Abstract
BackgroundThe 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.ObjectiveA cross-cultural adaptation of the SOSGOQ2.0 to the German language and its multicenter evaluation.MethodsIn 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.ResultsWe 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.ConclusionsAccording 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.
Highlights
The total number of patients with malignant spinal tumors increases continuously
The EORTC QLQ-BM22 [10] and FACT-BP questionnaires [11, 12] were available in German for quality of life studies in patients with bone lesions
After consent of the Knowledge Forum (KF) Tumor of the AOSpine an cross-cultural adaptation of the SOSGOQ2.0 was performed according to the published guidelines [15]
Summary
The total number of patients with malignant spinal tumors increases continuously. With a constant number of new primary tumor cases, a significant increment in incidence of spinal metastases can be observed. A specific questionnaire to assess HRQOL of patients with malign tumors of the spine together with a generic questionnaire would increase the sensitivity and specificity of the assessment [13] For this purpose, the Spine Oncology Study Group Outcomes Questionnaire (SOSGOQ) was developed, which showed excellent results regarding face and content validity [14] and proved to be a valid and reliable instrument in the clinical setting in Englishspeaking countries [14] as well as its revised second version SOSGOQ2.0 [13]. 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.
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