Endpoints and cutpoints in head and neck oncology trials: methodical background, challenges, current practice and perspectives.

This article reviews the methodical and statistical basics of designing a trial, with a special focus on the process of defining and choosing endpoints and cutpoints as the foundations of clinical research, and ultimately that of evidence-based medicine. There has been a significant progress in the treatment of head and neck cancer in the past few decades. Currently available treatment options can have a variety of different goals, depending e.g. on tumor stage, among other factors. The outcome of a specific treatment in clinical trials is measured using endpoints. Besides classical endpoints, such as overall survival or organ preservation, other endpoints like quality of life are becoming increasingly important in designing and conducting a trial. The present work is based on electronic research and focuses on the solid methodical and statistical basics of a clinical trial, on the structure of study designs and on the presentation of various endpoints.

Inventory of economic evaluation of head and neck oncology from the German perspective.

New treatment strategies for head and neck neoplasms include induction chemotherapy and biomarker treatment. Moreover, different therapeutic modalities, especially robotic surgery, induction chemotherapy, biotherapy and altered fractionation schedules of chemo-(radio)therapy are newly combined to optimize treatment benefit and minimize treatment-associated morbidity. Often, overall survival does not change significantly between the competing treatment schedules. Therefore, the evaluation of the patient's treatment-related quality of life (QoL) and organ function becomes more and more important. Finally, the sponsor's financial resources are restricted, which makes it necessary to evaluate therapies for pricing and effectiveness. In head and neck cancer in Europe, analyses of the current situation are lacking. Selective literature research for publications on economic cost-effectiveness analyses was performed. An overview of the current situation with a special focus on Europe is provided. Cost-effectiveness values and QoL assessments should be respected in former prospective study construction to gain systematic information on this topic.

The value of digital volume tomography in assessing the position of cochlear implant arrays in temporal bone specimens.

OBJECTIVES: Radiological evaluation of the position of cochlear implant (CI) devices is an upcoming method for quality control after CI surgery. First, results of imaging of the middle and inner ear with digital volume tomography (DVT) show considerable advantages such as exceptional image quality, thin slice thickness, and low radiation dose. The aim of this study was to evaluate whether DVT is an appropriate method for postoperative imaging of CI patients and to identify the exact position of the implant array within the cochlear by multiple measurements. DESIGN: Thirteen formalin-fixed temporal bone specimens were implanted with a CI array and scanned in DVT. To determine the exact electrode position, these specimens were ground and stained for microscopic measurements. The measurements on grindings acted as a referee and were compared with the measurements in DVT scans. The statistical analysis between the two measurement protocols was performed using the Bland-Altman method. RESULTS: Best achievable agreement between DVT scans and histological reference was shown. Mean differences between DVT and grindings from -1.55 to -65.40 microm were calculated. All means are within the region of accuracy. General positioning of the implant into the cochlea could be verified in all specimens. The exact position of the implanted array within the cochlear scalae could be recognized correctly in 11 of 13 cases in DVT. It was possible to identify shiftings between the tympanic and vestibular scalae in all cases. CONCLUSION: DVT seems to be a convenient technique for postoperative position control after cochlear implantation.