Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice

Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 recent publications of single-arm studies of cancer treatment involving PRO data for current practice on design, analysis, reporting, and interpretation. We further examined their handling of potential bias and how they informed decision-making. Most studies (97%) analyzed PROs without stating a predefined research hypothesis. Thirteen studies (22%) used a PRO as a (co)primary endpoint. Definitions of PRO objectives, study population, endpoints, and strategies of handling missing data varied widely. Twenty-three studies (38%) compared the PRO data to external information, most often by using a clinically important difference value; one study used a historical control group. Appropriateness of methods to handle missingness and intercurrent events including death were seldom discussed. Most studies (85%) concluded that PRO results supported treatment. Conducting and reporting of PROs in cancer single-arm studies lacks standards, and a critical discussion of statistical methods and possible biases. These findings will guide the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Data in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) in developing recommendations for the use of PRO-measures in single arm studies

Thermogravimetric and reaction kinetic analysis of biomass samples from an energy plantation

The products of a Hungarian experimental plantation for energy crops were investigated. Young shoots of poplar clones (Populus x euramericana and Populus x interamericana), black locust (Robinia pseudoacacia), willow (Salix alba), and an herbaceous plant (Miscanthus sinensis) revealed unexpectedly similar thermal behavior in inert and oxidative atmospheres, as well. An 8-fold difference in the level of grinding did not result in substantial differences in the thermal decomposition. The effect of oxygen in the ambient gas was studied at low sample masses (0.2-0.4 mg) that excluded the overheating due to the high reaction heat of the combustion process. The presence of oxygen affects the decomposition from ca. 220 degreesC. Nevertheless, the extrapolated onset temperature of the hemicellulose decomposition is practically the same at 0, 5, and 21 V/V% oxygen. A group of 12 experiments, representing two grinding levels, three plant genera and four different heating programs were evaluated simultaneously by the method of least squares employing the model of independent pseudocomponents. All evaluated experiments were well described by the same set of kinetic parameters; only the parameters describing the peak area of the partial processes differed. A technique was recommended for the appropriate handling of the nonrandom errors in the simultaneous evaluation of experiment series

Behavioural indicators of welfare in farmed fish

Behaviour represents a reaction to the environment as fish perceive it and is therefore a key element of fish welfare. This review summarises the main findings on how behavioural changes have been used to assess welfare in farmed fish, using both functional and feeling-based approaches. Changes in foraging behaviour, ventilatory activity, aggression, individual and group swimming behaviour, stereotypic and abnormal behaviour have been linked with acute and chronic stressors in aquaculture and can therefore be regarded as likely indicators of poor welfare. On the contrary, measurements of exploratory behaviour, feed anticipatory activity and reward-related operant behaviour are beginning to be considered as indicators of positive emotions and welfare in fish. Despite the lack of scientific agreement about the existence of sentience in fish, the possibility that they are capable of both positive and negative emotions may contribute to the development of new strategies (e. g. environmental enrichment) to promote good welfare. Numerous studies that use behavioural indicators of welfare show that behavioural changes can be interpreted as either good or poor welfare depending on the fish species. It is therefore essential to understand the species-specific biology before drawing any conclusions in relation to welfare. In addition, different individuals within the same species may exhibit divergent coping strategies towards stressors, and what is tolerated by some individuals may be detrimental to others. Therefore, the assessment of welfare in a few individuals may not represent the average welfare of a group and vice versa. This underlines the need to develop on-farm, operational behavioural welfare indicators that can be easily used to assess not only the individual welfare but also the welfare of the whole group (e. g. spatial distribution). With the ongoing development of video technology and image processing, the on-farm surveillance of behaviour may in the near future represent a low-cost, noninvasive tool to assess the welfare of farmed fish.Fundação para a Ciência e Tecnologia, Portugal [SFRH/BPD/42015/2007]info:eu-repo/semantics/publishedVersio

Tackling antibiotic resistance: the environmental framework

Antibiotic resistance is a threat to human and animal health worldwide, and key measures are required to reduce the risks posed by antibiotic resistance genes that occur in the environment. These measures include the identification of critical points of control, the development of reliable surveillance and risk assessment procedures, and the implementation of technological solutions that can prevent environmental contamination with antibiotic resistant bacteria and genes. In this Opinion article, we discuss the main knowledge gaps, the future research needs and the policy and management options that should be prioritized to tackle antibiotic resistance in the environment

Comparison of numerical response predictions for a bottom-fixed offshore wind turbine

Numerical simulations are widely used for response calculations on offshore wind turbines. Code-to-code comparisons are frequently used for verification of the codes, as full-scale measurements can be difficult to obtain. However, most code comparisons performed focus on documenting the responses predicted by the different codes, or on the effect of specific differences between the codes. Little insight is provided to how these differences would affect design calculations, such as the fatigue utilization. In this paper, the response predictions of the programs SIMA, vpOne and FAST are compared using the DTU 10 MW reference wind turbine on a monopile foundation. While differences in the models are first highlighted through a number of simplified load cases, a lifetime fatigue evaluation of the model is then performed for the monopile at mudline. In the deterministic load cases the response of all models are quite similar, while some differences become apparent in the stochastic analysis. For the fatigue calculations, a difference of 14 % is found in the damage equivalent bending moment at mudline. This demonstrates how sensitive the fatigue utilization is to small differences is code capabilities and modelling

Modelling of Synthetic Fibre Rope Mooring for Floating Offshore Wind Turbines

Fibre ropes offer beneficial properties for mooring of floating offshore wind turbines (FOWTs). However, the mooring line’s stiffness is both load-history and load-rate dependent. A quasi-static stiffness is observed for slow loading, with a higher stiffness related to rapid, cyclic loading (dynamic stiffness). Design standards provide different guidelines for how to combine these in the mooring analysis. This paper describes procedures for adapting laboratory test stiffness results to the Syrope and a bi-linear model and investigates the consequence of using the models for load calculations. The Syrope model accounts for the quasi-static and permanent rope elongation, while performing the analyses with the dynamic stiffness. The bi-linear model applies both the quasi-static and dynamic stiffness in the dynamic analyses. Based on fibre rope tests performed by Bridon-Bekaert, a Syrope model and two bi-linear models are adapted to the same fibre rope. Fatigue damage and ultimate loads on the mooring lines of Saitec’s SATH FOWT are calculated. The bi-linear model artificially reduces the tension ranges, particularly if there is a large difference between the quasi-static and dynamic stiffness of the fibre rope. This leads to a longer predicted fatigue lifetime. Differences in the extreme loads are caused by the permanent elongation of the Syrope model. This may be countered if the elongation is known and included in the bi-linear model. Finally, the bi-linear model introduces an amplitude-dependency in the horizontal natural periods