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.

[Diagnosis and Treatment of Spondylodiscitis/Spondylitis in Clinical Practice]. / Diagnose und Behandlung der Spondylitis/Spondylodiszitis in der Klinikroutine.

BACKGROUND: The clinical presentation of spondylsodiscitis/spondylitis are manifold. This commonly leads to a period of several months from initial symptoms to final diagnosis. A standardised treatment is difficult. The purpose of this study is to investigate the treatment carried out for patients with spondylodiscitis or spondylitis to develop an individualised standard care for better treatment. PATIENTS AND METHODS: Data of 90 patients were retrospective analysed. In particular documented data of the initial examination and the following treatments concerning identification of causes and systematically control of pathogens were examined. RESULTS: In 91 % of patients a diagnostically conclusive MRI was conducted. The degree of spondylidiscitis/spondylitis was mainly ASA criteria I or II (86 %). In 96 % of patients different diagnostic methods for identification of pathogens were conducted and documented. RESULTS confirmed the most common pathogens mentioned in the literature. 75 % of patients were treated by surgery. In 93 % of patients an antibiotic treatment was documented. 50 patients (81 %) were successfully healed. CONCLUSION: It is important to identify and treat spondylodiscitis/spondylitis as early as possible. Diagnosis by means of blood culture and MRI and treatment of the infection with antibiotics and possibly surgical interventions seem be very suitable, but need to be individualised to each and every patient.

[Comparison of clinical and radiological data in the treatment of patients with osteoporotic vertebral compression fractures using radiofrequency kyphoplasty or balloon kyphoplasty]. / Vergleich klinischer und radiologischer Daten bei der Behandlung von Patienten mit osteoporotischen Wirbelkörper-Kompressionsfrakturen mit Radiofrequenz-Kyphoplastie oder mit Ballon-Kyphoplastie.

PURPOSE: Since the 1990s, balloon kyphoplasty has been proven as an effective method of treating patients with painful vertebral compression fractures (VCF). The radiofrequency kyphoplasty is an innovative procedure available since 2009, for which an ultra-high viscosity cement is used. For the statistical comparison of the two methods of augmentation, the clinical and radiological data of 2 larger patient groups were evaluated. MATERIALS AND METHODS: As part of the surgical treatment of patients with conservative therapy-resistant osteoporotic vertebral fractures, a prospective study of radiofrequency kyphoplasty (RFK) was performed between 2009 and September 2010. The treatment was minimally invasive using the StabiliT® Vertebral Augmentation System by DFine for which the StabiliT® multiplex controller, the articulating VertecoR® Midline Osteotome, and the radiofrequency-sensitive StabiliT® ER2 bone cement were applied. From the clinical aspect, measurement parameters for efficacy and safety were the course of pain intensity using a visual analogue scale (VAS: 0 to 100 mm) and the Oswestry disability score (0-100%). For the radiological outcome the increase in the middle and anterior parts of the treated vertebra and also the reduction of kyphosis after surgery and after 6 months were evaluated. Furthermore, the extent of cement extrusion and the duration of operation time were compared. There were 2 groups of patients chosen with the same indication, and with the same average VAS prior to treatment. For the balloon kyphoplasty (BKP) the Kyphon® technology was used. For the BKP group the same parameters as in the first group were evaluated (matched pairs). To compare the data statistically, parametric and non-parametric tests were applied. RESULTS: For the radiofrequency kyphoplasty group (RFK) 114 patients were recruited, and for the balloon kyphoplasty group (BKP) 114 appropriate patients were selected. In 48% of the RFK patients and in 44% of the BKP patients more than one vertebral body were treated (thoracic or lumbar). Prior to treatment 84 mm on the VAS were calculated in both groups. The decrease in VAS values (RFK vs. BKP) immediately after surgery was 58.8 vs. 54.7 mm (p = 0.02), and 73.0 vs. 58.9 mm after 6 months (p < 0.001). In both groups improvements in the Oswestry scores were registered after 6 months without a statistically significant difference. In both groups, the middle part of the vertebral bodies was increased by an average of 3.1 mm. RFK yielded a decrease in the average kyphosis angle of 4.4, the BKP resulted in about 3.8 degrees. Concerning cement leakage a key difference in favor of the radio frequency kyphoplasty was detected (6.1 % vs. 27.8%; p < 0.0001). For RFK a significant shorter duration of operation time was calculated (28.2 vs. 49.6 min; p < 0.001). CONCLUSIONS: The RFK has proven to be a clinically very effective procedure that does somewhat better than BKP in long-lasting pain relief. No differences could be detected regarding improvement of functioning and the mean restoration of mid- and anterior vertebral height. As far as the safety aspect is concerned the RFK offers the advantage of a statistically significant lower proportion of cement extrusion.