Best Practice Guideline – DEGUM Recommendations on Breast Ultrasound – Part I – Examination technique, DEGUM ultrasound criteria, and documentation

For many years, breast ultrasound has been used in addition to mammography as an important method for clarifying breast findings. However, differences in the interpretation of findings continue to be problematic 1 2. These differences decrease the diagnostic accuracy of ultrasound after detection of a finding and complicate interdisciplinary communication and the comparison of scientific studies 3. In 1999, the American College of Radiology (ACR) created a working group (International Expert Working Group) that developed a classification system for ultrasound examinations based on the established BI-RADS classification of mammographic findings under consideration of literature data 4. Due to differences in content, the German Society for Ultrasound in Medicine (DEGUM) published its own BI-RADS-analogue criteria catalog in 2006 3. In addition to the persistence of differences in content, there is also an issue with formal licensing with the current 5th edition of the ACR BI-RADS catalog, even though the content is recognized by the DEGUM as another system for describing and documenting findings. The goal of the Best Practice Guideline of the Breast Ultrasound Working Group of the DEGUM is to provide colleagues specialized in senology with a current catalog of ultrasound criteria and assessment categories as well as best practice recommendations for the various ultrasound modalities.

Multi-omics approach to COVID-19: a domain-based literature review

Background Omics data, driven by rapid advances in laboratory techniques, have been generated very quickly during the COVID-19 pandemic. Our aim is to use omics data to highlight the involvement of specific pathways, as well as that of cell types and organs, in the pathophysiology of COVID-19, and to highlight their links with clinical phenotypes of SARS-CoV-2 infection. Methods The analysis was based on the domain model, where for domain it is intended a conceptual repository, useful to summarize multiple biological pathways involved at different levels. The relevant domains considered in the analysis were: virus, pathways and phenotypes. An interdisciplinary expert working group was defined for each domain, to carry out an independent literature scoping review. Results The analysis revealed that dysregulated pathways of innate immune responses, (i.e., complement activation, inflammatory responses, neutrophil activation and degranulation, platelet degranulation) can affect COVID-19 progression and outcomes. These results are consistent with several clinical studies. Conclusions Multi-omics approach may help to further investigate unknown aspects of the disease. However, the disease mechanisms are too complex to be explained by a single molecular signature and it is necessary to consider an integrated approach to identify hallmarks of severity.

Care of Congenital Melanocytic Nevi in Newborns and Infants: Review and Management Recommendations

A pediatric dermatology expert working group performed a narrative review to describe care related to congenital melanocytic nevi (CMN) in neonates and infants. There are no published guidelines for most aspects of care, including routine skin care and visit intervals. Few guidelines exist for surgical management; newer recommendations favor conservative practice. Emerging evidence contributes to recommendations for screening MRI to evaluate for neural melanosis and related central nervous system complications, however, more research is needed. Risk for melanoma is generally low, but those with large, giant, or multiple CMN have a higher risk. Multidisciplinary care, with a focus on family and patient preferences, is of paramount importance. Without standardized screening and management guidelines, questions abound regarding appropriate physical examination intervals, potential treatment including full or partial excision, timing and frequency of imaging, melanoma risk, and assessment for neural melanosis. This review highlights the current state of knowledge concerning care of patients with CMN, reveals gaps in the literature surrounding skin care, and provides management recommendations. We additionally discuss cutaneous complications of CMN, such as pruritus, hypertrichosis, and wound healing. Resources and references for families and providers can help patients navigate this sometimes challenging diagnosis. Finally, we contribute expert care recommendations to the current body of literature as a foundation for the development of future, more comprehensive care guidelines.

Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation

Background The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is undertaking a major revision of ICH E6 Good Clinical Practice (GCP) decided to involve external stakeholders in ICH-GCP renovation. Activities such as surveys and public conferences have taken place in the United States, European Union, and Japan. For stakeholder engagement in Japan, a designated research group conducted a survey of academic stakeholders. Methods A total of 105 academic stakeholders from 18 institutions responded to the survey. The research group developed recommendations reflecting the survey results and the opinions from patients and the public. Results The survey showed the top four principles needing renovation were (i) informed consent (Chapter 2.9, 12.4% of respondents believed it needed renovation), (ii) systems for quality assurance (Chapter 2.13, 9.5%), (iii) information on an investigational product (Chapter 2.4, 5.7%), and (iv) procedures on clinical trial information (Chapter 2.10, 5.7%). The top three sections identified as needing renovation were: (i) informed consent (Chapter 4.8, 27.6%), (ii) monitoring (Chapter 5.18, 22.9%), and (iii) composition, functions, and operations of the ethics committee (Chapter 3.2, 14.3%). Recommendations included clarification of ICH-GCP’s scope, proportionality in various aspects of clinical trials, diversity and liquidity of ethics committee members, modernization of informed consent procedures, variations in monitoring, and regulatory grade when using real-world data. Conclusion The recommendations from Japanese investigators and patients have been submitted to the ICH E6 Expert Working Group, which will strengthen the robustness of the GCP renovation.

OCTG Connection Testing Aiding in the Integrity of Multi-Fractured Horizontal Wells

With the increase in shale oil and gas activity and complexity, companies deploy new solutions to safely and efficiently drill, complete, and produce wells in unconventional plays. These include Oil Country Tubular Goods (OCTG) connections, which must withstand installation, stimulation, and production loads specific to this application. Industry available standards provide manufacturers and operators a framework for quality founded on best practices and testing. In some instances, existing testing protocols may not be adequate (e.g. insufficient or overconservative) to assess connections’ performance for this application. For this reason, the American Petroleum Institute established an expert working group to develop Technical Report 5SF (TR 5SF) intended to evaluate casing connections performance in multi-fractured horizontal wells. The objective of this paper is to present a set of verified testing protocols applicable to casing connections used in the most common shale plays, complementing the existing body of knowledge. We discuss testing elements and parameters tailored to the conditions of various shale plays. Based on the operations planned for the life of a well, the testing procedure is adjusted to resemble the expected conditions and loads in the correct order. This includes make-up, high-cycle fatigue associated with the casing string installation, thread compound degradation under temperature and time, and mechanical load cycles generated by stimulation. Specimen sealability is confirmed under production loads, after which failure testing is performed. Some of the inputs to build the testing protocol are: maximum internal pressure, axial load, dogleg severity, number of cycles, temperature, and fluid type. Since connections play a crucial role in the integrity of a well, a testing procedure to ensure their performance is shown. Testing protocols for Multi-fractured Horizontal Wells (MFHW) applied to two connection types are presented, highlighting how tailored testing protocols and robust engineering improve product reliability and well integrity assurance. We compile a set of testing inputs for the most relevant shale plays worldwide, together with the testing elements, sequence, and acceptance criteria. This should help end users validate and benchmark products’ performance while improving industry knowledge of connections capabilities.

Prehospital management of exertional heat stroke at sports competitions for Paralympic athletes

ObjectivesTo adapt key components of exertional heat stroke (EHS) prehospital management proposed by the Intenational Olympic Committee Adverse Weather Impact Expert Working Group for the Olympic Games Tokyo 2020 so that it is applicable for the Paralympic athletes.MethodsAn expert working group representing members with research, clinical and lived sports experience from a Para sports perspective reviewed and revised the IOC consensus document of current best practice regarding the prehospital management of EHS.ResultsSimilar to Olympic competitions, Paralympic competitions are also scheduled under high environmental heat stress; thus, policies and procedures for EHS prehospital management should also be established and followed. For Olympic athletes, the basic principles of EHS prehospital care are: early recognition, early diagnosis, rapid, on-site cooling and advanced clinical care. Although these principles also apply for Paralympic athletes, slight differences related to athlete physiology (eg, autonomic dysfunction) and mechanisms for hands-on management (eg, transferring the collapsed athlete or techniques for whole-body cooling) may require adaptation for care of the Paralympic athlete.ConclusionsPrehospital management of EHS in the Paralympic setting employs the same procedures as for Olympic athletes with some important alterations.

Care transition for complex patients: a framework to analyse and develop the Operating Centres for Transition

PurposeTransitional care (TC) models emerged to ensure healthcare coordination and continuity, as at-risk patients transfer between different settings or different levels of care within the same setting. TC models have been developed in many countries as well as within different healthcare service delivery models and organizations. This paper aims to focus on a TC model developed in Italy called Operating Centre for Transition (OCT), in order to (1) explore its distinctive features by establishing a framework of analysis, (2) apply the framework to study two OCTs and (3) provide recommendations on how to use the framework to evaluate and develop new OCTs in the future.Design/methodology/approachThe authors adopted a grounded theory method to develop and validate the framework of analysis. The authors employed several qualitative methods following four iterative and recursive steps: (1) desk analysis of relevant documents, (2) in-depth interviews to key informants, (3) three meetings of an expert working group and (4) application of the framework to two case studies.FindingsThe framework of analysis identifies three core dimensions that are always present in any OCT: the service model, the functions and the organizational features. Moreover, for every dimension several variables that capture and understand OCTs’ nature, role and development level are identified.Originality/valueThe results of the study highlight the key elements of the OCT model in Italy and show that the proposed framework can be useful both to analyse existing OCTs and to support health managers and policy makers to create new OCTs or develop those already active.

Establishing the Regional Sustainable Developmental Role of Universities—From the Multilevel-Perspective (MLP) and Beyond

This article establishes the multilevel perspective (MLP) as one of the main research approaches in transition research to study complex systemic change processes in socio-technical systems at different structural levels. The application of the MLP to the higher education system, especially to conceptualize the transition of universities towards a sustainable (regional) developmental role, is still in its infancy. Through using a descriptive narrative analysis of seminal articles, the results of the four-years cooperation within an expert working group, and own empirical findings, the present paper investigates the suitability of the MLP to study the transition of universities and university systems towards a sustainable developmental role in the regional context. Based on these investigations, three further perspectives (which must be considered for establishing a more comprehensive understanding of the universities’ sustainable developmental role) are identified and conceptualized: (a) The target dimension of sustainable regional development, (b) the role of agency, and (c) the introduction of space and place to multiscalar regional transitions. Based on these perspectives, a future research agenda beyond the MLP is developed.