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Although implantable cardioverter defibrillators (ICDs) are a powerful preventive therapy for cardiac sudden death, there are some populations in whom ICDs cannot be applied because of a lack of a definitive indication (grey‐zone patients), such as in patients during the acute phase of cardiac injury with a susceptible risk for lethal arrhythmias. In such patients, wearable cardioverter defibrillators (WCDs) provide safer bridging period during the acute phase until the final decision‐making for the ICD use and it may eliminate any inappropriate overuse of ICDs in the subacute phase. The JCS/JHRS practical guidelines provide the criteria for WCD use in Japan. Nevertheless, the evidence for that is totally limited in Japan and is dependent on the accumulation of actual real‐world data from other countries in order to be able to discuss the appropriate criteria for WCD use. This study will be conducted retrospectively and/or prospectively, and is an observational and multicenter study among Japanese institutions (J‐WCDR, Japan WCD Registry). This will provide evidence for WCD use in our own country and contribute to upcoming updates for the future guideline revisions., This is the design paper of upcoming J‐WCDR that is the clinical registry study of WCD which will be held by JHRS.

Paraquat intoxication is characterized by acute kidney injury and multi-organ failure, causing substantial mortality and morbidity. This study aims to develop a 2-in-1 paper-based analytical device to detect the concentrations of paraquat and creatinine in human serum, which can help clinicians diagnose patients with paraquat poisoning in a more rapid and geographically unrestricted manner. The procedure involves fabrication of a paper-based analytical device, i.e., printing of design on a filter paper, heating of wax-printed micro zone plates so as molten wax diffusing into and completely through the paper to the other side, forming hydrophobic boundaries that could act as detection zones for the paraquat colorimetric assay, and finally analysis using ImageJ software. The paper employed a colorimetric sodium dithionite assay to indicate the paraquat level in a buffer or human serum system in less than 10 min. In this study, colorimetric changes into blue color could be observed by the naked eye. By curve fitting models of sodium dithionite in normal human serum, we evaluated the serum paraquat levels for five paraquat patients. In the sodium dithionate assay, the measured serum paraquat concentrations in patients 1&ndash, 5 were 22.59, 5.99, 26.52, 35.19 and 25.00 ppm, respectively. On the other hand, by curve fitting models of the creatinine assay in normal human serum, the measured serum creatinine concentrations were 16.10, 12.92, 13.82, 13.58 and 12.20 ppm, respectively. We found that the analytical performance of this device can compete with the standard of Clinical Laboratory of Chang Gung Memorial Hospital, with a less complicated sample preparation process and more rapid results. In conclusion, this 2-in-1 paper-based analytical device has the advantage of being simple and cheap, enabling rapid detection of paraquat intoxication as well as assessment of renal prognosis.

Summary The protective effect of dual antiplatelet therapy (DAPT) following acute coronary syndrome is undisputed, but its duration is subject of debate. Several studies show that prolonged therapy provides a clinical benefit in patients following acute coronary syndrome. The aim of this position paper authored by Austrian experts is to outline the current evidence and provide an overview of recent studies. It is also intended to serve as a practical guide to identify those patients who may benefit from prolonged DAPT.

Amphimeriasis, a fish-borne zoonotic disease caused by the liver fluke Amphimerus spp., has recently been reported as an emerging disease affecting an indigenous Ameridian group, the Chachi, living in Ecuador. The only method for diagnosing amphimeriasis was the microscopic detection of eggs from the parasite in patients' stool samples with very low sensitivity. Our group developed an ELISA technique for detection of anti-Amphimerus IgG in human sera and a molecular method based on LAMP technology (named LAMPhimerus) for specific and sensitive parasite DNA detection. The LAMPhimerus method showed to be much more sensitive than classical parasitological methods for amphimeriasis diagnosis using human stool samples for analysis. The objective of this work is to demonstrate the feasibility of using dried stool samples on filter paper as source of DNA in combination with the effectiveness of our previously designed LAMPhimerus assay for successfully Amphimerus sp. detection in clinical stool samples. A total of 102 untreated and undiluted stool samples collected from Chachi population were spread as thin layer onto common filter paper for easily transportation to our laboratory and stored at room temperature for one year until DNA extraction. When LAMPhimerus method was applied for Amphimerus sp. DNA detection, a higher number of positive results was detected (61/102; 59.80%) in comparison to parasitological methods (38/102; 37.25%), including 28/61 (45.90%) microscopy-confirmed Amphimerus sp. infections. The diagnostic parameters for the sensitivity and specificity werecalculated for our LAMPhimerus assay, which were 79.17% and 65.98%, respectively. We demonstrate, for the first time, that common filter paper is useful for easy collection and long-term storage of human stool samples for later DNA extraction and molecular analysis of human-parasitic trematode eggs. This simple, economic and easily handling method combined with the specific and sensible LAMPhimerus assay has the potential to beused as an effective molecular large-scale screening test for amphimeriasis-endemic areas.

[Abstract] Exercise training (ET) and secondary prevention measures in cardiovascular disease aim to stimulate early physical activity and to facilitate recovery and improve health behaviours. ET has also been proposed for heart failure patients with a ventricular assist device (VAD), to help recovery in the patient's functional capacity. However, the existing evidence in support of ET in these patients remains limited. After a review of current knowledge on the causes of the persistence of limitation in exercise capacity in VAD recipients, and concerning the benefit of ET in VAD patients, the Heart Failure Association of the European Society of Cardiology has developed the present document to provide practical advice on implementing ET. This includes appropriate screening to avoid complications and then starting with early mobilisation, ET prescription is individualised to meet the patient's needs. Finally, gaps in our knowledge are discussed.

International audience; Aortic stenosis is a frequent disease in the elderly. Its prevalence is 0.4% with a sharp increase after the age of 65, and its outcome is very poor when the patient becomes symptomatic. The interventional procedure known as TAVI (trans-catheter aortic valve implantation), which was developed in France and carried out for the first time in Rouen by Prof. Alain Cribier and his team in 2002, has proven to be a valid alternative to surgical aortic valve replacement. At first, this technique was shown to be efficient in patients with contra-indications to surgical treatment or deemed to be at high surgical risk. Given the very promising outcomes achieved as a result of close heart team collaboration, appropriate patient selection, simplified procedures and reduced complication rates, transfemoral (TF) TAVI is now preferred in symptomatic intermediate risk patients>75 years old according to the latest ESC guidelines. In 2017, in France, TAVI is currently performed in 50 centers with on-site cardiac surgery. The 2016 TAVI outcomes recorded in the French national TAVI registry (France TAVI) are very encouraging and show that for 7133 patients treated (age 83.4±7 years, logistic Euroscore 14%), 87% of whom via the TF approach, cross-over to surgery was very low (0.5%) with a 3.0% in-hospital mortality rate. The substantial increase in TAVI indications and the improvement of its outcomes may in the near future call for a reconsideration of the number of high volume centers authorized to carry out this technique.

International audience; Ischaemic heart disease and the heart failure that often results, remain the leading causes of death and disability in Europe and worldwide. As such, in order to prevent heart failure and improve clinical outcomes in patients presenting with an acute ST-segment elevation myocardial infarction and patients undergoing coronary artery bypass graft surgery, novel therapies are required to protect the heart against the detrimental effects of acute ischaemia/reperfusion injury (IRI). During the last three decades, a wide variety of ischaemic conditioning strategies and pharmacological treatments have been tested in the clinic-however, their translation from experimental to clinical studies for improving patient outcomes has been both challenging and disappointing. Therefore, in this Position Paper of the European Society of Cardiology Working Group on Cellular Biology of the Heart, we critically analyse the current state of ischaemic conditioning in both the experimental and clinical settings, provide recommendations for improving its translation into the clinical setting, and highlight novel therapeutic targets and new treatment strategies for reducing acute myocardial IRI.

Each year, the Heart editorial team selects the most meritorious research paper to receive the Heart Best Research Paper Award. Primary considerations are the relevance of the clinical question addressed by the research, the quality of the research study design and data presentation and the interest generated by the paper among other researchers, clinical cardiologists and the general public. This year, we are pleased to announce the winner and two finalists for the 2021 Heart Best Paper Research Award, highlighting the first author of each paper and sincerely congratulating the entire research team on their outstanding research contribution (table 1). Each of the authors contributed the text below summarising their background, research goals and the key findings of these studies. View this table: Table 1 Heart Best Research Paper Award winner and finalists 2020 Julia Hippisley-Cox (figure 1) is Professor of Clinical Epidemiology and General Practice at the University of Oxford and an NHS GP in Oxfordshire. She undertakes research to advance understanding of many diseases using routinely collected large-scale linked electronic health records. She is particularly interested in translational research where the results can lead to improvements in patient care and the health services. …

The reference to the term acute coronary syndrome with normal or near-normal (non-obstructive) coronary arteries (ACSNNOCA) from Manolis et al. (2018) was inadvertently omitted to the original published article. Therefore, the following reference should be added to our paper:Manolis AS, Manolis AA, Manolis TA, Melita H. Acute coronary syndromes in patients with angiographically normal or near normal (non-obstructive) coronary arteries. Trends Cardiovasc Med. 2018;28(8):541–51. https://doi.org/10.1016/j.tcm. 2018.05.006. The authors would like to apologise for any inconvenience caused.

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The purpose of this study was to explore validity of the paper pull test (PPT) to assess hallux flexion strength and function in persons with hallux valgus (HV). The following hypotheses were tested: 1) The PPT is valid for inferring 1st MTP flexion strength and heel rise (HR) performance (e.g. heel height). 2) A specified threshold of force during the PPT can be identified that discriminates patients with HV. 3) Muscle activity (abductor hallucis [AH], flexor hallucis brevis [FHB]), in patients with HV will be distinct from controls across three tasks: 1) PPT, 2) lowering phase of a HR, and 3) rising phase of a HR. Methods: Participants (24 controls, 22 with HV) performed: 1st MTP flexion, PPT, and heel rise. A force transducer in a jig assessed 1st MTP flexion. The same transducer recorded force during the PPT. Electromyography (EMG) was used to record FHB/AH muscle activity during 1st MTP flexion, PPT, and heel rising. 3D movement analysis was used to measure heel height and divide the HR into an up (HR-Up) and down (HR-Dwn) phase. One practice and 3 maximum 1st MTP flexion efforts were recorded. Manchester Scale of hallux deformity was used; 63.6% were classified as C or D. Validity was assessed with Pearson correlation’s between force during the PPT and 1st MTP flexion and PPT and HR height. Assessment of a threshold value for discriminating participants with HV from controls was determined using receiver operator curve (ROC) analysis. A two-way ANOVA for muscle groups and tasks were used to assess muscle activation. Results: The correlation between PPT force and maximum 1st MTP force was high (r=0.87, pConclusion: This data validates the PPT as simple, effective, clinical evaluation of 1st MTP flexion strength in patients with HV. This data also documents that patients with HV (surgery or not) may avoid using 1st MTP flexion explaining their significant weakness. The importance of this weakness on function is supported by the correlation with the heel rise test. The abnormal EMG findings suggests altered muscle control contributes to a lower PPT. The threshold of 1st MTP strength may assist with clinical decisions regarding whether rehabilitation or advice on increasing physical activity might benefit patients with various degrees of HV.

SummaryPlaque rupture and subsequent thrombotic occlusion of the coronary artery account for as many as three quarters of myocardial infarctions. The concept of plaque stabilisation emerged about 20 years ago to explain the discrepancy between the reduction of cardiovascular events in patients receiving lipid lowering therapy and the small decrease seen in angiographic evaluation of atherosclerosis. Since then, the concept of a vulnerable plaque has received a lot of attention in basic and clinical research leading to a better understanding of the pathophysiology of the vulnerable plaque and acute coronary syndromes. From pathological and clinical observations, plaques that have recently ruptured have thin fibrous caps, large lipid cores, exhibit outward remodelling and invasion by vasa vasorum. Ruptured plaques are also focally inflamed and this may be a common denominator of the other pathological features. Plaques with similar characteristics, but which have not yet ruptured, are believed to be vulnerable to rupture. Experimental studies strongly support the validity of anti-inflammatory approaches to promote plaque stability. Unfortunately, reliable non-invasive methods for imaging and detection of such plaques are not yet readily available. There is a strong biological basis and supportive clinical evidence that low-density lipoprotein lowering with statins is useful for the stabilisation of vulnerable plaques. There is also some clinical evidence for the usefulness of antiplatelet agents, beta blockers and renin-angiotensin-aldosterone system inhibitors for plaque stabilisation. Determining the causes of plaque rupture and designing diagnostics and interventions to prevent them are urgent priorities for current basic and clinical research in cardiovascular area.

BackgroundElectronic applications are increasingly being used in hospitals for numerous purposes. ObjectiveOur aim was to assess differences in the characteristics of patients who choose paper versus electronic questionnaires and to evaluate the data quality of both approaches. MethodsBetween October 2012 and June 2013, 136 patients participated in a study on diagnosis-induced stress and anxiety. Patients were asked to fill out questionnaires at six different moments during the diagnostic phase. They were given the opportunity to fill out the questionnaires on paper or electronically (a combination of tablet and Web-based questionnaires). Demographic characteristics and completeness of returned data were compared between groups. ResultsNearly two-thirds of patients (88/136, 64.7%) chose to fill out the questionnaires on paper, and just over a third (48/136, 35.3%) preferred the electronic option. Patients choosing electronic questionnaires were significantly younger (mean 47.3 years vs mean 53.5 in the paper group, P=.01) and higher educated (P=.004). There was significantly more missing information (ie, at least one question not answered) in the paper group during the diagnostic day compared to the electronic group (using a tablet) (28/88 vs 1/48, P

Background The use of the Internet to administer questionnaires has many potential advantages over the use of pen-and-paper administration. Yet it is important to validate Internet administration, as most questionnaires were initially developed and validated for pen-and-paper delivery. While some have been validated for use over the Internet, these questionnaires have predominately been used amongst the healthy general population. To date, information is lacking on the validity of questionnaires administered over the Internet in patients with chronic diseases such as heart failure. Objectives To determine the validity of three heart failure questionnaires administered over the Internet compared to pen-and-paper administration in patients with heart failure. Methods We conducted a prospective randomized study using test-retest design comparing administration via the Internet to pen-and-paper administration for three heart failure questionnaires provided to patients recruited from a heart failure clinic in Toronto, Ontario, Canada: the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Self-Care Heart Failure Index (SCHFI). Results Of the 58 subjects enrolled, 34 completed all three questionnaires. The mean difference and confidence intervals for the summary scores of the KCCQ, MLHFQ, and SCHFI were 1.2 (CI -1.5 to 4.0, scale from 0 to 100), 4.0 (CI -1.98 to 10.04, scale from 0 to 105), and 10.1 (CI 1.18 to 19.07, scale from 66.7 to 300), respectively. Conclusions Internet administration of the KCCQ appears to be equivalent to pen-and-paper administration. For the MLHFQ and SCHFI, we were unable to demonstrate equivalence. Further research is necessary to determine if the administration methods are equivalent for these instruments.

This expert opinion paper on atrial fibrillation detection after ischemic stroke includes a statement of the "Heart and Brain" consortium of the German Cardiac Society and the German Stroke Society. This paper was endorsed by the Stroke Unit-Commission of the German Stroke Society and the German Atrial Fibrillation NETwork. In patients with ischemic stroke, detection of atrial fibrillation should usually lead to a change in secondary stroke prevention, since oral anticoagulation is superior to antiplatelet drugs. The detection of previously undiagnosed atrial fibrillation can be improved in patients with ischemic stroke to optimize stroke prevention. This paper summarizes the present knowledge on atrial fibrillation detection after ischemic stroke. We propose an interdisciplinary standard for a "structured analysis of ECG monitoring" on the stroke unit as well as a staged diagnostic scheme for the detection of atrial fibrillation. Since the optimal duration and mode of ECG monitoring has not yet been finally established, this paper is intended to give advice to physicians who are involved in stroke care. In line with the nature of an expert opinion paper, labeling of classes of recommendations is not provided, since many statements are based on the expert opinion, reported case series and clinical experience. Therefore, this paper is not intended as a guideline.

This report updates concepts on hypertension management in patients with diabetes. It focuses on clinical outcomes literature published within the last 3 years and incorporates these observations into modifications of established guidelines. While the fundamentals of treatment and goal blood pressures remain unchanged, approaches to specific patient-related issues has changed. This update focuses on questions such as what to do when a patient has an elevated potassium level when therapy is initiated and whether combinations of agents that block the renin-angiotensin system still be used. In addition, there are updates from trials, just published and in press, that focus on related management issues influencing cardiovascular outcomes in persons with diabetes. Last, an updated algorithm is provided that incorporates many of the new findings and is suggested as a starting point to achieve blood pressure goals.

In the last three decades, oesophageal pH monitoring has progressed from a physiological research tool to a routine outpatient clinical investigation in patients with suspected gastro-oesophageal reflux disease, one of the most common gastrointestinal disorders. Technological progress has considerably simplified both the procedure and the interpretation of data obtained, and there is currently reasonable consensus as to the parameters that best discriminate between physiological and pathological reflux. There remains a need for internationally agreed definitions and standards with regard to indexes to quantitate the extent and the significance of the relationship between occurrence of symptoms and reflux episodes during the examination. It is felt that national or local normal values are to be used to circumvent different eating habits and other socio-cultural differences which may influence gastro-oesophageal reflux. The reproducibility of the test appears, at present, to be at least good enough to allow classification of the patient as a pathological or physiological refluxer, albeit wide day-to-day variations seem to exist as far as concerns the extent of gastro-oesophageal reflux. Clinical applications of the technique have increased with better knowledge of the protean clinical manifestations of gastro-oesophageal reflux disease, and include the evaluation of “typical” gastro-oesophageal reflux disease patients with negative endoscopy or refractory oesophagitis, the “atypical” manifestations of gastro-oesophageal reflux disease and the pre- and post-operative evaluation of patients undergoing antireflux surgery.

Objectives In this paper, we present a review of critical concepts and research perspectives and produce recommendations on the optimal use of pixantrone in non-Hodgkin lymphoma (NHL) by group discussion from an expert panel appointed by the Italian Society of Hematology and the affiliate societies, Societa Italiana di Ematologia Sperimentale and Gruppo Italiano Trapianto di Midollo Osseo. Methods Recommendations were produced using the Delphi process. Scientific evidence on pixantrone efficacy was analyzed using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology in the areas where at least one randomized trial was published. The following key issues were addressed for practical recommendations: pixantrone monotherapy in aggressive relapsed or refractory non-Hodgkin B-cell lymphomas and toxicity risk management in patients candidates to pixantrone. Results and conclusions After a balanced and value-oriented discussion, the panel agreed that the benefit/risk profile was in favor of pixantrone in the treatment of adult patients with multiply relapsed or refractory aggressive NHL B-cell lymphomas. Pixantrone was deemed to be contraindicated in patients with uncontrolled cardiovascular disease. Despite a low rate of cardiotoxicity of pixantrone reported in clinical trials, the panel recommended that all patients receiving pixantrone should undergo periodical cardiac monitoring.

have been reported in the text. The authors have wondered whether there is a significant difference between the three groups (control, MS ON and MS non-ON). As we have mentioned in detail in the article, both MS ON and MS non-ON eyes had significantly reduced average-RNFL thickness measurements when compared with healthy controls, and the average-RNFL thickness measurements in MS ON eyes were significantly thinner than those in MS non-ON eyes. We believe that the measurement of RNFL thicknesses might be a useful parameter for the assessment of the axonal loss and for monitoring the effects of demyelination on visual pathway integrity as complementary tools to other functional markers in MS patients. Dear Editor We thank Yolcu and Ilhan [1] for their valuable contributions to our article entitled Evaluation of choroidal vascular changes in patients with multiple sclerosis using enhanced depth imaging optical coherence tomography [2] . In our study, we evaluated the choroidal thickness in multiple sclerosis (MS) patients with enhanced depth imaging optical coherence tomography to provide insight into the potential effects of the disease on vessel structure. We also evaluated the average retinal nerve fiber layer (RNFL) thickness and compared the measurements of MS eyes with optic neuritis (ON; MS ON), MS eyes without ON (MS non-ON) and controls. The average values and the statistical significance of differences between these three groups Received: November 20, 2015 Accepted: November 26, 2015 Published online: January 5, 2016

After more than a year of deliberation the journal of the American Society for Reproductive Medicine is to withdraw a Korean paper at the centre of a dispute about authorship and plagiarism ( BMJ 2007;334:717-20, 7 Apr doi: 10.1136/bmj.39168.517234.AD), solely on the grounds that it had been published previously in another journal. In a statement issued last week the board of Fertility and Sterility made no reference to the allegations of perjury and plagiarism that had been made by its editor in chief in the LA Times two months earlier. On 18 February Alan DeCherney had told the newspaper, “I'm sure that it's plagiarism,” and said he would be recommending to his editorial board that all the listed authors be banned from publishing in Fertility and Sterility for three years (www.latimes.com, 18 Feb, “Credit for U.S. journal article at issue,” www.latimes.com/news/local/la-me-research18feb18,0,6268481.story?coll=la-headlines-california). In the event Fertility and Sterility has announced that only one of the authors will be banned. The decision has infuriated Jeong Hwan Kim, a Korean doctor now working in Singapore, who wrote to Fertility and Sterility in March last year to alert the journal of his concerns relating to the paper “Quantification of mitochondrial DNA using real-time polymerase chain reaction in patients with premature ovarian failure” ( Fertility and …

Sir, We read with interest the paper of Guarrera & Rebora (1) on the hydrosoluble antioxidant capacity (HAOC) of serum of patients with polymorphic light eruption (PLE). We were involved in a similar study that aimed to establish the role of uric acid in total HAOC. In particular, Guarrera & Rebora observed that the total HAOC is reduced in females regardless of whether they are patients or controls. We regard this novel finding as important and worthy of confirmation. We studied 55 subjects (21 men and 34 women; age range 21–62 years). Fourteen of them (3 men and 11 women; aged 40±12.8 years) had PLE and 41 were controls (18 men and 23 women; aged 41±11.1 years). All patients gave their informed consent. Triplicate HAOC measurements in the presence and absence of uricase were obtained with commercial kits, PAO and PAO-U (MED-DIA, Vercelli, Italy). All serum samples were processed at the time of collection. Statistical analysis was performed with MiniTab ver. 15. (Table I). HAOC measurements in samples deprived of uric acid (HAOC-uricase) were lower than in those with uric acid (F=205.6, p

Cardiovascular magnetic resonance (CMR) has become the primary tool for noninvasive assessment of myocardial inflammation in patients with suspected myocarditis. The International Consensus Group on CMR Diagnosis of Myocarditis was founded in 2006 to achieve consensus among CMR experts and develop recommendations on the current state-of-the-art use of CMR for myocarditis. The recommendations include indications for CMR in patients with suspected myocarditis, CMR protocol standards, terminology for reporting CMR findings, and diagnostic CMR criteria for myocarditis (i.e., “Lake Louise Criteria”).

Parathyroid hormone (PTH) determination is of greatest importance for patients suffering from parathyroid gland disorders and for the follow-up of bone turnover in patients suffering from chronic kidney disease (CKD). Two generations of PTH assays are simultaneously present on the market for PTH quantification. As these assays are not yet standardized, this results in a significant level of confusion in the care of CKD patients. One key objective of the IFCC Committee for Bone Metabolism is to improve this situation. In this position paper, we will highlight the current state of PTH testing and propose a pathway to ultimately overcome issues resulting from PTH assay variability.

Background: The present paper reports on analysis of 184 patients who were diagnosed with endometrial cancer. The main objective of this study was to address parameter V rec(30Gy) which determines a volume of the rectum irradiated with a dose of 30 Gy during radiotherapy. Material and methods: All patients were irradiated with an IMRT technique on linear accelerators. The planning target volume (PTV) contour was determined by a radiation oncologist. The clinical target volume (CTV) was drawn on CT images obtained in a prone position. For statistical analysis, appropriate tests (e.g. the Shapiro-Wilk, Wilcoxon) were used. Results and discussion: The performed analysis showed that the recommended condition for V rec(30Gy) is met only in 3% of patients and the observed median value exceeds 90%. The obtained results were compared with the studies in which the V rec(30Gy) values were related to various radiotherapy techniques. Conclusions: The analysis showed that the condition for V rec(30Gy) is satisfied in the case of only 3% of patients. Due to the difficulty with meeting the condition, it should be reconsidered based on real results.

Background Patients and carers should be actively involved in patient safety and empowered to use person‐centred approaches where they are asked to both identify safety concerns and partner in preventing them. Objectives The aim of this study was to co‐design a patient safety guide for primary care (PSG‐PC) to support patients and carers to address key patient safety questions and identify key points where they can make their care safer. The objectives were to i) identify when and how patients and carers can be involved in primary care patient safety, and ii) identify the relevant information to include in the PSG‐PC. Design An experience‐based co‐design approach. Setting and Participants We conducted three workshops with patients, carers, community pharmacists and general practitioners to develop and refine the PSG‐PC. Results Participants identified both explicit and implicit issues of primary care patient safety especially relating to technical and relational components of involving patients and carers. The importance of communication, understanding roles and responsibilities, and developing partnerships between patients and health‐care providers were considered essential for actively involving patients in patient safety. Co‐developing the PSG‐PC provided insight to improve care to develop the PSG‐PC. Discussion The PSG‐PC is the first guide to be developed for primary care, co‐designed with patients, carers, general practitioners and pharmacists. The PSG‐PC will support patients and carers to partner with health‐care professionals to improve patient safety addressing international and national priorities to continuously improve patient safety.

Hepatitis B virus (HBV) middle surface antigen (MHBs) mutation or deletion occurs in patients with chronic HBV infection. However, the functional role of MHBs in HBV infection is still an enigma. Here, we reported that 7.33% (11/150) isolates of CHB patients had MHBs start codon mutations compared with 0.00% (0/146) in acute hepatitis B (AHB) patients. Interestingly, MHBs loss accounted for 11.88% (126/1061) isolates from NCBI GenBank, compared with 0.09% (1/1061) and 0.00% (0/1061) for HBV large surface antigen (LHBs) loss and HBV small surface antigen (SHBs) loss, respectively. One persistent HBV clone of genotype B (B56, MHBs loss) from a CHB patient was hydrodynamically injected into BALB/c mice. B56 persisted for >70 weeks in BALB/c mice, whereas B56 with restored MHBs (B56M+) was quickly cleared within 28 days. Serum cytokine assays demonstrated that CXCL1, CXCL2, IL-6 and IL-33 were significantly increased during rapid HBV clearance in B56M+ mice. Furthermore, the enhancers and promoters of B56 were proved to be required for B56 persistence in mice. Ablating MHBs expression improved the persistence of a new clone (HBV1.3, genotype B) which was recreated by using enhancers and promoters of B56. These data demonstrated that MHBs deletion can promote the persistence of specific HBV variants in a hydrodynamic mouse model. MHBs re-expression restored a rapid clearance of HBV, which was accompanied by cytokine responses including the elevation of CXCL1, CXCL2, IL-6 and IL-33.

Objective To describe the clinical profile and microbiology trends in patients undergoing therapeutic keratoplasty at a multi-tier ophthalmology hospital network in India. Methods This cross-sectional hospital-based study included 3147 eyes undergoing therapeutic keratoplasty between Jan 2016 and Dec 2020 (5 years period) as cases. The demographic data, clinical profile and microbiological analysis were collected using an electronic medical record system. Results Of a total of 13,625 eyes with microbial keratitis(non-viral), 3147 (23.1%) underwent therapeutic keratoplasty during the study duration. Majority of patients were males (68.35%), from a rural geography (49.89%) and in 51–60 years age bracket (23.74%). The mean age of the patients was 50.54 ± 15.83 years. Two-thirds of patients were from lower socio-economic strata (66.63%) with an agrarian background (36.51%). Of the 3,147 eyes, fungus (51.8%) was the most common indication of therapeutic keratoplasty followed by bacteria (16.87%) and parasite (1.27%). No organisms could be identified in about a third (29.33%) of the cases. Between 2016 and 2020, the trend of therapeutic keratoplasties for fungal infections steadily grew (39.9% vs 45.49%) while the bacterial infections showed a steady decline (23.15% vs 11.81%). Conclusions Medical cure rate was seen in majority of those with microbial keratitis, and 23.1% eventually required management with therapeutic keratoplasty. Fungal keratitis was the most common indication for therapeutic keratoplasty. Male gender, rural setting, low socio-economic background and agricultural occupation are common risk factors for patients undergoing therapeutic keratoplasty in India.

Objective: This study assessed the prevalence of anaplastic lymphoma kinase (ALK) rearrangements in US oncology practices. Materials and Methods: Using a nationwide real-world database, we included adults with advanced non-small cell lung cancer (aNSCLC, stage IIIB- IV) diagnosed January 2015 – May 2019, with documented ALK testing results and smoking status. Rearrangement prevalence was assessed overall and then stratified by patient characteristics. Results: The cohort included 19,895 eligible patients with a mean age 68.5 years, majority ever-smokers (85.5%) and from community centers (92.2%). The overall ALK rearrangement prevalence was 2.6%. Positivity rate varied by histology and smoking status; it was the highest among non-smoking patients with non-squamous histology (9.3%). Differences in ALK status also varied by age and race, with young patients (18–39 years) having a higher prevalence (21.6%) vs. older patients (age ≥55 = 2.2%); Asian patients had a prevalence of 6.3%. Patients that were positive for other mutations or rearrangements had a lower ALK positivity rate (0.5%) and patients positive for PD-L1 had a rate of 3.0%. Conclusions: The likelihood of finding an ALK translocation was highest in younger patients and nonsmokers; however, age and smoking history were not discriminative enough to exclude testing based on clinical variables.

Patients with new-onset stable angina constitute a substantial part of the population seen by cardiologists. Currently, the diagnostic workup of these patients depends on the pre-test probability of having obstructive coronary artery disease. It consists of either functional testing for myocardial ischaemia or anatomical testing by using coronary computed tomographic angiography (CCTA) or invasive coronary angiography. In case the pre-test probability is > 5%, the current guidelines for the management of chronic coronary syndromes do not state a clear preference for one of the noninvasive techniques. However, based on the recently published cost-effectiveness analysis of the PROMISE trial and considering the diagnostic yield in patients with angina and nonobstructive coronary artery disease, we argue a more prominent role for CCTA as a gatekeeper for patients with new-onset stable angina.

Transcatheter aortic valve implantation (TAVI) is still developing and changing our approach to treating patients with severe symptomatic aortic stenosis. Aortic stenosis frequently coexists with coronary artery disease. Both diseases have similar risk factors for their development and one should expect a future progression of coronary artery disease. The current guidelines have expanded TAVI indications to include intermediate-risk patients, and perhaps they will be expanded to include low-risk patients in the future. Survival after TAVI in younger patients will depend on the durability of the aortic valves and methods of coronary artery disease treatment. This paper presents some aspects of performing coronary angiography and percutaneous coronary intervention in patients who had TAVI performed using the two most popular aortic valves - balloon expandable aortic valves (Edward Sapien/Edward Sapien XT/Sapien 3) and self-expandable aortic valves (CoreValve/Evolut R) - on the basis of several examples. This paper also focuses on technical aspects associated with a proper implantation of aortic valves to ensure easy access to coronary arteries, as well as on possible problems when the implantation is not optimal. We discuss interactions between the structure of the aortic valve stent, catheters, commissures of new aortic valves, and coronary ostia.

BACKGROUND AND PURPOSE In TB-HIV co-infection, prompt initiation of TB therapy is recommended but anti-retroviral treatment (ART) is often delayed due to potential drug-drug interactions between rifampicin and efavirenz. In a longitudinal cohort study, we evaluated the effects of efavirenz/rifampicin co-treatment and time of ART initiation on CYP3A induction. EXPERIMENTAL APPROACH Treatment-naive TB-HIV co-infected patients (n = 102) were randomized to efavirenz-based-ART after 4 (n = 69) or 8 weeks (n = 33) of commencing rifampicin-based anti-TB therapy. HIV patients without TB (n = 94) receiving efavirenz-based-ART only were enrolled as control. Plasma 4β-hydroxycholesterol/cholesterol (4β-OHC/Chol) ratio, an endogenous biomarker for CYP3A activity, was determined at baseline, at 4 and 16 weeks of ART. KEY RESULTS In patients treated with efavirenz only, median 4β-OHC/Chol ratios increased from baseline by 269% and 275% after 4 and 16 weeks of ART, respectively. In TB-HIV patients, rifampicin only therapy for 4 and 8 weeks increased median 4β-OHC/Chol ratios from baseline by 378% and 576% respectively. After efavirenz/rifampicin co-treatment, 4β-OHC/Chol ratios increased by 560% of baseline (4 weeks) and 456% of baseline (16 weeks). Neither time of ART initiation, sex, genotype nor efavirenz plasma concentration were significant predictors of 4β-OHC/Chol ratios after 4 weeks of efavirenz/rifampicin co-treatment. CONCLUSION AND IMPLICATIONS Rifampicin induced CYP3A more potently than efavirenz, with maximum induction occurring within the first 4 weeks of rifampicin therapy. We provide pharmacological evidence that early (4 weeks) or deferred (8 weeks) ART initiation during anti-TB therapy has no significant effect on CYP3A induction. LINKED ARTICLES This article is part of a themed issue on Oxysterols, Lifelong Health and Therapeutics. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v178.16/issuetoc.

Background We aimed to assess feasibility of self-completion of the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) by head and neck cancer patients, and to assess self-reported increased awareness regarding malnutrition risk after self-completion.Methods Participants were randomized to complete the PG-SGA SF by paper or app. Feasibility was assessed by time needed to complete the PG-SGA SF, perceived difficulty, and help needed during completion. Participants were asked if they knew what malnutrition was (yes/no) and if they could define "malnutrition." They were also asked 9 questions on whether they perceived increased awareness of malnutrition risk after having completed the PG-SGA SF and 2 on their intention to change lifestyle habits.Results Of all participants (n = 59; 65.9 +/- 12.6 years; 73% male), 55% completed the PG-SGA SF paper version and 46% the Pt-Global app. Median time needed for self-completion of the PG-SGA SF was 2 minutes 41 seconds (interquartile range: 1 minute 49 seconds-3 minutes 50 seconds). Forty-eight percent needed help with completion, indicating acceptable feasibility. Participants who completed the Pt-Global app needed help significantly more often (66%; 21/32) than those who completed the PG-SGA SF paper version (26%; 7/27) (P = 0.005). All difficulty scores were excellent. For 7/9 questions on malnutrition risk awareness, >50% of the participants answered positively.Conclusion The results of this study show that self-completion of the PG-SGA SF by head and neck cancer patients is feasible and that awareness regarding malnutrition risk may increase after completing the PG-SGA SF.

In light of the rapidly changing landscape of haemophilia treatment, the authors of the position paper on the “European Principles of Inhibitor Management” published in 2018 (Table 1) [1] now provide an update on the major impact of novel therapies that bypass and/or substitute clotting factor VIII (FVIII) and IX (FIX) in the care of haemophilia patients with FVIII- or FIX-neutralizing allo-inhibitory antibodies (inhibitors). [...]

Sulphonylureas (SU) form an important role in management of people with type 2 diabetes. This safety history of SU was tainted for various reasons, the predominant one being lack of demonstration of cardiovascular safety. Since its introduction, SU's have never been subjected to a formal study for its cardiovascular safety. The cardiovascular safety of SUs was derived from small, inadequately powered randomised controlled trials (RCT) and observational studies. CAROLINA (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) trial planned as a cardiovascular outcome trial randomised people with type 2 diabetes and high cardiovascular risk to Linagliptin and Glimepiride. This opinion paper outlines the salient features of this landmark trial and its implications in general cardiology practice.

Purpose: To develop and validate a random forest (RF) based predictive model of early refractoriness to transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC). Methods: A total of 227 patients with unresectable HCC who initially treated with TACE from three independent institutions were retrospectively included. Following a random split, 158 patients (70%) were assigned to a training cohort and the remaining 69 patients (30%) were assigned to a validation cohort. The process of variables selection was based on the importance variable scores generated by RF algorithm. A RF predictive model incorporating the selected variables was developed, and five-fold cross-validation was performed. The discrimination and calibration of the RF model were measured by a receiver operating characteristic (ROC) curve and the Hosmer-Lemeshow test. Results: The potential variables selected by RF algorithm for developing predictive model of early TACE refractoriness included patients' age, number of tumors, tumor distribution, platelet count (PLT), and neutrophil-to-lymphocyte ratio (NLR). The results showed that the RF predictive model had good discrimination ability, with an area under curve (AUC) of 0.863 in the training cohort and 0.767 in the validation cohort, respectively. In Hosmer-Lemeshow test, the RF model had a satisfactory calibration with P values of 0.538 and 0.068 in training cohort and validation cohort, respectively. Conclusion: The RF algorithm-based model has a good predictive performance in the prediction of early TACE refractoriness, which may easily be deployed in clinical routine and help to determine the optimal patient of care.

Several widely recognized metabolites play a role in regulating the pathophysiological processes of various disorders. Nonetheless, the lack of effective biomarkers for the early diagnosis of polycystic ovarian syndrome (PCOS) and premature ovarian failure (POF) has led to the discovery of serum-based metabolic biomarkers for these disorders. We aimed to identify various differentially expressed metabolites (DEMs) through serum-based metabolic profiling in patients with PCOS and POF and in healthy individuals by using liquid chromatography–mass spectrometry analysis. Furthermore, heatmap clustering, correlation, and Z-score analyses were performed to identify the top DEMs. Kyoto Encyclopedia of Genes and Genomes enriched pathways of DEMs were determined using metabolite-based databases. Moreover, the clinical significance of these DEMs was evaluated on the basis of area under the receiver operating characteristic curve. Significantly dysregulated expressions of several metabolites were observed in the intergroup comparisons of the PCOS, POF, and healthy control groups. Furthermore, 6 DEMs were most frequently observed among the three groups. The expressions of these DEMs were not only directly correlated but also exhibited potential significance in patients with PCOS and POF. Novel metabolites with up/downregulated expressions can be discovered in patients with PCOS and POF using serum-based metabolomics; these metabolites show good diagnostic performance and can act as effective biomarkers for the early detection of PCOS and POF. Furthermore, these metabolites might be involved in the pathophysiological mechanisms of PCOS and POF via interplay with corresponding genes.

The main characteristics of panic disorder (PD) include recurrent panic attacks and persistent worry, accompanied by other physical and cognitive symptoms. While recent studies have revealed that gut bacteria play an important role in anxiety and depression, little is known about the relationship between oral microbiota and PD. Therefore, the objective of this study was to explore a possible correlation between oral microbiota and PD. We conducted 16S rRNA sequencing to compare differences in the oral microbiota of patients with PD (n = 26) and healthy controls (n = 40). Patients with PD exhibited higher alpha diversity (abundance and evenness) in their oral microbiota than healthy controls, while analysis of beta diversity revealed that the two groups differed in microbial community composition. Moreover, the relative abundance of 61 genera differed between them. Overall, PD resulted in distinct oral microbial profiles that could be potential diagnostic markers and therapeutic targets.

PURPOSE: We aimed to evaluate choroidal thickness (CT) in patients who have recovered from COVID-19 by using enhanced depth imaging optical coherence tomography (EDI-OCT). METHODS: We included fifty-eight patients who have recovered from COVID-19 (group 1) and fifty healthy control subjects (group 2) in this prospective study. Best corrected visual acuity, anterior segment and posterior segment examinations of all subjects were performed. CT scan and measurements were taken with the EDI mode of the Spectral Domain OCT device. RESULTS: Of the 108 subjects included in this study, 57 were female and 51 were male. The mean age was similar in both groups (36.10 ± 7.12 and 35.58 ± 7.29, respectively, p = 0.276). Group 1 had the following characteristics: the mean time since diagnosis was 53.18 ± 2.84; it had been 38.48 ± 4.07 days since the PCR test was negative; and all subjects were outpatients. It was detected that the CT of the patients in group 1 decreased in all areas compared to group 2, and this decrease was significant in subfoveal, temporal and inferior areas (257.48 ± 32.79, 273.62 ± 45.04, p = 0.04; 232.96 ± 41.79, 252.76 ± 46.09, p = 0.02, and 245.22 ± 44.58, 271.54 ± 55.07, p = 0.01, respectively). In the retinal nerve fiber layer analysis for group 1, thickening was detected in all areas, although it was not statistically significant, except in the temporal area where it was (superotemporal, superonasal, nasal, inferonasal, inferotemporal, temporal, and global [p = 0 .08, p = 0.45, p = 0.73, p = 0.64, p = 0.74, p = 0.02, and p = 0.10, respectively]). CONCLUSION: For individuals who had recovered from COVID-19, it was found that CT decreased in all areas in these patients. Therefore, this study in which we have demonstrated the decrease in the thickness of the choroidal tissue, a tissue with high blood flow, may contribute to the understanding of the systemic microvascular waste of this disease.

Background: Changes in platelet count (PLT) are strongly associated with patient survival and may be clinically indicative of certain underlying diseases. However, there were few studies on the prognosis of patients with cancer cachexia. Objective: The purpose of this study was to investigate the relationship between PLT and 1-year survival in patients with cancer cachexia. Methods: We performed a nested case-control study of data from a multicenter clinical study of cancer. There were 252 patients with cancer cachexia whose survival time was less than or equal to 1 year and 252 patients with cancer cachexia whose survival time was more than 1 year meeting the inclusion criteria. The mortality risk and the adjusted risk were estimated by logistic regression and displayed as odds ratios (ORs) and 95% confidence intervals (95% CIs). Results: PLT was negatively correlated with 1-year overall survival (OS) of patients with cancer cachexia (increased per standard deviation (SD): OR = 1.29; 95% CI: 1.05-1.60; P = 0.018). The higher the PLT, the lower the OS of patients. When classified by dichotomy (D1 < 296×109/L, D2 ≥ 296×109/L), OS of patients in the D2 group was worse (OR = 2.18; 95% CI: 1.38-3.47; P = 0.001). When classified by quartile (Q1- Q3 < 305×109/L, Q4 ≥ 305×109/L), OS of patients in the Q4 group was poorer (OR = 1.82; 95% CI: 1.14-2.94; P = 0.013). In addition, patients with a low PLT (< 296×109/L) and either a high total bilirubin (TBIL) (≥ 17.1 µmol/L) or a smoking history had poor 1-year survival. Based on our primary cohort study, we conducted a survival analysis of 3130 patients with cancer cachexia and found that OS was better in patients with low PLT (< 296×109/L). Conclusion: PLT was negatively correlated with 1-year overall survival of patients with cancer cachexia.

The COVID-19 pandemic has forced to rapidly encourage the use of face masks during medical consultations, with significant implication for psychiatry. This study examined the opinions and attitudes of psychiatrists toward the impact of wearing a face mask on the psychiatric interview. 513 psychiatrists and trainee psychiatrists completed an electronic survey about the impact of wearing a face mask on the psychiatric interview. Less efficiency in capturing clinical signs/symptoms, emergence of false inferences in patients and altered patient-clinician interactions were commonly reported negative impacts of face mask (66-96%). The quality of the therapeutic alliance was reported as affected by the mask by 47% of the sample. Results were mixed on the use of telepsychiatry as a potential solution to mask-related inconvenience. The use of face masks has significant negative effects on the psychiatric interview. Providing specific training to clinicians could be a potential solution for masks-induced biases. Supplementary Information The online version contains supplementary material available at 10.1007/s11126-021-09962-3.

Objectives: Several studies have shown associations of ABO and Rh blood groups with various diseases; however, the relationship of ABO and Rh blood groups with rheumatic diseases are scarce. The aim of the present study was to examine whether there is an association between ABO and Rh blood groups and the types of rheumatic diseases. Method: In this multi-centre cross-sectional study, sociodemographic data, type of rheumatic disease, and type ABO and Rh blood groups were examined for patients with different rheumatic diseases. Results: A total of 304 patients; 207 (68.1%) were diagnosed with rheumatoid arthritis, and 40 (13.2%) had systemic lupus erythematosus. The patients were assessed for blood types; 37.8% patients had A type, 27.6% had B type, 19.1% had O type, and 15.4% had AB type. The Rh (+) blood group was more prevalent (89.1%) than Rh (–). Blood group A was more prevalent in patients with rheumatic disease, followed by B, O, and AB respectively, although there was no significant difference in the distribution of ABO groups among rheumatic diseases. Female gender, smoking, and anti-cyclic citrullinated peptide are significantly different between the blood groups within rheumatic diseases. Conclusion: The A and Rh (+) blood groups were more commonly observed in patients with rheumatic diseases. There was lack of association between types of rheumatic diseases and ABO blood groups. The study provides knowledge for the interaction between ABO blood groups and several risk factors related to rheumatic diseases and may serve a guide for future clinical studies.

The most affected disease in recent years is Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) that is notable as COVID-19. It has been started as a disease in one place and arisen as a pandemic throughout the world. A serious health problem is developed in the lungs due to the effect of this coronavirus. Sometimes it may result in death as a consequence of extensive alveolar damage and progressive respiratory failure. Hence, early detection and appropriate diagnosis of corona virus in patient’s body is very essential to save the lives of affected patients This work evolves a Silicon (Si) based label-free electrical device i.e. the reduced graphene oxide field-effect transistor (rGO FET) for SARS-CoV-2 detection. Firstly rGO FET functionalized with SARS-CoV-2 monoclonal antibodies (mAbs). Then the rGO FET characteristic response is observed to detect the antibody-antigen reaction of SARS-CoV-2 with different molar ranges. The developed GFET shows better performance towards the drain current and limit-of-detection (LoD) up to 2E-18 M. Therefore, we believe that an intense response was observed than the earlier developed devices and signifies impressive capability for subsequent implementation in point-of-care (PoC) diagnostic tests.

Introduction In recent years numerous research studies have indicated that chronic inflammation in psoriasis can be associated with an increased risk of developing atherosclerosis. Aim The presented study was aimed at demonstrating whether patients suffering from psoriasis vulgaris are at a greater risk of developing atherosclerosis depending on the presence of selected cardiovascular risk factors and the course and severity of the disease. Material and methods Sixty-two patients with diagnosed psoriasis vulgaris and 42 healthy volunteers were included in the study. All the patients underwent carotid ultrasound with the assessment of the common carotid artery intima-media thickness (IMT) and the computed tomography with determination of coronary artery calcification (CAC). Results The IMT was significantly higher in the study group (1.030 ±0.303 mm vs. 0.838 ±0.151 mm, p < 0.0001). We also found a significantly increased severity of Calcium Score (CS) in Agatston units (168.20 ±309.63 vs. 24.52 ±43.21, p = 0.0207) of CAC in patients with psoriasis. There was no significant correlation between the degree of atherosclerosis and psoriasis severity determined in the PASI (Psoriasis Area and Severity Index) scale, duration of the disease, number of exacerbations per year or C-reactive protein values. Conclusions The study showed an increased risk of developing atherosclerosis in patients diagnosed with psoriasis vulgaris, but no correlation was found between the degree of atherosclerosis and the severity of the disease.

Purpose: This study aims to develop and validate a nomogram based on a novel platelet index score (PIS) to predict prognosis in patients with renal cell carcinoma (RCC). Patients and methods: We retrospectively analyzed the data of 759 consecutive patients with RCC. The Kaplan-Meier curves were performed to analyze the platelet parameters and PIS was established. The patients were randomly divided into training (N=456, 60%) and validation cohorts (N=303, 40%). The nomogram was created based on the factors determined by multivariable Cox proportional hazard regression of the training cohort. We assessed the discrimination and calibration of our nomogram in both training and validation cohorts. And then the nomogram was compared with other reported models. Results: High platelet count (PLT>285×109/L) and low platelet distribution width (PDW≤10.95fL) were associated with shorter progression-free survival (PFS). Thus, PLT and PDW were incorporated in a novel score system called PIS. On multivariable analysis of training cohort, PIS, American Joint Committee on Cancer (AJCC) stage, and sarcomatoid differentiation were independent prognostic factors, which were all selected into the nomogram. The nomogram exhibited good discrimination in both training (C-index: 0.835) and validation cohorts (C-index: 0.883). The calibration curves also showed good agreement between prediction and observation in both cohorts. The C-index of the nomogram (C-index: 0.810~0.902) for predicting 2-year, 3-year, and 4-year PFS were significantly higher than Leibovich (C-index: 0.772~0.813), SSIGN (C-index: 0.775~0.876), Cindolo (C-index: 0.642~0.798), Yaycioglu (C-index: 0.648~0.804), MSKCC (C-index: 0.761~0.862), Karakiewicz (C-index: 0.747~0.851), and AJCC stage models (C-index: 0.759~0.864). Conclusion: The nomogram based on a novel PIS could offer better risk stratification in patients with RCC.