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Background: Fluid thickening is a well-established management strategy for oropharyngeal dysphagia (OD). However, the effects of thickening agents on the physiology of impaired swallow responses are not fully understood, and there is no agreement on the degree of bolus thickening.Aim: To review the literature and to produce a white paper of the European Society for Swallowing Disorders (ESSD) describing the evidence in the literature on the effect that bolus modification has upon the physiology, efficacy and safety of swallowing in adults with OD.Methods: A systematic search was performed using the electronic Pubmed and Embase databases. Articles in English available up to July 2015 were considered. The inclusion criteria swallowing studies on adults over 18 years of age; healthy people or patients with oropharyngeal dysphagia; bolus modification; effects of bolus modification on swallow safety (penetration/aspiration) and efficacy; and/or physiology and original articles written in English. The exclusion criteria consisted of oesophageal dysphagia and conference abstracts or presentations. The quality of the selected papers and the level of research evidence were assessed by standard quality assessments.Results: At the end of the selection process, 33 articles were considered. The quality of all included studies was assessed using systematic, reproducible, and quantitative tools (Kmet and NHMRC) concluding that all the selected articles reached a valid level of evidence. The literature search gathered data from various sources, ranging from double-blind randomised control trials to systematic reviews focused on changes occurring in swallowing physiology caused by thickened fluids. Main results suggest that increasing bolus viscosity (a) results in increased safety of swallowing, (b) also results in increased amounts of oral and/or pharyngeal residue which may result in post-swallow airway invasion, (c) impacts the physiology with increased lingual pressure patterns, no major changes in impaired airway protection mechanisms, and controversial effects on oral and pharyngeal transit time, hyoid displacements, onset of UOS opening and bolus velocity-with several articles suggesting the therapeutic effect of thickeners is also due to intrinsic bolus properties, (d) reduces palatability of thickened fluids and (e) correlates with increased risk of dehydration and decreased quality of life although the severity of dysphagia may be an confounding factor.Conclusions: The ESSD concludes that there is evidence for increasing viscosity to reduce the risk of airway invasion and that it is a valid management strategy for OD. However, new thickening agents should be developed to avoid the negative effects of increasing viscosity on residue, palatability, and treatment compliance. New randomised controlled trials should establish the optimal viscosity level for each phenotype of dysphagic patients and descriptors, terminology and viscosity measurements must be standardised. This white paper is the first step towards the development of a clinical guideline on bolus modification for patients with oropharyngeal dysphagia. [ABSTRACT FROM AUTHOR]

To determine the rate at which abstracts orally presented at the ECR 2000 were published between 2000-2004, and to identify predictive factors of publication and differences between abstracts and subsequently published papers. Specific search profiles were devised to retrieve items from the Medline database. From 1020 abstracts originating from 39 countries, 479 articles (publication rate 47%) were subsequently published in 139 Medline-indexed journals, most frequently in European Radiology (14%). Country of origin statistically (P<0.0001) influences the subsequent publication of the abstract, Germany having the highest number of presentations (n=343) and derived articles (publication rate 54%). Abstracts presented by authors from the USA (n=21) had the highest publication rate (76%). Most papers were published within the first 3 years after the meeting, as original articles and in English-language journals. Both the study sample size and the first author frequently changed. Chest and cardiac studies had the highest publication rates (56%, both). In summary, abstracts presented at the ECR 2000 had a high publication rate in Medline-indexed journals. Country of origin and subspecialty of presentation appeared to influence subsequent full publication. More articles were published in European Radiology than in other journal. [ABSTRACT FROM AUTHOR]

Purpose: Trabecular bone score (TBS) is a grey-level textural measurement acquired from dual-energy X-ray absorptiometry lumbar spine images and is a validated index of bone microarchitecture. In 2015, a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) published a review of the TBS literature, concluding that TBS predicts hip and major osteoporotic fracture, at least partly independent of bone mineral density (BMD) and clinical risk factors. It was also concluded that TBS is potentially amenable to change as a result of pharmacological therapy. Further evidence on the utility of TBS has since accumulated in both primary and secondary osteoporosis, and the introduction of FRAX and BMD T-score adjustment for TBS has accelerated adoption. This position paper therefore presents a review of the updated scientific literature and provides expert consensus statements and corresponding operational guidelines for the use of TBS. Methods: An Expert Working Group was convened by the ESCEO and a systematic review of the evidence undertaken, with defined search strategies for four key topics with respect to the potential use of TBS: (1) fracture prediction in men and women; (2) initiating and monitoring treatment in postmenopausal osteoporosis; (3) fracture prediction in secondary osteoporosis; and (4) treatment monitoring in secondary osteoporosis. Statements to guide the clinical use of TBS were derived from the review and graded by consensus using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. Results: A total of 96 articles were reviewed and included data on the use of TBS for fracture prediction in men and women, from over 20 countries. The updated evidence shows that TBS enhances fracture risk prediction in both primary and secondary osteoporosis, and can, when taken with BMD and clinical risk factors, inform treatment initiation and the choice of antiosteoporosis treatment. Evidence also indicates that TBS provides useful adjunctive information in monitoring treatment with long-term denosumab and anabolic agents. All expert consensus statements were voted as strongly recommended. Conclusion: The addition of TBS assessment to FRAX and/or BMD enhances fracture risk prediction in primary and secondary osteoporosis, adding useful information for treatment decision-making and monitoring. The expert consensus statements provided in this paper can be used to guide the integration of TBS in clinical practice for the assessment and management of osteoporosis. An example of an operational approach is provided in the appendix. Summary: This position paper presents an up-to-date review of the evidence base, synthesised through expert consensus statements, which informs the implementation of Trabecular Bone Score in clinical practice. [ABSTRACT FROM AUTHOR]

Objective: The aim of this paper is to critically re-appraise the published trials assessing amitriptyline for migraine prophylaxis. Methods: We report our methods and results following the Preferred Reporting Items for Systematic Reviews (PRISMA), by searching MEDLINE, EMBASE, Cochrane CENTRAL, and ClinicalTrials.gov for randomized trials of pharmacologic treatments for migraine prophylaxis. We included randomized trials that compared amitriptyline with placebo for migraine prophylaxis in adults. Our outcomes of interest were informed by the Outcome Set for preventive intervention trials in chronic and episodic migraine (COSMIG) and include the proportion of patients who experience a 50% or more reduction in migraine days per month, migraine days per month, and adverse events leading to discontinuation. We assessed risk of bias by using a modified Cochrane RoB 2.0 tool and the certainty of evidence by using the GRADE approach. Results: Our search yielded 10.826 unique records, of which three trials (n = 622) were eligible for data synthesis and analysis. We found moderate certainty evidence that amitriptyline increases the proportion of patients who experience a 50% or more reduction in monthly migraine days, compared to placebo (relative risk: 1.60 (95% CI 1.17 to 2.19); absolute risk difference: 165 more per 1,000 (95% CI 47 more to 327 more). We found moderate certainty evidence that amitriptyline increases the proportion of patients who discontinue due to adverse events compared to placebo (risk difference: 0.05 (95% CI 0.01 to 0.10); absolute risk difference: 50 more per 1,000 (95% CI 10 more to 100 more). Conclusions: Our meta-analysis showed that amitriptyline may have a prophylactic role in migraine patients, however these results are far from robust. This warrants further large-scale research to evaluate the role of amitriptyline in migraine prevention. [ABSTRACT FROM AUTHOR]

Background/objectives: The aims of this study were to (1) document currently available guidelines aimed at healthcare professionals and including some information on the nutritional management of cancer survivors in Europe; (2) assess the quality of these guidelines and (3) document the nutrition recommendations promoted.Methods: Four search strategies were implemented in 2018 and updated in 2021 to locate guidelines. Papers were included if they described a European guideline or recommendation for cancer survivors that contained nutrition guidance and there were no language restrictions. Two reviewers independently assessed guideline quality using the AGREE II instrument and nutrition content was extracted and summarised.Results: Five guidelines (of 593 documents located through the searches) met the inclusion criteria. The ESPEN guidelines were deemed to have the highest methodological quality. Limited information on nutrition was available in these guidelines with the majority of focus being on the promotion of fruit, vegetables and wholegrains and reducing fat, red meat and alcohol. Weight management was mentioned by all five guidelines. There was no detailed information available for cancer survivors or their healthcare team and no practical strategies for the implementation of recommendations.Conclusions: There is a need for nutrition guidelines specific for cancer survivors in a European setting. Current guidelines are limited and focus on broad recommendations, while lacking in practical strategies for implementation. There is also a tendency to recommend cancer prevention guidelines be used for cancer survivors rather than developing specific guidance for this group. [ABSTRACT FROM AUTHOR]

The paper aims to identify and describe the European evidence on opportunities and barriers to access and utilization of palliative care among non- western migrants. A systematic review in accordance with PRISMA guidelines was conducted in June 2020, searching Medline, CINAHL, PsychINFO and EMBASE databases. PROSPERO# CRD42020193651. Studies included empirical research published between 2011 and 2020. Search words were, for example, ethnic groups and palliative care. Thematic analysis was used to analyze data. Twenty nine qualitative and six quantitative studies were included. Four main themes were identified: communication and language; knowledge and awareness; patient preferences, cultural and religious issues; and lack of resources at different levels of palliative care service provision. Migrants' access to palliative care is impeded at system, community and individual levels, yet, recommendations are mostly at the individual level. Closer attention is required to these different levels when designing future palliative interventions for migrants. [ABSTRACT FROM AUTHOR]

Little is known about the use of Complementary and Alternative Medicine (CAM) among refugees, despite the common practice of CAM in many non-Western countries. We performed a systematic review of peer-reviewed literature using nine electronic databases. We included articles pertaining to refugees and CAM (whole medical systems, mind body medicine, herbal remedies, manipulative therapies, energy medicine). Qualitative and quantitative data were compiled and analyzed through descriptive statistics and chi square distribution tables. We reviewed 237 abstracts, and 47 publications met our inclusion criteria. Twenty-six papers documented whole medical systems; 11 mind-body medicine; 5 biologically based practices; 4 manipulative and body-based therapies; and 1 study documented the use of energy medicine. There were 3 clinical trials, 20 surveys, 12 case reports, 2 participant-observer qualitative papers, and 10 review papers. Most studies focused on Asian refugee populations (66%; n = 31). Mental problems related to trauma accounted for 36% of CAM use (17). Among included articles, methodological quality was extremely low. Our results show evidence that type of CAM used by refugees may vary based on ethnicity, yet this is most likely due to a bias in the medical literature. Efforts are needed to further explore these results and expand research within this field. [ABSTRACT FROM AUTHOR]

Purpose: Over the last few years, the share of public spending for orphan drugs (ODs) has increased in several western countries, raising concern on the exemptions granted to this sector with respect to the implementation of health technology assessment (HTA) principles. The aim of this paper is to shed light on both the HTA criteria adopted and the international agreements implemented in the OD regulation, given the new challenges imposed on western countries by a growing number of therapies for rare diseases. Methods: We carried out a literature review to analyse the development of the international debate on the adaptability of HTA criteria for the OD assessment and regulation. The time span lies between January 1990 and May 2018, and the policies considered relate to both market authorization and reimbursement decisions within western countries. We focus specifically on HTA criteria in some of the dimensions included in the Core Model of the European net for HTA (EUnetHTA). Results: OD high prices, the absence of clarity on the possible high revenues realized by the distribution of a new OD outside the national borders, the risk that – once marketed – a new OD can be used to treat common diseases, are all issues that raise concern on OD regulation and have to be carefully monitored by policymakers in the next future. Conclusions: Across western countries, the preferential track granted to ODs in the implementation of HTA principles is not homogeneous, but fragmented and differentiated. The need for common rules at an international level is underlined, with a view to assessing the sustainability of a sector which, due to this regulatory void, can lend itself to producers' strategic and opportunistic behaviours. [ABSTRACT FROM AUTHOR]

Regulatory frameworks for artificial intelligence (AI) are needed to mitigate risks while ensuring the ethical, secure, and effective implementation of AI technology in healthcare and population health. In this article, we present a synthesis of 141 binding policies applicable to AI in healthcare and population health in the EU and 10 European countries. The EU AI Act sets the overall regulatory framework for AI, while other legislations set social, health, and human rights standards, address the safety of technologies and the implementation of innovation, and ensure the protection and safe use of data. Regulation specifically pertaining to AI is still nascent and scarce, though a combination of data, technology, innovation, and health and human rights policy has already formed a baseline regulatory framework for AI in health. Future work should explore specific regulatory challenges, especially with respect to AI medical devices, data protection, and data enablement. [ABSTRACT FROM AUTHOR]

Human migration is not a new phenomenon, but it has changed significantly with the advance of globalization. We focus on differences in the published literature concerning migration and health (EU vs the US), centering specifically on reproductive health outcomes. We conducted a literature search in the Pubmed and Embase databases. We reviewed papers that contrast migrants to native-born populations and analyzed differences between countries as well as challenges for future research. The prevalence of low birthweight among migrants varies by the host country characteristics as well as the composition of migrants to different regions. The primary driver of migrant health is the migrant 'regime' in different countries at specific periods of time. Future health outcomes of immigrants will depend on the societal characteristics (legal protections, institutions and health systems) of host countries. [ABSTRACT FROM AUTHOR]

Cancer screening rates among immigrant and refugee populations in high income countries is significantly lower than native born populations. The objective of this study is to systematically review the effectiveness of interventions to improve screening adherence for breast, cervical and colorectal cancer among Somali immigrants. A literature search was conducted for the years 2000–2021 and eight studies met eligibility criteria. The following intervention components were found to increase adherence to cervical cancer screening: home HPV test, educational workshop for women and education for general practitioners. A patient navigator intervention was found to increase screening for breast cancer. Educational workshops motivated or increased knowledge regarding cancer screening for breast, cervical and colorectal cancer. However, most of the studies had limitations due to methodology with potential for introduction of bias. Therefore, future studies comparing effectiveness of specific intervention components to reduce disparities in cancer screening among Somali immigrants and refugees are encouraged. [ABSTRACT FROM AUTHOR]

This paper reviews recent literature on factors influencing suicide behaviours, including thoughts, plans, and attempts, in immigrant and ethno-cultural minority groups, to inform a more comprehensive understanding of suicide behaviours in increasingly culturally diverse populations. Thirty-three studies published between 2002 and 2013 were identified through digital databases searches and included in this review. Analysis of study findings focused on impacts of ethno-cultural identity and acculturation, other cultural and immigration influences, and family and community supports on suicide behaviours. Policy, practice, and research recommendations are identified, to inform relevant suicide prevention efforts and enhance mental health supports for immigrant and ethno-cultural minority populations. [ABSTRACT FROM AUTHOR]

Unequivocal international guidelines regarding the diagnosis and management of patients with acute appendicitis are lacking. The aim of the consensus meeting 2015 of the EAES was to generate a European guideline based on best available evidence and expert opinions of a panel of EAES members. After a systematic review of the literature by an international group of surgical research fellows, an expert panel with extensive clinical experience in the management of appendicitis discussed statements and recommendations. Statements and recommendations with more than 70 % agreement by the experts were selected for a web survey and the consensus meeting of the EAES in Bucharest in June 2015. EAES members and attendees at the EAES meeting in Bucharest could vote on these statements and recommendations. In the case of more than 70 % agreement, the statement or recommendation was defined as supported by the scientific community. Results from both the web survey and the consensus meeting in Bucharest are presented as percentages. In total, 46 statements and recommendations were selected for the web survey and consensus meeting. More than 232 members and attendees voted on them. In 41 of 46 statements and recommendations, more than 70 % agreement was reached. All 46 statements and recommendations are presented in this paper. They comprise topics regarding the diagnostic work-up, treatment indications, procedural aspects and post-operative care. The consensus meeting produced 46 statements and recommendations on the diagnostic work-up and management of appendicitis. The majority of the EAES members supported these statements. These consensus proceedings provide additional guidance to surgeons and surgical residents providing care to patients with appendicitis. [ABSTRACT FROM AUTHOR]

Purpose: To summarize the data published over the last 5 years in the European Union related to the health-related quality of life (HRQoL) of patients with psoriasis and its conditioning factors.Methods: International electronic databases and gray literature were searched to identify studies conducted on patient-reported outcomes in patients with psoriasis, published in Europe between January 1, 2009 and December 31, 2013. Bibliographic references were hand-searched. Editorials, letters, commentaries, opinion papers, and studies related to specific treatments were excluded.Results: A total of 46 studies met the inclusion criteria, 27 of them reporting data related to HRQoL or its conditioning factors. The publications reviewed highlighted the substantial negative impact of psoriasis on patients' HRQoL. Most of the studies that analyzed the relationship between HRQoL and sociodemographic characteristics described a relation between gender (female) and age (young patients) and poorer HRQoL. An association between HRQoL impairment and visibility of skin lesions and disease activity and severity was also established. Skin discomfort and pruritus were identified as elements that negatively influenced HRQoL. Use of biological agents had a positive impact on HRQoL and on treatment satisfaction, a better HRQoL being seen in patients treated with systemic therapies and biologics.Conclusions: HRQoL has been broadly addressed in patients with psoriasis in Europe. Several disease- and patient-related factors contributed to its deterioration. Therapeutic measures with proven effectiveness in controlling disease symptoms and reducing PASI should be considered in patients with a severe disease who have a poorer HRQoL. [ABSTRACT FROM AUTHOR]

Many ethnic minorities in Europe have a higher type 2 diabetes (T2D) prevalence than their host European populations. The risk size differs between ethnic groups, but the extent of the differences in the various ethnic minority groups has not yet been systematically quantified. We conducted a meta-analysis of published data on T2D in various ethnic minority populations resident in Europe compared to their host European populations. We systematically searched MEDLINE (using PUBMED) and EMBASE for papers on T2D prevalence in ethnic minorities in Europe published between 1994 and 2014. The ethnic minority groups were classified into five population groups by geographical origin: South Asian (SA), Sub-Saharan African (SSA), Middle Eastern and North African (MENA), South and Central American (SCA), and Western Pacific (WP). Pooled odds ratios with corresponding 95 % confidence interval (CI) were calculated using Review Manager 5.3. Twenty articles were included in the analysis. Compared with the host populations, SA origin populations had the highest odds for T2D (3.7, 95 % CI 2.7-5.1), followed by MENA (2.7, 95 % CI 1.8-3.9), SSA (2.6, 95 % CI 2.0-3.5), WP (2.3, 95 % CI 1.2-4.1), and lastly SCA (1.3, 95 % CI 1.1-1.6). Odds ratios were in all ethnic minority populations higher for women than for men except for SCA. Among SA subgroups, compared with Europeans, Bangladeshi had the highest odds ratio of 6.2 (95 % CI 3.9-9.8), followed by Pakistani (5.4, 95 % CI 3.2-9.3) and Indians (4.1, 95 % CI 3.0-5.7). The risk of T2D among ethnic minority groups living in Europe compared to Europeans varies by geographical origin of the group: three to five times higher among SA, two to four times higher among MENA, and two to three times higher among SSA origin. Future research and policy initiatives on T2D among ethnic minority groups should take the interethnic differences into account. [ABSTRACT FROM AUTHOR]

Over the past two decades, new anti-immigration policies and laws have emerged to address the migration of undocumented immigrants. A systematic review of the literature was conducted to assess and understand how these immigration policies and laws may affect both access to health services and health outcomes among undocumented immigrants. Eight databases were used to conduct this review, which returned 325 papers that were assessed for validity based on specified inclusion criteria. Forty critically appraised articles were selected for analysis; thirty articles related to access to health services, and ten related to health outcomes. The articles showed a direct relationship between anti-immigration policies and their effects on access to health services. In addition, as a result of these policies, undocumented immigrants were impacted by mental health outcomes, including depression, anxiety, and post-traumatic stress disorder. Action items were presented, including the promotion of cultural diversity training and the development of innovative strategies to support safety-net health care facilities serving vulnerable populations. [ABSTRACT FROM AUTHOR]

Aim: To provide a summary of the available evidence concerning prevalence and risk factors of frailty in elderly patients with CHF. Methods: PubMed, Embase, Web of Science, CINAHL, The Cochrane Library, China National Knowledge Infrastructure Database (CNKI), Chinese Biomedical Database (Sinomed), Weipu Database (VIP), and Wanfang database were searched from inception to July 2023. This study strictly followed the PRISMA guidelines. The quality of the included studies was rated by the Agency for Healthcare and Research and Quality and the Newcastle–Ottawa Scale. Results: A total of 21 original studies were included, involving 4,797 patients. Meta-analysis results showed that the prevalence of frailty in older patients with heart failure was 38% (95%CI: 0.32–0.44). Age, cardiac function grading, left atrial diameter, left ventricular ejection fraction, hemoglobin, polypharmacy, BNP, nutritional risk, and hospitalization day are the influential factors of frailty in older patients with CHF. Conclusion: The prevalence of frailty in older patients with CHF is high, and clinical medical personnel should identify and intervene early to reduce or delay the frailty in older patients with CHF as much as possible. [ABSTRACT FROM AUTHOR]

Epidemiological evidence suggests that regular physical activity (PA) positively impacts individuals' mental health (MH). The PA-MH relationship may be critical among immigrants owing to psycho-social-cultural influences. This scoping review of 61 studies employed a holistic bio-psycho-socio-cultural framework to thoroughly investigate the complex relationship between PA (across life domains) and immigrants' MH in Western countries. A systematic search of five electronic databases (Medline, PubMed, Embase, PsycINFO and Anthropology Plus) was conducted to locate relevant articles. No limitations were applied to study design, age, gender, home country, MH condition or PA type. A bio-psycho-socio-cultural-informed conceptual model guided the analysis of the multi-domain PA-MH relationship. Immigrant PA-MH studies were conducted and reported most commonly in the USA (38%), Australia (18%), and Canada (11%). Overall, PA was positively related to MH. Each domain-specific PA appeared to be associated with unique MH-promoting pathways/mechanisms. Leisure-related PA may support MH by enhancing self-agency and minimizing risky behaviors, whilst travel- and domestic-related PA may promote self-accomplishment and physical engagement. Ethnic sports appeared to enhance resilience. Occupational-related PA was associated with either positive or negative MH, depending on the type of occupation. A bio-psycho-socio-cultural-informed model is required to gain an encompassing and integrated understanding of immigrants' health. The first iteration of such a model is presented here, along with an illustration of how the model may be used to deepen analysis and understanding of the multi-domain PA-MH relationship among immigrants and inform public health planners and practitioners. [ABSTRACT FROM AUTHOR]

The European Union has a substantial investment in research and development and demand side-measures in the health sector in order to promote new initiatives, prevent disease and foster healthy lifestyles. In particular, the European Commission and other European entities have funded research projects focused on the use of technology in the health sector. In this context, health research initiatives have evolved from user-centred monolithic solutions into collaborative partnerships of different stakeholders that gather around different technological platforms. In order to identify the lacks and opportunities in this area, a systematic mapping study was conducted with the aim of identifying and analysing the recent research projects developed in Europe related to technological ecosystems in the health sector. The study covered closed European research projects from 2003 to 2018. This paper aims to extend that systematic mapping study through ongoing research projects. The analysis of these research projects provides an overview of the current trends and identify the lacks and opportunities to define new advances in this research area. Moreover, the comparison between the first mapping study focused on closed projects, and the current study, allows getting an overview of the evolution of technological ecosystems in the health sector. [ABSTRACT FROM AUTHOR]

Backround: Guidelines for economic analyses of health care technologies require local input data for reimbursement decisions in the countries of Central and Eastern Europe (CEE). The aim of this study was to systematically review and analyse the available empirical studies using the EQ-5D instrument as a measure of the health-related quality of life (HRQoL) in patients with neurological diseases.Methods: A systematic literature search was performed up to 1st April 2018 to identify relevant studies in eight selected CEE countries. Original articles reporting on studies of neurological diseases using the EQ-5D instrument were analysed.Results: Thirty-six articles, describing the results of 38 samples of patients and a total of 13,005 patients were included in the review. Most studies were from Hungary (44.4%) and none from Romania or Slovakia. EQ-5D utility scores were reported in 33 (91.7%) articles. In multiple sclerosis (MS) being the most represented disease, the average utility scores ranged from 0.49 in Austria to 0.80 in Poland with a weighted average of 0.69. EQ VAS scores for MS ranged from 39 in Czech Republic to 72.0 in Poland, with weighted average of 59.1. MS patients, together with epilepsy and essential tremor patients, estimated their HRQoL among the highest.Conclusions: EQ-5D research activity in neurology has been increasing through the years in studied CEE countries. There are clinical areas with the significant social burden, such as a migraine or meningitis, that are completely lacking data, other areas, such as stroke or epilepsy, with very scarce data. [ABSTRACT FROM AUTHOR]

Purpose: The European Union Horizon 2020 research and innovation funding program awarded the NIGHTINGALE grant to develop a toolkit to support first responders engaged in prehospital (PH) mass casualty incident (MCI) response. To reach the projects' objectives, the NIGHTINGALE consortium used a Translational Science (TS) process. The present work is the first TS stage (T1) aimed to extract data relevant for the subsequent modified Delphi study (T2) statements. Methods: The authors were divided into three work groups (WGs) MCI Triage, PH Life Support and Damage Control (PHLSDC), and PH Processes (PHP). Each WG conducted simultaneous literature searches following the PRISMA extension for scoping reviews. Relevant data were extracted from the included articles and indexed using pre-identified PH MCI response themes and subthemes. Results: The initial search yielded 925 total references to be considered for title and abstract review (MCI Triage 311, PHLSDC 329, PHP 285), then 483 articles for full reference review (MCI Triage 111, PHLSDC 216, PHP 156), and finally 152 articles for the database extraction process (MCI Triage 27, PHLSDC 37, PHP 88). Most frequent subthemes and novel concepts have been identified as a basis for the elaboration of draft statements for the T2 modified Delphi study. Conclusion: The three simultaneous scoping reviews allowed the extraction of relevant PH MCI subthemes and novel concepts that will enable the NIGHTINGALE consortium to create scientifically anchored statements in the T2 modified Delphi study. [ABSTRACT FROM AUTHOR]

Background: Although expanded access is an increasingly used pathway for patients to access investigational medicine, little is known on the magnitude and content of published scientific research collected via expanded access. Methods: We performed a review of all peer-reviewed expanded access publications between January 1, 2000 and January 1, 2022. We analyzed the publications for drugs, diseases, disease area, patient numbers, time, geographical location, subject, and research methodology (single center/multicenter, international/national, prospective/retrospective). We additionally analyzed endpoints reported in all COVID-19-related expanded access publications. Results: We screened 3810 articles and included 1231, describing 523 drugs for 354 diseases for 507,481 patients. The number of publications significantly increased over time ( p < 0.001 ). Large geographical disparities existed as Europe and the Americas accounted for 87.4% of all publications, whereas Africa only accounted for 0.6%. Oncology and hematology accounted for 53% of all publications. Twenty-nine percent of all expanded access patients (N = 197,187) reported on in 2020 and 2021 were treated in the context of COVID-19. Conclusions: By summarizing characteristics of patients, diseases, and research methods described in all scientific literature published on expanded access, we provide a unique dataset for future research. We show that published scientific research on expanded access has surged over the past decades, partly due to COVID-19. However, international collaboration and equity in geographic access remain an issue of concern. Lastly, we stress the need for harmonization of research legislation and guidance on the value of expanded access data within real-world data frameworks to improve equity in patient access and streamline future expanded access research. [ABSTRACT FROM AUTHOR]

Purpose Of the Review: The purpose of the current paper was to review and summarize the literature on ADHD and maltreatment over the past 10 years.Recent Findings: The majority of research on ADHD and exposure to maltreatment focuses on the high rates of comorbidity, including international studies from Asia, South America, North America, and Europe. Longitudinal studies showed that early exposure to maltreatment is a risk factor for ADHD symptoms later in development; however, this finding was not consistent. There were some preliminary studies on the neurological and genetic mechanisms underlying the link between ADHD and exposure to maltreatment. Finally, ADHD and exposure to maltreatment were found to have an additive effect on clinically salient outcomes (e.g., aggression, suicide attempts). Results from the review have direct clinical and future implications, including the need to understand the effect of comorbid ADHD and exposure to maltreatment in treatment studies. [ABSTRACT FROM AUTHOR]

Purpose: The burden of health and safety related issues emanating from the modern workplace is overwhelming. Although the prevailing statistics found in the literature show that victims of workplace fatalities and injuries are higher in developing countries and transition economies, there is a very limited understanding of the causal factors that may correspond to the continuous increase in the occupational exposure of employees to various fatalities and injuries. The purpose of this study was to review the literature on occupational safety of workers with the objective of highlighting the major causal factors of workplace injuries and fatalities from a multi-regional perspective, particularly on job-contexts with highest safety and health related hazards. Methodology: A systematic review of the literature was conducted on 73 empirical studies in the regions of Europe, Africa, the Middle East, Asia, Australia, and the Americas (the US & Canada). Findings: The results showed that the highest number of injuries and fatalities were mostly found in the construction industry. It further emerged that most of the studies were centered in developing countries within Africa and Asia. Other results and recommendations were discussed for each region. Value: The findings from this study have the potential to expose the regional dynamics in relation to safety in the workplace. This study also addresses the main areas of concern for stakeholders to promote organizational development and safety culture. [ABSTRACT FROM AUTHOR]

Purpose: This study investigated the impact of the Covid-19 pandemic in Europe on consultations, surgeries, and traumas in the field of orthopaedic and trauma surgery. Strategies to resume the clinical activities were also discussed. Methods: This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the 2020 PRISMA statement. All the comparative studies reporting data on the impact of Covid-19 in the field of orthopaedic and trauma surgery in Europe were accessed. Only comparative clinical studies which investigated the year 2020 versus 2019 were eligible. Results: 57 clinical investigations were included in the present study. Eight studies reported a reduction of the orthopaedic consultations, which decreased between 20.9 and 90.1%. Seven studies reported the number of emergency and trauma consultations, which were decreased between 37.7 and 74.2%. Fifteen studies reported information with regard to the reasons for orthopaedic and trauma admissions. The number of polytraumas decreased between 5.6 and 77.1%, fractures between 3.9 and 63.1%. Traffic accidents admissions dropped by up to 88.9%, and sports-related injuries dropped in a range of 59.3% to 100%. The overall reduction of the surgical interventions ranged from 5.4 to 88.8%. Conclusion: The overall trend of consultations, surgeries, and rate of traumas and fragility fractures appear to decrease during the 2020 European COVID pandemic compared to the pre-pandemic era. Given the heterogeneities in the clinical evidence, results from the present study should be considered carefully. Level of evidence: Level IV, systematic review. [ABSTRACT FROM AUTHOR]

Agriculture is a niche market for migrant workers, and one of the sectors with the highest rates of accidents, deaths and work-related health problems. To review and synthesize existing literature on the health conditions of international migrant agricultural workers in Europe. A scoping review of scientific literature published until March 2021 was conducted in PubMed, Scopus, WoS and OpenGrey, following Arksey & O'Malley's theoretical framework where 5894 references were retrieved and screened. Nineteen articles were selected, reviewed and synthetized. The country with the highest number of studies published (n = 9) was Spain. The design of the studies was mainly cross-sectional (n = 13). The main health problems identified were: lower back pain and other musculoskeletal problems, dermatitis, gastrointestinal and respiratory infections, anxiety, stress, depression and barriers to access healthcare services. Migrant agricultural workers are a neglected population with conditions of vulnerability and precariousness, physical and mental health problems and poor working conditions. Interventions to reduce or eliminate language, cultural and administrative barriers to ensure access to healthcare services are needed, as well as designing a common European framework to protect the rights of migrant agricultural workers and their families. [ABSTRACT FROM AUTHOR]

Background: Triptans are migraine-specific acute treatments. A well-accepted definition of triptan failure is needed in clinical practice and for research. The primary aim of the present Consensus was to provide a definition of triptan failure. To develop this definition, we deemed necessary to develop as first a consensus definition of effective treatment of an acute migraine attack and of triptan-responder. Main body: The Consensus process included a preliminary literature review, a Delphi round and a subsequent open discussion. According to the Consensus Panel, effective treatment of a migraine attack is to be defined on patient well-being featured by a) improvement of headache, b) relief of non-pain symptoms and c) absence of adverse events. An attack is considered effectively treated if patient's well-being, as defined above, is restored within 2 hours and for at least 24 hours. An individual with migraine is considered as triptan-responder when the given triptan leads to effective acute attack treatment in at least three out of four migraine attacks. On the other hand, an individual with migraine is considered triptan non-responder in the presence of failure of a single triptan (not matching the definition of triptan-responder). The Consensus Panel defined an individual with migraine as triptan-resistant in the presence of failure of at least 2 triptans; triptan refractory, in the presence of failure to at least 3 triptans, including subcutaneous formulation; triptan ineligibile in the presence of an acknowledged contraindication to triptan use, as specified in the summary of product characteristics. Conclusions: The novel definitions can be useful in clinical practice for the assessment of acute attack treatments patients with migraine. They may be helpful in identifying people not responding to triptans and in need for novel acute migraine treatments. The definitions will also be of help in standardizing research on migraine acute care. [ABSTRACT FROM AUTHOR]

Background: Due to the COVID-19 pandemic, matches and soccer-specific training were suspended for several weeks, matches after resumption were congested, and substitutions per team and game increased from three to five. Objective: The aim of this review was to examine possible differences in physical match performance and injuries between before and after the COVID-19 induced break of matches and training in professional male European soccer leagues during the 2019/2020 season. Methods: A systematic search identified all scientifically peer-reviewed publications involving elite male soccer players competing in the European leagues which reported physical match performance variables such as total running distance and running distance at different speed zones and/or injury parameters pre- and post-COVID-19 induced break. Results: In total, 11 articles were included, which were coming from German Bundesliga, Polish Ekstraklasa, Croatian HNL, Spanish La Liga, and Italian Serie A. In all studies investigating the German Bundesliga, most parameters of physical match performance remained unaffected (0.08 ≤ p ≤ 0.82; − 0.15 ≤ ES 0.15), while studies investigating the Polish Ekstraklasa (p ≤ 0.03; − 0.27 ≤ ES − 0.18), Croatian HNL (p ≤ 0.04; − 1.42 ≤ ES ≤ 1.44), Spanish La Liga (p ≤ 0.017; − 0.32 ≤ ES ≤ 5.5), and Italian Serie A (p ≤ 0.014; − 1.01 ≤ ES 0.24) showed a decrease in most parameters of physical match performance after the COVID-19 break. Injury rates were only investigated by studies targeting the German Bundesliga and Italian Serie A. In the majority of studies (3 out of 4 studies), there occurred no difference in injuries between pre- and post-COVID-19 break (p > 0.05; ES = N/A). Conclusion: Results indicate that Bundesliga teams maintained physical match performance during the 9-weeks break in matches and 3-weeks break in group training, whereas a longer match and group training interruption up to 15 weeks and 8 weeks, respectively, in the other leagues appeared to lead to a decreased physical match performance. Regarding injuries, we speculate that the increase in substitutions from 3 to 5 substitutions per game might prevent an increase in injury occurrence during matches. The underlying studies' results provide hints for possible upcoming unexpected interruptions with respect to optimal physical preparations for the resumption of matches and a congested schedule to maintain physical match performance, or for possible rule changes such as 5 instead of 3 substitutions to avoid physical overload during congested match schedules. [ABSTRACT FROM AUTHOR]

The present article covers the range of various factors that impact dietary change among immigrant women, the consequences for health as well as suggestions for an improved intervention. The factors like: busier lifestyle, lack of social relations, higher level of stress, children's preferences, taste, food insecurity, lack of traditional foods and others can result in high fat and sugar diets, low consumption of fruits/vegetables, greater portions, consumption of convenience food and inactivity. These unfavorable dietary changes can in turn cause chronic diseases including cardiovascular diseases, hypertension, type 2 diabetes and others. These negative impacts increase with the time spent in a foreign country, especially in USA and Canada, whereas cases in Europe show minor negative or even positive impacts. For a successful intervention a better understanding of the whole process is needed with a special focus on low-income females due to their double discrimination and their influence towards the health of all family members. [ABSTRACT FROM AUTHOR]

Purpose: Hip fractures are of growing interest due to their increasing number, subsequent functional decline and high institutionalization rate of patients, mortality, and costs. Several process measurements are essential for hip fracture care. To compare and improve these, hip fracture registries in Europe became popular. This systematic review aims to describe the differences between hip fracture registries in Europe as well as the differences in hip fracture treatment between countries. Methods: A systematic search using the keywords "hip fracture" AND "national" AND "database OR audit OR registry OR register" was performed in PubMed, Embase and Cochrane Library according to PRISMA guidelines till 3rd December 2020. Recent annual reports of identified hip fracture registries in Europe were additionally identified in June 2021. Comparisons of most common case-mix, process and outcome measurements were performed. Results: 11 registries in Europe were identified. Differences were observed regarding inclusion criteria of the different registries. Comparison of the different registries was difficult due to differences in the way to report measurements. While mortality rates differed substantially between countries, most of the process measurements met recommendations according to recent guidelines. Conclusion: Hip fracture registries were a valid tool to compare hospitals within one country. However, a comparison between registries of different countries should have also been easily possible. For this, the registries need to make their data easily accessible and further unify their way of measuring and reporting. [ABSTRACT FROM AUTHOR]

Asylum-seeking and refugee women currently residing in Europe face unique challenges in the perinatal period. A range of social support interventions have been developed to address these challenges. However, little is known about which women value and why. A critical interpretive synthesis was undertaken using peer reviewed and grey literature to explore the nature, context and impact of these perinatal social support interventions on the wellbeing of asylum-seeking and refugee women. Four types of interventions were identified which had varying impacts on women's experiences. The impacts of the interventions were synthesised into five themes: Alleviation of being alone, Safety and trust, Practical knowledge and learning, being cared for and emotional support, and increased confidence in and beyond the intervention. The interventions which were most valued by women were those using a community-based befriending/peer support approach as these provided the most holistic approach to addressing women's needs. [ABSTRACT FROM AUTHOR]

Purpose: Childhood bone and joint infection (BJI) is a potentially severe disease that may have permanent sequelae, including growth impairment and limb deformity. It has been characterised in the literature with a focus on Western epidemiology; there are currently no reports detailing global epidemiology and bacteriology. This omits key data from determining temporal trends, appropriate antibiotic therapy, and resource allocation. This review aims to identify studies that characterise the incidence of childhood bone and joint infection or provide detailed bacteriology within their region. Methods: A systematic review of the literature was performed from 01/01/1980 to 31/12/2020. Data has been analysed to give incidence of disease per 100,000 children, primary pathogen by country where available, and risk ratio (RR) for disease by ethnicity. This is applicable for areas that experience race-related inequitable burden of disease. Results: Forty-four articles met the inclusion area; of these, seven were population-wide studies, primarily from Europe or the United States, and the remainder were cohort studies. Incidence could be derived from 26 studies compromising over 34, 000 children. Information on bacteriology was available from 39 publications (10, 957 cases). Methicillin-sensitive Staphylococcus aureus is the most common pathogen in the West. Recently, disease secondary to Kingella kingae and methicillin-resistant S. aureus has increased. Salmonella remains a dominant pathogen in African regions. Increased risk of disease is observed in Aboriginal, New Zealand Māori, Pacific, Indigenous Fijian, and Bedouin children. Conclusion: The current state of the literature detailing incidence of childhood BJI focuses on disease patterns from the West. There is a paucity of high-quality publications in the developing world. Despite these limitations, global trends in burden of disease show race-related inequitable risk of BJI. Temporal and regional variation in bacteriology can be demonstrated. Level of evidence: III. [ABSTRACT FROM AUTHOR]

Part II of the European clinical guidelines for Tourette syndrome and other tic disorders (ECAP journal, 2011) provides updated information and recommendations for psychological interventions for individuals with tic disorders, created by a working group of the European Society for the Study of Tourette Syndrome (ESSTS). A systematic literature search was conducted to obtain original studies of psychological interventions for tic disorders, published since the initial European clinical guidelines were issued. Relevant studies were identified using computerized searches of the MEDLINE and PsycINFO databases for the years 2011–2019 and a manual search for the years 2019–2021. Based on clinical consensus, psychoeducation is recommended as an initial intervention regardless of symptom severity. According to a systematic literature search, most evidence was found for Habit Reversal Training (HRT), primarily the expanded package Comprehensive Behavioral Intervention for Tics (CBIT). Evidence was also found for Exposure and Response Prevention (ERP), but to a lesser degree of certainty than HRT/CBIT due to fewer studies. Currently, cognitive interventions and third-wave interventions are not recommended as stand-alone treatments for tic disorders. Several novel treatment delivery formats are currently being evaluated, of which videoconference delivery of HRT/CBIT has the most evidence to date. To summarize, when psychoeducation alone is insufficient, both HRT/CBIT and ERP are recommended as first-line interventions for tic disorders. As part of the development of the clinical guidelines, a survey is reported from ESSTS members and other tic disorder experts on preference, use and availability of psychological interventions for tic disorders. [ABSTRACT FROM AUTHOR]

In 2011 a working group of the European Society for the Study of Tourette Syndrome (ESSTS) has developed the first European assessment guidelines for Tourette syndrome (TS). Now, we present an updated version 2.0 of these European clinical guidelines for Tourette syndrome and other tic disorders, part I: assessment. Therefore, the available literature has been thoroughly screened, supplemented with national guidelines across countries and discussions among ESSTS experts. Diagnostic changes between DSM-IV and DSM-5 classifications were taken into account and new information has been added regarding differential diagnoses, with an emphasis on functional movement disorders in both children and adults. Further, recommendations regarding rating scales to evaluate tics, comorbidities, and neuropsychological status are provided. Finally, results from a recently performed survey among ESSTS members on assessment in TS are described. We acknowledge that the Yale Global Tic Severity Scale (YGTSS) is still the gold standard for assessing tics. Recommendations are provided for scales for the assessment of tics and psychiatric comorbidities in patients with TS not only in routine clinical practice, but also in the context of clinical research. Furthermore, assessments supporting the differential diagnosis process are given as well as tests to analyse cognitive abilities, emotional functions and motor skills. [ABSTRACT FROM AUTHOR]

Purpose: Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. Methods: A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist. Results: The search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue. Conclusion: The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years. [ABSTRACT FROM AUTHOR]

Summary: In this meta-analysis, we analyzed 9 cross-sectional studies for an association between type 1 diabetes mellitus (T1DM) and bone mineral density (BMD) in children. We found that BMD Z-scores were significantly reduced in children with T1DM. Introduction: Recent cross-sectional studies have examined how T1DM influences bone health in children and adolescents, but the relationship between T1DM and BMD remains unclear due to conflicting reports. Methods: In this meta-analysis, we systematically searched PubMed, Cochrane library, and Web of Science databases (for publications through March 12, 2020), and calculated weight mean difference (WMD) along with 95% confidence intervals (CI) using a random-effects model. Heterogeneity was evaluated using the I2 method. The Newcastle-Ottawa Scale was used to assess the quality of the included studies. Results: Data were analyzed from 9 eligible studies, including a total of 1522 children and adolescents. These data were tested for an association between T1DM and BMD. This analysis found a significant decrease in BMD Z-score in the whole body (pooled WMD, − 0.47, 95% CI, − 0.92 to − 0.02, I2 = 80.2%) and lumbar spine (pooled WMD, − 0.41, 95% CI, − 0.69 to − 0.12, I2 = 80.3%) in children and adolescents with T1DM, which was consistent in published studies from Asia and South America, but inconsistent in the North America and Europe. Importantly, the differences in BMD Z-scores were independent of age, level of glucose control (HbA1c), and prepubertal stage. Sensitivity analyses did not modify these findings. Funnel plot and the Egger test did not reveal significant publication bias. Conclusion: This meta-analysis suggests that T1DM may play a role in decreasing BMD Z-scores in the whole body and lumbar spine in children. [ABSTRACT FROM AUTHOR]

As the reported data on oral health status among the migrants in Europe is fragmented, we systematically reviewed the published literature on the oral health status, behaviours and care utilisation among migrants residing in Europe. For this, we retrieved publications from PubMed and EMBASE, supplemented by manual citation screening and grey literature search on Google scholars. Two independent reviewers screened the studies, extracted data and critically appraised the publications. A total of 69 studies included showed higher dental caries among migrant children. But some studies on adolescents and adults reported similar or even better oral health among migrants compared to the host population, while other reported the opposite. Poor oral health behaviours were generally reported among the migrants and they frequently made use of emergency service utilisation compared to the host population. We shed light on the gaps in dental literature and make some recommendations for the future. [ABSTRACT FROM AUTHOR]

Mental health disorders in children and adolescents are highly prevalent yet undertreated. A detailed understanding of the reasons for not seeking or accessing help as perceived by young people is crucial to address this gap. We conducted a systematic review (PROSPERO 42018088591) of quantitative and qualitative studies reporting barriers and facilitators to children and adolescents seeking and accessing professional help for mental health problems. We identified 53 eligible studies; 22 provided quantitative data, 30 provided qualitative data, and one provided both. Four main barrier/facilitator themes were identified. Almost all studies (96%) reported barriers related to young people's individual factors, such as limited mental health knowledge and broader perceptions of help-seeking. The second most commonly (92%) reported theme related to social factors, for example, perceived social stigma and embarrassment. The third theme captured young people's perceptions of the therapeutic relationship with professionals (68%) including perceived confidentiality and the ability to trust an unknown person. The fourth theme related to systemic and structural barriers and facilitators (58%), such as financial costs associated with mental health services, logistical barriers, and the availability of professional help. The findings highlight the complex array of internal and external factors that determine whether young people seek and access help for mental health difficulties. In addition to making effective support more available, targeted evidence-based interventions are required to reduce perceived public stigma and improve young people's knowledge of mental health problems and available support, including what to expect from professionals and services. [ABSTRACT FROM AUTHOR]

Background: Inclusion of productivity losses and gains in cost-effectiveness analyses for drugs is recommended by pharmacoeconomic guidelines in some countries and is considered optional in others. Often guidelines recommend analysis based on the payer perspective, but suggest that a supplemental analysis based on the societal perspective may be submitted that includes productivity losses/gains. However, there is no universally recognized framework for the approach to including productivity losses and gains in pharmacoeconomic analyses.Objectives: This study aimed to systematically review literature on cost-effectiveness analyses of drug interventions that included costs associated with productivity losses/gains and to summarize the types cost elements included and cost calculation methods employed. Moreover, this study examines variations in the calculation of productivity losses/gains by target disease type, geographic region, income group, period of analysis, and analysis time horizon-as well as the impact of their inclusion on the study outcomes.Methods: A search of three databases was performed, including MEDLINE, Embase, and the Cochrane Library, to identify cost-effectiveness and cost-utility analyses that included indirect costs such as productivity losses/gains. Publications from January 2010 to October 2019 were examined and selected for inclusion by two independent reviewers. In addition to the citation details, data on the country of analysis, country income group, target disease area, study sponsorship, type of analysis, study design, time horizon, analysis perspective, productivity loss/gain elements included, the approach used to estimate productivity losses/gains, and the impact of their inclusion on the study outcome-namely the incremental cost effectiveness ratio-were extracted and summarized.Results: The search strategy identified 5038 unique studies, and 208 were included in the final analysis. Among the studies reviewed, 165 (79%) were conducted in high-income countries and 160 (77%) were conducted for North American and European/Central Asian countries. The productivity loss/gain elements included in the analysis were reported for 169 studies (81%). Absenteeism only was included for 98 studies (47%), and absenteeism plus presenteeism was included for 29 studies (14%). Absenteeism plus some other element such as costs associated with unemployment and/or early retirement was included for 32 studies (15%) examined. Only one out of four of the studies reviewed included information on the approach used to estimate productivity losses/gains, which was predominantly the human capital approach. One-hundred forty-four studies (69%) reported the impact of including productivity losses/gains on the ICER, with 110 studies (53%) reporting that their inclusion contributed to more favorable cost-effectiveness.Conclusions: Although inclusion of productivity losses/gains was shown to have a favorable impact on evaluations for many studies, their impact and method of calculation was often not reported or was unclear. Further examination and discussion is needed to consider the optimal framework for considering productivity losses/gains in cost-effectiveness analyses, including the appropriate cost elements to include (e.g., patient absenteeism, caregiver absenteeism, presenteeism, unemployment, etc.) and how those costs should be estimated. [ABSTRACT FROM AUTHOR]

Objectives: The main aim of this study was to find the prevalence of mortality among hospitalized COVID-19 infected patients and associated risk factors for death. Methods: Three electronic databases including PubMed, Science Direct and Google Scholar were searched to identify relevant cohort studies of COVID-19 disease from January 1, 2020, to August 11, 2020. A random-effects model was used to calculate pooled prevalence rate (PR), risk ratio (RR) and 95% confidence interval (CI) for both effect measures. Cochrane chi-square test statistic Q, I 2 , and τ 2 tests were used to measure the presence of heterogeneity. Publication bias and sensitivity of the included studies were also tested. Results: In this meta-analysis, a total of 58 studies with 122,191 patients were analyzed. The pooled prevalence rate of mortality among the hospitalized COVID-19 patients was 18.88%, 95% CI (16.46–21.30), p < 0.001. Highest mortality was found in Europe [PR 26.85%, 95% CI (19.41–34.29), p < 0.001] followed by North America [PR 21.47%, 95% CI (16.27–26.68), p < 0.001] and Asia [PR 14.83%, 95% CI (12.46- 17.21), p < 0.001]. An significant association were found between mortality among COVID-19 infected patients and older age (> 65 years vs. < 65 years) [RR 3.59, 95% CI (1.87–6.90), p < 0.001], gender (male vs. female) [RR 1.63, 95% CI (1.43–1.87), p < 0.001], ICU admitted patients [RR 3.72, 95% CI (2.70–5.13), p < 0.001], obesity [RR 2.18, 95% CI (1.10–4.34), p < 0.05], hypertension [RR 2.08,95% CI (1.79–2.43) p < 0.001], diabetes [RR 1.87, 95% CI (1.23–2.84), p < 0.001], cardiovascular disease [RR 2.51, 95% CI (1.20–5.26), p < 0.05], and cancer [RR 2.31, 95% CI (1.80–2.97), p < 0.001]. In addition, significant association for high risk of mortality were also found for cerebrovascular disease, COPD, coronary heart disease, chronic renal disease, chronic liver disease, chronic lung disease and chronic kidney disease. Conclusion: This meta-analysis revealed that the mortality rate among COVID-19 patients was highest in the European region and older age, gender, ICU patients, patients with comorbidity had a high risk for case fatality. Those findings would help the health care providers to reduce the mortality rate and combat this pandemic to save lives using limited resources. [ABSTRACT FROM AUTHOR]

Purpose: To plan for the continuance of elective hip and knee arthroplasty during a resurgence or new wave of COVID-19 infections.Method: A systematic review was conducted using the terms "COVID-19" or "SARS-Cov-2" and "second wave". No relevant citations were found to inform on recommendations the plan. Therefore, an expert panel of the European Hip Society and the European Knee Associates was formed to provide the recommendations.Results: Overall, the recommendations consider three phases; review of the first wave, preparation for the next wave, and during the next wave. International and national policies will drive most of the management. The recommendations focus on the preparation phase and, in particular, the actions that the individual surgeon needs to undertake to continue with, and practice, elective arthroplasty during the next wave, as well as planning their personal and their family's lives. The recommendations expect rigorous data collection during the next wave, so that a cycle of continuous improvement is created to take account of any future waves.Conclusions: The recommendations for planning to continue elective hip and knee arthroplasty during a new phase of the SARS-Cov-2 pandemic provide a framework to reduce the risk of a complete shutdown of elective surgery. This involves engaging with hospital managers and other specialities in the planning process. Individuals have responsibilities to themselves, their colleagues, and their families, beyond the actual delivery of elective arthroplasty. [ABSTRACT FROM AUTHOR]

Introduction: Risk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety.Objective: The aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs.Methods: Peer-reviewed articles published between January 2012 and December 2018 were selected from three online databases (MEDLINE, PubMed, Embase). Eligible studies reported on effectiveness evaluations of mandated risk minimization measures (beyond labeling) and were written in English. Two reviewers independently examined 2744 titles of articles and 52 full articles were included. Forty-eight sources of gray literature from conference abstract presentations and publicly available regulatory documents were also included.Results: Key opportunities for improvement in reporting included the provision of information regarding (1) selection, design, and testing of risk minimization measures, (2) implementation of programs, (3) process and outcome metrics, including the extent to which programs reached the intended audience, were integrated into the target healthcare settings, or were sustained over time, and (4) burden of the program on the healthcare system and implications for patient access.Conclusions: Gaps in reporting of risk minimization program evaluation studies were identified. Addressing gaps will help build the evidence base regarding risk minimization initiatives, as well as ensure that programs are maximally effective and minimally burdensome on the healthcare system, and do not unduly interfere with patient access to the medicine. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to explore the relationship between proton pump inhibitors use and the risk of dementia. Methods: A comprehensive literature search was conducted in English and Chinese databases from origination to December 2018. The pooled hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated with a random-effects model. Subgroup analyses and sensitivity analyses were also conducted. Cochran's Q test and the I2 statistic were used to evaluate the heterogeneity. Publication bias was assessed by Begg's test and Egger's test. Results: Six studies were included, which contained a total of 166,146 participants. The overall result demonstrated a significant increase in dementia risk with proton pump inhibitors use (HR = 1.29, 95% CI = 1.12–1.49). In subgroup analyses, a significant association was detected between proton pump inhibitors use and the risk of dementia in Europe (HR = 1.46, 95% CI = 1.23–1.73) and among participants aged ≥ 65 years (HR = 1.39, 95% CI = 1.17–1.65). For the factor follow-up time ≥ 5 years, the pooled HR was 1.28 (95% CI = 1.12–1.46), demonstrating a 1.28-fold increase in the risk of dementia among proton pump inhibitors users. In the case of regional impact, participants from Europe showed an overall pooled HR estimate of 1.46 (95% CI = 1.23–1.73). There was no evidence of publication bias. Conclusions: The overall result of this meta-analysis supports the hypothesis that proton pump inhibitors increase the risk of dementia. Furthermore, high-quality cohort studies are needed to confirm these findings. [ABSTRACT FROM AUTHOR]

Background: Antimicrobial de-escalation (ADE) is a strategy of antimicrobial stewardship, aiming at preventing the emergence of antimicrobial resistance (AMR) by decreasing the exposure to broad-spectrum antimicrobials. There is no high-quality research on ADE and its effects on AMR. Its definition varies and there is little evidence-based guidance for clinicians to use ADE in the intensive care unit (ICU).Methods: A task force of 16 international experts was formed in November 2016 to provide with guidelines for clinical practice to develop questions targeted at defining ADE, its effects on the ICU population and to provide clinical guidance. Groups of 2 experts were assigned 1-2 questions each within their field of expertise to provide draft statements and rationale. A Delphi method, with 3 rounds and an agreement threshold of 70% was required to reach consensus.Results: We present a comprehensive document with 13 statements, reviewing the evidence on the definition of ADE, its effects in the ICU population and providing guidance for clinicians in subsets of clinical scenarios where ADE may be considered.Conclusion: ADE remains a topic of controversy due to the complexity of clinical scenarios where it may be applied and the absence of evidence to the effects it may have on antimicrobial resistance. [ABSTRACT FROM AUTHOR]

Developing culturally appropriate diabetes nutrition interventions for immigrants could be facilitated knowing what is successful in the home country and other relevant countries. The primary purpose of this scoping review was to identify the design and delivery methods of nutrition interventions for Chinese populations with type 2 diabetes, in their home countries and as immigrants to western countries. A total of 14 articles was retrieved and included. Overall, the approaches used in China often were modelled on intensive lifestyle programs although alternative strategies were also identified. Most interventions were not focussed solely on nutrition, and only a few were conducted in community settings. Most of the interventions were delivered in a group format, while those conducted in China also included individual counselling, particularly for nutrition. In addition, the diabetes and nutrition-related outcomes, cultural relevance and acceptability, and other factors that influenced protocol compliance were considered. Improvements in blood glucose control were observed in participants in all interventions where it was measured. Participants reported increased nutritional knowledge but nutritional behaviour was generally not well documented. Trials conducted in the United States emphasized the importance of cultural adaptation of intervention programs, particularly with respect to dietary patterns and specific foods. Practice-transferable characteristics are highlighted. Research gaps included trials conducted in community settings with pragmatic implementation and evaluation, comparative trials of interventions to gauge relative effectiveness, and measuring and reporting dietary outcomes for better understanding of the impact on dietary behaviours and their relationship to health outcomes. [ABSTRACT FROM AUTHOR]

Background: To date, a multi-country review evaluating the cost-of-illness (COI) studies from the Central and Eastern European (CEE) region has not yet been published. Our main objective was to provide a general description about published COI studies from CEE.Methods: A systematic search was performed between 1 January 2006 and 1 June 2017 in Medline, EMBASE, The Cochrane Library, CINAHL, and Web of Science to identify all relevant COI studies from nine CEE countries. COI studies reporting costs without any restrictions by age, co-morbidities, or treatment were included. Methodology, publication standards, and cost results were analysed.Results: We identified 58 studies providing 83 country-specific COI results: Austria (n = 9), Bulgaria (n = 16), Croatia (n = 3), the Czech Republic (n = 10), Hungary (n = 24), Poland (n = 11), Romania (n = 3), Slovakia (n = 3), and Slovenia (n = 4). Endocrine, nutritional, and metabolic diseases (18%), neoplasms (12%), infections (11%), and neurological disorders (11%) were the most frequently studied clinical areas, and multiple sclerosis was the most commonly studied disease. Overall, 57 (98%) of the studies explicitly stated the source of resource use data, 45 (78%) the study perspective, 34 (64%) the costing method, and 24 (58%) reported at least one unit costs. Regardless of methodological differences, a positive relationship was observed between costs of diseases and countries' per capita GDP.Conclusions: Cost-of-illness studies varied considerably in terms of methodology, publication practice, and clinical areas. Due to these heterogeneities, transferability of the COI results is limited across Central and Eastern European countries. [ABSTRACT FROM AUTHOR]

Purpose: Return to work (RTW) of cancer survivors (CSs) fluctuates in different contexts. This systematic review searched for recent data on the RTW rate of CSs in Europe, investigating associated factors.Methods: Bibliographic search covered the period from January 2010 to February 2018, with no language restrictions. European population-based studies assessing RTW rate after cancer diagnosis were included. We excluded studies focusing on a specific cancer diagnosis.Results: Twelve observational studies were selected. The cohorts investigated included 280 to 46,720 individuals from Northwestern and Central Europe diagnosed with cancer from 1987 to 2010. The median interval between diagnosis and documented RTW was 2 years (0.2-23.4 years). RTW rates of CSs ranged from 39 to 77%. RTW of individuals employed at the time of diagnosis ranged from 60 to 92%, the latter registered in a sample with good prognosis. Personal factors, work-related factors, and cancer-related factors were all associated with RTW. Healthcare team interventions facilitated reintegration to work.Conclusions: Data from Mediterranean and Central European countries are urgently needed to understand whether RTW is an issue for CSs there as well and whether socio-rehabilitative interventions are required to mitigate the potential negative impact of cancer on individuals and society. [ABSTRACT FROM AUTHOR]

Purpose: Despite an acknowledged dearth of data on serum 25-hydroxyvitamin D (25(OH)D) concentrations from Southern European countries, inter-country comparison is hampered by inconsistent data reporting. The purpose of the current study was to conduct a systematic literature review of available data on serum 25(OH)D concentrations and estimate vitamin D status in Southern European and Eastern Mediterranean countries, both at a population level and within key population subgroups, stratified by age, sex, season and country.Methods: A systematic review of the literature was conducted to identify and retrieve scientific articles reporting data on serum 25(OH)D concentration and/or vitamin D status following standard procedures.Results: Data were extracted from 107 studies, stratified by sex and age group, representing 630,093 individuals. More than one-third of the studies reported mean 25(OH)D concentrations below 50 nmol/L and ~ 10% reported mean serum 25(OH)D concentrations below 25 nmol/L. Overall, females, neonates/ infants and adolescents had the higher prevalence of poor vitamin D status. As expected, there was considerable variability between studies. Specifically, mean 25(OH)D ranged from 6.0 (in Italian centenarians) to 158 nmol/L (in elderly Turkish men); the prevalence of serum 25(OH)D < 50 nmol/L ranged from 6.8 to 97.9% (in Italian neonates).Conclusions: Contrary to expectations, there was a high prevalence of low vitamin D status in the Southern Europe and the Eastern Mediterranean regions, despite abundant sunshine. These data further emphasize the need for strategies, such as fortification of foods with vitamin D and/or vitamin D supplementation, which will be tailored to the needs of specific population groups with higher risk of insufficiency or deficiency, to efficiently tackle the pandemic of hypovitaminosis D in Europe. [ABSTRACT FROM AUTHOR]

Purpose: The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies.Methods: Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology.Results: Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate.Conclusion: In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account. [ABSTRACT FROM AUTHOR]

A systematic review was undertaken to identify lifestyle intervention studies in South Asian migrant populations to determine the effect on the components of the metabolic syndrome. A total of seven studies were identified, of which six focused on educational advice and the seventh on intensive exercise intervention. Four studies were Randomised Controlled Trials of which two studies reported significant reductions in waist circumference. One of these studies focused on home based education with cooperation of the home cook (adjusted waist reduction of 1.9 cm, 95 % CI 0.52-3.3 cm; p = 0.007) and the other entailed an intensive physical activity program (adjusted waist reduction 3.4 cm, 95 % CI 2.0-4.7 cm). The evidence whether lifestyle intervention studies in South Asians can improve components of the metabolic system is not clear. Further lifestyle interventions for South Asians should be culturally adapted, involve friends and family, especially those with cooking responsibilities. [ABSTRACT FROM AUTHOR]