Search

Objective To identify determinants of neuropsychiatric (NP) flares in patients with systemic lupus erythematosus (SLE) treated for active SLE yet no ongoing severe NPSLE with non-biologic standard therapy plus belimumab or placebo. Methods We analysed data from five phase III trials (BLISS-52, BLISS-76, BLISS-NEA, BLISS-SC, EMBRACE; N = 3638) after exclusion of patients with baseline NP BILAG A. Factors associated with NPSLE flare, defined as a new NP BILAG A or B, were investigated using Cox regression. In a subgroup analysis, we studied patients with baseline NP BILAG E for determinants of de novo NPSLE flare. Organ damage was assessed using the SLICC/ACR Damage Index (SDI). Results We documented 105 (2.9%) NPSLE flares. In multivariable analysis, male sex (HR = 2.37; 95% CI: 1.31–4.28; p = 0.004), baseline NP BILAG B–D (HR = 5.91; 95% CI: 3.86–9.06; p Conclusion Male sex, NPSLE history, and NP damage were strong determinants of impending NPSLE flare. No clear protection or predisposition was conferred from add-on belimumab.

Research data should be managed, curated, stored and shared in a way that lives up to the expectations regarding trustworthiness and quality, provides sustainability and preserves the investments. The Trustworthy Digital Repository standards which have emerged from the Open Archival Information System (OAIS) reference model offer a certification solution for repositories. CoreTrustSeal (CTS) offers baseline certification and supports the concept of outsourcing. Adopting workflows and guidelines from CoreTrustSeal is also a way to assure that the data published by the repository follow the FAIR principles. Even outside of the formal certification framework the CoreTrustSeal criteria provide a demonstrable approach to internal and external review, supporting a benchmark for comparison and a means to determine the strengths and weaknesses of data repositories. This deliverable is the final deliverable of the SSHOC Task 8.2 Trust & Quality Assurance. It will describe the certification standards of Trustworthy Digital Repositories (TDRs) from the perspective of the SSH domain and summarise the certification support activities provided to the SSHOC community. The experiences gained from the support process will be considered in addition to the results of the examination of the trust in the domain of Social Sciences and Humanities (SSH) and the certification landscape. The support activities are based on the earlier work of T8.2 outlined in the Deliverable 8.1 Certification plan for SSHOC repositories, which laid the ground for the SSHOC trust work to facilitate the adoption of TDR standards and the FAIR principles in SSH data repositories. In this deliverable, ‘trust’ refers to the myriad of issues, standards and processes related to the level of trustworthiness of digital repositories. The deliverable will also discuss possible certification solutions for SSH repositories, consider the complex partnership models of TDRs and outsourcing of their services, and examine how trust can be sustainably managed after the SSHOC project. The experiences and feedback gained from the trust support work demonstrate that the support process has been beneficial for the repositories involved and allowed them to improve their procedures. While certification can be resource-intensive for certain repositories, there are few alternatives for a lighter certification beyond the core certification. The diversity of the SSH repository and data service landscape means that there is no certification solution suitable for all. Complex partnership models and outsourcing of services should also be considered when seeking certification. In some cases, organisations may opt for an assessment instead of formal certification. This has proven beneficial and useful for certain data services in improving their practices. Ensuring the sustainable management of trust is not solely dependent on assessment or certification, as trust goes beyond the technical aspects of repositories and also involves people. Therefore, future endeavours to manage trust should make use of the existing and planned networks of trustworthyrepositories that can share both expertise and responsibility, while recognising the need for more enduring sources of funding for managing trust sustainably.

FAIRsFAIR, SSHOC and EOSC-Nordic co-organised a virtual workshop on 13 January 2022, 11:00-12:30 CET around the creation of a European network of FAIR-enabling Trustworthy Digital Repositories (TDRs).FAIRsFAIR, SSHOC and EOSC-Nordichave each offered support to repositories who are seeking certification as a TDR, and are seeking to sustain the efforts. These initial groups of support providers and receivers could provide the seed for the initial establishment of such a community and could be a starting point in facilitating a European network of FAIR-enabling TDRs. The goal of this workshop was to together explore ideas and needs of such a network and identify steps to progress towards it.Theworkshop welcomedsupport providers and receivers from FAIRsFAIR, SSHOC and EOSC-Nordic as well as existing European CoreTrustSeal certified repositories. In addition, EOSC TF long-term data preservation co-chairs and European Commission DG Research and Innovation representatives were invited. This record provides the presentation slides from the workshop. Included are the results of a Mentimeter discussion in which initial ideas about a European network of FAIR-enabling TDRs were explored. The recording of the workshop can be found on the FAIRsFAIR website (https://www.fairsfair.eu/events/fairsfair-event/workshop-network-fair-enabling-trustworthy-digital-repositories-tdrs).

The SSHOC project aims to build the SSH (Social Science and Humanities) part of the EOSC (European Open Science Cloud). One of the main goals of the project is to ensure that SSH will be present in EOSC and that their specifics are taken into account. In this regard, an important point is to be able to give high visibility to the research data used in Social Science and Humanities following FAIR data principles. This can be achieved by fostering “Data Citation” through providing a common mechanism to cite SSH data and build stronger links between data and publications. An expected side effect would be to enhance the reproducibility of SSH research, which is not very common nowadays. In line with these goals, this report delivers an overview of existing data-citing mechanisms intended for citing data, that are currently used in different communities with a focus on the SSH. We then provide some guidelines describing what we think is relevant in the SSHOC context with respect to the technology to be implemented and also about the structuring of the content. This report aims to prepare further work in common with other SSHOC tasks and Work Packages. Currently, we see the following links with other SSHOC tasks: SSHOC task 3.6 will generalise and integrate the CLARIN Language Resource Switchboard (Switchboard) for the infrastructure of the other SSHOC stakeholders. The Switchboard will also make citations human actionable. SSHOC task 5.2 works on a SSHOC version of the DataVerse repository system for the SSH. The citations function in SSHOC DataVerse should align with the recommendations put forward in this document. collaboration in engagement and training activities of WP6; it is essential to be able to give a solid overview of practices and recommendations in the SSHOC training and outreach effort. WP6 will coordinate targeted training in the Social Sciences and Humanities. Appropriate audiences will be targeted for a workshop and a webinar dedicated to “Data Citation principles and practice”. WP7 is creating the future SSHOC Marketplace. This Marketplace will, of course, integrate SSH data sets and associated services. In this respect, a system that allows an extensive scientific description of data, strong identification of provenance and information that makes it possible to associate a relevant tool to a data set and make it actionable, would prove useful. This kind of information should be provided by Data Citation recommendations in cooperation with WP7 and other Work Packages. WP8, more specifically on certification aspects provided by task 8.2, “Trust and Quality Assurance”. Naturally, we should be involved in SSHOC activities whenever citation expertise is called on., This deliverable has been accepted by the European Commission on - 03 November 2020, {"references":["Developing Data Attribution and Citation Practices and Standards: Summary of an International Workshop - https://www.nap.edu/read/13564/chapter/1","State of the art report on open access publishing of research data in the humanities from Has (Humanities At Scale) project - https://hal.archives-ouvertes.fr/halshs-01357208","CODATA report - http://datascience.codata.org/articles/abstract/10.2481/dsj.OSOM13-043","http://www.nap.edu/catalog/13564/for-attribution-developing-data-attribution-and-citation-practices- and-standards","The Problem of Citation in the Digital Humanities / Jonathan Blaney https://www.dhi.ac.uk/openbook/chapter/dhc2012-blaney","Data citation practices across earth, life, social sciences and humanities - opportunities for OpenAIRE https://zenodo.org/record/54570/files/Data-Citation.pdf","Chen, Xiaoli. (2017, October). Where are we with Data Citation. Zenodo. http://doi.org/10.5281/zenodo.1004744","Graef, Florian, & McEntyre, Jo. (2016). OpenAIRE2020 D7.5 – Data citation standards and index requirements. Zenodo. https://doi.org/10.5281/zenodo.1257267","Dorch, S. B. F. (2012, July 5). On the Citation Advantage of linking to data. Zenodo. http://doi.org/10.5281/zenodo.6772","Parsons, Mark A., & Fox, Peter A. (2014). Why Data Citation Currently Misses the Point. Zenodo. http://doi.org/10.5281/zenodo.1241521","Hourclé, J., Chang, W., Linares, F., Palanisamy, G., & Wilson, B. (2012). Linking Articles to Data. Zenodo. http://doi.org/10.5281/zenodo.13802","Kristian Garza. (2018, October). Exploring data citation in Crossref and DataCite's Event Data service. Zenodo. http://doi.org/10.5281/zenodo.1472279","Parsons, Mark A., Duerr, Ruth E., & Jones, Matthew B. (2019). The History and Future of Data Citation. Zenodo. http://doi.org/10.5281/zenodo.2619468","Hourclé, J. (2014). Data Citation in Astronomy. Zenodo. http://doi.org/10.5281/zenodo.10505","Wright, C., Hodson, S., Deventer, M. van ., Selematsela, D., Lötter, L., Vahed, A., ... Walt, I. van . der . (2016, January). CODATA Data Citation Workshop, South Africa: Presentations. Zenodo. http://doi.org/10.5281/zenodo.44946","Rueda, Laura. (2016, November). Making research better by enabling people to find, share, use and cite data. Zenodo. http://doi.org/10.5281/zenodo.168213","Hourclé, Joseph. (2015, April). Data Realities: Citation Equals Funding. Zenodo. http://doi.org/10.5281/zenodo.2654574","LIBER Research Data Group https://www.openaire.at/fileadmin/user_upload/openaire/LIBER_The_research_data_group_2012_v7_fina l.pdf","Librarians' Competencies Profile for Research Data Management, 2016, https://www.coar- repositories.org/files/Competencies-for-RDM_June-2016.pdf","The Anatomy of a Data Citation: Discovery, Reuse, and Credit https://academiccommons.columbia.edu/doi/10.7916/D8MW2STM","Credit data generators for data reuse https://www.nature.com/articles/d41586-019-01715-4","Data Citation as a computational problem https://frew.eri.ucsb.edu/private/preprints/bdf-cacm-data- citation.pdf","Mary Vardigan: Data Citation for the Social Sciences, https://www.nap.edu/read/13564/chapter/9","Sieber, Joan E. & Bruce E. Trumbo (1995). \"(Not) giving credit where credit is due: Citation of data sets\". Science and Engineering Ethics 1: 1, 11–20.","Dodd, Sue A. (1979). \"Bibliographic References for Numeric Social Science Data Files: Suggested Guidelines\". Journal of the American Society for Information Science 30: 2, 77–82.","Marwick, B. and S. E. Pilaar Birch (2018) A Standard for the Scholarly Citation of Archaeological Data. Advances in Archaeological Practice https://doi.org/10.1017/aap.2018.3","Wilkinson, M. D., Dumontier, M., Aalbersberg, Ij. J., Appleton, G., Axton, M., Baak, A., ... Bourne, P. E. (2016). The FAIR Guiding Principles for scientific data management and stewardship. Sci. Data, 3, 160018. https://doi.org/10.1038/sdata.2016.18","«Presentation of Data Papers», Cybergeo : European Journal of Geography [En ligne], Data papers, http://journals.openedition.org/cybergeo/28922","Brill Research Data Journal https://brill.com/view/journals/rdj/rdj-overview.xml?lang=en","The Web Annotation Data Model (W3C 2017a, 2017b)","Facilitating Fine-grained Open Annotations of Scholarly Sources. / Boot, P.; Haentjens Dekker, R.; Koolen, Marijn; Melgar, Liliana. https://pure.knaw.nl/portal/en/publications/facilitating-finegrained-open- annotations-of-scholarly-sources(c4fda9e2-bb42-4e8a-9c35-1361b89e0ee6).html","Europe's Digital Humanities landscape https://doi.org/10.5281/zenodo.3247285","The Language Resource Switchboard, Zinn, Claus, Computational Linguistics 2018 vol. 44 num. 4, p631- 639, retrieved from https://doi.org/10.1162/coli_a_00329","Klein, M., Shankar, H., and Van de Sompel, H. (2018) Signposting for Repositories. Proceedings of the 18th ACM/IEEE on Joint Conference on Digital Libraries, JCDL 2018. https://doi.org/10.1145/3197026.3203879","Andreas Rauber; Ari Asmi; Dieter van Uytvanck; Stefan Proell (2015): Data Citation of Evolving Data: Recommendations of the Working Group on Data Citation (WGDC). DOI: 10.15497/RDA00016 https://zenodo.org/record/1406002#.XG2FVOhKhaQ"]}