Search Results (6)

Objectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation’s (EU HTAR) legislative wording. Therefore, we aimed to explore the roles, challenges, and most important activities to increase the level of involvement per stakeholder group. Methods: At the 2022 Fall Convention of the European Access Academy (EAA), working groups addressed the involvement of patients, clinicians, regulators, health technology developers (HTD), and national HTA bodies and payers within the EU HTA process. Each working group revisited the pre-convention survey results, determined key role characteristics for each stakeholder, and agreed on the most important activities to fulfill the role profile. Finally, the activities suggested per group were prioritized by plenary group. Results: The prioritized actions for patients included training and capacity building, the establishment of a patient involvement committee, and the establishment of a patient unit at the EC secretariat. For clinicians, it included alignment on evidence assessment from a clinical vs. HTA point of view, capacity building, and standardization of processes. The most important actions for regulators are to develop joint regulatory-HTA guidance documents, align processes and interfaces under the regulation, and share discussions on post-licensing evidence generation. HTDs prioritized scientific advice capacity and the review of the scoping process, and further development of the scope of the assessment report fact checks. The top three actions for national HTA bodies and payers included clarification on the early HTD dialogue process, political support and commitment, and clarification on financial support. Conclusions: Addressing the activities identified as the most important for stakeholders/collaborators in the EU HTA process (e.g., in the implementation of the EU HTA Stakeholder Network and of the guidance documents developed by the EUnetHTA 21 consortium) will be key to starting an “inclusive civil society dialogue”, as suggested by the European Commission’s Pharmaceutical Strategy. Full article

As manufacturing and assembly processes continue to require more adaptable systems for automated handling, innovative solutions for universal gripping are emerging. These grasping systems can enable the handling of wide varieties of shapes, with gripping forces varying with grasped geometries. For the efficient usage of handling systems, precise offline and online prediction models for resulting grasping forces for different objects are necessary. In previous research, a flexible vacuum-based granular gripper was developed, for which no option for predicting gripping forces is currently available. Various gripping force prediction methodologies within the current state of the art are examined and evaluated. For an assessment of grasping forces of previously untested objects for the examined gripper with limited data and low computational effort, two methodologies are proposed. An analytical, 2D-geometry-derived gripper-specific metric for geometries is compared to a methodology based on similarities of objects to a small existing dataset. The applicability and prediction quality for different object types is analyzed through validation experiments. Gripping force estimations are possible with both methodologies, with individual weaknesses towards geometric features such as air permeabilities. With further development, robust predictions of gripping forces could be achieved for a wide range of unknown object geometries with limited experimental effort. Full article

Background: Given the dismal prognosis of small cell lung cancer (SCLC), novel therapeutic targets are urgently needed. We aimed to evaluate whether SSTR expression, as assessed by positron emission tomography (PET), can be applied as a prognostic image biomarker and determined subjects eligible for peptide receptor radionuclide therapy (PRRT). Methods: A total of 67 patients (26 females; age, 41–80 years) with advanced SCLC underwent SSTR-directed PET/computed tomography (somatostatin receptor imaging, SRI). SRI-avid tumor burden was quantified by maximum standardized uptake values (SUV_max) and tumor-to-liver ratios (T/L) of the most intense SCLC lesion. Scan findings were correlated with progression-free (PFS) and overall survival (OS). In addition, subjects eligible for SSTR-directed radioligand therapy were identified, and treatment outcome and toxicity profile were recorded. Results: On a patient basis, 36/67 (53.7%) subjects presented with mainly SSTR-positive SCLC lesions (>50% lesions positive); in 10/67 patients (14.9%), all lesions were positive. The median SUV_max was found to be 8.5, while the median T/L was 1.12. SRI-uptake was not associated with PFS or OS, respectively (SUV_max vs. PFS, ρ = 0.13 with p = 0.30 and vs. OS, ρ = 0.00 with p = 0.97; T/L vs. PFS, ρ = 0.07 with p = 0.58 and vs. OS, ρ = −0.05 with p = 0.70). PRRT was performed in 14 patients. One patient succumbed to treatment-independent infectious complications immediately after PRRT. In the remaining 13 subjects, disease control was achieved in 5/13 (38.5%) with a single patient achieving a partial response (stable disease in the remainder). In the sub-group of responding patients, PFS and OS were 357 days and 480 days, respectively. Conclusions: SSTR expression as detected by SRI is not predictive of outcome in patients with advanced SCLC. However, it might serve as a therapeutic target in selected patients. Full article

Involvement of all relevant stakeholders will be of utmost importance for the success of the developing EU HTA harmonization process. A multi-step procedure was applied to develop a survey across stakeholders/collaborators within the EU HTA framework to assess their current level of involvement, determine their suggested future role, identify challenges to contribution, and highlight efficient ways to fulfilling their role. The ‘key’ stakeholder groups identified and covered by this research included: patients’, clinicians’, regulatory, and Health Technology Developer representatives. The survey was circulated to a wide expert audience including all relevant stakeholder groups in order to determine self-perception by the ‘key’ stakeholders regarding involvement in the HTA process (self-rating), and in a second, slightly modified version of the questionnaire, to determine the perception of ‘key’ stakeholder involvement by HTA bodies, payers, and policymakers (external rating). Predefined analyses were conducted on the submitted responses. Fifty-four responses were received (patients 9; clinicians: 8; regulators: 4; HTDs 14; HTA bodies: 7; Payers: 5; policymakers 3; others 4). The mean self-perceived involvement score was consistently lower for each of the ‘key’ stakeholder groups than the respective external ratings. Based on the qualitative insights generated in the survey, a RACI Chart (Responsible/Accountable/Consulted/Informed) was developed for each of the stakeholder groups to determine their roles and involvement in the current EU HTA process. Our findings suggest extensive effort and a distinct research agenda are required to ensure adequate involvement of the key stakeholder groups in the evolving EU HTA process. Full article

Bulk mineral waste materials are one of the largest waste streams worldwide and their management systems can differ greatly depending on regional conditions. Due to this variation, the decision-making context is of particular importance when studying environmental impacts of mineral waste management systems with life cycle assessment (LCA). We follow the premise that LCA results—if applied in practice—are always used in an improvement (i.e., decision-making) context. But how suitable are existing LCA studies on bulk mineral waste management for decision support? To answer this question, we quantitatively and qualitatively assess 57 peer-reviewed bulk mineral waste management LCA studies against 47 criteria. The results show inadequacies regarding decision support along all LCA phases. Common shortcomings are insufficient attention to the specific decision-making context, lack of a consequential perspective, liberal use of allocation and limited justification thereof, missing justifications for excluded impact categories, inadequately discussed limitations, and incomplete documentation. We identified the following significant issues for bulk mineral waste management systems: transportation, the potential leaching of heavy metals, second-order substitution effects, and the choice to include or exclude avoided landfilling and embodied impacts. When applicable, we provide recommendations for improvement and point to best practice examples. Full article

Characterizing consumers in terms of their propensity to practice sustainable consumption represents an interesting research challenge in which a crucial role is played by the questionnaire in terms of its structure and classification criteria. Various classification rules have been proposed in the literature, which can be used to identify consumer types and signify their propensity to practice the principles of sustainable development in daily life. In this paper, we based our approach in designing a classification tool on a combination of two elements: the concept of voluntary simplicity as a pillar for consumer characteristics and the idea of assessing consumers by using filters, in a modified form introducing many new aspects of life-cycle thinking. The tool proposed provides insight into the relationship between the consumer’s typology and behavior during purchasing decisions in daily life. The main function of the proposed tool is to assign respondents to one of the proposed consumer types distinguished and characterized in terms of many aspects of life cycle thinking. A pilot survey has been performed in order to verify the proposed tool, and the survey results have been presented in the paper, as well. Full article