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Patients with the dual burden of chronic kidney disease (CKD) and cardiovascular disease (CVD) experience unacceptably high rates of morbidity and mortality, which also entail unfavorable effects on healthcare systems. Currently, concerted efforts to identify, prevent and treat CVD in CKD patients are lacking at the institutional level, with emphasis still being placed on individual specialty views on this topic. The authors of this position paper endorse the need for a dedicated interdisciplinary team of subspecialists in cardio-nephrology that manages appropriate clinical interventions across the inpatient and outpatient settings. There is a critical need for training programs, guidelines and best clinical practice models, and research funding from nephrology, cardiology and other professional societies, to support the development of the subspecialty of cardio-nephrology. This position paper from the coordinating committee from the Working Group for Cardiorenal Medicine of the Spanish Society of Nephrology (S.E.N.) is intended to be the starting point to develop the subspecialty of cardio-nephrology within the S.E.N.. The implementation of the subspecialty in day-to-day nephrological practice will help to diagnose, treat, and prevent CVD in CKD patients in a precise, clinically effective, and health cost-favorable manner. Resumen: Los pacientes con enfermedad renal crónica (ERC) que presentan enfermedad cardiovascular (ECV) tienen índices de morbilidad y mortalidad inaceptablemente elevados, que impactan desfavorablemente sobre los sistemas de salud. En la actualidad, se requieren actuaciones multidisciplinares para identificar, prevenir y tratar la ECV en los pacientes con ERC, debiendo pues superarse la época de las actuaciones de las especialidades individuales. Los autores de este artículo respaldan la necesidad de un equipo interdisciplinar de subespecialistas en cardionefrología que gestione las intervenciones clínicas adecuadas en el entorno hospitalario y en el ambulatorio. Existe una gran necesidad de programas de formación, de guías y modelos de práctica clínica, y de fondos para la investigación en las sociedades de nefrología, cardiología y otras, para apoyar el desarrollo de la subespecialidad de cardio-nefrología. Este documento de opinión del comité coordinador del Grupo de Trabajo de Medicina Cardiorenal de la Sociedad Española de Nefrología (S.E.N.) pretende ser el inicio del desarrollo de la subespecialidad de Cardionefrología en el marco de la S.E.N. La implementación de la subespecialidad en la práctica nefrológica diaria contribuirá a diagnosticar, tratar y prevenir la ECV en los pacientes con ERC de una manera precisa, clínicamente efectiva y sanitariamente rentable.

This White Paper by the European Society for Swallowing Disorders (ESSD) reports on the current state of screening and non-instrumental assessment for dysphagia in adults. An overview is provided on the measures that are available, and how to select screening tools and assessments. Emphasis is placed on different types of screening, patient-reported measures, assessment of anatomy and physiology of the swallowing act, and clinical swallowing evaluation. Many screening and non-instrumental assessments are available for evaluating dysphagia in adults; however, their use may not be warranted due to poor diagnostic performance or lacking robust psychometric properties. This white paper provides recommendations on how to select best evidence-based screening tools and non-instrumental assessments for use in clinical practice targeting different constructs, target populations and respondents, based on criteria for diagnostic performance, psychometric properties (reliability, validity, and responsiveness), and feasibility. In addition, gaps in research that need to be addressed in future studies are discussed. The following recommendations are made: (1) discontinue the use of non-validated dysphagia screening tools and assessments; (2) implement screening using tools that have optimal diagnostic performance in selected populations that are at risk of dysphagia, such as stroke patients, frail older persons, patients with progressive neurological diseases, persons with cerebral palsy, and patients with head and neck cancer; (3) implement measures that demonstrate robust psychometric properties; and (4) provide quality training in dysphagia screening and assessment to all clinicians involved in the care and management of persons with dysphagia.

Approximately 10 years have passed since the Peritoneal Dialysis Guidelines were formulated in 2009. Much evidence has been reported during the succeeding years, which were not taken into consideration in the previous guidelines, e.g., the next peritoneal dialysis PD trial of encapsulating peritoneal sclerosis (EPS) in Japan, the significance of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), the effects of icodextrin solution, new developments in peritoneal pathology, and a new international recommendation on a proposal for exit-site management. It is essential to incorporate these new developments into the new clinical practice guidelines. Meanwhile, the process of creating such guidelines has changed dramatically worldwide and differs from the process of creating what were “clinical practice guides.” For this revision, we not only conducted systematic reviews using global standard methods but also decided to adopt a two-part structure to create a reference tool, which could be used widely by the society’s members attending a variety of patients. Through a working group consensus, it was decided that Part 1 would present conventional descriptions and Part 2 would pose clinical questions (CQs) in a systematic review format. Thus, Part 1 vastly covers PD that would satisfy the requirements of the members of the Japanese Society for Dialysis Therapy (JSDT). This article is the duplicated publication from the Japanese version of the guidelines and has been reproduced with permission from the JSDT.

Multiple sclerosis is a complex, autoimmune-mediated disease of the central nervous system characterized by inflammatory demyelination and axonal/neuronal damage. The approval of various disease-modifying therapies and our increased understanding of disease mechanisms and evolution in recent years have significantly changed the prognosis and course of the disease. This update of the Multiple Sclerosis Therapy Consensus Group treatment recommendation focuses on the most important recommendations for disease-modifying therapies of multiple sclerosis in 2021. Our recommendations are based on current scientific evidence and apply to those medications approved in wide parts of Europe, particularly German-speaking countries (Germany, Austria, Switzerland).Die Multiple Sklerose ist eine komplexe, autoimmun vermittelte Erkrankung des zentralen Nervensystems, charakterisiert durch inflammatorische Demyelinisierung sowie axonalen/neuronalen Schaden. Die Zulassung verschiedener verlaufsmodifizierender Therapien und unser verbessertes Verständnis der Krankheitsmechanismen und -entwicklung in den letzten Jahren haben die Prognose und den Verlauf der Erkrankung deutlich verändert. Diese Aktualisierung der Behandlungsempfehlung der Multiple Sklerose Therapie Konsensus Gruppe konzentriert sich auf die wichtigsten Empfehlungen für verlaufsmodifizierende Therapien der Multiplen Sklerose im Jahr 2021. Unsere Empfehlungen basieren auf aktuellen wissenschaftlichen Erkenntnissen und gelten für diejenigen Medikamente, die in weiten Teilen Europas, insbesondere in den deutschsprachigen Ländern (Deutschland, Österreich, Schweiz), zugelassen sind.

Simple Summary Although secondary enucleation (SE) is the treatment of choice for retinoblastoma eyes that did not respond favorably to conservative therapies, clear criteria for its indication are, however, currently missing. In this position paper on behalf of the European Retinoblastoma Group (EURbG), we discuss the available literature on SE, including its influence on metastases rate and survival, and propose guidelines to assist decision-making to interrupt eye-preserving therapies depending on the availabilities of advanced diagnostic and therapeutic modalities. Absolute indications to SE may be restricted to eyes with refractory tumor activity resisting all salvage treatments or eyes under apparent tumor control but no visual potential and irreducible complications. In contrast, eyes with an obscured optic nerve head and/or ocular complications amenable to specific surgical or medical management can be considered relative indications, provided that appropriate follow-up can be implemented and that parents are fully aware of a residual risk. Abstract Secondary enucleation (SE) puts an irreversible end to eye-preserving therapies, whenever their prolongation is expected to violate the presumed state of metastatic grace. At present, it must be acknowledged that clear criteria for SE are missing, leading to empiric and subjective indications commonly related to disease progression or relapse, disease persistence masking the optic nerve head or treatment-related complications obscuring the fundus view. This absence of evidence-based consensus regarding SE is explained by the continuously moving frontiers of the conservative management as a result of diagnostic and therapeutic advances, as well as by the lack of studies sufficiently powered to accurately stratify the risk of metastasis in conservatively treated patients. In this position paper of the European Retinoblastoma Group (EURbG), we give an overview of the progressive shift in the indications for SE over the past decades and propose guidelines to assist decision-making with respect to when SE becomes imperative or recommended, with corresponding absolute and relative SE indications. Further studies and validation of biologic markers correlated with the risk of metastasis are expected to set more precisely the frontiers of conservative management and thus consensual criteria for SE in the future.

The cardiovascular system is significantly affected in coronavirus disease-19 (COVID-19). Microvascular injury, endothelial dysfunction, and thrombosis resulting from viral infection or indirectly related to the intense systemic inflammatory and immune responses are characteristic features of severe COVID-19. Pre-existing cardiovascular disease and viral load are linked to myocardial injury and worse outcomes. The vascular response to cytokine production and the interaction between severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and angiotensin-converting enzyme 2 receptor may lead to a significant reduction in cardiac contractility and subsequent myocardial dysfunction. In addition, a considerable proportion of patients who have been infected with SARS-CoV-2 do not fully recover and continue to experience a large number of symptoms and post-acute complications in the absence of a detectable viral infection. This conditions often referred to as ‘post-acute COVID-19’ may have multiple causes. Viral reservoirs or lingering fragments of viral RNA or proteins contribute to the condition. Systemic inflammatory response to COVID-19 has the potential to increase myocardial fibrosis which in turn may impair cardiac remodelling. Here, we summarize the current knowledge of cardiovascular injury and post-acute sequelae of COVID-19. As the pandemic continues and new variants emerge, we can advance our knowledge of the underlying mechanisms only by integrating our understanding of the pathophysiology with the corresponding clinical findings. Identification of new biomarkers of cardiovascular complications, and development of effective treatments for COVID-19 infection are of crucial importance., Graphical Abstract Graphical Abstract

Urine bags are commonly used to collect urine samples from neonates. However, the sample can be contaminated by stool, or detachment of the bag due to body movement can lead to failure of the collection. A qualitative urine collection kit containing ten filter papers of 3.2 mm diameter was developed and clinically verified among 138 neonates. During a single diaper change (approximately 3 h), the rate of urine collection was calculated. Urine collection was considered to be successful if any filter paper in the urine collection sheet turned from blue to white. Of the 127 neonates who passed urine, 122 had a change in the filter paper. The urine collection rate was 96%, with changes in all 10 filter papers observed in 98 neonates (80%). Urine collection rate was not influenced by sex (p = 1.00), age at collection (p = 0.72), preterm birth (p = 1.00), low birth weight (p = 0.92), or fecal contamination (p = 1.00). The incidence of dermatitis was not higher than in the group in which urine bags were used (urine collection kit: 2/68 [3%]; urine bag: 5/68 [7%]; p = 0.44). Novel urine collection kits using filter paper can collect samples from neonates safely and with a high probability of success.

Minimal invasive extracorporeal circulation (MiECC) systems have initiated important efforts within science and technology to further improve the biocompatibility of cardiopulmonary bypass components to minimize the adverse effects and improve end-organ protection. The Minimal invasive Extra-Corporeal Technologies international Society was founded to create an international forum for the exchange of ideas on clinical application and research of minimal invasive extracorporeal circulation technology. The present work is a consensus document developed to standardize the terminology and the definition of minimal invasive extracorporeal circulation technology as well as to provide recommendations for the clinical practice. The goal of this manuscript is to promote the use of MiECC systems into clinical practice as a multidisciplinary strategy involving cardiac surgeons, anaesthesiologists and perfusionists.

International audience; Button batteries (BB) remain a health hazard to children as ingestion might lead to life-threatening complications, especially if the battery is impacted in the esophagus. Worldwide initiatives have been set up in order to prevent and also timely diagnose and manage BB ingestions. A European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) task force for BB ingestions has been founded, which aimed to contribute to reducing the health risks related to this event. It is important to focus on the European setting, next to other worldwide initiatives, to develop and implement effective management strategies. As one of the first initiatives of the ESPGHAN task force, this ESPGHAN position paper has been written. The literature is summarized, and prevention strategies are discussed focusing on some controversial topics. An algorithm for the diagnosis and management of BB ingestions is presented and compared to previous guidelines (NASPGHAN, National Poison Center). In agreement with earlier guidelines, immediate localization of the BB is important and in case of esophageal impaction, the BB should be removed instantly (preferably 12 hours after ingestion or time point of removal >12 hours after ingestion) and esophageal impaction the guideline suggests to perform a CT scan in order to evaluate for vascular injury before removing the battery. In delayed diagnosis, even if the battery has passed the esophagus, endoscopy to screen for esophageal damage and a CT scan to rule out vascular injury should be considered even in asymptomatic children. In asymptomatic patients with early diagnosis (

Cardiovascular (CV) engagement in coronavirus disease 2019 (COVID‐19) is a huge determinant of prognosis during the acute phase of the disease. However, little is known about the potential chronic implications of the late phase of COVID‐19 and about the appropriate approach to these patients. Heart failure, type 1 and type 2 myocardial infarction, arrhythmias, myocarditis, pulmonary fibrosis, and thrombosis have been shown to be related to severe acute respiratory syndrome coronavirus 2 infection, and a ‘long COVID‐19’ illness has been recognized with fatigue, chest pain, and dyspnoea among the most frequent symptoms reported after discharge from hospital. This paper focuses on some open questions that cardiologists are going to face during the next months in a general cardiology outpatient clinic, in particular how to evaluate a ‘post‐COVID’ patient during follow‐up of CV complications of the acute phase and how to manage new CV symptoms that could be the consequence, at least in part, of heart/vessels and/or lung involvement of the previous virus infection. Present symptoms and signs, history of previous CV disease (both preceding COVID‐19 and occurring during viral infection), and specific laboratory and imaging measurements during the acute phase may be of interest in focusing on how to approach the clinical evaluation of a post‐COVID patient and how to integrate in our standard of care the new information on COVID‐19, possibly in a multidisciplinary view. Dealing with the increased COVID‐associated CV risk burden and becoming acquainted with potential new e‐cardiology approaches aimed at integrating the cardiology practice are relevant new challenges brought by severe acute respiratory syndrome coronavirus 2 infection and its sequelae.

International audience; Multidisciplinary management of worsening heart failure (HF) in the elderly improves survival. To ensure patients have access to adequate care, the current HF and French health authority guidelines advise establishing a clearly defined HF patient pathway. This pathway involves coordinating multiple disciplines to manage decompensating HF. Yet, recent registry data indicate that insufficient numbers of patients receive specialised cardiology care, which increases the risk of rehospitalisation and mortality. The patient pathway in France involves three key stages: presentation with decompensated HF, stabilisation within a hospital setting and transitional care back out into the community. In each of these three phases, HF diagnosis, severity and precipitating factors need to be promptly identified and managed. This is particularly pertinent in older, frail patients who may present with atypical symptoms or coexisting comorbidities and for whom geriatric evaluation may be needed or specific geriatric syndrome management implemented. In the transition phase, multi-professional post-discharge management must be coordinated with community health care professionals. When the patient is discharged, HF medication must be optimised, and patients educated about self-care and monitoring symptoms. This review provides practical guidance to clinicians managing worsening HF in the elderly.

Background One year after the declaration of the coronavirus disease 2019 (COVID-19) pandemic by the World Health Organization (WHO) and despite the implementation of mandatory physical barriers and social distancing, humanity remains challenged by a long-lasting and devastating public health crisis. Management Non-pharmacological interventions (NPIs) are efficient mitigation strategies. The success of these NPIs is dependent on the approval and commitment of the population. The launch of a mass vaccination program in many countries in late December 2020 with mRNA vaccines, adenovirus-based vaccines, and inactivated virus vaccines has generated hope for the end of the pandemic. Current Issues The continuous appearance of new pathogenic viral strains and the ability of vaccines to prevent infection and transmission raise important concerns as we try to achieve community immunity against severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) and its variants. The need of a second and even third generation of vaccines has already been acknowledged by the WHO and governments. Perspectives There is a critical and urgent need for a balanced and integrated strategy for the management of the COVID-19 outbreaks organized on three axes: (1) Prevention of the SARS-CoV-2 infection, (2) Detection and early diagnosis of patients at risk of disease worsening, and (3) Anticipation of medical care (PDA). Conclusion The “PDA strategy” integrated into state policy for the support and expansion of health systems and introduction of digital organizations (i.e., telemedicine, e-Health, artificial intelligence, and machine-learning technology) is of major importance for the preservation of citizens' health and life world-wide.

AimsTo highlight the need for the development of effective and realistic workforce strategies for critical care nurses, in both a steady state and pandemic.BackgroundIn acute care settings, there is an inverse relationship between nurse staffing and iatrogenesis, including mortality. Despite this, there remains a lack of consensus on how to determine safe staffing levels. Intensive care units (ICU) provide highly specialised complex healthcare treatments. In developed countries, mortality rates in the ICU setting are high and significantly varied after adjustment for diagnosis. The variability has been attributed to systems, patient and provider issues including the workload of critical care nurses.DesignDiscursive paper.FindingsNursing workforce is the single most influential mediating variable on ICU patient outcomes. Numerous systematic reviews have been undertaken in an effort to quantify the effect of critical care nurses on mortality and morbidity, invariably leading to the conclusion that the association is similar to that reported in acute care studies. This is a consequence of methodological limitations, inconsistent operational definitions and variability in endpoint measures. We evaluated the impact inadequate measurement has had on capturing relevant critical care data, and we argue for the need to develop effective and realistic ICU workforce measures.ConclusionCOVID-19 has placed an unprecedented demand on providing health care in the ICU. Mortality associated with ICU admission has been startling during the pandemic. While ICU systems have largely remained static, the context in which care is provided is profoundly dynamic and the role and impact of the critical care nurse needs to be measured accordingly. Often, nurses are passive recipients of unplanned and under-resourced changes to workload, and this has been brought into stark visibility with the current COVID-19 situation. Unless critical care nurses are engaged in systems management, achieving consistently optimal ICU patient outcomes will remain elusive.Relevance to clinical practiceObjective measures commonly fail to capture the complexity of the critical care nurses' role despite evidence to indicate that as workload increases so does risk of patient mortality, job stress and attrition. Critical care nurses must lead system change to develop and evaluate valid and reliable workforce measures.

Objective The aim of the study was to determine the response rate to a mixed-mode survey using email compared with that to a paper survey in survivors of critical illness. Design This is a prospective randomised controlled trial. Setting The study was conducted at a single-centre quaternary intensive care unit (ICU) in Adelaide, Australia. Participants Study participants were patients admitted to the ICU for ≥48 h and discharged from the hospital. Interventions The participants were randomised to receive a survey by paper (via mail) or via online (via email, or if a non-email user, via a letter with a website address). Patients who did not respond to the initial survey received a reminder paper survey after 14 days. The survey included quality of life (EuroQol-5D-5L), anxiety and depression (Hospital Anxiety and Depression Scale), and post-traumatic symptom (Impact of Event Scale-Revised) assessment. Main outcome measures Survey response rate, extent of survey completion, clinical outcomes at different time points after discharge, and survey cost analysis were the main outcome measures. Outcomes were stratified based on follow-up time after ICU discharge (3, 6, and 12 months). Results A total of 239 patients were randomised. The response rate was similar between the groups (mixed-mode: 78% [92/118 patients] vs. paper: 80% [97/121 patients], p = 0.751) and did not differ between time points of follow-up. Incomplete surveys were more prevalent in the paper group (10% vs 18%). The median EuroQol-5D-5L index value was 0.83 [0.71–0.92]. Depressive symptoms were reported by 25% of patients (46/187), anxiety symptoms were reported by 27% (50/187), and probable post-traumatic stress disorder was reported by 14% (25/184). Patient outcomes did not differ between the groups or time points of follow-up. The cost per reply was AU$ 16.60 (mixed-mode) vs AU$ 19.78 (paper). Conclusion The response rate of a mixed-mode survey is similar to that of a paper survey and may provide modest cost savings.

Despite years of study, controversy remains regarding the optimal graft for anterior cruciate ligament reconstruction (ACLR), suggesting that a single graft type is not ideal for all patients. A large community based ACLR Registry that collects prospective data is a powerful tool that captures information and can be analyzed to optimize surgery for individual patients. The studies highlighted in this paper were designed to optimize and individualize ACLR surgery and have led to changes in surgeon behavior and improvements in patient outcomes. Kaiser Permanente (KP) is an integrated health care system with 10.6 million members and more than 50 hospitals. Every KP member who undergoes an ACLR is entered into the Registry, and prospectively monitored. The Registry uses a variety of feedback mechanisms to disseminate Registry findings to the ACLRR surgeons and appropriately influence clinical practices and enhance quality of care. Allografts were found to have a 3.0 times higher risk of revision than bone-patellar tendon-bone (BPTB) autografts. Allograft irradiation >1.8 Mrad, chemical graft processing, younger patients, BPTB allograft, and male patients were all associated with a higher risk of revision surgery. By providing feedback to surgeons, overall allograft use has decreased by 27% and allograft use in high-risk patients ≤21 years of age decreased 68%. We have identified factors that influence the outcomes of ACLR. Statement of Clinical Significance: We found that information derived from an ACLR Registry and shared with the participating surgeons directly decreased the use of specific procedures and implants associated with poor outcomes.

Introduction: Although calcium pyrophosphate deposition (CPPD) is common, there are no published outcome domains or validated measurement instruments for CPPD studies. In this paper, we describe the framework for development of the Outcome Measures in Rheumatology (OMERACT) CPPD Core Domain Sets. Methods: The OMERACT CPPD working group performed a scoping literature review and qualitative interview study. Generated outcomes were presented at the 2020 OMERACT CPPD virtual Special Interest Group (SIG) meeting with discussion focused on whether different core domain sets should be developed for different calcium pyrophosphate deposition (CPPD) clinical presentations and how the future CPPD Core Domain Set may overlap with already established osteoarthritis (OA) domains. These discussions informed development of a future work plan for development of the OMERACT CPPD Core Domain Sets. Findings: Domains identified from a scoping review of 112 studies and a qualitative interview study of 36 people (28 patients with CPPD, 7 health care professionals, one stakeholder) were mapped to core areas of OMERACT Filter 2.1. The majority of SIG participants agreed there was need to develop separate core domain sets for "short term" and "long term" studies of CPPD. Although CPPD + OA is common and core domain sets for OA have been established, participants agreed that existing OA core domain sets should not influence the development of OMERACT core domain sets for CPPD. Prioritization exercises (using Delphi methodology) will consider 40 potential domains for short term studies of CPPD and 47 potential domains for long term studies of CPPD. Conclusion: Separate OMERACT CPPD Core Domain Sets will be developed for "short term" studies for an individ-ual flare of acute CPP crystal arthritis and for "long term" studies that may include participants with any clinical presentation of CPPD (acute CPP crystal arthritis, chronic CPP crystal inflammatory arthritis, and/or CPPD + OA). (c) 2021 Elsevier Inc. All rights reserved.

IntroductionFront-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.Methods and analysisStudy areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.Ethics and disseminationEthics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.Trial registration numberPACTR201904664660639; Pre-results.

The early diagnosis of active hepatitis C virus (HCV) infection remains a significant barrier to the treatment of the disease and to preventing the associated significant morbidity and mortality seen, worldwide. Current testing is delayed due to the high cost, long turnaround times and high expertise needed in centralised diagnostic laboratories. Here we demonstrate a user-friendly, low-cost pan-genotypic assay, based upon reverse transcriptase loop mediated isothermal amplification (RT-LAMP). We developed a prototype device for point-of-care use, comprising a LAMP amplification chamber and lateral flow nucleic acid detection strips, giving a visually-read, user-friendly result in, Current HCV nucleic acid-based diagnosis is largely performed in centralised laboratories. Here, the authors present a pan-genotypic RNA assay, based on reverse transcriptase loop mediated isothermal amplification and develop a low-cost prototype paper-based lateral flow device for point-of-care use, providing a visually read result within 40 min.

Background\ud \ud Food anaphylaxis is commonly elicited by unintentional ingestion of foods containing the allergen above the tolerance threshold level of the individual. While labeling the 14 main allergens used as ingredients in food products is mandatory in the EU, there is no legal definition of declaring potential contaminants. Precautionary allergen labeling such as “may contain traces of” is often used. However, this is unsatisfactory for consumers as they get no information if the contamination is below their personal threshold. In discussions with the food industry and technologists, it was suggested to use a voluntary declaration indicating that all declared contaminants are below a threshold of 0.5 mg protein per 100 g of food. This concentration is known to be below the threshold of most patients, and it can be technically guaranteed in most food production. However, it was also important to assess that in case of accidental ingestion of contaminants below this threshold by highly allergic patients, no fatal anaphylactic reaction could occur. Therefore, we performed a systematic review to assess whether a fatal reaction to 5mg of protein or less has been reported, assuming that a maximum portion size of 1kg of a processed food exceeds any meal and thus gives a sufficient safety margin.\ud \ud \ud \ud Methods\ud \ud MEDLINE and EMBASE were searched until 24 January 2021 for provocation studies and case reports in which one of the 14 major food allergens was reported to elicit fatal or life-threatening anaphylactic reactions and assessed if these occurred below the ingestion of 5mg of protein. A Delphi process was performed to obtain an expert consensus on the results.\ud \ud \ud \ud Results\ud \ud In the 210 studies included, in our search, no reports of fatal anaphylactic reactions reported below 5 mg protein ingested were identified. However, in provocation studies and case reports, severe reactions below 5 mg were reported for the following allergens: eggs, fish, lupin, milk, nuts, peanuts, soy, and sesame seeds.\ud \ud \ud \ud Conclusion\ud \ud Based on the literature studied for this review, it can be stated that cross-contamination of the 14 major food allergens below 0.5 mg/100 g is likely not to endanger most food allergic patients when a standard portion of food is consumed. We propose to use the statement “this product contains the named allergens in the list of ingredients, it may contain traces of other contaminations (to be named, e.g. nut) at concentrations less than 0.5 mg per 100 g of this product” for a voluntary declaration on processed food packages. This level of avoidance of cross-contaminations can be achieved technically for most processed foods, and the statement would be a clear and helpful message to the consumers. However, it is clearly acknowledged that a voluntary declaration is only a first step to a legally binding solution. For this, further research on threshold levels is encouraged.

In 1996, when I was prescribed an antidepressant, there was already published research that showed selective serotonin reuptake inhibitors (SSRIs), commonly known as antidepressants, caused withdrawal effects.1 However, at that time, the Defeat Depression campaign had successfully created a narrative adopted by most prescribers, in which anxiety or depression were described to the patient as caused by a ‘chemical imbalance in the brain’ and that SSRIs were safe, effective, and non-addictive. Why would a doctor feel the need to do a full literature review? Today the word is out that my experience of attempting repeatedly to stop taking the drug and experiencing increasingly severe withdrawal effects is by no means uncommon. We now know a drug can cause dependence without causing addiction. Dependence is simply the physiological consequence of taking a drug that causes the body (especially the brain and central nervous system) to change its structure and functioning in response to the ongoing presence of the drug — for example, an antidepressant. The Public Health England (PHE) report Dependence and withdrawal associated with some prescribed medicines. An evidence review , published in 2019,2 established that 25% of adults in England were taking a dependence-forming drug. This led to the Royal College of Psychiatrists publishing a new position statement on antidepressant withdrawal, identifying it as potentially ‘severe and long-lasting’ , and something that patients should be made aware of during informed consent for these medications.3 As a busy GP, should you wish to learn more through reading current research, which papers give you the best insight into …

Background: \ud Nutrition related publications in pediatric population cover wide range of topics and therefore it is usually difficult for clinicians to get an overview of recent nutrition related guidelines or recommendations.\ud \ud Methods: \ud The Special Interest Group (SIG) of Pediatrics of European Society for Clinical Nutrition and Metabolism (ESPEN) performed a literature search to capture publications in the last five years aiming to provide the latest information concerning nutritional issues in children in general and in specific diseases and to discuss progression in the field of pediatric nutrition evidence-based practice.\ud \ud Results: \ud Eight major topics were identified as the most frequently reported including allergy, critical illness, neonatal nutrition, parenteral and enteral nutrition, micronutrients, probiotics and malnutrition. Furthermore, it was noted that many reports were disease focused or included micronutrients and were, therefore, represented as tables.\ud \ud Conclusion: \ud Overall, it has been shown that most reports on nutrition topics in pediatrics were systematic reviews or guidelines/position papers of relevant societies, but many of them basing the conclusion on a limited number of high-quality randomized controlled trials or large observational cohort studies.

Transfluthrin is a fast-acting insecticide used in household and hygiene products, mainly against flying insects, such as mosquito and flies, and in agriculture material pests. Its uses in these areas have not been without health risk to humans and the ecosystem. Therefore, the current study was designed to investigate the effect of smoke emanating from Transfluthrin Coated Insecticide Paper (TCIP) on adult Wistar rats’ testicular functions. The rats were grouped into three. Group A was exposed to normal environmental air. Group B and C rats were exposed via whole-body inhalation to smoke emanating from 6 g and 12 g of TCIP every day for 8 weeks. The entire groups contained eight rats each. At the end of the exposure, body and organs weight, semen analysis, biochemical assay and histological examination were evaluated and determined. The results show that the exposure significantly altered the testicular cytoarchitecture, sperm quality, hormonal profile and oxidative parameters with an increase in exposure to TCIP. This study revealed that exposure to transfluthrin is detrimental to the reproductive functions of male rats.

During the COVID-19 pandemic, parents with sick or premature babies have faced challenges following admission to a neonatal unit due to the imposed lock-down restrictions on social contact, hospital visitation and the wearing of personal protective equipment. The negative short-term impact on neonatal care in relation to the prevention of close proximity, contact and bonding between parents and babies is potentially significant. However, an interesting finding has been reported of a reduction in premature birth admissions to the neonatal intensive care unit during the pandemic, raising important questions. Why was this? Was it related to the effect of the modifiable risk-factors for premature birth? This discussion paper focuses on an exploration of these factors in the light of the potential impact of COVID-19 restrictions on neonatal care. After contextualising both the effect of premature birth and the pandemic on neonatal and parental short-term outcomes, the discussion turns to the modifiable risk-factors for premature birth and makes recommendations relevant to the education, advice and care given to expectant mothers.

The management of breast cancer has evolved into a multidisciplinary evidence-based surgical speciality, with emphasis on conservative surgery. A number of landmark trials have established lumpectomy followed by radiation as the standard of care for many patients. The aim of this study is to construct a narrative review of recent developments in the surgical management of breast cancer and how such developments have impacted surgical practice. A comprehensive literature search of Pubmed was conducted. The latest search was performed on October 31st, 2020. Search terms “breast cancer” were used in combinations with specific key words and Boolean operators relating to surgical management. The reference lists of retrieved articles were comprehensively screened for additional eligible publications. Articles were selected and reviewed based on relevance. We selected publications in the past 10 years but did not exclude commonly referenced and highly regarded previous publications. Review articles and book chapters were also cited to provide reference on details not discussed in the academic literature. This article reviews the current evidence in surgical management of early-stage breast cancer, discusses recent trends in surgical practice for therapeutic and prophylactic procedures and provides commentary on implications and factors associated with these trends.

Background Near-patient access to appropriate tests is a major obstacle for the efficient diagnosis of tuberculosis (TB) and associated drug resistance. Methods We recently developed the “TB Concentration & Transport” kit for bio-safe, ambient-temperature transportation of dried sputum on Trans-Filter, and the “TB DNA Extraction” kit for DNA extraction from Trans-Filter for determining drug resistance by DNA sequencing. In the present study, we evaluated the compatibility of Kit-extracted DNA with Hain's line probe assays (LPAs), which are endorsed by National TB programmes for the detection of drug resistance in sputum collected from presumptive multidrug-resistant TB patients (n=207). Results Trans-Filter-extracted DNA was seamlessly integrated with the LPA protocol (Kit-LPA). The sensitivity of Kit-LPA for determining drug resistance was 83.3% for rifampicin (95% CI 52–98%), 77.7% for isoniazid (95% CI 52–94%), 85.7% for fluoroquinolones (95% CI 42–100%) and 66.6% for aminoglycosides (95% CI 9–99%), with a specificity range of 93.7% (95% CI 87–97) to 99.1% (95% CI 95–100) using phenotypic drug susceptibility testing (DST) as a reference standard. A high degree of concordance was noted between results obtained from Kit-LPA and LPA (99% to 100% (κ value: 0.83–1.0)). Conclusions This study demonstrates successful integration of our developed kits with LPA. The adoption of these kits across Designated Microscopy Centres in India can potentially overcome the existing challenge of transporting infectious sputum at controlled temperature to centralised testing laboratories and can provide rapid near-patient cost-effective “Universal DST” services to TB subjects residing in remote areas., The adoption of bio-safe “TB Concentration & Transport” kit by Microscopy Centres can potentially overcome the challenge of transporting infectious sputum to central laboratories and provide universal DST services to TB subjects residing in remote areas. https://bit.ly/2QrQ5qL

Breast cancer is increasingly prevalent in older adults and is a substantial part of routine oncology practice. However, management of breast cancer in this population is challenging because the disease is highly heterogeneous and there is insufficient evidence specific to older adults. Decision making should not be driven by age alone but should involve geriatric assessments plus careful consideration of life expectancy, competing risks of mortality, and patient preferences. A multidisciplinary taskforce, including members of the European Society of Breast Cancer Specialists and International Society of Geriatric Oncology, gathered to expand and update the previous 2012 evidence-based recommendations for the management of breast cancer in older individuals with the endorsement of the European Cancer Organisation. These guidelines were expanded to include chemotherapy toxicity prediction calculators, cultural and social considerations, surveillance imaging, genetic screening, gene expression profiles, neoadjuvant systemic treatment options, bone-modifying drugs, targeted therapies, and supportive care. Recommendations on geriatric assessment, ductal carcinoma in situ, screening, primary endocrine therapy, surgery, radiotherapy, adjuvant systemic therapy, and secondary breast cancer were updated.

The increasing chronicity and multimorbidities associated with people living with HIV have posed important challenges to health systems across the world. In this context, payment models hold the potential to improve care across a spectrum of clinical conditions. This study aims to systematically review the evidence of HIV performance-based payments models. Literature searches were conducted in March 2020 using multiple databases and manual searches of relevant papers. Papers were limited to any study design that considers the real-world utilisation of performance-based payment models applied to the HIV domain. A total of 23 full-text papers were included. Due to the heterogeneity of study designs, the multiple types of interventions and its implementation across distinct areas of HIV care, direct comparisons between studies were deemed unsuitable. Most evidence focused on healthcare users (83%), seeking to directly affect patients' behaviour based on principles of behavioural economics. Despite the variability between interventions, the implementation of performance-based payment models led to either a neutral or positive impact throughout the HIV care continuum. Moreover, this improvement was likely to be cost-effective or, at least, did not compromise the healthcare system's financial sustainability. However, more research is needed to assess the durability of incentives and its appropriate relative magnitude.La creciente cronicidad y multimorbilidades asociadas con las personas que viven con el VIH han planteado importantes desafíos para los sistemas de salud en todo el mundo. En este contexto, los modelos de pago tienen el potencial de mejorar la atención en un espectro de condiciones clínicas. Este estudio tiene como objetivo revisar sistemáticamente la evidencia de los modelos de pagos basados ​​en el desempeño aplicados al dominio del VIH. Las búsquedas bibliográficas se realizaron en marzo de 2020 utilizando múltiples bases de datos y búsquedas manuales de artículos relevantes. Los artículos se limitaron a cualquier diseño de estudio que considere la utilización en el mundo real de modelos de pago basados ​​en el desempeño aplicados al dominio del VIH. Se incluyeron un total de 23 artículos de texto completo. Debido a la heterogeneidad de los diseños de los estudios, los múltiples tipos de intervenciones y su implementación en distintas áreas de la atención del VIH, las comparaciones directas entre diferentes estudios se consideraron inadecuadas. La mayoría de la evidencia se centró en los usuarios de la salud (83%), buscando afectar directamente el comportamiento de los pacientes basándose en los principios de la economía del comportamiento. A pesar de la variabilidad entre las intervenciones, la implementación de modelos de pago basados ​​en el desempeño generó un impacto neutral o positivo en todo el proceso de atención del VIH. Además, es probable que esta mejora sea costo-efectiva o, al menos, no comprometa la sostenibilidad financiera del sistema de salud. Sin embargo, se necesita más investigación para evaluar la durabilidad de los incentivos y su magnitud relativa apropiada.

Objective: To develop a predictive model for identifying patients at high risk of all-cause unplanned readmission within 30 days after discharge, using administrative data available before discharge. Materials and methods: Hospital administrative data of all adult admissions in three tertiary metropolitan hospitals in Australia between July 01, 2015, and July 31, 2016, were extracted. Predictive performance of four mixed-effect multivariable logistic regression models was compared and validated using a split-sample design. Diagnostic details (Charlson Comorbidity Index CCI, components of CCI, and primary diagnosis categorised into International Classification of Diseases chapters) were added gradually in the clinically simplified model with socio-demographic, index admission, and prior hospital utilisation variables. Results: Of the total 99 470 patients admitted, 5796 (5.8%) were re-admitted through the emergency department of three hospitals within 30 days after discharge. The clinically simplified model was as discriminative (C-statistic 0.694, 95% CI [0.681-0.706]) as other models and showed excellent calibration. Models with diagnostic details did not exhibit any substantial improvement in predicting 30-days unplanned readmission. Conclusion: We propose a 10-item predictive model to flag high-risk patients in a diverse population before discharge using readily available hospital administrative data which can easily be integrated into the hospital information system.

© The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/, Purpose: Fluid management is challenging in malaria patients given the risks associated with intravascular fluid depletion and iatrogenic fluid overload leading to pulmonary oedema. Given the limitations of the physical examination in guiding fluid therapy, we evaluated point-of-care ultrasound (POCUS) of the inferior vena cava (IVC) and lungs as a novel tool to assess volume status and detect early oedema in malaria patients. Methods: To assess the correlation between IVC and lung ultrasound (LUS) indices and clinical signs of hypovolaemia and pulmonary oedema, respectively, concurrent clinical and sonographic examinations were performed in an observational study of 48 malaria patients and 62 healthy participants across age groups in Gabon. Results: IVC collapsibility index (CI) ≥ 50% on enrolment reflecting intravascular fluid depletion was associated with an increased number of clinical signs of hypovolaemia in severe and uncomplicated malaria. With exception of dry mucous membranes, IVC-CI correlated with most clinical signs of hypovolaemia, most notably sunken eyes (r = 0.35, p = 0.0001) and prolonged capillary refill (r = 0.35, p = 0.001). IVC-to-aorta ratio ≤ 0.8 was not associated with any clinical signs of hypovolaemia on enrolment. Among malaria patients, a B-pattern on enrolment reflecting interstitial fluid was associated with dyspnoea (p = 0.0003), crepitations and SpO2 ≤ 94% (both p < 0.0001), but not tachypnoea (p = 0.069). Severe malaria patients had increased IVC-CI (p < 0.0001) and more B-patterns (p = 0.004) on enrolment relative to uncomplicated malaria and controls. Conclusion: In malaria patients, POCUS of the IVC and lungs may improve the assessment of volume status and detect early oedema, which could help to manage fluids in these patients.

Social isolation has been suggested to foster paranoia. Here we investigate whether social company (i.e., being alone vs. not) and its nature (i.e., stranger/distant vs. familiar other) affects paranoia differently depending on psychosis risk. Social interactions and paranoid thinking in daily life were investigated in 29 patients with clinically stable non-affective psychotic disorders, 20 first-degree relatives, and 26 controls (n = 75), using the experience sampling method (ESM). ESM was completed up to ten times daily for 1 week. Patients experienced marginally greater paranoia than relatives [b = 0.47, p = 0.08, 95% CI (− 0.06, 1.0)] and significantly greater paranoia than controls [b = 0.55, p = 0.03, 95% CI (0.5, 1.0)], but controls and relatives did not differ [b = 0.07, p = 0.78, 95% CI (− 0.47, 0.61)]. Patients were more often alone [68.5% vs. 44.8% and 56.2%, respectively, p = 0.057] and experienced greater paranoia when alone than when in company [b = 0.11, p = 0.016, 95% CI (0.02, 0.19)]. In relatives this was reversed [b = − 0.17, p b = − 0.02, p = 0.67, 95% CI (− 0.09, 0.06)]. The time-lagged association between being in social company and subsequent paranoia was non-significant and paranoia did not predict the likelihood of being in social company over time (both p’s = 0.68). All groups experienced greater paranoia in company of strangers/distant others than familiar others [X2(2) = 4.56, p = 0.03] and being with familiar others was associated with lower paranoia over time [X2(2) = 4.9, p = 0.03]. Patients are frequently alone. Importantly, social company appears to limit their paranoia, particularly when being with familiar people. The findings stress the importance of interventions that foster social engagement and ties with family and friends.

The COVID-19 pandemic highlights the need for effective infectious disease outbreak prevention. This could entail installing an integrated, international early warning system, aiming to contain and mitigate infectious diseases outbreaks. The amount of resources governments should spend on such preventive measures can be informed by the value citizens attach to such a system. This was already recognized in 2018, when a contingent valuation willingness to pay (WTP) experiment was fielded, eliciting the WTP for such a system in six European countries. We replicated that experiment in the spring of 2020 to test whether and how WTP had changed during an actual pandemic (COVID-19), taking into account differences in infection rates and stringency of measures by government between countries. Overall, we found significant increases in WTP between the two time points, with mean WTP for an early warning system increasing by about 50% (median 30%), from around €20 to €30 per month. However, there were marked differences between countries and subpopulations, and changes were only partially explained by COVID-19 burden. We discuss possible explanations for and implication of our findings. Supplementary Information The online version contains supplementary material available at 10.1007/s10198-021-01353-6.

The aim of this Phase 1/2, 2-part, multicenter trial was to report clinical safety and efficacy of long-term golodirsen treatment among ambulatory patients with exon 53 skip-amenable Duchenne muscular dystrophy (DMD). Part 1 was a 12-week, randomized, double-blind, placebo-controlled, dose-titration study followed by 9-week safety review. Part 2 was a 168-week, open-label evaluation of golodirsen 30 mg/kg. Part 1 primary endpoint was safety. Part 2 primary endpoints were dystrophin protein expression and 6-minute walk test (6MWT); secondary endpoints were percent predicted forced vital capacity (FVC%p) and safety. Post hoc ambulation analyses used mutation-matched external natural history controls. All patients from Part 1 (golodirsen, n = 8; placebo, n = 4) plus 13 additional patients entered Part 2; 23 completed the study. Adverse events were generally mild, nonserious, and unrelated to golodirsen, with no safety-related discontinuations or deaths. Golodirsen increased dystrophin protein (16.0-fold; P

To provide patient-centered care, it is essential to explore what patients consider important and to adjust care accordingly. This may specifically be relevant for patients with complex skin cancer, for whom the care process is often more complicated and psychological and social problems may play a larger role. The objective was to explore the experiences and needs of patients who had undergone surgical treatment by a dermatologist for a complex skin cancer with a subsequent reconstruction by a plastic surgeon. An interview study was conducted among 16 patients who had undergone surgical treatment by a dermatologist and reconstruction by a plastic surgeon for basal cell carcinoma, cutaneous squamous cell carcinoma, or lentigo maligna. The interviews focused on patients’ experiences and needs regarding care using a predefined topic list. All interviews were audio-taped, transcribed verbatim and inductively analyzed using Atlas.ti. Patients reported a need for a skilled and friendly physician who tailors information and communication to their individual situation. A need for continuity of care and improved collaboration between healthcare providers was also emphasized. Furthermore, patients experienced complications and unmet expectations and expressed a need for shared decision-making at various steps throughout the treatment process (depending on age). Patients also considered completeness of tumor removal, follow-up visits with multiple specialists to be planned the same day and recognition of the psychological impact of the disease on the partner important. To improve patient-centered care for complex skin cancer patients, more efforts should be directed towards improving continuity of care and collaboration. Furthermore, it is advocated for physicians to be sensitive to the individual needs of patients and their partner and adjust information, communication and (supportive) care accordingly.

BACKGROUND AND PURPOSE Skeletal muscle dysfunction is a major comorbidity of chronic obstructive pulmonary disease (COPD). This type of muscle dysfunction may be a direct consequence of oxidative insults evoked by cigarette smoke (CS) exposure. The present study examined the effects of a potent Nox inhibitor and reactive oxygen species (ROS) scavenger, apocynin, on CS-induced muscle dysfunction. EXPERIMENTAL APPROACH Male BALB/c mice were exposed to either room air (sham) or CS generated from nine cigarettes per day, 5 days a week for 8 weeks, with or without the coadministration of apocynin (5 mg·kg-1 , i.p.). C2C12 myotubes exposed to either hydrogen peroxide (H2 O2 ) or water-soluble cigarette smoke extract (CSE) with or without apocynin (500 nM) were used as an experimental model in vitro. KEY RESULTS Eight weeks of CS exposure caused muscle dysfunction in mice, reflected by 10% loss of muscle mass and 54% loss of strength of tibialis anterior which were prevented by apocynin administration. In C2C12 myotubes, direct exposure to H2 O2 or CSE caused myofibre wasting, accompanied by ~50% loss of muscle-derived insulin-like growth factor (IGF)-1 and two-fold induction of Cybb, independent of cellular inflammation. Expression of myostatin and MAFbx, negative regulators of muscle mass, were up-regulated under H2 O2 but not CSE conditions. Apocynin treatment abolished CSE-induced Cybb expression, preserving muscle-derived IGF-1 expression and signalling pathway downstream of mammalian target of rapamycin (mTOR), thereby preventing myofibre wasting. CONCLUSION AND IMPLICATIONS Targeted pharmacological inhibition of Nox-derived ROS may alleviate the lung and systemic manifestations in smokers with COPD.

Background Patients need medication and medical condition‐related information to better self‐manage their health. Health‐care professionals (HCPs) should be able to actively provide information outside of one‐on‐one consultations; however, patient consent may be required. Objective To investigate the Australian public's preferences, and factors that may influence their preferences, towards an opt‐in versus an opt‐out approach to health communication. Design A cross‐sectional study using a structured questionnaire administered via Computer‐Assisted Telephone Interviewing. Setting and participants Participants across Australia who were adults, English‐speaking and had a long‐term medical condition. Main outcome measures Preferences for opt‐in vs opt‐out approach to receiving follow‐up tailored information. Results A total of 8683 calls were made to achieve the required sample size of 589 completed surveys. Many (346/589; 58.7%) indicated that they were interested in receiving tailored, ongoing follow‐up information from their HCP. Nearly half (n = 281; 47.7%) preferred an opt‐in service and 293/589 (49.7%) an opt‐out service for receiving follow‐up information. Reasons for preferring an opt‐in service were being in control of the information received (n = 254); able to make a decision that is best for them (n = 245); opt‐in service would save time for HCPs (n = 217); they may not want or need the information (n = 240). Many (n = 255) felt that an opt‐out service should be part of the normal duty of care of their HCP and believed (n = 267) that this approach would ensure that everyone has access to information. Conclusions Respondents were interested in receiving tailored information outside of consultation times. However, preferences for an opt‐in or opt‐out approach were divided.

Summary Acute Myeloid Leukaemia (AML) is a rare but serious group of diseases that require critical decision-making for curative treatment. Over the past decade, scientific discovery has revealed dozens of prognostic gene mutations for AML while sequencing costs have plummeted. In this study, we compared the cost-effectiveness of multigene integrative analysis (genomic analysis) with the standard molecular testing currently used for diagnosis of intermediate-risk AML. We used a decision analytic model with data for costs and outcomes from British Columbia, Canada, to assess the long-term (10-year) economic impacts. Our results suggest that genomic analysis would result in a 26% increase in the use of first-remission allogeneic stem cell transplantation. The resulting treatment decisions and downstream effects would come at an additional cost of $12 556 [2013 Canadian dollars (CAD)] per person and the incremental cost-effectiveness ratio would be $49 493 per quality-adjusted life-year gained. Cost-effectiveness was dependent on quality of life during the long-term (5–10) years of survival, relapse rates following first-remission chemotherapy and the upfront cost of transplantation. Non-relapse mortality rates, short-term quality of life and the cost of genomic sequencing had only minor impacts. Further research on post-remission outcomes can lead to improvements in the cost-effectiveness of curative treatments for AML.

Aims To assess differences in long-term outcome and functional status of patients with cardiogenic shock (CS) treated by percutaneous mechanical circulatory support (pMCS) and intra-aortic balloon pump (IABP). Methods and results Long-term follow-up of the multicentre, randomized IMPRESS in Severe Shock trial (NTR3450) was performed 5-year after initial randomization. Between 2012 and 2015, a total of 48 patients with severe CS from acute myocardial infarction (AMI) with ST-segment elevation undergoing immediate revascularization were randomized to pMCS by Impella CP (n = 24) or IABP (n = 24). For the 5-year assessment, all-cause mortality, functional status, and occurrence of major adverse cardiac and cerebrovascular event (MACCE) were assessed. MACCE consisted of death, myocardial re-infarction, repeat percutaneous coronary intervention, coronary artery bypass grafting, and stroke. Five-year mortality was 50% (n = 12/24) in pMCS patients and 63% (n = 15/24) in IABP patients (relative risk 0.87, 95% confidence interval 0.47–1.59, P = 0.65). MACCE occurred in 12/24 (50%) of the pMCS patients vs. 19/24 (79%) of the IABP patients (P = 0.07). All survivors except for one were in New York Heart Association Class I/II [pMCS n = 10 (91%) and IABP n = 7 (100%), P = 1.00] and none of the patients had residual angina. There were no differences in left ventricular ejection fraction between the groups (pMCS 52 ± 11% vs. IABP 48 ± 10%, P = 0.53). Conclusions In this explorative randomized trial of patients with severe CS after AMI, there was no difference in long-term 5-year mortality between pMCS and IABP-treated patients, supporting previously published short-term data and in accordance with other long-term CS trials., Graphical Abstract

Objective To compare clinical, sports, work, and radiological outcomes between primary and secondary osteochondral lesions of the talus (OLTs; Design Secondary OLTs were matched to primary OLTs in a 1:2 ratio to assess the primary outcome measure—the Numeric Rating Scale (NRS) during activities. Secondary outcomes included the pre- and 1-year postoperative NRS at rest, American Orthopaedic Foot and Ankle Society score, Foot and Ankle Outcome Score subscales, and the EQ-5D general health questionnaire. The rates and time to return to work and sports were collected. Radiological examinations were performed preoperatively and at final follow-up using computed tomography (CT). Results After matching, 22 and 12 patients with small (Conclusion No differences in outcomes were observed between arthroscopic bone marrow stimulation in primary and secondary OLTs at 1-year follow-up. Repeat BMS may therefore be a viable treatment option for failed OLTs in the short term.

Background after hospitalisation for cardiac disease, older patients are at high risk of readmission and death. Objective the cardiac care bridge (CCB) transitional care programme evaluated the impact of combining case management, disease management and home-based cardiac rehabilitation (CR) on hospital readmission and mortality. Design single-blind, randomised clinical trial. Setting the trial was conducted in six hospitals in the Netherlands between June 2017 and March 2020. Community-based nurses and physical therapists continued care post-discharge. Subjects cardiac patients ≥ 70 years were eligible if they were at high risk of functional loss or if they had had an unplanned hospital admission in the previous 6 months. Methods the intervention group received a comprehensive geriatric assessment-based integrated care plan, a face-to-face handover with the community nurse before discharge and follow-up home visits. The community nurse collaborated with a pharmacist and participants received home-based CR from a physical therapist. The primary composite outcome was first all-cause unplanned readmission or mortality at 6 months. Results in total, 306 participants were included. Mean age was 82.4 (standard deviation 6.3), 58% had heart failure and 92% were acutely hospitalised. 67% of the intervention key-elements were delivered. The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI −4.7 to 18%], risk ratios 1.14 [95% CI 0.91–1.42], P = 0.253). The study was discontinued prematurely due to implementation activities in usual care. Conclusion in high-risk older cardiac patients, the CCB programme did not reduce hospital readmission or mortality within 6 months. Trial registration Netherlands Trial Register 6,316, https://www.trialregister.nl/trial/6169

Purpose A large percentage of anterior cruciate ligament (ACL) surgical reconstructions experience sub-optimal outcomes within 2 years. A potential factor contributing to poor outcomes is an incomplete understanding of micro-level, regional ACL biomechanics. This research aimed to demonstrate a minimally invasive method that uses micro-CT imaging to quantify regional ACL strains under clinically relevant joint loading. Methods A pattern of 0.8 mm diameter zirconium dioxide beads were arthroscopically inserted into four regions of the ACL of four cadaveric knee specimens (mean [SD] age = 59 [9] years). A custom micro-CT compatible joint motion simulator then applied clinically relevant joint loading conditions, while an image was acquired at each condition. From the resulting images, strains within each region were calculated using the centroid coordinates of each tissue-embedded bead. Strain repeatability was assessed using the mean intra-specimen standard deviation across repeated load applications. A one-way repeated measures ANOVA (α = 0.05) was used to determine regional strain variations. Results The mean intra-specimen standard deviation across repeated load application was ±0.003 strain for all specimens. No statistically significant differences were found between tissue regions, although medium and large effect sizes (0.095–0.450) suggest that these differences may be clinically relevant. Conclusions The method presented here demonstrates a minimally invasive measurement of regional ACL strain under clinically relevant joint loads using micro-CT imaging. The strain measurements demonstrated excellent reliability across the five repeated load applications and suggest a non-homogenous distribution of strain through the ACL.

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Objective Salivary gland tumors account for 6%–8% of head and neck neoplasms with the parotid gland as the most common primary site. Pleomorphic adenomas (PA) are considered the most common benign parotid gland neoplasms, followed by Warthin tumors (WT). The goal of this study was to investigate the distribution of parotid gland neoplasms among a United States veteran population. Design Retrospective chart review. Setting Washington DC Veterans Affairs Medical Center. Participants Veterans who underwent fine needle aspiration (FNA) for a parotid gland mass from 2000 to 2018 were included. Medical records were reviewed for gender, age, tobacco use, surgery date, and pathology results. Main outcome measures Changes in the distribution of parotid neoplasms and tobacco use over an 18-year period. Results Of 141 patients with parotid gland masses, 86.5% (n = 122) were benign, 9.9% (n = 14) were malignant, and 3.5% (n = 5) were indeterminate. Of benign tumors, WT accounted for the majority at 51.6%, followed by PA at 40.2%. When stratified by decade (2000–2009 and 2010–2018), the proportion of WT compared to all other benign and malignant neoplasms increased from 31.6% to 53.6%, whereas the proportion of PA decreased from 36.8% to 33.3%. The rate of tobacco use was unchanged at approximately 32.0% among our cohort from 2000 to 2018. Conclusion Among our cohort of veteran patients, WT was the most common benign parotid tumor and has increased in incidence over the last two decades despite an unchanged smoking rate.

Migration is increasing at unprecedented rates worldwide, but inadequate mechanisms for granting citizenship or permanent residence have rendered many immigrants without legal status. We study the health of people without immigration status in Canada, building on a 2010 review on being without status and health. We employ an expanded definition of health, guided by the WHO Social Determinants of Health (SDoH) framework. Using a scoping review methodology, we reviewed literature from 2008 to 2018 on the SDoH of people without legal immigration status in Canada, selecting 33 articles for analysis. We found that structural determinants of health, such as stigmatization and criminalization, and intermediary determinants, such as fear of deportation and healthcare avoidance, produce ill health. We show how different social positions are produced by SDoH, finding immigration status to be the foundational determinant of health for people without status in Canada. We argue that lack of immigration status as a SDoH is missing from the WHO framework.

Objective To evaluate the necessity and effectiveness of a preplanned technique for drilling during transcanal endoscopic ear surgery. Methods Study design: Retrospective case series study from June 2011 to June 2015. Setting: Private tertiary care hospital. Patients: Eighty-five ears of 78 patients, age ranging from 9 to 57 years underwent transcanal endoscopic drilling for various types of pathology in their middle and external ear. Interventions: Application of a preplanned technique for transcanal drilling in endoscopic ear surgery that involved short timed drilling with use of intermittent irrigation and suction. Every events of the procedure were done one after another with the single hand of the surgeon. An attachment providing protecting sheath around rotating burr was used during each time of drilling. Main outcomes measure: Efficacy of such drilling technique in single handed endoscopic ear surgery. Presence of any postoperative thermal injury of facial nerve and any lacerated injury of skin of external ear. Results This preplanned technique was found suitable for transcanal endoscopic drilling with the single hand of the surgeon. Postoperative facial nerve palsy or laceration of skin of external ear was not noted in any patient. Conclusion After using the present technique, transcanal endoscopic drilling could be done easily and safely with single hand of the surgeon.

Background Analysis of fluid metabolites has the potential to provide insight into the neuropathophysiology of injury in patients with traumatic brain injury (TBI). Objective Using a 1H nuclear magnetic resonance (NMR)-based quantitative metabolic profiling approach, this study determined (1) if urinary metabolites change during recovery in patients with mild to severe TBI; (2) whether changes in urinary metabolites correlate to injury severity; (3) whether biological pathway analysis reflects mechanisms that mediate neural damage/repair throughout TBI recovery. Methods Urine samples were collected within 7 days and at 6-months post-injury in male participants (n = 8) with mild-severe TBI. Samples were analyzed with NMR-based quantitative spectroscopy for metabolomic profiles and analyzed with multivariate statistical and machine learning-based analyses. Results Lower levels of homovanillate (R = −0.74, p ≤ 0.001), L-methionine (R = −0.78, p, Highlights • NMR-based metabolomics of urine can identify metabolic fingerprints associated with functional recovery following TBI. • Metabolic profiles in urine correlate to injury severity. • Biological pathway analysis reflects mechanisms that mediate neural damage and repair processes throughout recovery. • Metabolomics provides insight into the neuropathophysiology of injury in TBI patients.

Objective: We conducted this study to determine the associations of possible risk factors and prevalence of recurrent otitis media with effusion (OME) in a cohort of children in Upper Egypt. Methods: This was a cross-sectional study undertaken in two tertiary referral centers in Upper Egypt. Associations of possible risk factors with prevalence of recurrent OME were studied. Multi-factor logistic regression analysis was done to recognize the statistically significant risk factors associated with recurrent OME. Results: We collected the data of 2003 pediatric patients, of which 1016 were males (50.7%). A total number of 310 children have OME, including 159 males (51.3%). The prevalence rate of OME in our cohort was 15.5%. Multi-factor logistic regression analysis of the risk factors related to recurrent OME showed it was strongly associated with adenoid hypertrophy (P

Objectives: Describe the h index as a bibliometric that can be utilized to objectively evaluate scholarly impact. Identify which otolaryngology subspecialties are the most scholarly. Describe if NIH funding to one’s choice of medical school, residency, or fellowship has any impact on one’s scholarly output. Determine other factors predictive of an academic otolaryngologist’s productivity. Study design: Analysis of bibliometric data of academic otolaryngologists. Methods: Active grants from the National Institutes of Health (NIH) to otolaryngology departments were ascertained via the NIH Research Portfolio Online Reporting Tools Expenditures and Reports database. Faculty listings from these departments were gleaned from departmental websites. H index was calculated using the Scopus database. Results: Forty-seven otolaryngology programs were actively receiving NIH funding. There were 838 faculty members from those departments who had a mean h index of 9.61. Otology (h index 12.50) and head and neck (h index 11.96) were significantly (P

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) causing the COVID-19 pandemic, has had an enormous effect on conventional clinical practice. Telemedicine has emerged as critical to the provision of healthcare services when reducing the transmission of COVID-19 among patients, families, and clinicians. It has been an essential tool for continuing care for patients with lower urinary tract symptoms (LUTS) during the COVID-19 pandemic and has been the link between socially distant patient contact. The aim of this perspective paper was to identify the strengths and limitations of technology-based care focusing on literature linked to patients with lower urinary tract symptoms (LUTS). We search PubMed and CINHAL Plus for grey literature and secondary research on LUTS and telemedicine during the COVID-19 pandemic. Publications dated between the year March 2020 and March 2021were searched. We gathered key specialist opinions in the field of LUTS from several countries around the world, including the countries that had been hit significantly with COVID-19. This perspective paper proposes that there is evidence to support the use of modern technology to facilitate continued healthcare services for patients with LUTS during the COVID-19 pandemic. Telemedicine has been recognised a crucial digital tool for diagnosis, treatment and follow-up appointments during a time of social distancing. Although there are many advantages of telemedicine, the older adult population and those economically disadvantaged with technology may not benefit from technology-based healthcare. The available literature on telemedicine during the COVID-19 pandemic has proven to be successful in the management of some patients with LUTS. It is certain that the COVID-19 pandemic has given telemedicine a significant drive for implementation now and in the immediate future. Robust data on long-term efficacy and safety of telemedicine is required to ensure there are governance protocols embedded when looking after patients with LUTS.

Background The Patient Health Questionnaire-9 (PHQ-9) is a widely used measure of depression in primary care. It was, however, originally designed as a diagnostic screening tool, and not for measuring change in response to antidepressant treatment. Although the Quick Inventory of Depressive Symptomology (QIDS-SR-16) has been extensively validated for outcome measurement, it is poorly adopted in UK primary care, and, although free for clinicians, has licensing restrictions for healthcare organisation use. Aims We aimed to develop a modified version of the PHQ-9, the Maudsley Modified PHQ-9 (MM-PHQ-9), for tracking symptom changes in primary care. We tested the measure's validity, reliability and factor structure. Method A sample of 121 participants was recruited across three studies, and comprised 78 participants with major depressive disorder and 43 controls. MM-PHQ-9 scores were compared with the QIDS-SR-16 and Clinical Global Impressions improvement scale, for concurrent validity. Internal consistency of the scale was assessed, and principal component analysis was conducted to determine the items’ factor structure. Results The MM-PHQ-9 demonstrated good concurrent validity with the QIDS-SR-16, and excellent internal consistency. Sensitivity to change over a 14-week period was d = 0.41 compared with d = 0.61 on the QIDS-SR-16. Concurrent validity between the paper and mobile app versions of the MM-PHQ-9 was r = 0.67. Conclusions These results indicate that the MM-PHQ-9 is a valid and reliable measure of depressive symptoms in paper and mobile app format, although further validation is required. The measure was sensitive to change, demonstrating suitability for use in routine outcome assessment.

Introduction: Tapes have been used to aid fresh wound closure. For hypertrophic scars, the use of tapes as a therapy to reduce the mechanical forces that stimulate excessive and long-term scarring is yet to be evaluated. The aim of this comprehensive review was to explore the current clinical application of tapes, as a minimally invasive option, as purposed specifically for the management of hypertrophic scarring, regardless of scar causation. Method: Databases were searched using MeSH terms including one identifier for hypertrophic scar and one for the intervention of taping. Studies included the following: patients who received tape for a minimum of 12 weeks as a method of wound closure specifically for the purpose of scar prevention; those who received tape as a method of scar management after scar formation; reported outcomes addressing subjective and/or objective scar appearance; and were available in English. Results: With respect to non-stretch tapes, their use for the prevention of linear surgical scarring is evident in reducing scar characteristics of height, colour and itch. Statistically significant results were found in median scar width, reduction in procedure times and overall scar rating. Tapes were predominately applied by participants themselves, and incidence of irritation was infrequently reported. After 12 months, significance with respect to scar pain, itch, thickness and overall scar elevation was reported in one study investigating paper tape. Two papers reported the use of high stretch tapes; however, subjective results limited formal analysis. Although the use of taping for abnormal hypertrophic scar management is in its infancy, emerging research indicates tapes with an element of stretch may have a positive impact. Conclusions: Non-stretch tapes, for the prevention of linear surgical scarring, are effective in reducing scar characteristics of height, colour and itch. Paper tapes have shown effectiveness when applied during wound remodelling or even on mature scarring, with reported subjective changes in scar colour, thickness and pliability. Preliminary evidence of the benefits of high-stretch, elasticised tapes for scar management in the remodelling phase of wound healing have also been reported. Lay Summary Patients are often concerned about unsightly scars that form on their bodies after trauma, especially burn injuries. These scars can be thick, red and raised on the skin, and can impact on the patient’s quality of life. For some scars, the process of skin thickening continues for up to two years after an injury. Unfortunately, scar formation is a part of the body’s healing process, whereby there is a constant pull or tension under and along the skin’s surface. The use of simple tapes, such as microporetm, to help with wound closure are sometimes used as a therapy to reduce the tension on the skin’s surface when a wound is healing to minimise scar formation. However, the effectiveness of taping has not been proven. This paper looks at the available evidence to support the use of taping to reduce scar features of height, thickness and colour. Initial evidence of mixed levels, suggests some benefits of tapes for scar management and show preliminary efficacy for reduction of scar height, thickness and colour. More research is required to determine the direct impact, comparison to other treatments available and patient viewpoint for this therapy.