The aim of this Global Allergy and Asthma European Network (GA(2)LEN) consensus report is to provide recommendations for patient-reported outcomes (PROs) evaluation in clinical trials for allergic diseases, which constitute a global health problem in terms of physical, psychological economic and social impact. During the last 40 years, PROs have gained large consideration and use in the scientific community, to gain a better understanding of patients' subjective assessment with respect to elements concerning their health condition. They include all health-related reports coming from the patient, without involvement or interpretation by physician or others. PROs assessment should be performed by validated tools (disease-specific tools when available or generic ones) selected taking into account the aim of the study, the expected intervention effects and the determinant and confounding factors or patient-related factors which could influence PROs. Moreover, each tool should be used exclusively in the patient population following the authors' indications without modification and performing a cross-cultural validation if the tool must be used in a language that differs from the original. The result analysis also suggests that the relevance of PROs results in any interventional study should include a pre-post assessment providing information concerning statistical differences within or among groups, rates of response for the PROs and a minimal important difference for the population. The report underlines the importance of further investigation on some topics, such as the quality assessment of existing PROs tools, the definition of inclusion and exclusion criteria and a more extensive evaluation of the correlation between PROs, besides health-related quality of life, and clinical data.
The GA(2)LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patient-related factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaining increasing importance, and it must be performed with a rigorous methodological procedure and using validated tools. This approach enables to better understand patient-related factors influencing clinical trials and real-life management outcomes, identify patients subgroups that can benefit from specific treatment and management plan and tailor treatment to address PROs (not only physician-defined targets) to improve asthma and rhinitis management.
Non-anatomic, mobile-bearing, hydroxyapatite-coated and non tibial-stemmed total ankle replacements are positively associated with more periprosthetic bone cysts.
Collaborative robots (cobots) could help humans in tasks that are mundane, dangerous or where direct human contact carries risk. Yet, the collaboration between humans and robots is severely limited by the aspects of the safety and comfort of human operators. In this paper, we outline the use of extended reality (XR) as a way to test and develop collaboration with robots. We focus on virtual reality (VR) in simulating collaboration scenarios and the use of cobot digital twins. This is specifically useful in situations that are difficult or even impossible to safely test in real life, such as dangerous scenarios. We describe using XR simulations as a means to evaluate collaboration with robots without putting humans at harm. We show how an XR setting enables combining human behavioral data, subjective self-reports, and biosignals signifying human comfort, stress and cognitive load during collaboration. Several works demonstrate XR can be used to train human operators and provide them with augmented reality (AR) interfaces to enhance their performance with robots. We also provide a first attempt at what could become the basis for a human–robot collaboration testing framework, specifically for designing and testing factors affecting human–robot collaboration. The use of XR has the potential to change the way we design and test cobots, and train cobot operators, in a range of applications: from industry, through healthcare, to space operations.
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