Interventions In Europe Research Articles

Temporal Trends in Chronic Total Occlusion Interventions in Europe.

The study focuses on the evolution of practice, procedural outcomes, and in-hospital complications of chronic total occlusion percutaneous coronary intervention in Europe. Data from 17 626 procedures enrolled in European Registry of Chronic Total Occlusion between January 2008 and June 2015 were assessed. The mean patient age was 63.9±10.9 years; 85% were men. Procedural success increased from 79.7% to 89.3% through the study period. Patients enrolled during the years had increasing comorbidities and lesion complexity (J-CTO score [Multicenter CTO Registry of Japan] increased from 1.76±1.03 in 2008 to 2.17±0.91 in 2015; P for trend, <0.001). Retrograde approach utilization steadily increased from 10.1% in 2008 to 29.9% in 2015 ( P for trend, <0.001). Antegrade dissection reentry adoption was low, not exceeding 5.5%. In-hospital mortality decreased during the study period from 0.4% to 0.1% ( P for trend, <0.001), whereas in-hospital complication rates remained essentially unchanged, in the range 4.4% to 5.2% ( P for trend, 0.390). Chronic total occlusion percutaneous coronary intervention has shown a steady increase in procedural success rate over time, with unchanged complication rates, despite the increasing complexity of the lesions attempted. The J-CTO score predictive value for procedural success was low for the entire registry and had no predictive ability for the retrograde approach.

PMD38 - Innovative Access Pathways for Digital Healthcare Solutions: Learnings From a European Analogue Analysis for Asian HTA Bodies

The FDA defines the scope of digital health as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. According to an IQVIA report, the number of digital health apps available on iTunes and Google Play nearly doubled between 2015 and 2017. Japan's HTA agency will be launched in an environment where digital interventions are becoming increasingly prevalent; Japan’s and other Asian HTA bodies will need to develop processes to appraise digital interventions. Question: How are digital health interventions obtaining access and reimbursement in France, Italy and the UK; and what factors led to their success? An analogue analysis of the access pathways of three digital health interventions in Europe was conducted via desk research. A set of selection criteria was developed and used to select six interventions. After initial review, three were shortlisted for a deep dive analysis. These were: Diabeo (for diabetes), Monsenso (for mental illness) and SmartInhaler (for respiratory diseases). Diabeo was assessed by CNEDiMTS in France and is being funded as part of a national digital health experiment. Professionals using the service were also provided funding to facilitate the use of the app. Monsenso is being trialled by an NHS Trust in the UK. SmartInhaler was recommended by NICE in a MedTech innovation briefing. Yet none were guaranteed reimbursement. All three have been tested in clinical trials. There is no single, defined pathway for access and reimbursement of digital interventions in the countries assessed. However, HTA agencies have shown willingness to engage with digital interventions and local providers are keen to trial them if they show promise either in improving outcomes or efficiency of care. Asian HTA agencies can use these case studies to develop their own guidance.

Comprehensive analysis of the mutation spectrum in 301 German ALS families

ObjectivesRecent advances in amyotrophic lateral sclerosis (ALS) genetics have revealed that mutations in any of more than 25 genes can cause ALS, mostly as an autosomal-dominant Mendelian trait. Detailed knowledge...

Addressing female genital mutilation in Europe: a scoping review of approaches to participation, prevention, protection, and provision of services

BackgroundPublic and policy attention to female genital mutilation (FGM) in diaspora communities has increased in Europe, but research remains limited and misinformation abounds. As a first step to addressing these issues, this study explored FGM prevention and response interventions in Europe, using a scoping literature review and key informant interviews.MethodsA scoping study design was selected, using Arksey and O’Malley’s six-stage scoping framework to review identified sources. Key informant interviews were used to inform and add depth to literature findings. Findings were summarised thematically, guided by the Scottish Government’s ‘4Ps’ framework for tackling violence against women (i.e. participation, prevention, protection, providing services).ResultsSeventy literature sources, of 1095 screened, plus 16 individual and 3 group interview sources were included. Several countries have developed promising interventions supporting FGM resistance and recovery. However, gaps remain including community participation, professional knowledge and linkages, and evaluation of approaches.ConclusionsThis scoping review is an initial attempt to describe available primary evidence on European initiatives responding to FGM. Further research is required to determine whether interventions are effective, while policy and practice development must be shaped and driven by the experiences, needs, and views of affected communities.

Chondrocyte-based intraoperative processing strategies for the biological augmentation of a polyurethane meniscus replacement

ABSTRACTPurpose/aim of study: Menisectomies account for over 1.5 million surgical interventions in Europe annually, and there is a growing interest in regenerative strategies to improve outcomes in meniscal replacement. The overall objective of this study was to evaluate the role of intraoperatively applied fresh chondrocyte (FC) isolates compared to minced cartilage (MC) fragments, used without cell isolation, to improve bioactivity and tissue integration when combined with a polyurethane replacement.Materials and methods: First, to optimize the intraoperative cell isolation protocol, caprine articular cartilage biopsies were digested with 750 U/ml or 3000 U/ml collagenase type II (ratio of 10 ml per g of tissue) for 30 min, 1 h or 12 h with constant agitation and compared to culture-expanded chondrocytes in terms of matrix deposition when cultured on polyurethane scaffolds. Finally, FCs and MC-augmented polyurethane scaffolds were evaluated in a caprine meniscal explant model to assess the potential enhancements on tissue integration strength.Results: Adequate numbers of FCs were harvested using a 30 min chondrocyte isolation protocol and were found to demonstrate improved matrix deposition compared to standard culture-expanded cells in vitro. Upon evaluation in a meniscus explant defect model, both FCs and MC showed improved matrix deposition at the tissue-scaffold interface and enhanced push-out strength, fourfold and 2.5-fold, respectively, compared with the acellular implant.Conclusions: Herein, we have demonstrated a novel approach that could be applied intraoperatively, using FCs or MC for improved tissue integration with a polyurethane meniscal replacement.

Evaluating FINDRISC as a screening tool for type 2 diabetes among overweight adults in the PREVIEW:NZ cohort

AimsThis study aimed to evaluate the efficacy of a high (≥12) Finnish diabetes risk (FINDRISC) score in identifying undiagnosed prediabetes and type 2 diabetes (T2D) in an New Zealand population of overweight and obese individuals, across a variety of ethnic groups. MethodsWe estimated the efficacy of elevated FINDRISC scores in predicting prediabetes and T2D in 424 overweight adults with no prior diagnosis recruited for the PREVention of diabetes through lifestyle Interventions in Europe and Worldwide (PREVIEW) study. All participants who completed the FINDRISC questionnaire during a pre-screening phase with a score of ≥12 were then screened using a 2h oral glucose tolerance test (2h-OGTT) to identify undiagnosed dysglycaemia. ResultsOf the 424 participants, 65% (n=280) were pre-diabetic and 7% (n=32) had undiagnosed T2D. A higher FINDRISC score was significantly associated with prediabetes and T2D (P=0.02). There was a significant association between ethnicity and glycaemic status (normal vs prediabetes/T2D, P=0.02). Increasing the FINDRISC cut-off to ≥15 resulted in a non-significant increase in the proportion of participants correctly classified with dysglycaemia. ROC-AUC=0.6 with sensitivity=0.6026 (95% CI: 0.5459–0.6573) and specificity=0.5536 (95% CI: 0.4567–0.6476). Isolated impaired fasting glucose (IFG) was more efficient in predicting dysglycaemia than isolated impaired glucose tolerance (IGT). ConclusionsThe FINDRISC questionnaire is a useful and efficacious screening tool to identify unknown prediabetes and T2D in overweight New Zealanders, particularly in Maori individuals.

Effectiveness of interventions to improve lifestyle behaviors among socially disadvantaged children in Europe

Unhealthy lifestyle behaviors and childhood overweight are more common among children from families with a low socioeconomic position and ethnic minority children (referred to as social disadvantaged children). : This systematic review evaluates the effectiveness of interventions aimed to improve lifestyle behaviours and/or prevent overweight among socially disadvantaged children in Europe. : Six major databases were searched for studies reporting intervention effects on adiposity measures, sedentary behaviours, physical activity behaviours or dietary behaviours. Studies were included when the study sample consisted of at least 50% socially disadvantaged children or when results were presented for subgroups of socially disadvantaged children separately. Methodological quality assessment was based on Cochrane criteria. In total, 11 studies reporting on eight interventions (one among infants 0-2 years, one among preschoolers 2-6 years, six among school-aged children 6-12 years) were identified. Of these eight interventions, five interventions primarily aimed to improve at least one adiposity measure and three primarily aimed to improve a specific lifestyle behaviour. In general, modest positive effects were found but interventions were limited by a short follow-up duration. Despite an urgent need for effective interventions to improve lifestyle behaviours and prevent overweight among socially disadvantaged children, research on the effectiveness of interventions in Europe is still scarce. Those interventions that have been evaluated show modest effects on lifestyle behaviours and adiposity measures, but long-term follow-up is needed to establish whether these effects are sustained over a longer period of time.

China Expert Consensus on Clinical Application of the Drug-Coated Balloon

Percutaneous coronary intervention (PCI) has become the mainstay in the treatment of coronary heart disease (CHD). In the past 10 years, the number of PCI procedures for CHD has maintained an annual growth of 15%–20% on average in China. As a consequence, in-stent restenosis (ISR) has become an increasingly serious problem with the wide application of coronary stents. Certainly, current treatment regimens for ISR are unsatisfactory in some aspects. Coronary artery bypass surgery has many risk factors and contradictions and a second stent implantation is associated with the risk for recurrent ISR and additional stent implantations; the rate of recurrent ISR in lesions after plain old balloon angioplasty is high (up to 27%). Therefore, all these regimens are suboptimal for the treatment of ISR. In recent years, drug-coated balloon (DCB), a novel interventional technique, has been increasingly used in coronary and peripheral artery interventions in Europe and Asia. In China, several DCB products have been or will be marketed for clinical application. The introduction of DCB provides a new choice for the treatment of coronary artery diseases in China. Based on several national and international clinical trials, >20 experienced experts in the PCI field from China have proposed the China expert consensus on clinical application of the DCB with evidence-based validation and session discussion in order to promote the standardized application of the DCB in the treatment of coronary artery diseases in China.

Europe needs a central, transparent, and evidence-based approval process for behavioural prevention interventions.

Fabrizio Faggiano and colleagues discuss how a central, transparent, and evidence-based approval process is needed for behavioral prevention interventions in Europe and propose a way forward. Please see later in the article for the Editors' Summary.

Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: A quality improvement project

PurposeProlonged periods of mechanical ventilation are associated with significant physical and psychosocial adverse effects. Despite increasing evidence supporting early rehabilitation strategies, uptake and delivery of such interventions in Europe have been variable. The objective of this study was to evaluate the impact of an early and enhanced rehabilitation program for mechanically ventilated patients in a large tertiary referral, mixed-population intensive care unit (ICU). MethodA new supportive rehabilitation team was created within the ICU in April 2012, with a focus on promoting early and enhanced rehabilitation for patients at high risk for prolonged ICU and hospital stays. Baseline data on all patients invasively ventilated for at least 5 days in the previous 12 months (n = 290) were compared with all patients ventilated for at least 5 days in the 12 months after the introduction of the rehabilitation team (n = 292). The main outcome measures were mobility level at ICU discharge (assessed via the Manchester Mobility Score), mean ICU, and post-ICU length of stay (LOS), ventilator days, and in-hospital mortality. ResultsThe introduction of the ICU rehabilitation team was associated with a significant increase in mobility at ICU discharge, and this was associated with a significant reduction in ICU LOS (16.9 vs 14.4 days, P = .007), ventilator days (11.7 vs 9.3 days, P < .05), total hospital LOS (35.3 vs 30.1 days, P < .001), and in-hospital mortality (39% vs 28%, P < .05). ConclusionA quality improvement strategy to promote early and enhanced rehabilitation within this European ICU improved levels of mobility at critical care discharge, and this was associated with reduced ICU and hospital LOS and reduced days of mechanical ventilation.

Trends in Consumption of Alcoholic Beverages and Policy Interventions in Europe: An Uncertainty “Associated” Perspective

Having qualitatively investigated, both the temporal curves of alcoholic beverage consumption trends and the introduction of preventive alcohol policy measures in six European countries during the 1960s–2000s, drinking control policy measures often appeared to operate as co-factors of change, while during some periods of time they were not even present even if effective consumption changes were occurring. Study limitations are noted.

Equity impact of European individual-level smoking cessation interventions to reduce smoking in adults: a systematic review.

Smoking is the leading cause of health inequalities in Europe. Adults from lower socioeconomic status (SES) groups are more likely to smoke and less likely to quit than adults from higher SES groups. Smoking cessation support is an important element of tobacco control; however, the equity impact of individual-level cessation support is uncertain. Systematic review of individual-level smoking cessation interventions delivered in European countries, reporting a smoking cessation outcome (quit) in adults of lower compared with higher SES. Equity impact was assessed as positive (reduced inequality), neutral (no difference by SES), negative (increased inequality) or unclear. Twenty-nine studies were included using different types of support: behavioural and pharmacological (17); behavioural only (11), including specialist (5), brief advice (1), mass media (2), text-based (1) and Internet-based (2); and pharmacological only (1). The distribution of equity effects on quitting was 10 neutral, 18 negative and 1 unclear. Two national studies of UK National Health Service (NHS) stop-smoking services showed overall positive equity impact on smoking prevalence. The evidence suggests that UK NHS services that target low-SES smokers achieve a relatively higher service uptake among low-SES smokers, which can compensate for their lower quit rates. Untargeted smoking cessation interventions in Europe may have contributed to reducing adult smoking but are, on balance, likely to have increased inequalities in smoking. However, UK NHS stop-smoking services appear to reduce inequalities in smoking through increased relative reach through targeting services to low-SES smokers. More research is needed to strengthen the evidence-base for reducing smoking inequalities.

Challenges for the Development of Bone-Forming Agents in Europe

In recent years, significant advances have been made in the management of osteoporosis, particularly with respect to the development of pharmacological interventions to reduce fracture risk. Approved pharmacological interventions in Europe include bisphosphonates, strontium ranelate, raloxifene, bazedoxifene, denosumab, and parathyroid hormone peptides [1–4] (Table 1). Treatments are approved for osteoporosis in postmenopausal women, but alendronate, etidronate, risedronate zoledronic acid, and teriparatide are also approved for the prevention and treatment of glucocorticoid-induced osteoporosis in Europe [3], and alendronate, risedronate, zoledronic acid, strontium ranelate, and teriparatide are approved for the treatment of osteoporosis in men. Most of these agents are primarily inhibitors of bone turnover, sometimes referred to as anticatabolic agents [5], whereas teriparatide, parathyroid hormone (PTH), and, arguably, strontium ranelate act in part or predominately by the stimulation of bone formation (anabolic agents). There is now a number of bone-forming agents in clinical development, including agents targeting the endogenous inhibitors of bone formation sclerostin and dickkopf-1, cathepsin K inhibitors, new formulations of PTH and PTH related protein (PTHrp) analogs, and calcilytics. The clinical use of these agents in the management of osteoporosis is dependent on marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Guidelines for product development are available and are regularly updated. The last revision came into effect in 2007 [6]. In phase 3 (the demonstration of efficacy), authorization is dependent on the demonstration of significant efficacy on fracture risk reduction and acceptable safety in postmenopausal women at high or imminent risk of experiencing osteoporotic fractures on the basis of an increased 10-year probability of fractures. Because treatment to prevent fractures may be regarded as a long-term treatment, the CHMP recommends that a duration of randomized JAK has received consulting fees, advisory board fees, lecture fees, and/or grant support from the majority of companies concerned with skeletal metabolism. C C has received consulting fees and paid advisory boards for Alliance for Better Bone Health, GlaxoSmithKline, Roche, Merck Sharp and Dohme, Lilly, Amgen, Wyeth, Novartis, Servier, and Nycomed. RR: Paid advisory boards and lecture fee for Merck Sharp and Dohme, Eli Lilly, Amgen, Servier, Takeda, and Danone. J-Y R on behalf of the Department of Public Health, Epidemiology and Health Economics of the University of Liege, Liege, Belgium. Consulting fees or paid advisory boards: Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB. Lecture fees when speaking at the invitation of a commercial sponsor: Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, Novo-Nordisk.

Public Intervention for Free/Open Source Software

This paper reviews the main theoretical and practical arguments in favor and against governments’ policies supporting Free/Open Source (F/OS) software. Using the information gathered from the OSOR.eu website, we build an original dataset about F/OS software interventions across Europe and we show that public adoption and advisory are the most common type of interventions in Europe. Our analysis suggests that, to evaluate in a meaningful way rationales, motivations and consequences of public interventions, one has to properly distinguish between the various roles played by policy makers and the different categories of software involved. We provide empirical evidence that F/OS support is stronger in countries i) where egovernment services are more largely available, and ii) where the domestic software industry is lagging behind. This evidence supports common views among F/OS advocates.

Genetic basis for cholecystolithiasis. Existing state of knowledge

Introduction and objective: The pathogenesis of cholecystolithiasis is not well recognized. It is postulated that coexistence of environmental factors with genetic factors in individuals predispose to this illness. In this study the authors present the current state of knowledge about the pathogenesis of cholecystolithiasis and predisposing genetic factors such as: genes polymorphisms, genes expression and genetic mutations. Abbreviated description of the state of knowledge: The obesity, the female sex, numerous pregnancies, diabetes, cirrhosis, type C hepatitis, coronary heart disease, long-term parenteral nutrition are well known risk factors. Also the polymorphisms in some genes are connected with cholecystolithiasis, for example: polymorphisms within MUC1 and MUC2 mucin genes, ABCG8 D19H gene encoding halftransporter. Mutated forms of some proteins such as: SLC10A2 (Solute Carrier Family 10 Member 2), increased expression of NPC1L1 protein (Niemann Pick C1 Like Protein 1) and ACAT2 (Acyl Coenzyme A-cholesterol Transferase), over expression of SCP2 gene (Carrier Sterol Protein 2), the mutation of the UGT1A1 gene (Uridine 5’-diphosphate-glucuronosyltransferase 1 A1) can predispose to the development of gallstones. Summary: The incidence of cholecystolithiasis is constantly increasing. At present this disease constitutes the most frequent cause of surgical interventions in Europe, in the USA and in Australia. The lengthened life span, the rising percentage of obese individuals, suffering from diseases associated with the progress of civilization as well as the ageing of societies may influence on the development of cholecystolithiasis.

Various morphological types of fragmented ventricular premature beats on 12 lead Holter ECG had positive relationship with LV fibrotic volume on CMR in HCM subjects

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Review: Brutalism: Post-war British Architecture by Alexander Clement; Neo-avant-garde and Postmodern: Postwar Architecture in Britain and Beyond by Mark Crinson and Claire Zimmerman, editors; A Guide to the New Ruins of Great Britain by Owen Hatherley

Alexander Clement. Brutalism: Post-war British Architecture . Wiltshire, England: The Crowood Press, 2011, 160 pp., 150 color illus. £19.95 (cloth), ISBN 9781847972309 Mark Crinson and Claire Zimmerman, editors. Neo-avant-garde and Postmodern: Postwar Architecture in Britain and Beyond . New Haven: Yale University Press, 2010, 420 pp., 103 illus. incl. 76 in color. $65 (cloth), ISBN 9780300166187 Owen Hatherley. A Guide to the New Ruins of Great Britain . London and New York: Verso Books, 2010, 369 pp., $29.95 (cloth), ISBN 9781844676514 “For many years since the war we have continued in our habit of debasing the coinage of M. le Corbusier and have created a style—‘Contemporary’—easily recognizable by its misuse of traditional materials and its veneer of ‘modern’ details, frames, recessed plinths, decorative piloti,” Theo Crosby wrote in a 1955 editorial on the New Brutalism.1 For Crosby, “contemporary” functioned as shorthand for a bastardized version of modernism—a modernism that had already been liquidated of its ideals and reduced to nothing more than a style for up-to-date living. As an antidote to such degradation, Crosby positioned New Brutalism as an archaeology of the modern movement that would include a rigorous reevaluation of its key architects—Le Corbusier and Mies van der Rohe in particular—as well as a thorough reexamination of its programs and intents. New Brutalism, for example, would push modernism’s truth-to-materials rhetoric to its limit with its interest in the “as found” just as it would reaffirm the earlier movement’s commitment to housing and the social. Though Alison and Peter Smithson, the figureheads of New Brutalism along with the critic-historian Reyner Banham, first used the phrase in conjunction with their design for a single-family warehouse-like house for Soho, in the following years the term became most closely identified with institutional building, giving rise to schools, council flats, and city halls frequently cast of rough concrete. In an age of postwar reconstruction, Brutalism positioned itself as a new kind of civic language—more vernacular slang than received pronunciation—and in time more and more architects came to speak its language. As the word spread, however, the critical contours of Brutalism often lost their shape, and the term quickly transformed into yet another style. Indeed, Brutalism is often employed today as nothing more than a vague epithet lobbed at vast expanses of postwar institutional building—a …

The effectiveness of school-based smoking prevention interventions among low- and high-SES European teenagers.

Preventing smoking initiation among adolescents of lower socio-economic groups is crucial for the reduction of socio-economic inequalities in health. The aim of the present study was to examine whether effective smoking prevention interventions in Europe are equally effective among adolescents of low- and high-socio-economic status (SES). As part of the European Union-funded TEENAGE project, three school-based smoking prevention intervention studies in Europe were selected for secondary analyses: (i) a Dutch class competition intervention, (ii) the European Smoking Prevention Framework (ESFA) study and (iii) the A Stop Smoking in Schools Trial (ASSIST) intervention. All three studies differed in effectiveness by SES. The Dutch class competition study only had a significant effect among higher SES adolescents. The results for the ESFA study and ASSIST study were mixed and depended on which SES indicator was used. The conclusion of the study is that stratified analyses provide important insights in differential intervention effects for higher and lower socio-economic groups. Although findings from the different studies were mixed, interventions that use a social network approach in which youngsters are allowed to deliver the intervention themselves may be a successful strategy in targeting adolescents from lower socio-economic groups.

Self-management of chronic pain in Malaysian patients: effectiveness trial with 1-year follow-up.

Self-management of chronic illnesses has been widely recognised as an important goal on quality of life, health service utilisation and cost grounds. This study describes the first published account on the application of this approach to people suffering from chronic pain conditions in a Southeast Asian country, Malaysia. A heterogeneous sample of chronic pain patients in Malaysia attended a 2-week cognitive–behavioural pain management programme (PMP) aimed at improving daily functional activities and general psychological well-being. Complete datasets from 70 patients out of 102 patients who attended 11 programmes conducted from 2002 to 2007, as well as the 1-month and 1-year follow-up sessions at the hospital clinic, are reported. The pre- to post-treatment results on self-report measures indicate that significant gains were achieved on the dimensions of pain, disability and psychological well-being. These gains were maintained at both 1-month and 1-year follow-ups. The results mirror those reported from similar interventions in Europe and North America and indicate the concept of self-management of a chronic illness is acceptable and meaningful to Asian patients. Importantly, the achieved outcomes were independent of gender and ethnic group status.

Geo-politics versus market structure interventions in Europe's infrastructure industries c. 1830–1939

Throughout the nineteenth and twentieth centuries, the natural monopoly features of infrastructure industries, together with their strategic roles, have been important elements in state intervention. The aim of this paper is to evaluate what relative weight was attached to market failure problems on the one hand and geo-political factors on the other. For the period 1830–1939, how far were geo-political factors stronger than natural monopoly problems in accounting for the scale of intervention in the various countries of the Western World? How far did the policy instruments for security and market failure overlap? Whilst most of the infrastructure sectors are covered – including internal telecommunications, coal, gas, shipping, electricity and water – special attention is devoted to international submarine telegraph tables and railways. The paper concludes by demonstrating strong differences between Britain and USA on the one hand and Continental Europe plus Japan on the other.