Search

Neonatal and infantile cholestasis (NIC) can represent the onset of a surgically correctable disease and of a genetic or metabolic disorder worthy of medical treatment. Timely recognition of NIC and identification of the underlying etiology are paramount to improve outcomes. Upon invitation by the Italian National Institute of Health (ISS), an expert working grouped was formed to formulate evidence-based positions on current knowledge about the diagnosis of NIC. A systematic literature search was conducted to collect evidence about epidemiology, etiology, clinical aspects and accuracy of available diagnostic tests in NIC. Evidence was scored using the GRADE system. All recommendations were approved by a panel of experts upon agreement of at least 75% of the members. The final document was approved by all the panel components. This position document summarizes the collected statements and defines the best-evidence diagnostic approach to cholestasis in the first year of life.

This article is part of a series on methods for living guidelines, consolidating practical experiences from developing living guidelines. It focuses on methods for identification, selection, and prioritisation of clinical questions for a living approach to guideline development.Members of the Australian Living Evidence Consortium (ALEC), the National Institute of Health and Care Excellence (NICE) and the US Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Network, convened a working group. All members have expertise and practical experience in the development of living guidelines. We collated methods documents on prioritisation from each organisation's living guidelines, conducted interviews and held working group discussions. We consolidated these to form best-practice principles, which were then edited and agreed on by the working group members.We developed best-practice principles for 1) identification, 2) selection, and 3) prioritisation, of questions for a living approach to guideline development. Several different strategies for undertaking prioritising questions are explored.The paper provides guidance for prioritising questions in living guidelines. Subsequent papers in this series explore consumer involvement, search decisions, and methods decisions, that are appropriate for questions with different priority levels.

Producing living guidelines requires making important decisions about methods for evidence identification, appraisal and integration to allow the living mode to function. Clarifying what these decisions are and the trade-offs between options is necessary. This paper provides Living Guideline developers with a framework to enable them to choose the most suitable model for their living guideline topic, question or context.We developed this guidance through an iterative process informed by interviews, feedback and a consensus process with an international group of Living Guideline developers.Several key decisions need to be made both before commencing and throughout the continual process of Living Guideline development and maintenance. These include deciding what approach is taken to the systematic review process; decisions about methods to be applied for the evidence appraisal process, including the use of unpublished data; and selection of "triggers" to incorporate new studies into Living Guideline recommendations. In each case, there are multiple options and trade-offs.We identify trade-offs and important decisions to be considered throughout the Living Guideline development process. The most appropriate, and most sustainable, mode of development and updating will be dependent on the choices made in each of these areas.

English The last decade has witnessed the emergence of new psychoactive substances that are analogues of classical drugs of abuse in order to escape the regulations surrounding the latter drugs. These drugs were of both herbal and synthetic origin and were advertised initially as ‘legal highs’; thus, they were perceived as safe by users. Hence, upon their emergence, they were not controlled by the Misuse of Drugs Act 1971, which contributed to their popularity and increased sales online and within street markets. In 2016, the Psychoactive Substance Act introduced a blanket ban on all new psychoactive substances except for caffeine, alcohol, and nicotine. This in turn, contributed to the change in the sale of new psychoactive substances products that have been sold as concealed in different matrices, including herbal products, papers, fabrics, and textiles. Concealing drugs in paper has been very popular, especially since the drug product is of lightweight and can be sent via postal services. However, new psychoactive concealed in papers are toxic not only to the users; but also, to the person handling them (i.e. mail employees). One of the classes of new psychoactive substances that have been commonly concealed in papers and that have been linked to toxicity and hospitalization cases is synthetic cannabinoids. Therefore, there is a need to identify new psychoactive substances concealed in papers non-destructively and rapidly to prevent toxicity linked to them. Handheld Raman spectroscopy offers this advantage as it is of lightweight and carries the sample to the matrix. Therefore, this work used handheld Raman spectroscopy for identifying synthetic cannabinoids concealed in papers using Raman spectroscopy combined with machine learning analytics. Synthetic cannabinoid and paper samples were measured non-destructively using a handheld Raman spectrometer equipped with a 1064 nm laser wavelength. Spectral data was exported into Matlab 2020b where machine learning analytics including identification and prediction was. The results showed that Raman spectroscopy could identify specific synthetic cannabinoids in papers that were either deposited on the surface of the paper or diffused inside the paper substrate. When machine learning analytics were applied to the Raman spectra of the papers, quantitative information was obtained regarding the amount of synthetic cannabinoid deposited on the paper surface. In summary, handheld Raman spectroscopy could identify and quantify synthetic cannabinoids on paper rapidly and non-destructively. Future work involves testing other classes of new psychoactive substance and applying deep learning analytics

To describe and reflect on the consumer engagement approaches used in five living guidelines from the perspectives of consumers (i.e., patients, carers, the public and their representatives) and guideline developers.In a descriptive report, we used a template to capture engagement approaches and the experiences of consumers and guideline developers in living guidelines in Australia and the UK. Responses were summarised using descriptive synthesis.One guideline used a Consumer Panel, three included two to three consumers in the guideline development group and one did both. Much of our experience was common to all guidelines (e.g., consumers felt welcome but that their role initially lacked clarity). We identified six challenges and opportunities specific to living guidelines: managing the flow of work; managing engagement in online environments; managing membership of the panel; facilitating more flexibility, variety and depth in engagement; recruiting for specific skills - although these can be built over time; developing living processes to improve and adapt consumer engagement together.Consumer engagement in living guidelines should follow established principles of consumer engagement in guidelines. Conceiving the engagement as living, underpinned by a living process evaluation, allows the approach to be developed with consumers over time.

This is a pre-copyedited, author-produced version of an article accepted for publication in European Journal of Preventive Cardiology following peer review. The version of record Kavousi, Pisinger, Barthelemy, Smedt, Koskinas, Marques-Vidal, Panagiotakos, Prescott, Tiberi, Vassiliou, Løchen. Electronic cigarettes and health with special focus on cardiovascular effects: position paper of the European Association of Preventive Cardiology (EAPC). European Journal of Preventive Cardiology (EJPC). 2020:2047487320941993, is available online at: https://doi.org/10.1177/2047487320941993. Background - Tobacco use is the single largest preventable risk factor for premature death of non-communicable diseases and the second leading cause of cardiovascular disease. In response to the harmful effects of tobacco smoking, the use of electronic cigarettes (e-cigarettes) has emerged and gained significant popularity over the past 15 years. E-cigarettes are promoted as safe alternatives for traditional tobacco smoking and are often suggested as a way to reduce or quit smoking. However, evidence suggests they are not harmless. Discussion - The rapid evolution of the e-cigarette market has outpaced the legislator’s regulatory capacity, leading to mixed regulations. The increasing use of e-cigarettes in adolescents and young individuals is of concern. While the long-term direct cardiovascular effects of e-cigarettes remain largely unknown, the existing evidence suggests that the e-cigarette should not be regarded as a cardiovascular safe product. The contribution of e-cigarette use to reducing conventional cigarette use and smoking cessation is complex, and the impact of e-cigarette use on long-term cessation lacks sufficient evidence. Conclusion - This position paper describes the evidence regarding the prevalence of e-cigarette smoking, uptake of e-cigarettes in the young, related legislations, cardiovascular effects of e-cigarettes and the impact of e-cigarettes on smoking cessation. Knowledge gaps in the field are also highlighted. The recommendations from the population science and public health section of the European Association of Preventive Cardiology are presented.

Made available in DSpace on 2020-12-10T20:03:52Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-03-15 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Study Design. Cross-sectional study. Objective. To investigate the equivalence of electronic and paper version of self-report questionnaires for the assessment of disability, pain, fear of movement, depression, and physical activity of patients with chronic low back pain (LBP). Summary of Background Data. Paper and electronic versions of self-report questionnaires are commonly used for assessment of patients with LBP. However, the equivalence of self-report questionnaires commonly used for assessment of patients with chronic LBP remains unclear. Methods. Seventy-nine individuals with chronic LBP seeking physiotherapy care were recruited. Participants attended the clinic twice with an interval of 1 week and completed the self-reported questionnaires in a random order. The following questionnaires were administered: Roland Morris Disability Questionnaire (RMDQ); 11-point numerical rating scale (NRS); Tampa Scale for Kinesiophobia (TSK); Center for Epidemiological Studies-Depression (CES-D), and Baecke Habitual Physical Activity Questionnaire (BPAQ). To investigate the equivalence between the two questionnaire versions, intraclass correlation coefficient with 95% confidence interval and Bland-Altman plotting was used. Results. The paper and electronic versions of the RMDQ, TSK, and CES-D showed good reliability and the showed moderate reliability. In contrast, the NRS showed poor reliability between the electronic and paper versions. Conclusion. Our findings support that the electronic version of the RMDQ, TSK, CES-D, and BPAQ can be administered in clinical and research settings for assessment of patients with chronic LBP. Nevertheless, electronic version of the NRS for assessment of pain intensity should not be used interchangeably in clinical practice in patients with chronic LBP. Univ Estadual Paulista, Dept Fisioterapia, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Fed Minas Gerais UFMG, Dept Phys Therapy, Belo Horizonte, MG, Brazil Univ Estadual Paulista, Dept Educ Fis, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Estadual Paulista, Dept Fisioterapia, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Estadual Paulista, Dept Educ Fis, Fac Ciencias & Tecnol, Presidente Prudente, Brazil FAPESP: 2017/21336-8 FAPESP: 2016/03826-5 FAPESP: 2017/12246-5

Heart failure is a complex syndrome affecting several organs including kidney, lungs, liver, brain muscles and sympathetic system. Each of these organs might contribute to its severity and prognosis. The prognosis assessment is critical for a correct heart failure management. It has already been demonstrated that a single parameter is weaker for prognosis than different parameters combined. The Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score has been built and validated for heart failure with reduced ejection fraction (HFrEF) patients by considering cardiopulmonary exercise test data combined with clinical, laboratory and echocardiographic measurements. The betablockers treatment is a milestone in the HFrEF management. In the MECKI score database, the association of betablockers treatment with outcome has been investigated in different settings.

Antimicrobial resistance (AMR) continues to threaten global health. Although global and national AMR action plans are in place, infection prevention and control is primarily discussed in the context of healthcare facilities with home and everyday life settings barely addressed.\ud \ud As seen with the recent global SARS-CoV-2 pandemic, everyday hygiene measures can play an important role in containing the threat from infectious microorganisms.\ud \ud This position paper has been developed following a meeting of global experts in London, 2019. It presents evidence that home and community settings are important for infection transmission and also the acquisition and spread of AMR. It also demonstrates that the targeted hygiene approach offers a framework for maximizing protection against colonization and infections, thereby reducing antibiotic prescribing and minimizing selection pressure for the development of antibiotic resistance. If combined with the provision of clean water and sanitation, targeted hygiene can reduce the circulation of resistant bacteria in homes and communities, regardless of a country's Human Development Index (overall social and economic development). Achieving a reduction of AMR strains in healthcare settings requires a mirrored reduction in the community.\ud \ud The authors call upon national and international policy makers, health agencies and healthcare professionals to further recognize the importance of targeted hygiene in the home and everyday life settings for preventing and controlling infection, in a unified quest to tackle AMR.

Infections by SARS CoV2 - COVID-19 became in a short time a worldwide health emergency. The present SARS-CoV-2 pandemic induced in a short time, an unprecedented impact on public health and on the pre-existing care pathways. In order to appropriately address this epidemiological emergency, urgent solutions were needed, such as remodelling or stopping hospitalization and deferrable clinical activities to avoid spreading the SARS-CoV-2 infection. After the first emergency lockdown phase, care pathways must guarantee healthcare to patients and preserve the safety of the healthcare personnel and of all the other subjects that refer to the cardiological surgeries. Rigorous prescriptive appropriateness of the requested exams with consequent reduction of unnecessary examinations is an essential requirement to preserve prioritized diagnostic and care pathways to patients in need, minimizing the risks connected to the SARS-CoV-2 contagion in hospitals. Telemedicine services represent a valid answer to cardiovascular disease patients’ need for care and assistance, including those in quarantine and voluntary isolation. These services successfully contribute to fight the spread of the virus guaranteeing at the same time therapy and support through remote services that must therefore be considered a resource to be implemented and enhanced. This document has to be used by the healthcare personnel working in hospitals and in district offices, if applicable, and aims at managing patients, in complete safety and considered not suspect/not probable (‘not at risk’) of SARS-CoV-2 infection, eligible for diagnostic activity and subsequent therapy in outpatient surgeries. In particular, this document provides indications for patient evaluation to prevent COVID-19 exposure, gives general indications on managing appointments and waiting rooms, on how to strictly adhere to environmental safety measures, on the proper use of Individual Protective Equipment (IPE). It also provides specific indications for outpatient service procedures, like electrocardiogram, cardiologic examination, cardiologic checkup, Dynamic Holter Electrocardiogram, Transthoracic Echocardiography, Echo Stress, Transoesophageal Echocardiography, Bike Ergometer stress test, Ergospirometry, Outpatient Checkup of implantable electronic cardiac devices.

Objective : Most systematic reviews of interventions focus on potential benefits. Common methods and assumptions that are appropriate for assessing benefits can be inappropriate for harms. This paper provides a primer on researching harms, particularly in systematic reviews. Study Design and Setting : Commentary describing challenges with assessing harm. Results : Investigators should be familiar with various terminologies used to describe, classify, and group harms. Published reports of clinical trials include limited information about harms, so systematic reviewers should not depend on these studies and journal articles to reach conclusions about harms. Visualizations might improve communication of multiple dimensions of harms such as severity, relatedness, and timing. Conclusion : The terminology, classification, detection, collection, and reporting of harms create unique challenges that take time, expertise, and resources to navigate in both primary studies and evidence syntheses. Systematic reviewers might reach incorrect conclusions if they focus on evidence about harms found in published reports of randomized trials of a particular health problem. Systematic reviews could be improved through better identification and reporting of harms in primary studies and through better training and uptake of appropriate methods for synthesizing evidence about harms.

Objectives A recent paper by Doi et al. advocated completely replacing the relative risk (RR) with the odds ratio (OR) as the effect measure in clinical trials and meta-analyses with binary outcomes. Besides some practical advantages of RR over OR, Doi et al.’s key assumption that the OR is “portable” in the meta-analysis, that is, study-specific ORs are likely not correlated with baseline risks, was not well justified. Study designs and settings We summarized Spearman's rank correlation coefficient between study-specific ORs and baseline risks in 40,243 meta-analyses from the Cochrane Database of Systematic Reviews. Results Study-specific ORs tend to be higher in studies with lower baseline risks of disease for most meta-analyses in Cochrane Database of Systematic Reviews. Using an actual meta-analysis example, we demonstrate that there is a strong negative correlation between OR (RR or RD) with the baseline risk and the conditional effects notably vary with baseline risks. Conclusions Replacing RR or RD with OR is currently unadvisable in clinical trials and meta-analyses. It is possible that no effect measure is “portable” in a meta-analysis. In addition to the overall (or marginal) effect, we suggest presenting the conditional effect based on the baseline risk using a bivariate generalized linear mixed model.

Contains fulltext : 237219.pdf (Publisher’s version ) (Open Access) Objective: To describe characteristics of randomised controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria. Study design: MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011–2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form. Results 183 RCT publications were identified; 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for the majority of trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was 'adequately reported', three were reported 'inadequately or not at all', the other 'partially'. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation. Conclusion: Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting. 12 p.

In 2020 COVID-19 led to an unprecedented stream of papers being submitted to journals. Scientists and physicians all around the globe were in need for information about this new disease. In this climate, many articles were accepted after extremely fast peer-reviews to provide the scientific community with the latest discoveries and knowledge. Unfortunately, this also led to articles retraction due to authors' misconduct or errors in methodology and/or conclusions. The aim of this study is to investigate the number and characteristics of retracted papers, and to explore the main causes that led to retraction. We conducted a systematic review on retracted articles, using PubMed as data source. Our inclusion criteria were the following: English-language retracted articles that reported original data, results, opinions or hypotheses on COVID-19 and Sars-CoV-2. Twenty-seven retracted articles were identified, mainly reporting observational studies and opinion pieces. Many articles published during the first year of the pandemic have been retracted, mainly due to the authors' scientific misconduct. Duplications, plagiarism, frauds and absence of consent, were the main reasons for retractions. In modern medicine, researchers are required to publish frequently, and, especially during situations like the COVID-19 pandemic, when articles were rapidly published, gaps in peer-reviews system and in the path to scientific publication arose.

Objective : In this methodologic study (Part 2 of 2), we examined the overlap in sources of evidence and the corresponding results for harms in systematic reviews for gabapentin. Study Design & Setting : We extracted all citations referenced as sources of evidence for harms of gabapentin from 70 systematic reviews, as well as the harms assessed and numerical results. We assessed consistency of harms between pairs of reviews with a high degree of overlap in sources of evidence (>50%) as determined by corrected covered area (CCA). Results : We found 514 reports cited across 70 included reviews. Most reports (244/514, 48%) were not cited in more than one review. Among 18 pairs of reviews, we found reviews had differences in which harms were assessed and their choice to meta-analyze estimates or present descriptive summaries. When a specific harm was meta-analyzed in a pair of reviews, we found similar effect estimates. Conclusion : Differences in harms results across reviews can occur because the choice of harms is driven by reviewer preferences, rather than standardized approaches to selecting harms for assessment. A paradigm shift is needed in the current approach to synthesizing harms.

Objective Recently Doi et al. argued that risk ratios should be replaced with odds ratios in clinical research. We disagreed, and empirically documented the lack of portability of odds ratios, while Doi et al. defended their position. In this response we highlight important errors in their position. Study design and setting We counter Doi et al.’s arguments by further examining the correlations of odds ratios, and risk ratios, with baseline risks in 20,198 meta-analyses from the Cochrane Database of Systematic Reviews. Results Doi et al.’s claim that odds ratios are portable is invalid because 1) their reasoning is circular: they assume a model under which the odds ratio is constant and show that under such a model the odds ratio is portable; 2) the method they advocate to convert odds ratios to risk ratios is biased; 3) their empirical example is readily-refuted by counter-examples of meta-analyses in which the risk ratio is portable but the odds ratio isn't; and 4) they fail to consider the causal determinants of meta-analytic inclusion criteria: Doi et al. mistakenly claim that variation in odds ratios with different baseline risks in meta-analyses is due to collider bias. Empirical comparison between the correlations of odds ratios, and risk ratios, with baseline risks show that the portability of odds ratios and risk ratios varies across settings. Conclusion The suggestion to replace risk ratios with odds ratios is based on circular reasoning and a confusion of mathematical and empirical results. It is especially misleading for meta-analyses and clinical guidance. Neither the odds ratio nor the risk ratio is universally portable. To address this lack of portability, we reinforce our suggestion to report variation in effect measures conditioning on modifying factors such as baseline risk; understanding such variation is essential to patient-centered practice.

Heart failure (HF) is a long-term clinical syndrome, with increasing prevalence and considerable healthcare costs that are further expected to increase dramatically. Despite significant advances in therapy and prevention, mortality and morbidity remain high and quality of life poor. Epidemiological data, that is, prevalence, incidence, mortality, and morbidity, show geographical variations across the European countries, depending on differences in aetiology, clinical characteristics, and treatment. However, data on the prevalence of the disease are scarce, as are those on quality of life. For these reasons, the ESC-HFA has developed a position paper to comprehensively assess our understanding of the burden of HF in Europe, in order to guide future policies for this syndrome. This manuscript will discuss the available epidemiological data on HF prevalence, outcomes, and human costs—in terms of quality of life—in European countries.

This is a pre-copyedited, author-produced version of an article accepted for publication in European Journal of Preventive Cardiology following peer review. The version of record Piepoli, M.F., Abreu, A., Albus, C., Ambrosetti, M., Brotons, C., Catapano, A.L. ... Tiberi, M. (2020). Update on cardiovascular prevention in clinical practice: A position paper of the European Association of Preventive Cardiology of the European Society of Cardiology*. European Journal of Preventive Cardiology (EJPC), 27(2), 181-205 is available online at: https://doi.org/10.1177/2047487319893035. European guidelines on cardiovascular prevention in clinical practice were first published in 1994 and have been regularly updated, most recently in 2016, by the Sixth European Joint Task Force. Given the amount of new information that has become available since then, components from the task force and experts from the European Association of Preventive Cardiology of the European Society of Cardiology were invited to provide a summary and critical review of the most important new studies and evidence since the latest guidelines were published. The structure of the document follows that of the previous document and has six parts: Introduction (epidemiology and cost effectiveness); Cardiovascular risk; How to intervene at the population level; How to intervene at the individual level; Disease-specific interventions; and Settings: where to intervene? In fact, in keeping with the guidelines, greater emphasis has been put on a population-based approach and on disease-specific interventions, avoiding re-interpretation of information already and previously considered. Finally, the presence of several gaps in the knowledge is highlighted.

It is estimated that 621 million children throughout the world have untreated caries on primary teeth. 1 Early childhood caries (ECC), which affects preschool children, progresses rapidly and is associated with pain, difficulty chewing, weight loss, difficulty sleeping, altered behaviour, and a poorer quality of life for affected children and theirfamilies. Children with dental caries have greater treatmentneed, which is expensive and not readily accessible in most developing countries. In South Africa, ECC is a major public health problem with caries rates among children as high as 70% in some provinces.

This study's objective was to assess which caring recruitment behaviors correlate with the successful recruitment of older African-American adults-a two-step cross-sectional design employing a vignette-based survey methodology. Kristen Swanson's middle-range theory of caring was used to guide the examination of African-American adults' (65 years of age and older) perceptions of research-study-recruiter recruitment behaviors. This study's main findings are twofold: Step 1: Seven of ten invited experts identified major revisions of the two core vignettes, written at an eighth-grade reading level and high school comprehension. Step 2: A 51% response rate yielded findings that this methodology successfully captured older African-American adults' perception of research study recruiters' behavioral characteristics during the recruitment process. Older African-Americans who received the hypothetical caring vignette were twice as likely to indicate their willingness to enroll in a research study with a high commitment (i.e., brain donation) compared to their counterparts who received the hypothetical uncaring recruitment scenario. Vignette-based survey methodology holds promise as a tool for informing the recruitment of older African-American adults and other minorities into federally funded health-related research studies.

The prevalence and public health burden of chronic heart failure (CHF) in Europe is steadily increasing mainly caused by the ageing population and prolonged survival of patients with CHF. Frequent hospitalizations, high morbidity and mortality rates, and enormous healthcare costs contribute to the health-related burden. However, multidisciplinary frameworks that emphasize effective long-term management and the psychological needs of the patients are sparse. The present position paper endorsed by the European Association of Preventive Cardiology (EAPC) provides a comprehensive overview on the scientific evidence of psychosocial aspects of heart failure (HF). In order to synthesize newly available information and reinforce best medical practice, information was gathered via literature reviews and consultations of experts. It covers the evidence for aetiological and prospective psychosocial risk factors and major underlying psycho-biological mechanisms. The paper elucidates the need to include psychosocial aspects in self-care concepts and critically reviews the current shortcomings of psychotherapeutic and psycho-pharmacological interventions. It also highlights the need for involvement of psychological support in device therapy for patients with HF and finally calls for better palliative care in the final stage of HF progression.

In this paper, we describe and discuss evidence implementation as a venture in global human collaboration within the framework of "people, process, evidence, and technology" as a roadmap for navigating implementation. At its core implementation is not a technological, or theoretical process, it is a human process. That health professionals central to implementation activities may not have had formal training in implementation, highlights the need for processes and programs that can be integrated within healthcare organization structures. Audit with feedback is an accessible implementation approach that includes the capacity to embed theory, frameworks, and bottom-up change processes to improve the quality of care. In this third paper in the JBI series, we discuss how four overarching principals necessary for sustainability (Culture, Capacity, Communication, and Collaboration) are combined with evidence, technology, and resources for evidence-based practice change. This approach has been successfully used across hundreds of evidence implementation projects around the globe for over 15 years. We present healthcare practitioner-led evidence-based practice improvement as sustainable and achievable in collaborative environments such as the global JBI network as a primary interest of the practicing professions and provide an overview of the JBI approach to evidence implementation.

Szypłowska Małgorzata, Gorecka Adrianna, Kuś Adrian, Zaremba Bartłomiej, Obel Michał. Diagnosis and management of lipoedema – a review paper. Journal of Education, Health and Sport. 2020;10(9):494‑499. eISSN 2391-8306. DOI http://dx.doi.org/10.12775/JEHS.2020.10.09.059 https://apcz.umk.pl/czasopisma/index.php/JEHS/article/view/JEHS.2020.10.09.059 https://zenodo.org/record/4042181 The journal has had 5 points in Ministry of Science and Higher Education parametric evaluation. § 8. 2) and § 12. 1. 2) 22.02.2019. © The Authors 2020; This article is published with open access at Licensee Open Journal Systems of Nicolaus Copernicus University in Torun, Poland Open Access. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author (s) and source are credited. This is an open access article licensed under the terms of the Creative Commons Attribution Non commercial license Share alike. (http://creativecommons.org/licenses/by-nc-sa/4.0/) which permits unrestricted, non commercial use, distribution and reproduction in any medium, provided the work is properly cited. The authors declare that there is no conflict of interests regarding the publication of this paper. Received: 15.09.2020. Revised: 21.09.2020. Accepted: 22.09.2020. Diagnosis and management of lipoedema – a review paper Małgorzata Szypłowska1, Adrianna Gorecka1, Adrian Kuś1, Bartłomiej Zaremba1, Michał Obel2 1Student Research Circle at the Department of Epidemiology and Clinical Research Methodology, Medical University of Lublin 2Student Research Circle at the Department of Endocrinology, Medical University of Lublin Supervisor: PhD Halina Piecewicz-Szczęsna3 3Department of Epidemiology and Clinical Research Methodology, Medical University of Lublin Corresponding author: malgorzata.szyplowska@gmail.com Abstract Lipoedema is a chronic progressive disorder of adipose tissue leading to an enlargement of lower extremities. It is considered to be rare; however, the prevalence of the disease is underestimated because it is commonly misdiagnosed as obesity or lymphedema and the general awareness is poor. The etiology of the disorder is considered to be multifarious, including genetic inheritance, hormonal imbalance and microcirculation alterations. Diagnosis is mainly based on medical history and physical examination. Management of lipoedema is focused on reducing the symptoms, improving the quality of life and preventing further progression of the disease. The aim of this paper is to raise the awareness of the disease and provide appropriate clinical guidance for the assessment of lipoedema. We searched through the PubMed/MEDLINE database and took into consideration all of the results available as of 6 September, 2020 and outlined the current evidence regarding lipoedema epidemiology, etiology, clinical presentation, differential diagnosis, and management. Better understanding of lipoedema is crucial for establishing an early diagnosis and a proper treatment, which in turn will reduce the psychological and physical implications associated with the disease. Key words: lipoedema, lymphoedema, lipolymphoedema

Breakthrough invasive fungal infections (IFI) have emerged as a significant problem in patients receiving systemic antifungals; however, consensus criteria for defining breakthrough IFI are missing. This position paper establishes broadly applicable definitions of breakthrough IFI for clinical research. Representatives of the Mycoses Study Group Education and Research Consortium (MSG-ERC) and the European Confederation of Medical Mycology (ECMM) reviewed the relevant English literature for definitions applied and published through 2018. A draft proposal for definitions was developed, and circulated to all members of the two organizations for comment and suggestions. The authors addressed comments received, and circulated the updated document for approval. Breakthrough IFI was defined as any IFI occurring during exposure to an antifungal drug, including fungi outside the spectrum of activity of an antifungal. The time of breakthrough IFI was defined as the first attributable clinical sign or symptom, mycological finding or radiological feature. The period defining breakthrough IFI depends on pharmacokinetic properties and extends at least until one dosing interval after drug discontinuation. Persistent IFI describes IFI that is unchanged/stable since treatment initiation with ongoing need for antifungal therapy. It is distinct from refractory IFI, defined as progression of disease and therefore similar to non-response to treatment. Relapsed IFI occurs after treatment, and is caused by the same pathogen at the same site, although dissemination can occur. These proposed definitions are intended to support the design of future clinical trials and epidemiological research in clinical mycology, with the ultimate goal of increasing the comparability of clinical trial results.

This document is part of the “SHEA Neonatal Intensive Care Unit (NICU) White Paper Series.” It is intended to provide practical, expert opinion, and/or evidence-based answers to frequently asked questions about CLABSI detection and prevention in the NICU. This document serves as a companion to the CDC Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Prevention of Infections in Neonatal Intensive Care Unit Patients. Central line-associated bloodstream infections (CLABSIs) are among the most frequent invasive infections among infants in the NICU and contribute to substantial morbidity and mortality. Infants who survive CLABSIs have prolonged hospitalization resulting in increased healthcare costs and suffer greater comorbidities including worse neurodevelopmental and growth outcomes. A bundled approach to central line care practices in the NICU has reduced CLABSI rates, but challenges remain. This document was authored by pediatric infectious diseases specialists, neonatologists, advanced practice nurse practitioners, infection preventionists, members of the HICPAC guideline-writing panel, and members of the SHEA Pediatric Leadership Council. For the selected topic areas, the authors provide practical approaches in question-and-answer format, with answers based on consensus expert opinion within the context of the literature search conducted for the companion HICPAC document and supplemented by other published information retrieved by the authors. Two documents in the series precede this one: “Practical approaches to Clostridioides difficile prevention” published in August 2018 and “Practical approaches to Staphylococcus aureus prevention,” published in September 2020.

Contains fulltext : 237435.pdf (Publisher’s version ) (Open Access) Objective: We evaluated reporting completeness and transparency in randomised controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria. Study Design and Setting: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items. Results: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in

Melioidosis is an uncommon, opportunistic disease caused by Burkholderia pseudomallei that lives freely in soil, water, and harsh environments. Transmission occurs from direct exposure of the bacteria to soil or contaminated water supplies. The case fatality rate (CFR) of Melioidosis is high and increases in children and underdeveloped countries. Unfortunately, the disease remains understudied around the world. We carried out an extensive literature review in a systematic approach. A detailed search strategy and PRISMA chart was used to select the relevant articles from reliable medical databases. Articles published from 2016 to 2020 that addressed the incidences, case fatality rates and epidemiology of Melioidosis are selected based on selection criteria. Finally, a total of 34 articles were included in this review. We identified 15,202 cases of Melioidosis globally from 1913-2018 with a total CFR of 33.9%. We calculated the global incidence of ~2607 per year and a CFR of ~814 (35.4%) per year. There are 80% (n = 2476) of adult cases and 20% (n = 620) of paediatric cases. The total (n = 12,413) male to female ratio of Melioidosis is 2.21:1. We also found that the male to female ratio of adult cases (n = 804) is 3.57:1, whereas that of paediatric cases (n = 318) is 1.39:1. The number of patients found working in the agricultural sector was 36.5% (n = 1068). We found a higher incidence and a lower total CFR which are consistent with previously reported studies. We also found that the percentage of paediatric cases was higher than in previous studies, and there is a considerable difference in male to female ratio between adult cases and paediatric cases. This review provides significant evidence to the public health policy makers to develop an effective preventable intervention to reduce the incidence and case fatality of this neglected tropical disease.

Background Staphylococcus argenteus and Staphylococcus schweitzeri, previously known as divergent Staphylococcus aureus clonal lineages, have been recently established as novel, difficult-to-delimit, coagulase-positive species within the S. aureus complex. Methicillin-resistant strains of S. argenteus are known from Australia and the UK. Knowledge of their epidemiology, medical significance and transmission risk is limited and partly contradictory, hampering definitive recommendations. There is mounting evidence that the pathogenicity of S. argenteus is similar to that of ‘classical' S. aureus, while as yet no S. schweitzeri infections have been reported. Aim To provide decision support on whether and how to distinguish and report both species. Sources PubMed, searched for S. argenteus and S. schweitzeri. Content This position paper reviews the main characteristics of both species and draws conclusions for microbiological diagnostics and surveillance as well as infection prevention and control measures. Implications We propose not distinguishing within the S. aureus complex for routine reporting purposes until there is evidence that pathogenicity or clinical outcome differ markedly between the different species. Primarily for research purposes, suitably equipped laboratories are encouraged to differentiate between S. argenteus and S. schweitzeri. Caution is urged if these novel species are explicitly reported. In such cases, a specific comment should be added (i.e. ‘member of the S.aureus complex') to prevent confusion with less- or non-pathogenic staphylococci. Prioritizing aspects of patient safety, methicillin-resistant isolates should be handled as recommended for methicillin-resistant Staphylococcus aureus (MRSA). In these cases, the clinician responsible should be directly contacted and informed by the diagnosing microbiological laboratory, as they would be for MRSA. Research is warranted to clarify the epidemiology, clinical impact and implications for infection control of such isolates.

OBJECTIVES: Most researchers who study the effects of hormonal contraception on menstrual bleeding rely on self-reported data via paper diaries, for which completeness and timeliness have been shown to be poor. The purpose of this exploratory study was to compare the completeness and timeliness of bleeding data collected via paper diaries, text messages or smartphone application (a.k.a “app”). METHODS: This was a sub-study of a double-blinded, placebo-controlled randomized trial comparing the effects of a non-steroidal anti-inflammatory drug, naproxen, with placebo when using a copper IUD. Participants tracked bleeding and symptoms over 112 days. Participants tracked bleeding daily using a paper diary as well as with either text messages or a smartphone app. Participants who used paper and the app were also able to record non-bleeding symptoms. RESULTS: Twenty-five participants submitted diaries. Of these participants, 10 completed both paper and app diaries, 7 completed both paper and text messages, 4 completed the paper diary only, 4 completed the app only. Text messages had the most complete data (108 days), followed by the app (96 days) and paper diaries (84 days). The lag time between a bleeding event and the date recording that event was 0.10 days for text, 1.0 days for app, and 4.73 days for paper diaries. Participants using the app reported a median of 33 other symptoms over the study period compared to 7 for the paper diaries DISCUSSION: Our findings suggest texts demonstrated more complete and timely bleeding data than either paper diaries, or the app. Compared to paper diaries, the app delivered more complete, timely data, and also collected a large set of symptoms.

Hydatidosis is a potential zoonotic helminthic disease affecting a broad spectrum of mammals, including humans, worldwide. The current review was conducted to investigate the genotypic status and prevalence of hydatid disease in camels across the world. For the purpose of the study, the articles addressing the worldwide prevalence of hydatidosis in camels were searched in several English language databases. The search process resulted in the inclusion of 122 papers. Based on the data presented in the reviewed articles, the pooled prevalence of hydatid disease in camels across the world was measured at 23.75% (95% CI 20.15–27.55). Moreover, the subgroup analysis demonstrated significant differences in the overall prevalence of hydatidosis among camels based on year, geographic area, climate parameters, camel population, gender, infected organ, fertility rate of the cyst and laboratory diagnostic technique. Furthermore, the Echinococcus granulosus genotypes identified in camels with hydatidosis included G1, G2, G3, G1–G3, G5, G6, G7, G6–G7 and G6–G10, with G6 being the most common genotype throughout the world. The data obtained from the current study are central to the better conceptualization of the biological and epidemiological characteristics of E. granulosus s.l. genotypes around the world, which can be helpful in the planning and adoption of more comprehensive control strategies.

Urolithiasis is a disease of the genitourinary system, which is defined as the presence of urinary stones at any place in the urinary tract, resulting from the precipitation reaction of chemical compounds. The aim of this study is to demonstrate the important role of selected environmental factors (climate, ambient temperature) and the type of profession performed in the development of urolithiasis. In this field, the literature including original and review papers related to the epidemiology, pathogenesis and risk factors of urolithiasis was analyzed. The study used electronic databases such as Medline, Web of Science and Google Scholar. The prevalence of urolithiasis has increased in recent decades in both developed and developing countries. It is believed that this growing trend is associated with lifestyle changes such as the lack of physical activity, poor eating habits and global warming. Many factors are responsible for the formation of urinary stones. In literature, there is a division into individual and environmental factors. Today, external factors in the form of climate changes (global warming), geographical conditions and seasonal fluctuations, and the type of profession performed are becoming more and more important in the context of the occurrence of urinary stones. Currently, the presence of urolithiasis is becoming a significant problem all over the world and searching for causes is not easy, but particular attention should be paid to certain predispositions resulting from environmental factors, such as ambient temperature and the type of work performed. Int J Occup Med Environ Health. 2019;32(6):761-75.

This article provides reflections on the 1962 paper by Sir Austin Bradford Hill, entitled “The Statistician in Medicine.” It discusses several key takeaways of this paper, including causal inference for big data, reproducibility and replicability in science, and integration of statistics and data science with domain science.

Evidence synthesis is critical in evidence-based healthcare and is a core program of JBI. JBI evidence synthesis is characterised by a pluralistic view of what constitutes evidence and is underpinned by a pragmatic ethos to facilitate the use of evidence to inform practice and policy. This second paper in this series provides a descriptive overview of the JBI evidence synthesis toolkit with reference to resources for 11 different types of reviews. Unique methodologies such as qualitative syntheses, mixed methods reviews, and scoping reviews are highlighted. Key features include standardised and collaborative processes for development of methodologies and a broad range of tailored resources to facilitate the conduct of a JBI evidence synthesis, including appraisal and data extraction tools, software to support the conduct of a systematic review and an intensive systematic review training program. JBI is one of the leading international protagonists for evidence synthesis, providing those who want to answer health-related questions with a toolkit of resources to synthesize the evidence.

Objective: Registries are important data sources for randomised controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries. Study Design and Setting: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed. Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate). Conclusion: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials. Keywords: registries, CONSORT, CONSORT-ROUTINE, randomised controlled trials, reporting guideline, routinely collected data Running Title: Completeness and Transparency of Reporting of RCTs using Registries

BackgroundSmall bowel obstruction (SBO) is a common surgical emergency, causing high morbidity and healthcare costs. The majority of SBOs are caused by adhesions that result from previous surgeries. Bowel obstruction, however, also occurs in patients without previous operation or known pathology, a so called virgin abdomen. It is unknown if small bowel obstruction in the virgin abdomen (SBO-VA) can be managed according to the same principles as other cases of small bowel obstruction. The aim of this position paper is to evaluate the available evidence on etiology and management of small bowel obstruction in the virgin abdomen.MethodsThis is a narrative review with scoping aspects. Clinical topics covered in this review include epidemiology and etiology of SBO-VA, diagnosis and imaging, initial assessment, the role of surgical management in SBO-VA, and the role of non-operative management in SBO-VA.ResultsOur scoping search revealed seven original studies reporting original patient data related to SBO-VA. All the included studies are retrospective cohorts, with populations ranging between 44 and 103 patients with SBO-VA. Adhesions were found to be the cause of the obstruction in approximately half of the reported cases of SBO-VA. A relatively high number of cases of SBO-VA were managed surgically with studies reporting 39–83%. However, in cases where a trial of non-operative management was started, this was generally successful.ConclusionThe data available suggest that etiology and treatment results for patients with SBO-VA are largely comparable to the results in patients with SBO after previous abdominal surgery. We therefore propose that patients with a virgin abdomen could be treated according to existing guidelines for SBO and adhesive small bowel obstruction.

Objective : We compared methods used with current recommendations for synthesizing harms in systematic reviews and meta-analyses (SRMAs) of gabapentin. Study Design & Setting : We followed recommended systematic review practices. We selected reliable SRMAs of gabapentin (i.e., met a pre-defined list of methodological criteria) that assessed at least one harm. We extracted and compared methods in four areas: pre-specification, searching, analysis, and reporting. Whereas our focus in this paper is on the methods used, Part 2 examines the results for harms across reviews. Results : We screened 4320 records and identified 157 SRMAs of gabapentin, 70 of which were reliable. Most reliable reviews (51/70; 73%) reported following a general guideline for SRMA conduct or reporting, but none reported following recommendations specifically for synthesizing harms. Across all domains assessed, review methods were designed to address questions of benefit and rarely included the additional methods that are recommended for evaluating harms. Conclusion : Approaches to assessing harms in SRMAs we examined are tokenistic and unlikely to produce valid summaries of harms to guide decisions. A paradigm shift is needed. At a minimal, reviewers should describe any limitations to their assessment of harms and provide clearer descriptions of methods for synthesizing harms.

The Global Globin Network (GGN) is a project-wide initiative of the Human Variome/Global Variome Project (HVP) focusing on haemoglobinopathies to build the capacity for genomic diagnosis, clinical services, and research in low- and middle-income countries. At present, there is no framework to evaluate the improvement of care, treatment, and prevention of thalassaemia and other haemoglobinopathies globally, despite thalassaemia being one of the most common monogenic diseases worldwide. Here, we propose a universally applicable system for evaluating and grouping countries based on qualitative indicators according to the quality of care, treatment, and prevention of haemoglobinopathies. We also apply this system to GGN countries as proof of principle. To this end, qualitative indicators were extracted from the IthaMaps database of the ITHANET portal, which allowed four groups of countries (A, B, C, and D) to be defined based on major qualitative indicators, supported by minor qualitative indicators for countries with limited resource settings and by the overall haemoglobinopathy carrier frequency for the target countries of immigration. The proposed rubrics and accumulative scores will help analyse the performance and improvement of care, treatment, and prevention of haemoglobinopathies in the GGN and beyond. Our proposed criteria complement future data collection from GGN countries to help monitor the quality of services for haemoglobinopathies, provide ongoing estimates for services and epidemiology in GGN countries, and note the contribution of the GGN to a local and global reduction of disease burden.

Background In cardiovascular prevention and rehabilitation, care activities are carried out by different professionals in coordination, each with their own specific competence. This GICR–IACPR position paper has analysed the interventions performed by the nurse, physiotherapist, dietician and psychologist in order to identify what constitutes minimal care, and it lists the activities that are fundamental and indispensable for each team member to perform in clinical practice. Results In analysing each type of intervention, the following dimensions were considered: the level of clinical care complexity, determined both by the disease and by environmental factors; the ‘area’ complexity, i.e. the specific level of competence required of the professional in each professional section; organisational factors, i.e. whether the care is performed in an inpatient or outpatient setting; duration of the rehabilitation intervention. The specific contents of minimal care have been identified for each professional area together with the specific goals, the assessment tools and the main essential interventions. For the assessments, only a few validated tools have been indicated, leaving the choice of which instrument to use to the individual professional based on experience and usual practice. Conclusion For the interventions, attention has been focused on conditions of major complexity requiring special care, taking into account the different care settings, the clinical conditions secondary to the disease event, and the distinct tasks of each area according to the operator's specific role. The final report performed by each professional has also been included.

The Coronavirus Disease 2019 (COVID-19) has had a continuous and robust impact on world health. The resulting COVID-19 pandemic has had a devastating physical, mental and fiscal impact on the millions of people living with noncommunicable diseases (NCDs). In addition to older age, people living with CVD, stroke, obesity, diabetes, kidney disease, and hypertension are at a particularly greater risk for severe forms of COVID-19 and its consequences. Meta-analysis indicates that hypertension, diabetes, chronic kidney disease, and thrombotic complications have been observed as both the most prevalent and most dangerous co-morbidities in COVID-19 patients. And despite the nearly incalculable physical, mental, emotional, and economic toll of this pandemic, forthcoming public health figures continue to place cardiovascular disease as the number one cause of death across the globe in the year 2020. The world simply cannot wait for the next pandemic to invest in NCDs. Social determinants of health cannot be addressed only through the healthcare system, but a more holistic multisectoral approach with at its basis the Sustainable Development Goals (SDGs) is needed to truly address social and economic inequalities and build more resilient systems. Yet there is reason for hope: the 2019 UN Political Declaration on UHC provides a strong framework for building more resilient health systems, with explicit calls for investment in NCDs and references to fiscal policies that put such investment firmly within reach. By further cementing the importance of addressing circulatory health in a future Framework Convention on Emergency Preparedness, WHO Member States can take concrete steps towards a pandemic-free future. As the chief representatives of the global circulatory health community and patients, the Global Coalition for Circulatory Health calls for increased support for the healthcare workforce, global vaccine equity, embracing new models of care and digital health solutions, as well as fiscal policies on unhealthy commodities to support these investments.