Construction and Interpretation of Clinical Comprehensive Evaluation Index System for Chinese Patent Medicine Based on EVIDEM Framework / 中国实验方剂学杂志

ObjectiveTo establish the clinical comprehensive evaluation index system for Chinese patent medicine（CPM） based on Evidence and Value：Impact on DEcisionMaking（EVIDEM） framework， so as to promote the scientific， systematic and standardized implementation of clinical comprehensive evaluation of CPM. MethodThe clinical comprehensive evaluation index system was determined through literature review， semi-structured interview and Delphi method， and the weights of each index were clarified by analytic hierarchy process（AHP）. ResultThe recovery rates of both rounds of expert consultation were 100%， and the authority coefficient of experts was 0.90 and 0.905， respectively. Kendall's coordination coefficients（W） of the second- and third-level indicators in the first-round consultation were 0.320 and 0.283（P<0.001）， and in the second round were 0.411 and 0.351， respectively（P<0.001）. The finally constructed clinical comprehensive evaluation index system for CPM included 6 first-level indicators， 13 second-level indicators and 28 third-level indicators. Among the first-level indicators， the weights of effectiveness， safety， economy， innovation， suitability and accessibility were 37.34%， 32.68%， 11.85%， 5.87%， 5.79% and 6.47%， respectively. ConclusionThis study has constructed a universal clinical comprehensive evaluation index system for CPM， and the domain and criteria are introduced and interpreted in detail， which can provide reference and information for carrying out the clinical comprehensive evaluation of CPM， but it needs to be refined and improved in combination with the clinical practice of CPM for specialized diseases.

Current Situation of Health Technology Assessment in Traditional Chinese Medicine Hospitals / 中国实验方剂学杂志

ObjectiveThis study aims to understand the recognition of practitioners in traditional Chinese medicine （TCM） hospitals on hospital-based health technology assessment （HB-HTA）， assessment needs， challenges， and suggestions， so as to provide references for the future work. MethodThe convenient sampling method was adopted to survey the relevant practitioners in TCM hospitals. The questionnaire included 39 questions in 4 dimensions and was distributed through the online platform Weijuanxing. ResultA total of 244 questionnaires were recovered， and the obtained data were analyzed in SPSS. The results showed that 137 practitioners were very familiar with HB-HTA and there was no significant difference in the recognition of practitioners in different occupations （F=0.251； P=0.778）. The practitioners in Hong Kong， Macao， and Taiwan had lower recognition than those in other regions. In terms of the assessment needs， 127 practitioners believed that it was very necessary to carry out HB-HTA in TCM hospitals in the future. Chinese patent medicines/Chinese herbal medicine decoction pieces （5.91） and TCM appropriate technology （5.57） had higher assessment priority scores. The assessment needs were high for the effectiveness （235 practitioners） and safety （224 practitioners） of health technology. The lack of specialized organization and standardized evaluation process system and the shortage of talents were considered to be the major challenges for the future development in this field. ConclusionThe stakeholders carrying out the health technology assessment in TCM hospitals had certain awareness of HB-HTA. Most practitioners believed that it was necessary to carry out HB-HTA in TCM hospitals in the future， while the work might face challenges such as the lack of organizations and system and the shortage of talents， which requires policy support.

Profil métabolique des patients hypertendus pris en charge dans le service de cardiologie du CHU mère-enfant ?le Luxembourg" / Metabolic profile of hypertensive patients treated in the cardiology department of the university teaching hospital le Luxembourg

Objectif : Évaluer le profil du syndrome métabolique (SM) dans une population hypertendue au Mali. Patients et méthodes : Étude prospective du 1er juin 2022 au 31 juin 2022, dans le service de cardiologie du CHU Mère ­enfant le Luxembourg de Bamako. Notre échantillon d'étude était composé de patients hypertendus adultes, âgés de 18 ans et plus, reçus en consultation externe. Les patients étaient inclus dans notre étude après consentement éclairé. Le SM a été établi sur la base des définitions de l'International Diabetes Federation (IDF). Résultats : Sur 520 patients, 238 ont été inclus dans notre étude. La prévalence du SM était de 30,2 % selon les critères de l'IDF. On notait une prédominance féminine (66 %).L'âge moyen était de 57 ± 5 ans.L'HTA grade II était majoritaire avec 39%.Soixantequinze pourcent des patients avec syndrome métabolique ont présenté 3 facteurs de risque.L'AVC ischémique a été la complication la plus retrouvée avec un taux de 12%.La bithérapie était indiquée chez 59,23% des patients. Les inhibiteurs calciques ont été les plus prescrits avec un taux de74,5%. Le SM constitue une réalité au Mali. Des mesures adéquates de prévention sont nécessaires afin de limiter sa progression

Objective: To assess the profile of metabolic syndrome (MS) in a hypertensive population in Mali. Patients and methods: Prospective study from June 1, 2022 to June 31, 2022, in the cardiology department of the Mother-Child University Hospital in Bamako, Luxembourg. Our study sample consisted of adult hypertensive patients, aged 18 years and older, received as an outpatient. Patients were included in our study after informed consent. The SM was established based on International Diabetes Federation (IDF) definitions. Results: Out of 520 patients, 238 were included in our study. The prevalence of SM was 30.2% according to IDF criteria. There was a female predominance (66%). The mean age was 57 ± 5 years. Grade II hypertension was in the majority with 39%. Seventy-five percent of patients with metabolic syndrome had 3 risk factors. Ischemic stroke was the most common complication with a rate of 12%. Dual therapy was indicated in 59.23% of patients. Calcium channel blockers were the most prescribed with a rate of 74.5%. SM is a reality in Mali. Adequate preventive measures are necessary to limit its progression

Tamizaje de niveles tensionales en individuos no hipertensos entre 18-65 años en la comunidad de pizarrete abajo, municipio nizao, provincia peravia, república dominicana, durante el período agosto-septiembre 2018 / Screening of blood pressure levels in non-hypertensive individuals between 18-65 years of age in the community of Pizarrete Abajo, Nizao municipality, Peravia province, Dominican Republic, during the period of august-september 2018

Introducción: la presión arterial elevada es el principal factor de riesgo de enfermedad global. En la República Dominicana el 31 % de la población padece de hipertensión arterial (HTA) y de este, un 60 % lleva tratamiento médico. Objetivo: determinar los niveles tensionales en individuos no hipertensos entre 18-65 años en la comunidad de Pizarrete Abajo, durante el período agosto-septiembre 2018. Metodología: estudio prospectivo, descriptivo y de corte longitudinal, en el que se analizaron 85 individuos que residen en la comunidad de Pizarrete Abajo, de los cuales 44 resultaron con niveles tensionales alterados. Resultados: el 51.7 % de los encuestados presentó niveles de tensión arterial alterados, sin haber sido anteriormente diagnosticado con hipertensión arterial. Un 24 % de las personas mostró niveles alterados una semana después de la primera toma de presión arterial. Conclusiones: en una muestra de 85 personas se encontraron niveles tensionales alterados en 44 individuos. Se procedió a una segunda toma de presión arterial una semana después de la primera y se observó que un 56.8 % correspondió a valores tensionales elevados, un 20.4 % a valores de HTA estadio 1 y un 18.1 % a valores de HTA estadio 2.

Introduction: High blood pressure is the main risk factor for global disease. In the Dominican Republic, 31% of the population suffers from arterial hypertension (HTN) and of these, 60% have medical treatment. Objective: To determine blood pressure levels in non-hypertensive individuals between 18-65 years of age in the community of Pizarrete Abajo during the period of August - September 2018. Methodology: Prospective, descriptive, and longitudinal study in which 85 individuals residing in the community of Pizarrete Abajo were analyzed, of which 44 resulted in altered blood pressure levels. Results: 51.7% of the individuals presented altered blood pressure levels without previously being diagnosed with hypertension. 24% of people showed altered levels one week after the first blood pressure measurement. Conclusions: In a sample of 85 people, altered blood pressure levels were found in 44 individuals. A second blood pressure measurement was carried out one week after the first measurement and it was observed that 56.8% corresponded to high blood pressure values, 20.4% corresponded to stage 1 HTN levels, and 18.1% corresponded to stage 2 HTN levels.

Clinical comprehensive evaluation of Tianshu Capsules in treatment of migraine (syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) / 中国中药杂志

This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.

An Introduction of EVIDEM Framework and Its Application in Healthcare Decision Making / 中国实验方剂学杂志

Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.

Insuffisance rénale chronique: aspects épidémiologique, diagnostique, thérapeutique et évolutif au CHU de Bouaké de 2016 à 2020 / Epidemiological aspects, diagnosis features and therapeutic outcome of chronic kidney disease at the Teaching Hospital of Bouake from 2016 to 2020

Le profil épidémiologique de l'insuffisance rénale chronique (IRC) varie d'un pays à un autre et d'une région à une autre dans un même pays. L'objectif de la présente étude était de décrire les cas d'IRC observés dans la ville de Bouaké. Méthodes : il s'agissait d'une étude rétrospective réalisée dans le service de Médecine Interne du CHU de Bouaké durant la période allant du 1er Janvier 2016 au 31 Décembre 2020. L'IRC était définie par un DFG inférieur à 60 ml/minute évoluant depuis plus de trois mois et/ou une atrophie rénale. Résultats : nous avons recensé 150 cas donnant une prévalence hospitalière de 3,6%. L'âge moyen était de 38,8±10 ans avec une prédominance masculine. Les antécédents étaient dominés par l'automédication traditionnelle et l'hypertension artérielle dans 68% des cas chacun. Dans 91% des cas, l'IRC était classée grade 5. Les étiologies étaient dominées par l'hypertension artérielle (34%). Le traitement symptomatique était la transfusion dans 73% et l'usage des antihypertenseurs dans 73%. Le traitement de suppléance était indiqué dans 91% et réalisé dans 3%. La mortalité était de 25%. Les facteurs associés à la survenue du décès étaient une altération de l'état général, une hypercréatininémie, une hyperphosphorémie, des reins atrophiés et le recours à la transfusion sanguine. Conclusion: l'IRC était diagnostiquée à un stade sévère. La principale cause était l'hypertension artérielle. La mortalité demeure élevée, faute d'accès au traitement de suppléance. L'accent doit être mis sur la prévention de l'IRC au cours des pathologies à risque.

Background: The epidemiological profile of chronic kidney disease (CKD) varies from country to country and from region to region within, even in the same country. The objective of this study was to describe the cases of CKD found in the city of Bouake (Ivory Coast). Methods: We proceeded to a retrospective study carried out in the Internal Medicine department of the Bouake University Hospital from January 1, 2016 till December 31, 2020. CKD was defined by a GFR (Glomerular Filtration Rate) at less than 60 ml/ minute and small kidneys. Results: In all , we identified 150 cases corresponding to 3.6% as hospital prevalence . The mean age was 38 .8 ± 10 years with a male predominance. The history was dominated by traditional self-medication and high blood pressure (HBP) for respectively 68% of cases. In 91% of cases , the CKD was classified as grade 5. The etiologies were dominated by HBP (34%). The care was a symptomatic one using transfusion in 73% and antihypertensive medication was prescribed for 73% of the patients. The substitution treatment was indicated in 91% of cases and carried out in 3%. The rate of mortality was 25 % and factors associated with death were a deterioration of the general condition, increased of blood level of creatininemia, hyperphosphatemia, small size of kidneys and the use of blood transfusion. Conclusion: CKD was diagnosed at a severe stage. The main cause was high blood pressure. Mortality remains high due to lack of access to replacement therapy . Emphasis should be placed on the prevention of CKD in high-risk pathologies

3．Value Assessment of Vaccines and Drugs： Learnings from COVID-19 Pandemic / 薬剤疫学

The COVID-19 pandemic has had a major impact on all citizens, industries, governments, and academia, and has provided an opportunity to consider the intrinsic value of various resources and activities. The pharmaceutical industries are making a concerted effort to prevent and treat against COVID-19 with rapid research and development to address the emerging need for vaccines and therapeutic drugs for infectious diseases. In terms of HTA, previous guidelines for evaluating the value of vaccines and therapeutics have focused on cost-effectiveness, but the experience of the pandemic has led to the need to consider factors other than cost and utility, which are quantitative evaluations. With the pandemic experience, values that should be considered in addition to the quantitative evaluation of cost and utility were discussed in terms of previously published papers and industry perspectives.

1．COVID-19 and HTA / 薬剤疫学

“Appropriate/Rational allocation for limited healthcare resources”, which was the fundamental concept of the health economics, had not been widely accepted/disseminated for the general public in Japan. Although vast majority agreed with the existence of healthcare budget constraint, it had not been widely recognized that “physical” healthcare resources, such as healthcare professional and/or healthcare facilities, were also limited and restricted, until current COVID-19 ERA. The HTA （Health Technology Assessment） concept could be used for COVID-19 related resource allocation issues, such as prioritization of the vaccination. Kohli et al. conducted cost-utility analysis of various treatment strategy for the hypothetical vaccine in the US setting. They proved that vaccination for elderly and stuffs for health care/long term care facilities were cost-effective （dominant and USD 20,000/QALY, respectively）, while we need to take into account relatively low incidence rate of COVID-19 in Japan.However, current framework of the HTA with narrower perspective, could not capture entire value of the preventive intervention against COVID-19. Appleby et al. argued that broader perspective, under which external impacts, outside of healthcare area, would be incorporated, would be needed for appropriate decision making.Faced with COVID-19 pandemic, importance of re-defining （or expanding） the value of intervention would be widely recognized and further conceptual research should be warranted.

Task Analysis On Maintenance Worker (Rail Grinder) Of Light Rail Transit (LRT)

@#Rail maintenance routines are necessary to enable the all rail operations to achieve its aim in maintaining a safe and efficient operation. The maintenance tasks expose the workers to vibration and noise, as they handle specialized machineries and heavy self-propelled vehicles. Exposure of noise above the permissible exposure limit and over the daily allowable duration may cause noise-induce hearing loss (NIHL). Investigation on the type of task that has high noise level exposure on the maintenance workers was conducted to justify the needs to further detailed of this study. This paper will describe the task analysis on maintenance workers and to identify possible tasks with exposure to high level of noise. It scopes down to grinding crew of the maintenance department of light rail transit. Methods used were real-time sound measurement using a sound level meter, observation and interviews. Then, data were analysed to understand the situation of exposure of noise during rail maintenance. An ergonomic risk assessment was also conducted by adoption of the latest guideline on Ergonomic Risk Assessment (ERA) at Workplace Guidelines recommended by Department of Occupational Safety and Health (DOSH), Malaysia. A hierarchical task analysis (HTA) was generated on the task of the maintenance worker, focusing on rail grinding crew. The newly generated HTA had allowed better understanding about the nature of work and the task conducted by a rail grinder during the work shifts. Tasks involving high noise level was identified. Data recorded shows that the noise level for the blowing activity was relatively high and exceeded the permissible exposure limit of 90dBA. The exposure level was currently controlled by practicing the usage of hearing protection equipment (HPE) and by controlling exposure time in accordance to recommendations of the Factory and Machinery Act (FMA). Thus, it had confirmed that maintenance workers were exposed to high noise levels when performing their daily task. Further studies are needed to investigate the relationship between the duration of exposure and noise-induce hearing loss (NIHL) with consideration of the lifestyles of the maintenance workers.

Monitorización ambulatoria de presión arterial (MAPA): recomendaciones de la rama de nefrología pediátrica / Ambulatory blood pressure monitoring (ABPM): statement from chilean pediatric nephrology committee

Resumen: La monitorización ambulatoria de la presión arterial (MAPA) es una herramienta clínica útil para el diagnóstico y confirmación de hipertensión arterial en pediatría y permite igualmente el diagnóstico de condiciones especiales como la hipertensión de delantal blanco e hipertensión enmascarada. Exis ten recomendaciones internacionales para su realización e interpretación, sin embargo, aún quedan interrogantes por resolver. En esta guía se resume la bibliografía disponible y se intenta estandarizar, a través de consenso de especialistas nacionales, la aplicación de esta técnica. Se necesitan más estudios de investigación en niños que aporten nuevos valores de referencia y que determinen la relación de alteraciones en MAPA con resultados clínicos a largo plazo.

Abstract: Ambulatory blood pressure monitoring (ABPM) is a useful clinical tool for the diagnosis and confir mation of arterial hypertension in pediatrics, and also allows the diagnosis of special conditions such as white coat hypertension and masked hypertension. There are international recommendations for its implementation and interpretation, however, there are still unresolved questions. This guide summarizes the available literature and attempts to standardize, through consensus of national specia lists, the application of this technique. More research studies are needed that provide new reference values and determine the relationship of alterations in ABPM with long-term clinical results.

Epidemiológica del ataque cerebro vascular en un hospital universitario / Epidemiological of cerebrovascular attack in a university hospital / Epidemiologia do ataque cerebrovascular em hospital universitário

Resumen: Introducción: El ataque cerebro vascular es una enfermedad prevalente en nuestro medio con elevada morbimortalidad. El Hospital Pasteur es un centro de tercer nivel, que asiste un elevado número de pacientes con esta patología. Conocer los datos epidemiológicos de esta afección permitirá desarrollar medidas de promoción de salud y prevención primaria. Identificar la forma de presentación clínica y los algoritmos de estudio, permitirán un adecuado diagnóstico, tratamiento precoz y desarrollo de medidas de prevención secundaria. Objetivos: Conocer las características sociodemográficas de la población con diagnóstico de ataque cerebro vascular o accidente isquémico transitorio asistidas en las salas de medicina del Hospital Pasteur, los factores de riesgo asociados, las formas de presentación clínica y precisar si se cumplió con el algoritmo diagnóstico propuesto. Métodos y procedimiento: Estudio descriptivo observacional y transversal realizado en el Hospital Pasteur. La población de estudio fueron pacientes adultos ingresados en sala de medicina con diagnóstico de ataque cerebro vascular o accidente isquémico transitorio que presentaron el evento durante su internación, en el periodo comprendido entre Julio y Setiembre de 2018. Resultados y discusión: Se recabaron datos de 29 pacientes, 20 de sexo femenino. La media de edad fue de 70.34 años. La naturaleza isquémica fue la más prevalente. Los factores de riesgo cardiovascular más frecuentes fueron HTA, sedentarismo, dislipemia y tabaquismo. La principal forma de presentación fue síndrome piramidal. Se cumplió con el algoritmo diagnostico en todos los pacientes. Conclusión: Conocer los factores de riesgo, naturaleza y forma de presentación clínica permite elaborar estrategias de prevención primaria y secundaria para el abordaje integral de estos pacientes, intentando así reducir la incidencia y secuelas de esta enfermedad.

Abstract: Introduction: Acute ischemic stroke is a prevalent condition in our working environment, with high morbility and mortality. Hospital Pasteur is a tertiary level institution, which assists an elevated number of patients with acute ischemic stroke. Getting to know its epidemiologic characteristics will enable the development of health promotion and primary prevention measures. Identifying its clinical presentation form and applying validated study algorithms will allow for a proper diagnosis, early treatment and development of secondary prevention measures. Objectives: To study the sociodemographic characteristics of patients diagnosed with acute ischemic stroke or transient ischemic attack assisted in Hospital Pasteur´s Internal Medicine wards, their associated risk factors, clinical presentation and to determine whether the proposed study algorithm was followed. Methodology and procedure: This is a descriptive, observational and transversal study which took place at Hospital Pasteur. The population consisted of adult patients admitted to Internal Medicine wards with the diagnosis of acute ischemic stroke, transient ischemic attack or who presented the event during their stay, between the months of July and September 2018. Results and discussion: The data of 29 patientes was obtained; 20 were female. The mean age was 70.34 years. Ischemic nature was the most prevalent. The most frequent risk factors were arterial hypertension, sedentary lifestyle, dyslipidemia and smoking. Pyramidal syndrome was the most common clinical presentation. A study algorithm was followed in all patients. Conclusion: Getting to know the risk factors, nature and clinical presentation form of AIS and TIA allows for the creation of primary and secondary prevention strategies for the comprehensive approach of these patients, therefore intending to reduce this disease´s incidence and its terrible consequences.

Resumo: Introdução: O ataque cerebrovascular é uma doença prevalente em nosso meio, com alta morbimortalidade. O Hospital Pasteur é um centro de terceiro nível, que auxilia um grande número de pacientes com essa patologia. Conhecer os dados epidemiológicos dessa condição permitirá o desenvolvimento de ações de promoção da saúde e prevenção primária. Identificar a forma de apresentação clínica e os algoritmos do estudo permitirá um diagnóstico adequado, tratamento precoce e desenvolvimento de medidas de prevenção secundária. Objetivos: Conhecer as características sociodemográficas da população com diagnóstico de ataque cerebrovascular ou ataque isquêmico transitório assistido nas salas médicas do Hospital Pasteur, os fatores de risco associados, as formas de apresentação clínica e determinar se o algoritmo de diagnóstico proposto foi atendido. Métodos e procedimentos: Estudo observacional e transversal descritivo realizado no Hospital Pasteur. A população do estudo foi de pacientes adultos admitidos na enfermaria com diagnóstico de ataque cerebrovascular, ataque isquêmico transitório que apresentaram o evento durante sua internação, no período entre julho e setembro de 2018. Resultados e discussão: Os dados foram coletados de 29 pacientes, sendo 20 do sexo feminino. A idade média foi de 70,34 anos, sendo a natureza isquêmica a mais prevalente. Os fatores de risco cardiovascular mais frequentes foram hipertensão arterial, sedentarismo, dislipidemia e tabagismo. A principal forma de apresentação foi a síndrome piramidal. O algoritmo de diagnóstico foi preenchido em todos os pacientes. Conclusão: Conhecer os fatores de risco, natureza e forma de apresentação clínica permite desenvolver estratégias de prevenção primária e secundária para abordagem abrangente desses pacientes, buscando reduzir a incidência e sequelas da doença.

Aplicação de Avaliação de Tecnologias em Saúde (ATS) na tomada de decisão em hospitais / Application of health technology assessment (HTA) in the decision-making in hospitals

Objetivo: A incorporação de tecnologias em saúde por hospitais afeta o desempenho financeiro e assistencial do sistema de saúde de todo um país, e faltam informações na literatura sobre a aplicação de Avaliação de Tecnologias em Saúde (ATS) em hospitais no Brasil. Adicionalmente, há indícios de que a aplicação de ATS em hospitais pode melhorar o uso dos investimentos financeiros de todo o setor de saúde. O objetivo deste trabalho foi analisar a aplicação dos métodos de ATS na tomada de decisão em hospitais vinculados à Rebrats (Rede Brasileira de Avaliação de Tecnologias em Saúde). Métodos: Optou-se por utilizar o método da Grounded Theory, ou Teoria Fundamentada nos Dados, e os dados foram analisados com o uso do software ATLAS.ti. Foram realizadas entrevistas com gestores de 11 Núcleos de ATS (NATS), baseadas em roteiro semiestruturado preparado a partir dos 15 princípios orientadores para boas práticas de ATS em hospitais. Resultados: Os resultados indicaram que a ATS é aplicada de maneira incipiente no processo de tomada de decisão em hospitais. Conclusão: A análise do conteúdo das entrevistas permitiu, ainda, concluir que o sucesso dos NATS para a incorporação e desincorporação de tecnologias em saúde depende de uma cadeia de ações estratégicas relacionadas, e a falta de qualquer uma das etapas enfraquece, ou mesmo inviabiliza, a plena aplicação da ATS para a tomada de decisões em hospitais.

Objective: The incorporation of health technologies by hospitals affects the financial and healthcare performance of the health system of a whole country, and there is a lack in literature about the use of Health Technology Assessment (HTA) for decision making in Brazilian's hospitals. In addition, there is evidence that the application of HTA in hospitals can improve the use of financial investments of the whole health sector. The objective of this study was to analyze the application of HTA methods in decision making in hospitals linked to REBRATS (Brazilian Network for the Health Technologies Assessment). Methods: Grounded Theory methodology has been applied, and the interviews data were analyzed using the ATLAS.ti software. Interviews were conducted with managers of 11 hospital-based HTA units (called "NATS", Núcleo de Avaliação de Tecnologias em Saúde), based on a semi- -structured script prepared from the 15 guiding principles for good practices in hospital-based HTA units. Results: The results indicated that HTA is applied in an incipient way in the decision making process in hospitals. Conclusion: The analysis of the interviews' content also allowed us to conclude that the success of the hospital-based HTA units for the incorporation and disincorporation of health technologies depends on a chain of related strategic actions, and the lack of any of the stages weakens or even impedes the full application of HTA for decision-making in hospitals.

Considerations on the health techology assessment for rare diseases and orphan drugs in China / 国际药学研究杂志

There are about 7000 kinds of rare diseases in the world;the estimated number of patients with rare diseases is 4.3% of the world population and it is therefore a serious public health issue. For rare diseases, two questions are critical: (1)research and development for innovative treatments/medicines(orphan drugs);(2)access to launched orphan drugs in terms of availability and affordability. Many countries, including China, have paid significant attentions to the first question in terms of the regulatory review policy and financial incentive. As to the second question, there is a great difference in access to orphan drugs in different countries and regions due to many factors, including the different medical care systems and high drug expenses. Recently, health technology assessment(HTA)has played an important role in evaluating clinical and economic value of innovative medicines, including orphan drugs. This paper discusses how to do HTA evaluation on orphan drugs in China with several policy suggestions.

Consideration of pharmacoeconomic evaluation model and standard of payment threshold for rare diseases in China / 国际药学研究杂志

Rare diseases are usually defined as diseases with a low incidence in the population. According to re-ports, there were 6084 rare diseases found worldwide in 2016, involving 3715 related genes. 80% of rare diseases are caused by heredity, dominant or recessive inheritance or mutations. The definition of rare diseases by”incidence”in the population varies from country to country, like the EU <1/2000 and the United States <1/2500. A drug used to prevent, treat, or diagnose a rare disease is called an orphan drug. Due to the difficulty of research and development in this small target population, the high investment risk and the high R&D cost, the problem associated with high price of orphan drugs is very prominent. In the cost-effectiveness evaluation, the resulting incremental cost-effectiveness ratio(ICER)is likely to exceed the willingness to pay threshold adopted by most countries and regions, resulting in multiple countries raising its willingness to pay threshold reference standard(3-25 times GDP per capital)for orphan drugs, or simply ex-empting health technology assessment(HTA)assessment for orphan drugs and only evaluating the impact on medical in-surance fund. This paper systematically reviewed the various internationally accepted orphan drug HTA assessment meth-odologies. Based on the characteristics of rare diseases, the paper discusses the establishment of a model for the evalua-tion of orphan drugs and the multi-dimensional value assessment framework for HTA. At the same time, according to the internationally accepted norm, the paper also explores the way to determine the willingness to pay threshold in HTA as-sessment for orphan drugs in China.

Scale development of transformation from health technology assessment to policy-making / 中国卫生政策研究

Through literature review and theoretical analysis,an initial scale was designed with five dimensions namely"evidence influence","organizational support","channel connectivity","communication and collabora-tion"and"decision-makers impetus". The reliability and validity of the scale were evaluated through questionnaire survey on HTA researchers. It is reported that the overall Cronbach's α coefficient of the questionnaire was 0.904, meanwhile the Cronbach's α coefficient of each dimension was more than 0.80 except the dimension of"decision-makers impetus". The average variance extraction of each dimension was more than 0.50. The maximum of correla-tion coefficients between each dimension was 0.571,which was less than the threshold value of 0.85. Additionally, for certain dimensions,the standardized correlation coefficients to each other dimensions was less than regarding arith-metic square root of average variance extraction.

8．HTA is NICE for Cancer Patients? / 薬剤疫学

The recent developed medicine for various cancer types tends to be highly priced. If those expenssive medicines are sold for the large number of cancer patients with lung cancer, stomach cancer, colon cancer, etc, the nationwide health insurance systems covering every citizen would be no longer sustainable in Japan. Because of these concerns, the Central Social Insurance Medical Council ― an advisory body of the Health and Welfare minister ― have started discussions about HTA (health technology assessment) since 2005. And then, the assessment will start at next April. It is a very important assessment for keeping sustainability of the medical policy, but on the other side we find some issues which have to be solved, namely lack of human resources, lack of voices from patients and the public, and lack of transparency in policy making processes. HTA in Japan has been lagged compared to the Western countries, and I would expect many more new challenges in Japan and hope to see us learn from the past.

5．The Utilization of Database Research for Japanese HTA from the Perspective of Pharmaceutical Industory / 薬剤疫学

A pilot program of cost effectiveness evaluation of pharmaceuticals and medical devices was started in 2016 in Japan. Some values necessary for the evaluation, such as the number of patients, treatment pattern, medical costs, and prevalence of adverse events, can be determined based on analysis of medical databases. The databases used for health economics and outcomes research in Japan are divided into insurance claims databases and hospital-based databases. From the perspective of the pharmaceutical industry, private medical databases, such as Japan Medical Data Center (JMDC) and Medical Data Vision (MDV), which are insurance claims and hospital-based databases, respectively, are easily accessed. When using these databases, it is important to understand the advantages and disadvantages of each. Public databases such as the National Database and MID-NET are expected to resolve the limitations of the databases above. However, they still have issues related to sufficiency of data, generalizability of results, and user access. For the purpose of analysis for future formal programs of cost effectiveness evaluation of pharmaceuticals and medical devices in Japan, improved quality and general use of these databases are desired. Pharmaceutical companies use the medical databases in various departments depending on the purposes. It is urgently required that pharmaceutical companies establish career development plans for the people in charge of cost effectiveness evaluation, to ensure their capability of keeping up to date with the characteristics of the latest medical databases and performing reasonable analysis based on them.

4．How Should We Consider Several Factors Other Than Cost-Effectiveness Analysis? ーProblems Regarding ‘Appraisal’ (Comprehensive Evaluation) Process / 薬剤疫学

In Japan, cost-effectiveness evaluations for medicines and medical devices are scheduled to be introduced in April, 2019 in a full-scale mode, following 2-year trial. The whole process of the “Cost-Effectiveness Evaluation (Japanese HTA：Health Technology Assessment)” is divided into three steps that are “Assessment” , “Appraisal” , and “Decision” . In the process of the “Appraisal”, the results of cost-effectiveness analysis (CEA) are evaluated along with the several factors other than CEA, such as social and ethical elements. The Special Committee on Cost-Effectiveness Evaluation (SCCEE) of Central Social Insurance Medical Council (CSIMC) has determined four factors that should be considered during the “Appraisal” process, as follows. 1) Benefit from the standpoint of public health (e.g. measures for infectious diseases), 2) Additional costs which are not included in public health insurance (e.g. long-term care costs, productivity costs), 3) Life-prolonging therapy for long-standing severe diseases, 4) Treatment for the diseases in which alternative treatment is not sufficiently present. Special attention for ‘Innovation’ used to be discussed in SCCEE, however, they decided not to employ it as a considerable factor for the “Appraisal” , since it had already received ‘Innovation premium’ at an initial pricing process. It is controversial whether the Japanese HTA agency should ask the pharmaceutical companies to present another CEA model that includes public health view or indirect costs, or just consider 1) and/or 2) factors as qualitative or semi-quantitative ones during “Appraisal” process. As for 3), they should pay attention for the special situation of the patients with end of life stage. SCCEE has declared that they will use the results of HTA just for adjusting the price of medicines or devices, not for insurance covering decision, while UK uses it for the latter purpose. It will be necessary further discussion on problems regarding “Appraisal” process, considering the difference of purpose for utilizing HTA results between Japan and UK.

The use of the health technology assessment for technology acquisition in hospitals / El uso de la evaluación de tecnología de salud para la adquisición de tecnología en hospitales / O uso da avaliação de tecnologia de saúde para a aquisição de tecnologia em hospitais

Decision makers at the national and local level of health systems require evidence of effectiveness, safety and costs of health technologies for resource allocation. In this sense Health Technology Assessment (HTA) is a favorable tool considering it is a multidisciplinary process to evaluate the benefits as well as the social, economic, organizational and ethical issues of a health technology. The aim of this study was to review the literature in order to identify the attributes used in the process of technology acquisition. It was analyzed the attributes of HTA with the purpose of classifying them, to see which are the most recommended for acquisition in hospitals. The identified literature indicated that not only the clinical and economic attributes were considered, but also attributes related to the context of the hospital such as the effect of technology on other hospital services and others associated with the organization.

Los tomadores de decisiones a nivel nacional y local de los sistemas de salud requieren evidencia de la efectividad, seguridad y costos de las tecnologías de la salud para la asignación de recursos. En este sentido, la Evaluación de la Tecnología de la Salud (HTA, por sus siglas en inglés) es una herramienta favorable considerando que es un proceso multidisciplinario para evaluar los beneficios, así como las cuestiones sociales, económicas, organizativas y éticas de una tecnología de la salud. El objetivo de este estudio fue revisar la literatura con el fin de identificar los atributos utilizados en el proceso de adquisición de tecnología. Se analizaron los atributos de HTA con el fin de clasificarlos, para ver cuáles son los más recomendados para adquisición en hospitales. La literatura identificada indicó que no sólo se consideraron los atributos clínicos y económicos, sino también atributos relacionados con el contexto del hospital como el efecto de la tecnología en otros servicios hospitalarios y otros asociados con la organización.

Os tomadores de decisões a nível nacional e local dos sistemas de saúde requerem evidência da efetividade, segurança e custos das tecnologias de saúde para a atribuição de recursos. Neste sentido, a Avaliação da Tecnologia da Saúde (HTA) é uma ferramenta favorável considerando que é um processo multidisciplinar para avaliar os benefícios, bem como as questões sociais, económicas, organizativas e éticas de uma tecnologia da saúde. O objetivo deste estudo foi revisar a literatura com o fim de identificar os atributos utilizados no processo de aquisição de tecnologia. Analisaram-se os atributos de HTA com o fim de classificá-los, para ver quais são os mais recomendados para aquisição em Hospitais. A literatura identificada indicou que não só se consideraram os atributos clínicos e económicos, assim como também alguns atributos relacionados com o contexto do hospital como o efeito da tecnologia em outros serviços hospitalários e outros associados com a organização.