Post-introduction observation of healthcare technologies after coverage: The Spanish proposal

International Journal of Technology Assessment in Health Care

Volumn 28, Issue 3, 2012, Pages 285-293

  Varela Lema, Leonor ^a   Ruano Ravina, Alberto ^a,b,c   Mota, Teresa Cerdá ^d   Ibargoyen Roteta, Nora ^e   Gutiérrez Ibarluzea, Inaki ^d   Blasco Amaro, Juan Antonio ^f   Soto Pedre, Enrique ^g   Sampietro Colom, Laura ^h  

^a Galician Regional Health Authority   (Spain)

^b UNIVERSITY OF SANTIAGO DE COMPOSTELA   (Spain)

^c CIBER EPIDEMIOLOGÍA Y SALUD PÚBLICA CIBERESP   (Spain)

^d Basque Country Regional Health Authority   (Spain)

^e Instituto de Salud Carlos III Carlos III Institute for Health   (Spain)

^f Madrid Regional Health Technology Assessment Unit   (Spain)

^g A Coruña University Hospital Foundation   (Spain)

^h HOSPITAL CLÍNIC   (Spain)

Author keywords

Coverage with evidence development; Evidence based healthcare; Health services research; Outcome assessment

Indexed keywords

CLINICAL PRACTICES; COVERAGE WITH EVIDENCE DEVELOPMENT; GOVERNMENTAL INSTITUTION; HEALTH ORGANIZATIONS; HEALTH SERVICES RESEARCH; HEALTH SYSTEMS; HEALTH TECHNOLOGY; HEALTHCARE TECHNOLOGY; IN-LINE; LITERATURE REVIEWS; OUTCOME ASSESSMENT; POLICY FRAMEWORK; PRIORITIZATION; PROTOCOL DEVELOPMENT; SOCIAL POLICY;

HEALTH CARE; TECHNOLOGY;

HEALTH;

ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; CLINICAL EFFECTIVENESS; ECONOMIC ASPECT; EVIDENCE BASED PRACTICE; GOOD CLINICAL PRACTICE; GOVERNMENT; HEALTH CARE; HEALTH CARE ORGANIZATION; HEALTH SERVICE; HUMAN; OUTCOME ASSESSMENT; PATIENT SAFETY; SPAIN;

DIFFUSION OF INNOVATION; EVIDENCE-BASED MEDICINE; OUTCOME ASSESSMENT (HEALTH CARE); QUESTIONNAIRES; SPAIN; TECHNOLOGY ASSESSMENT, BIOMEDICAL;

EID: 84866386094     PISSN: 02664623     EISSN: 14716348     Source Type: Journal    
DOI: 10.1017/S0266462312000232     Document Type: Article

References (25)

1. Al-Khatib SM, Hellkamp A, Curtis J. Non-evidence-based ICD implantations in the United States. JAMA. 2011;305:43-49.
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.
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.
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. (Pubitemid 44683363)
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.
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).
7. Eisenberg MJ. Ten lessons for evidence-based technology assessment. JAMA. 1999;282:1865-1869.
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.
9. Goodman CS. HTA 101: Introduction to health technology assessment. Washington, DC: United States National Library of Medicine; 2004.
10. Hannon EL. Randomized clinical trials and observational studies: Guidelines for assessing respective strengths and limitations. JACC Cardiovasc Interv. 2008;1:211-217.
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.
12. Levin L, Goeree R, LevineM, et al. Coverage with evidence development: The Ontario experience. Int J Health Technol Assess. 2011;27:159-168.
13. National 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.
14. Norris S, Atkins D, Bruening W. Selecting observational studies for comparing medical interventions. In: Agency for Healthcare Research and Quality, ed. Methods guide for comparative effectiveness rewiews. Rockville: Agency for Healthcare Research and Quality; 2010.
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.
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.
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.
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.
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. (Pubitemid 44748358)
20. The Health and Social Care Information Centre. Patient Reported Outcome Measures (PROMS). London: National Health System; 2011.
21. Trueman P, Grainger DL, Downs KE. Coverage with evidence development: Applications and issues. Int J Health Technol Assess. 2010;26:79-85.
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.
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.
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.
25. Whitted GS. Medical technology diffusion and its effects on the modern hospital. Healthcare Manage Rev. 1981;6:45-54.