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Background It is unclear whether femoroacetabular impingement syndrome (FAIS) affect hip range of motion (ROM). Sources of data We performed a systematic review with meta-analysis searching six electronic databases from inception to March 21, 2022. We included studies assessing hip ROM in FAIS, FAI morphology without symptoms (FAIm), and healthy controls. Mean differences between groups were measured in ROM degrees with 95% confidence interval (CI). Areas of agreement A total of 17 studies (1702 hips) were included. Comparison of FAIS patients versus healthy controls showed that hip ROM was clinically and statistically reduced in FAIS for internal rotation (90° hip flexion, −8.01°, 95% CI: –11.21, −4.90; 0° hip flexion −6.38°, 95% CI: –9.79, −2.97); adduction (90° hip flexion, −4.74°, 95% CI: –8.13, −1.34); flexion (−5.41°, 95% CI: –7.05, −3.49), abduction (0° hip flexion, −5.76°, 95% CI: –8.38, −3.23), and external rotation (90° hip flexion, −3.5°, 95% CI: –5.32, −1.67) ranging from low to high certainty of evidence. Comparison of FAIm versus healthy controls showed no statistically significant differences in any direction of movement, albeit with uncertainty of evidence. Areas of controversy The certainty of evidence was unclear, particularly for asymptomatic FAIm. Growing points Hip ROM may be reduced in all directions except extension in FAIS compared to controls. Hip ROM may not be restricted in asymptomatic FAIm. Areas timely for developing research Further studies are needed to resolve the uncertainty of evidence about ROM restrictions in asymptomatic FAIm compared to healthy controls.

Aim: Research and innovation (R&I) actors are fundamental in shortening the translational gap of personalized medicine in health systems. In the context of the ‘Integrating China in the International Consortium for Personalized Medicine’ project, we aimed to map the current landscape of R&I actors in the field of personalized medicine in the EU and China. Methods: A two-phase desk research study was conducted. Results: We identified 78 R&I actors. Research and technology organizations were the most frequent in both the EU and China. The identified R&I actors were active in a wide range of fields. The EU and China have many different R&I actors addressing personalized medicine-related issues, with few characteristics in common. Conclusion: More efforts are needed to ensure these R&I actors are encouraged to work together to bridge each other’s gaps.

The aim of this study is to investigate the prognostic role of body mass index (BMI) and survival from head and neck cancer (HNC). We performed a pooled analysis of studies included in the International Head and Neck Cancer Epidemiology consortium in order to investigate the prognostic role of BMI and survival from HNC. We used Cox proportional hazards models to estimate the adjusted hazard ratios (HR) for overall survival and HNC-specific survival, by cancer site. The study included 10,177 patients from 10 studies worldwide. Underweight patients had lower overall survival (HR = 1.69, 95%CI: 1.31–2.19) respect to those having normal weight with consistent results across the HNC sites. Overweight and obese patients with oropharyngeal cancers had a favourable HNC-specific survival (HR = 0.50 (95%CI: 0.33–0.75) and HR = 0.51 (95%CI: 0.36–0.72), respectively). Among ever smokers overweight and obese patients showed a favourable HNC-specific survival (HR = 0.69 (95%CI: 0.56–0.86) and HR = 0.70 (95%CI: 0.61–0.80)). Our findings show that high BMI values at cancer diagnosis predict the survival rates in smoking patients with HNC. This association may be explained by residual confounding, reverse causation, and collider stratification bias, but may also suggest that a nutritional reserve may help patients survive HNC cancer.

Considering the importance of evidence on interventions to tackle mental health problems in healthcare workers (HCWs) during pandemics, we conducted a systematic review, aiming to identify and summarize the implemented interventions to deal with mental health issues of HCWs during infectious disease outbreaks and report their effectiveness. Web of Science, PubMed, Cochrane, Scopus, CINAHL and PsycInfo electronic databases were searched until October 2nd, 2020. Primary-data articles, describing any implemented interventions and their effectiveness were considered pertinent. Studies were screened according to the inclusion/exclusion criteria and subsequently data extraction was performed. Twenty-four articles, referring to SARS, Ebola, Influenza AH1N1 and COVID-19 were included. Interventions addressing mental health issues in HCWs during pandemics/epidemics were grouped into four categories: 1) informational support (training, guidelines, prevention programs), 2) instrumental support (personal protective equipment, protection protocols); 3) organizational support (manpower allocation, working hours, re-organization of facilities/structures, provision of rest areas); 4) emotional and psychological support (psychoeducation and training, mental health support team, peer-support and counselling, therapy, digital platforms and tele-support). These results might be helpful for researchers, stakeholders, and policymakers to develop evidence-based sustainable interventions and guidelines, aiming to prevent or reduce the immediate and long-term effect of pandemics on mental health status of HCWs.

The continuous development and use of genomic sequencing requires healthcare professionals to constantly integrate these advancements into their clinical practice. There is a documented lack of cancer genomics contents in the teaching and learning programs. We aimed to identify the core competencies in cancer genomics for non-genetic healthcare professionals. We performed a literature review in PubMed, SCOPUS, and Web of Science databases to retrieve articles published from 2000 to 2018, in English or Italian language. We included articles that reported the competencies for non-genetic healthcare professionals in cancer genomics. A web-based modified Delphi survey was conducted, aiming to define, through consensus, a set of core competencies that should be covered in the curricula. The international expert panel included specialists in genetics, genomics, oncology, and medical specialists. In the literature review, we retrieved nine articles, from which we identified core competencies for general physicians and nurses. The competencies were organized in three main domains: knowledge, attitudes, and practical abilities. In the second round of Delphi survey, consensus of 83.3% was reached for the definition of the core competencies. Thirty-seven items were defined as the competencies required for physicians and forty-two items for nurses. Through a consensus-based approach, a set of core competencies in cancer genomics for non-genetic healthcare professionals has been identified. Our findings could benchmark standards for curriculum development and future educational strategies.

“Integrating China in the International Consortium for Personalized Medicine” (IC2PerMed) is a coordination and support action funded within the Horizon 2020 work program. Following the guidance of the International Consortium for Personalized Medicine (ICPerMed), the project’s overarching aim is to align the European Union and China’s research agendas in the field of personalized medicine (PM) to enable a swift development of PM approaches in the EU with strong leverage upon EU-Chinese collaboration. Living in the CO­VID-19 era, we are witnessing how the challenges imposed by the pandemic all around the globe have been acting as a catalyst for collaborations and knowledge sharing among national health systems worldwide. Given the strong interest on behalf of both Europe and China in the advancement of PM approaches, now more than ever, a cross-border collaboration between the 2 powers can accelerate the effective translation of such innovation to healthcare systems, advance research, and ensure that such change follows the directions toward the path of sustainability. IC2PerMed developments will be led by European and Chinese experts equally assembled into 3 Working Groups: (1) people and organization, (2) innovation and market, and (3) research and clinical studies in PM. This complex and dynamic network of actions thrives on dialog, cooperation, and alignment of research at national and global levels; work in the direction taken by IC2PerMed shall pave the way toward the realization of PM’s full potential, prevent it from becoming a burden for healthcare systems, and, rather, prove that it provides an essential and irreplaceable contribution to their effectiveness, efficiency, and sustainability.

ObjectiveTo examine SARS-CoV-2 vaccine confidence, attitudes and intentions in Australian adults as part of the iCARE Study.Design and settingCross-sectional online survey conducted when free COVID-19 vaccinations first became available in Australia in February 2021.ParticipantsTotal of 1166 Australians from general population aged 18–90 years (mean 52, SD of 19).Main outcome measuresPrimary outcome: responses to question ‘If a vaccine for COVID-19 were available today, what is the likelihood that you would get vaccinated?’.Secondary outcome: analyses of putative drivers of uptake, including vaccine confidence, socioeconomic status and sources of trust, derived from multiple survey questions.ResultsSeventy-eight per cent reported being likely to receive a SARS-CoV-2 vaccine. Higher SARS-CoV-2 vaccine intentions were associated with: increasing age (OR: 2.01 (95% CI 1.77 to 2.77)), being male (1.37 (95% CI 1.08 to 1.72)), residing in least disadvantaged area quintile (2.27 (95% CI 1.53 to 3.37)) and a self-perceived high risk of getting COVID-19 (1.52 (95% CI 1.08 to 2.14)). However, 72% did not believe they were at a high risk of getting COVID-19. Findings regarding vaccines in general were similar except there were no sex differences. For both the SARS-CoV-2 vaccine and vaccines in general, there were no differences in intentions to vaccinate as a function of education level, perceived income level and rurality. Knowing that the vaccine is safe and effective and that getting vaccinated will protect others, trusting the company that made it and vaccination recommended by a doctor were reported to influence a large proportion of the study cohort to uptake the SARS-CoV-2 vaccine. Seventy-eight per cent reported the intent to continue engaging in virus-protecting behaviours (mask wearing, social distancing, etc) postvaccine.ConclusionsMost Australians are likely to receive a SARS-CoV-2 vaccine. Key influencing factors identified (eg, knowing vaccine is safe and effective, and doctor’s recommendation to get vaccinated) can inform public health messaging to enhance vaccination rates.

Background: complete uterine septum, double cervix and vaginal septum is a rare complex Müllerian anomaly affecting patients’ quality of life in terms of fertility and pelvic pain. The aim of our review is to gather the studies concerning the diagnosis and treatment this complex malformation and to describe the related fertility outcomes. Methods: this study was conducted in 2022, according to the criteria of Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and the protocol was submitted to the International Prospective Register for Systematic Reviews (PROSPERO). PubMed, Scopus and Web of Science electronic databases were searched to find eligible articles. In total, 538 articles were identified through literature research. A total of ten articles satisfied the eligibility criteria and were included in the systematic review. Results: 86 affected women were evaluated, and 71 of them were treated. Almost all patients included in our research presented with primary infertility or with a history of recurrent miscarriages; half of all patients also reported dyspareunia. After surgical treatment, 47 pregnancies were achieved: 41 live birth and ongoing pregnancies and six spontaneous miscarriages occurred; a significantly lower miscarriage rate was reported after surgical treatment. Conclusion: hysteroscopic treatment of U2b C2 V1 anomaly can be safely performed, leading to favorable fertility outcomes, measured as the achievement of pregnancy and a reduction in miscarriage rate.

Background To keep a high quality of assistance it is important for hospitals to invest in health technologies (HTs) that have the potential of improving health outcomes. Even though guidance exists on how HTs should be introduced, used and dismissed, there is a surprising gap in literature concerning the awareness of hospitals in the actual utilization of HTs. Methods We performed a systematic literature review of qualitative and quantitative studies aimed at investigating hospital contextual factors that influence the actual utilization of HTs. PubMed, Scopus, Web of Science, Econlit and Ovid Medline electronic databases were searched to retrieve articles published in English and Italian from January 2000 to January 2019. The quality of the included articles was assessed using the Critical Appraisal Skills Programme checklist for qualitative studies, Newcastle-Ottawa Scale for the cross-sectional studies and the Mixed Methods Appraisal Tool for mixed method studies. Results We included 33 articles, which were of moderate to high methodological quality. The included articles mostly addressed the contextual factors that impact the implementation of information and communication technologies (ICTs). Overall, for all HTs, the hospital contextual factors were part of four categories: hospital infrastructure, human resource management, financial resources and leadership styles. Conclusion Our systematic review reported that the contextual factors influencing the HTs utilization at hospital level are mainly explored for ICTs. Several factors should be considered when planning the implementation of a new HTs at hospital level. A potential publication bias might be present in our work, since we included articles published only in English and Italian Language, from January 2000 to January 2019. There remains a gap in the literature on the facilitators and barriers influencing the implementation and concrete utilization of medical and surgical HTs, suggesting the need for further studies for a better understanding.

The development of high-throughput omics technologies represents an unmissable opportunity for evidence-based prevention of adverse effects on human health. However, the applicability and access to multi-omics tests are limited. In Italy, this is due to the rapid increase of knowledge and the high levels of skill and economic investment initially necessary. The fields of human genetics and public health have highlighted the relevance of an implementation strategy at a national level in Italy, including integration in sanitary regulations and governance instruments. In this review, the emerging field of public health genomics is discussed, including the polygenic scores approach, epigenetic modulation, nutrigenomics, and microbiomes implications. Moreover, the Italian state of implementation is presented. The omics sciences have important implications for the prevention of both communicable and noncommunicable diseases, especially because they can be used to assess the health status during the whole course of life. An effective population health gain is possible if omics tools are implemented for each person after a preliminary assessment of effectiveness in the medium to long term.

BackgroundSeveral healthcare systems facing respiratory viral infections outbreaks, like COVID-19, have not been prepared to manage them. Public health mitigation solutions ranging from isolation of infected or suspected cases to implementation of national lockdowns have proven their effectiveness for the outbreak’s control. However, the adjustment of public health measures is crucial during transition phases to avoid new outbreaks. To address the need for designing evidence-based strategies, we performed a systematic review to identify healthcare systems interventions, experiences and recommendations that have been used to manage different respiratory viral infections outbreaks in the past.MethodsPubMed, Web of Science, Scopus and Cochrane were searched to retrieve eligible studies of any study design, published in English until 17 April 2020. Double-blinded screening process was conducted by titles/abstracts and subsequently eligible full texts were read and pertinent data were extracted. When applicable, quality assessment was conducted for the included articles. We performed a narrative synthesis of each implemented public health approaches.ResultsWe included a total of 24 articles addressing the public health approaches implemented for respiratory viral infections outbreaks for COVID-19, influenza A H1N1, MERS and severe acute respiratory syndrome . The identified approaches are ascribable to two main categories: healthcare system strategies and healthcare provider interventions. The key components of an effective response on respiratory viral outbreaks included the implementation of evidence-based contextual policies, intrahospital management actions, community healthcare facilities, non-pharmaceutical interventions, enhanced surveillance, workplace preventive measures, mental health interventions and communication plans.ConclusionThe identified healthcare system strategies applied worldwide to face epidemics or pandemics are a useful knowledge base to inform decision-makers about control measures to be used in the transition phases of COVID-19 and beyond.

The last fifteen years have seen the emergence of Public Health Genomics (PHG), a multidisciplinary field related to the effective and responsible translation of genome-based knowledge and technologies to improve population health. While at the beginning the main concern of PHG was that genetic/genomic applications should be evaluated rigorously before entering into clinical and public health (PH) practice, now the main matter is around the fact that there are some genetic/genomic applications with proved efficacy and cost-effectiveness that should be implemented and become citizens’ rights. In any case, there is a critical need for a robust evaluation process, that takes into account also context-related dimensions (delivery models, economic evaluation and organizational aspects) to facilitate the implementation of these technologies. Systematic reviews of full economic evaluations of genetic/genomic applications are of paramount importance to identify all feasible health programs involving a defined use of a particular genetic/genomic application and to recognize which health programs can maximize the value of that genetic/genomic application. Cost-effectiveness analyses may be useful also in the early stages of the evaluation process to assess which characteristics of a genetic/genomic application need to be improved. Finally, the implementation of genetic/genomics applications requires specific training efforts for public health professional to increase their current level of competence. All these issues are addressed in this chapter, using the population health perspective and the point of view of PH.

Background: Food insecurity, an issue also affecting developed countries, is associated with different negative outcomes. Particularly in pregnant women, a vulnerable population group, it has a double burden, as it affects both the woman and her child. Food insecurity has been associated with low birth weight and shorter gestational age, but there is less evidence on the association with fetal structural anomalies. Aim: To fill this gap, a study will be conducted to examine if pregnant women in a condition of food insecurity have a higher risk for fetal structural anomalies. Methods: A case-control study will be conducted in three centers. Cases will be pregnant women (>18 years old) diagnosed with a fetal structural anomaly during the prenatal ultrasound examination of the II–III trimester, while controls will be pregnant women (>18 years old) with a negative result for fetal structural anomaly at the II–III trimester prenatal ultrasound examination. The exposure of interest will be food insecurity during the last 12 months, measured using the validated Household Food Insecurity Access Scale. A dedicated questionnaire will be given to women after they sign the informed consent form. Summary: Finding a positive association between food insecurity in pregnant women and fetal structural anomalies could be the first step towards screening for it among pregnant women and designing policies that could mitigate this condition. Lowering food insecurity could prevent a certain number of fetal structural anomalies, leading to fewer negative pregnancy outcomes and health problems during childhood and adulthood.

The disruptive advances in genomics contributed to achieve higher levels of precision in the diagnosis and treatment of cancer. This scientific advance entails the need for greater literacy for all healthcare professionals. Our study summarizes the training initiatives conducted worldwide in cancer genomics field for healthcare professionals. We conducted a web search of the training initiatives aimed at improving healthcare professionals’ literacy in cancer genomics undertaken worldwide by using two search engines (Google and Bing) in English language and conducted from 2003 to 2021. A total of 85,649 initiatives were identified. After the screening process, 36 items were included. The majority of training programs were organized in the United States (47%) and in the United Kingdom (28%). Most of the initiatives were conducted in the last five years (83%) by universities (30%) and as web-based modalities (80%). In front of the technological advances in genomics, education in cancer genomics remains fundamental. Our results may contribute to provide an update on the development of educational programs to build a skilled and appropriately trained genomics health workforce in the future.

Background Several countries facing the COVID-19 pandemic were not prepared to manage it. Public health mitigation strategies, ranging from isolation of infected cases to implementation of national lockdowns, proved their effectiveness for the outbreaks control. However, the adjustment of public health measures is crucial during transition phases to avoid new outbreaks. To address the need for designing evidence-based strategies, we performed a systematic review, identifying healthcare systems approaches, experiences and recommendations used to manage COVID-19 and other epidemics. Methods PubMed, Web of Science, Scopus and Cochrane were searched to retrieve eligible studies of any study design, published in English until April 17th, 2020. Double-blinded screening process was conducted by titles/abstracts and subsequently eligible full-texts were read and pertinent data were extracted. We performed a narrative analysis of each implemented strategy. Results We included a total of 24 articles addressing the public health strategies implemented for respiratory viral infections outbreaks as COVID-19, influenza A H1N1, MERS and SARS. The identified strategies are ascribable to two main categories: healthcare systems management at a national level and healthcare providers strategies at a local level. The key components of the transition strategies regarded the implementation of evidence-based contextual policies, intrahospital management approaches, community healthcare facilities, non-pharmaceutical interventions, enhanced surveillance, workplace preventive measures, mental health interventions and communication plans. Conclusions The identified healthcare systems strategies applied worldwide to face epidemics or pandemics, are a useful knowledge base to inform decision-makers about control measures to be used in the transition phases of COVID-19 and beyond. Key messages Healthcare systems strategies that can be implemented to manage pandemics/epidemics transition phases are a useful knowledge base to inform policy makers about the most effective solutions to adopt. The evidence reporting the healthcare systems management of respiratory viruses epidemics/pandemics, show the lack of a common and shared approach and more evidence-based research is needed.

Introduction Various single nucleotide polymorphisms (SNPs) have been associated with Head and Neck Cancer (HNC) susceptibility and prognosis. The pathogenesis of HNC is related to alterations in metabolite concentrations. Dietary intake may also influence the metabolic profile. We aimed to evaluate the association between serologic metabolites on the one hand and on the other hand HNC related SNPs and dietary intake. Methods This study included participants from the Erasmus Rucphen Family Study (ERF). We identified the SNPs associated with HNC from the GWAS Catalog, reaching genome-wide significance at P Results The study included 2758 participants, in whom 820 metabolites were analyzed. Four SNPs showed a significant association with circulating metabolites: rs174549 with phosphatidylcholine diacyl (β = 0.45; p-value= 7.17 × 10− 40), rs310518 with lipoprotein IDL sub-fraction, rs1229984 with triglycerides and rs1494961 with propionylcarnitine. The minor variant allele of the 4 SNPs showed increased level of the metabolites in blood. As to the association diet and metabolite concentration, significant associations were found for dairy products with sphingomyelin, fish intake with phosphatidylcholines, cholesterol esters with vegetables and myoinositol with fruits intake. When the results of both analyses were merged, 5 metabolites were found to be associated with dietary variables and rs174549. In the minor allele carriers, phosphatidylcholines increased with consumption of fish and phosphatidylethanolamine increased with consumption of diary products. Conclusions The genetic variants rs174549, which is a determinant of genetic HNC susceptibility, is associated with phosphatidylcholines and phosphatidylethanolamine in the circulation. Key messages In the minor allele carriers of rs174549, phosphatidylcholine diacyl level in circulation increased with consumption of fish. In the minor allele carriers of rs174549, phosphatidylethanolamine level in circulation increased with consumption of diary products.

Background Extended evidence has established that healthcare workers face several mental health problems during a disease outbreak, which could have a long-term impact. To address these issues, elaboration and implementation of psychological/psychiatric interventions or strategies is of utmost importance. In this context, this systematic review aimed at identifying strategies to manage mental health issues in healthcare workers during infectious disease outbreaks. Methods PubMed, Cochrane, Scopus and Web of Science were searched to retrieve pertinent articles published in English until May 2020. Articles reporting measures, interventions, strategies, or recommendations to manage mental health problems in healthcare workers during an infectious disease outbreak, of any study design were included. The quality assessment was performed according to the study design of the included articles. Results Our search strategy produced a total of 2358 articles. After the screening process 33 articles met the inclusion criteria, addressing COVID-19 (40%), followed by SARS (21%) and Ebola Virus (15%). The findings emphasized that organisations should follow an evidence-based approach and establish comprehensive programs to assist hospital staff during disease outbreaks. The preliminary results show that the creation of a psychological response team, training, e-learning, courses, psychosocial counselling, screening instruments and telemedicine activities could improve the capacity of response and coping, and reduce mental health issues in healthcare workers. Conclusions To minimize the psychological impact of future infectious disease outbreaks, evidence-based intervention strategies should be implemented to retain mental health among healthcare workers. Our results may provide the necessary insights that could be applied during the COVID-19 pandemic. Key messages During infectious disease outbreaks healthcare workers are faced with mental health issues, that need to be addressed through tailored interventions offering coping strategies and increase resilience. Mental health related interventions or strategies include the implementation of professional training, psychosocial counselling, courses, and the creation of a psychological response team.

Objective Head and neck cancer (HNC) is the sixth leading cancer worldwide with approximately 600,000 new cases per year. Several studies suggest that HNC survivors may have an increased risk of developing second primary cancers (SPCs). A systematic review and meta-analysis was performed aiming to quantify the overall and site-specific risk of metachronous SPCs in HNC survivors. Methods PubMed, Web of Science and Scopus were searched to identify studies published until October 2019. Studies investigating the standardised incidence ratio (SIR) of metachronous SPC were included. A random-effects meta-analysis was performed to calculate the overall and site-specific SIRs. Newcastle-Ottawa Scale was used to assess the study's quality. Heterogeneity was quantified using the I2 statistics and explored using meta-regression. Results Twenty-six studies were included in the systematic review. Studies differed by the definition of metachronous SPC used. For the meta-analyses, the studies were grouped according to these definitions. In the three groups, the overall risk of metachronous SPC was increased. The highest SPC risk was for oropharynx, oesophagus and lung. Conclusions Head and neck cancer survivors are at increased overall risk of metachronous SPCs. The canonical upper aerodigestive sites, HNLE (head and neck, oesophagus and lung), were the SPC sites with the highest risk. Implication for cancer survivors Our results emphasise the importance of targeted surveillance strategies aimed at early detection and tertiary preventive interventions.

Background Direct-to-consumer genetic tests (DTC-GTs) are genetic tests for a medical or non-medical trait that are sold directly to the public, usually ordered without the engagement of a healthcare professional. Our aim was to explore the knowledge, attitudes and behaviors toward DTC-GTs among European citizens. Methods We updated the most recent systematic review on citizens’ perspectives toward DTC-GTs. Relevant English language studies were searched on PubMed, ISI Web of Science, Scopus, Embase and Google Scholar from October 2014 to April 2019. We extended our search on Scopus without publication date restriction, since it was not included in the former review. Eligible studies were conducted in European countries and reported original data. The quality of the studies was evaluated using a checklist developed by Kmet et al. Results We included six studies conducted in European countries between 2015 and 2018. The studies were performed among general population in the Netherlands, students in Italy and Greece, laypeople in Germany and older adults in Switzerland. The level of awareness, in overall low, differed by country and population group. Most of the participants were interested in undergoing a DTC-GT, mainly for knowing the risk predisposition to a common disease. Concerns were raised about tests’ validity and utility and data privacy. Conclusions Our review shows that European citizens, overall, have a low level of knowledge on DTC-GTs and a high interest in their purchase. This understanding might contribute to the development of educational programs in order to the increase of general public capabilities to make appropriate health decisions.

BACKGROUND: Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review. METHODS: PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential eligible articles published until 31 May 2020 in English. Additionally, through a desk research in HTA agencies' repositories, we retrieved the published reports on the practical use of these frameworks. RESULTS: Twenty-three articles were included in the systematic review. Twenty-two frameworks, which addressed genetic and/or genomic technologies, were described. Most of them derived from the ACCE framework and evaluated the domains of analytical validity, clinical validity and clinical utility. We retrieved forty-five reports, which mainly addressed the commercial transcriptomic prognostics and next generation sequencing, and evaluated clinical effectiveness, economic aspects, and description and technical characteristics. CONCLUSIONS: A value assessment framework for the HTA evaluation of omics technologies is not standardized and accepted, yet. Our work reports that the most evaluated domains are analytical validity, clinical validity and clinical utility and economic aspects. ispartof: INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH vol:17 issue:21 ispartof: location:Switzerland status: published

Background Past decades have witnessed enormous progress in the field of genetics and genomics, and yet a low level of awareness among general public has been described. Our aim was to explore the general populations’ knowledge, attitudes and behaviors towards genomic sciences, with a focus on direct-to-consumer genetic tests (DTC-GTs). DTC-GTs are genetic tests ordered directly by the public, without the involvement of a healthcare provider. Methods Two systematic reviews were conducted related to citizens’ knowledge, attitudes and behaviours. Firstly, we updated the current literature on DTC-GTs by searching PubMed, Web of Science, Embase, Scopus and Google Scholar. Studies published in English from October 2014 to January 2019, conducted in Europe were included. Secondly, we searched PubMed, Web of Science and Embase to review English and Italian studies on genomic sciences from 2003 to 2019. Results In the systematic review on DTC-GTs, we included six studies from Italy, Greece, Germany, The Netherlands and Switzerland. European citizens had an overall low level of awareness and a very small proportion of them had personal experience with DTC-GTs. More than half of the participants were interested in undergoing a DTC-GT, mainly for knowing the risk predisposition to a common disease such as cancer or cardiovascular disease. Concerns were raised about tests’ validity and utility as well as data privacy. In the systematic review on genomic sciences, 55 studies were included. The data extraction process is still in progress and our preliminary results indicate low levels of awareness on genomics. Conclusions Our findings showed that European citizens have a modest level of awareness and a high interest in DTC-GT. Understanding the citizens’ perspectives toward genomic sciences may contribute to the development of educational programs related to their needs. Key messages European citizens expressed modest levels of awareness and high levels of interest in DTC-GTs, mainly for knowing the risk predisposition to common diseases. European citizens are concerned with the data privacy and DTC-GT’s validity and utility.

Background Healthcare systems are facing great challenges due to increased share of aging population, growing health needs and economic restraints. To keep a high quality of assistance it is important to invest in health technologies (HTs) that have the potential of improving health outcomes. Even though a lot of guidance does exist on how HTs should be introduced, used and dismissed, there is a surprising gap in literature concerning the awareness of hospitals in the actual utilization of HTs, namely utilization in daily practice after formal adoption. Methods We performed a systematic literature review of qualitative and quantitative studies aimed at investigating hospital contextual factors that influence the actual utilization of HTs at hospital level. PubMed, Scopus, Web of Science, Econlit and Ovid were searched to retrieve studies published in English from 1st January 2010 to 31st May 2018. Results A total of 33 studies were included mostly addressing information and communication technologies (ICTs). Findings suggest that contextual factors that impact on actual utilization of HTs at hospital level are ascribable to four main families: financial factors, leadership styles, human resource management and hospital infrastructure. It emerges also that involving professionals at all levels and planning people’s work and competencies are major determinants of HTs actual utilization. Conclusions The evidence suggests that several contextual factors play a major role in HTs actual utilization at hospital level even though data are mostly referred to ICTs being the other HTs unexplored. Indeed, findings from this study suggest that numerous items should be evaluated when considering to use a new HTs at hospital level. Nevertheless, evidence regarding actual utilization of medical and surgical HTs is still lacking and future research is needed. Key messages Financial factors, leadership styles, human resource management, hospital infrastructure are relevant determinants of actual utilization of new HTs at hospital level. The evidence on contextual factors that influence actual utilization of HTs is mostly referred to ICTs and further research is indeed deserved.

IntroductionPrecision health requires citizens that are empowered to orient health decisions towards their personal values, aware of the benefits and risks, and committed to sharing their personal data to trustful institutions. Effective citizen engagement initiatives are fundamental for the success of a precision health approach.ObjectiveTo provide an overview of citizen engagement initiatives in precision health in European Union (EU) member states.DesignScoping review.MethodsThe electronic databases PubMed, Web of Science, CINAHL and Embase were searched to include articles published in English. Furthermore, desk research was conducted in English, Dutch, French, Italian and Spanish. Articles or reports regarding ongoing initiatives of citizen engagement in precision health conducted in EU member states and published from January 2015 to July 2020 were considered eligible. A quality assessment of the retrieved entries using Critical Appraisal Skills Programme tool was conducted.ResultsWe identified nine documents, which reported eight ongoing citizen engagement initiatives, with substantial variability. Government agencies, non-governmental organisations and scientific societies were the main organisers and funders. Most of the initiatives were conducted in the UK. Genomics was the most emphasised aspect of precision health in these initiatives. Among the identified initiatives, both in-person and digital means were reported.ConclusionOur work provides an overview of current citizen engagement initiatives in the EU that can be useful for stakeholders interested in designing and developing precision health projects enriched by meaningful citizen participation.PROSPERO registration numberCRD42020193866.

Objective: Current evidence suggests that the most common cardiovascular complications in the COVID-19 patients include acute myocardial injury, congestive heart failure (CHF), coronary artery disease (CAD), cardiac arrhythmias and thromboembolic events. Considering that the mechanism for myocardial injury is reported to result mainly from the direct viral involvement of cardiomyocytes and the effects of systemic inflammation, our scope is to evaluate the relation of the increased level of C-Reactive Protein (CRP) and the cardiovascular complications due to COVID-19. Design and method: We conducted a systematic literature search on various databases such as PubMed, Web of Science and Scopus to identify the relevant articles. We included studies published until September 2020. The receiver operating characteristic (ROC) curve was utilized to analyze the prognostic ability of CRP in the cardio-vascular complications from COVID-19. Subgroup and sensitivity analyses were performed. Heterogeneity was assessed using Cochran's Q test and I2 test. The presence of publication bias was evaluated by visual inspection of the symmetry in funnel plots Results: Nineteen studies met the inclusion criteria with more than 10,630 participants. Subgroup analysis of the clinical classification included acute myocardial injury, CHF, CAD and thromboembolic events. The ROC curve shows that AUC (CHF)=85% (95% CI of 0.598 to 1);AUC (CAD)=81% (95% CI of 05.44 to 1);AUC (Thromboembolic events)=100% (95% CI of 1 to 1). The Kaplan-Meier curve and the log-rank test were applied to further assess the potential risk factors associated with the progression of cardiovascular complications from COVID-19. The Youden index was implemented to set cutoff values. Data analysis was conducted using SPSS 23.0 software. Conclusions: This meta-analysis implies that CRP could be a valuable marker to anticipate the cardiovascular complications from COVID-19. Further evidence based research is mandated for the evaluation of the prognostic role of CRP in these patients.

IntroductionOmics technologies enable the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics) and thus proved to be valuable tools for personalized decision-making in clinical practice. For their evaluation, a health technology assessment (HTA) framework is not standardized and accepted, yet. Therefore, we aim at designing an omics-technologies HTA evaluation framework to facilitate their assessment, through a mixed-method approach. This work is part of the ExACT project, which aims to produce a range of tools to facilitate the implementation of precision health in clinical practice.MethodsA systematic review was conducted to identify the existing HTA frameworks used for the evaluation of omics-technologies. Desk research on the HTA agencies’ websites was performed to identify the reports on omics-technologies HTA evaluation frameworks used by these agencies. A questionnaire evaluating HTA agencies’ experience on evaluation of omics-technologies was designed. The new framework will be elaborated based on the findings from the three methodological steps, and will be validated through a Delphi process.ResultsTwenty-three articles were included in the systematic review. The main identified HTA frameworks were ACCE and “Evaluation of Genomic Applications in Practice and Prevention” (EGAPP). The desk research showed that these frameworks were seldom used by HTA agencies, which for the evaluation of omics-technologies mostly refer to the HTA Core Model®, mainly assessing the following domains: clinical effectiveness and economic evaluation. Data collection process of the questionnaire HTA agencies’ experience is in progress.ConclusionsAlthough two main HTA frameworks for the evaluation of omics-technologies have been identified, these frameworks are sporadically used by HTA agencies in their practice. The particular interest of HTA agencies on clinical effectiveness and economic evaluation, might potentially reflect the uncertainty and difficulties when evaluating omics-technologies. This could indicate that these HTA frameworks are not feasible and practical to be used in routine HTA agency processes for omics technologies, emphasizing the need for a new framework. Our methodological approach might contribute to the development of a new HTA framework, feasible and practical to use not only for HTA agencies.

IntroductionUnderstanding of the role of contextual factors in determining the real value of health technologies is one of the major challenges for the use of Health Technology Assessment (HTA) methodology within hospitals. Moreover, the responsibility of assessing hospital performance is problematic. Although a number of managerial tools are available to appraise outcomes, there is little evidence on the role of contextual variables and how they might contribute to hospital performance.MethodsBased on three extensive literature reviews, a pragmatic framework has been developed to understand interactions between organizational factors and health technologies on hospitals’ performance. Three main causal relationships emerge: (i) direct relationship between contextual factors and performance; (ii) an effect of contextual factors on the capability of technologies to “produce value”; (iii) an influence of organizational factors on clinical evidence-based decision-making. This pragmatic framework was designed within the IMPACT HTA EU Horizon 2020 Research Project.ResultsThe contextual dimensions are ascribable to five domains: organizational structure; managerial accounting tools; information, communication and technology (ICT) tools; human resource management (HRM) tools; hospital-based HTA procedures. The impact of contextual factors on technologies’ ability to produce value is highly overlooked in literature. Some effort in this sense exists only in the analysis of health information technologies. Moreover, among the contextual dimensions, only HRM tools have inspired a lively debate. The definition of hospital performance is amenable to multiple domains: accessibility, appropriateness, efficiency, safety and patient centeredness (continuity of care).ConclusionsAlthough hospital performance is a pivotal topic in the healthcare sector, a deep understanding of how contextual factors may affect it is missing. The theoretical framework developed provides a tool to understand the multiple dimensions able to affect hospital performance. On one hand contextual dimensions may provide a direct effect on hospital performance. On the other, they may affect the extent to which technologies are capable of producing value.