SSHOC D8.2 Certification plan for SSHOC repositories

This report is the first deliverable of Task 8.2 “Trust & Quality Assurance” within WP8 of the SSHOC project. The distributed character of data infrastructures within the SSHOC communities requires developing an agreed approach to assessing the trustworthiness and quality of data repositories. This deliverable provides an overview of Trusted Digital Repository (TDR) standards offering a certification framework for communities represented in the SSHOC project (CESSDA, CLARIN, DARIAH, E-RIHS). Moreover, the deliverable lays the ground for the SSHOC trust work that is needed in order to facilitate the adoption of TDR standards and the FAIR principles in SSH data repositories across the board. In this report, ‘trust’ refers to the landscape of issues, standards and processes related to trustworthy digital repositories. Trust between all parties in the quality of data and services is critical for research infrastructure in terms of people, processes and technologies. The level of trustworthiness can be assessed through evaluation against agreed requirements

Parthenos D3.2 Report on Guidelines for Common Policies Implementation (Final)

The aim of this report is to present to its stakeholders (researchers, policy makers, cultural heritage institutions, research infrastructures, archives) a series of recommendations and guidelines about which policies to apply during and after their research or infrastructure work. “During their research work”, because policies on data and repositories guide the data creator to produce high quality data; “after their research work”, because policies on access and reuse help make the data more accessible and reusable. The research communities are: Archaeology, History, Language related studies and social sciences

Report on Standardization (draft)

The present report reflects the second stage of the definition of the Standardisation Survival Kit (SSK) within Work Package 4 of the PARTHENOS project. On the basis of the various user scenarios presented in Deliverable 4.1, where each stage of the research process has been annotated according to the actual standards that are actually needed in order to fulfill the research task, we present here a systematic review of the activities that have to be carried out to provide support to researchers in using, but also contributing to, these standards

A Real-Life Multicenter National Study on Nintedanib in Severe Idiopathic Pulmonary Fibrosis

BACKGROUND: Two therapeutic options are currently available for patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF): pirfenidone and nintedanib. To date, there is still insufficient data on the efficacy of these 2 agents in patients with more severe disease. OBJECTIVES: This national, multicenter, retrospective real-life study was intended to determine the impact of nintedanib on the treatment of patients with severe IPF. METHODS: All patients included had severe IPF and had to have at least 6 months of follow-up before and at least 6 months of follow-up after starting nintedanib. The aim of the study was to compare the decline in lung function before and after treatment. Patient survival after 6 months of therapy with nintedanib was assessed. RESULTS: Forty-one patients with a forced vital capacity (FVC) 6450% and/or a diffusing capacity of the lung for carbon monoxide (DLCO) 6435% predicted at the start of nintedanib treatment were enrolled. At the 6-month follow-up, the decline of DLCO (both absolute and % predicted) was significantly reduced compared to the pretreatment period (absolute DLCO at the -6-month, T0, and +6-month time points (5.48, 4.50, and 5.03 mmol/min/kPa, respectively, p = 0.03; DLCO% predicted was 32.73, 26.54, and 29.23%, respectively, p = 0.04). No significant beneficial effect was observed in the other functional parameters analyzed. The 1-year survival in this population was 79%, calculated from month 6 of therapy with nintedanib. CONCLUSIONS: This nationwide multicenter experience in patients with severe IPF shows that nintedanib slows down the rate of decline of absolute and % predicted DLCO but does not have significant impact on FVC or other lung parameters