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Hydrodynamic cavitation reactors are of great promise for the applications of chemical process intensification and water treatment. In this work, a novel cylindrical rotational hydrodynamic cavitation reactor (CRHCR) with rectangular grooves and oblique tooth protrusions on the rotor surface was studied. The three-dimensional characterization of cavitation within the CRHCR was observed from the front and left views by the high-speed camera experiments. Interestingly, a new phenomenon of simultaneous formation of the attached cavitation and shear cavitation was found in the CRHCR. The synergistic effect of attached cavitation and shear cavitation contributes to the enhancement of the cavitation performance of CRHCR. In addition, the evolution of attached cavitation is explored. It is found that attached cavitation forms a trapezoidal-shaped cavitation cloud in the groove, which undergoes three various stages: incipient, development, and collapse. Finally, the pulsation frequency and cavitation intensity of shear cavitation in the chamber were investigated. The results show that the cavitation pulsation frequency is the same at the same rotational speed in the chamber near diverse oblique teeth. As the rotational speed increases, the cavitation pulsation frequency increases linearly. These findings in this paper are of great benefit to understanding the mechanism of the cavitation effect of CRHCR.

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Transferring successful implementation strategies from research to practice requires approaches for assessing fidelity to the strategy's core components. Implementation facilitation (IF) is a strategy involving an interactive process of problem-solving, enabling, and supporting individuals in efforts to implement clinical innovations that occurs in the context of a recognized need for improvement and supportive interpersonal relationships. Because IF is a dynamic strategy involving numerous activities, our objective was to conduct a rigorous consensus development process to identify core activities for monitoring fidelity to IF when applied in clinical settings. We first conducted a scoping literature review to identify the range of activities used when IF has been applied in clinical settings, searching multiple citation databases for English-language articles including "facilitation" or other commonly-used terms for the strategy published from 1996-2015. Through multi-stage screening, 135 articles (from 94 studies) were identified for data extraction on IF activities, frequency with which IF activities were identified as 'core' by study authors, and study outcomes. From the literature review, we identified 32 distinct IF activities and developed definitions/examples for each. Next, we conducted a 3-stage, modified-Delphi expert panel consensus development process to identify core IF activities across three implementation phases (i.e., Pre-Implementation, Implementation, Sustainment). The expert panel identified 8 core activities for the Pre-Implementation Phase, 8 core activities for the Implementation Phase, and 4 core activities for the Sustainment Phase. This work provides an important foundation for developing measures/tools to assess use of core IF activities to ensure the strategy is delivered with fidelity.

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BACKGROUND: Confidentiality is one of the central preconditions for clinical ethics support (CES). CES cases which generate moral questions for CES staff concerning (breaching) confidentiality of what has been discussed during CES can cause moral challenges. Currently, there seems to be no clear policy or guidance regarding how CES staff can or should deal with these moral challenges related to (not) breaching confidentiality within CES. Moral case deliberation is a specific kind of CES. METHOD: Based on experiences and research into MCD facilitators' needs for ethics support in this regard, we jointly developed an ethics support tool for MCD facilitators: the Confidentiality Compass. This paper describes the iterative developmental process, including our theoretical viewpoints and reflections on characteristics of CES tools in general. RESULTS: The content and goals of the ethics support tool, which contains four elements, is described. Part A is about providing information on the concept of confidentiality in MCD, part B is a moral compass with reflective questions, part C focuses on courses of action for careful handling of moral challenges related to confidentiality. Part D contains general lessons, best practices and tips for dealing with confidentiality in future cases. CONCLUSIONS: This paper concludes with providing some lessons-learned related to developing ethics support tools and some reflections on issues of quality and normativity of ethics support tools.

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As artificial intelligence systems gain traction, their trustworthiness becomes paramount to harness their benefits and mitigate risks. This study underscores the pressing need for an expectation management framework to align stakeholder anticipations before any system-related activities, such as data collection, modeling, or implementation. To this end, we introduce a comprehensive framework tailored to capture end-user expectations specifically for trustworthy artificial intelligence systems. To ensure its relevance and robustness, we validated the framework via semi-structured interviews, encompassing questions rooted in the framework's constructs and principles. These interviews engaged fourteen diverse end users across the healthcare and education sectors, including physicians, teachers, and students. Through a meticulous qualitative analysis of the interview transcripts, we unearthed pivotal themes and discerned varying perspectives among the interviewee groups. Ultimately, our framework stands as a pivotal tool, paving the way for in-depth discussions about user expectations, illuminating the significance of various system attributes, and spotlighting potential challenges that might jeopardize the system's efficacy.

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Background: Effective medication adherence is vital for older adult stroke survivors, yet 20-33% cease treatment within a year post-discharge, increasing risks of recurrent strokes and mortality. A mobile health (mHealth) app could be a novel tool to improve medication adherence among stroke survivors because of its potential to increase patient empowerment. A few stroke-related apps provide information and support to stroke survivors. However, none have focused on medication adherence and documented their development and evaluation process, particularly those focused on this older population. Objective: This study aims to design and develop a smartphone app called OASapp to improve medication adherence among older adult stroke survivors and evaluate its usability. Methods: OASapp was developed in a three-phase development process. Phase 1 is the exploration phase (including a cross-sectional survey, a systematic review, a search for stroke apps on the app stores of Apple App Store and Google Play Store, and a nominal group technique). In phase 2, a prototype was designed based on the Health Belief Model and Technology Acceptance Model. In phase 3, Alpha and Beta testing was conducted to validate the app. Results: Twenty-five features for inclusion in the app were collected in round one, and 14 features remained and were ranked by the participants during nominal group technique. OASapp included five core components (medication management, risk factor management, health information, communication, and stroke map). Users of OASapp were satisfied based on reports from Alpha and Beta testing. The mean Usability Metric for User Experience (UMUX) score was 71.4 points (SD 14.6 points). Conclusion: OASapp was successfully developed using comprehensive, robust, and theory-based methods and was found to be highly accepted by users. Further research is needed to establish the clinical efficacy of the app so that it can be utilized to improve clinically relevant outcomes.

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OBJECTIVE: To report on the process of developing the Lebanese Economic Evaluation Guideline (LEEG), and to provide relevant material that could assist guideline developers in the future. METHODS: The development of the LEEG closely followed the process proposed by the World Health Organization, i.e. to set up a Guideline Development Group (composed of three Lebanese experts), to establish the rationale for developing the guideline in Lebanon, to identify its scope, to search and retrieve evidence through two systematic reviews, to assess and present the evidence, to translate the evidence into guidelines and recommendations through a deliberative process, and to consult international experts. The deliberative process included a survey, an in-person interview, and a consensus workshop with 16 Lebanese key stakeholders. Data was collected and quantitative analysis was conducted using SPSS software. International experts from Maastricht University - The Netherlands were consulted for issuing the LEEG. Supported by the Lebanese Ministry of Public Health (MoPH), the LEEG will be available for public consultation on the MoPH's webpage, and a final version will be made available thereafter. CONCLUSION: Clear and transparent reporting of the guideline development process should support international organizations as well as other developers in establishing their guidelines within their national context.

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Epithelial-mesenchymal transition (EMT) and primary ciliogenesis are two cell-biological programs that are essential for development of multicellular organisms and whose abnormal regulation results in many diseases (i.e., developmental anomalies and cancers). Emerging studies suggest an intricate interplay between these two processes. Here, we discuss physiological and pathological contexts in which their interconnections promote normal development or disease progression. We describe underlying molecular mechanisms of the interplay and EMT/ciliary signaling axes that influence EMT-related processes (i.e., stemness, motility and invasion). Understanding the molecular and cellular mechanisms of the relationship between EMT and primary ciliogenesis may provide new insights in the etiology of diseases related to EMT and cilia dysfunction.

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It is necessary to develop rapid and living guidelines in order to improve the evidence translation and guidance for clinical practice in emergency situations， and to enhance the participation of traditional Chinese medicine （TCM） in management of emergencies. This paper introduced the process of developing rapid and living guidelines of TCM and divided it into three stages， that is preparation， rapid development and dynamic updating， which highlights the features of rapid development， high quality， and dynamic updating and the integration with the predominance of TCM. By comparing with general guidelines on composition， personnel number， timing to formulate and communication patterns of the guideline working groups， as well as the content and number of clinical questions， this paper mainly gave suggestions on how to formulate a concise but authoritative team during the preparation stage， how to efficiently manage the guideline team and promote the development process from conflict of interest management， working and communication mode adjustment， and how to formulate and update the important and prioritized clinical questions， all of which may provide reference for the development of TCM rapid and living guidelines.

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The FDA approved a total of 37 new drugs in 2022, including 22 new molecular entities and 15 new biological products. This is the year with the lowest number of new drugs approved by the FDA since 2017. Among these approved drugs, 21 new drugs belong to the "first-in-class" category, accounting for 56% of the total approved drugs, which is the highest ratio in the past 10 years. Among the drugs approved in 2022, there are 5 small molecule kinase modulators, including the tyrosine kinase 2 (TYK2) allosteric inhibitor deucravacitinib, the first oral pyruvate kinase (PK) activator mitapivat, the Janus kinase 1 (JAK1) selective inhibitor abcrocitinib, the JAK2 selective inhibitor pacritinib and the broad-spectrum fibroblast growth factor receptor (FGFR) inhibitor futibatinib. This review briefly describes the discovery background, research and development process, synthesis routes and clinical efficacy and safety of small molecule kinase modulators approved by the FDA in 2022, hoping to provide ideas and methods for further research on kinase modulators.

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Embryology provides an understanding of individual's origin and developmental patterns. Turtles are among the oldest living reptiles and have unique body structure. However, the morphogenesis and mechanisms of turtles are not fully understood. In this study, we focused on the embryonic development of red-eared slider (Trachemys scripta elegans) which widely distributes in the world. At an incubation temperature of 28 °C, the turtle eggs had a 61-day incubation cycle, and the entire embryonic development process was divided into 27 stages and 3 phases according to variations in age, body size, and morphological characteristics. The early phase of embryonic development (the first 12 stages) were characterized by embryo growth, and the appearance of internal organ precursors. The middle phase (stages 13-20) involved prominent heart division at stage 13 and the appearance of carapace and plastron at stages 14 and 17, respectively. In the later phase (stages 21-27), the hatchlings formed, and the carapace and plastron thickened. Transcriptome analysis of embryos showed enrichment of the differential genes in pathways related to development, metabolism, disease, and cellular processes. The Kyoto Encyclopedia of Genes and Genomes enrichment (KEGG) analysis implied the crucial regulatory role of the axon guidance pathway. Real-time fluorescence quantitative PCR indicated upregulated expression of wnt5a and bmp7 in stages 7 and 16 compared to that in stage 12. This study revealed the development process of red-eared slider embryo and the dynamics of the signaling pathway affecting its development, which supplemented the theory of embryo development, and provided new ideas for the molecular mechanism of turtle embryo development.

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Accurate disclosure of financial conflicts of interest (COI) among clinical practice guideline (CPG) developers is critical to ensure the quality of CPGs. However, there is limited evidence on the impact of underreporting COIs on the quality of CPGs. This study aimed to examine the proportion of underreported COI disclosures in the development of Japanese CPGs and to estimate the association between underreported COIs and CPG quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II. Twenty-three Japanese CPGs published in 2019 and their 1114 developers were included in the study. The results show that underreporting of COIs occurred in 52% of the included CPGs and 8% of all CPG developers. Underreporting COI disclosures was negatively associated with low-quality CPG (Odds ratio [OR], 0.57; 95% confidence interval [CI]: 0.11, 3.04). On the other hand, CPGs that had more than 13% of CPG developers with voting rights on recommendation decisions and underreporting of COI disclosures were positively associated with low quality (OR, 1.78; 95% CI: 0.25, 12.45). For individual CPG developers with voting rights for recommendation decisions, the presence of a COI was positively associated with low quality (OR, 1.11; 95% CI: 0.71, 1.75). This study demonstrates that the involvement and underreporting of COIs did not seriously distort the CPG development process. However, the COI-related factors of CPG developers with voting rights for recommendation decisions may be associated with low CPG quality.

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BACKGROUND: Common data models (CDMs) are essential tools for data harmonization, which can lead to significant improvements in the health domain. CDMs unite data from disparate sources and ease collaborations across institutions, resulting in the generation of large standardized data repositories across different entities. An overview of existing CDMs and methods used to develop these data sets may assist in the development process of future models for the health domain, such as for decision support systems. OBJECTIVE: This scoping review investigates methods used in the development of CDMs for health data. We aim to provide a broad overview of approaches and guidelines that are used in the development of CDMs (ie, common data elements or common data sets) for different health domains on an international level. METHODS: This scoping review followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. We conducted the literature search in prominent databases, namely, PubMed, Web of Science, Science Direct, and Scopus, starting from January 2000 until March 2022. We identified and screened 1309 articles. The included articles were evaluated based on the type of adopted method, which was used in the conception, users' needs collection, implementation, and evaluation phases of CDMs, and whether stakeholders (such as medical experts, patients' representatives, and IT staff) were involved during the process. Moreover, the models were grouped into iterative or linear types based on the imperativeness of the stages during development. RESULTS: We finally identified 59 articles that fit our eligibility criteria. Of these articles, 45 specifically focused on common medical conditions, 10 focused on rare medical conditions, and the remaining 4 focused on both conditions. The development process usually involved stakeholders but in different ways (eg, working group meetings, Delphi approaches, interviews, and questionnaires). Twenty-two models followed an iterative process. CONCLUSIONS: The included articles showed the diversity of methods used to develop a CDM in different domains of health. We highlight the need for more specialized CDM development methods in the health domain and propose a suggestive development process that might ease the development of CDMs in the health domain in the future.

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OBJECTIVES: We aimed to gain an overview of the methods and approaches used to develop, disseminate, and implement patient versions of clinical practice guidelines (PVGs). METHODS: We searched PubMed and MEDLINE through Ovid for articles reporting on the development, dissemination, or implementation of PVGs until March 2022. We searched the homepages of guideline organizations, screened the reference lists of the included documents, and asked experts to complement the publications. We narratively synthesized the findings. RESULTS: Of 3,941 publications screened, 27 were included in the study. The identified method reports focused on patient involvement and peer-review processes. The other included publications highlighted the relevance of broad dissemination strategies and emphasized the importance of patient involvement and improving the readability of PVGs by using lay terms and shorter sentences. CONCLUSION: The terminology used for PVGs varies widely. The extent to which the methods were described was heterogeneous. Organizations developing PVGs should make their methods publicly available and use uniform labeling for PVGs in English to improve their use and recognition, not only for other PVG producers but also for patients and the public. A consensus regarding a minimum reporting standard for developing PVGs internationally and developing guiding principles is desirable.

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BACKGROUND: People with inflammatory arthritis often experience challenges at work and balancing paid work and energy in everyday life. Low work ability is common, and people with inflammatory arthritis face high risks of losing their jobs and permanent exclusion from the labour market. Context-specific tailored rehabilitation targeting persons with inflammatory arthritis is limited. The aim of this study is to describe the development of WORK-ON - a vocational rehabilitation for people with inflammatory arthritis. METHODS: Following the Medical Research Council's framework for complex interventions, WORK-ON was developed based on existing evidence, interviews with patients and rehabilitation clinicians, a workshop, and an iterative process. RESULTS: The six-month vocational rehabilitation, WORK-ON, consists of 1) an initial assessment and goal setting by an occupational therapist experienced in rheumatology rehabilitation, 2) coordination by the same occupational therapist and individual support, including navigating across the primary and secondary health sectors, as well as social care, 3) group sessions for peer support, and 4) optionally individually tailored consultations with physiotherapists, nurses, or social workers. CONCLUSION: WORK-ON is ready to be tested in a feasibility study. TRIAL REGISTRATION: The Regional Committees on Health Ethics for Southern Denmark stated that no formal ethical approval was necessary in this study (20,192,000-105).

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The French and Japanese Developmental Biology Societies, teaming up with Human Frontier Science Program, were eager to meet back in person in November 2022 in the lovely city of Strasbourg. Top scientists in the developmental biology field from France and Japan, but also from United States, United Kingdom, Switzerland or Germany shared their exciting science during the 4 days of this meeting. Core fields of developmental biology such as morphogenesis, patterning, cell identity, and cell state transition, notably at the single cell level, were well represented, and a diversity of experimental models, including plants, animals, and other exotic organisms, as well as some in vitro cellular models, were covered. This event also extended the scope of classic scientific gatherings for two reasons. First the involvement of artists during the preparation of the event and on site. Second, part of the meeting was open for the general public through a series of outreach events, including a music and video presentation through projection mapping at Rohan palace, as well as public lectures.

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The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been widespread globally, and vaccination is critical for preventing further spread or resurgence of the outbreak. Inactivated vaccines made from whole inactivated SARS-CoV-2 virus particles generated in Vero cells are currently the most widely used COVID-19 vaccines, with China being the largest producer of inactivated vaccines. As a result, the focus of this review is on inactivated vaccines, with a multidimensional analysis of the development process, platforms, safety, and efficacy in special populations. Overall, inactivated vaccines are a safe option, and we hope that the review will serve as a foundation for further development of COVID-19 vaccines, thus strengthening the defense against the pandemic caused by SARS-CoV-2.

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BACKGROUND: Clinical trial design must consider the specific resource constraints and overall goals of the drug development process (DDP); for example, in designing a phase I trial to evaluate the safety of a drug and recommend a dose for a subsequent phase II trial. Here, we focus on design considerations that involve the sequence of clinical trials, from early phase I to late phase III, that constitute the DDP. METHODS: We discuss how stylized simulation models of clinical trials in an oncology DDP can quantify important relationships between early-phase trial designs and their consequences for the remaining phases of development. Simulations for three illustrative settings are presented, using stylized models of the DDP that mimic trial designs and decisions, such as the potential discontinuation of the DDP. RESULTS: We describe: (1) the relationship between a phase II single-arm trial sample size and the likelihood of a positive result in a subsequent phase III confirmatory trial; (2) the impact of a phase I dose-finding design on the likelihood that the DDP will produce evidence of a safe and effective therapy; and (3) the impact of a phase II enrichment trial design on the operating characteristics of a subsequent phase III confirmatory trial. CONCLUSIONS: Stylized models of the DDP can support key decisions, such as the sample size, in the design of early-phase trials. Simulation models can be used to estimate performance metrics of the DDP under realistic scenarios; for example, the duration and the total number of patients enrolled. These estimates complement the evaluation of the operating characteristics of early-phase trial design, such as power or accuracy in selecting safe and effective dose levels.

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Background: There is no clear description of the evolution of the progression of abdominal adhesions over time.Method: The optimized model was selected using different adhesion scoring systems. Then, this model was used to observe the progression of abdominal adhesions. Visualized observation of abdominal adhesion evolution was performed by laparoscopy and computed tomography. The inflammatory cell infiltration and collagen fibers in adhesion tissues at different times were evaluated by hematoxylin-eosin and picrosirius red staining. RNA sequencing was used to predict potential key targets of abdominal adhesions at different times.Results: The abdominal adhesion model showed the highest reproducibility when it was established using a circular tool and an electric brush. Based on this model, we found that the inflammatory response was activated early in the process of adhesion formation, peaking on day 3 and then gradually decreasing until stabilization on day 7. Collagen and fibronectin formed on day 1 and gradually increased until remaining stable on day 7. In addition, the characteristic changes in the adhesion zone from initial congestion, edema and fragile tissue to later dense and stable tissue could be vividly observed in live mice by laparoscopy and artificial pneumoperitoneum CT. The RNA sequencing results revealed that Hck on day 1, Ndufs3 and Ndufs8 on day 3 and Aif1 on day 7 might play key roles in abdominal adhesion formation.Conclusion: The construction of a standard process for describing the evolution of abdominal adhesions based on an optimized mouse model will help to facilitate subsequent adhesion-related studies.

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OBJECTIVE: Our working group has developed a set of quality assessment tools for different types of patient information material. In this paper we review and evaluate these tools and their development process over the past eight years. METHODS: We compared the content and structure of quality assessment tools for websites, patient decision aids (PDAs), question prompt lists (QPLs), and videos. Using data from their various applications, we calculated inter-rater concordance using Kendall's W. RESULTS: The assessment tools differ in content, structure and length, but many core aspects remained throughout the development over time. We found a relatively large variance regarding the amount of quality aspects combined into one item, which may influence the weighting of those aspects in the final scores of evaluated material. Inter-rater concordance was good in almost all applications of the tool. Subgroups of similar expertise showed higher concordance rates than the overall agreement. CONCLUSION: All four assessment tools are ready to be used by people of different expertise. However, varying expertise may lead to some differences in the resulting assessments when using the tools. The lay and patient perspective needs to be further explored and taken into close consideration when refining the instruments.

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