Health economic analysis of neurologically intact thoracolumbar A3 and A4 fractures is dominant in supporting surgery over nonsurgical treatment

BACKGROUND CONTEXT: Many efforts have been made to determine what is the best treatment strategy for neurologically intact patients with TL burst fractures: surgery or nonoperative management. Studies comparing clinical outcomes have produced mixed and inconclusive results creating lack of consensus in the expert community. Therefore, it is necessary to explore other important components of healthcare such as economics that may settle this controversial debate. PURPOSE: The goal of the current study was to perform a cost-utility analysis comparing surgical treatment to nonoperative treatment for neurologically intact TL burst fractures from a societal perspective. STUDY DESIGN/SETTING: We performed a cost-utility analysis from a societal perspective comparing the cost-utility of surgical treatment versus nonsurgical treatment of thoracolumbar (TL) burst fractures in neurologically intact patients. PATIENT SAMPLE: Patient demographics and all clinical and outcome data were taken from an observational, prospective multicenter cohort study comparing surgical versus nonsurgical treatment of TL burst fractures in neurological intact patients. The surgical/nonsurgical procedure(s)/study procedure(s) were per standard of care at each institution and at the discretion of the treating surgeon. OUTCOME MEASURES: For the in-hospital, as well as 1- and 2-year health care resource utilization (direct costs) data were taken from the clinical study, including but not limited to information about the surgical and nonsurgical treatment, length of hospital, emergency room visits, diagnostic tests, physical therapy, pain medication and antibiotics and care giver days. For the indirect costs, patients were asked to fill in a patient diary, containing the Indirect Cost Questionnaire, in which any productivity loss was documented. Cost data were taken from current scientific literature in addition to national and international healthcare costing guidelines and databases and for the different healthcare resources utilized as well as the costs for caregiver care and cost of lost wages calculated. The EQ-5D-3L utility scores obtained from patients in the clinical study were converted to quality adjusted life years (QALYs) by multiplying a person's life expectancy by the value of the Quality of Life (QoL) experienced in each period, measured by the EQ-5D-3L utility score. METHODS: Cost-utility was assessed using the Incremental Cost-Effectiveness Ratio (ICER), which is determined by calculating the difference in costs divided by the difference in QALYs between the two treatment groups (surgical treatment versus nonsurgical treatment). The mean difference in cost between the two treatment groups were calculated, firstly by applying the central limit theorem, and secondly by using bootstrapping. To calculate the average cost per patient in each treatment group, the Kaplan-Meier Sample Average (KMSA) estimator was used in order to take account of the censored patients. The ICER was calculated comparing surgical versus nonsurgical treatment for the full analysis population with a 1-year time horizon, 2-year time horizon as well as the working-live time horizon. Treatments were considered cost-effective at an incremental cost-effectiveness ratio (ICER) of 100,000 USD or less per QALY (willingness to pay). To evaluate the derived models and to explore uncertainty, sensitivity analysis was used. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted. RESULTS: Eleven sites from different regions (North America, Europe, Middle East, and Asia) completed the recruitment and follow-up for 213 patients. One hundred thirty patients were treated surgically (61.0 %) and 83 patients (39.0 %) were treated nonsurgically. Surgical patients were more likely to come from Europe, the Middle East and India while nonsurgical treatment was more common in North America and Australia. At 1-year, the nonsurgical patients were twice as likely to be using opioids and had more days lost from work (115.53 vs 95.82 days) and more caregiver days (14.53 vs 2.19 days) than the surgical patients. The difference in QALY between surgical and nonsurgical was only 0.02 and the costs were $32,247.77 USD (surgical) and $28,686.46 (nonsurgical). The ICER for surgical treatment was $183,065.50 USD per QALY. At two-years, the nonsurgical group had visited the surgeon or general practitioner more often (0.31 vs 0.25). The nonsurgical group had visited physiotherapist and other allied health more often (3.68 vs 1.68). The utilization of NSAIDs and opioids remained higher in the nonsurgical group (2.66 vs 2.39) (1.52 vs 0.75). The average workdays lost remained higher in the nonsurgical group (143.12 vs 114.78). The caregiver days taken off work remained higher in the nonsurgical group (29.86 vs 2.39). At 2 years, indirect costs for nonsurgical patients had increased to over $10,000 more than for surgical ($20,903.66 surgical and $31,560.46 nonsurgical). These indirect costs (lost workdays and caregiver burden) led to the total cost for nonsurgical care ($37,056.19) being higher than that for surgical care ($36,476.62) and led to an ICER of -$28,978.50, ie, surgery was the dominant treatment modality. CONCLUSIONS: While surgical and nonsurgical treatment of AO A3 and A4 thoracolumbar burst fractures with normal neurology appear to have similar clinical outcomes after two years following treatment, a cost-utility analysis revealed surgery to be the dominant strategy after two years and over a working lifetime time horizon from a societal perspective, mainly driven by caregiver burden in the first two years after injury and lost days from work over the working lifetime for nonsurgical patients. FDA Device/Drug Status: This abstract does not discuss or include any applicable devices or drugs.