Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario

Gabrielle van der Velde, Pierre Côté, Ahmed M Bayoumi, J David Cassidy, Eleanor Boyle, Heather M Shearer, Maja Stupar, Craig Jacobs, Carlo Ammendolia, Simon Carette, Maurits van Tulder, Gabrielle van der Velde, Pierre Côté, Ahmed M Bayoumi, J David Cassidy, Eleanor Boyle, Heather M Shearer, Maja Stupar, Craig Jacobs, Carlo Ammendolia, Simon Carette, Maurits van Tulder

Abstract

Background: Whiplash injury affects 83% of persons in a traffic collision and leads to whiplash-associated disorders (WAD). A major challenge facing health care decision makers is identifying cost-effective interventions due to lack of economic evidence. Our objective is to compare the cost-effectiveness of: 1) physician-based education and activation, 2) a rehabilitation program developed by Aviva Canada (a group of property and casualty insurance providers), and 3) the legislated standard of care in the Canadian province of Ontario: the Pre-approved Framework Guideline for Whiplash developed by the Financial Services Commission of Ontario.

Methods/design: The economic evaluation will use participant-level data from the University Health Network Whiplash Intervention Trial and will be conducted from the societal perspective over the trial's one-year follow-up. Resource use (costs) will include all health care goods and services, and benefits provided during the trial's 1-year follow-up. The primary health effect will be the quality-adjusted life year. We will identify the most cost-effective intervention using the incremental cost-effectiveness ratio and incremental net-benefit. Confidence ellipses and cost-effectiveness acceptability curves will represent uncertainty around these statistics, respectively. A budget impact analysis will assess the total annual impact of replacing the current legislated standard of care with each of the other interventions. An expected value of perfect information will determine the maximum research expenditure Canadian society should be willing to pay for, and inform priority setting in, research of WAD management.

Discussion: Results will provide health care decision makers with much needed economic evidence on common interventions for acute whiplash management.

Trial registration: http://ClinicalTrials.gov identifier NCT00546806 [Trial registry date: October 18, 2007; Date first patient was randomized: February 27, 2008].

References

    1. Cassidy JD, Caroll LJ, Côté P, Lemstra M, Berglund A, Nygren A. The effect of eliminating compensation for pain and suffering on the outcome of insurance claims for whiplash injury. New England Journal of Medicine. 2000;342(6):1179–1186. doi: 10.1056/NEJM200004203421606.
    1. Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa S, Zeiss E. Scientific monograph of the Quebec Task Force on Whiplash-Associated Disorders: redefining "whiplash" and its management. Spine. 1995;20(8 Suppl):1S–73S.
    1. Carroll LJ, Cassidy JD, Côté P. Frequency, timing, and course of depressive symptomatology after whiplash. Spine. 2006;31:E551–E556. doi: 10.1097/01.brs.0000225979.26966.9e.
    1. Berglund A, Alfredsson L, Jensen I, Cassidy JD, Nygren A. The association between exposure to a rear-end collision and future health complaints. J Clin Epidemiol. 2001;54:851–856. doi: 10.1016/S0895-4356(00)00369-3.
    1. Côté P, Cassidy JD, Caroll LJ. Is a lifetime history of neck injury in a traffic collision associated with prevalent neck pain, headache and depressive symptomatology? Accident Analysis & Prevention. 2000;32:151–159. doi: 10.1016/S0001-4575(99)00117-7.
    1. Berglund A, Alfredsson L, Cassidy JD, Jensen I, Nygren A. The association between exposure to a rear-end collision and future neck or shoulder pain: a cohort study. J Clin Epidemiol. 2000;53(11):1089–1094. doi: 10.1016/S0895-4356(00)00225-0.
    1. Leth-Petersen S, Rotger GP. Long-term labour-market performance of whiplash claimaints. Journal of Health Economics. 2009;28:996–1011. doi: 10.1016/j.jhealeco.2009.06.013.
    1. Holm LW, Carroll LJ, Cassidy JD, Hogg-Johnson S, Côté P, Guzman J, Peloso P, Nordin M, Hurwitz E, van der Velde G, Carragee E, Haldeman S. The burden and determinants of neck pain in whiplash-associated disorders after traffic collisions. Spine. 2008;33:S52–S59. doi: 10.1097/BRS.0b013e3181643ece.
    1. Versteegen GJ, Kingma J, Meijler WJ, ten Duis HJ. Neck sprain in patients injured in car accidents: a retrospective study covering the period 1970-1994. Eur Spine J. 1998;7(3):195–200. doi: 10.1007/s005860050055.
    1. Insurance Bureau of Canada. Submission to the Superintendent, Financial Services, FSCO: Submitted for the review of Part VI of the Insurance Act. A submission by the Insurance Bureau of Canada. 2008.
    1. Daw J. Motorists to get a break on soaring insurance. Toronto Star. 2009. p. A1.
    1. Côté P, Hogg-Johnson S, Cassidy JD, Carroll LJ, Frank JW, Bombardier C. Initial patterns of clinical care and recovery from whiplash injuries: a population-based cohort study. Archives of Internal Medicine. 2005;165(19):2257–2263. doi: 10.1001/archinte.165.19.2257.
    1. Côté P, Hogg-Johnson S, Cassidy JD, Carroll LJ, Frank JW, Bombardier C. Early aggressive care and delayed recovery from whiplash: isolated finding or reproducible result? Arthritis Rheum. 2007;57(5):861–868. doi: 10.1002/art.22775.
    1. Cassidy JD, Caroll LJ, Côté P, Frank JW. Does multidiscliplinary rehabilitation benefit whiplash recovery?: Results of a population-based incidence cohort study. Spine. 2007;32(1):126–131. doi: 10.1097/01.brs.0000249526.76788.e8.
    1. Scholten-Peeters GG, Neeleman-van der Steen CW, van der Windt DA, Hendriks EJ, Verhagen AP, Oostendorp RA. Education by general practitioners or education and exercises by physiotherapists for patients with whiplash-associated disorders? A randomized clinical trial. Spine. 2006;31:723–731. doi: 10.1097/01.brs.0000206381.15224.0f.
    1. Hurwitz E, Carragee E, van der Velde G, Caroll LJ, Nordin M, Guzman J, Peloso P, Côté P, Hogg-Johnson S, Cassidy JD, Haldeman S. Treatment of neck pain: non-invasive interventions: Results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine. 2008;33:S123–S152. doi: 10.1097/BRS.0b013e3181644b1d.
    1. Côté P, Cassidy JD, Carrette S, Boyle E, Shearer HM, Stupar M, Ammendolia C, van der Velde G, Hayden JA, Yang X, van Tulder M, Frank JW. Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: the University Health Network Whiplash Intervention Trial. Trials. 2008;9:75. doi: 10.1186/1745-6215-9-75.
    1. Douglass AB, Bope ET. Evaluation and treatment of posterior neck pain in family practice. J Am Board Fam Pract. 2004;17:S13–S22. doi: 10.3122/jabfm.17.suppl_1.S13.
    1. Guzman J, Haldeman S, Carroll LJ, Carragee E, Hurwitz E, Peloso P, Nordin M, Cassidy JD, Holm L, Côté P, van der Velde G, Hogg-Johnson S. Clinical practice implications of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and its Associated Disorders. Spine. 2008;33:S199–S213. doi: 10.1097/BRS.0b013e3181644641.
    1. Financial Services Commission of Ontario. Pre-approved framework guideline for Grade I and II Whiplash Associated Disorders. Financial Services Commission of Ontario, Toronto ON. 2007.
    1. Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H. Capturing the patient's view of change as a clinical outcome measure. JAMA. 1999;282:1157–1162. doi: 10.1001/jama.282.12.1157.
    1. Ngo T, Stupar M, Côté P, Boyle E, Shearer H. A study of the test-retest reliability of the self-perceived general recovery and self-perceived change in neck pain questions in patients with recent whiplash-associated disorders. Eur Spine J. 2010.
    1. Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990;13:227–236. doi: 10.1002/nur.4770130405.
    1. Pinfold M, Niere KR, O'Leary EF, Hoving JL, Green S, Buchbinder R. Validity and internal consistency of a whiplash-specific disability measure. Spine. 2004;29(3):263–268. doi: 10.1097/01.BRS.0000107238.15526.4C.
    1. Haley SM, McHorney CA, Ware JE Jr. Evaluation of the MOS SF-36 physical functioning scale (PF-10): I. Unidimensionality and reproducibility of the Rasch item scale. J Clin Epidemiol. 1994;47:671–684. doi: 10.1016/0895-4356(94)90215-1.
    1. McHorney CA, Ware JE, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31:247–263. doi: 10.1097/00005650-199303000-00006.
    1. Garratt AM, Ruta DA, Abdalla MI, Buckingham JK, Russell IT. The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS? BMJ. 1993;306:1440–1444. doi: 10.1136/bmj.306.6890.1440.
    1. Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385–401. doi: 10.1177/014662167700100306.
    1. Carroll LJ, Cassidy JD, Côté P. The Saskatchewan Health and Back Pain Survey: the prevalence and factors associated with depressive symptomatology in Saskatchewan adults. Canadian Journal of Public Health. 2000;91(6):459–464.
    1. Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385–401. doi: 10.1177/014662167700100306.
    1. Boyd JH, Weissman MM, Thompson WD, Myers JK. Screening for depression in a community sample. Understanding the discrepancies between depression symptom and diagnostic scales. Arch Gen Psychiatry. 1982;39:1195–1200.
    1. Allison PD. Survival analysis using the SAS system: a practical guide. Cary, NC: SAS Institute; 1995.
    1. Cox DR. Regression Models and Life-Tables. J Roy Statist Soc (B) 1972;34(2):187–202.
    1. Hosmer DW, Lemeshow S. In: Applied survival analysis: regression modeling of time to event data. Hosmer DW, Lemeshow S, editor. New York: John Wiley & Sons; 1999. Assessment of model adequacy; pp. 196–240.
    1. Murray DM, Varnell SP, Blitstein JL. Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health. 2004;94:423–432. doi: 10.2105/AJPH.94.3.423.
    1. Lee KJ, Thompson SG. The use of random effects models to allow for clustering in individually randomized trials. Clin Trials. 2005;2:163–173. doi: 10.1191/1740774505cn082oa.
    1. Kleinbaumm DG. Survival analysis: a self-learning text. New York: Springer-Verlag, New York, Inc; 1996.
    1. Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GI. Methods for the economic evaluation of health care programmes. 3. New York: Oxford University Press; 2005.
    1. Gold MR, Siegel JE, Russel LB, Weinstein MC, Eds. Cost-effectiveness in health and medicine. New York, Oxford: Oxford University Press; 1996.
    1. Lin DY, Feuer EJ, Etzioni R, Wax Y. Estimating medical costs from incomplete follow-up data. Biometrics. 1997;53:419–434. doi: 10.2307/2533947.
    1. Fenwick E, Marshall DA, Blackhouse G, Vidaillet H, Slee A, Shemanski L. Assessing the impact of censoring of costs and effects on health-care decision-making: an example using the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) study. Value in Health. 2008;11:365–375. doi: 10.1111/j.1524-4733.2007.00254.x.
    1. Etzioni R, Urban N, Baker M. Estimating the costs attributable to a disease with application to ovarian cancer. J Clin Epidemiol. 1996;49(1):95–103. doi: 10.1016/0895-4356(96)89259-6.
    1. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. Journal of Health Economics. 2002;21:271–292. doi: 10.1016/S0167-6296(01)00130-8.
    1. Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Economics. 2005;14:487–496. doi: 10.1002/hec.944.
    1. Black WC. The CE plane: a graphic representation of cost-effectiveness. Medical Decision Making. 1990;10:212–214. doi: 10.1177/0272989X9001000308.
    1. Anderson JP, Bush JW, Chen M, Dolenc D. Policy space areas and properties of benefit-cost/utility analysis. Journal of the American Medical Association. 1986;255(6):794–795. doi: 10.1001/jama.1986.03370060108029.
    1. van Hout BA, Maiwenn JA, Gordon GS, Rutten FH. Costs, effects, and C/E ratios alongside a clinical trial. Health Econ. 1994;3:309–319. doi: 10.1002/hec.4730030505.
    1. Briggs AH, Fenn P. Confidence intervals or surfaces? Uncertainty on the cost-effectiveness plane. Health Economics. 1998;7:723–740. doi: 10.1002/(SICI)1099-1050(199812)7:8<723::AID-HEC392>;2-O.
    1. Briggs AH, O'Brien BJ. The death of cost-minimization analysis? Health Econ. 2001;10:179–184. doi: 10.1002/hec.584.
    1. Stinnett AA, Mullahy J. Net health benefits: a new framework for the analysis of uncertainty in cost-effectiveness analysis. Med Decis Making. 1998;18(suppl):S68–S80.
    1. Tambour M, Zethraeus N, Johannesson M. A note on confidence intervals in cost-effectiveness analysis. International Journal of Technology Assessment in Health Care. 1998;14:467–471. doi: 10.1017/S0266462300011442.
    1. Hoch JS, Rockx MA, Krahn AD. Using net benefit regression framework to construct cost-effectiveness acceptability curves: an example using data from a trial of external loop recorders versus Holter monitoring for ambulator monitoring of 'community acquired' syncope. BMC Health Services Research. 2006;6:68. doi: 10.1186/1472-6963-6-68.
    1. Fenwick E, Marshall DA, Levy AR, Nichol G. Using and interpreting cost-effectiveness acceptability curves: an example using data from a trial of management strategies for atrial fibrillation. BMC Health Services Research. 2006;6
    1. Fenwick E, O'Brien BJ, Briggs AH. Cost-effectiveness acceptability curves - facts, fallacies and frequently asked questions. Health Economics. 2004;13:405–415. doi: 10.1002/hec.903.
    1. Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Economics. 2002;11:415–430. doi: 10.1002/hec.678.
    1. McFarlane PA, Bayoumi AM, Pierratos A, Redelmeier DA. The quality of life and cost utility of home nocturnal and conventional in-center hemodialysis. Kidney International. 2003;64:1004–1011. doi: 10.1046/j.1523-1755.2003.00157.x.
    1. Carroll LJ, Holm LW, Hogg-Johnson S, Côté P, Cassidy JD, Haldeman S, Nordin M, Hurwitz E, Carragee E, van der Velde G, Peloso P, Guzman J. Course and prognostic factors for neck pain in whiplash-associated disorder (WAD). Results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and its Associated Disorders. Spine. 2008;33:S83–S92. doi: 10.1097/BRS.0b013e3181643eb8.
    1. Schafer Jl. Multiple imputation: A primer. Statistical Methods in Medical Research. 1999;8:3–15. doi: 10.1191/096228099671525676.
    1. Kristman VL, Manno M, Côté P. Methods to account for attrition in longitudinal data: Do they work? A simulation study. Eur J Epidemiology. 2005;20:657–662. doi: 10.1007/s10654-005-7919-7.
    1. Kristman VL, Manno M, Côté P. Loss to follow-up in cohort studys: how much is too much? European Journal of Epidemiology. 2004;19:751–760.
    1. Mauskopf JA, Sullivan SD, Annemans L, Caro J, Mullins CD, Nuitjen M. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on Good Research Practices - Budget Impact Analysis. Value in Health. 2007;10:336–347. doi: 10.1111/j.1524-4733.2007.00187.x.
    1. Marshall DA, Douglas P, Drummond MF, Torrance GW, MacLeod S, Manti O, Cheruvu L, Corcari R. Guidelines for conducting pharmaceutical budget impact analyses for submission to public drug plans in Canada. Pharmacoeconomics. 2008;26(6):477–495. doi: 10.2165/00019053-200826060-00003.

Source: PubMed

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