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Background: Minimally invasive approaches to the hip joint for total hip arthroplasty such as the DAA ("Direct Anterior Approach with bikini incision") are increasingly utilized. According to the literature, this approach is more muscle-sparing, results in less postoperative pain, and achieves higher patient satisfaction. The existence of postoperative lymphedema after hip arthroplasty is hardly considered. The aim of this paper is to contribute to the evaluation of the different access methods related to postoperative lymphedema and their functional outcomes. Methods: This is a prospective non-randomized study at an orthopedic specialist clinic in Northern Europe. The surgeons that performed the arthroplasties are high-volume surgeons in private practice affiliated to the clinic. The study included 188 patients with primary hip arthroplasty in a 1:1 ratio (DAA: standard accesses (posterior, transgluteal, and anterolateral access)). Epidemiologic data, Harris Hip Score, Oxford Hip Score, European Quality of Life 5, and Visual Analog Scale were collected preoperatively on admission day, 3rd and 5th postoperative day, and follow-up after 1 year. Furthermore, the range of motion, gait, and ability to climb stairs, as well as the presence of hypesthesia were assessed. To evaluate the edema situation, both legs were measured on the 3rd and 5th postoperative day. The prescription of manual lymphatic drainage and remaining swelling conditions 1 year postoperatively were recorded. Results: For each group, 94 patients with a mean age of 61.7 years (DAA 60.7 and standard access 62.6) were included. All but one patient in the DAA group showed postoperative lymphedema (n: 93/94; 98.9%). In the standard surgery group, only n: 37/94 (39.4%) showed swelling symptoms requiring treatment. After 1 year, lymphedema persisted in 20 patients in the DAA group and 0 patients in the standard-OR group. Hypesthesia at the ventral thigh persisted in 16/94 (= 17%) patients of the DAA group versus 0/94 patients of the standard group after 12 months. Of these 16 cases, 10 had concomitant edema (62.5%). The DAA showed better results than the standard accesses in terms of Oxford Hip Score (p < 0.05) and ability to climb stairs (p < 0.05). In contrast, the Visual Analog Scale and patient quality of life results showed no significant difference (p > 0.05). Conclusion: The present study demonstrated the increased incidence of postoperative lymphedema in patients operated on via DAA access using a Bikini-type skin incision. In the follow-up, significantly more hypesthesia of the ventral thigh occurred in the DAA group. Otherwise, the DAA proved to be superior to the standard approaches from a functional point of view at short-term follow-up. Future research is needed to compare the horizontally oblique to the longitudinal oblique skin incision technique in direct anterior hip surgery regarding the above-mentioned adverse effects found in this study. [ABSTRACT FROM AUTHOR]

Background: The new European Medicines Agency (EMA) Clinical Trials Information System (CTIS), based on the Clinical Trials Regulation (CTR EU 536/2014), came into full effect on 31 January 2022 and was intended to provide an easier, more streamlined approach to the registration of clinical trials taking place in Europe. Using the experience gained on the new regulatory framework from three multi-national European clinical research studies of outbreak-prone infectious diseases, this article describes the advantages and shortcomings of the new clinical trial submission procedure. Methods: We report the time to approval, size of the application dossier, and number of requests for information (RFIs) for each study. We also explore the experience of each study within the regulatory framework and its use of CTIS to document the real-world, practical consequences of the system on individual studies. The study assesses the experience of three multi-country studies conducted in Europe working within the EU and non-EU regulatory environments. Results: While the time to regulatory and ethical approval has improved since the implementation of the new regulation, the timelines for approvals are still unacceptably slow, particularly for studies being conducted in the context of an evolving outbreak. Within the new regulatory approval procedure, there is evidence of conflicting application requirements, increased document burden, barriers to submitting important modifications, and debilitating technical hurdles. Conclusions: CTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings can help improve pan-European clinical trials, especially for the purpose of epidemic preparedness and response. Trial registration: This paper references experiences gained during management of three pan-European trials: EU-SolidAct's Bari-SolidAct (CT No. 2022-500385-99-00 - 15 March 2022) and AXL-SolidAct (CT No. 2022-500363-12-00 - 19 April 2022), and MOSAIC (CT No. 2022-501132-42-00 - 22 June 2022). [ABSTRACT FROM AUTHOR]

Background: Despite a long history of political discourse around refugee integration, it wasn't until 2016 that this issue emerged as a global political priority. Limited research has examined the evolution of policies of global actors around health service provision to refugees and how refugee integration into health systems came onto the global agenda. This study seeks to fill this gap. Methods: Drawing on a document review of 20 peer-reviewed articles, 46 global policies and reports, and 18 semi-structured interviews with actors representing various bilateral, multilateral and non-governmental organizations involved with refugee health policy and funding, we analyze factors that have shaped the global policy priority of integration. We use the Shiffman and Smith Policy Framework on determinants of political priority to organize our findings. Results: Several important factors generated global priority for refugee integration into national health systems. Employing the above-mentioned framework, actor power increased due to network expansion through collaborations between humanitarian and development actors. Ideas took hold through the framing of integration as a human rights and responsibility sharing. While political context was influenced through several global movements, it was ultimately the influx of Syrian refugees into Europe and the increasing securitization of the refugee crisis that led to key policies, and critically, global funding to support integration within refugee hosting nations. Finally, issue characteristics, namely the magnitude of the global refugee crisis, its protractedness and the increasing urbanicity of refugee inflows, led integration to emerge as a manageable solution. Conclusion: The past decade has seen a substantial reframing of refugee integration, along with increased financing sources and increased collaboration, explains this shift towards their integration into health systems. However, despite the emergence of integration as a global political priority, the extent to which efforts around integration have translated into action at the national level remains uncertain. [ABSTRACT FROM AUTHOR]

Background: The demand for plasma products is growing, necessitating an increase in plasma collection by plasmapheresis. While the 20th edition of the European Guidelines permits plasma donors in Europe to donate with 96-h donation intervals, the potential short- and long-term consequences of high-frequency plasma donations on donor health remain unknown. This study aims to measure the effect of plasma donation frequency on plasma protein composition, including total serum protein (TSP) and immunoglobulin G (IgG), in Norwegian male blood donors. Methods: This randomized controlled trial (RCT) included 120 male blood donors who were randomized into two intervention groups and one control group: high-frequency plasma donors (HFPDs) who donated 650 mL of plasma 3 times every 2 weeks, whereas regular-frequency plasma donors (RFPDs) who donated 650 mL of plasma 1 time every 2 weeks. The control group consisted of whole blood donors. The primary outcomes are the concentrations of TSP and IgG. Discussion: The findings from this study may have implications for recommendations related to donor health and plasma donation frequencies and may contribute to supporting the strategic independence of plasma products in Norway and Europe without compromising donor health. Trial registration: ClinicalTrials.gov: NCT05179200. Registered December 20th, 2021. [ABSTRACT FROM AUTHOR]

Background: Music therapy interventions with informal carers of individuals with life-threatening illness at pre- and post-bereavement is an increasingly important clinical area. This systematic review is the first to synthesise and critically evaluate the international evidence associated with music therapy with adult informal carers pre- and post-bereavement. Specifically, the objectives were: i) to describe the characteristics and effectiveness of music therapy interventions which aim to improve health-related outcomes for adult informal carers of adults with life-threatening illness (pre- and post-bereavement), and ii) to describe the experience of music therapy for adult informal carers of adults with life-threatening illness (pre- and post-bereavement). Methods: Eligibility: adult informal carers of adults at end of life or bereaved; music therapy interventions for improving health-related outcomes; qualitative; mixed-method; and quantitative studies including comparators of any other intervention; published in English from 1998 onwards. Six databases were searched up to July 2022. A JBI mixed-methods systematic review approach was followed throughout, including quality appraisal, data extraction and a convergent segregated approach to synthesis and integration. Results: A total of 34 studies were included, published between 2003 and 2022. Most were conducted in North America (n = 13), Australia (n = 10), or Europe (n = 8). No studies were conducted in low- and middle-income countries or in the UK. The majority were qualitative (n = 17), followed by quasi-experimental (n = 8), mixed-methods (n = 7) and two RCTs. The majority focused on carers of individuals with dementia (n = 21) or advanced cancer (n = 7). Seventeen studies were purely quantitative or included a quantitative component. During meta-synthesis, findings were aligned to core outcomes for evaluating bereavement interventions in palliative care and previously identified risk factors for complicated grief. Commonly targeted outcomes in quantitative studies included quality of life and mental wellbeing, showing equivocal effectiveness of music therapy with significant and non-significant results. Twenty-two studies either purely qualitative or with a qualitative component underwent meta synthesis and suggested a diverse range of improved pre- and post-bereavement outcomes for informal carers across all core outcomes, and across all risk and protective factors, including psychological, spiritual, emotional, and social outcomes. Conclusions: Qualitative studies provide moderate to strong evidence for improved health-related outcomes for adult informal carers of adults with life-threatening illness pre-bereavement. Limited studies including those bereaved negates conclusions for the bereavement phase. Comparisons and explanations for effectiveness across quantitative and qualitative studies are equivocal, with a high risk of bias and small samples in the limited number of quantitative studies, demonstrating a need for high-quality RCTs. Systematic review pre-registration: PROSPERO [CRD42021244859]. [ABSTRACT FROM AUTHOR]

Background: Variation in hospital stroke care is problematic. The Quality in Acute Stroke (QASC) Australia trial demonstrated reductions in death and disability through supported implementation of nurse-led, evidence-based protocols to manage fever, hyperglycaemia (sugar) and swallowing (FeSS Protocols) following stroke. Subsequently, a pre-test/post-test study was conducted in acute stroke wards in 64 hospitals in 17 European countries to evaluate upscale of the FeSS Protocols. Implementation across countries was underpinned by a cascading facilitation framework of multi-stakeholder support involving academic partners and a not-for-profit health organisation, the Angels Initiative (the industry partner), that operates to promote evidence-based treatments in stroke centres..We report here an a priori qualitative process evaluation undertaken to identify factors that influenced international implementation of the FeSS Protocols using a cascading facilitation framework. Methods: The sampling frame for interviews was: (1) Executives/Steering Committee members, consisting of academics, the Angels Initiative and senior project team, (2) Angel Team leaders (managers of Angel Consultants), (3) Angel Consultants (responsible for assisting facilitation of FeSS Protocols into multiple hospitals) and (4) Country Co-ordinators (senior stroke nurses with country and hospital-level responsibilities for facilitating the introduction of the FeSS Protocols). A semi-structured interview elicited participant views on the factorsthat influenced engagement of stakeholders with the project and preparation for and implementation of the FeSS Protocol upscale. Interviews were recorded, transcribed verbatim and analysed inductively within NVivo. Results: Individual (n = 13) and three group interviews (3 participants in each group) were undertaken. Three main themes with sub-themes were identified that represented key factors influencing upscale: (1) readiness for change (sub-themes: negotiating expectations; intervention feasible and acceptable; shared goal of evidence-based stroke management); (2) roles and relationships (sub-themes: defining and establishing roles; harnessing nurse champions) and (3) managing multiple changes (sub-themes: accommodating and responding to variation; more than clinical change; multi-layered communication framework). Conclusion: A cascading facilitation model involving a partnership between evidence producers (academic partners), knowledge brokers (industry partner, Angels Initiative) and evidence adopters (stroke clinicians) overcame multiple challenges involved in international evidence translation. Capacity to manage, negotiate and adapt to multi-level changes and strategic engagement of different stakeholders supported adoption of nurse-initiated stroke protocols within Europe. This model has promise for other large-scale evidence translation programs. [ABSTRACT FROM AUTHOR]

Background: GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate the feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and data collection to design a large efficacy trial. Method: GOIZ ZAINDU is a 1-year, randomized, controlled trial of a multidomain intervention in persons aged 60+ years, with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥ 6, no diagnosis of dementia, and below-than-expected performance in at least one of three cognitive screening tests. Randomization to a multidomain intervention (MD-Int) or regular health advice (RHA) was stratified by sex, age (>/≤ 75), and cognitive status (mild cognitive impairment (MCI)/normal cognition). MD-Int included cardiovascular risk factor control, nutritional counseling, physical activity, and cognitive training. The primary outcomes were retention rate and adherence to the intervention program. Exploratory cognitive outcomes included changes in the Neuropsychological Test Battery z-scores. Analyses were performed according to the intention to treat. Results: One hundred twenty-five participants were recruited (mean age: 75.64 (± 6.46); 58% women). The MD-Int (n = 61) and RHA (n = 64) groups were balanced in terms of their demographics and cognition. Fifty-two (85%) participants from the RHA group and 56 (88%) from the MD-Int group completed the study. More than 70% of the participants had high overall adherence to the intervention activities. The risk of cognitive decline was higher in the RHA group than in the MD-Int group in terms of executive function (p =.019) and processing speed scores (p =.026). Conclusions: The GOIZ-ZAINDU study proved that the FINGER methodology is adaptable and feasible in a different socio-cultural environment. The exploratory efficacy results showed a lower risk of decline in executive function and processing speed in the intervention group. These results support the design of a large-scale efficacy trial. Trial registration: GOIZ ZAINDU feasibility trial was approved and registered by the Euskadi Drug Research Ethics Committee (ID: PI2017134) on 23 January 2018. Retrospectively registered in ClinicalTrials.gov (NCT06163716) on 8 December 2023. [ABSTRACT FROM AUTHOR]

One of the most relevant challenges for healthcare providers during the COVID– 19 pandemic has been assuring the continuity of care to patients with complex health needs such as people living with rare diseases (RDs). The COVID–19 pandemic accelerated the healthcare sector's digital transformation agenda. The delivery of telemedicine services instead of many face-to-face procedures has been expanded and, many healthcare services not directly related to COVID-19 treatments shifted online remotely. Many hospitals, specialist centres, patients and families started to use telemedicine because they were forced to. This trend could directly represent a good practice on how care services could be organized and continuity of care could be ensured for patients. If done properly, it could boast improved patient outcomes and become a post COVID-19 major shift in the care paradigm. There is a fragmented stakeholders spectrum, as many questions arise on: how is e-health interacting with 'traditional' healthcare providers; about the role of the European Reference Networks (ERNs); if remote care can retain a human touch and stay patient centric. The manuscript is one of the results of the European Brain Council (EBC) Value of Treatment research project on rare brain disorders focusing on progressive ataxias, dystonia and phenylketonuria with the support of Academic Partners and in collaboration with European Reference Networks (ERNs) experts, applying empirical evidence from different European countries. The main purpose of this work is to investigate the impact of the COVID-19 pandemic on the continuity of care for ataxias, dystonia and phenylketonuria (PKU) in Europe. The analysis carried out makes it possible to highlight the critical points encountered and to learn from the best experiences. Here, we propose a scoping review that investigates this topic, focusing on continuity of care and novel methods (e.g., digital approaches) used to reduce the care disruption. This scoping review was designed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) standards. This work showed that the implementation of telemedicine services was the main measure that healthcare providers (HCPs) put in place and adopted for mitigating the effects of disruption or discontinuity of the healthcare services of people with rare neurological diseases and with neurometabolic disorders in Europe. [ABSTRACT FROM AUTHOR]

Introduction: Public health campaigns with a well-defined outcome behaviour have been shown to successfully alter behaviour. However, the complex nature of antimicrobial resistance (AMR) creates challenges when evaluating campaigns aimed at raising awareness and changing behaviour. Aims: To determine what campaigns have been conducted and which reported being effective at improving awareness of antimicrobial resistance and changing behaviour around antimicrobial use in members of the public. It also sought to determine the outcome measures studies have used to assess campaign effectiveness. Methods: A systematic search of Ovid MEDLINE and Embase, was conducted in October 2022 using a predefined search strategy. Studies which were published between 2010 and September 2022 that outlined a campaign or invention aimed at the public and focusing on AMR or antibiotic usage were eligible for inclusion and studies which solely targeted healthcare professionals (HCP) were excluded. Results: Literature searches retrieved 6961 results. De-duplication and screening removed 6925 articles, five articles from grey literature and reference screening were included, giving a total of 41 studies and 30 unique interventions. There was a distribution of campaigns globally with the majority run in Europe (n = 15) with most campaigns were conducted nationally (n = 14). Campaigns tended to focus on adult members of the public (n = 14) or targeted resources towards both the public and HCPs (n = 13) and predominately assessed changes in knowledge of and/or attitudes towards AMR (n = 16). Campaigns where an improvement was seen in their primary outcome measure tended to use mass media to disseminate information, targeted messaging towards a specific infection, and including the use of HCP-patient interactions. Discussion: This review provides some evidence that campaigns can significantly improve outcome measures relating to AMR and antibiotic usage. Despite a lack of homogeneity between studies some common themes emerged between campaigns reported as being effective. However, the frequent use of observational study designs makes it difficult to establish causation between the campaign and changes seen in the studies outcome measures. It is important that clear evaluation processes are embedded as part of the design process for future campaigns; a campaign evaluation framework for use by campaign developers may facilitate this. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to examine the Coronavirus disease 2019(COVID-19) vaccine policies disparities and effectiveness in Germany, Denmark and Bulgaria, with a view to providing lessons for global vaccination and response to possible outbreak risks. Methods: This study analyzed big data through public information on the official websites of the Ministries of Health of the European Union, Germany, Denmark and Bulgaria and the official websites of the World Health Organization. We systematically summarized the COVID-19 vaccine policies of the three countries, and selected the following six indicators for cross-cutting vaccination comparisons: COVID-19 vaccine doses administered per 100 people, COVID-19 vaccination rate, the share of people with fully vaccinated, the share of people only partly vaccinated, cumulative confirmed COVID-19 cases per million, cumulative confirmed COVID-19 deaths per million. Meanwhile, we selected the following four indicators for measuring the effectiveness of COVID-19 vaccine policy implementation: daily cases per million, daily deaths per million, the effective reproduction rate (Rt), the moving-average case fatality rate (CFR). Results: Although these three EU countries had the same start time for vaccination, and the COVID-19 vaccine supply was coordinated by the EU, there are still differences in vaccination priorities, vaccination types, and vaccine appointment methods. Compared to Germany and Denmark, Bulgaria had the least efficient vaccination efforts and the worst vaccination coverage, with a vaccination rate of just over 30% as of June 2023, and the maximum daily deaths per million since vaccination began in the country was more than three times that of the other two countries. From the perspective of implementation effect, vaccination has a certain effect on reducing infection rate and death rate, but the spread of new mutant strains obviously aggravates the severity of the epidemic and reduces the effectiveness of the vaccine. Among them, the spread of the Omicron mutant strain had the most serious impact on the three countries, showing an obvious epidemic peak. Conclusions: Expanding vaccination coverage has played a positive role in reducing COVID-19 infection and mortality rates and stabilizing Rt. Priority vaccination strategies targeting older people and at-risk groups have been shown to be effective in reducing COVID-19 case severity and mortality in the population. However, the emergence and spread of new variant strains, and the relaxation of epidemic prevention policies, still led to multiple outbreaks peaking. In addition, vaccine hesitancy, mistrust in government and ill-prepared health systems are hampering vaccination efforts. Among the notable ones are divergent types of responses to vaccine safety issue could fuel mistrust and hesitancy around vaccination. At this stage, it is also necessary to continue to include COVID-19 vaccination in priority vaccination plans and promote booster vaccination to prevent severe illness and death. Improving the fairness of vaccine distribution and reducing the degree of vaccine hesitancy are the focus of future vaccination work. [ABSTRACT FROM AUTHOR]