Rikke Soegaard

Cost-utility evaluation of a randomized, controlled trial with a 4- to 8-year follow-up. To investigate the incremental cost per quality-adjusted-life-year (QALY) when comparing circumferential fusion to posterolateral fusion in a long-term, societal perspective. The cost-effectiveness of circumferential fusion in a long-term perspective is uncertain but nonetheless highly relevant as the ISSLS prize winner 2006 in clinical studies reported the effect of circumferential fusion superior to the effect of posterolateral fusion. A recent trial found no significant difference between posterolateral and circumferential fusion reporting cost-effectiveness from a 2-year viewpoint. A total of 146 patients were randomized to posterolateral or circumferential fusion and followed 4 to 8 years after surgery. The mean age of the cohort was 46 years (range, 20-65 years); 61% were females, 49% were smokers, 30% had primary diagnosis of isthmic spondylolisthesis, 35% had disc degeneration and no previous surgery, and 35% had disc degeneration and previous surgery. Eighty-two percent of patients have had symptoms for more than 2 years and 50% were out of the labor market due to sickness. The EQ-5D instrument was applied for the measurement of health-related quality of life and costs (2004 U.S. dollars) were measured in a full-scale societal perspective. Productivity costs were valued by the Friction Cost method, and both costs and effects were discounted. Arithmetic means and 95% bias-corrected, bootstrapped confidence intervals were reported. Nonparametric statistics were used for tests of statistical significance. Comprehensive sensitivity analysis was conducted and reported using cost-effectiveness acceptability curves. The circumferential group demonstrated clinical superiority over the posterolateral fusion group in functional outcome (P < 0.01), fusion rate (P < 0.04), and number of reoperations (P < 0.01) among others. Cost-utility analysis demonstrated circumferential fusion dominant over posterolateral fusion, that is, for each QALY gained performing circumferential fusion, the incremental saving was estimated at U.S. $49,306 (95% confidence interval, $27,183-$2,735,712). Results proved to be strong to various sensitivity analyses; only a differentiated underestimation of patients' need for postoperative household help against the circumferential approach could alter the dominance; however, still the probability of cost-effectiveness was >0.85 given a threshold for willingness to pay of U.S. $50,000 per QALY. Circumferential fusion is dominant over instrumented posterolateral fusion, that is, both being significantly cheaper and significantly better in a long-term, societal perspective.

Up to one third of patients undergoing lumbar spinal fusion show no improvement after the procedure and thus, despite evidence from RCTs, there might be a rationale for observational studies clarifying indications. Similarly, selection of the right patients for the right procedure could have significant impact on cost-effectiveness, which in some countries, in turn, affects whether procedures are to be available through the National Health Service. The aim of this study was to investigate determinants of cost-effectiveness in lumbar spinal fusion. An observational cohort study with 2-year follow-up was conducted: 695 patients who underwent lumbar spinal fusion from 1996 to 2002 were included and followed for 2 years. Patients had a localized segmental pathology and were diagnosed with MRI-verified isthmic spondylolisthesis (26%) or disc degeneration (74%). The surgical techniques were non-instrumented posterolateral fusion (14%), instrumented posterolateral fusion (54%), and circumferential fusion (32%). Societal costs and improvement in functional disability (Dallas Pain Questionnaire) were transformed into a net benefit measure. Classical linear regression of the net benefit was conducted using predictors of age, sex, diagnosis, duration of pain, smoking habits, occupational status, severity of disability, emotional distress, surgical technique, and number of levels fused. The main results were that two determinants were found to negatively influence net benefit: smoking and diagnosis, whereas two others were found to be positively associated with the net benefit: severe disability and emotional distress. In conclusion, predicting net benefit reverses the picture usually seen in studies predicting clinical outcomes, because the response variable is based on improvement over time rather than end-point measures alone. Smoking habits, diagnosis, pre-operative disability, and pre-operative emotional distress were found to be significantly associated with the net benefit of spinal fusion.

Although cost-effectiveness is becoming the foremost evaluative criterion within health service management of spine surgery, scientific knowledge about cost-patterns and cost-effectiveness is limited. The aims of this study were (1) to establish an activity-based method for costing at the patient-level, (2) to investigate the correlation between costs and effects, (3) to investigate the influence of selected patient characteristics on cost-effectiveness and, (4) to investigate the incremental cost-effectiveness ratio of (a) posterior instrumentation and (b) intervertebral anterior support in lumbar spinal fusion. We hypothesized a positive correlation between costs and effects, that determinants of effects would also determine cost-effectiveness, and that posterolateral instrumentation and anterior intervertebral support are cost-effective adjuncts in posterolateral lumbar fusion. A cohort of 136 consecutive patients with chronic low back pain, who were surgically treated from January 2001 through January 2003, was followed until 2 years postoperatively. Operations took place at University Hospital of Aarhus and all patients had either (1) non-instrumented posterolateral lumbar spinal fusion, (2) instrumented posterolateral lumbar spinal fusion, or (3) instrumented posterolateral lumbar spinal fusion + anterior intervertebral support. Analysis of costs was performed at the patient-level, from an administrator’s perspective, by means of Activity-Based-Costing. Clinical effects were measured by means of the Dallas Pain Questionnaire and the Low Back Pain Rating Scale at baseline and 2 years postoperatively. Regression models were used to reveal determinants for costs and effects. Costs and effects were analyzed as a net-benefit measure to reveal determinants for cost-effectiveness, and finally, adjusted analysis (for non-random allocation of patients) was performed in order to reveal the incremental cost-effectiveness ratios of (a) posterior instrumentation and (b) anterior support. The costs of non-instrumented posterolateral spinal fusion were estimated at DKK 88,285(95% CI 81,369;95,546), instrumented posterolateral spinal fusion at DKK 94,396(95% CI 89,865;99,574) and instrumented posterolateral lumbar spinal fusion + anterior intervertebral support at DKK 120,759(95% CI 111,981;133,738). The net-benefit of the regimens was significantly affected by smoking and functional disability in psychosocial life areas. Multi-level fusion and surgical technique significantly affected the net-benefit as well. Surprisingly, no correlation was found between treatment costs and treatment effects. Incremental analysis suggested that the probability of posterior instrumentation being cost-effective was limited, whereas the probability of anterior intervertebral support being cost-effective escalates as willingness-to-pay per effect unit increases. This study reveals useful and hitherto unknown information both about cost-patterns at the patient-level and determinants of cost-effectiveness. The overall conclusion of the present investigation is a recommendation to focus further on determinants of cost-effectiveness. For example, patient characteristics that are modifiable at a relatively low expense may have greater influence on cost-effectiveness than the surgical technique itself—at least from an administrator’s perspective.

The goal of this systematic literature review was to assess the evidence for cost-effectiveness of various surgical techniques in lumbar spinal fusion in conformity with the guidelines provided by the Cochrane Back Review Group. As new technology continuously emerges and divergent directions in clinical practice are present, economic evaluation is needed in order to facilitate the decision-makers’ budget allocations. NHS Economic Evaluation Database, MEDLINE, EMBASE and Cochrane Library were searched. Two independent reviewers (one clinical content expert and one economic content expert) applied the eligibility criteria. A list of criteria for methodological quality assessment was established by merging the criteria recommended by leading health economists with the criteria recommended by the Cochrane Back Review Group. The two reviewers independently scored the selected literature and the disagreement was resolved by means of consensus following discussion. Key data were extracted and the level of evidence concluded. Seven studies were eligible; these studies reflected the diversified choices of economic methodology, study populations (diagnosis), outcome measures and comparators. At the conclusion of quality assessment, the methodological quality of three studies was judged credible. Two studies investigated posteolateral fusion (PLF) ± instrumentation in different populations: one investigated non-specific low back pain and one investigated degenerative stenosis + spondylolisthesis. Both studies reflected that cost-effectiveness of instrumentation in PLF is not convincing. The third study concerned the question of circumferential vs anterior lumbar interbody fusion and found a non-significant difference between the techniques. In conclusion, the literature is limited and, in view of the fact that the clinical effects are statistically synonymous, it does not support the use of high-cost techniques. There is a great potential for improvement of methodological quality in economic evaluations of lumbar spinal fusion and further research is imperative.

Very few studies have investigated the effects or costs of rehabilitation regimens following lumbar spinal fusion. The effectiveness of in-hospital rehabilitation regimens has substantial impact on patients’ demands in the primary health care sector. The aim of this study was to investigate patient-articulated demands to the primary health care sector following lumbar spinal fusion and three different in-hospital rehabilitation regimens in a prospective, randomized study with a 2-year follow-up. Ninety patients were randomized 3 months post lumbar spinal fusion to either a ‘video’ group (one-time oral instruction by a physiotherapist and patients were then issued a video for home exercise), or a ‘café’ group (video regimen with the addition of three café meetings with other fusion-operated patients) or a ‘training’ group (exercise therapy; physiotherapist-guided; two times a week for 8 weeks). Register data of service utilization in the primary health care sector were collected from the time of randomization through 24 months postsurgery. Costs of in-hospital protocols were estimated and the service utilization in the primary health care sector and its cost were analyzed. A significant difference (P=0.023) in number of contacts was found among groups at 2-year follow-up. Within the periods of 3–6 months and 7–12 months postoperatively, the experimental groups required less than half the amount of care within the primary health care sector as compared to the video group (P=0.001 and P=0.008). The incremental costs of the café regimen respectively, the training regimen were compensated by cost savings in the primary health care sector, at ratios of 4.70 (95% CI 4.64; 4.77) and 1.70 (95% CI 1.68; 1.72). This study concludes that a low-cost biopsychosocial rehabilitation regimen significantly reduces service utilization in the primary health care sector as compared to the usual regimen and a training exercise regimen. The results stress the importance of a cognitive element of coping in a rehabilitation program.