Assessing the assessments: evaluation of four impact assessment protocols for invasive alien species

Aim: Effective policy and management responses to the multiple threats posed by invasive alien species (IAS) rely on the ability to assess their impacts before conclusive empirical evidence is available. A plethora of different IAS risk and/or impact assessment protocols have been proposed, but it remains unclear whether, how and why the outcomes of such assessment protocols may differ. Location: Europe. Methods: Here, we present an in-depth evaluation and informed assessment of the consistency of four prominent protocols for assessing IAS impacts (EICAT, GISS, Harmonia and NNRA), using two non-native parrots in Europe: the widespread ring-necked parakeet (Psittacula krameri) and the rapidly spreading monk parakeet (Myiopsitta monachus). Results: Our findings show that the procedures used to assess impacts may influence assessment outcomes. We find that robust IAS prioritization can be obtained by assessing species based on their most severe documented impacts, as all protocols yield consistent outcomes across impact categories. Additive impact scoring offers complementary, more subtle information that may be especially relevant for guiding management decisions regarding already established invasive alien species. Such management decisions will also strongly benefit from consensus approaches that reduce disagreement between experts, fostering the uptake of scientific advice into policy-making decisions. Main conclusions: Invasive alien species assessments should take advantage of the capacity of consensus assessments to consolidate discussion and agreement between experts. Our results suggest that decision-makers could use the assessment protocol most fit for their purpose, on the condition they apply a precautionary approach by considering the most severe impacts only. We also recommend that screening for high-impact IAS should be performed on a more robust basis than current ad hoc practices, at least using the easiest assessment protocols and reporting confidence scores.This study is a joint effort from a workshop organized under COST European Cooperation in Science and Technology Actions Parrotnet (ES1304) and Alien Challenge (TD1209). We would also like to thank two anonymous referees for helpful comments on an earlier version of this manuscript. D.S is currently funded by a Marie Skłodowska‐Curie Action under the Horizon 2020 call (H2020‐MSCA‐IF‐2015, grant number 706318) and acknowledges the Danish National Research Foundation for support to the Center for Macroecology, Evolution and Climate (grant number DNRF96). J.C.S. was supported by funds from the Ministry of Economy and Competitivity, Spanish Research Council (CGL‐2016‐79568‐C3‐3‐P)

Protection des personnes dans la recherche en santé : un équilibre à atteindre

Le Louarn Anne. Protection des personnes dans la recherche en santé : un équilibre à atteindre. In: Revue juridique de l'Ouest, N° Spécial 2015. 20 ans de législation sanitaire. Bilan et perspectives. Colloque organisé par l Association des Etudiants en Droit de la Santé (AEDS) pour les 20 ans du Master "Droit, Santé, Ethique" (1994-2014) pp. 91-97

Challenges in recording race and ethnicity data in biomedical research: the French and Swedish perspectives

A viewpoint about the importance of ethnicity in medical research

Making data sharing the norm in medical research

International audienc

Cost-Effectiveness of UGT1A1*28 Genotyping in Preventing Severe Neutropenia Following FOLFIRI Therapy in Colorectal Cancer

International audiencePurpose. Functional polymorphisms of the UGT1A1 gene, particularly the UGT1A1*28 variant, are associated with the severity of the bone marrow suppression in patients with metastatic colorectal cancer receiving irinotecan. This study assesses the cost-effectiveness of screening for UGT1A1*28 polymorphism associated with primary prophylactic Granulocytes Colony Stimulating Factor in patients homozygous for the *28 allele. The effectiveness was estimated based on the number of neutropenia avoided. Methods. This study was conducted from a hospital perspective. Relevant literature was analysed from 2000 to 2009 in order to select data and model parameters. We modelled a theoretical population treated with combined 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) for metastatic colorectal cancer. A decision tree simulated the health outcomes, measured by the prevalence of neutropenic events for two strategies, with or without UGT1A1 genotype screening. The model incorporated direct hospital costs in 2006 and was validated with a sensitivity analysis. We calculated the cost-effectiveness ratio: CE=Delta C / Delta E = "genotyping" cost - "no genotyping" cost / number of febrile neutropenia avoided. Results. In the "genotyping strategy", the cost to avoid one febrile neutropenia event per 1000 patients treated was (sic) 942.8 to (sic) 1090.1. The sensitivity analysis showed a better CE ratio of (sic) 733.4 to (sic) 726.6 per febrile neutropenic event avoided. Conclusions. UGT1A1 genotype screening before irinotecan treatment is a cost-efficient strategy for the hospital. Systematic genotyping prior to chemotherapy, and administration of CSF in patients homozygotes for the *28 allele allow to avoid 91 febrile neutropenias at an acceptable cost

Navigating US participant data sharing requirements: implications for international clinical trials

International audienc

Evaluation of the two intraoperative examination methods for sentinel lymph node assessment: a multicentric and retrospective study on more than 2,000 nodes.

International audienceBACKGROUND: Intraoperative frozen section (FS) and imprint cytology (IC) are currently used to detect sentinel lymph node (SLN) metastasis, allowing for complete dissection when necessary. MATERIALS AND METHODS: A 2-year retrospective chart review was performed for patients who underwent SLN procedure in five French hospitals. The FS and IC results were compared to the definitive histology in order to calculate the sensitivity, specificity and false-negative rate. These results were studied from both the surgeon's and the pathologist's point of view. RESULTS: The comparison of the FS group (n=672) and IC group (n=576) showed a lack of sensitivity for both techniques, even if it was better for FS (59.3% vs. IC=33.3%). The false-negative rate (among patients with metastases) was very high in the two groups (FS=40.7% vs. IC=66.6%), leading to high re-intervention rates (FS=40.7% vs. IC=30.2%). False-negative nodes were more often small metastases and lobular carcinoma type. CONCLUSION: The interest in intraoperative examination is questionable. To avoid intraoperative examination failures, we think that complete staging of the disease before surgical treatment would be more relevant

Ten (not so) simple rules for clinical trial data-sharing.

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirementsRule 2: Anticipate the possibility of clinical trial data-sharing before obtaining fundingRule 3: Declare your intent to share data in the registration stepRule 4: Involve research participantsRule 5: Determine the method of data accessRule 6: Remember there are several other elements to shareRule 7: Do not proceed aloneRule 8: Deploy optimal data management to ensure that the data shared is usefulRule 9: Minimize risksRule 10: Strive for excellence

Ten (not so) simple rules for clinical trial data-sharing

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirements Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding Rule 3: Declare your intent to share data in the registration step Rule 4: Involve research participants Rule 5: Determine the method of data access Rule 6: Remember there are several other elements to share Rule 7: Do not proceed alone Rule 8: Deploy optimal data management to ensure that the data shared is useful Rule 9: Minimize risks Rule 10: Strive for excellence

Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools

International audienceClinical research in outpatient healthcare, particularly in general practice, which is the first line of contact with the population, is now a public health issue. However, this type of research has specific characteristics that differentiate it from clinical research conducted in a hospital setting and requires an adaptation of its conditions of practice: in terms of organisation, the development of research in outpatient healthcare relies on the appropriation of its fundamentals by the investigators, which implies their presentation, upstream, from the initial cycle, and the participation of practitioners in training modules adapted to research in primary care, such as those already organised by several GIRCI (Groupement Inter régional de la Recherche Clinique et de l’Innovation [French Interregional Clusters for Clinical Research and Innovation]). To compensate for the fragmented nature of their location, on the model of the EMRCs (équipes mobiles de recherche clinique [mobile clinical research teams]) in oncology, mobile research teams should enable general medical practices to participate in clinical trials. This presupposes, on the one hand, the allocation of earmarked funding to ensure the sustainability of a base of dedicated personnel and, on the other hand, the impetus of a national dynamic through the setting up of a multi-organisation thematic institute for "research in primary care" associated, at the operational level, with a national scale investigation network supported by a platform of excellence. The use of digital tools and innovations (telemedicine; data collection via connected tools; e-consent; electronic signature) which make it possible to digitise and relocate all or part of the research procedures for both the participant and the investigation teams. An adaptation of the legal framework in order to bring the place of research closer to the patient and not the other way round, which means moving the equipment and investigations closer to the patient. Taking into account the acceptability of the patient, thus limiting the disruption that may be caused by his or her participation in a research protocol and motivating the practitioner by valuing his or her contribution and providing all the guarantees of scientific relevance and independence of practice. In view of the contextual analysis, positive feedback and the availability of organisational and digital support points facilitating the delocalisation and digitisation of the conduct of research activity as close as possible to the patient and his or her doctor, the round table concluded that opportunities exist today which favour the development of clinical research in general practice. It is important to seize this opportunity and make the most of it without delay