Implementing pharmacogenomics decision support across seven European countries: The Ubiquitous Pharmacogenomics (U-PGx) project.
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SUBMITTER: Blagec K
PROVIDER: S-EPMC6016647 | biostudies-literature | 2018 Jul
REPOSITORIES: biostudies-literature
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Implementing pharmacogenomics decision support across seven European countries: The Ubiquitous Pharmacogenomics (U-PGx) project.
Blagec Kathrin K Koopmann Rudolf R Crommentuijn-van Rhenen Mandy M Holsappel Inge I van der Wouden Cathelijne H CH Konta Lidija L Xu Hong H Steinberger Daniela D Just Enrico E Swen Jesse J JJ Guchelaar Henk-Jan HJ Samwald Matthias M
Journal of the American Medical Informatics Association : JAMIA 20180701 7
Clinical pharmacogenomics (PGx) has the potential to make pharmacotherapy safer and more effective by utilizing genetic patient data for drug dosing and selection. However, widespread adoption of PGx depends on its successful integration into routine clinical care through clinical decision support tools, which is often hampered by insufficient or fragmented infrastructures. This paper describes the setup and implementation of a unique multimodal, multilingual clinical decision support interventi ...[more]
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Project description:PurposeDue to the diversity within Europe, the implementation of pharmacogenomic testing in clinical practice faces specific challenges. In the context of the European pharmacogenomics implementation project "Ubiquitous Pharmacogenomics" (U-PGx; funded by the European Commission), we studied the current educational background.MethodsWe developed a questionnaire including 29 questions. It was spread out to healthcare professionals working at the future implementation sites (in Austria, Greece, Italy, Netherlands, Slovenia, Spain and Great Britain) of the U-PGx project in preparation of an educational programme. Aim of the survey was to analyse the current educational situation at the implementation sites.ResultsIn total, 70 healthcare professionals participated in the survey. Of participants, 84.3% found pharmacogenomics relevant to their current practice, but experience was still rare. More than two-thirds (65.7%) did not order nor recommend a pharmacogenomic test in the past year. This was mainly attributed to not having enough knowledge on pharmacogenomics (40.0%). Needs were identified in application of pharmacogenomics (identifying drugs 41.4%, interpreting test results 37.2%) as well as in underlining mechanisms (better knowledge on drug metabolism 67.1%, better knowledge on basic principles of pharmacogenomics 60.0%).ConclusionsThis study analysed the specific attitudes, experience and education on pharmacogenomics of future users. There was a general positive attitude and interest towards pharmacogenomic testing. However, the grade of own experience, and knowledge about application and interpretation of pharmacogenomics caused uncertainty. Thus, education and training programmes may be helpful for implementation of pharmacogenomics at a homogenous level within Europe.
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Project description:We describe here the design and initial implementation of the eMERGE-PGx project. eMERGE-PGx, a partnership of the Electronic Medical Records and Genomics Network and the Pharmacogenomics Research Network, has three objectives: (i) to deploy PGRNseq, a next-generation sequencing platform assessing sequence variation in 84 proposed pharmacogenes, in nearly 9,000 patients likely to be prescribed drugs of interest in a 1- to 3-year time frame across several clinical sites; (ii) to integrate well-established clinically validated pharmacogenetic genotypes into the electronic health record with associated clinical decision support and to assess process and clinical outcomes of implementation; and (iii) to develop a repository of pharmacogenetic variants of unknown significance linked to a repository of electronic health record-based clinical phenotype data for ongoing pharmacogenomics discovery. We describe site-specific project implementation and anticipated products, including genetic variant and phenotype data repositories, novel variant association studies, clinical decision support modules, clinical and process outcomes, approaches to managing incidental findings, and patient and clinician education methods.
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Project description:BackgroundMinistries of health in low- and middle-income countries often lack timely quality data for data-driven decision making in healthcare networks. We describe the design and implementation of decision-support electronic tools by the Ministry of Health of the State of Chiapas, in Mexico, as part of Salud Mesoamerica Initiative.MethodsThree electronic decision-support tools were designed through an iterative process focused on streamlined implementation: 1) to collect and report health facility data at health facilities; 2) to compile and analyze data at health district and central level; and, 3) to support stratified sampling of health facilities. Data was collected for five composite indicators measuring availability of equipment, medicines, and supplies for maternal and child health. Quality Assurance Teams collected data, evaluated results and supported quality improvement. Data was also analyzed at the central level and health districts for decision-making.ResultsData from 300 health facilities in four health districts was collected and analyzed (November 2014-June 2015). The first wave revealed gaps on availability of equipment and supplies in more than half of health facilities. Electronic tools provided the ministry of health officers new ways to visualize data, identify patterns and make hypothesis on root-causes. Between the first and second measurement, the number of missing items decreased, and actions performed by quality improvement teams became more proactive. In the final measurement, 89.7-100% of all health facilities achieved all the required items for each indicator.ConclusionsOur experience could help guide others seeking to implement electronic decision-support tools in low- and middle-income countries. Electronic decision-support tools supported data-driven decision-making by identifying gaps on heatmaps and graphs at the health facility, subdistrict, district or state level. Through a rapid improvement process, the Ministry of Health met targets of externally verified indicators. Using available information technology resources facilitated prompt implementation and adoption of technology.
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Project description:BackgroundActive clinical decision support (CDS) delivered through an electronic health record (EHR) facilitates gene-based drug prescribing and other applications of genomics to patient care.ObjectiveWe describe the development, implementation, and evaluation of active CDS for multiple pharmacogenetic test results reported preemptively.Materials and methodsClinical pharmacogenetic test results accompanied by clinical interpretations are placed into the patient's EHR, typically before a relevant drug is prescribed. Problem list entries created for high-risk phenotypes provide an unambiguous trigger for delivery of post-test alerts to clinicians when high-risk drugs are prescribed. In addition, pre-test alerts are issued if a very-high risk medication is prescribed (eg, a thiopurine), prior to the appropriate pharmacogenetic test result being entered into the EHR. Our CDS can be readily modified to incorporate new genes or high-risk drugs as they emerge.ResultsThrough November 2012, 35 customized pharmacogenetic rules have been implemented, including rules for TPMT with azathioprine, thioguanine, and mercaptopurine, and for CYP2D6 with codeine, tramadol, amitriptyline, fluoxetine, and paroxetine. Between May 2011 and November 2012, the pre-test alerts were electronically issued 1106 times (76 for thiopurines and 1030 for drugs metabolized by CYP2D6), and the post-test alerts were issued 1552 times (1521 for TPMT and 31 for CYP2D6). Analysis of alert outcomes revealed that the interruptive CDS appropriately guided prescribing in 95% of patients for whom they were issued.ConclusionsOur experience illustrates the feasibility of developing computational systems that provide clinicians with actionable alerts for gene-based drug prescribing at the point of care.
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Project description:BackgroundTobacco-control policies have been suggested to reduce smoking among adolescents. However, there is limited evidence on the real-world costs of implementation in different settings. In this study, we aimed at estimating the costs of school smoking bans, school prevention programmes and non-school bans (smoking bans in non-educational public settings, bans on sales to minors and bans on point-of-sale advertising), implemented in Finland, Ireland, the Netherlands, Belgium, Germany, Italy and Portugal, for 2016.MethodsWe retrospectively collected costs related to the inspection, monitoring and sanctioning activities related to bans and educational activities related to smoking prevention programmes. We used an 'ingredients-based' approach, identifying each resource used, quantity and unit value for one full year, under the state perspective. Costs were measured at national, regional, local and school-level and were informed by data on how these activities were performed in reality.ResultsPurchasing power parities adjusted-costs varied between €0.02 and €0.74 (average €0.24) per person (pp) for bans implemented outside schools. Mean costs of school smoking bans ranged from €3.31 to €34.76 (average €20.60), and mean costs of school educational programmes from €0.75 to €4.65 (average €2.92).ConclusionsIt is feasible to estimate costs of health policies as implemented in different settings. Costs of the tobacco control policies evaluated here depend mainly on the number of person-hours allocated to their implementation, and on the scale of intervention. Non-school bans presented the lowest costs, and the implementation of all policies cost up to €36 pp for 1 year.
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Project description:Changes in behavior are necessary to apply genomic discoveries to practice. We prospectively studied medication changes made by providers representing eight different medicine specialty clinics whose patients had submitted to preemptive pharmacogenomic genotyping. An institutional clinical decision support (CDS) system provided pharmacogenomic results using traffic light alerts: green = genomically favorable, yellow = genomic caution, red = high risk. The influence of pharmacogenomic alerts on prescribing behaviors was the primary endpoint. In all, 2,279 outpatient encounters were analyzed. Independent of other potential prescribing mediators, medications with high pharmacogenomic risk were changed significantly more often than prescription drugs lacking pharmacogenomic information (odds ratio (OR) = 26.2 (9.0-75.3), P < 0.0001). Medications with cautionary pharmacogenomic information were also changed more frequently (OR = 2.4 (1.7-3.5), P < 0.0001). No pharmacogenomically high-risk medications were prescribed during the entire study when physicians consulted the CDS tool. Pharmacogenomic information improved prescribing in patterns aimed at reducing patient risk, demonstrating that enhanced prescription decision-making is achievable through clinical integration of genomic medicine.
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Project description:BackgroundAlthough walking for travel can help in reaching the daily recommended levels of physical activity, we know relatively little about the correlates of walking for travel in the European context.ObjectiveWithin the framework of the European Physical Activity through Sustainable Transport Approaches (PASTA) project, we aimed to explore the correlates of walking for travel in European cities.MethodsThe same protocol was applied in seven European cities. Using a web-based questionnaire, we collected information on total minutes of walking per week, individual characteristics, mobility behavior, and attitude (N=7,875). Characteristics of the built environment (the home and the work/study addresses) were determined with geographic information system (GIS)-based techniques. We conducted negative binomial regression analyses, including city as a random effect. Factor and principal component analyses were also conducted to define profiles of the different variables of interest.ResultsLiving in high-density residential areas with richness of facilities and density of public transport stations was associated with increased walking for travel, whereas the same characteristics at the work/study area were less strongly associated with the outcome when the residential and work/study environments were entered in the model jointly. A walk-friendly social environment was associated with walking for travel. All three factors describing different opinions about walking (ranging from good to bad) were associated with increased minutes of walking per week, although the importance given to certain criteria to choose a mode of transport provided different results according to the criteria.DiscussionThe present study supports findings from previous research regarding the role of the built environment in the promotion of walking for travel and provides new findings to help in achieving sustainable, healthy, livable, and walkable cities. https://doi.org/10.1289/EHP4603.
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Project description:INTRODUCTION:Economic evaluations of tobacco control policies targeting adolescents are scarce. Few take into account real-world, large-scale implementation costs; few compare cost-effectiveness of different policies across different countries. We assessed the cost-effectiveness of five tobacco control policies (nonschool bans, including bans on sales to minors, bans on smoking in public places, bans on advertising at points-of-sale, school smoke-free bans, and school education programs), implemented in 2016 in Finland, Ireland, the Netherlands, Belgium, Germany, Italy, and Portugal. METHODS:Cost-effectiveness estimates were calculated per country and per policy, from the State perspective. Costs were collected by combining quantitative questionnaires with semi-structured interviews on how policies were implemented in each setting, in real practice. Short-term effectiveness was based on the literature, and long-term effectiveness was modeled using the DYNAMO-HIA tool. Discount rates of 3.5% were used for costs and effectiveness. Sensitivity analyses considered 1%-50% short-term effectiveness estimates, highest cost estimates, and undiscounted effectiveness. FINDINGS:Nonschool bans cost up to €253.23 per healthy life year, school smoking bans up to €91.87 per healthy life year, and school education programs up to €481.35 per healthy life year. Cost-effectiveness depended on the costs of implementation, short-term effectiveness, initial smoking rates, dimension of the target population, and weight of smoking in overall mortality and morbidity. CONCLUSIONS:All five policies were highly cost-effective in all countries according to the World Health Organization thresholds for public health interventions. Cost-effectiveness was preserved even when using the highest costs and most conservative effectiveness estimates. IMPLICATIONS:Economic evaluations using real-world data on tobacco control policies implemented at a large scale are scarce, especially considering nonschool bans targeting adolescents. We assessed the cost-effectiveness of five tobacco control policies implemented in 2016 in Finland, Ireland, the Netherlands, Belgium, Germany, Italy, and Portugal. This study shows that all five policies were highly cost-effective considering the World Health Organization threshold, even when considering the highest costs and most conservative effectiveness estimates.
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Project description:BackgroundDespite widespread age-of-sale restrictions on tobacco, adolescents continue to obtain cigarettes and experiment with smoking. This mixed-methods study aimed to understand how European adolescents access cigarettes and how the policy context may influence this process, using a realist evaluation approach. This is the first study to assess access to cigarettes across various European contexts.MethodsA survey of 4104 students was combined with qualitative data from focus groups among 319 adolescents aged 14-19 across seven European countries. Data were synthesized to explore mechanisms via which young people obtain cigarettes despite age-of-sale restrictions.ResultsWhile purchasing cigarettes from supermarkets was widely regarded as difficult, many participants purchased cigarettes from noncompliant retailers (often in smaller shops or cafes). Other contra-mechanisms included circumventing age checks, proxy purchases, and/or social sources. Dominant forms of access differed across the seven contexts, with direct purchases more common where perceived enforcement was low (eg, Belgium) and proxy purchases more important where perceived enforcement of age-of-sale laws was high (eg, Finland). The effectiveness of age-of-sale restrictions in reducing youth access appears to be influenced by a range of contextual factors including retailer compliance, the availability of vending machines, and the specific minimum age-of-sale.ConclusionsOur findings illustrate the relevance of programme theory in understanding the contra-mechanisms that undermine the effectiveness of age-of-sale laws in discouraging youth smoking. Young people's access to cigarettes could be further limited by addressing these contra-mechanisms, including an increase in the legal sales age (particularly in Belgium), banning vending machines, and strengthening enforcement.ImplicationsDespite widespread implementation of age-of-sale laws, a substantial proportion of minors continue to access cigarettes. Young people use a number of contra-mechanisms to circumvent age-of-sale restrictions. These include accessing cigarettes via social sources, proxy sales or by circumventing age checks. Our findings show that in contexts where perceived enforcement of age-of-sale restrictions is high, young people are more reliant on irregular forms of access such as proxy sales. Young people's access to cigarettes may be further reduced by policy interventions that address these contra-mechanisms-for example, banning vending machines, strengthening enforcement of age-of-sale laws, and increasing the minimum age-of-sale.
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Project description:AIM:Culture is becoming increasingly important in relation to end of life (EoL) care in a context of globalization, migration and European integration. We explore and compare socio-cultural issues that shape EoL care in seven European countries and critically appraise the existing research evidence on cultural issues in EoL care generated in the different countries. METHODS:We scoped the literature for Germany, Norway, Belgium, The Netherlands, Spain, Italy and Portugal, carrying out electronic searches in 16 international and country-specific databases and handsearches in 17 journals, bibliographies of relevant papers and webpages. We analysed the literature which was unearthed, in its entirety and by type (reviews, original studies, opinion pieces) and conducted quantitative analyses for each country and across countries. Qualitative techniques generated themes and sub-themes. RESULTS:A total of 868 papers were reviewed. The following themes facilitated cross-country comparison: setting, caregivers, communication, medical EoL decisions, minority ethnic groups, and knowledge, attitudes and values of death and care. The frequencies of themes varied considerably between countries. Sub-themes reflected issues characteristic for specific countries (e.g. culture-specific disclosure in the southern European countries). The work from the seven European countries concentrates on cultural traditions and identities, and there was almost no evidence on ethnic minorities. CONCLUSION:This scoping review is the first comparative exploration of the cultural differences in the understanding of EoL care in these countries. The diverse body of evidence that was identified on socio-cultural issues in EoL care, reflects clearly distinguishable national cultures of EoL care, with differences in meaning, priorities, and expertise in each country. The diverse ways that EoL care is understood and practised forms a necessary part of what constitutes best evidence for the improvement of EoL care in the future.
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