BackgroundIn an international randomised controlled phase II study of temozolomide (TMZ) versus TMZ in combination with bevacizumab (BEV) in locally diagnosed non-1p/19q co-deleted World Health... Show moreBackgroundIn an international randomised controlled phase II study of temozolomide (TMZ) versus TMZ in combination with bevacizumab (BEV) in locally diagnosed non-1p/19q co-deleted World Health Organization grade 2 or 3 gliomas with a first and contrast-enhancing recurrence after initial radiotherapy, and overall survival at 12 months was not significantly different (61% in the TMZ arm and 55% in the TMZ + BEV arm).ObjectivesHealth-related quality of life (HRQoL) was a key secondary end-point in this trial, and the main objective of this study was to determine the impact of the addition of BEV to TMZ on HRQoL.MethodsHRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 (version 3) and QLQ-BN20 at baseline, and then every 12 weeks until disease progression. The pre-selected primary HRQoL end-point was the QLQ-C30 global health scale, with self-perceived cognitive functioning and pain selected as secondary HRQoL issues. Analysis was undertaken using linear mixed modelling and complemented with sensitivity analyses using summary statistics. A difference was considered clinically relevant with ≥10 points difference on a 100-point scale.ResultsBaseline compliance was high at 94% and remained above 60% until 72 weeks, limiting the analysis to 60 weeks. Compliance was similar in both arms. We found no statistically significant or clinically significant differences between the primary HRQoL end-point in both treatment arms (p = 0.2642). The sensitivity analyses confirmed this finding. The overall test for post-baseline differences between the two treatment arms also showed no statistically or clinically significant differences regarding the selected secondary end-point scales. Show less
In the field of orthopedic trauma surgery, great progress has been made over the last decades which has improved patient care and enhanced the likelihood of surviving serious injury. As a result,... Show moreIn the field of orthopedic trauma surgery, great progress has been made over the last decades which has improved patient care and enhanced the likelihood of surviving serious injury. As a result, focus has shifted from patient survival to improving quality of life and reducing the burden of nonfatal injury. However, research-based advances that improve these outcomes for patients with orthopedic injuries have been constrained. The aims of this thesis were to provideinsight into the value of different study designs which evaluate the effects of medical interventions for trauma patients in everyday clinical practice and to assess the use of patient-reported outcome measures (PROMs) as an integrated part of research practice for the assessment of quality of life after nonfatal trauma injury. Show less
