland	Oregon
United States	University of California - Davis	Sacramento	California
United States	University of California - San Francisco Medical Center	San Francisco	California
United States	Washington University at St. Louis	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Shay Bess	DePuy Spine, Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (35)

Avorn J. Debate about funding comparative-effectiveness research. N Engl J Med. 2009 May 7;360(19):1927-9. doi: 10.1056/NEJMp0902427. — View Citation

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. Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific? Spine (Phila Pa 1976). 2008 Sep 15;33(20):2214-8. doi: 10.1097/BRS.0b013e31817c0466. — View Citation

Berven S, Deviren V, Demir-Deviren S, Hu SS, Bradford DS. Studies in the modified Scoliosis Research Society Outcomes Instrument in adults: validation, reliability, and discriminatory capacity. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2164-9; discussion 2169. — View Citation

Bonham AC, Rich EC, Davis DA, Longnecker DE, Heinig SJ. Commentary: Putting evidence to work: an expanded research agenda for academic medicine in the era of health care reform. Acad Med. 2010 Oct;85(10):1551-3. doi: 10.1097/ACM.0b013e3181effdbc. — View Citation

Bridwell KH, Berven S, Glassman S, Hamill C, Horton WC 3rd, Lenke LG, Schwab F, Baldus C, Shainline M. Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery? Spine (Phila Pa 1976). 2007 Sep 15;32(20):2220-5. — View Citation

Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, Hilton JF, Shainline M, Baldus C, Wootten D. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2171-8. doi: 10.1097/BRS.0b013e3181a8fdc8. — View Citation

Carter OD, Haynes SG. Prevalence rates for scoliosis in US adults: results from the first National Health and Nutrition Examination Survey. Int J Epidemiol. 1987 Dec;16(4):537-44. — View Citation

Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338. — View Citation

Everett CR, Patel RK. A systematic literature review of nonsurgical treatment in adult scoliosis. Spine (Phila Pa 1976). 2007 Sep 1;32(19 Suppl):S130-4. Review. — View Citation

Garber AM, Tunis SR. Does comparative-effectiveness research threaten personalized medicine? N Engl J Med. 2009 May 7;360(19):1925-7. doi: 10.1056/NEJMp0901355. — View Citation

Garrison KR, Donell S, Ryder J, Shemilt I, Mugford M, Harvey I, Song F. Clinical effectiveness and cost-effectiveness of bone morphogenetic proteins in the non-healing of fractures and spinal fusion: a systematic review. Health Technol Assess. 2007 Aug;11(30):1-150, iii-iv. Review. — View Citation

Glassman SD, Berven S, Kostuik J, Dimar JR, Horton WC, Bridwell K. Nonsurgical resource utilization in adult spinal deformity. Spine (Phila Pa 1976). 2006 Apr 15;31(8):941-7. — View Citation

Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2024-9. — View Citation

Glassman SD, Carreon LY, Shaffrey CI, Polly DW, Ondra SL, Berven SH, Bridwell KH. The costs and benefits of nonoperative management for adult scoliosis. Spine (Phila Pa 1976). 2010 Mar 1;35(5):578-82. doi: 10.1097/BRS.0b013e3181b0f2f8. — View Citation

Glassman SD, Polly DW, Dimar JR, Carreon LY. The cost effectiveness of single-level instrumented posterolateral lumbar fusion at 5 years after surgery. Spine (Phila Pa 1976). 2012 Apr 20;37(9):769-74. doi: 10.1097/BRS.0b013e3181e03099. — View Citation

Hirth RA, Bloom BS, Chernew ME, Fendrick AM. Patient, physician, and payer perceptions and misperceptions of willingness to pay for diagnostic certainty. Int J Technol Assess Health Care. 2000 Winter;16(1):35-49. — View Citation

Hirth RA, Chernew ME, Miller E, Fendrick AM, Weissert WG. Willingness to pay for a quality-adjusted life year: in search of a standard. Med Decis Making. 2000 Jul-Sep;20(3):332-42. Review. — View Citation

Hogan P, Dall T, Nikolov P; American Diabetes Association.. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. — View Citation

Lafage V, Schwab F, Patel A, Hawkinson N, Farcy JP. Pelvic tilt and truncal inclination: two key radiographic parameters in the setting of adults with spinal deformity. Spine (Phila Pa 1976). 2009 Aug 1;34(17):E599-606. doi: 10.1097/BRS.0b013e3181aad219. — View Citation

Lafage V, Schwab F, Skalli W, Hawkinson N, Gagey PM, Ondra S, Farcy JP. Standing balance and sagittal plane spinal deformity: analysis of spinopelvic and gravity line parameters. Spine (Phila Pa 1976). 2008 Jun 15;33(14):1572-8. doi: 10.1097/BRS.0b013e31817886a2. — View Citation

Laupacis A, Feeny D, Detsky AS, Tugwell PX. How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ. 1992 Feb 15;146(4):473-81. — View Citation

Loomes G, McKenzie L. The use of QALYs in health care decision making. Soc Sci Med. 1989;28(4):299-308. Review. — View Citation

Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656. Erratum in: JAMA. 2008 Jun 11;299(22):2630. — View Citation

McCabe C, Claxton K, Culyer AJ. The NICE cost-effectiveness threshold: what it is and what that means. Pharmacoeconomics. 2008;26(9):733-44. Review. — View Citation

Pérennou D, Marcelli C, Hérisson C, Simon L. Adult lumbar scoliosis. Epidemiologic aspects in a low-back pain population. Spine (Phila Pa 1976). 1994 Jan 15;19(2):123-8. — View Citation

Ridyard CH, Hughes DA. Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment program. Value Health. 2010 Dec;13(8):867-72. doi: 10.1111/j.1524-4733.2010.00788.x. Epub 2010 Oct 12. Review. — View Citation

Rihn JA, Berven S, Allen T, Phillips FM, Currier BL, Glassman SD, Nash DB, Mick C, Crockard A, Albert TJ. Defining value in spine care. Am J Med Qual. 2009 Nov-Dec;24(6 Suppl):4S-14S. doi: 10.1177/1062860609349214. Review. — View Citation

Russell LB, Gold MR, Siegel JE, Daniels N, Weinstein MC. The role of cost-effectiveness analysis in health and medicine. Panel on Cost-Effectiveness in Health and Medicine. JAMA. 1996 Oct 9;276(14):1172-7. Review. — View Citation

Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. — View Citation

Schwab F, Lafage V, Patel A, Farcy JP. Sagittal plane considerations and the pelvis in the adult patient. Spine (Phila Pa 1976). 2009 Aug 1;34(17):1828-33. doi: 10.1097/BRS.0b013e3181a13c08. Review. — View Citation

Smith JS, Shaffrey CI, Berven S, Glassman S, Hamill C, Horton W, Ondra S, Schwab F, Shainline M, Fu KM, Bridwell K; Spinal Deformity Study Group.. Operative versus nonoperative treatment of leg pain in adults with scoliosis: a retrospective review of a prospective multicenter database with two-year follow-up. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1693-8. doi: 10.1097/BRS.0b013e3181ac5fcd. — View Citation

Testa MA, Nackley JF. Methods for quality-of-life studies. Annu Rev Public Health. 1994;15:535-59. Review. — View Citation

Torrance GW. Measurement of health state utilities for economic appraisal. J Health Econ. 1986 Mar;5(1):1-30. Review. — View Citation

Tosteson AN, Lurie JD, Tosteson TD, Skinner JS, Herkowitz H, Albert T, Boden SD, Bridwell K, Longley M, Andersson GB, Blood EA, Grove MR, Weinstein JN; SPORT Investigators.. Surgical treatment of spinal stenosis with and without degenerative spondylolisthesis: cost-effectiveness after 2 years. Ann Intern Med. 2008 Dec 16;149(12):845-53. — View Citation

Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SRS22r	Assess pain, function, self image, and mental health.	Initial (Day1) and six months post enrollment
Other	EQ5D-3L	Assess health state (best imaginable vs worst imaginable).	Initial (Day1) and six months post enrollment
Other	Work Productivity and Activity Impairment (WPAI:SHP)	Assess ability to work and perform regular activities as relates to spinal deformity.	Initial (Day1) and six months post enrollment
Other	NRS	Assess back and leg pain.	Initial (Day1) and six months post enrollment
Other	Resource Utilization (RRU)	Document nonoperative treatment modalities, such as observation only, pain medicine, physical therapy, chiropractic care, injections, diagnostic radiology, emergency visits, and other therapies. Analysis of this data will determine cost associated with nonoperative care for adult spinal disorders.	Initial clinic visit (Day1) , Phone interviews at 1, 2, 3, 4, and 5 months, and 6 months clinic visit
Primary	Oswestry Disability Index (ODI)	This questionnaire has been designed to provide information as to how back pain affects ability to manage in everyday life. Score must be equal to or greater than 30 for eligibility to enroll.	Initial visit and six months post enrollment
Secondary	Radiographs	Coronal and sagittal radiographic views of the spine obtained to assess coronal curvature and sagittal balance.	Initial visit (Day 1)