Towards Better Pharmaceutical Provision in Europe-Who Decides the Future?

Significant progress has been achieved in human health in the European Union in recent years. New medicines, vaccines, and treatments have been developed to tackle some of the leading causes of disease and life-threatening illnesses. It is clear that investment in research and development (R&D) for innovative medicines and treatments is essential for making progress in preventing and treating diseases. Ahead of the legislative process, which should begin by the end of 2022, discussions focus on how Europe can best promote the huge potential benefits of new science and technology within the regulatory framework. The challenges in European healthcare were spelled out by the panellists at the roundtable organised by European Alliance for Personalised Medicine (EAPM). Outcomes from panellists' discussions have been summarized and re-arranged in this paper under five headings: innovation, unmet medical need, access, security of supply, adapting to progress, and efficiency. Some of the conclusions that emerged from the panel are a call for a better overall holistic vision of the future of pharmaceuticals and health in Europe and a collaborative effort among all stakeholders, seeing the delivery of medicines as part of a broader picture of healthcare.

HTA Metro Map: a patient centred model for optimizing the decision making process.

Health Technology Assessment (HTA) is a systematic evaluation of a health technology, designed to appraise the direct or intended effects and indirect or unintended consequences of the technology with an overall goal of supporting informed decision making regarding the use of these health technologies in the healthcare system. In this paper, we present fundamental HTA concepts and provide a conceptual framework that embraces the processes and outcomes required for integrated healthcare decision-making. The "HTA Metro Map" was designed to guide the user through the different areas on: where to use, what and whom to involve within the decision process. The map reflects the complexity and inter-connectedness of the different kind of healthcare services that need to work together to be able to efficiently deliver coordinated decisions at local, regional, national, and international levels. This tool may also serve as base for facilitating developments and improvements of the HTA structure worldwide. The paper discusses the main features of the "HTA Metro Map" while reinforcing the key concepts underlying HTA's integrated approach. The first view of the map provides the several layers of complexity seen in HTA and the various lines within the map represent the main actors involved in the assessment processes. The map connections and crossings symbolize the interprofessional and interpersonal collaborations while the stations denote the knowledge, skills, experiences, and attitudes of each professionals as they interact within this framework. Every line represents a HTA stakeholder and the circular line in the centre represents the patient at the centre of the system. The zones, from social to community and hospital level, represent the need for integration from the perspective of health systems. The HTA Metro Map also has different dimensions depicted by the level of profoundness. Finally, the concepts of different healthcare stakeholder perspectives are introduced both in visual and temporal terms. The "HTA Metro Map" is designed as a flexible model for easy adaptability and in accurately capturing the complexity inherent in any healthcare system. It is hoped that the map will assist different stakeholders to build network capacity, pool existing resources, and develop a more holistic vision that will result in a sustainable, efficient and collaborative decision-making process.

ENVIRONMENTAL IMPACT ASSESSMENT OF A HEALTH TECHNOLOGY: A SCOPING REVIEW.

INTRODUCTION: The Health Technology Expert Review Panel is an advisory body to Canadian Agency for Drugs and Technologies in Health (CADTH) that develops recommendations on health technology assessments (HTAs) for nondrug health technologies using a deliberative framework. The framework spans several domains, including the environmental impact of the health technology(ies). Our research objective was to identify articles on frameworks, methods or case studies on the environmental impact assessment of health technologies. METHODS: A literature search in major databases and a focused gray literature search were conducted. The main search concepts were HTA and environmental impact/sustainability. Eligible articles were those that described a conceptual framework or methods used to conduct an environmental assessment of health technologies, and case studies on the application of an environmental assessment. RESULTS: From the 1,710 citations identified, thirteen publications were included. Two articles presented a framework to incorporate environmental assessment in HTAs. Other approaches described weight of evidence practices and comprehensive and integrated environmental impact assessments. Central themes derived include transparency and repeatability, integration of components in a framework or of evidence into a single outcome, data availability to ensure the accuracy of findings, and familiarity with the approach used. CONCLUSIONS: Each framework and methods presented have different foci related to the ecosystem, health economics, or engineering practices. Their descriptions suggested transparency, repeatability, and the integration of components or of evidence into a single outcome as their main strengths. Our review is an initial step of a larger initiative by CADTH to develop the methods and processes to address the environmental impact question in an HTA.

[Predictive value of ultra-sound densitometry as a method of selective screening for osteoporosis in primary care]. / Valor predictivo de la densitometría por ultrasonidos como método de cribado selectivo de la osteoporosis en atención primaria.

OBJECTIVE: To determine the cut-off point of calcaneous quantitative ultrasound densitometry (QUS) as a selection method in primary care for referral of postmenopausal women for dual energy x-ray absorptiometry (DXA). DESIGN: Diagnostic techniques trial. SETTING: Four general practices in the Basque Country Autonomous Region, Spain. PARTICIPANTS: Randomly selected Caucasian women older than 45, chosen at random. A sample size of 146 women was used. INTERVENTIONS: Calcaneous ultrasound bone mineral density (BMD) measurement, using Achilles Express(R) and DXA. PRINCIPAL MEASUREMENTS: T-score BMD measurement on both devices. The sensitivity, specificity and positive predictive values of QUS and finally the ideal cut-off value were calculated. RESULTS: The mean age of the sample was 58.2 (17.7) (range, 48-83 years old). The prevalence of women with osteoporosis, osteopaenia and normal DXA was 14.1%, 50.4% and 35.5%, respectively. The estimated sensitivity of QUS was 78.9% (56.7-91.5) and the specificity was 64.7% (55.6-72.8). The negative predictive value (NPV) was 94.9% (87.7-98.0) and the positive predictive value (PPV) was 26.8% (17.0-39.6). After the COR curve analysis, the ideal cut-off for QUS was determined as a T-score

Valor predictivo de la densitometría por ultrasonidos como método de cribado selectivo de la osteoporosis en atención primaria / Predictive value of ultra-sound densitometry as a method of selective screening for osteoporosis in primary care

Objetivo. Determinar el punto de corte de la densitometría por ultrasonidos de calcáneo (DUC) como método de selección de mujeres posmenopáusicas candidatas a una densitometría mediante absorciometría de doble energía (DEXA) en atención primaria. Diseño. Estudio de pruebas diagnósticas. Emplazamiento. Cuatro unidades de atención primaria de la Comunidad Autónoma del País Vasco. Participantes. Mujeres de raza caucásica mayores de 45 años, escogidas de manera aleatoria. Se estimó un tamaño muestral de 146 mujeres. Intervenciones. Medición de la densidad mineral ósea (DMO) mediante ultrasonidos de calcáneo Achilles Express® y DEXA. Mediciones principales. DMO recogida como valor T-score en ambos aparatos. Se estimaron la sensibilidad, la especificidad y los valores predictivos de la DUC y el punto óptimo de corte. Resultados. La media de edad fue 58,2 ± 17,7 años, con un rango de 48-83 años. La prevalencia de osteoporosis fue del 14,1%, el 50,4% de las mujeres tenían osteopenia y el 35,5%, una densitometría normal. Se estimó que la DUC tenía una sensibilidad del 78,9% (56,7-91,5), con una especificidad del 64,7% (55,6-72,8). El valor predictivo negativo (VPN) fue del 94,9% (87,7-98,0), y el valor predictivo positivo (VPP), del 26,8% (17-39,6). Tras el análisis de la curva ROC, se identificó como mejor punto de corte para osteoporosis un T-score ≤ ­2,0 Conclusiones. La DUC tiene un alto VPN, lo que lleva a considerarla como técnica de cribado previa a la DEXA. Su bajo VPP hace necesario combinarla con otros métodos de cribado selectivo complementarios o sustitutivos, como las reglas de predicción, que se deberían analizar en cada contexto de aplicación

Objective. To determine the cut-off point of calcaneous quantitative ultrasound densitometry (QUS) as a selection method in primary care for referral of postmenopausal women for dual energy x-ray absorptiometry (DXA). Design. Diagnostic techniques trial. Setting. Four general practices in the Basque Country Autonomous Region, Spain. Participants. Randomly selected Caucasian women older than 45, chosen at random. A sample size of 146 women was used. Interventions. Calcaneous ultrasound bone mineral density (BMD) measurement, using Achilles Express® and DXA. Principal measurements. T-score BMD measurement on both devices. The sensitivity, specificity and positive predictive values of QUS and finally the ideal cut-off value were calculated. Results. The mean age of the sample was 58.2 (17.7) (range, 48-83 years old). The prevalence of women with osteoporosis, osteopaenia and normal DXA was 14.1%, 50.4% and 35.5%, respectively. The estimated sensitivity of QUS was 78.9% (56.7-91.5) and the specificity was 64.7% (55.6-72.8). The negative predictive value (NPV) was 94.9% (87.7-98.0) and the positive predictive value (PPV) was 26.8% (17.0-39.6). After the COR curve analysis, the ideal cut-off for QUS was determined as a T-score ≤ ­2.0. Conclusions. Given its high NPV, QUS can be considered a useful device for screening before DXA. Its low PPV means it has to be combined with other complementary or substitutive selective screening methods, such as predictive rules, which should be evaluated in each specific use

[Assessment of clinical practice guidelines evaluation. Scales and criteria]. / Valoración de escalas y criterios para la evaluación de Guías de Práctica Clínica.

Not only are there large number of guides, protocols and other support tools available for the clinical decision-making process in the Spanish National Health System, but there is also a major degree of variability among them, reflecting inconsistencies and low quality of those documents. This study is aimed at conducting all inventory of the Clinical Practice Guideline assessment scales and clinical analysis tools and to propose a scale or set of criteria for assessing the quality of the Clinical Practice Guidelines put out in Spain. A systematic search of critical evaluation scales was conducted. The inclusion criteria and the concordance analysis of the items by three evaluators were independently applied. The discordances were resolved by explicit consensus. Ten suggested critical assessment scales and sets of criteria from eleven institutions were identified, eight of which consist of scales and tools proposed for assessing the quality of the Clinical Practice Guidelines, the other two being proposals for assessing the implementation and inclusion of the Clinical Practice Guidelines in a register. In the comparative analysis, the criteria most often repeated on the scales analysed were related to the areas included in the AGREE Instrument. The areas considered in most of the critical assessment scales were the same as those of the AGREE Instrument. Although this tool does not take in criteria for guide implementation assessment purposes, it is considered suitable for use in the assessment prior to inclusion to the national CPG register.