Hostname: page-component-78c5997874-v9fdk Total loading time: 0 Render date: 2024-11-14T07:06:29.212Z Has data issue: false hasContentIssue false
  • English
  • Français

POST-INTRODUCTION OBSERVATION OF HEALTHCARE TECHNOLOGIES AFTER COVERAGE: THE SPANISH PROPOSAL

Published online by Cambridge University Press:  14 September 2012

Leonor Varela-Lema ,
Alberto Ruano-Ravina ,
Teresa Cerdá Mota ,
Nora Ibargoyen-Roteta ,
Inaki Imaz ,
Inaki Gutiérrez-Ibarluzea ,
Juan Antonio Blasco-Amaro ,
Enrique Soto-Pedre  and
Laura Sampietro-Colom
Leonor Varela-Lema
Affiliation:
Galician Regional Health Authority
Alberto Ruano-Ravina
Affiliation:
Galician Regional Health Authority; University of Santiago de Compostela; CIBER de Epidemiología y Salud Pública, CIBERESP email: alberto.ruano@usc.es
Teresa Cerdá Mota
Affiliation:
Hospital Complex of Pontevedra
Nora Ibargoyen-Roteta
Affiliation:
Basque Country Regional Health Authority
Inaki Imaz
Affiliation:
Health Technology Assessment Agency of Carlos III Institute of Health (AETS)
Inaki Gutiérrez-Ibarluzea
Affiliation:
Basque Country Regional Health Authority
Juan Antonio Blasco-Amaro
Affiliation:
Madrid Regional Health Technology Assessment Unit
Enrique Soto-Pedre
Affiliation:
A Coruña University Hospital Foundation
Laura Sampietro-Colom
Affiliation:
Barcelona Clinical Hospital
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: When a new health technology has been approved by a health system, it is difficult to guarantee that it is going to be efficiently adopted, adequately used, and that effectiveness, safety, and consumption of resources and costs are in line with what was expected in preliminary investigations. Many governmental institutions promote the idea that efficient mechanisms should be established aimed at developing and incorporating continuous evidence into health technologies management. The purpose of this article is to stimulate the discussion on systematic post-introduction observation of health technologies.

Methods: Literature review and input of HTA experts.

Results: The study addresses the key issues related to post-introduction observation and presents a summary of the guide commissioned by the Spanish Ministry of Health, Social Policy and Equality to the Galician HTA agency for the prioritization and implementation of systematic post-introduction observation in Spain. The manuscript describes the prioritization tool developed as part of this project and discusses the main aspects of protocol development, observation implementation, and assessment of results.

Conclusions: The observation of prioritized health technologies after they are introduced in standard clinical practice can provide useful information for health organizations. However, implementing the observation of health technologies can require specific policy frameworks, commitment from different stakeholders, and dedicated funding.

Keywords

Evidence-based healthcareCoverage with evidence developmentOutcome assessmentHealth services research
Type
POLICIES
Information
International Journal of Technology Assessment in Health Care , Volume 28 , Issue 3 , July 2012 , pp. 285 - 293
Copyright
Copyright © Cambridge University Press 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Al-Khatib, SM, Hellkamp, A, Curtis, J. Non-evidence-based ICD implantations in the United States. JAMA. 2011;305:43–49.CrossRefGoogle ScholarPubMed
2.Botting, B, Reilly, H, Harris, D. Use of office of population censuses and surveys records in medical research and clinical audit. Health Trends. 1995;27:4–7.Google ScholarPubMed
3.Carbonneil, C, Quentin, F, Lee-Robin, SH, European Network for Health Technology Assessment (EUnetHTA). A common policy framework for evidence generation on promising health technologies. Int J Technol Assess Healthcare. 2009;25 (Suppl 2):56–67.CrossRefGoogle ScholarPubMed
4.Claxton, K, Sculpher, MJ. Using value information analysis to prioritise health research: Some lessons from recent UK experience (conference paper). Pharmacoeconomics. 2008;24:1055–1068.CrossRefGoogle Scholar
5.Dhalla, IA, Garner, S, Chalkidou, K, Littlejohns, P. Perspectives on the National Institute for Health Clinical Excellence's recommendations to use health technologies only in research. Int J Health Technol Assess. 2009;25:272–280.CrossRefGoogle ScholarPubMed
6.Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. Official Journal of the European Union, L 247/21 (September 21, 2007).Google Scholar
7.Eisenberg, MJ. Ten lessons for evidence-based technology assessment. JAMA. 1999;282:1865–1869.CrossRefGoogle ScholarPubMed
8.Fronsdal, KB, Facey, K, Klemp, M, et al.Health technology assessment to optimize health technology utilization: Using implementation initiatives and monitoring processes. Int J Health Technol Assess. 2010;26:309–316.CrossRefGoogle ScholarPubMed
9.Goodman, CS. HTA 101: Introduction to health technology assessment. Washington, DC: United States National Library of Medicine; 2004.Google Scholar
10.Hannon, EL. Randomized clinical trials and observational studies: Guidelines for assessing respective strengths and limitations. JACC Cardiovasc Interv. 2008;1:211–217.CrossRefGoogle Scholar
11.Hutton, JL, Trueman, P, Henshall, C. Coverage with evidence development: An examination of conceptual and policy issues. Int J Health Technol Assess. 2007;23:425–435.CrossRefGoogle ScholarPubMed
12.Levin, L, Goeree, R, Levine, M, et al.Coverage with evidence development: The Ontario experience. Int J Health Technol Assess. 2011;27:159–168.CrossRefGoogle ScholarPubMed
13National coverage determinations with data collection as a condition of coverage: Coverage with evidence development. Baltimore: Centers for Medicare & Medicaid. US Department of Health & Human Services; 2011.Google Scholar
14.Norris, S, Atkins, D, Bruening, W. Selecting observational studies for comparing medical interventions. In: Agency for Healthcare Research and Qualityx, ed. Methods guide for comparative effectiveness rewiews. Rockville: Agency for Healthcare Research and Quality; 2010.Google Scholar
15.O'Malley, SP, Selby, WS, Jordan, E. A successful practical application for coverage with evidence development in Australia: Medical Services Advisory Committee interim funding and the PillCam Capsule Endoscopy Register. Int J Technol Assess Healthcare. 2009;25:290–296.CrossRefGoogle ScholarPubMed
16.Rao, SV, Shaw, RE, Brindis, RG, et al.On-versus off-label use of drug-eluting coronary stents in clinical practice (report from the American College of Cardiology National Cardiovascular Data Registry [NCDR]). Am J Cardiol. 2006;97:1478–1481.CrossRefGoogle ScholarPubMed
17.Robert, G, Greenhalgh, T, Macfarlane, F, Peacock, R. Organisational factors influencing technology adoption and assimilation in the NHS: A systematic literature review. Report No: 08/1819/223. London: National Institute for Health Research (NIHR); 2009.Google Scholar
18.Schluessmann, E, Diel, P, Aghayev, E, et al.SWISSspine: A nationwide registry for health technology assessment of lumbur disc prostheses. Eur Spine J. 2009;18:851–861.CrossRefGoogle Scholar
19.Sorensen, HT, Lash, T, Rodman, KJ. Beyond randomized controlled trials: A critical comparison of trials with non randomized studies. Hepatology. 2006;44:1075–1082.CrossRefGoogle Scholar
20.The Health and Social Care Information Centre. Patient Reported Outcome Measures (PROMS). London: National Health System; 2011.Google Scholar
21.Trueman, P, Grainger, DL, Downs, KE. Coverage with evidence development: Applications and issues. Int J Health Technol Assess. 2010;26:79–85.CrossRefGoogle ScholarPubMed
22.Turner, JA, Hollingworth, W, Comstock, B, Downs, KE, Deyo, RA. Comparative effectiveness research and policy: Experiences conducting coverage with evidence development study of a therapeutic device. Med Care. 2010;48 (Suppl 6):129–136.CrossRefGoogle ScholarPubMed
23.Varela Lema, L, Atienza Merino, G, López García, M, et al.Requirements ¡and expectations of health technology assessment in Galicia (Spain). A qualitative study from the perspective of decision makers and clinicians. Gac Sanit. 2011;25:454–460.Google Scholar
24.Varela Lema, L, Ruano Raviña, A, Cerdá Mota, T, et al.Post-introduction observation of health technologies. Methodological guideline. Abridged version. Report No: avalia-t. No. 2007/02. Madrid: Ministry of Health & Consumer Affairs; 2009.Google Scholar
25.Whitted, GS. Medical technology diffusion and its effects on the modern hospital. Healthcare Manage Rev. 1981;6:45–54.CrossRefGoogle ScholarPubMed