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Background: Unhealthy diet is a key risk factor for Non-Communicable Diseases (NCDs) that contribute to increased morbidity and premature mortality. With increased computer literacy and mobile phone penetration, there is a high opportunity for mobile application-based interventions. The current study was conducted to develop a mobile application to monitor dietary intake and to assess its acceptability and effectiveness in diet control compared to a similar paper-based intervention. A mobile application was developed based on research evidence and opinions of local experts. The mobile application was introduced to a selected group of office workers who were in preparation, action, and maintenance stages of the Trans Theoretical Model (TTM) and a paper-based intervention was used as the comparator. Socio-demographic data were collected through a self-administered questionnaire. Participants were followed up for three months for adherence. The effectiveness of interventions was assessed at the end of three months by comparing the progressive change in the stage of change and the change from unhealthy to healthy dietary intake between two groups as primary and secondary outcomes respectively. Results: Among 123 office workers who participated in the study, 19.5% preferred the mobile intervention over the paper-based intervention. Younger, unmarried office workers and those who do not have children, had a higher acceptance for the mobile intervention (p < 0.05). There was no difference in adherence (in all three months) or outcomes between the two groups of intervention. Conclusion and recommendations: Mobile application-based interventions are better accepted among the young age group and further studies are recommended to explore their applicability. Trial registration: The study was registered in the Sri Lankan Clinical Trial Registry (Registration No. SLCTR/2020/025; Date 15th December 2020). [ABSTRACT FROM AUTHOR]

Summary This Good Practice Paper provides recommendations for the diagnosis and initial management of transplant‐eligible high‐risk myeloma patients. It describes recent updates to the genetic diagnostics of high‐risk myeloma and provides recommendations for treatment on the basis of recent prospective clinical trial evidence. [ABSTRACT FROM AUTHOR]

Many individuals with autism spectrum disorder (ASD) experience various degrees of impairment in social interaction and communication, restricted, repetitive behaviours, interests/activities. These impairments make a significant contribution to poorer everyday adaptive functioning. Yet, there are no pharmacological therapies to effectively treat the core symptoms of ASD. Since symptoms of ASD likely emerge from a complex interplay of vulnerabilities, environmental factors and compensatory mechanisms during the early developmental period, pharmacological interventions arguably would have the greatest impact to improve long-term outcomes when implemented at a young age. It is essential therefore, that clinical development programmes of investigational drugs in ASD include the paediatric population early on in clinical trials. Such trials need to offer the prospect of direct benefit (PDB) for participants. In most cases in drug development this prospect is supported by evidence of efficacy in adults. However, the effectiveness of treatment approaches may be age-dependent, so that clinical trials in adults may not provide sufficient evidence for a PDB in children. In this white paper, we consolidate recommendations from regulatory guidelines, as well as advice from the Food and Drug Administration, USA (FDA) and the Committee for Human Medicinal Products (CHMP) consultations on various development programmes on: 1) elements to support a PDB to participants in early paediatric clinical trials in ASD, including single-gene neurodevelopment disorders, 2) aspects of study design to allow for a PDB. This white paper is intended to be complementary to existing regulatory guidelines in guiding industry and academic sponsors in their conduct of early paediatric clinical trials in ASD. [ABSTRACT FROM AUTHOR]

The apps for drawing are present in our children's life. Nevertheless, little is known about the impact of mobile technology on the freehand drawing educational activity. There are few works which are contextualised within short periods of time, with teachers who are not theirs and, in some cases, outside the children's classroom. In this paper, we are focussed on the use of technology on freehand drawing activity. Thus, we have compared the graphics produced by 4- and 5-year-old children with paper&crayon in comparison with those with tablet-finger. Children made the drawings during a planned free-drawing activity, in their ordinary classrooms, with their teachers and during five sessions. Assessment of drawings has evidenced tablet feasibility for making graphics. Nevertheless, with the passing of time, quality of graphics (tablet-finger vs paper&crayons), are nearly matched, demonstrating the low impact level technology has on this activity. In addition, if drawings are analysed specifically according to ages, results have shown that both groups have to develop adaptation strategies of visual perceptual skills and fine motor skills for the touch screen in order to obtain the same quality in the drawings made on both support types. [ABSTRACT FROM AUTHOR]

Introduction: In allergic asthma patients, one of the more common phenotypes might benefit from allergen immunotherapy (AIT) as add‐on intervention to pharmacological treatment. AIT is a treatment with disease‐modifying modalities, the evidence for efficacy is based on controlled clinical trials following standardized endpoint measures. However, so far there is a lack of a consensus for asthma endpoints in AIT trials. The aim of a task force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) is evaluating several outcome measures for AIT in allergic asthma. Methods: The following domains of outcome measures in asthmatic patients have been evaluated for this position paper (PP): (i) exacerbation rate, (ii) lung function, (iii) ICS withdrawal, (iv) symptoms and rescue medication use, (v) questionnaires (PROMS), (vi) bronchial/nasal provocation, (vii) allergen exposure chambers (AEC) and (viii) biomarkers. Results: Exacerbation rate can be used as a reliable objective primary outcome; however, there is limited evidence due to different definitions of exacerbation. The time after ICS withdrawal to first exacerbation is considered a primary outcome measure. Besides, the advantages and disadvantages and clinical implications of further domains of asthma endpoints in AIT trials are elaborated in this PP. Conclusion: This EAACI‐PP aims to highlight important aspects of current asthma measures by critically evaluating their applicability for controlled trials of AIT. [ABSTRACT FROM AUTHOR]

Background: Multi-arm, multi-stage (MAMS) platform trials can accelerate the identification of disease-modifying treatments for Parkinson's disease (PD) but there is no current consensus on the optimal outcome measures (OM) for this approach. Objective: To provide an up-to-date inventory of OM for disease-modifying PD trials, and a framework for future selection of OM for such trials. Methods: As part of the Edmond J Safra Accelerating Clinical Trials in Parkinson Disease (EJS ACT-PD) initiative, an expert group with Patient and Public Involvement and Engagement (PPIE) representatives' input reviewed and evaluated available evidence on OM for potential use in trials to delay progression of PD. Each OM was ranked based on aspects such as validity, sensitivity to change, participant burden and practicality for a multi-site trial. Review of evidence and expert opinion led to the present inventory. Results: An extensive inventory of OM was created, divided into: general, motor and non-motor scales, diaries and fluctuation questionnaires, cognitive, disability and health-related quality of life, capability, quantitative motor, wearable and digital, combined, resource use, imaging and wet biomarkers, and milestone-based. A framework for evaluation of OM is presented to update the inventory in the future. PPIE input highlighted the need for OM which reflect their experience of disease progression and are applicable to diverse populations and disease stages. Conclusion: We present a range of OM, classified according to a transparent framework, to aid selection of OM for disease-modifying PD trials, whilst allowing for inclusion or re-classification of relevant OM as new evidence emerges. [ABSTRACT FROM AUTHOR]

A high number of citations can indicate the potential of any specific paper to influence other research and generate changes in clinical practice. Analyzing the most-cited papers in a certain scientific field may assist researchers to identify the influential papers as well their main characteristics. The present study aimed to analyze the 100 most-cited papers concerning dental fluorosis (DF) through a bibliometric review. A search was performed in the Web of Science Core Collection (WoS-CC) database in November 2021. The papers were displayed in descending order according to the number of citations in WoS-CC. Two independent researchers performed the selection. Scopus and Google Scholar were used to compare the number of citations with WoS-CC. The following data were extracted from the papers: title, authors, number and density of citations, institution, country, continent, year of publication, journal title, keywords, study design, and theme. Collaborative networks were generated using the VOSviewer software. The top 100 most-cited papers were published between 1974 and 2014 and were cited 6,717 times (ranging from 35 to 417). Community Dentistry and Oral Epidemiology (24%), Journal of Dental Research (21%), Journal of Public Health Dentistry (17%), and Caries Research (13%) published the most papers. Observational studies (60%) and literature reviews (19%) were the most common study designs. The main topics were epidemiology (44%) and fluoride intake (32%). The countries with the highest number of papers were the USA (44%), Canada (10%), and Brazil (9%). The University of Iowa (USA) had the most papers (12%). Levy SM was the author with the highest number of papers (12%). The 100 most-cited papers on DF were mainly observational studies focused on epidemiology and originated in North America. There were few interventional studies and systematic reviews among the most-cited papers concerning this topic. [ABSTRACT FROM AUTHOR]

Emerging evidence has shown that microRNAs play pivotal roles in wound healing. MicroRNA-21 (miR-21) was previously found to upregulate in order to fulfill an anti-inflammation role for wounds. Exosomal miRNAs have been identified and explored as essential markers for diagnostic medicine. However, the role of exosomal miR-21 in wounds has yet to be well studied. In order to facilitate the early management of poorly healing wounds, we developed an easy-to-use, rapid, paper-based microfluidic-exosomal miR-21 extraction device to determine wound prognosis in a timely manner. We isolated and then quantitatively examined exosomal miR-21 in wound fluids from normal tissues and acute and chronic wounds. Eight improving wounds displayed lower levels of exosomal miR-21 expression after wound debridement. However, four instances of increased exosomal miR-21 expression levels were notably associated with patients with poor healing wounds despite aggressive wound debridement, indicating a predictive role of tissue exosomal miR-21 for wound outcome. Paper-based nucleic acid extraction device provides a rapid and user-friendly approach for evaluating exosomal miR-21 in wound fluids as a means of monitoring wounds. Our data suggest that tissue exosomal miR-21 is a reliable marker for determining current wound status. [ABSTRACT FROM AUTHOR]

This ENETS guidance paper, developed by a multidisciplinary working group, provides an update on the previous colorectal guidance paper in a different format. Guided by key clinical questions practical advice on the diagnosis and management of neuroendocrine tumours (NET) of the caecum, colon, and rectum is provided. Although covered in one guidance paper colorectal NET comprises a heterogeneous group of neoplasms. The most common rectal NET are often small G1 tumours that can be treated by adequate endoscopic resection techniques. Evidence from prospective clinical trials on the treatment of metastatic colorectal NET is limited and discussion of patients in experienced multidisciplinary tumour boards strongly recommended. Neuroendocrine carcinomas (NEC) and mixed neuroendocrine non‐neuroendocrine neoplasms (MiNEN) are discussed in a separate guidance paper. [ABSTRACT FROM AUTHOR]

In clinical trials, biochemical markers provide useful information on the drug's mode of action, therapeutic response and side effect monitoring and can act as surrogate endpoints. In pharmacological intervention development for sarcopenia management, there is an urgent need to identify biomarkers to measure in clinical trials and that could be used in the future in clinical practice. The objective of the current consensus paper is to provide a clear list of biochemical markers of musculoskeletal health and aging that can be recommended to be measured in Phase II and Phase III clinical trials evaluating new chemical entities for sarcopenia treatment. A working group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) proposed classifying biochemical markers into 2 series: biochemical markers evaluating musculoskeletal status and biochemical markers evaluating causal factors. For series 1, the group agreed on 4 biochemical markers that should be assessed in Phase II or Phase III trials (i.e., Myostatin-Follistatin, Brain Derived Neurotrophic Factor, N-terminal Type III Procollagen and Serum Creatinine to Serum Cystatin C Ratio – or the Sarcopenia Index). For series 2, the group agreed on 6 biochemical markers that should be assessed in Phase II trials (i.e., the hormones insulin-like growth factor-1 (IGF-I), dehydroepiandrosterone sulphate, and cortisol, and the inflammatory markers C-reactive protein (CRP), interleukin-6 and tumor necrosis factor-α), and 2 in Phase III trials (i.e., IGF-I and CRP). The group also proposed optional biochemical markers that may provide insights into the mode of action of pharmacological therapies. Further research and development of new methods for biochemical marker assays may lead to the evolution of these recommendations. [ABSTRACT FROM AUTHOR]

The safety and efficacy of pharmacotherapy in children, particularly preterms, neonates and infants, is limited by a paucity of good‐quality data from prospective clinical drug trials. A specific challenge is the establishment of valid biomarkers. OMICs technologies may support these efforts by complementary information about targeted and nontargeted molecules through systematic characterization and quantitation of biological samples. OMICs technologies comprise at least genomics, epigenomics, transcriptomics, proteomics, metabolomics and microbiomics in addition to the patient's phenotype. OMICs technologies are in part hypothesis‐generating, allowing an in depth understanding of disease pathophysiology and pharmacological mechanisms. Application of OMICs technologies in paediatrics faces major challenges before routine adoption. First, developmental processes need to be considered, including a subdivision into specific age groups as developmental changes clearly impact OMICs data. Second, compared to the adult population, the number of patients is limited as are the type and amount of necessary biomaterial, especially in neonates and preterms. Thus, advanced trial designs and biostatistical methods, noninvasive biomarkers, innovative biobanking concepts including data and samples from healthy children, as well as analytical approaches (eg liquid biopsies) should be addressed to overcome these obstacles. The ultimate goal is to link OMICs technologies with innovative analysis tools, such as artificial intelligence at an early stage. The use of OMICs data based on a feasible approach will contribute to the identification complex phenotypes and subpopulations of patients to improve the development of medicines for children with potential economic advantages. [ABSTRACT FROM AUTHOR]

Cognitive remediation is now widely recognized as an effective treatment for cognitive deficits in schizophrenia. Its effects are meaningful, durable, and related to improvements in everyday functional outcomes. As with many therapies, the evolution of cognitive remediation has resulted in treatment programs that use a variety of specific techniques, yet share common core principles. This paper is the product of a cognitive remediation expert working group consensus meeting to identify core features of the treatment and produce recommendations for its design, conduct, reporting, and implementation. Four techniques were identified as core features of cognitive remediation: facilitation by a therapist, cognitive exercise, procedures to develop problem-solving strategies, and procedures to facilitate transfer to real world functioning. Treatment techniques within each of these core features are presented to facilitate decisions for clinical trials and implementation in clinical settings. [ABSTRACT FROM AUTHOR]

The placebo (Latin "I will please") effect commonly occurs in clinical trials. The psychological and physiological factors associated with patients' expectations about a treatment's positive and negative effects have yet to be well characterized, although a functional prefrontal cortex and intense bidirectional communication between the central nervous system and the immune system appear to be prerequisites for a placebo effect. The use of placebo raises certain ethical issues, especially if patients in a placebo group are denied an effective treatment for a long period of time. The placebo effect appears to be relatively large (up to 77%, relative to pretreatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double‐blind, placebo‐controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide. The European Academy of Allergy and Clinical Immunology (EAACI) therefore initiated a Task Force, in order to better understand the placebo effect in AIT and its specific role in comorbidities, blinding issues, adherence, measurement time points, variability and the natural course of the disease. In this Position Paper, the EAACI Task Force highlights several important topics regarding the placebo effect in AIT such as a) regulatory aspects, b) neuroimmunological and psychological mechanisms, c) placebo effect sizes in AIT trials, d) methodological limitations in AIT trial design and e) potential solutions in future AIT trial design. In conclusion, this Position Paper aims to examine the methodological problem of placebo in AIT from different aspects and also to highlight unmet needs and possible solutions for future trials. [ABSTRACT FROM AUTHOR]

In the last decade there has been a revolution in terms of genetic findings in neurodevelopmental disorders (NDDs), with many discoveries critical for understanding their aetiology and pathophysiology. Clinical trials in single-gene disorders such as fragile X syndrome highlight the challenges of investigating new drug targets in NDDs. Incorporating a developmental perspective into the process of drug development for NDDs could help to overcome some of the current difficulties in identifying and testing new treatments. This paper provides a summary of the proceedings of the 'New Frontiers Meeting' on neurodevelopmental disorders organised by the European College of Neuropsychopharmacology in conjunction with the Innovative Medicines Initiative-sponsored AIMS-2-TRIALS consortium. It brought together experts in developmental genetics, autism, NDDs, and clinical trials from academia and industry, regulators, patient and family associations, and other stakeholders. The meeting sought to provide a platform for focused communication on scientific insights, challenges, and methodologies that might be applicable to the development of CNS treatments from a neurodevelopmental perspective. Multidisciplinary translational consortia to develop basic and clinical research in parallel could be pivotal to advance knowledge in the field. Although implementation of clinical trials for NDDs in paediatric populations is widely acknowledged as essential, safety concerns should guide each aspect of their design. Industry and academia should join forces to improve knowledge of the biology of brain development, identify the optimal timing of interventions, and translate these findings into new drugs, allowing for the needs of users and families, with support from regulatory agencies. [ABSTRACT FROM AUTHOR]

Background: The coronavirus disease 2019 (COVID‐19) has evolved into a pandemic infectious disease transmitted by the severe acute respiratory syndrome coronavirus (SARS‐CoV‐2). Allergists and other healthcare providers (HCPs) in the field of allergies and associated airway diseases are on the front line, taking care of patients potentially infected with SARS‐CoV‐2. Hence, strategies and practices to minimize risks of infection for both HCPs and treated patients have to be developed and followed by allergy clinics. Method: The scientific information on COVID‐19 was analysed by a literature search in MEDLINE, PubMed, the National and International Guidelines from the European Academy of Allergy and Clinical Immunology (EAACI), the Cochrane Library, and the internet. Results: Based on the diagnostic and treatment standards developed by EAACI, on international information regarding COVID‐19, on guidelines of the World Health Organization (WHO) and other international organizations, and on previous experience, a panel of experts including clinicians, psychologists, IT experts, and basic scientists along with EAACI and the "Allergic Rhinitis and its Impact on Asthma (ARIA)" initiative have developed recommendations for the optimal management of allergy clinics during the current COVID‐19 pandemic. These recommendations are grouped into nine sections on different relevant aspects for the care of patients with allergies. Conclusions: This international Position Paper provides recommendations on operational plans and procedures to maintain high standards in the daily clinical care of allergic patients while ensuring the necessary safety measures in the current COVID‐19 pandemic. [ABSTRACT FROM AUTHOR]

Cardiovascular disease is the leading cause of death of women in the United States, yet cardiovascular research is disproportionately conducted using male human subjects and male animal models. This article deploys Katrina Hutchison's (2019) analysis of gender disparity in clinical trials as a moral aggregation problem to address the problem of underrepresentation of women in cardiovascular research. I identify cost concerns, convenience, pregnancy, and negligence as potential reasons for the underrepresentation of women in CVD research. Finally, I suggest that multilevel strategies will be needed to eliminate sex disparity in CVD research and improve patient care. [ABSTRACT FROM AUTHOR]

Introduction: Flexibility is an essential component of muscle function, and insufficient muscle flexibility may lead to muscle injuries. Decreased hamstring flexibility is one of the frequently reported risk factors for a hamstring strain and diminished athletic performance. Stretching is a commonly used intervention for increasing muscle length. There is a lack of evidence concerning the possible effects of hamstring stretching in balance and gait biomechanics. So, this study was designed to investigate the potential effects of static hamstring stretching on the range of motion (ROM), dynamic balance, and biomechanical variables of gait in athletes with hamstring tightness. Materials and Methods: This study is a single-group, pretest-posttest clinical trial performed on semi-professional female athletes. Twelve female athletes aged 20 to 35 years with bilateral hamstring tightness received a single session of unilateral static hamstring stretching on their randomly selected side. All subjects were assessed for straight leg raise, popliteal angle (using standard goniometry), perceived hamstring tightness (using a visual analog scale). They completed single-leg standing and 15-m walking and running tasks before and immediately after the intervention. The biomechanical parameters, including gait-line length, swing duration, and stance duration in walking tasks, maximum total force and mean total force in running task, and center of pressure (COP) displacement and standard deviation during balance task were measured using OpenGo sensor insole system. The pre-post values were compared using the paired sample t-test, and the level of significance was 0.05. Results: The values for straight leg raise and popliteal angle significantly increased (P<0.05) compared with the baseline, while perceived tightness significantly decreased following stretching (P<0.001). The amplitude (P₌0.006) and standard deviation (P₌0.016) of COP displacement in the mediolateral direction during the single leg stance balance task were significantly decreased after the intervention. Stance duration in slow walking (P₌0.004), as well as stance duration (P₌0.012) and swing duration (P<0.001) in fast walking, were significantly decreased (P<0.05) after stretching. No change was observed in gait biomechanical variables during the running test (P>0.05). Conclusion: The results of this study indicate that static hamstring stretching can be a promising intervention not just for increasing hamstring flexibility but also for improving balance ability. [ABSTRACT FROM AUTHOR]

Great expectations have been set around the clinical potential of regenerative and reparative medicine in the treatment of cardiovascular diseases [i.e. in particular, heart failure (HF)]. Initial excitement, spurred by encouraging preclinical data, resulted in a rapid translation into clinical research. The sobering outcome of the resulting clinical trials suggests that preclinical testing may have been insufficient to predict clinical outcome. A number of barriers for clinical translation include the inherent variability of the biological products and difficulties to develop potency and quality assays, insufficient rigour of the preclinical research and reproducibility of the results, manufacturing challenges, and scientific irregularities reported in the last years. The failure to achieve clinical success led to an increased scrutiny and scepticism as to the clinical readiness of stem cells and gene therapy products among clinicians, industry stakeholders, and funding bodies. The present impasse has attracted the attention of some of the most active research groups in the field, which were then summoned to analyse the position of the field and tasked to develop a strategy, to re-visit the undoubtedly promising future of cardiovascular regenerative and reparative medicine, based on lessons learned over the past two decades. During the scientific retreat of the ESC Working Group on Cardiovascular Regenerative and Reparative Medicine (CARE) in November 2018, the most relevant and timely research aspects in regenerative and/or reparative medicine were presented and critically discussed, with the aim to lay out a strategy for the future development of the field. We report herein the main ideas and conclusions of that meeting. [ABSTRACT FROM AUTHOR]

An editorial is presented the journal's success with an impact factor of 3.0 and offers readers an extensive collection of publications in critical care nursing research; it discusses the capabilities and limitations of large language models (LLMs) in research, presents various research articles with diverse topics and methodologies, emphasizing the use of LLMs in healthcare research, and highlights the importance of domain-specific expertise when utilizing LLMs.

The phenomenon of acute behavioral disturbance is an under-recognized and potentially life-threatening syndrome, and sometimes an emergency in psychiatric settings. Patients presenting to the Italian Emergency Departments (EDs) with acute behavioral disturbances account for approximately 3.2% of all ED visits. The spectrum of behaviors and of the signs overlaps with many clinical diseases. In addition to patients with behavioral problems related to mental disorders or substance abuse and toxicity, there is also a large group whose behavioral emergencies result from a medical illness. The complexity of these patients, as well as the interdisciplinary nature of their care, requires a clear and consensual framework for the appropriate medical management. A network of Italian scientific societies developed ten recommendations for good clinical practice. The main purpose is to draw up a document that presents a standardized method for the organization of the care of patients with acute behavioral disorders in EDs. [ABSTRACT FROM AUTHOR]

PURPOSE: To evaluate the effect of electronic and paper-based standardized nursing care plans (SNCPs) use on quality of nurses’ documentation. METHODS: Using quasi-experimental design, two wards were grouped into electronic and paper-based wards. Nurses were trained to use electronic- and paperbased SNCPs for care-planning and documentation. Data was collected before, 3, and 6 months postintervention and analyzed with SPSS version 20. FINDINGS: There was improvement in documentation quality in the two wards after introducing SNCPs with higher quality scores in the electronic ward postintervention. CONCLUSION: Providing SNCPs in electronic and paper formats is critical to improving nursing documentation. IMPLICATION FOR NURSING PRACTICE: Adequate training and support for nurses are needed for successful implementation of SNCPs in electronic health records (EHRs) in developing nations. [ABSTRACT FROM AUTHOR]

Management of decompensated cirrhosis is currently geared towards the treatment of complications once they occur. To date there is no established disease-modifying therapy aimed at halting progression of the disease and preventing the development of complications in patients with decompensated cirrhosis. The design of clinical trials to investigate new therapies for patients with decompensated cirrhosis is complex. The population of patients with decompensated cirrhosis is heterogeneous (i.e. , different etiologies, comorbidities and disease severity), leading to the inclusion of diverse populations in clinical trials. In addition, primary endpoints selected for trials that include patients with decompensated cirrhosis are not homogeneous and at times may not be appropriate. This leads to difficulties in comparing results obtained from different trials. Against this background, the LiverHope Consortium organized a meeting of experts, the goal of which was to develop recommendations for the design of clinical trials and to define appropriate endpoints, both for trials aimed at modifying the natural history and preventing progression of decompensated cirrhosis, as well as for trials aimed at managing the individual complications of cirrhosis. [ABSTRACT FROM AUTHOR]

The proportion of patients with at least minimal improvement in TIS was significantly greater for those who received IVIG relative to placebo. A similar issue of emphasis on patients with muscle involvement arises in using TIS as the primary outcome measure. These results led to US Food and Drug Administration (FDA) approval of IVIG use in treating DM. [Extracted from the article]

Objectives: Digitised patient-reported outcome may be beneficial for physicians and patients. The Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) can only be completed with paper and pencil (pJHEQ). We newly developed a web version of the JHEQ (wJHEQ). This study aimed to determine whether the scores obtained with the wJHEQ are equivalent to those from the pJHEQ, how much the wJHEQ would decrease missing answers, and which JHEQ the participants preferred to use. Methods: To measure equivalence between the pJHEQ and wJHEQ, we evaluated the mean score difference for each subscale (pain, movement, mental) and Visual Analogue Scale (VAS; satisfaction, right hip pain, left hip pain) and then assessed the intraclass correlation coefficients (ICC) between the two scores. ICC values ≥0.75 were defined as excellent agreement. We used Bland-Altman analysis to assess level of agreement between the values of the two questionnaires. We compared the number of incomplete forms and amount of missing data between the two questionnaires. We investigated ease of use by asking the participants which format was easier to use. Results: This study comprised 113 patients (mean age 58.1 years, 81% female) with hip disease. Mean score differences for each subscale between the wJHEQ and pJHEQ were not significantly different. The values of ICC for each subscale and each VAS were all >0.75. All 113 participants completed the wJHEQ questionnaire, whereas nine patients did not complete the pJHEQ form. There was a significant statistical difference between the completion rate of the wJHEQ and that of the pJHEQ (p = .0017). Fifty-seven participants (55%) preferred the wJHEQ, whereas 33 participants (32%) preferred the pJHEQ. Conclusion: The wJHEQ was found to be equivalent to the original pJHEQ. The wJHEQ significantly decreased the numbers of missing answers and incomplete forms. The participants felt ease of use was nearly equivalent. The wJHEQ might help facilitate more complete assessments in clinical trials and research. [ABSTRACT FROM AUTHOR]

Introduction: Sustained Attention (SA) failure is one of the main characteristics of Specific Learning Disorders (SLD). Recent studies have reported a positive effect of Cognitive Rehabilitation (CR) and Neurofeedback (NFB) on SA in SLD. Thus, the effectiveness of CR and NFB is well understood. This preliminary study aimed to compare the effects of CR and NFB on SA among the elementary school students with SLD, using a randomized controlled clinical trial. Methods: In this preliminary randomized controlled clinical trial, 53 eligible students with SLD (based on DSM-5) within the age range of 7 to 10 years were randomly assigned in the NFB (n=18), CR (n=18), and control group (n=17). All the participants were evaluated for SA using the Continuous Performance Test (CPT), at the time of entry to the study, and one month later. The intervention groups participated in 20 sessions of CR and 20 sessions of NFB, while the control group was evaluated without any intervention. Results: A total number of 24 boys and 36 girls in four groups (n=15) completed the study. The Mean±SD age of the participants in the CR, NFB, and control groups were 8.66±1.48 years, 8.40±1.73 years, and 8.53±1.63 years, respectively. Results showed a significant difference in the variables of the CPT between the study groups (P<0.05). Also, the CPT scores of the CR group were higher than that of the NFB group (P<0.001). Conclusion: This study supports that CR is more effective than NFB on SA in students with SLD. [ABSTRACT FROM AUTHOR]

To describe current practice in the management of rectal cancer, to identify uncertainties that usually arise in the multidisciplinary team (MDT)'s discussions ('grey zones') and propose next generation studies which may provide answers to them. A questionnaire on the areas of controversy in managing T2, T3 and T4 rectal cancer was drawn up and distributed to the Rectal-Assisi Think Tank Meeting (ATTM) Expert European Board. Less than 70% agreement on a treatment option was indicated as uncertainty and selected as a 'grey zone'. Topics with large disagreement were selected by the task force group for discussion at the Rectal-ATTM. The controversial clinical issues that had been identified within cT2–cT3–cT4 needed further investigation. The discussions focused on the role of (1) neoadjuvant therapy and organ preservation on cT2-3a low-middle rectal cancer; (2) neoadjuvant therapy in cT3 low rectal cancer without high risk features; (3) total neoadjuvant therapy, radiotherapy boost and the best chemo-radiotherapy schedule in T4 tumors. A description of each area of investigation and trial proposals are reported. The meeting successfully identified 'grey zones' and, in the light of new evidence, proposed clinical trials for treatment of early, intermediate and advanced stage rectal cancer. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Pelvic floor physiotherapy has been utilized extensively over the past decades for the treatment of pelvic floor dysfunctions. The aim of this study was to identify and characterize the most frequently cited articles on pelvic floor physiotherapy published in the last 30 years.Methods: A PubMed search of all articles published between 1983 and 2013 was performed. Articles with more than 100 citations were identified as “classic,” and were further analyzed based on author names, year of publication, journal of publication, subject, study design, country of research, and number of citations. In 2017, a new search for papers on pelvic floor physiotherapy was conducted using the same methods to compare them with the 2013 data.Results: Of 1,285 articles published between 1983 and 2013, only 20 articles were cited more than 100 times. Among them, we found 12 randomized clinical trials (RCTs) and only 4 reviews. The most common topics among the classic articles were behavior therapy, pelvic floor muscle training (PFMT), biofeedback-assisted PFMT, and neuromuscular electrical stimulation. In 2017, we found 1,745 papers containing the term “pelvic floor physiotherapy,” indicating an increase of around 35% in 4 years.Conclusions: Although there is a fast-growing number of publications, we still have few classic papers on pelvic floor physiotherapy, concentrated in a few research centers. However, the large number of RCTs shows that these papers have a high scientific level, confirming that they can be classified as classic papers. [ABSTRACT FROM AUTHOR]

Background: There is an often-held assumption that the engagement of clinicians and healthcare organizations in research improves healthcare performance at various levels. Previous reviews found up to 28 studies suggesting a positive association between the engagement of individuals and healthcare organizations in research and improvements in healthcare performance. The current study sought to provide an update. Methods: We updated our existing published systematic review by again addressing the question: Does research engagement (by clinicians and organizations) improve healthcare performance? The search covered the period 1 January 2012 to March 2024, in two phases. First, the formal updated search ran from 1 January 2012 to 31 May 2020, in any healthcare setting or country and focussed on English language publications. In this phase two searches identified 66 901 records. Later, a further check of key journals and citations to identified papers ran from May 2020 to March 2024. In total, 168 papers progressed to full-text appraisal; 62 were identified for inclusion in the update. Then we combined papers from our original and updated reviews. Results: In the combined review, the literature is dominated by papers from the United States (50/95) and mostly drawn from the Global North. Papers cover various clinical fields, with more on cancer than any other field; 86 of the 95 papers report positive results, of which 70 are purely positive and 16 positive/mixed, meaning there are some negative elements (i.e. aspects where there is a lack of healthcare improvement) in their findings. Conclusions: The updated review collates a substantial pool of studies, especially when combined with our original review, which are largely positive in terms of the impact of research engagement on processes of care and patient outcomes. Of the potential engagement mechanisms, the review highlights the important role played by research networks. The review also identifies various papers which consider how far there is a "dose effect" from differing amounts of research engagement. Additional lessons come from analyses of equity issues and negative papers. This review provides further evidence of contributions played by systems level research investments such as research networks on processes of care and patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Interest in and use of electronic consent (e-consent) in the conduct of academic clinical trials has increased since the COVID-19 pandemic. E-consent offers advantages including increased efficiency and accessibility, and reduced burden on site staff, which can be appealing to academic trialists anticipating challenges in recruitment to complex trial designs or with limited funding. However, there are many options to consider when using e-consent in a study protocol. This paper presents five case studies from Norwich Clinical Trials Unit, demonstrating how e-consent models can be effectively tailored to the needs of different trials. These examples illustrate the options around and benefits of e-consent, the acceptability of e-consent by participants, and the design considerations that were made during the development of the trial protocols. Case studies: Five randomised trials are presented, selected from a range of different trial designs, disease areas, interventions, and patient populations. E-consent was either offered as an alternative to paper consent, according to participant preference, or as the sole method of consent. E-consent was generally used to facilitate remote consent in decentralised trials but was also chosen to increase efficiency and reduce burden in an emergency department setting. The technical implementation of e-consent and detailed participant procedures were tailored to the needs of the trial settings and patient populations. For example, accompanying participant information sheets were provided in paper or electronic form, and electronic signatures could be typed or drawn. Administrative data on uptake of e-consent is presented where available. Conclusion: This paper demonstrates that the operational and technical aspects of implementing e-consent in clinical trials can be influenced by the trial design, the needs and characteristics of the trial population, financial/efficiency considerations, and level of risk. E-consent is not a one-size-fits-all tool for trials, and its use should be carefully considered during the development of the trial protocol, in conjunction with patient and public involvement contributors, site staff and other trial stakeholders. [ABSTRACT FROM AUTHOR]

Background Aims Methods Main Contribution Conclusions WHAT THIS PAPER ADDS What is already known on the subject What this paper adds to existing knowledge What are the clinical implications of this work? Communication impairments are a leading concern for parent caregivers of individuals with rare neurodevelopmental disorders (RNDDs). Clinical trials of disease modifying therapies require valid and responsive outcome measures that are relevant to individuals with RNDDs. Identifying and evaluating current psychometric properties for communication measures is a critical step towards the selection and use of appropriate instruments.This systematic review offers (1) a description of parent‐reported communication measures and (2) evidence for their psychometric properties, in RNDDs.The systematic review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO; CRD42022334649). MEDLINE (Ovid), Embase, PsychINFO, Web of Science, CINAHL Plus, Cochrane Library, ClinicalTrials.gov, the Australian New Zealand Clinical Trials Registry were searched from inception to August 2023. Methodological assessment of quality was completed using the COnsensus‐based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. Parent‐reported measures used in observational studies and clinical trials were identified. Data on utility, reliability and validity for RNDDs were extracted.Sixteen parent‐reported communication measures were used in RNDD research, the Vineland Adaptive Behavior Scales being most commonly used. Validation data in RNDDs were identified for six of these measures. Limitations related to sample size or the scope of psychometric testing.Many communication measures have been used for RNDDs but there are few data validating their use. Valid and reliable methods of measuring communication in persons with RNDDs is a priority for future high‐quality clinical trials. Communication is a critical domain for families with a child with a rare neurodevelopmental disorder (RNDD). Validated outcome measures are essential for accurate evaluation and interpretation of responses to treatments in clinical trials. We identified 16 parent‐reported communication measures that have been used with RNDDs, but only six measures had validation data for at least one RNDD. High quality evidence is accumulating, with all validation studies in this review published between 2020 to 2023. Modifications of existing measures may be required to assess communication for RNDDs. This systematic review catalogues the available psychometric data for communication measures and indicates an ongoing need for new validation studies to ensure they are fit‐for‐purpose for upcoming clinical trials in RNDDs. This review will inform the selection of communication measures for clinical trials and research studies. [ABSTRACT FROM AUTHOR]

In silico clinical trials (ISCTs) are an emerging method in modeling and simulation where medical interventions are evaluated using computational models of patients. ISCTs have the potential to provide cost-effective, time-efficient, and ethically favorable alternatives for evaluating the safety and effectiveness of medical devices. However, ensuring the credibility of ISCT results is a significant challenge. This paper aims to identify unique considerations for assessing the credibility of ISCTs and proposes an ISCT credibility assessment workflow based on recently published model assessment frameworks. First, we review various ISCTs described in the literature, carefully selected to showcase the range of methodological options available. These studies cover a wide variety of devices, reasons for conducting ISCTs, patient model generation approaches including subject-specific versus 'synthetic' virtual patients, complexity levels of devices and patient models, incorporation of clinician or clinical outcome models, and methods for integrating ISCT results with real-world clinical trials. We next discuss how verification, validation, and uncertainty quantification apply to ISCTs, considering the range of ISCT approaches identified. Based on our analysis, we then present a hierarchical workflow for assessing ISCT credibility, using a general credibility assessment framework recently published by the FDA's Center for Devices and Radiological Health. Overall, this work aims to promote standardization in ISCTs and contribute to the wider adoption and acceptance of ISCTs as a reliable tool for evaluating medical devices. Author summary: A new method for evaluating a medical device is an in silico clinical trial, where the device performance is tested using computational models representing a cohort of patients. Demonstrating that in silico clinical trials are reliable is clearly of paramount importance. However, little information is available on how to ensure this. In this paper we present a workflow for evaluating an in silico clinical trial. This workflow was developed by considering a wide-ranging sample of previously published in silico clinical trials, together with a detailed assessment of how specific model evaluation activities apply to in silico clinical trials. [ABSTRACT FROM AUTHOR]

Biostatistics plays a pivotal role in developing, interpreting and drawing conclusions from clinical, biological and epidemiological data. However, the improper application of statistical methods can lead to erroneous conclusions and misinterpretations. This paper provides a comprehensive examination of the most frequent mistakes encountered in the biostatistical analysis process. We identified and elucidated 10 common errors in biostatistical analysis. These include using the wrong metric to describe data, misinterpreting P -values, misinterpreting the 95% confidence interval, misinterpreting the hazard ratio as an index of prognostic accuracy, ignoring the sample size calculation, misinterpreting analysis by strata in randomized clinical trials, confusing correlation and causation, misunderstanding confounders and mediators, inadequately codifying variables during the data collection, and bias arising when group membership is attributed on the basis of future exposure in retrospective studies. We discuss the implications of these errors and propose some practical strategies to mitigate their impact. By raising awareness of these pitfalls, this paper aims to enhance the rigor and reproducibility of biostatistical analyses, thereby fostering more robust and reliable biomedical research findings. [ABSTRACT FROM AUTHOR]

Background: This study examines the effect of a Theory of Mind (ToM) intervention on ToM abilities and social–emotional functioning in adolescents with developmental language disorder (DLD) or who are deaf/hard of hearing (D/HH). It emphasizes the importance of self‐reflection and measurement for personal growth. The research design incorporates both subjective and objective measures to evaluate the intervention's efficacy. Aims: To investigate the impact of the ToM intervention on ToM abilities and social–emotional functioning in adolescents with DLD or who are D/HH. It hypothesizes that participants in the intervention groups will show improved ToM and social–emotional functioning compared with those in the control groups. Methods & Procedures: Adolescents with DLD or who are D/HH were recruited through collaboration with educational institutions. The study utilized a pre‐/post‐test design, assigning participants to either the intervention or the control group. The ToM intervention involved targeted activities to enhance ToM abilities. ToM abilities and social–emotional functioning were assessed using standardized tests and self‐report questionnaires. Statistical analyses compared outcomes between the intervention and no intervention groups. Outcomes & Results: The findings reveal subjective improvements in social–emotional functioning among the D/HH intervention group. However, no significant effects on objective ToM measures were observed. These results highlight the need for further investigation and refinement of interventions in these areas. Future research should focus on improving intervention strategies and exploring additional objective measures to gain a comprehensive understanding of the intervention's impact on ToM and social–emotional functioning in this population. Conclusions & Implications: The ToM intervention shows subjective benefits in improving social–emotional functioning among D/HH adolescents. However, it does not yield significant effects on objective ToM measures. These findings emphasize the ongoing need to refine interventions targeting ToM abilities and social–emotional functioning in this population. Future studies should explore alternative strategies and incorporate additional objective measures to enhance understanding and outcomes. WHAT THIS PAPER ADDS: What is already known on this subject: Before this study, it was known that ToM interventions have the potential to enhance ToM abilities. However, the specific effects of such interventions on subjective and objective measures for ToM and social–emotional functioning in adolescents with DLD or who are D/HH remained unclear, necessitating further research. What this paper adds to the existing knowledge: This study adds to the existing knowledge by demonstrating subjective improvements in social–emotional functioning among adolescents who are D/HH and underwent a ToM intervention. However, no significant effects on objective ToM measures were observed. These findings highlight the need for refining interventions and exploring additional measures to better understand the intervention's impact. What are the potential or actual clinical implications of this work?: The subjective improvements in social–emotional functioning observed in this study have important clinical implications. They suggest that ToM interventions can positively impact the social well‐being of adolescents who are D/HH. However, the lack of significant effects on objective ToM measures emphasizes the need for further research and intervention refinement to address specific areas of improvement in this population. [ABSTRACT FROM AUTHOR]

Conceptualizing tobacco dependence as a chronic relapsing condition suggests the need to use analytic strategies that reflect that premise. However, clinical trials for smoking cessation typically define the primary endpoint as a measure of abstinence at a single timepoint distal to the intervention, typically 3–12 months. This reinforces the concept of tobacco outcomes as a dichotomous state—one is, or is not, abstinent. Fortunately, there are several approaches available to handle longitudinal data that reflect the relapsing and remitting nature of tobacco use during treatment studies. In this paper, sponsored by the Society for Research on Nicotine and Tobacco's Treatment Research Network, we present an introductory overview of these techniques and their application in smoking cessation clinical trials. Topics discussed include models to examine abstinence outcomes (eg, trajectory models of abstinence, models for transitions in smoking behavior, models for time to event), models that examine reductions in tobacco use, and models to examine joint outcomes (eg, examining changes in the use of more than one tobacco product). Finally, we discuss three additional relevant topics (ie, heterogeneity of effects, handling missing data, and power and sample size) and provide summary information about the type of model that can be used based on the type of data collected and the focus of the study. We encourage investigators to familiarize themselves with these techniques and use them in the analysis of data from clinical trials of smoking cessation treatment. Implications Clinical trials of tobacco dependence treatment typically measure abstinence 3–12 months after participant enrollment. However, because smoking is a chronic relapsing condition, these measures of intervention success may not accurately reflect the common trajectories of tobacco abstinence and relapse. Several analytical techniques facilitate this type of outcome modeling. This paper is meant to be an introduction to these concepts and techniques to the global nicotine and tobacco research community including which techniques can be used for different research questions with visual summaries of which types of models can be used for different types of data and research questions. [ABSTRACT FROM AUTHOR]

Extracellular vesicles (EVs) hold great promise for clinical application as new diagnostic and therapeutic modalities. This paper describes major GMP-based upstream and downstream manufacturing processes for EV large-scale production, also focusing on post-processing technologies such as surface bioengineering and uploading studies to yield novel EV-based diagnostics and advanced therapy medicinal products. This paper also focuses on the quality, safety, and efficacy issues of the bioengineered EV drug candidates before first-in-human studies. Because clinical trials involving extracellular vesicles are on the global rise, this paper encompasses different clinical studies registered on clinical-trial register platforms, with varying levels of advancement, highlighting the growing interest in EV-related clinical programs. Navigating the regulatory affairs of EVs poses real challenges, and obtaining marketing authorization for EV-based medicines remains complex due to the lack of specific regulatory guidelines for such novel products. This paper discusses the state-of-the-art regulatory knowledge to date on EV-based diagnostics and medicinal products, highlighting further research and global regulatory needs for the safe and reliable implementation of bioengineered EVs as diagnostic and therapeutic tools in clinical settings. Post-marketing pharmacovigilance for EV-based medicinal products is also presented, mainly addressing such topics as risk assessment and risk management. [ABSTRACT FROM AUTHOR]

The application of STEM (Science, Technology, Engineering, and Math) education in solving real-world problems is challenging. To tackle this challenge, a project-based learning approach that integrates robots with cost-effective self-made toys to problem-solving was adopted to assist rural primary school students to apply STEM skills. The purpose of this study was to evaluate the effects of the project-based learning approach which includes lecturing and hands-on activities on primary school students' STEM learning outcomes and attitudes. An experiment was conducted with 25 primary school students who voluntarily participated in a STEM summer-camp programme. Students were asked to assemble a paper house equipped with an IoT control module and LED light switches, and write and edit robot scripts to produce a robot-based storytelling narrative using the paper house they made as a context. The results show that the project-based learning approach was an effective approach for cultivating primary school students' STEM knowledge and skills as evidenced from the post-written test. The relationships between the students' STEM learning outcomes and attitudes were also confirmed by a clustering analysis. Students who had higher learning attitudes also achieved higher STEM learning outcomes; the findings are also supported by the feedback from the open-ended questionnaire items. This study suggests that integrating low-cost self-made toys and robots in project-based learning activities is an effective and practical approach to enhance primary school students' learning outcomes and learning attitudes in STEM education. [ABSTRACT FROM AUTHOR]

Clinical trials are very important for determining the safety and efficacy of medical trials, which is further critical to the progress of the various healthcare businesses. Conducting such studies requires substantial preparation and adherence to the various ethical norms; such norms which are especially crucial when dealing with medical emergencies like the COVID-19 outbreak. This paper discusses the Site Initiation Visit (SIV) and the development of Essential Document Files (EDF) for clinical research. Site initiation visit specifies fundamental tasks to ensure team preparedness, logistical planning, and regulatory compliance. Team training, investigational product (IP) storage, and post-SIV follow-up procedures are all valuable considerations. On the other hand, throughout the trial's lifecycle, the document files play a very vital role in ensuring a complete documentation process thereby promoting transparency and adherence to Good Clinical Practice (GCP) guidelines. The paper highlights the importance of established protocols and regulatory compliance, in safeguarding safety by outlining these procedures. [ABSTRACT FROM AUTHOR]

Background: The lack of a clear answer regarding the efficacy of physiotherapy in the treatment of cubital tunnel syndrome (CuTS) has led to attempts to critically assess the scientific studies conducted to date. Materials and Methods: Two databases (MEDLINE via PubMed and PEDro) and Google Scholar were used to search for papers. The inclusion criteria were randomized controlled trials, case series, and case reports that evaluate the effects of physiotherapy in the treatment of patients with CuTS. Results: A total of 18 studies met the eligibility criteria, capturing a total of 425 participants. Seven papers were randomized controlled trials, three more described prospective studies without a control group, and eight papers contained case reports. An analysis of the literature evaluating the effectiveness of various forms of broadly defined physiotherapy indicates that their use can have a beneficial effect in reducing many subjective and objective symptoms and improving function. In the majority of papers included in this review, their authors indicated positive therapeutic effects. Only one randomized controlled trial reported no change following therapy. It can therefore be stated that the results of the research conducted so far are optimistic. However, only 7 of the 18 papers were randomized controlled trials, while 3 were prospective studies, and 8 papers were case studies, in which 23 people with CuTS were studied. Conclusions: The small number of randomized clinical trials and their considerable heterogeneity do not allow firm conclusions to be drawn about the effectiveness of physiotherapy in the conservative treatment of CuTS. [ABSTRACT FROM AUTHOR]

Background: A skin tear is a traumatic wound that occurs in up to one in five hospitalized patients. Nursing care includes application of a dressing to create a moist wound healing environment. Aim: To compare the effectiveness of two standard dressings (adhesive silicone foam vs. meshed silicone interface) to heal hospital‐acquired skin tear. Methods: An intention‐to‐treat pilot study was designed using a randomized, non‐inferiority trial in an Australian tertiary hospital setting. Consenting participants (n = 52) had acquired a skin tear within the previous 24 h and had agreed to a 3‐week follow‐up. Data were collected between 2014 and 2020. The primary outcome measure was wound healing at 21 days. Results: Baseline characteristics were similar in both arms. Per protocol, 86% of skin tears were fully healed at 3 weeks in the adhesive silicone foam group, compared to 59% in the meshed silicone interface group. Greater healing was observed across all skin tear categories in the adhesive silicone foam dressing group. In the intention‐to‐treat sample, healing was 69% and 42%, respectively. Conclusions: Results suggest the adhesive silicone foam dressing may be superior, as it produced clinically significant healing of skin tears at 3 weeks compared to the meshed silicone interface dressing. Accounting for potential loss to follow‐up, a sample of at least 103 participants per arm would be required to power a definitive study. Summary statement: What is already known about this topic? A skin tear is a traumatic wound that is commonly acquired during hospitalization that affects older adults in particular. In hospital settings, it may occur in up to one in five patients.A variety of skin tear dressings have been used in previous studies, with healing rates ranging from 34% to 97% at 21 days; however, evidence for the most effective dressing type is inconclusive.If treated inappropriately, or left untreated, minor skin tears can become chronic or complicated wounds, yet prevalence and treatment of hospital‐acquired injuries are under‐reported. What this paper adds? Based on our per‐protocol results, an adhesive silicone foam dressing may be superior, as it produced clinically significant healing of 86% of skin tears at 3 weeks compared to 59% with the meshed silicone interface dressing.Based on the methods and results from this pilot study, a future definitive trial would be feasible but would need to account for a relatively large loss to follow‐up rate. The implications of this paper: Using our intention‐to‐treat results, a future study would need a sample size of 103 per arm to be sufficiently powered, which may be impractical to achieve within a single hospital setting; thus, a multi‐site study would be advisable. [ABSTRACT FROM AUTHOR]

Background: The prevalence of sexually transmitted diseases (STDs) remains high worldwide in today's society, especially among young people. Youth education on STDs could help to reduce the prevalence of the condition in society and prevent new cases. Aim: The aim of this study is to assess the effectiveness of peer‐based short‐form educational videos on youths' knowledge of STDs. Methods: This quasi‐experimental study was conducted in Turkey. The sample consisted of 121 students divided into experimental and control groups. Pre‐ and post‐test control group quasi‐experimental research design was employed in this study during the spring semester of the academic year 2021–2022. Peer‐based short‐form educational videos created by nursing students were used as an intervention. The survey form and Sexually Transmitted Disease Knowledge Questionnaire were used to collect data. Results: Participants with parental responsibilities and had previous STD experience had higher knowledge score than the other subgroups. There was a significant main effect of peer‐based short‐form educational video on participants overall knowledge score of STDs. Additionally, the effect of intervention continued at 12‐week follow‐up measurement. Conclusion: Peer‐based short‐form educational videos increase young people's knowledge of STD, and the impact of the intervention continued at 12‐week follow up. Summary statement: What is already known about this topic? Sexually transmitted diseases continue to be prevalent in society, particularly among young people.Sexually transmitted diseases can lead to serious health conditions and have a significant impact on sexual and reproductive health.The effectiveness of internet‐based education and lectures on sexually transmitted diseases has already been investigated.Little research has been addressed to determine the impact of educational materials, which are short videos on knowledge of sexually transmitted diseases created by utilizing nursing students' peer assessment. What this paper adds? Peer‐based short‐form educational videos increase young people's sexually transmitted disease knowledge.People with parental responsibilities and a previous sexually transmitted infections responded to interventions more favourably.The effects of peer‐based short‐form educational videos persisted 3 months afterwards. The implications for this paper: This cost‐free method has a potential to be widely used as a public health intervention to educate young people on sexually transmitted diseases.The peer‐based short‐form educational videos can be combined with other interventions to increase young people's knowledge of sexually transmitted diseases. [ABSTRACT FROM AUTHOR]

The quality of the very early emotional experiences in a child's life are recognized today as foundational in the mental health of becoming an adult. Unsurprisingly, clinicians and health authorities agree on the importance of early detection and treatment of any mental health issues experienced by the preschool child. This is even more important and challenging as young children do not yet have the language skills necessary to express their distress. But do the caregivers in charge of these populations have the best tools at their disposal to carry out that important mission in an efficient and scientifically robust manner reflecting the latest research findings and scientific literature? This is the question we try to answer in this paper. We revisited the theoretical underpinnings behind the concept of mentalization as playing a key role in the ability to understand the other's inner reality. We then carried out an extensive review of scientific papers written over the past 30 years on the subject. We examined mental representations of the adult on the child and analyzed those mentalizations as key inputs. We focused on extracting cross analyses of the mentalizations of one child by several adults with different functions in the life of the child. In this process, we used the PRISMA methodology applied to large international medical databases. We found that the qualitative approach, usually associated with a lengthy process, has been overwhelmingly used in trying to assess patients' mental states and to analyze the mentalizations on the patient, adult or child. Furthermore, cross analyses of mentalizations from more than one adult on a given child were almost nonexistent, despite having high epistemic and clinical potential. There is a dearth of reliable quantitative tools, able to capture and analyze the mentalizations on a patient, that are scientifically robust, transposable, and easy to implement in a clinical setting. The absence of such tools for medical professionals in charge of assessing preschool children contributes, in our view, the low detection and poor treatment of mental disorders in that particularly vulnerable population. We believe there is here an urgent unmet need and that such tools should be designed, validated, and deployed into the target populations as early as possible. [ABSTRACT FROM AUTHOR]

Complex and enduring mental health problems require greater treatment resources, usually in the form of multidisciplinary support, including providing psychological therapies. This paper reports on an NHS, tertiary-level specialist psychotherapy service offering Psychodynamic therapies with longer-term, exploratory transdiagnostic approaches to support complexity and sustained personality functioning. This paper adopts a naturalistic study design evaluating the effectiveness of Psychodynamic therapy using pre- and post-outcomes across a 10-year period. A total of n = 474 participants self-report pre- and post-outcome measures were used as the marker of effectiveness along with therapist assessments during intake and engagement. The findings showed that Psychodynamic therapy was effective in reducing psychological distress based on service-user self-report and therapist assessments. While intake scores varied by socio-demographic factors, the rate of change across most groups was similar. There were several limitations relating to data quality and completeness which reflect the naturalistic design. Despite the limits of a naturalistic design, this study provides evidence of support for the place of Psychodynamic therapies within NHS mental health care, catering to those with complex and enduring mental health problems. [ABSTRACT FROM AUTHOR]

JAMA: Journal of the American Medical Association has published a Special Communication titled "The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided," which discusses the need to integrate clinical trials with clinical practice. The authors highlight the separate missions and infrastructures of clinical trialists and clinicians, leading to inefficiencies and limitations in trials. They propose solutions such as implementation science, novel statistical analysis approaches, and integration of trials with electronic health records. JAMA is launching a new series called "Integrating Clinical Trials and Practice" to explore innovations in trial design, funding, regulation, education, and application. The goal is to align clinical trials with clinical practice and improve patient care. [Extracted from the article]

Background and Objectives: Given the fact that randomized controlled clinical trials are more valid than other research methods to determine the therapeutic effects of treatment, proper design and accurate reporting is of particular importance. This study was conducted with the aim of evaluating the quality of writing the title and abstract of randomized clinical trials of Iranian medical universities journals in 2016 using the Consolidated Standards of Reporting Trials (CONSORT) checklist. Materials and Methods: In this descriptive study, information gathering through internet search was limited to Persian language journals affiliated to the medical universities of the country. Based on the CONSORT checklist, which contains 18 questions, all randomly controlled clinical trials, consisting of 262 papers published in these magazines in 2016, were reviewed. Statistical analysis was performed using descriptive statistics and Chi-square and Fisher’s exact tests. Results: Only 34 (13%) of the articles refered to “randomized” word in the title of the article. Regarding the proportion of cases observed in the articles, based on the gender of the author, only two "mentioning the place of data collection" (p=0.009) and "mentioning clinical trial registration number" (p=0.020) and based on the scientific rank two cases, namely, “mentioning the full details of the responsible author” (p=0.002) and "mentioning the randomized method" (p=0.039) were significantly different. Conclusion: The need to follow CONSORT criteria and eliminate the deficiencies mentioned for conducting these studies in the country seems necessary. Therefore, it is recommended to the authors to use the CONSORT clinical checklist while writing randomized controlled clinical trials. [ABSTRACT FROM AUTHOR]

Abstract A new disposable microfluidic electrochemical paper-based device (ePAD) consisting of two spot sensors in the same working electrode for the simultaneous determination of uric acid and creatinine was developed. The spot 1 surface was modified with graphene quantum dots for direct uric acid oxidation and spot 2 surface modified with graphene quantum dots, creatininase and a ruthenium electrochemical mediator for creatinine oxidation. The ePAD was employed to construct an electrochemical sensor (based on square wave voltammetry analysis) for the simultaneous determination of uric acid and creatinine in the 0.010–3.0 µmol L−1 range. The device showed excellent analytical performance with a very low simultaneous detection limit of 8.4 nmol L−1 to uric acid and 3.7 nmol L−1 to creatinine and high selectivity. The ePAD was applied to the rapid and successful determination of those clinical biomarkers in human urine samples. Graphical abstract fx1 Highlights • An ePAD used for clinical biomarkers determination. • The ePAD consisting of two spot sensors in the same working electrode. • The spot 1 surface with graphene quantum dots for direct uric acid oxidation. • The spot 2 surface with GQDs, creatininase and an redox mediator for creatinine oxidation. • The ePAD showed high sensitivity for simultaneous determination of biomarkers. [ABSTRACT FROM AUTHOR]

Summary: After more than 120 hand‐upper extremity and 37 face transplant procedures performed worldwide, vascularized composite allotransplantation (VCA) now falls under the scope of organ transplant legislation in Europe and the United States. While in the USA, VCA has been considered as standard care since 2014, VCA in Europe is still performed through clinical research trials, except in United Kingdom. However, after two decades of favourable experience with upper extremity transplantation (UET), professionals in Europe are proposing hand allotransplantation as "controlled standard" care, as opposed to face transplantation (FT), which is still a challenging activity. The European Committee on Organ Transplantation (CD‐P‐TO) has elaborated a position paper to provide recommendations concerning regulatory aspects for UET and FT. It is aimed at Health Authorities in charge of the oversight – and coordination – of organ donation and transplantation, and at professional groups to help them manage such complex and costly programs dedicated to properly selected patients. [ABSTRACT FROM AUTHOR]

Abstract Background Our current understanding of the pathophysiology and management of sepsis is associated with a lack of progress in clinical trials, which partly reflects insufficient appreciation of the heterogeneity of this syndrome. Consequently, more patient-specific approaches to treatment should be explored. Aims To summarize the current evidence on precision medicine in sepsis, with an emphasis on translation from theory to clinical practice. A secondary objective is to develop a framework enclosing recommendations on management and priorities for further research. Sources A global search strategy was performed in the MEDLINE database through the PubMed search engine (last search December 2017). No restrictions of study design, time, or language were imposed. Content The focus of this Position Paper is on the interplay between therapies, pathogens, and the host. Regarding the pathogen, microbiologic diagnostic approaches (such as blood cultures (BCs) and rapid diagnostic tests (RDTs)) are discussed, as well as targeted antibiotic treatment. Other topics include the disruption of host immune system and the use of biomarkers in sepsis management, patient stratification, and future clinical trial design. Lastly, personalized antibiotic treatment and stewardship are addressed (Fig. 1). Implications A road map provides recommendations and future perspectives. RDTs and identifying drug-response phenotypes are clear challenges. The next step will be the implementation of precision medicine to sepsis management, based on theranostic methodology. This highly individualized approach will be essential for the design of novel clinical trials and improvement of care pathways. [ABSTRACT FROM AUTHOR]

Modulation of vessel growth holds great promise for treatment of cardiovascular disease. Strategies to promote vascularization can potentially restore function in ischaemic tissues. On the other hand, plaque neovascularization has been shown to associate with vulnerable plaque phenotypes and adverse events. The current lack of clinical success in regulating vascularization illustrates the complexity of the vascularization process, which involves a delicate balance between pro- and anti-angiogenic regulators and effectors. This is compounded by limitations in the models used to study vascularization that do not reflect the eventual clinical target population. Nevertheless, there is a large body of evidence that validate the importance of angiogenesis as a therapeutic concept. The overall aim of this Position Paper of the ESC Working Group of Atherosclerosis and Vascular biology is to provide guidance for the next steps to be taken from pre-clinical studies on vascularization towards clinical application. To this end, the current state of knowledge in terms of therapeutic strategies for targeting vascularization in post-ischaemic disease is reviewed and discussed. A consensus statement is provided on how to optimize vascularization studies for the identification of suitable targets, the use of animal models of disease, and the analysis of novel delivery methods. [ABSTRACT FROM AUTHOR]