eCross-cultural adaptation of the spine oncology-specific SOSGOQ2.0 questionnaire to German language and the assessment of its validity and reliability in the clinical setting.

BACKGROUND: The recently developed Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ2.0) was proven a valid and reliable instrument measuring health-related quality of life (HRQOL) for patients with spinal malignancies. A German version was not available. OBJECTIVE: A cross-cultural adaptation of the SOSGOQ2.0 to the German language and its multicenter evaluation. METHODS: In a multistep process, a cross-cultural adaptation of the SOSGOQ2.0 was conducted. Subsequently, a multicenter, prospective observational cohort study was initiated to assess the reliability and validity of the German adaptation. To assess external construct validity of the cross-cultural adapted questionnaire, a comparison to the established questionnaire QLQ-C30 from the European Organisation for Research and Treatment of Cancer was conducted. Mean-difference plots were used to measure the agreement between the questionnaires in total score and by domain (deviation from mean up to 10% allowed). Further reliability and validity tests were carried out. Change to baseline was analysed 3-16 weeks later after different interventions occurred. Clinically relevant thresholds in comparison to the EORTC QLQ-C30 questionnaire were evaluated by ROC curve analysis. RESULTS: We could enroll 113 patients from four different university hospitals (58 females, 55 males). Mean age was 64.11 years (sd 11.9). 80 patients had an ECOG performance status of 2 or higher at baseline. External construct validity in comparison to the EORTC QLQ-C30 questionnaire in total score and by domain was confirmed (range of deviation 4.4 to 9.0%). Good responsiveness for the domains Physical Functioning (P < .001) and Pain (P < .001) could be shown. The group mean values also displayed a difference in the domains of Social Functioning (P = .331) and Mental Health (P = .130), but not significant. The minimum clinically relevant threshold values for the questionnaire ranged from 4.0 to 7.5 points. CONCLUSIONS: According to our results, the cross-cultural adapted questionnaire is a reliable and valid tool to measure HRQOL in German speaking patients with spinal malignancies. Especially the domains Physical Functioning and Pain showed overall good psychometric characteristics. In this way, a generic questionnaire, such as the EORTC QLQ-C30, can be usefully supplemented by spine-specific questions to increase the overall accuracy measuring HRQOL in patients with spinal malignancies.

[Multidisciplinary outpatient care program vs. usual care : Cost-benefit analysis in patients with chronic low back pain]. / Interdisziplinäre, multimodale Schmerztherapie vs. konventionelle Therapie : Eine Kostenanalyse bei Patienten mit chronischen Rückenschmerzen.

BACKGROUND: Chronic low back pain (CLBP) is a major health problem in industrialized nations and is associated with very high total costs. These costs are split between direct costs brought about by the utilization of health care services and indirect costs due to back pain-related loss of productivity. Despite the existence of some evidence about the effectiveness of a multidisciplinary outpatient care programmes in Germany, the economic benefit of these programmes has not yet been studied in detail. OBJECTIVE: To provide an economic evaluation of the cost benefits of a multidisciplinary outpatient care programme for patients with chronic low back pain (CLBP) compared to those undergoing conventional care. MATERIALS AND METHODS: An economic evaluation was performed in 514 patients who have been diagnosed with LBP. Two interventions will be compared: (1) a multidisciplinary outpatient care programme consisting of education, activity programmes, cognitive behavioural therapy, work hardening and functional restoration and (2) the usual noninvasive care provided by medical specialists and health care professionals. In all, 257 patients were involved in a 4 week multidisciplinary outpatient care programme, while the other 257 were subject to conventional care. RESULTS: The total costs per patient were estimated to be 10,584.14 (± 9,730.87) after 1 year in the group with the multidisciplinary care programme. The results show a significant reduction in the total amount of costs 3,161.63 (range 2,845.30-3,477.96) compared to the usual care group. However, the direct costs are minor (6-12%) compared to the indirect costs (80-93%). CONCLUSION: This study provides important information which is of value for decision-making and making an adequate allocation of medical resources for patients with CLBP. A multidisciplinary outpatient care programme can facilitate rapid return to work.

Prospective quantitative assessment of spinal range of motion before and after minimally invasive surgical treatment of vertebral body fractures.

INTRODUCTION: Randomized clinical trials have generated doubts regarding the therapeutic effectiveness of spinal kyphoplasty to reduce pain and improve quality of life in patients with vertebral fractures. There is a paucity of data on the influence of kyphoplasty on spinal range of motion. To quantify early postoperative changes following kyphoplasty in spinal motion, a noninvasive, radiation-free measurement method was used and results related to clinical and radiological parameters. METHODS: The study group included 30 patients with an overall number of 54 symptomatic pathological vertebral compression fractures. All patients were treated with balloon kyphoplasty. Clinical results were recorded using the visual analog scale, SF 36, Roland Morris Score and the Oswestry Disability Index, at three time points; preoperative, 2 days postoperative, and at 12 weeks postoperative. The kyphosis angle/sagittal index were determined with biplanar X-rays. Amplitude/velocity of motion in extension/flexion was measured at each time point by use of the EpionicsSPINE(©) system (Epionics Medical GmbH; Potsdam, Germany) using two external sensor strips. RESULTS: Preoperative magnetic resonance imaging scans showed bone marrow edema in all vertebral bodies indicative of a recent, non-consolidated fracture. Pain and quality of life was significantly improved by kyphoplasty, both for the immediate postoperative period, as well as at 12 weeks postoperative. Radiological parameters also showed significant improvement following surgery. Total ROM did not significantly change 2 days after kyphoplasty, but amplitude and velocity were found to be increased 12 weeks postoperatively. Significant positive correlations were observed between increased range of motion and improved clinical/radiological scores. CONCLUSION: Significant clinical and radiological improvement following kyphoplasty supports the rational for cement augmentation in patients with pathological vertebral body fractures. To the knowledge of the authors, no prior study has assessed the influence of preservation and improvement of spinal range of motion on clinical outcome following kyphoplasty.

MRI-guided and CT-guided cervical nerve root infiltration therapy: a cost comparison.

PURPOSE: To evaluate and compare the costs of MRI-guided and CT-guided cervical nerve root infiltration for the minimally invasive treatment of radicular neck pain. MATERIALS AND METHODS: Between September 2009 and April 2012, 22 patients (9 men, 13 women; mean age: 48.2 years) underwent MRI-guided (1.0 Tesla, Panorama HFO, Philips) single-site periradicular cervical nerve root infiltration with 40 mg triamcinolone acetonide. A further 64 patients (34 men, 30 women; mean age: 50.3 years) were treated under CT fluoroscopic guidance (Somatom Definition 64, Siemens). The mean overall costs were calculated as the sum of the prorated costs of equipment use (purchase, depreciation, maintenance, and energy costs), personnel costs and expenditure for disposables that were identified for MRI- and CT-guided procedures. Additionally, the cost of ultrasound guidance was calculated. RESULTS: The mean intervention time was 24.9 min. (range: 12 - 36 min.) for MRI-guided infiltration and 19.7 min. (range: 5 - 54 min.) for CT-guided infiltration. The average total costs per patient were EUR 240 for MRI-guided interventions and EUR 124 for CT-guided interventions. These were (MRI/CT guidance) EUR 150/60 for equipment use, EUR 46/40 for personnel, and EUR 44/25 for disposables. The mean overall cost of ultrasound guidance was EUR 76. CONCLUSION: Cervical nerve root infiltration using MRI guidance is still about twice as expensive as infiltration using CT guidance. However, since it does not involve radiation exposure for patients and personnel, MRI-guided nerve root infiltration may become a promising alternative to the CT-guided procedure, especially since a further price decrease is expected for MRI devices and MR-compatible disposables. In contrast, ultrasound remains the less expensive method for nerve root infiltration guidance.