Rebecca J. Taylor

Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures : A Comparative Systematic Review of Efficacy and Safety

Study Design. Systematic review and meta-regression. Objectives. To compare the efficacy and safety of balloon kyphoplasty and vertebroplasty for the treatment of vertebral compression fractures, and to examine the prognostic factors that predict outcome. Summary of Background Data. A previous systematic review of vertebroplasty by Levine et al in 2000 identified seven case series studies and no controlled studies. Methods. A number of electronic databases were searched through March 1, 2004. Citation searches of included studies were undertaken and contact was made with experts in the field. No language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Results. The following studies were included: balloon kyphoplasty (three nonrandomized comparative studies against conventional medical therapy and 13 case series), vertebroplasty (one nonrandomized comparative study against conventional medical care and 57 cases series), balloon kyphoplasty versus vertebroplasty (one nonrandomized comparative study). The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. At this time, there is no good quality direct comparative evidence of balloon kyphoplasty versus vertebroplasty. From indirect comparison of case series evidence, the procedures appear to provide similar gains in pain relief while for balloon kyphoplasty there is better documentation of gains in patient functionality and quality of life. The level of cement leakage and number of reported adverse events (pulmonary emboli and neurologic injury) in balloon kyphoplasty was significantly lower than for vertebroplasty. These findings were confirmed by meta-regression analysis. Conclusions. There is Level III evidence to support balloon kyphoplasty and vertebroplasty as effective therapies in the management of patients with symptomatic osteoporotic vertebral compression fractures refractory to conventional medical therapy. Although there was a good ratio of benefit to harm for both procedures, balloon kyphoplasty appears to offer the better adverse event profile. These conclusions need to be updated on the basis of the findings of ongoing randomized controlled trials.

Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis

This systematic review updates the understanding of the evidence base for balloon kyphoplasty (BKP) in the management of vertebral compression fractures. Detailed searches of a number of electronic databases were performed from March to April 2006. Citation searches of included studies were undertaken and no language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Combined with previous evidence, a total of eight comparative studies (three against conventional medical therapy and five against vertebroplasty) and 35 case series were identified. The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. In direct comparison to conventional medical management, patients undergoing BKP experienced superior improvements in pain, functionality, vertebral height and kyphotic angle at least up to 3-years postprocedure. Reductions in pain with BKP appeared to be greatest in patients with newer fractures. Uncontrolled studies suggest gains in health-related quality of life at 6 and 12-months following BKP. Although associated with a finite level of cement leakage, serious adverse events appear to be rare. Osteoporotic vertebral compression fractures appear to be associated with a higher level of cement leakage following BKP than non-osteoporotic vertebral compression fractures. In conclusion, there are now prospective studies of low bias, with follow-up of 12 months or more, which demonstrate balloon kyphoplasty to be more effective than medical management of osteoporotic vertebral compression fractures and as least as effective as vertebroplasty. Results from ongoing RCTs will provide further information in the near future.

Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial)

Background: Chronic back and leg pain conditions result in patients’ loss of function, reduced quality of life and increased costs to the society.

Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effectiveness analysis.

OBJECTIVES The aim of this study was to develop a decision-analytic model to assess the cost-effectiveness of spinal cord stimulation (SCS), relative to nonsurgical conventional medical management (CMM), for patients with failed back surgery syndrome (FBSS). METHODS A decision tree and Markov model were developed to synthesize evidence on both health-care costs and outcomes for patients with FBSS. Outcome data of SCS and CMM were sourced from 2-year follow-up data of two randomized controlled trials (RCTs). Treatment effects were measured as levels of pain relief. Short- and long-term health-care costs were obtained from a detailed Canadian costing study in FBSS patients. Results are presented as incremental cost per quality adjusted life year (QALY) and expressed in 2003 Euros. Costs were discounted at 6 percent and outcomes at 1.5 percent. RESULTS Over the lifetime of the patient, SCS was dominant (i.e., SCS is cost-saving and gives more health gain relative to CMM); a finding that was robust across sensitivity analyses. At a 2-year time horizon, SCS gave more health gain but at an increased cost relative to CMM. Given the uncertainty in effectiveness and cost parameters, the 2-year cost-effectiveness of SCS ranged from 30,370 Euros in the base case to 63,511 Euros in the worst-case scenario. CONCLUSIONS SCS was found to be both more effective and less costly than CMM, over the lifetime of a patient. In the short-term, although SCS is potentially cost-effective, the model results are highly sensitive to the choice of input parameters. Further empirical data are required to improve the precision in the estimation of short-term cost-effectiveness.

Measuring the success of treatment for chronic obstructive pulmonary disease: patient, physician and healthcare payer perspectives

The success of treatments for chronic obstructive pulmonary disease (COPD) is evaluated by measuring the impact on a range of health outcomes. However, outcome measures differ in their relative importance to the various stakeholder groups. Patients are most interested in the impact on quality of life and on mortality, while physicians also value information about the effect of treatments on lung function and disease progression. In contrast to patients and physicians, healthcare payers take a population perspective, and need to balance the health gains achieved and the costs of treatment. If the management of COPD is to be improved, it is important, first, to understand the outcomes of importance to each relevant stakeholder group, and then second, to refocus the measures in terms that all stakeholders can value.

Decision-making by healthcare payers.

Healthcare payers are faced with the need to allocate finite resources to maximize population health. To assist in decision-making, healthcare payers are increasingly using health outcomes information and economic analyses. Healthcare payers are often under pressure to make early decisions (around the time of product launch), when the evidence available is imperfect. They must also consider the equitable distribution of resources between therapeutic areas. Tools to help healthcare payers reach transparent and objective decisions include cost-utility analysis and decision modelling. In practice, healthcare payers in different countries (for example, Ireland, France and Canada) vary in the approaches taken to reimbursement and formulary listing decisions. The key to decision-making among healthcare payers is the provision of appropriate evidence, comparing any new treatment approach to current best practice, in situations corresponding to real life. When data assumptions have to be made, these should be clearly stated with consideration of the impact of varying the assumptions. The impact on budgets should also be considered.

433 Cost effectiveness of spinal cord stimulation for neuropathic pain: A european survey on quality of life and healthcare resource utilisation

Background and aims. Faced with rising healthcare costs, payers increasingly require evidence on costs and cost effectiveness of healthcare technologies. To date, information on the cost effectiveness of spinal cord stimulation (SCS) for neuropathic pain due to failed back surgery syndrome (FBSS) has been limited. A recent decision analytic model analysis showed that the addition of SCS to usual care is potentially cost effective. However, the report authors highlight the need for more definitive data, i.e. health-related quality of life, healthcare resources and costs. European survey on utilities and resource utilisation in failed back surgery syndrome (SURF) was set up with the aim of collecting such data. Methods. Between January 2005 and September 2006 data was collected in FBSS patients who had had been implanted with SCS or were receiving conventional medical management (CMM) across nine centres in France, Spain, Germany and UK. Generic health-related quality of life data was collected using the EQ-5D. Health care resources were assessed retrospectively and costed at 2005-6 prices. Cost effectiveness is reported as the incremental cost per quality adjusted life year (QALY). Results. Data has been collected on a total of 169 neuropathic patients with FBSS. This data will be used to populate the previously published economic model with the purpose of reassessing the cost-effectiveness of SCS. Conclusions. This presentation presents costs and quality of life data collected in the SURF project and updates the cost effectiveness of SCS vs. CMM in patients with neuropathic pain due to FBSS.

474 COST EFFECTIVENESS OF SPINAL CORD STIMULATION: DEVELOPING A EUROPEAN BASED DECISION ANALYTIC MODEL (SURF PROJECT)

differences in CRPS. When introducing a quantitative threshold of at least 2oC in at least 8% of all measurements, 9 out of 10 CRPS patients did meet the criteria (meaning a sensitivity of 90%), while only two healthy controls turned out to be false positive (meaning a specificity of 80%). Conclusion: These preliminary results indicate that the measurement of the temperature differences bilaterally in CRPS patients in a quantitative way could be developed to be an additional and robust method for diagnosing CRPS in a clinical as well as a scientific setting.