Digital research data: from analysis of existing standards to a scientific foundation for a modular metadata schema in nanosafety

Background Assessing the safety of engineered nanomaterials (ENMs) is an interdisciplinary and complex process producing huge amounts of information and data. To make such data and metadata reusable for researchers, manufacturers, and regulatory authorities, there is an urgent need to record and provide this information in a structured, harmonized, and digitized way. Results This study aimed to identify appropriate description standards and quality criteria for the special use in nanosafety. There are many existing standards and guidelines designed for collecting data and metadata, ranging from regulatory guidelines to specific databases. Most of them are incomplete or not specifically designed for ENM research. However, by merging the content of several existing standards and guidelines, a basic catalogue of descriptive information and quality criteria was generated. In an iterative process, our interdisciplinary team identified deficits and added missing information into a comprehensive schema. Subsequently, this overview was externally evaluated by a panel of experts during a workshop. This whole process resulted in a minimum information table (MIT), specifying necessary minimum information to be provided along with experimental results on effects of ENMs in the biological context in a flexible and modular manner. The MIT is divided into six modules: general information, material information, biological model information, exposure information, endpoint read out information and analysis and statistics. These modules are further partitioned into module subdivisions serving to include more detailed information. A comparison with existing ontologies, which also aim to electronically collect data and metadata on nanosafety studies, showed that the newly developed MIT exhibits a higher level of detail compared to those existing schemas, making it more usable to prevent gaps in the communication of information. Conclusion Implementing the requirements of the MIT into e.g., electronic lab notebooks (ELNs) would make the collection of all necessary data and metadata a daily routine and thereby would improve the reproducibility and reusability of experiments. Furthermore, this approach is particularly beneficial regarding the rapidly expanding developments and applications of novel non-animal alternative testing methods.

Quality certificates for homeopathic matrices

Background: To produce homeopathic medicines, pharmacies need raw materials (mother tinctures and diluted-agitated solutions, named “matrices”), provided by insumes suppliers. The “matrices” are ultra high dilutions and can not be tested against Analysis Reports. Aims: to propose alternatives to the matrices Analysis Report; to contribute to the quality of homeopathic medicines and treatment. Method: search of information present in the documentation provided from 2 national and 3 European suppliers in order to develop criteria. Discussion: the needed concepts for compliance with the orders throughout their production process were presented. The control of information involved in the process allows to trace the production of matrices, providing an indication of the quality with which they were obtained. Each supplier gives different approach to issuing a document, calling it Certificate of Conformity Protocol Preparation, Manufacturing Certificate or Quality Certificate. Summarizing, it is a supplier's declaration, which involves the quality control of raw materials, packaging materials and of the process used, but not a report that enables customers to repeat the analysis. A model was proposed for a Certificate of Quality, with the minimum information needed to indicate to the pharmacies that there is a control of the process. This certificate shall contain statements about the process. Conclusion: Quality Certificate seems to be the best document to ensure the pharmacy that the matrix obtained presents characteristics compatible with the preparation of a quality homeopathic medicine.

Systematic Review of Platelet-Rich Plasma for Rotator Cuff Repair: Are We Adhering to the Minimum Information for Studies Evaluating Biologics in Orthopaedics?

Background: The therapeutic efficacy of orthobiologic therapies for rotator cuff repair is difficult to evaluate owing to reporting inconsistences. In response, the Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO) guidelines were developed to ensure standard reporting on orthobiologic therapies. Purpose: To systematically review clinical studies evaluating platelet-rich plasma (PRP) for full-thickness rotator cuff repair and adherence to MIBO guidelines. Study Design: Scoping review; Level of evidence, 4. Methods: A search was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines using PubMed, EMBASE, and the Cochrane Library databases. Inclusion criteria were clinical studies reporting on rotator cuff tears (≥1 cm) surgically repaired with PRP. Patient demographics, biologic intervention, and adherence to the MIBO guidelines were systematically reviewed. Results: A total of 19 studies (1005 patients) were included in this review. Across all studies, 58.5% of the MIBO checklist items for PRP were reported. Out of 47 checklist items, 19 were reported in over 85% of studies, whereas 22 were reported in less than half of studies. Details of whole-blood processing and characteristics, as well as PRP processing and characteristics, were reported inconsistently, and no study provided adequate information to enable the precise replication of preparation protocols for PRP. Conclusion: This systematic review highlights the current reporting deficiencies within the scientific literature of important variables for evaluating PRP for full-thickness rotator cuff repair. There was widespread variability among published studies that evaluate PRP for this application and, more specifically, studies were limited by inconsistent universal reporting of whole-blood and PRP processing and postprocessing characteristics. To improve our understanding of biologic efficacy and to promote repeatability, stricter adherence to the MIBO guidelines is necessary. We propose that the checklist limitations be addressed and that modification of the MIBO guidelines be considered to improve the reporting of individual components within certain categories.

A community-developed extension to Darwin Core for reporting the chronometric age of specimens

Darwin Core, the data standard used for sharing modern biodiversity and paleodiversity occurrence records, has previously lacked proper mechanisms for reporting what is known about the estimated age range of specimens from deep time. This has led to data providers putting these data in fields where they cannot easily be found by users, which impedes the reuse and improvement of these data by other researchers. Here we describe the development of the Chronometric Age Extension to Darwin Core, a ratified, community-developed extension that enables the reporting of ages of specimens from deeper time and the evidence supporting these estimates. The extension standardizes reporting about the methods or assays used to determine an age and other critical information like uncertainty. It gives data providers flexibility about the level of detail reported, focusing on the minimum information needed for reuse while still allowing for significant detail if providers have it. Providing a standardized format for reporting these data will make them easier to find and search and enable researchers to pinpoint specimens of interest for data improvement or accumulate more data for broad temporal studies. The Chronometric Age Extension was also the first community-managed vocabulary to undergo the new Biodiversity Informatics Standards (TDWG) review and ratification process, thus providing a blueprint for future Darwin Core extension development.

MISpheroID: a knowledgebase and transparency tool for minimum information in spheroid identity

Spheroids are three-dimensional cellular models with widespread basic and translational application across academia and industry. However, methodological transparency and guidelines for spheroid research have not yet been established. The MISpheroID Consortium developed a crowdsourcing knowledgebase that assembles the experimental parameters of 3,058 published spheroid-related experiments. Interrogation of this knowledgebase identified heterogeneity in the methodological setup of spheroids. Empirical evaluation and interlaboratory validation of selected variations in spheroid methodology revealed diverse impacts on spheroid metrics. To facilitate interpretation, stimulate transparency and increase awareness, the Consortium defines the MISpheroID string, a minimum set of experimental parameters required to report spheroid research. Thus, MISpheroID combines a valuable resource and a tool for three-dimensional cellular models to mine experimental parameters and to improve reproducibility.

Sustainable development and corporate social responsibility – organisation level

Sustainable development and CSR are included in the strategies of most companies. To learn more what companies do for the environment and society—usually, one can visit their websites and read about their SD or CSR activities in reports. However—the quality of such reports differs—from minimum information to very deep immersion into explaining to stakeholders how an organisation understands its role in society. The aim of this chapter is to explain how sustainable development (SD) and Corporate Social Responsibility (CSR) influence corporate strategy, both on a corporate level—mission, vision and its goals, and functional areas of organisation.

MIDS Level 1: Specification, conformance checklist, mapping template and instructions for use

Approved formally as a TDWG Task Group (TG) in September 2020, TG MIDS is working to harmonise a framework for "Minimum Information about a Digital Specimen (MIDS)". MIDS clarifies what is meant by different levels of digitization (MIDS levels) and specifies the minimum information to be captured at each level. Capturing and presenting data in future digitization in standard formats is essential so that data can be more easily understood, compared, analysed and communicated via the Internet. Adopting MIDS and working to achieve specific MIDS levels in digitization ensures that enough data are captured, curated and published such that they are useful for the widest possible range of future research, teaching and learning purposes. Adopting MIDS makes it easier to consistently measure the extent of digitization achieved over time and to set priorities for the remaining work. In the year since MIDS was first introduced at TDWG 2020, the TG has focussed on the details of MIDS level 1, representing the basic minimum level of information to be expected and captured in basic digitization activities such as creating a catalogue record and (optionally) making photographic or other digital images of specimens. To help the community adopt and embed MIDS conformance as a core part of digitization and data publishing/management pipelines, the MIDS specification consists of definitions of the expected information elements, a template for mapping terms/fields in institutional collection management systems and other data management schemas to those information elements, a conformance proforma allowing declaration of how a digitization or data publishing event conforms to MIDs, and instructions for use.