| BMC Musculoskeletal Disorders | |
| Comparison of the SF6D, the EQ5D, and the oswestry disability index in patients with chronic low back pain and degenerative disc disease | |
| Margreth Grotle6  Gunnar Leivseth3  Ivar Rossvoll4  Jens I Brox2  Kjersti Storheim1  Øystein P Nygaard5  Christian Hellum2  Lars G Johnsen4  | |
| [1] Clinic for Surgery and Neurology, Oslo University, Oslo, Norway;Clinic for Surgery and Neurology, Department of Orthopedics, Oslo University Hospital and University of Oslo, Oslo, Norway;Department of Clinical Medicine, Neuromuscular Diseases and Research Group, University of Tromsø, Tromsø, Norway;Department Of Neuromedicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway;Department of neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway;Faculty of health Sciences, Department of Physiotherapy, Oslo and Akershus University College of Applied Sciences, Oslo, Norway | |
| 关键词: SF6D; EQ5D; Lumbar disc prosthesis; Low back pain; Health economics; Measurement properties; Outcome assessment; Utility measures; | |
| Others : 1132731 DOI : 10.1186/1471-2474-14-148 |
|
| received in 2012-05-14, accepted in 2013-04-19, 发布年份 2013 | |
PDF
|
|
【 摘 要 】
Background
The need for cost effectiveness analyses in randomized controlled trials that compare treatment options is increasing. The selection of the optimal utility measure is important, and a central question is whether the two most commonly used indexes - the EuroQuol 5D (EQ5D) and the Short Form 6D (SF6D) – can be used interchangeably. The aim of the present study was to compare change scores of the EQ5D and SF6D utility indexes in terms of some important measurement properties. The psychometric properties of the two utility indexes were compared to a disease-specific instrument, the Oswestry Disability Index (ODI), in the setting of a randomized controlled trial for degenerative disc disease.
Methods
In a randomized controlled multicentre trial, 172 patients who had experienced low back pain for an average of 6 years were randomized to either treatment with an intensive back rehabilitation program or surgery to insert disc prostheses. Patients filled out the ODI, EQ5D, and SF-36 at baseline and two-year follow up. The utility indexes was compared with respect to measurement error, structural validity, criterion validity, responsiveness, and interpretability according to the COSMIN taxonomy.
Results
At follow up, 113 patients had change score values for all three instruments. The SF6D had better similarity with the disease-specific instrument (ODI) regarding sensitivity, specificity, and responsiveness. Measurement error was lower for the SF6D (0.056) compared to the EQ5D (0.155). The minimal important change score value was 0.031 for SF6D and 0.173 for EQ5D. The minimal detectable change score value at a 95% confidence level were 0.157 for SF6D and 0.429 for EQ5D, and the difference in mean change score values (SD) between them was 0.23 (0.29) and so exceeded the clinical significant change score value for both instruments. Analysis of psychometric properties indicated that the indexes are unidimensional when considered separately, but that they do not exactly measure the same underlying construct.
Conclusions
This study indicates that the difference in important measurement properties between EQ5D and SF6D is too large to consider them interchangeable. Since the similarity with the “gold standard” (the disease-specific instrument) was quite different, this could indicate that the choice of index should be determined by the diagnosis.
【 授权许可】
2013 Johnsen et al.; licensee BioMed Central Ltd.
【 预 览 】
| Files | Size | Format | View |
|---|---|---|---|
| 20150304070546581.pdf | 699KB | ||
| Figure 4. | 64KB | Image | |
| Figure 3. | 44KB | Image | |
| Figure 2. | 42KB | Image | |
| 20150303090511662.pdf | 243KB |
【 图 表 】
Figure 2.
Figure 3.
Figure 4.
【 参考文献 】
- [1]Brazier J: Measuring and valuing health benefits for economic evaluation. New York: Oxford University Press; 2007.
- [2]Nord E: Health state values from multiattribute utility instruments need correction. Ann Med 2001, 33(5):371-374.
- [3]Brazier J, Roberts J, Deverill M: The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002, 21(2):271-292.
- [4]Dolan P: Modeling valuations for EuroQol health states. Med Care 1997, 35(11):1095-1108.
- [5]Drummond MF: Methods for the economic evaluation of health care programmes, 3rd edn. Oxford. New York: Oxford University Press; 2005.
- [6]Barton GR, Sach TH, Avery AJ, Jenkinson C, Doherty M, Whynes DK, Muir KR: A comparison of the performance of the EQ-5D and SF-6D for individuals aged >or= 45 years. Health Econ 2008, 17(7):815-832.
- [7]Brazier J, Roberts J, Tsuchiya A, Busschbach J: A comparison of the EQ-5D and SF-6D across seven patient groups. Health Econ 2004, 13(9):873-884.
- [8]Grieve R, Grishchenko M, Cairns J: SF-6D versus EQ-5D: reasons for differences in utility scores and impact on reported cost-utility. Eur J Health Econ 2009, 10(1):15-23.
- [9]Sach TH, Barton GR, Jenkinson C, Doherty M, Avery AJ, Muir KR: Comparing cost-utility estimates: does the choice of EQ-5D or SF-6D matter? Med Care 2009, 47(8):889-894.
- [10]Soegaard R: Interchangeability of the EQ-5D and the SF-6D in Long-Lasting Low Back Pain Source: Value in Health 12, no. 4 (2009): 606–612 Additional Info: Blackwell Publishing; 20090601 Standard No: ISSN: 1098–3015. Value Health 2009, 12(4):606-612.
- [11]Sogaard R, Christensen FB, Videbaek TS, Bunger C, Christiansen T: Interchangeability of the EQ-5D and the SF-6D in long-lasting low back pain. Value Health 2009, 12(4):606-612.
- [12]Bland JM, Altman DG: Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986, 1(8476):307-310.
- [13]Bryan S, Longworth L: Measuring health-related utility: why the disparity between EQ-5D and SF-6D? Eur J Health Econ 2005, 6(3):253-260.
- [14]Longworth L, Bryan S: An empirical comparison of EQ-5D and SF-6D in liver transplant patients. Health Econ 2003, 12(12):1061-1067.
- [15]Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M, Sandvik L, Grundnes O: Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ 2011, 342:d2786.
- [16]Fairbank JC, Couper J, Davies JB, O’Brien JP: The Oswestry low back pain disability questionnaire. Physiotherapy 1980, 66(8):271-273.
- [17]Fairbank JC, Pynsent PB: The Oswestry Disability Index. Spine 2000, 25(22):2940-2952. discussion 2952
- [18]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(5):241-247.
- [19]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30(6):473-483.
- [20]Dolan P, Gudex C, Kind P, Williams A: The time trade-off method: results from a general population study. Health Econ 1996, 5(2):141-154.
- [21]The EuroQol Group: EuroQol--a new facility for the measurement of health-related quality of life. Health Policy 1990, 16(3):199-208.
- [22]Ostelo RW, de Vet HC: Clinically important outcomes in low back pain. Best Pract Res Clin Rheumatol 2005, 19(4):593-607.
- [23]Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, De Vet HC: COSMIN checklist manual. 2012.
- [24]Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, Bouter LM, de Vet HC: The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol 2010, 10:22. BioMed Central Full Text
- [25]van der Roer N, Ostelo RW, Bekkering GE, van Tulder MW, de Vet HC: Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain. Spine 2006, 31(5):578-582.
- [26]Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD: Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care 1999, 37(5):469-478.
- [27]Wyrwich KW, Tierney WM, Wolinsky FD: Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 1999, 52(9):861-873.
- [28]Crosby RD, Kolotkin RL, Williams GR: Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003, 56(5):395-407.
- [29]Bland JM, Altman DG: Measurement error. BMJ 1996, 313(7059):744.
- [30]de Vet HC, Terwee CB, Knol DL, Bouter LM: When to use agreement versus reliability measures. J Clin Epidemiol 2006, 59(10):1033-1039.
- [31]Beaton DE: Understanding the relevance of measured change through studies of responsiveness. Spine 2000, 25(24):3192-3199.
- [32]Hagg O, Fritzell P, Nordwall A: The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J 2003, 12(1):12-20.
- [33]Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC: The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 2010, 63(7):737-745.
- [34]Smith EV Jr: Detecting and evaluating the impact of multidimensionality using item fit statistics and principal component analysis of residuals. J Appl Meas 2002, 3(2):205-231.
- [35]Chou Y-T, Wang W-C: Checking Dimensionality in Item Response Models With Principal Component Analysis on Standardized Residuals. Educ Psychol Meas 2010, 70(5):717-731.
- [36]Fairbank JC, Pynsent PB, 22: The Oswestry Disability Index. Spine (Phila Pa 1976) 2000, 25:2940-2952. discussion 2952
- [37]Zweig MH, Campbell G: Receiver-operating characteristic (ROC) plots: a fundamental evaluation tool in clinical medicine. Clin Chem 1993, 39(4):561-577.
- [38]Deyo RA, Centor RM: Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance. J Chronic Dis 1986, 39(11):897-906.
- [39]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(6):968-974.
- [40]Tennant A, Conaghan PG: The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper? Arthritis Rheum 2007, 57(8):1358-1362.
- [41]Pallant JF, Tennant A: An introduction to the Rasch measurement model: an example using the Hospital Anxiety and Depression Scale (HADS). Br J Clin Psychol 2007, 46(Pt 1):1-18.
- [42]Bland JM, Altman DG: Measuring agreement in method comparison studies. Stat Methods Med Res 1999, 8(2):135-160.
- [43]van Stel HF, Buskens E: Comparison of the SF-6D and the EQ-5D in patients with coronary heart disease. Health Qual Life Outcomes 2006, 4:20. BioMed Central Full Text
- [44]Walters SJ, Brazier JE: Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005, 14(6):1523-1532.
- [45]Brazier J, Deverill M: A checklist for judging preference-based measures of health related quality of life: learning from psychometrics. Health Econ 1999, 8(1):41-51.
- [46]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(1):131-142.
- [47]Guyatt GH, Norman GR, Juniper EF, Griffith LE: A critical look at transition ratings. J Clin Epidemiol 2002, 55(9):900-908.
- [48]Terwee CB, Roorda LD, Dekker J, Bierma-Zeinstra SM, Peat G, Jordan KP, Croft P, de Vet HC: Mind the MIC: large variation among populations and methods. J Clin Epidemiol 2010, 63(5):524-534.
- [49]Turner D, Schunemann HJ, Griffith LE, Beaton DE, Griffiths AM, Critch JN, Guyatt GH: The minimal detectable change cannot reliably replace the minimal important difference. J Clin Epidemiol 2010, 63(1):28-36.
- [50]Cella D, Hahn EA, Dineen K: Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res 2002, 11(3):207-221.
- [51]Guyatt GH, Jaeschke RJ: Reassessing quality-of-life instruments in the evaluation of new drugs. Pharmaco Economics 1997, 12(6):621-626.
PDF