Изграждане на капацитет и институционализиране на структура за оценка на здравни технологии – сравнителен анализ на външната макро среда между България и добрите международни практики

  • Ралица Райчева
  • Румен Стефанов
Keywords: оценка на здравни технологии, ОЗТ капацитет, ОЗТ структура, характеристики на средата

Abstract

Въведение: Създаването на организация за оценка на здравни технологии (ОЗТ) или стартирането на ефективна ОЗТ програма, която да информира ключови политически решения, е амбициозна мисия. В литературата не съществуват стандартни модели или подходи, поради големите разлики в средата, в която ще се развива ОЗТ капацитета. Всяка страна, регион и провинция е необходимо да открие своя собствена, възможно най-ефикасна алтернатива, подходяща за здравния и организационен контекст, в който съществува.

Цел: Целта е да се систематизират, изучат и анализират най-добрите практики за оценка на здравни технологии (ОЗТ) в глобален мащаб и да се извърши съпоставка на характеристиките на средата с постигнатото в България ниво на изграждане на капацитет и институционализиране на ОЗТ.

Материали и методи: В периода 2013–2015 г. е проведено международно уеб-базирано анкетно проучване сред 312 НТА организации, със седалище в 83 страни, включително 11 международни организации. Данните са получени от полуструктуриран въпросник, който съдържа общо 106 въпроса – 17 закрити, 31 открити въпроси и 58 полуоткрити въпроса, разпределени в шест раздела, един панел и два сегмента за набиране на допълнителна информация. Анализът на данните се реализирана със статистическия пакет на софтуера за социални науки IBM SPSS Statistics v.22. Систематизирането и статистическата обработка на отворените въпроси бе постигната със Microsoft Office Excel 2013, Provalis Research QDA Miner 4 и WordStat 7.

Резултати: Общо бяха попълнени 111 въпросници (35.58% възвращаемост) от 39 държави на 5 континента. Изграждането на капацитет и институционализирането започва от макросредата с идентифициране на потребността от създаване на ОЗТ структура на най-високо политическо и административно ниво. Макросредата се свързва и с други два основополагащи за стартиране на ОЗТ структура елементи – нормативна база и икономическо ниво. Необходимо е и определянето на рамката и съответните характеристики на институционалното, физическо/технологичното и социално-културното ниво, за да се завърши цялостната инфраструктура на външната за извършване на ОЗТ среда.

Заключение: Улесняването на изграждане на капацитет и осигуряването на устойчиво развитие на ОЗТ структура на национално ново изисква детайлно опознаване на външната среда – законодателство, потребности на вземащите решения, политическия интерес и т.н., за да се очертаят възможните конфликти и бариери и да се изведат решения въз основа опита на други организации. За преодоляване на препятствията е важно глобалното и взаимосвързано възприемане на проблемите, без съсредоточаване върху само един ограничаващ фактор.

References

Moharra M, Kubesch N, Estrada MD, Parada A, Cortes M, Espallargues M on behalf of Work Package 8, European Network for Health Technology Assessment and Research (EUnetHTA project). Survey report on HTA organisations. Barcelona (Spain): Catalan Agency for Health Technology Assessment and Research. Catalan Health Service. Department of Health. Autonomous Government of Catalonia; May 2008.
Goodman CS. HTA 101: Introduction to Health Technology Assessment. Bethesda, MD: National Library of Medicine (US); 2014.
Hailey DM. Health technology assessment in Canada: Diversity and evolution. Med J Aus. 2007;187:286-288.
Banta D. The development of health technology assessment. Health Policy 2003; 63(2), 121-132.
Banta D, Oortwijn W. Conclusion. Health technology assessment and health care in the European Union. Int J Technol Assess Health Care. 2000;16:626-35.
Jonsson E, Banta D. Management of health technologies: An international view. BMJ. 1999;319:1-3.
Mears R, Taylor R. Littlejohns P, Dillon A. Review of International Health Technology Assessment (IHTA). Project report. London: National Institute for Clinical Excellence (NICE); 2000.
Martelli F, La Torre G, Di Ghionno E, Neroni M, Cicchetti A, Von Bremen K et al. Health technology assessment agencies: An international overview of organizational aspects. Int J Technol Assess Health Care 2007; 23 (4): 414-424.
Jonsson E, Banta HD, Henshall C, Sampietro-Colom L. Report from the ECHTA-ECAHI Project. European collaboration for health technology assessment: developing an assessment network. Int J Technol Assess Health Care. 2002; 18(2):213-455.
Lavis JN, Paulsen EJ, Oxman AD, Moynihan R. Evidence-informed health policy 2 – Survey of organizations that support the use of research evidence. Implementation Sci. 2008;3:54.
Thiene D, Torre1 GL, D’Ancona F, Giambi C. HTA for pneumococcal vaccines. Survey on the availability of Health Technology Assessment in the field of pneumococcal vaccines and availability of information to perform one. Collaboration between VENICE II project and ECDC Funded partially by ECDC (GRANT 2008/006). VENICE II Research Team: VENICE National Gatekeepers and Contact Points.
EUnetHTA Work Package 8. EUnetHTA Handbook on Health Technology Assessment Capacity Building. Barcelona (Spain): Catalan Agency for Health Technology Assessment and Research. Catalan Health Service. Department of Health Autonomous Government of Catalonia; 2008.
Kristensen FB. What is health technology assessment-and how is European Network for HTA (EUnetHTA) developing transnational collaboration? (2007, September) From International Society for Pharmacoeconomics and Outcomes Research. Webpage. Available at: https://www.ispor.org/news/articles/Oct08/LatinAmericaHTA.asp; Accessed on: 26 Sept 2015.
Luce B, Cohen RS. Health technology assessment in the United States. International Journal of Technology Assessment in Health Care, 25:Supplement 1 (2009), 33–41.
Battista RN., Cote B., Hodge MJ., Husereau D. Health technology assessment in Canada. International Journal of Technology Assessment in Health Care, 25:Supplement 1 (2009), 53–60.
Sampietro-Colom L, Asua J, Briones E, Gol J. History of health technology assessment: Spain International Journal of Technology Assessment in Health Care, 25 (Suppl. 1) (2009), pp. 163–173.
Favaretti C, Cicchetti A, Guarrera G, et al. Health technology assessment in Italy. Int J Technol Assess Health Care. 2009;25((Suppl 1)):127–133.
Hailey D. Health care technology in Australia. Health Policy. 1994;30:23-72.
Quintiles. The challenges of introducing HTA in Latin America. HTA Uncovered. 2014; 5. Webpage. Available online at: http://www.quintiles.com/~/media/library/fact%20sheets/hta-uncovered-may-2014.pdf; Accessed on: 25 Sept 2015.
Kuchenbecker R, Polanczyk CA. Institutionalizing health technology assessment in Brazil: challenges ahead Value in Health Regional Issues, 1 (2) (2012), pp. 257–261.
WHO Regional Office for Europe. Institutionalization of health technology assessment. Bonn: World Health Organization; 2000.
Rajan A, Gutierrez-Ibarluzea I, Moharra M. Addressing issues assessment promotion: Motives, enablers, and barriers. Int J Technol Assess Health Care. 2011;27(01):55–63.
Sigmund H, Kristensen FB. Health technology assessment in Denmark: strategy, implementation, and developments. Int. J. Technol. Assess. Health Care. 2009; 25(Suppl. 1): 94–101.
Perleth M, Busse R. Health technology assessment in Germany: Status, Challenges, and Development. Int J Technol Assess Health Care. 2000;16:412-428.
Banta D, Kristensen FB, Jonsson E. A history of health technology assessment at the European level. Int J Technol Assess Health Care 2009; 25 (Suppl 1): 68-73.
Ikeda S, Tomita N. Health technology assessment in France. The Japanese Journal of Social Security Policy, 2009;8(2);77-87.
BIQG/Bundesinstitut f¨ur Qualit¨at im Gesundheitswesen. Webpage. Available at: http://www.biqg.org/. Accessed on: 23 Sept 2015.
Poland Ministry of Health. Ordinance of the Minister of Health amending the ordinance concerning the Agency for Health Technology Assessment. (Ministra Zdrowia. Zarza˛dzenie Ministra Zdrowia zmieniaja˛ce zarza˛dzenie w sprawie Agencji Oceny Technologii Medycznych). Webpage. Availabe at: http://www2.mz.gov.pl/wwwmz/index?mr=q491&ms=383&ml=pl&mi=383&mx=0&mt=&my=589&ma=011485; Accessed on: 22 Sept 2015.
Agency for Quality and Accreditation in Health Care (Agencija za kvalitetu i akreditaciju u zdravstvu i socijalnoj skrbi). Homepage. Available at: http://www.aaz.hr/; Accessed on: 15 Sept 2015.
Jankauskiene D. Development of health technology assessment in Lithuania. Int J of Technology Assessment in Health Care, 25: Supplement 1, (2009). 140 – 142.
National Evidence-based healthcare Collaborating Agency (NECA). WebPage. Available at: http://www.neca.re.kr/eng/introduce/history.jsp; Accessed on: 23 Sept 2015.
Ministry of Health Malaysia. Malaysia’s health 2000. Kuala Lumpur: Ministry of Health Malaysia; 2000:146-158.
Brazilian Ministry of Health. Rule # 2.587/ 30th October 2008. Webpage. Available at: http://conitec.gov.br/images/Legislacao/Portaria2587_30.10.2008.pdf; Accessed 24 Nov 2015.
Kachieng’a MO, Boonzaier DA. Health care technology assessment – the South African health care system in transition. S Afr Med J 1999; 89(2): 149-155.
Antes G, Briones E, Britton M, Burnand B, Angel G, Gallo P, et al. Education and support networks for assessment of health intervention. Working Group 5 of the European Collaboration for Health Technology Assessment (ECHTA Project). Int J Technol Assess Health Care. 2002; 18 (2): 423-446.
Lehoux P, Tailliez S, Denis JL, Hivon M. Redefining HTA in Canada: diversification of products and contextualization of findings International Journal of Technology Assessment in Health Care, 20 (3) (2004), pp. 325–336.
Stephens JM, Handke B, Doshi JA, et al. International survey of methods used in health technology assessment (HTA): Does practice meet the principles proposed for good research? J Comp Eff Res. 2012;2:29-44.
Wulsin Jr. L, Dougherty A. A Briefing on Health Technology Assessment. USA: California Research Bureau, California State Library; 2008. p. 1-26.
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflict of interest in biomedical research: a systematic review. JAMA. 2003; 289:454-65.
Mears R et al. (2000). A review of international health technology assessment (IHTA). London, NICE.
The Haute Autorité de santé (HAS). Webpage. Available at: http://www.has-sante.fr/portail/jcms/c_415964/en/key-facts-and-figures; Accessed on: Oct 11 2015.
EUnetHTA JA1 Report. Facilitation of national strategies for continuous development and sustainability of HTA, 2011. Available online at: http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/JA1%20output_Facilitation%20of%20National%20Strategies%20for%20continuous%20development%20and%20sustainability%20of%20HTA.pdf (accessed August 18, 2015).
Sorenson C. Ensuring value for money in health care: the role of health technology assessment in the European Union. London, European Observatory for Health Systems and Policies, 2008.
The Lewin Group: Report Three: Health technology assessment and access to innovative medical technology. Advanced Medical Technology Association, 2003.
Chantler C. Health-care technology assessment: a clinical perspective. Int J Technol Assess Health Care 2004;20:87-91.
Schwarzer R., Siebert U.; Methods, procedures, and contextual characteristics of health technology assessment and health policy decision making: comparison of health technology assessment agencies in Germany, United Kingdom, France, and Sweden International Journal of Technology Assessment in Health Care, 25 (2009), pp. 305–314.
Neumann P.J., Drummond M.F., Jönsson B., et al. Are key principles for improved health technology assessment supported and used by health technology assessment organizations? Int J Technol Assess Health Care. 2010 Jan;26(1):71-8.
Elston J, Stein K. A rapid needs assessment of the provision of health technology assessment in the south-west peninsula. Journal of Public Health, 2007;29(2):157–164.
Catananti C, Cicchetti A, Marchetti M. Hospital-based health technology assessment: The experience of Agostino Gemelli University Hospital’s HTA Unit. Ital J Public Health. 2005;3:23-28.
Gagnon MP, Gagnon J, St-Pierre M, Gauvin FP, Piron F, Rhainds M, Coulombe M, Lepage-Savary D, Desmartis M, Tantchou Dipankui M, Légaré F: Involving patients in HTA activities at local level: a study protocol based on the collaboration between researchers and knowledge users. BMC Health Serv Res 2012, 12:14.
Garrido VM, Kristensen FB, Nielsen CP, Busse R, editors. Health Technology Assessment and Health Policy Making in Europe – current status, challenges and potential.Copenhagen: World Health Organisation; 2008.
Hailey D, Babidge W, Cameron A, Davignon L. Health technology assessment agencies and decision makers. An INAHTA guidance document. INAHTA website, May 2010.
Drummond M, Weatherly H. Implementing the findings of health technology assessments. If the CAT got out of the bag, can the TAIL wag the dog? Int J Technol Assess Health Care. 2000;16(1):1-12.
Battista RN. Expanding the scientific basis of health technology assessment: a research agenda for the next decade. Int J Technol Assess Health Care. 2006;22(3):275-80.
Arellano LE, Reza M, Blasco JA, Andradas E. A content analysis of Health Technology Assessment programs in Latin America. Int J Technol Assess Health Care. 2009;25(4):570-6.
Parada A, Gutiérrez-Ibarluzea I, grupo AUnETS. Evaluación del impacto bibliográfico de las agencias y unidades españolas de evaluación de tecnologías sanitarias. Plan de Calidad para el Sistema Nacional de Salud. Ministerio de Ciencia e Innovación. Agència d’Informació, Avaluació i Qualitat en Salut de Cataluña; 2010. Informes de Evaluación de Tecnologías Sanitarias, AIAQS núm. 2007/xx.
Anderson JG, Aydin CE. Evaluating the impact of health care information systems. Int J Technol Assess Health Care. 1997;13(2):380-93.
Barca Fernández I, Parejo Miguez R, Gutiérrez Martín P, Fernández Alarcón F, Alejandre Lázaro G, López de Castro F. La información al paciente y su participación en la toma de decisiones clínicas. Aten Primaria. 2004; 33 (7):361-4.
Lehoux P, Denis J.L, Tailliez S, Hivon M. Dissemination of Health Technology Assessments: Identifying the Visions Guiding an Evolving Policy Innovation in Canada. Journal of Health Politics, Policy and Law. 2005; 30 (4):603-42.
Neikter SA, Rehnqvist N, Rosen M, Dahlgren H. Toward a new information infrastructure in health technology assessment: communication, design, process, and results. Int J Technol Assess Health Care. 2009 ;25 Suppl 2:92-8.
Sobrido Prieto M, González Guitián C, Cerdá Mota T, Grupo de técnicos y expertos en documentación y difusión de las Agencias y Unidades de Evaluación de Tecnologías Sanitarias Españolas. Estrategias para la difusión y diseminación de los productos de Evaluación de Tecnologías Sanitarias (ETS). Madrid: Ministerio de Ciencia e Innovación, 2009 avalia-t Núm. 2007 / 07.
Gagnon M-P, Desmartis M, Gagnon J, St-Pierre M, Gauvin FP, Rhainds M, Lepage-Savary D, Coulombe M, Tantchou Dipankui M, Légaré F: Introducing the patient’s perspective in hospital health technology assessment (HTA): the views of HTA producers, hospital managers, and patients. BMC Health Services Research 2012, 12:14
Rettig RA. Health care in transition: Technology assessment in the private sector. Los Angeles, CA: Rand; 1997.
Goodman CS. Healthcare technology assessment: methods, framework, and role in policy making. Am J Manag Care. 1998;4:SP200-14.
Published
2017-03-15
How to Cite
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Райчева Р, Стефанов Р. Изграждане на капацитет и институционализиране на структура за оценка на здравни технологии – сравнителен анализ на външната макро среда между България и добрите международни практики. Редки болести и лекарства сираци [Internet]. 2017Mar.15 [cited 2024Mar.28];8(1):10-6. Available from: https://journal.raredis.org/index.php/RBLS/article/view/31
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