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Background: This study aims to develop and validate a new classification system that better predicts combined risk of neurological and neurovascular complications following CBT surgery, crucial for treatment decision‐making. Methods: Multinational retrospective cohort study with 199 consecutive cases. A cohort of 132 CBT cases was used to develop the new classification. To undertake external validation, assessment was made between the actual complication rate and predicted risk by the model on an independent cohort (n = 67). Results: Univariate analyses showed statistically significant associations between developing a complication and the following factors: craniocaudal dimension, volume, Shamblin classification, and Mehanna types. In the multivariate prognostic model, only Mehanna type remained as a significant risk predictor. The risk of developing complications increases with increasing Mehanna type. Conclusions: We have developed and then validated a new classification and risk stratification system for CBTs, which demonstrated better prognostic power for the risk of developing neurovascular complications after surgery. [ABSTRACT FROM AUTHOR]

Introduction: Menopausal problems are among the most prevalent and distressing problems following breast cancer treatment, with 70% women experiencing hot flushes and night sweats (HFNS). A working party was set up to support the development of new research into the management of these problems.Methods: We conducted surveys to explore the need as perceived by women with breast cancer and establish current UK management practices. A patient survey was conducted through a charity, Breast Cancer Care, and a health professional survey via the UK Breast Intergroup. The HFNS Problem Rating Scale was used, as well as specific questions addressing the aims of the study.Results: Six hundred and sixty-five patients responded and 185 health professionals. Twenty-eight percent women had considered stopping adjuvant endocrine treatment because of HFNS, yet 34% had never been asked about HFNS by any health professional. The most commonly offered interventions were SSRIs, such as venlafaxine, yet only 25% patients had been offered these drugs. Cognitive behavioural therapy was rarely suggested (2%) despite good evidence.Discussion: This study shows a lack of coherence in the management of HFNS in breast cancer survivors, which may lead to reduced adherence to adjuvant therapy. There is an urgent need to develop guidelines to support management of HFNS after breast cancer. [ABSTRACT FROM AUTHOR]

Background: The application of adaptive design methodology within a clinical trial setting is becoming increasingly popular. However the application of these methods within trials is not being reported as adaptive designs hence making it more difficult to capture the emerging use of these designs. Within this review, we aim to understand how adaptive design methodology is being reported, whether these methods are explicitly stated as an 'adaptive design' or if it has to be inferred and to identify whether these methods are applied prospectively or concurrently.Methods: Three databases; Embase, Ovid and PubMed were chosen to conduct the literature search. The inclusion criteria for the review were phase II, phase III and phase II/III randomised controlled trials within the field of Oncology that published trial results in 2015. A variety of search terms related to adaptive designs were used.Results: A total of 734 results were identified, after screening 54 were eligible. Adaptive designs were more commonly applied in phase III confirmatory trials. The majority of the papers performed an interim analysis, which included some sort of stopping criteria. Additionally only two papers explicitly stated the term 'adaptive design' and therefore for most of the papers, it had to be inferred that adaptive methods was applied. Sixty-five applications of adaptive design methods were applied, from which the most common method was an adaptation using group sequential methods.Conclusions: This review indicated that the reporting of adaptive design methodology within clinical trials needs improving. The proposed extension to the current CONSORT 2010 guidelines could help capture adaptive design methods. Furthermore provide an essential aid to those involved with clinical trials. [ABSTRACT FROM AUTHOR]