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Background: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. Objectives: This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis. Methods: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy. Results: FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34) except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61) pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55) pairwise comparisons and were statistically significant in 5. The “signal” in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical. Conclusion: There was no empirical evidence to suggest biased estimates between the two sources. Increased and detailed transparency in publications would improve the understanding and credibility of published results. Further, the FDA report was found to be a useful source when data are missing in the published report (i.e. reporting bias). [ABSTRACT FROM AUTHOR]

Background: Aesthetics medicine, a controversial branch of clinical medicine known for its high degree of commercialization, faces numerous conflicts, particularly in some developing countries. The global aesthetics medicine industry requires enhancements of its legal and supervision framework and risk management systems. Aims: This paper aimed to provide a comprehensive visual analysis of academic achievements related to regulatory and legal issues in the field of aesthetic medicine and to identify its development trends and research hotspots. Methods: The Web of Science Core Collection was employed to retrieve relevant studies, resulting in a total of 602 research articles after selection. Utilizing bibliometric methods and CiteSpace, this study analyzed the primary countries, institutions, authors, journals, hotspots, frontiers, and trends in this domain. Results: The findings indicated rapid increases in the number of published papers. The United States emerged as the leading contributor with 131 research papers and the highest intermediate centrality. Eleven keyword clusters were identified, with "adolescence" and "office‐based surgery" being the most recent topics. We also analyzed the trends and frontiers of legal research in medical aesthetics. Conclusion: The importance of informed consent has been increasingly emphasized, and research in the field of medical aesthetics has been gradually expanding beyond individual cosmetic procedures. The management system has become more comprehensive, moreover, guidelines and medical laws have been continually published, with research shifting toward a holistic perspective that encompasses patients, medical aesthetic providers, and regulatory authorities in the study of medical aesthetics regulation and legislation. This paper also proposes some innovative directions for future research and applications. [ABSTRACT FROM AUTHOR]

The editorial demonstrates changes in the number and subject matter of papers dealing with issues related to the coronavirus disease 2019 (COVID-19), which were published in Advances in Clinical and Experimental Medicine (ACEM) during 3 years of the pandemic (2020-2022). In 2020, 24 such manuscripts were submitted to the editorial office, of which 9 were published; in 2021, 48 were submitted and 10 published, while in 2022, there were 34 articles submitted and 4 published. Authors of this editorial point out that while initially chances for publication of papers regarding COVID-19 were greater than papers covering other issues, the editors of ACEM gradually enforced the same requirements for COVID-19-related papers as for the others (the acceptance rate for these papers was 37.5% in 2020, 20.8% in 2021 and 11.8% in 2022). The published papers described, among other aspects, the relationship between COVID-19 and other diseases (e.g., pneumonia, Parkinson's disease and acute kidney injury) and methods of preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among healthcare staff. An emergency situation of pandemic called for disseminating the results of scientific research as promptly as possible; however, the proper answer to this challenge is not lowering and simplifying requirements for peer review, but releasing the results in a form of registered preprints, which allow for provisionally making the paper available for the scientific community while the peer review verification is still ongoing. [ABSTRACT FROM AUTHOR]

Introduction: A National Cancer Information System is planned for phased implementation in Irish cancer centres to enable electronic prescribing (ePrescribing) of systemic anti-cancer therapy. This study aimed to capture the opinions of healthcare professionals in a hospital setting relating to the current paper-based workflow for systemic anti-cancer therapy prescribing and their attitudes and expectations of the new ePrescribing system to develop recommendations, which assist in the planning and implementation of future ePrescribing systems. Methods: A mixed methods study of concurrent design was conducted. Interviews with healthcare professionals primarily aimed to evaluate processes and identify areas requiring improvement within the current paper-based workflow for systemic anti-cancer therapy prescribing. An online questionnaire adapted from the Information Systems Expectations and Experiences tool primarily aimed to capture expectations of the new ePrescribing system and attitudes towards the transition. Results: Twelve healthcare professionals were interviewed, and 50 healthcare professionals responded to the online questionnaire (response rate: 33.3%). Eight major themes emerged from interview transcripts relating to opinions on the paper-based workflow. Questionnaire respondents reported positive attitudes towards ePrescribing implementation and had high expectations for workflow improvements and functionalities of the new system. Seven recommendations for ePrescribing implementation were developed: (1) prioritise specific processes; (2) plan for changes in communication; (3) repeat research in the post-implementation setting; (4) ensure good information technology infrastructure and system support; (5) ensure optimum training; (6) outline limitations of clinical decision support; (7) provide clear instructions on local configurability. Conclusion: This study identifies potential challenges in transitioning to ePrescribing and provides recommendations, which assist stakeholders in ensuring safe and effective transitions, thus informing future ePrescribing systems' implementation in haematology/oncology settings. [ABSTRACT FROM AUTHOR]

Digital health technologies (DHTs) at the intersection of health, medical informatics, and business aim to enhance patient care through personalised digital approaches. Ensuring the efficacy and reliability of these innovations demands rigorous clinical validation. A PubMed literature review (January 2006 to July 2023) identified 1250 papers, highlighting growing academic interest. A focused narrative review (January 2018 to July 2023) delved into challenges, highlighting issues such as diverse regulatory landscapes, adoption issues in complex healthcare systems, and a plethora of evaluation frameworks lacking pragmatic guidance. Existing frameworks often omit crucial criteria, neglect empirical evidence, and clinical effectiveness is rarely included as a criterion for DHT quality. The paper underscores the urgency of addressing challenges in accreditation, adoption, business models, and integration to safeguard the quality, efficacy, and safety of DHTs. A pivotal illustration of collaborative efforts to address these challenges is exemplified by the Digital Health Validation Center, dedicated to generating clinical evidence of innovative healthcare technologies and facilitating seamless technology transfer. In conclusion, it is necessary to harmonise evaluation approaches and frameworks, improve regulatory clarity, and commit to collaboration to integrate rigorous clinical validation and empirical evidence throughout the DHT life cycle. [ABSTRACT FROM AUTHOR]

Various guidelines for authors of research papers and the checklists that often accompany these statements play an important role in the creation of carefully written scientific papers - for authors, they serve as tools to ensure the correct structure and content of the manuscript, increasing the chances that a paper will be published in a journal with a high rejection rate. The aim of this editorial is to provide a concise outline of the checklists most frequently used to guide the structuring of papers published in Advances in Clinical and Experimental Medicine, and to support current and prospective authors of this journal in choosing a checklist for their manuscript. The EQUATOR website is presented as a useful tool in choosing a checklist: https://www.equator-network.org/. Then, 8 checklists that are most popular among authors who publish their work in Advances in Clinical and Experimental Medicine are outlined: STROBE - for observational studies; ARRIVE - for any area of bioscience research using laboratory animals; CASP - for qualitative studies; CONSORT - for parallel group randomized trials; PRISMA - for all reviews and meta-analyses; SQUIRE - for studies on quality improvement in healthcare; STARD - for diagnostic accuracy studies; REMARK - for tumor marker prognostic studies. Each of the 8 presented checklists is discussed in a following order: 1) the name of the checklist is explained; 2) the type of articles to which it is intended is pointed out; 3) the structure of the checklist is explained; 4) if there are any extensions of the presented checklist for specific subtypes of papers, they are listed; 5) the most important literature on the presented checklist is provided. As a take-home message, basic tips for choosing a checklist are formulated. Finally, examples of papers adhering to each discussed checklist are provided. [ABSTRACT FROM AUTHOR]

Background: India has a high prevalence of micronutrient deficiency-related health risks, which can be improved by food fortification. Objectives: To identify and analyze single or multiple micronutrient (MMN) food-fortification studies for their efficacy and effectiveness in India. Methods: Papers from searching 10 databases were independently screened by two researchers. Data were abstracted to summarize food fortification results on biological markers, anthropometry, clinical, morbidity, cognition, dietary intake, and physical performance. Results: Forty-seven papers, of which 25 were randomized controlled trials, were included for analysis. Children ≤ 12 y were the main population (n=38). Food vehicles were cereals (n=6), oils and salts (n=18), and other (e.g., school meals (n=23)). Improvements in ≥ 1 biological markers were reported in all 35 papers (22 MMN, 9 Iron, 4 Iodine) with interpretable results. More specifically, iron or hemoglobin improvements were noted in all papers fortifying with MMN or solely iron. Iodine nutriture was improved in all salt iodization papers. Eight of 14, 6 of 7, 2 of 6, 4 of 6, 1 of 4, and 1 of 1 papers with interpretable results showed ≥ 1 positive result of fortification in anthropometry, clinical signs, morbidity, cognition, dietary intake, and physical performance, respectively. Conclusion: Research in India suggests food fortification improves biological markers, particularly iron and hemoglobin when fortifying with MMN or iron. MMN fortification saw more health impacts than using single fortificants. Iodine status was improved through salt iodization. Existing government nutrition programs, especially those that target children, are good avenues for food fortification implementation. [ABSTRACT FROM AUTHOR]

Fundamental scientific advances can take decades to translate into improvements in human health. Shortening this interval would increase the rate at which scientific discoveries lead to successful treatment of human disease. One way to accomplish this would be to identify which advances in knowledge are most likely to translate into clinical research. Toward that end, we built a machine learning system that detects whether a paper is likely to be cited by a future clinical trial or guideline. Despite the noisiness of citation dynamics, as little as 2 years of postpublication data yield accurate predictions about a paper's eventual citation by a clinical article (accuracy = 84%, F1 score = 0.56; compared to 19% accuracy by chance). We found that distinct knowledge flow trajectories are linked to papers that either succeed or fail to influence clinical research. Translational progress in biomedicine can therefore be assessed and predicted in real time based on information conveyed by the scientific community's early reaction to a paper. [ABSTRACT FROM AUTHOR]

In recent years, medical image segmentation methods based on deep learning have been of great importance for disease diagnosis and treatment planning in clinical medicine. U-Net and a series of networks derived from it have led the research trend in medical image segmentation. In this paper, an end-to-end lightweight MLP-based medical image segmentation network G-UNeXt is proposed to address the problems of high computational complexity, large number of model parameters and slow inference in medical image segmentation networks. Firstly, this paper proposes a new skip connection method Ghost path. It reduces the semantic gap between features while combining different levels of features, and exploits the redundancy of features, which helps to improve the segmentation ability of the model for details. Secondly, this paper designs a cheap and effective G-S block, which uses low-cost linear operations to mine potential ghost features outside of intrinsic features. The G-S block reduce the number of parameters and computational complexity compared to traditional convolution. In addition, it can also adaptively calibrate the channel feature response, enhancing the characterization capability of the network and bringing some performance improvement at a lower computational cost. Finally, we build the lightweight MLP-based network G-UNeXt used Ghost path and G-S block for real-time segmentation of medical images. The results tested on the benchmark medical image segmentation datasets BUSI and ISIC2018 show that G-UNeXt reduces the parameters by 33% and the computational complexity by 23.7% compared with UNeXt. In addition, G-UNeXt also obtains faster inference speed and higher segmentation accuracy. [ABSTRACT FROM AUTHOR]

Background: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.Methods and Findings: We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value < 0.0001, Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs.Conclusions: In the orlistat trials, we identified important disparities in the reporting of adverse events between protocols, clinical study reports, and published papers. Reports of these trials seemed to have systematically understated adverse events. Based on these findings, systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles. [ABSTRACT FROM AUTHOR]

Objective: Clinical care ratios are used to quantify and benchmark the activity of allied health professionals. This study aims to review previous recommendations and identify what variables may influence them. Method: Data was collected from the core allied health professions (audiology, nutrition and dietetics, occupational therapy, physiotherapy, podiatry, prosthetics and orthotics, psychology, social work and speech pathology) across eight Australian hospitals. Data for 113 staff who were casual or from smaller professions (audiology, podiatry, prosthetics and orthotics and psychology) were excluded due to insufficient numbers for analysis. The remaining data were analysed according to profession, seniority (tiers 1, 2 and 3) and employment status (permanent versus casual staff). A two-way ANOVA was performed to assess the association of clinical care ratios with tier, profession, employment status and gender. Results: Data from 1246 staff from the five larger professions at participating hospitals were analysed. There were no interactions between profession and gender (P = 0.185) or employment status (P = 0.412). The relationship between clinical care ratio and profession was modified by tier (interaction term, P = 0.014), meaning that differences in clinical care ratios between professions depended on the tier. Conclusion: This research has confirmed that clinical care ratios are a useful tool in workload management and determining staffing levels for allied health professionals. The recommendations from this research provide a starting point that can be finessed with reference to profession, model of care, workforce structure, governance and training requirements. This will lead to increased staff wellbeing and improved patient outcomes. What is known about this topic? Clinical care ratios are a useful tool to quantify, monitor and compare workloads of allied health professionals. What does this paper add? This paper confirms that clinical care ratios are a useful workforce planning tool and that when developing roles and models of care, clinical care ratios need to be incorporated into staffing requests and considered as part of workload management tools. What are the implications for practitioners? Clinical care ratios enable the quantification and benchmarking of direct and clinical support activity components of a workload and can be used when planning new services and reviewing current services. [ABSTRACT FROM AUTHOR]

Biobanking plays a pivotal role in biomedical research by providing standardized processing, precise storing, and management of biological sample collections along with the associated data. Effective data management is a prerequisite to ensure the integrity, quality, and accessibility of these resources. This review provides a current landscape of data management in biobanking, discussing key challenges, existing strategies, and potential future directions. We explore multiple aspects of data management, including data collection, storage, curation, sharing, and ethical considerations. By examining the evolving technologies and methodologies in biobanking, we aim to provide insights into addressing the complexities and maximizing the utility of biobank data for research and clinical applications. [ABSTRACT FROM AUTHOR]

Introduction: A hiatal hernia (HH) can be defined as a condition in which elements from the abdominal cavity herniate through the oesophageal hiatus in the mediastinum and, in the majority of cases, parts of the proximal stomach. Today, the role of HHs within the complex entity of gastroesophageal reflux disease (GERD) is very important with regard to its pathophysiology, severity, and therapeutic and prognostic options. Despite this, the application and stringent use of the worldwide accepted classification (Skinner and Belsey: Types I–IV) are lacking. The aim of this study was to carry out a systematic review of the clinical applications of HH classifications and scientific documentation over time, considering their value in diagnosis and treatment. Methods: Following the PRISMA concept, all abstracts published on pubmed.gov until 12/2023 (hiatal hernia) were reviewed, and those with a focus and clear description of the application of the current HH classification in the full-text version were analysed to determine the level of classification and its use within the therapeutic context. Results: In total, 9342 abstracts were screened. In 9199 of the abstracts, the reports had a different focus than HH, or the HH classification was not used or was incompletely applied. After further investigation, 60 papers were used for a detailed analysis, which included more than 12,000 patient datapoints. Among the 8904 patients, 83% had a Type I HH; 4% had Type II; 11% had Type III; and 1% had Type IV. Further subgroup analyses were performed. Overall, the precise application of the HH classification has been insufficient, considering that only 1% of all papers and only 54% of those with a special focus on HH have documented its use. Conclusions: The application and documentation of a precise HH classification in clinical practice and scientific reports are decreasing, which should be rectified for the purpose of scientific comparability. [ABSTRACT FROM AUTHOR]

The paper examines 8519 publications on clinical pharmacology research in India as covered in Scopus database during 2005-14, using various quantitative and qualitative parameters with a focus on its growth, citation quality, share of national international collaborative papers, subject-wise distribution, contribution and contribution and impact of its leading scholars, contribution to most productive journals, etc. India's global publication share in clinical pharmacology was 4.80, which increased from 2.65% to 6.69% from 2005-09 to 2010-14. India's publications in clinical pharmacology witness an annual average growth rate of 25.89% and citation per paper of 6.75 during 2005-14, which decreased from 9.14 to 4.08 from 2005-09 to 2010-14. Nearly 61% of the Indian publications onclinical pharmacology registered citations from 0 to 605 citations and these citations witnessed highly skewed distribution. India's share of international collaborative publications in the total output was 12.22% during 2005-14, which decreased from 13.99% to 11.76% from 2005-09 to 2010-14. The top 15 most productive Indian organizations and authors together contributed 19.25% and 4.71% and 29.06% and 8.39% share of the cumulative publications and citations output of India in clinical pharmacology during 2005-14. The 10 most productive journals in India's clinical pharmacology research together contributed 33.82% share to the total India's publication output in clinical pharmacology during 2005-14. India's publication output in clinical pharmacology had on 51 highly cited papers (receiving 100 or more citations) and together received 8597 citations, leading to average citation per paper of 168.57. [ABSTRACT FROM AUTHOR]

Given the positive outcomes of patient-centred care on health outcomes, future doctors should learn how to deliver patient-centred care. The literature describes a wide variety of educational interventions with standardized patients (SPs) that focus on learning patient-centredness. However, it is unclear which mechanisms are responsible for learning patient-centredness when applying educational interventions with SPs. This study aims to clarify how healthcare learners and professionals learn patient-centredness through interventions involving SPs in different healthcare educational contexts. A realist approach was used to focus on what works, for whom, in what circumstances, in what respect and why. Databases were searched through 2019. Nineteen papers were included for analysis. Through inductive and deductive coding, CIC'MO configurations were identified to build partial program theories. These CIC'MOs describe how Interventions with SPs change the Context (C→C') such that Mechanisms (M) are triggered that are expected to foster patient-centredness as Outcome. Interventions with SPs create three contexts which are 'a safe learning environment,' 'reflective practice,' and 'enabling people to learn together.' These contexts trigger the following seven mechanisms: feeling confident, feeling a sense of comfort, feeling safe, self-reflection, awareness, comparing & contrasting perspectives, combining and broadening perspectives. A tentative final program theory with mechanisms belonging to three main learning components (cognitive, regulative metacognitive and affective) is proposed: Interventions with SPs create a safe learning environment (C') in which learners gain feelings of confidence, comfort and safety (affective M). This safe learning environment enables two other mutual related contexts in which learners learn together (C'), through comparing & contrasting, combining and broadening their perspectives (cognitive M) and in which reflective practice (C') facilitates self-reflection and awareness (metacognitive M) in order to learn patient-centeredness. These insights offer educators ways to deliberately use interventions with SPs that trigger the described mechanisms for learning patient-centredness. [ABSTRACT FROM AUTHOR]

Introduction and aim. One of the most dynamically developing scientific field is the detection of physicochemical properties of metabolites of the human body. Researchers currently focus on metabolome analysis due to the possibility of targeted therapies for various conditions where changes in metabolism concern not only the levels of single metabolites but quantitative relationships between the levels of small molecule compounds making up a whole metabolic profile. The aim of this research was to summarize the latest findings in the field of metabolomics and its applications in clinical medicine. Material and methods. The review was performed according to the up to date literature. Thorough analysis of the scientific data from PubMed database has been conducted. Analysis of literature. One groundbreaking study determined the metabolic profile of patients qualified for transcatheter aortic valve implantation (TAVI). Acute kidney injury (AKI) is a fairly common complication after TAVI and is associated with a significant increase in mortality. It has been proved that in an elderly population undergoing TAVI, metabolite profiling improves the prediction of AKI and may allow for its prevention by physicians. Metabolomics has also allowed for early detection of biochemical changes associated with the risk of type 2 diabetes. Amino acids such as isoleucine, leucine and valine turned out to be predictive markers of this condition. In multiple myeloma (MM), metabolomics is used to detect biomarkers that confirm the presence of MM and to assess disease progression. Carnitine and acetylcarnitine seem to be significant biomarkers - their concentration in the blood correlates with the stage of neoplastic disease. Increase in carnitine concentration can lead to increase in lipid oxidation in particularly metabolically active myeloma cells. This finding led to the insight that people suffering MM should avoid carnitine supplementation (dairy products, meat). It has been suggested that research into metabolism may also extend human life. So far, specific lipid compounds such as phosphatidylcholine and sphingomyelin have been identified as novel biomarkers of longevity. Conclusion. Metabolomics is an important tool which may provide valuable data used in diagnosis and monitoring of therapy in nearly every field of medicine. However, due to the complexity of human metabolism further studies and research are necessary. [ABSTRACT FROM AUTHOR]

Background: It is common practice for emergency physicians to give parenteral opioids for acute pain, however, some treating physicians have concerns that using parenteral opioids can lead to nausea and vomiting when used alone. Therefore, antiemetics are often given prophylactically with opioids for nausea and vomiting in the emergency department (ED). This systematic review evaluates the use of prophylactic antiemetics with parenteral opioids for the treatment of acute pain in the ED.Methods: A 10-year literature search using keywords was performed in PubMed for English-language human studies. Abstracts were screened to identify high-quality studies, which then underwent a more rigorous structured review. The recommendations are made based on the literature review.Results: Eight articles met criteria for structured review and citation in this article. These include one review article, two randomized controlled trials, three prospective observational trials, one retrospective study, and one pre- and post-intervention trial.Conclusions: Based on the literature review, routine use of prophylactic antiemetics are not indicated with administration of parenteral opioids for treatment of acute pain in the ED, as nausea and vomiting are infrequent side effects. The recent literature clearly demonstrates that there are potential undesirable side effects from the use of antiemetics when using opioids. However, one subgroup of patients, those with a known history of nausea and vomiting after opioid use or a history of travel sickness, may benefit from the use of prophylactic antiemetic when being treated with parenteral opioids. [ABSTRACT FROM AUTHOR]

Analytical performance specifications (APS) are used for the quantitative assessment of assay analytical performance, with the aim of providing information appropriate for clinical care of patients. One of the major locations where APS are used is in the routine clinical laboratory. These may be used to assess and monitor assays in a range of settings including method selection, method verification or validation, external quality assurance, internal quality control and assessment of measurement uncertainty. The aspects of assays that may be assessed include imprecision, bias, selectivity, sample type, analyte stability and interferences. This paper reviews the practical use of APS in a routine clinical laboratory, using the laboratory I supervise as an example. [ABSTRACT FROM AUTHOR]

Objective: This scoping review aims to map the available literature and provide an overview of the published articles discussing the impact of electronic prescribing on medication errors and pharmacy workflow. Methods: The literature search was conducted using PubMed®, Web of Science®, and the Cochrane Database of Systematic Reviews®, as well as grey literature reports, using the search terms and related components of "pharmacists", "electronic prescribing", "medication errors", and "efficiency". The search included all articles that were published from January 2011 to September 2023. Twenty-two relevant articles were identified and fully reviewed, ten of which were included in this review. Results: Electronic prescribing (e-prescribing) provides a solution for some of the challenges that are associated with handwritten and paper prescriptions. However, the implementation of e-prescribing systems has been recognized as a source of new unforeseen medication errors in all the reviewed articles. Productivity in community pharmacies has been affected with receiving electronic prescriptions (e-prescriptions) and having to deal with the issues that arise from them. The pharmacists' interventions were not eliminated with e-prescriptions compared to other prescription formats. The most frequently reported reason for intervention was related to incomplete instructions in the field of directions of use. Other common challenges with e-prescriptions were related to missing information, quantity, inappropriate dose, dosage form, and drug. Discussion: This review demonstrates the scarcity of research about the impact of electronic prescribing on medication error and efficiency in community pharmacies. In the literature, most of the studies had mainly focused on hospital pharmacies. The literature search demonstrated that there are still some barriers to overcome with e-prescribing systems and that medication errors were not fully eliminated with e-prescriptions. New errors have been identified with e-prescriptions, all of which caused delays in processing, which affected the productivity of the pharmacy staff, and could have negatively impacted patients' safety if not properly resolved. Conclusion: e-Prescribing solved some of the challenges associated with illegibility of handwritten prescriptions. However, more time is required to allow e-prescribing systems to mature. Further training for prescribers and pharmacists is also recommended before and after the implementation. [ABSTRACT FROM AUTHOR]

Objective: HealthPathways is a web-based platform designed for use during a consultation to offer health professionals locally agreed information to support clinical and referral decision making. This study aimed to investigate whether access to specific HealthPathways pages in the North Coast New South Wales (NSW) region increased during specific critical events. High pageviews is used as a proxy for platform usefulness, and/or trust as a source of up-to-date information. Methods: Data were extracted from Google Analytics from December 2015 to December 2021. Descriptive statistics were generated for the total number of pageviews for all pages by month and year (2015–2021); for the top 15 most viewed pages in 2019, February–March 2020 inclusive (early COVID-19 pandemic period), 10–24 March 2021 (North Coast NSW region local disaster declaration period) and 26 June–11 October 2021 (NSW COVID-19 lockdown period); and for monthly pageviews for the Influenza Immunisation pathway (2016–2021). Results: Access to specific pages in HealthPathways increased alongside the occurrence of critical events affecting the region. Spikes in access to specific pages were seen during COVID-19 lockdown periods, during natural disasters, as well as during the annual influenza season. Conclusions: HealthPathways is viewed as a useful and trusted source of information for health professionals in the North Coast NSW region. HealthPathways provides an opportunity for timely dissemination of information during critical events, including natural disasters and emergencies. What is known about the topic? Evidence from New Zealand suggests that HealthPathways is viewed as a useful and trusted source of information by health professionals during critical and emergency events, and when information needs are subject to frequent change. What does this paper add? This paper provides evidence in the Australian context that health professionals access specific pages in HealthPathways at higher rates during critical and emergency events. What are the implications for practitioners? HealthPathways has the capacity to provide timely and accurate information to health professionals during critical and emergency events, as well as to identify their emerging information needs. [ABSTRACT FROM AUTHOR]

Healthcare is a critical area where blockchain technology (BT) is being heralded as a potential game-changer for facilitating secure and efficient data sharing. The purpose of this review is to examine BT applications, performance challenges, and solutions in healthcare. To begin, This review paper explores popular blockchain networks for data exchange, encompassing both public and permissioned platforms, such as Ethereum and Hyperledger Fabric. This paper analyzes the potential applications of BT's decentralized, immutable, and smart contract capabilities in healthcare settings, including secure and interoperable health data exchange, patient consent management, drug supply chain oversight, and clinical trial management. The healthcare industry might greatly benefit from the increased privacy, transparency, and accessibility that these technologies provide. Despite BT's promising medical uses, the technology is not without its drawbacks. High energy consumption, throughput, and scalability are all concerns. We wrapped up by discussing the solutions that have been implemented, including consensus processes, scalability measures like sharding, and off-chain transactions that are designed to mitigate the drawbacks. [ABSTRACT FROM AUTHOR]

Background: Scientific research ability (SRA) is very important for clinical postgraduates. However, the factors affecting students' SRA are constantly changing with the development of medicine. The aim of this study was to investigate the current situation of SRA in clinical postgraduates and exploring the potential factors and the corresponding countermeasures under the background of new medical science. Methods: A total of 133 postgraduates (first- or second-year) were investigated by questionnaire in the Second Affiliated Hospital of Fujian Medical University. All results were analyzed by R software. Results: In terms of the SRA, academic-degree postgraduate students (ADPSs) were significantly better than professional-degree postgraduate students (PDPSs) (P = 0.001), the students with scientific research interest were remarkably better than those without scientific research interest (P = 0.004), the students who mastered statistical analysis methods were more prominent than those who did not (P = 0.007), the students with paper-writing skills were obviously superior to those without it (P = 0.003), and the second-year students were notably better than the first-year students (P = 0.003). Stratified analysis by the above factors except the degree type showed no significant difference in the first-year postgraduates. In the second-year postgraduates, the ADPSs were remarkably superior to the PDPSs (P = 0.002), the students with scientific research interest were obviously better than those without scientific research interest (P = 0.014), the students with more time investment in scientific research were more prominent than those with less time investment in scientific research (P = 0.025), the students with paper-writing skills were notably superior to those without it (P = 0.031), and the students with plotting ability were better than those without it (P = 0.013). Conclusion: The important factors affecting the SRA of clinical postgraduates include the degree type, the grade of student, scientific research interest, time investment in scientific research, statistical analysis methods, paper-writing skills, plotting ability. In short, earlier systematic SRA training contributes to the improvement of SRA in clinical postgraduates, especially in PDPSs. [ABSTRACT FROM AUTHOR]

Introduction: The threshold concept framework (TCF) was first described nearly 20 years ago, but its application in the field of medical education has recently seen a significant growth of interest with a diverse range of literature published on the subject. The transformative nature of threshold concepts (TCs) offers potential for the design of learning experiences and curricula across the medical education continuum. A scoping review was conducted to map the extent of the current literature regarding TCs in medical education—to describe the types of available evidence and its focus—and identify research gaps. Methods: The review followed the JBI Manual for Evidence Synthesis approach for scoping reviews. Four databases and two additional websites were searched for articles exploring TCs in medical education. Data were analysed using quantitative and qualitative thematic approaches. A framework of conceptual change was used to synthesise the TCs identified. Results: Thirty‐six papers, spanning undergraduate, postgraduate and continuing medical education, were included in the final analysis. The most frequent application of the TCF was in the identification of TCs, which related to basic scientific knowledge, ways of thinking and ways of practising in medicine. Uncertainty, patient care, clinical reasoning and professional identify formation were themes that emerged at multiple stages of training. Several papers evaluated the use of the TCF in teaching. Conclusion: The understanding and embodiment of TCs increases in complexity across the medical education continuum, with TCs recurring with changes in clinical environment and responsibilities. This lends support to a holistic approach to curriculum design spanning all stages of training. Further research is needed to develop a consistent approach for describing and applying the TCF in medical education and to address how the TCF can be used in teaching and how threshold crossing can be measured. Understanding and embodiment of threshold concepts across the medical education continuum is argued through this review to support a holistic approach to curriculum design. [ABSTRACT FROM AUTHOR]

Aim To develop an Australian nursing documentation in aged care ( Quality of Australian Nursing Documentation in Aged Care ( QANDAC)) instrument to measure the quality of paper-based and electronic resident records. Methods The instrument was based on the nursing process model and on three attributes of documentation quality identified in a systematic review. The development process involved five phases following approaches to designing criterion-referenced measures. The face and content validities and the inter-rater reliability of the instrument were estimated using a focus group approach and consensus model. Results The instrument contains 34 questions in three sections: completion of nursing history and assessment, description of care process and meeting the requirements of data entry. Estimates of the validity and inter-rater reliability of the instrument gave satisfactory results. Conclusion The QANDAC instrument may be a useful audit tool for quality improvement and research in aged care documentation. [ABSTRACT FROM AUTHOR]

Sentiment Analysis is the process of determining whether a part of writing is positive, negative or neutral. It is also known as opinion mining or emotion AI (Artificial Intelligence) and refers to the use of natural language processing, text analysis and biometrics to systematically identify, extract, quantify and study affective states and subjective information. It is widely applied to voice of the customer materials such as reviews and survey responses, online and social media and healthcare materials for applications that range from marketing to customer service to clinical medicine. In order to determine the sentiment of the overall document, we can use our own scoring algorithms--using the weighted phrases from the previous side and then using our proprietary way of adding them up. By taking a set of content we can build a document-level sentiment classifier on it. In this thesis we are going to see how frequent item set can be used for mining reviews from online reviews posted by the customers. Our main aim is to create a system for analyzing sentiments or opinions which implies judgment of different consumer products. [ABSTRACT FROM AUTHOR]

Purpose: This paper examines the historical background of accountingization, colonization and hybridization in the health services by exploring the relationship between hospital accounting and clinical medicine in Britain between the late 1960s and the early 2000s. Design/methodology/approach: The paper draws on an analysis of professional journals, government reports and other documentary sources relating to accounting and medical developments. It is informed by Abbott's sociology of professions and Eyal's sociology of expertise. Findings: The paper shows that not only accountants but also elements within the medical profession sought to make the practice of medicine more visible, calculable and standardized, and that accounting and medical attempts to make medicine calculable interacted in a mutually reinforcing manner. Consequently, it argues that a movement towards clinical forms of quantification within the medical profession made it more open to economic calculation, which underpinned hospital accounting reforms and the accountingization, colonization or hybridization of health services. Originality/value: The paper demonstrates that a fuller understanding of the relationship between accounting and public sector professions can be developed if we examine their mutual interactions rather than restricting ourselves to analyzing accounting's effects on public sector professions. The paper moreover illustrates instances of intraprofessional conflict and inter-professional cooperation, and draws on the sociology of expertise to suggests that while hospital accounting reforms have curbed the power of medical professionals, they have also enhanced the power of clinical expertise. [ABSTRACT FROM AUTHOR]

(1) Background: In digital-technology-assisted nasal defect reconstruction methods, a crucial step involves utilizing computer-aided design to virtually reconstruct the nasal defect's complete morphology. However, current digital methods for virtual nasal defect reconstruction have yet to achieve efficient, precise, and personalized outcomes. In this research paper, we propose a novel approach for reconstructing external nasal defects based on the Facial Mesh Generation Network (FMGen-Net), aiming to enhance the levels of automation and personalization in virtual reconstruction. (2) Methods: We collected data from 400 3D scans of faces with normal morphology and combined the structured 3D face template and the Meshmonk non-rigid registration algorithm to construct a structured 3D facial dataset for training FMGen-Net. Guided by defective facial data, the trained FMGen-Net automatically generated an intact 3D face that was similar to the defective face, and maintained a consistent spatial position. This intact 3D face served as the 3D target reference face (3D-TRF) for nasal defect reconstruction. The reconstructed nasal data were extracted from the 3D-TRF based on the defective area using reverse engineering software. The '3D surface deviation' between the reconstructed nose and the original nose was calculated to evaluate the effect of 3D morphological restoration of the nasal defects. (3) Results: In the simulation experiment of 20 cases involving full nasal defect reconstruction, the '3D surface deviation' between the reconstructed nasal data and the original nasal data was 1.45 ± 0.24 mm. The reconstructed nasal data, constructed from the personalized 3D-TRF, accurately reconstructed the anatomical morphology of nasal defects. (4) Conclusions: This paper proposes a novel method for the virtual reconstruction of external nasal defects based on the FMGen-Net model, achieving the automated and personalized construction of the 3D-TRF and preliminarily demonstrating promising clinical application potential. [ABSTRACT FROM AUTHOR]

This article aims to summarize performance indicators used in telephone triage services research, and make recommendations for the selection of valid indicators to measure the performance of telephone triage. We describe what kind of frameworks, performance indicators, or variables have been used for evaluating telephone triage performance by systematically mapping the telephone triage performance measurement. The objective was to find measures for each Triple Aim dimension. A scoping review method was used following Joanna Briggs Institute guidelines. Using this method, we defined indicators to measure the performance of telephone triage. We used the Triple Aim framework to identify indicators to measure the overall performance of telephone triage. The Triple Aim framework consists of improving the patient experience of care, improving the health of populations, and reducing cost per capita. The scoping review was performed using CINAHL, Medline, EBSCOhost, and PubMed electronic databases. The eligibility criterion was research published in English between 2015 and 2023. The inclusion focused on the use and performance of telephone triage services and system-focused studies. A total of 1098 papers were screened for inclusion, with 57 papers included in our review. We identified 13 performance indicators covering all Triple Aim dimensions: waiting times, access, patient satisfaction, the accuracy of triage decision, severity and urgency of the symptoms, triage response, patient compliance with the advice given, follow-up healthcare service use, and running costs of service. We didn't find any earlier framework covering all Triple Aim dimensions properly. Measuring the performance of telephone triage requires an extensive and comprehensive approach. We presented performance indicators that may be included in the framework for measuring the performance of telephone triage to support overall performance measurements of telephone triage. [ABSTRACT FROM AUTHOR]

In recent years, Artificial Intelligence (AI) has revolutionized people's lives.AI has long made breakthrough progress in the field of surgery. However, the research on the application of AI in orthopedics is still in the exploratory stage. The paper first introduces the background of AI and orthopedic diseases, addresses the shortcomings of traditional methods in the detection of fractures and orthopedic diseases, draws out the advantages of deep learning and machine learning in image detection, and reviews the latest results of deep learning and machine learning applied to orthopedic image detection in recent years, describing the contributions, strengths and weaknesses, and the direction of the future improvements that can bemade in each study. Next, the paper also introduces the difficulties of traditional orthopedic surgery and the roles played by AI in preoperative, intraoperative, and postoperative orthopedic surgery, scientifically discussing the advantages and prospects of AI in orthopedic surgery. Finally, the article discusses the limitations of current research and technology in clinical applications, proposes solutions to the problems, and summarizes and outlines possible future research directions. The main objective of this review is to inform future research and development of AI in orthopedics. [ABSTRACT FROM AUTHOR]

Purpose: Post-stroke patients constitute a large group suffering from disabilities that require rehabilitation long after discharge. Quality indicators (QIs) that specify the minimum expected standard of quality in outpatient rehabilitation could contribute to the valuation of the effectiveness of rehabilitation on decision-makers, health professionals, patients, and relatives. This review aims to identify QIs focusing on physiotherapists' outpatient rehabilitation of stroke patients. Materials and methods: The databases Cinahl, Cochrane, Embase, PubMed, and Scopus were searched for publications, and the grey literature was also searched. Through a pragmatic appraisal and assessment with the modified AGREE II-QI instrument, relevant QIs were selected. Results: A total of 1129 papers were retrieved, and five papers presenting 91 QIs were included. Thirty-six QIs were considered relevant to physiotherapy in outpatient rehabilitation. The QIs cover structure, process, and outcome and concern basic mobility, spasticity, organisation and content of the training, patient-reported outcome measures, education of patients and relatives, and follow-up and goal setting. Conclusions: The study appraised 36 QIs relevant for outpatient rehabilitation of stroke survivors conducted by physiotherapists. A Delphi panel is required to develop the final set of QIs for physiotherapists and, subsequently, the development of a core set of multidisciplinary QIs. [ABSTRACT FROM AUTHOR]

In recent years, Raman spectroscopy has garnered growing interest in the field of biomedical research. It offers a non-invasive and label-free approach to defining the molecular fingerprint of immune cells. We utilized Raman spectroscopy on optically trapped immune cells to investigate their molecular compositions. While numerous immune cell types have been studied in the past, the characterization of living human CD3/CD28-stimulated T cell subsets remains incomplete. In this study, we demonstrate the capability of Raman spectroscopy to readily distinguish between naïve and stimulated CD4 and CD8 cells. Additionally, we compared these cells with monocytes and discovered remarkable similarities between stimulated T cells and monocytes. This paper contributes to expanding our knowledge of Raman spectroscopy of immune cells and serves as a launching point for future clinical applications. [ABSTRACT FROM AUTHOR]

The integration of advanced diagnostic technologies in healthcare is crucial for enhancing the accuracy and efficiency of disease detection and management. This paper presents an innovative approach combining machine learning-assisted 3D flexible fiber-based organic transistor (FOT) sensors for high-accuracy metabolite analysis and potential diagnostic applications. Machine learning algorithms further enhance the analytical capabilities of FOT sensors by effectively processing complex data, identifying patterns, and predicting diagnostic outcomes with 100% high accuracy. We explore the fabrication and operational mechanisms of these transistors, the role of machine learning in metabolite analysis, and their potential clinical applications by analyzing practical human blood samples for hypernatremia syndrome. This synergy not only improves diagnostic precision but also holds potential for the development of personalized diagnostics, tailoring treatments for individual metabolic profiles. [ABSTRACT FROM AUTHOR]

Diabetic retinopathy, a microvascular condition associated with an increased risk of cardiovascular disease, poses a substantial global healthcare challenge. The demand for timely diagnosis has prompted the development of automated solutions due to the scarcity of specialists. In this paper, we introduce a ground-breaking approach to diabetic retinopathy detection – the Diabetic Retinopathy Residual Network (DR-ResNet +). The proposed model leverages the power of deep learning to automatically extract features, achieving optimal results in just seven training epochs. The DR-ResNet + architecture is meticulously designed by incorporating a series of convolutional, pooling, and fully connected layers. Hyperparameter optimization is done using both grid and random search techniques to ensure peak performance. To validate the proposed model's robustness, simulated results are compared with well-established deep learning models, such as GoogleNet, VGG16, and AlexNet, using a comprehensive Kaggle dataset comprising over 35,000 retinal images. Moreover, the proposed model is also tested on external datasets like MESSIDOR and IDRiD for its validation. Simulation results reveal that the proposed DR-ResNet + model not only reduces training time by an impressive 95% but also exhibits outstanding performance metrics, including an accuracy of 0.9898, specificity of 0.9916, precision of 0.9670, sensitivity of 0.9829, and an F1-score of 0.9748. These findings position the proposed model as exceptionally well-suited for real-time clinical applications, offering a potential game-changer in diabetic retinopathy diagnosis. This paper presents DR-ResNet + as a pioneering advancement in diabetic retinopathy diagnosis. With its rapid training, superior accuracy, and significant real-world implications, the model holds promise for transforming the landscape of healthcare by providing timely and precise diagnoses for this critical condition. [ABSTRACT FROM AUTHOR]

Dissolving microneedles (DMNs) represent an innovative advancement in drug delivery and skincare technologies, offering significant advantages compared to traditional needles. This paper presents an overview of the historical evolution of microneedles and the rise of dissolving types, exploring their definition, concept, and diverse clinical applications such as vaccinations, drug delivery, and skincare treatments. Design and manufacturing considerations cover the materials employed, fabrication techniques, and methods for characterizing DMNs, focusing on aspects like mechanical strength, dissolution rate, and delivery efficiency. The mechanism of action section examines skin penetration mechanics, the process of microneedle dissolution, controlled release of active compounds, and considerations of biocompatibility and safety. Recent developments in DMNs encompass technological advancements, improved delivery systems, and updates on clinical trials and studies. Challenges and opportunities in scaling up production, overcoming market adoption barriers, and future research directions are discussed, aiming to address unmet medical needs and expand applications. In summary, DMNs have the potential to transform drug delivery and skincare treatments, with ongoing advancements aimed at tackling current challenges and unlocking new opportunities for enhanced healthcare outcomes. [ABSTRACT FROM AUTHOR]

A knowledge of the complex phenomena that regulate T1 signal on Magnetic Resonance Imaging is essential in clinical practice for a more effective characterization of pathological processes. The authors review the physical basis of T1 Relaxation Time and the fundamental aspects of physics and chemistry that can influence this parameter. The main substances (water, fat, macromolecules, methemoglobin, melanin, Gadolinium, calcium) that influence T1 and the different MRI acquisition techniques that can be applied to enhance their presence in diagnostic images are then evaluated. An extensive case illustration of the different phenomena and techniques in the areas of CNS, abdomino-pelvic, and osteoarticular pathology is also proposed. Critical relevance statement: T1 relaxation time is strongly influenced by numerous factors related to tissue characteristics and the presence in the context of the lesions of some specific substances. An examination of these phenomena with extensive MRI exemplification is reported. Key Points: The purpose of the paper is to illustrate the chemical-physical basis of T1 Relaxation Time. MRI methods in accordance with the various clinical indications are listed. Several examples of clinical application in abdominopelvic and CNS pathology are reported. [ABSTRACT FROM AUTHOR]

Since three-dimensional (3D) bioprinting has emerged, it has continuously to evolved as a revolutionary technology in surgery, offering new paradigms for reconstructive and regenerative medical applications. This review highlights the integration of 3D printing, specifically bioprinting, across several surgical disciplines over the last five years. The methods employed encompass a review of recent literature focusing on innovations and applications of 3D-bioprinted tissues and/or organs. The findings reveal significant advances in the creation of complex, customized, multi-tissue constructs that mimic natural tissue characteristics, which are crucial for surgical interventions and patient-specific treatments. Despite the technological advances, the paper introduces and discusses several challenges that remain, such as the vascularization of bioprinted tissues, integration with the host tissue, and the long-term viability of bioprinted organs. The review concludes that while 3D bioprinting holds substantial promise for transforming surgical practices and enhancing patient outcomes, ongoing research, development, and a clear regulatory framework are essential to fully realize potential future clinical applications. [ABSTRACT FROM AUTHOR]

Motivated by a recent trend that advocates a reassessment of the aim of medical science and clinical practice, this paper investigates the epistemic aims of biomedical research. Drawing on contemporary discussions in epistemology and the philosophy of science, along with a recent study on scurvy, this paper (1) explores the concept of understanding as the aim of scientific inquiry and (2) establishes a framework that will guide the examination of its forms in biomedical research. Using the case of Tuberculosis (TB), (3) it is argued that grasping a mechanistic explanation is crucial for reaching a threshold of understanding at which we may speak of an objectual, biomedical understanding of TB. [ABSTRACT FROM AUTHOR]

In acute care settings, interactions between providers and tools drive clinical decision-making. Most studies of decision-making focus on individual cognition and fail to capture critical collaborations. Distributed Cognition (DCog) theory provides a framework for examining the dispersal of tasks among agents and artifacts, enhancing the investigation of decision-making and error. This scoping review maps the evidence collected in empiric studies applying DCog to clinical decision-making in acute care settings and identifies gaps in the existing literature. Thirty-seven articles were included. The majority (n=30) used qualitative methods (observations, interviews, artifact analysis) to examine the work of physicians (n=28), nurses (n=27), residents (n=16), and advanced practice providers (n=12) in intensive care units (n=18), operating rooms (n=7), inpatient units (n=7) and emergency departments (n=5). Information flow (n=30) and task coordination (n=30) were the most frequently investigated elements of DCog. Provider-artifact (n=35) and provider-provider (n=30) interactions were most explored. Electronic (n=18) and paper (n=15) medical records were frequently described artifacts. Seven prominent themes were identified. DCog is an underutilized framework for examining how information is obtained, represented, and transmitted through complex clinical systems. DCog offers mechanisms for exploring how technologies, like EMRs, and workspaces can help or hinder clinical decision-making. [ABSTRACT FROM AUTHOR]