UNASSIGNED: Semantic interoperability facilitates the exchange of and access to health data that are being documented in electronic health records (EHRs) with various semantic features. The main goals of semantic interoperability development entail patient data availability and use in diverse EHRs without a loss of meaning. Internationally, current initiatives aim to enhance semantic development of EHR data and, consequently, the availability of patient data. Interoperability between health information systems is among the core goals of the European Health Data Space regulation proposal and the World Health Organization\'s Global Strategy on Digital Health 2020-2025.
UNASSIGNED: To achieve integrated health data ecosystems, stakeholders need to overcome challenges of implementing semantic interoperability elements. To research the available scientific evidence on semantic interoperability development, we defined the following research questions: What are the key elements of and approaches for building semantic interoperability integrated in EHRs? What kinds of goals are driving the development? and What kinds of clinical benefits are perceived following this development?
UNASSIGNED: Our research questions focused on key aspects and approaches for semantic interoperability and on possible clinical and semantic benefits of these choices in the context of EHRs. Therefore, we performed a systematic literature review in PubMed by defining our study framework based on previous research.
UNASSIGNED: Our analysis consisted of 14 studies where data models, ontologies, terminologies, classifications, and standards were applied for building interoperability. All articles reported clinical benefits of the selected approach to enhancing semantic interoperability. We identified 3 main categories: increasing the availability of data for clinicians (n=6, 43%), increasing the quality of care (n=4, 29%), and enhancing clinical data use and reuse for varied purposes (n=4, 29%). Regarding semantic development goals, data harmonization and developing semantic interoperability between different EHRs was the largest category (n=8, 57%). Enhancing health data quality through standardization (n=5, 36%) and developing EHR-integrated tools based on interoperable data (n=1, 7%) were the other identified categories. The results were closely coupled with the need to build usable and computable data out of heterogeneous medical information that is accessible through various EHRs and databases (eg, registers).
UNASSIGNED: When heading toward semantic harmonization of clinical data, more experiences and analyses are needed to assess how applicable the chosen solutions are for semantic interoperability of health care data. Instead of promoting a single approach, semantic interoperability should be assessed through several levels of semantic requirements A dual model or multimodel approach is possibly usable to address different semantic interoperability issues during development. The objectives of semantic interoperability are to be achieved in diffuse and disconnected clinical care environments. Therefore, approaches for enhancing clinical data availability should be well prepared, thought out, and justified to meet economically sustainable and long-term outcomes.

BACKGROUND: Health apps are increasingly recognized as crucial tools for enhancing health care delivery. Many countries, particularly those in sub-Saharan Africa, can substantially benefit from using health apps to support self-management and thus help to achieve universal health coverage and the third sustainable development goal. However, most health apps published in app stores are of unknown or poor quality, which poses a risk to patient safety. Regulatory standards and guidance can help address this risk and promote patient safety.
OBJECTIVE: This review aims to assess the regulatory standards and guidance for health apps supporting evidence-based best practices in sub-Saharan Africa with a focus on self-management.
METHODS: A methodological framework for scoping reviews was applied. A search strategy was built and applied across the following databases, gray literature sources, and institutional websites: PubMed, Scopus, World Health Organization (WHO) African Index Medicus, OpenGrey, WHO Regional Office for Africa Library, ICTworks, WHO Directory of eHealth policies, HIS Strengthening Resource Center, International Telecommunication Union, Ministry of Health websites, and Google. The search covered the period between January 2005 and January 2024. The findings were analyzed using a deductive descriptive content analysis. The policy analysis framework was adapted and used to organize the findings. The Reporting Items for Stakeholder Analysis tool guided the identification and mapping of key stakeholders based on their roles in regulating health apps for self-management.
RESULTS: The study included 49 documents from 31 sub-Saharan African countries. While all the documents were relevant for stakeholder identification and mapping, only 3 regulatory standards and guidance contained relevant information on regulation of health apps. These standards and guidance primarily aimed to build mutual trust; promote integration, inclusion, and equitable access to services; and address implementation issues and poor coordination. They provided guidance on systems quality, software acquisition and maintenance, security measures, data exchange, interoperability and integration, involvement of relevant stakeholders, and equitable access to services. To enhance implementation, the standards highlight that legal authority, coordination of activities, building capacity, and monitoring and evaluation are required. A number of stakeholders, including governments, regulatory bodies, funders, intergovernmental and nongovernmental organizations, academia, and the health care community, were identified to play key roles in regulating health apps.
CONCLUSIONS: Health apps have huge potential to support self-management in sub-Saharan Africa, but the lack of regulatory standards and guidance constitutes a major barrier. Hence, for these apps to be safely and effectively integrated into health care, more attention should be given to regulation. Learning from countries with effective regulations can help sub-Saharan Africa build a more robust and responsive regulatory system, ensuring the safe and beneficial use of health apps across the region.
UNASSIGNED: RR2-10.1136/bmjopen-2018-025714.

Network meta-analyses (NMAs) have gained popularity and grown in number due to their ability to provide estimates of the comparative effectiveness of multiple treatments for the same condition. The aim of this study is to conduct a methodological review to compile a preliminary list of concepts related to bias in NMAs.
We included papers that present items related to bias, reporting or methodological quality, papers assessing the quality of NMAs, or method papers. We searched MEDLINE, the Cochrane Library and unpublished literature (up to July 2020). We extracted items related to bias in NMAs. An item was excluded if it related to general systematic review quality or bias and was included in currently available tools such as ROBIS or AMSTAR 2. We reworded items, typically structured as questions, into concepts (i.e. general notions).
One hundred eighty-one articles were assessed in full text and 58 were included. Of these articles, 12 were tools, checklists or journal standards; 13 were guidance documents for NMAs; 27 were studies related to bias or NMA methods; and 6 were papers assessing the quality of NMAs. These studies yielded 99 items of which the majority related to general systematic review quality and biases and were therefore excluded. The 22 items we included were reworded into concepts specific to bias in NMAs.
A list of 22 concepts was included. This list is not intended to be used to assess biases in NMAs, but to inform the development of items to be included in our tool.
• Our research aimed to develop a preliminary list of concepts related to bias with the goal of developing the first tool for assessing the risk of bias in the results and conclusions of a network meta-analysis (NMA).• We followed the methodology proposed by Whiting (2017) and Sanderson (2007) for creating systematically developed lists of quality items, as a first step in the development of a risk of bias tool for network meta-analysis (RoB NMA Tool).• We included items related to biases in NMAs and excluded items that are equally applicable to all systematic reviews as they are covered by other tools (e.g. ROBIS, AMSTAR 2).• Fifty-seven studies were included generating 99 items, which when screened, yielded 22 included items. These items were then reworded into concepts in preparation for a Delphi process for further vetting by external experts.• A limitation of our study is the challenge in retrieving methods studies as methods collections are not regularly updated.

Type IV hydrogen storage cylinders comprise a polymer liner and offer advantages such as lightweight construction, high hydrogen storage density, and good fatigue performance. However, they are also characterized by higher hydrogen permeability. Consequently, it is crucial for the polymer liner material to exhibit excellent resistance to hydrogen permeation. International organizations have established relevant standards mandating hydrogen permeation tests for the liner material of type IV on-board hydrogen storage cylinders. This paper provides a comprehensive review of existing research on hydrogen permeability and the hydrogen permeation test methods for the polymer liner material of type IV on-board hydrogen storage cylinders. By delving into the hydrogen permeation mechanism, a better understanding can be gained, offering valuable references for subsequent researchers in this field. This paper starts by thoroughly discussing the hydrogen permeation mechanism of the liner material. It then proceeds to compare and analyze the hydrogen permeation test methods specified by various standards. These comparisons encompass sample preparation, sample pretreatment, test device, test temperature and pressure, and qualification indicators. Then, this study offers recommendations aimed at enhancing the hydrogen permeation test method for the liner material. Additionally, the influence of test temperature, test pressure, and polymer material properties on the hydrogen permeability of the liner material is discussed. Finally, the influences of the test temperature, test pressure, and polymer material properties on the hydrogen permeability of the liner material are discussed. Future research direction on the hydrogen permeability and hydrogen permeation test method of the liner material of the type IV hydrogen storage cylinder has been prospected.

The current article focuses on non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), the heterogeneous group of mesenchymal tumours different from rhabdomyosarcoma that may affect children and adolescents, with clinical behaviour varying from relatively benign to highly malignant. This review represents the effort of the international scientific paediatric community within the context of the INternational Soft Tissue SaRcoma ConsorTium (INSTRuCT), a project founded by the leadership of three large cooperative groups - Children\'s Oncology Group, Cooperative Weichteilsarkom Studiengruppe and European paediatric Soft tissue sarcoma Study Group - with the main goal to pool expertise and resources on a broader international level in order to improve knowledge of soft tissue sarcomas of children, adolescents and young adults. This article describes the current standard treatment approach in NRSTS, with a focus on the controversies and challenges in the management of these tumours. Developing research projects and clinical protocols for NRSTS has always been challenging, supporting the need to develop international integrated prospective dedicated programs, including paediatric NRSTS experts together with the adult sarcoma community. INSTRuCT provides a unique mechanism to increase international collaboration by agreeing on a common language, developing consensus standards to guide diagnosis and treatment, comparing clinical trial results across cooperative groups, and through a shared data dictionary providing answers to questions that can only be addressed by a larger data set.

BACKGROUND: The use of low doses of recombinant tissue plasminogen activator (rt-PA) was initially proposed in Asian countries in response to racial peculiarities related to the functionality of fibrinogen and coagulation factors that potentially increased the risk of intracerebral haemorrhage, and with a view to saving costs. In view of the controversy over the use of rt-PA below the standard dose, we conducted a literature review of studies promoting the use of low doses or comparing different doses of rt-PA.
METHODS: We reviewed 198 abstracts related to the search terms and the full texts of 52 studies published in the last 30 years. We finally included 13 randomised clinical trials aiming to determine the efficacy and safety of the use of rt-PA at different doses in acute stroke, 14 observational cohort studies, 5 meta-analyses, and 3 systematic reviews.
CONCLUSIONS: There is insufficient evidence to classify low doses of rt-PA as superior or at least not inferior to the standard treatment in the management of acute stroke in western populations. More clinical trials are required to determine whether the use of low doses is beneficial in patients with relative contraindications for thrombolytic therapy or other particular circumstances that may increase the risk of intracerebral haemorrhage.

Mini percutaneous nephrolithotomy (mPNL) involves the creation of a smaller access tract compared with standard PNL (sPNL). Smaller tract sizes could lead to decreased blood loss, pain, and need for blood transfusion. Previous studies on this topic have reported variable findings and were of poor quality.
To compare the safety and efficacy of mPNL with those of sPNL for the management of patients with renal stone disease by conducting a systematic review and meta-analysis.
Systematic literature search was performed to identify relevant randomized controlled trials (RCTs) for the review. The primary outcomes for the study were stone-free rate (SFR) and blood transfusion rate. The secondary outcomes were complication rates, fever, fall in hemoglobin, operative time, length of stay (LOS), need for auxiliary procedure, and visual analog scale (VAS) score at 24 h. We followed Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, and the study protocol was registered with PROSPERO in priori (CRD42021252444).
In this review, 16 RCTs with 3961 patients were included. SFR was comparable between the two groups (risk ratio [RR] 1.01 [0.99, 1.04], p = 0.30), whereas the need for transfusion was lower with mPNL (RR 0.54 [0.37, 0.78], p = 0.001). Fall in hemoglobin (mean difference [MD] -0.67 [-0.93, -0.41], p = 0.000) and LOS (MD -0.59 [-0.81, -0.37], p = 0.000) were shorter with mPNL. Operative time was significantly shorter with sPNL (MD 8.28 [3.96, 12.59], p = 0.000). Complications were lower with mPNL (RR 0.89 [0.79, 0.97], p = 0.01). The need for auxiliary procedures (RR 0.77 [0.58, 1.03], p = 0.08) and VAS at 24 h (MD -0.79 [-1.63, 0.05], p = 0.06) were similar in the two groups.
Mini PNL has similar efficacy to sPNL in terms of SFRs. However, mPNL has a superior safety profile with fewer overall complications and a reduced need for blood transfusion.
In this study, we conducted a meta-analysis comparing mini and standard percutaneous nephrolithotomy (PNL) for the management of patients with renal stone disease. We showed that mini and standard PNL are associated with similar stone-free rates. Overall complications and the need for blood transfusion were lower with mini PNL.

The scientific publications of antimicrobial susceptibilities and resistance must be precise, with interpretations adjusted to the standard. In this frame, knowledge of antimicrobial resistance is fundamental in pathogenic microorganisms such as Salmonella spp., known for many annual deaths worldwide. The objective of this work was to compare the interpretation of standards, the concentrations, and the breakpoints, to study antimicrobial resistance in Non-Typhoidal Salmonella (NTS) isolated from beef, pork, and chicken meat, meat products, and propose additional considerations that improve the use and usefulness of published results.
After refining the search based on meeting the inclusion and exclusion criteria, 48 papers were selected. In 33 (68.8%) of them, the disc diffusion method was used, in 11 (22.9%) the MIC determination method, and in 4 (8.33%) were used both. In 24 (50%) of the articles, the selection of a different (correct) standard could have had an impact on the interpretation of antimicrobial susceptibility, which observed when considering three scenarios, i) comparison between the year of the isolation versus the implemented standard, ii) comparison between the year of submission versus implemented standard and iii) comparison between the year of publication versus implemented standard.
The most frequent scenario was the inadequate selection of standards, indicating that some studies had not ensured that applied standards kept in line with the date of isolation, date of publication and interpretation of susceptibilities. We proposed 2 years for standards use for resistance and multi-resistance interpretations. On the other hand, we invite researchers to publish their results in the shortest possible time, and editors and reviewers of scientific journals to prioritise these types of studies and verify the correspondence between the standard cited and the one used and the one to be taken into account.

By 2050, the global demand for orthotic and prosthetic services is expected to double. Unfortunately, the orthotic/prosthetic workforce is not well placed to meet this growing demand. Strengthening the regulation of orthotist/prosthetists will be key to meeting future workforce demands, however little is known about the extent of orthotist/prosthetist regulation nor the mechanisms through which regulation could best be strengthened. Fortunately, a number of allied health professions have international-level regulatory support that may serve as a model to strengthen regulation of the orthotic/prosthetic profession. The aims of this study were to describe the national-level regulation of orthotist/prosthetists globally, and the international-level regulatory support provided to allied health professions.
Two environmental scans benchmarked the national-level regulation of the orthotist/prosthetist workforce, and the regulatory support provided by international allied health professional bodies using a set of nine core practitioner standards (core standards) including: Minimum Training/Education, Entry-level Competency Standards, Scope of Practice, Code of Conduct and/or Ethics, Course Accreditation, Continuing Professional Development, Language Standard, Recency of Practice, and Return-to-Practice. Each identified country was categorised by income status (i.e. High-, Upper-Middle-, Lower-Middle-, and Low-Income countries).
Some degree of regulation of the orthotist/prosthetist workforce was identified in 30 (15%) of the world\'s 197 countries. All core standards were present in 6 of these countries. Countries of higher economic status had more core standards in place than countries of lower economic status. International-level professional bodies were identified for 14 of 20 allied health professions. International bodies for the physical therapy (8 core standards) and occupational therapy (5 core standards) professions provided regulatory support to help national associations meet most of the core standards.
Given the small proportion of countries that have national practitioner regulatory standards in place, most orthotist/prosthetists are working under little-to-no regulation. This presents an opportunity to develop rigorous national-level regulation that can support workforce growth to meet future workforce demands. Given the financial and expertise barriers that hinder the development of a more regulated orthotist/prosthetist workforce, particularly for Low- and Lower-Middle-Income countries, we recommend the establishment of an international professional body with the express purpose to support national-level regulation of orthotist/prosthetists, and thereby build the regulatory capacity of national orthotic/prosthetic associations.

OBJECTIVE: Chemotherapy drugs are often administered in combinations with predefined interdependent doses and cycle intervals. As yet, there is no global standardization system to describe these complex regimens in a universally comprehensive manner. The aim of this review is to identify which efforts for standardization have been undertaken and which recommendations for databases and nomenclature of chemotherapy regimens are available.
METHODS: A literature review was performed to identify all peer-reviewed full-text articles about oncology therapy regimen codification. In addition, the results of this search were evaluated and consensus recommendations from a European expert panel were subsequently added.
RESULTS: This review gives an overview of attempts to standardize chemotherapy nomenclature described in the literature, as well as of previously published identified gaps in regimen codification. In addition, we summarized the suggestions for improvement of chemotherapy codification found in the available literature, combining them with the expertise from a European expert panel of oncology pharmacists.
CONCLUSIONS: We believe that one of the most important error-prevention measures is standardization. However, there is a paucity of data how it may be achieved. Currently available data suggest that standardization has a positive impact on usability for data networks, prescription software, safety and the measurement of the quality of cancer care delivery. Standardization is also a strong pre-requisite for all discussions including oncology pharmacists and oncologists when evaluating chemotherapy regimen in countries in Europe but also all over the world. The recommendations compiled in this review can help to support overdue standardization efforts in this important therapeutic area.