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Objective: To assess the current trends in the field of artificial intelligence in medicine by analysing 100 most cited original articles relevant to the field., Methods: The bibliometric analysis was conducted in September 2022, and comprised literature search on Scopus database for original articles only. Google and Medical Subject Headings databases were used as resources to extract key words. In order to cover a broad range of articles, original studies comprising human as well as non-human subjects, studies without abstract and studies in languages other than English were part of the inclusion criteria. There was no specific time period applied to the search and no specific selection was done regarding the journals in the database. The screening was done using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to extract the top 100 most cited articles in the field of artificial intelligence usage in medicine. Data was analysed using SPSS 23., Results: Of the 11,571 studies identified, 100(0.86%) were analysed in detail. The studies were published between 1986 and 2021, with a median of 43 citations (IQR 53) per article. The journal 'Artificial Intelligence in Medicine' accounted for the highest number 9(9%)) of articles, and the United States was the country of origin for most of the articles 36(36%)., Conclusion: The trends, development and shortcomings in field of artificial intelligence usage in medicine need to be understood to conduct an effective research in areas that still need attention, and to guide the authorities to direct their funding accordingly.

The sterile paper-plastic barrier system for packaging sterilized medical equipment is studied, the main factors affecting its breakdown are revealed, and the inhalation rate during the pressure sterilization is experimentally analyzed. The results offer a new window of opportunity for a stricter risk-analysis and a robust strategy for the pressure sterilization, and this paper can be served as an example of strict clinical applications. [ABSTRACT FROM AUTHOR]

Introduction: Over the last decade, the emergence and spread of personalized medicine (PM) have defined a substantial revolution in healthcare. In principle, healthcare system sustainability is challenged by the investments required for research and development, as well as the adoption of PM techniques in routine clinical care. The "Integrating China in the International Consortium for Personalized Medicine" (IC2PerMed) EU-funded project aims to integrate China into the "International Consortium for Personalized Medicine" (ICPerMed). IC2PerMed aims to align the EU and China's research agendas in this field to enable a swift development of approaches in the EU and China with strong leverage upon EU-Chinese collaborations. Methods: Within this project, we first mapped relevant policies on PM in both the EU and China, and then we involved European and Chinese experts in PM in workshops and Delphi surveys in order to identify relevant priorities for the implementation of PM in sustainable healthcare. Results: As a result of this process, we identified nine overarching priorities, each addressing specific aspects of the sustainability of healthcare systems and PM implementation, with the main goal of supporting policymakers in integrating PM approaches in the EU and China. Discussion/conclusion: The implementation of PM in health systems is appealing in terms of improved accuracy in diagnostics, treatment, and prevention of disease, as well as reduction of the side effects resulting from inefficient use of drugs. Research, development, and implementation of needed techniques require time and resources that can slow the adoption of PM in healthcare systems. The nine priorities we identified address some of the most critical points, trying to lay the foundations for a comprehensive approach. [ABSTRACT FROM AUTHOR]

Objective: To evaluate changes in the role of academics and the sources of funding for the medical research cited most frequently over the past decade., Design: Database analysis., Data Sources: Web of Knowledge database., Methods: For each year from 1994 to 2003, articles in the domain of clinical medicine that had been cited most often by the end of 2004 were identified. Changes in authors' affiliations and funding sources were evaluated., Results: Of the 289 frequently cited articles, most had at least one author with a university (76%) or hospital (57%) affiliation, and the proportion of articles with each type of affiliation was constant over time. Government or public funding was most common (60% of articles), followed by industry (36%). The proportion of most frequently cited articles funded by industry increased over time (odds ratio 1.17 per year, P = 0.001) and was equal to the proportion funded by government or public sources by 2001. 65 of the 77 most cited randomised controlled trials received funding from industry, and the proportion increased significantly over time (odds ratio 1.59 per year, P = 0.003). 18 of the 32 most cited trials published after 1999 were funded by industry alone., Conclusion: Academic affiliations remain prominent among the authors of the most frequently cited medical research. Such research is increasingly funded by industry, often exclusively so. Academics may be losing control of the clinical research agenda.

We performed a systematic survey of original papers published in The Lancet throughout the years 1945, 1946, 1970 and 1995. The Lancet was chosen due to a conservative layout through these years, and the year 1946 added to the analysis to ponder for any war-induced bias. The general layout and structure of the journal were indeed maintained throughout these years. The number of authors per paper increased steadily (from 1.7 +/- 1.3 in 1945 to 6.4 +/- 3.4 in 1995), as well as the number of papers written on behalf of investigation groups (from 1 in 1945 to 37 in 1995). Major changes were observed in the area of origin of the papers, from an overwhelming British Isles' preponderance (87% of papers published in 1945) to a partake with Continental Europe, America and international groups (27, 33, 15 and 12%, respectively of the 1995 papers). The most often addressed fields of medicine shifted from war-, surgery- and microbiology-related subjects in 1945 towards cardiology-, oncology-, and virus-related works in 1995. The most impressive and enduring change was the increase in the use of statistical tools for data analysis and presentation (0.3% of papers in 1945 vs. 60% in 1995).

Benign conditions of the lower urinary tract, including benign prostatic hyperplasia, overactive bladder syndrome, and stress urinary incontinence, are frequent in the general population. Despite their benign nature, they have major adverse effects on the quality of life of the afflicted patients and their partners. Despite major progress in the diagnosis and treatment of these conditions, improved understanding and management of these patients remain substantial medical needs. This editorial discusses some recent high-quality articles published in the Journal of Clinical Medicine on the understanding of the epidemiology, pathophysiology, diagnostic, and treatment of benign diseases of the lower urinary tract tissues such as the bladder and prostate. [ABSTRACT FROM AUTHOR]

The purpose of this research was to conduct a comparative study of the impact of ResearchGate indicators on increasing citation and usage counts of hot papers in clinical medicine indexed in the Web of Science (WoS) database. This is an applied research and has been performed using scientometric methods. Article titles, the number of citations, "Usage count last 180 days", "Usage count since 2013", publication year, and authors of 583 hot papers in clinical medicine were extracted from the WoS database. Then, the readership and citation counts of articles were extracted from ResearchGate social network. The data were analyzed by descriptive and analytical statistics using Microsoft Excel and SPSS 21. The results showed that there was a significant relationship between the number of received citations, both usage counts in WoS and ResearchGate indicators (P value = 0.01). Selfarchiving in scientific social networking sites such as ResearchGate may be effective on visibility of articles that may also be related to their received citations. [ABSTRACT FROM AUTHOR]

To achieve clinical impact in daily oncological practice, emerging AI-based cancer imaging research needs to have clearly defined medical focus, AI methods, and outcomes to be estimated. AI-supported cancer imaging should predict major relevant clinical endpoints, aiming to extract associations and draw inferences in a fair, robust, and trustworthy way. AI-assisted solutions as medical devices, developed using multicenter heterogeneous datasets, should be targeted to have an impact on the clinical care pathway. When designing an AI-based research study in oncologic imaging, ensuring clinical impact in AI solutions requires careful consideration of key aspects, including target population selection, sample size definition, standards, and common data elements utilization, balanced dataset splitting, appropriate validation methodology, adequate ground truth, and careful selection of clinical endpoints. Endpoints may be pathology hallmarks, disease behavior, treatment response, or patient prognosis. Ensuring ethical, safety, and privacy considerations are also mandatory before clinical validation is performed. The Artificial Intelligence for Health Imaging (AI4HI) Clinical Working Group has discussed and present in this paper some indicative Machine Learning (ML) enabled decision-support solutions currently under research in the AI4HI projects, as well as the main considerations and requirements that AI solutions should have from a clinical perspective, which can be adopted into clinical practice. If effectively designed, implemented, and validated, cancer imaging AI-supported tools will have the potential to revolutionize the field of precision medicine in oncology. [ABSTRACT FROM AUTHOR]

The development and rapid progression of cancer are major social problems. Medical diagnostic techniques and smooth clinical care of cancer are new necessities that must be supported by innovative diagnostic methods and technologies. Current molecular diagnostic tools based on the detection of blood protein markers are the most common tools for cancer diagnosis. Biosensors have already proven to be a cost-effective and accessible diagnostic tool that can be used where conventional laboratory methods are not readily available. Paper-based biosensors offer a new look at the world of analytical techniques by overcoming limitations through the creation of a simple device with significant advantages such as adaptability, biocompatibility, biodegradability, ease of use, large surface-to-volume ratio, and costeffectiveness. In this review, we covered the characteristics of exosomes and their role in tumor growth and clinical diagnosis, followed by a discussion of various paper-based biosensors for exosome detection, such as dipsticks, lateral flow assays (LFA), and microfluidic paper-based devices (µPADs). We also discussed the various clinical studies on paper-based biosensors for exosome detection. [ABSTRACT FROM AUTHOR]

Background: Hypertension, hyperglycemia, dyslipidemia, overweight, obesity, and tobacco (smoking, chewing, and vaping), together with a pro-inflammatory and procoagulant state, are the main risk factors related to atherosclerotic cardiovascular disease. Objective and methods: A group of experts from the Americas, based on their clinical expertise in cardiology, cardiovascular prevention, and cardiometabolic (CM) diseases, joined together to develop these practical recommendations for the optimal evaluation and treatment of residual CM risk factors in Latin America, using a modified Delphi methodology (details in electronic TSI) to generate a comprehensive CM risk reduction guideline, and through personalized medicine and patient-centered decision, considering the cost-benefit ratio The process was well defined to avoid conflicts of interest that could bias the discussion and recommendations. Results: Residual risk reduction should consider therapeutic options adapted to specific patient needs, based on five treatment objectives: triglyceride-rich lipoproteins, inflammation, impaired glucose metabolism, high blood pressure, and prothrombotic status. Comprehensive control of all CM risk factors should be a priority to deal with this important public health problem and prevent premature deaths. The recommendations in this paper address the evidence-based treatment of CM risk and are intended for clinical application in Latin American countries. [ABSTRACT FROM AUTHOR]

The present editorial summarizes the last 2 calendar years of Advances in Clinical and Experimental Medicine (ACEM) publication (2021 and 2022). The specific aims were: 1) To clarify the classification of papers published in ACEM; 2) To present motivations behind choosing this classification; 3) To show how this classification is reflected in citations. Six categories of papers published in ACEM are presented: editorials, meta-analyses, reviews (including systematic reviews), multicenter studies, research-in-progress studies, and research letters; lack of clear definitions for editorials, research letters and research-in-progress studies is discussed. Thematic fields covered by all categories in 2021 and 2022 are presented and differences in this regard between 2021 and 2022 are highlighted. Reasons for not publishing case reports (CRs) are discussed, with some of the debate on this issue in medical literature summarized. The article type classification used in ACEM in only one of many possible solutions and may be modified in the future -- it should be both clear for the authors and allow for orientation in the journal's content. The motivation for choosing the employed categories stem both from their position on the accepted levels of evidence in evidence-based medicine (EBM) and their potential to be cited. [ABSTRACT FROM AUTHOR]

This editorial discusses graphical abstracts (GAs) as a relatively new tool used to concisely summarize a scientific paper and promote it on social media to boost the visibility of research and the number of citations. This article attempts to define GA as clearly as possible and to explain the role of GAs as scientific communication tools in medical journals. A clear definition of a GA is lacking. Several definitions from the literature are presented, which illustrates that the terms "visual abstract" and "graphical abstract" can be used interchangeably. The role of GAs can be described in 3 aspects: 1) time required for communication (GAs are meant to convey the key contents of a scientific paper in a time much shorter than required for reading the full text), 2) means of communication (social media), and 3) mechanism of communication (research results in many fields of medicine can be better conveyed through visual or at least more visual means rather than plain text). A review of the existing literature concerning the effectiveness of GAs presents studies regarding the use of GAs in promoting scientific papers on Twitter - visual abstracts attracted significantly more engagement than plain English ones, especially from medical professionals. Visual abstract tweets were associated with a significantly higher number of impressions, retweets, and link clicks compared to text abstract tweets. Journals that have introduced GAs demonstrated significantly higher impact factor (IF) increases for the past 3 years than those of journals without GAs. The longer GAs have been utilized in a journal, the higher the IF the journal had. The experience of the editors of Advances in Clinical and Experimental Medicine (ACEM) concerning GAs are discussed, divided by types of papers published in this journal (original papers, meta-analyses, reviews, research-in-progress articles, and editorials), illustrated with examples of well-prepared GAs, and supplemented with a brief description of the feedback from authors and readers amassed following the introduction of GAs in ACEM. Finally, the authors offer the readership of ACEM 8 practical tips on how to prepare a useful GA, and list 8 common mistakes and misconceptions regarding GAs - both in text form and summarized in tables. The conclusion of the paper is that there is currently no universal standard for GAs, which can lead to inconsistencies in their formats and content; therefore, more detailed guidelines to standardize GAs for scientific research are warranted. [ABSTRACT FROM AUTHOR]

Moderate-to-severe psoriasis is associated with significant comorbidity, an impaired quality of life, and increased medical costs, including those associated with treatments. Systematic reviews (SRs) and meta-analyses (MAs) of randomized clinical trials are considered two of the best approaches to the summarization of high-quality evidence. However, methodological bias can reduce the validity of conclusions from these types of studies and subsequently impair the quality of decision making. As co-authorship is among the most well-documented forms of research collaboration, the present study aimed to explore whether authors’ collaboration methods might influence the methodological quality of SRs and MAs of psoriasis. Methodological quality was assessed by two raters who extracted information from full articles. After calculating total and per-item Assessment of Multiple Systematic Reviews (AMSTAR) scores, reviews were classified as low (0-4), medium (5-8), or high (9-11) quality. Article metadata and journal-related bibliometric indices were also obtained. A total of 741 authors from 520 different institutions and 32 countries published 220 reviews that were classified as high (17.2%), moderate (55%), or low (27.7%) methodological quality. The high methodological quality subnetwork was larger but had a lower connection density than the low and moderate methodological quality subnetworks; specifically, the former contained relatively fewer nodes (authors and reviews), reviews by authors, and collaborators per author. Furthermore, the high methodological quality subnetwork was highly compartmentalized, with several modules representing few poorly interconnected communities. In conclusion, structural differences in author-paper affiliation network may influence the methodological quality of SRs and MAs on psoriasis. As the author-paper affiliation network structure affects study quality in this research field, authors who maintain an appropriate balance between scientific quality and productivity are more likely to develop higher quality reviews. [ABSTRACT FROM AUTHOR]

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]

Background: The CONSORT Statement is a reporting guideline for authors when reporting randomized controlled trials (RCTs). It offers a standard way for authors to prepare RCT reports. It has been endorsed by many high-impact medical journals and by international editorial groups. This study was conducted to assess the endorsement of the CONSORT Statement by high-impact medical journals in China by reviewing their instructions for authors. Methodology/Principal Findings: A total of 200 medical journals were selected according to the Chinese Science and Technology Journal Citation Reports, 195 of which publish clinical research papers. Their instructions for authors were reviewed and all texts mentioning the CONSORT Statement or CONSORT extension papers were extracted. Any mention of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM) developed by the International Committee of Medical Journal Editors (ICMJE) or 'clinical trial registration' was also extracted. For journals endorsing the CONSORT Statement, their most recently published RCT reports were retrieved and evaluated to assess whether the journals have followed what the CONSORT Statement required. Out of the 195 medical journals publishing clinical research papers, only six (6/195, 3.08%) mentioned 'CONSORT' in their instructions for authors; out of the 200 medical journals surveyed, only 14 (14/200, 7.00%) mentioned 'ICMJE' or 'URM' in their instructions for authors, and another five journals stated in their instructions for authors that clinical trials should have trial registration numbers and that priority would be given to clinical trials which had been registered. Among the 62 RCT reports published in the six journals endorsing the CONSORT Statement, 20 (20/62, 32.26%) contained flow diagrams and only three (3/62, 4.84%) provided trial registration information. Conclusions/Significance: Medical journals in China endorsing either the CONSORT Statement or the ICMJE's URM constituted a small percentage of the total; all of these journals used ambiguous language regarding what was expected of authors. [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]

Presents abstracts of papers and posters for presentation at the 2005 American Society for Clinical Laboratory Science Annual Meeting and Clinical Laboratory Exposition, July 26-30, 2005 in Orlando, Florida. "In Vitro Effects of Chloramine-T on Select Wound Pathogens," by Linda J. Laatsch; "Prospective Students' Preparation for a CLS Program," by Leonce H. Thierry Jr.; "Utility of Lecithin Cholesterol Acyl Transferase Mass as a Diagnostic Marker for Liver Disease and Liver Transplant," by Karen R. Murray.

Abstract. Objective. To provide an overview and methodology for the evaluation of impairment and functional residual capacity in complex regional pain syndrome I (CRPS I, RSD). This paper is intended to provide assistance to physicians asked to evaluate impairment- and disability-related issues and is not primarily geared to guide treatment of the CRPS I patient. Method. Conference and literature review by neurology, anesthesiology, pain medicine, physiatry, and disability evaluating physicians followed by description of issues, options, and recommendations based upon the committee's deliberations and the widely used AMA Guides to the Evaluation of Permanent Impairment , fourth and fifth editions. The authors present functional criteria for assessing the severity of CRPS. These criteria were developed by committee consensus opinion based on multidisciplinary clinical experience considering daily functional issues. They can be used in conjunction with CRPS-ADL Classes of Impairment in order to categorize an individual into a specific class for purposes of permanent impairment rating. Future reliability and validity studies of this rating scale are pending future use, acceptance and, hopefully, additional studies. Results. Evaluators should perform a comprehensive assessment of patients with CRPS I to make an accurate diagnosis and exclude other conditions that could explain the symptoms and signs of the condition. While radiological, laboratory, and other diagnostic studies may be of assistance in making the diagnosis, in the final analysis, this is a clinical diagnosis. Impairment is based on objectively validated limitation in activities of daily living (ADL). [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]

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]

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]

To obtain data on patient demographics, clinical practices, and long-term outcomes for patients with chronic low back pain treated with implantable drug-delivery systems. The National Outcomes Registry for Low Back Pain collected data at baseline, trialing, implant (or decision not to implant), and at 6- and 12-month follow-ups. Data were collected at all time points, regardless of implant status. Numeric pain ratings and Oswestry Low Back Pain Disability scores from implanted patients were compared among baseline and 6- and 12-month follow-ups. Patients were also asked to rate their quality of life and satisfaction with the therapy. Thirty-six physicians enrolled 166 patients to be trialed for drug-delivery systems. The trialing success rate was 93% (154 patients). In all, 136 patients (82%) were implanted. In the implant group, numeric pain ratings dropped by more than 47% for back pain and more than 31% for leg pain at the 12-month follow-up. More than 65% of implanted patients reduced their Oswestry scores by at least one level at their 12-month follow-ups compared with baseline. At 12-month follow-ups, 80% of implanted patients were satisfied with their therapy and 87% said they would undergo the procedure again. Current clinical practices related to trialing of drug-delivery systems resulted in the majority of patients successfully trialed. At 12-month follow-ups, implanted patients experienced reductions in numeric back and leg pain ratings, improved Oswestry scores, and high satisfaction with the therapy. [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: 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]