THE CLINICAL AND ECONOMIC BENEFITS OF SPINAL CORD STIMULATION IN THE TREATMENT OF FAILED BACK SURGERY SYNDROME (PRECISE STUDY)

Author(s)

Beccagutti G1, Zucco F2, Lavano A3, De Rose M4, Poli P5, Fortini G6, Demartini L7, De Simone E8, Menardo V9, Cisotto P10, Meglio M11, Grifi M12, De Santo T13, Costantini A141Medtronic Italia, Sesto San Giovanni, Milan, Italy, 2Azienda Ospedaliera Salvini,

OBJECTIVES: PRECISE study aims to assess the costs and the clinical benefits of Spinal Cord Stimulation (SCS) (plus conventional medical management, CMM) in the treatment of Failed Back Surgery Syndrome (FBSS) patients not adequately responding to CMM alone. Being the study closed, we report the preliminary clinical and resource consumption final results. METHODS: An observational, pre-post data collection with a 24-months follow-up (FU) was developed in 9 Italian Hospitals. Resource consumption, clinical outcomes (Pain Numerical Rating Scale - NRS, Oswestry Disability Index - ODI) and HR-QoL data (SF-36, EQ-5D) were collected before and after the SCS system implantation in order to be compared. RESULTS: Fifty-five of the 72 patients implanted (out of the 80 enrolled for the SCS screening) completed the study. Seventeen discontinued the therapy due to: consent withdrawal (24%), loss to FU (24%), SCS-related issues (29%), non-SCS related reasons (24%). Mean pain intensity decreased from 7.4±1.4 to 4.2±2.6 in the first 12 months, remaining consistent through the second year of FU (4.1±2.5). A continuous improvement in function measured with ODI was appreciated: 47 (85%) patients improved in the first year and 33 (60%) during the second, for a total of 41 (82%) patients improved at 24-month FU if compared to the baseline. EQ-VAS increased from 37 to 60 (12-months) to 63 (24-months). All SF-36 domains significantly improved, and especially “Bodily Pain”, “Social Functioning”, “Role Emotional”. With respect to the baseline, the monthly per-patient resource consumption decreased: considering the second year of follow-up, both pain-related hospitalizations and GP visits experienced a 70% reduction in number, diagnostic exams diminished by the 82%. Monthly caregivers’ days off from work dropped by the 80% (from 45 to 9). CONCLUSIONS: SCS allows a better and sustained pain control and HR-QoL improvement. If compared with CMM alone, SCS permits a reduction in resource consumption and productivity losses.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PMD21

Topic

Economic Evaluation

Topic Subcategory

Cost-comparison, Effectiveness, Utility, Benefit Analysis

Disease

Systemic Disorders/Conditions

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