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The principles of Health Technology Assessment in laboratory medicine

  • Giorgio Liguori EMAIL logo , Patrizia Belfiore , Maurizio D’Amora , Renato Liguori und Mario Plebani
Veröffentlicht/Copyright: 24. Juni 2016
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 55 Heft 1

Abstract

The Health Technology Assessment (HTA) is a multi-professional and multidisciplinary evaluation approach designed to assess health technology in the broadest sense of the term, from its instruments to the rearranging of its organizational structures. It is by now an established methodology at national and international levels that involves several medical disciplines thanks to its versatility. Laboratory medicine is one of these disciplines. Such specialization was subjected, in recent years, to deep changes even from an organizational standpoint, in order to meet the health needs of the population, making them as effective and cost-effective as possible. In this regard, HTA was the tool used to assess implications in different areas.

Keywords: Health Technology Assessment; innovation; laboratory medicine
Corresponding author: Prof. Giorgio Liguori, Department of Movement and Wellbeing Sciences, University of Naples “Parthenope”, via Medina 40, 80133 Naples, Italy, Phone: +39 081.5474790, Fax: +39 339.5790771

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. National Agency for Regional Health Services. The public spending in Europe years 2000–2013. Roma: June 2014. Available at: http://docplayer.it/10052869. Updated on 2014.Suche in Google Scholar

2. Meridiano Sanità. Report 2015. The coordinates for your health.Suche in Google Scholar

3. Convention Siais “Health care innovation”. Available at: http://www.innovazionesanita.it/. Updated on 2014.Suche in Google Scholar

4. Omachonu VK, Einspruch NG. Innovation in healthcare delivery systems: a conceptual framework. Innov J 2010;15:1–20.Suche in Google Scholar

5. Henshall C, Schuller T; HTAi Policy Forum. Health technology assessment, value-based decision making, and innovation. Int J Technol Assess Health Care 2013;29:353–9.10.1017/S0266462313000378Suche in Google Scholar PubMed

6. Brunetti M, Pregno S, Schünemann HJ, Plebani M, Trenti T. Economic evidence in decision-making process in laboratory medicine. Clin Chem Lab Med 2011;49:617–21.10.1515/CCLM.2011.119Suche in Google Scholar PubMed

7. Brunetti M, Shemilt I, Pregno S, Vale L, Oxman A, Lord J, et al. GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence. J Clin Epidemiol 2013;66:140–50.10.1016/j.jclinepi.2012.04.012Suche in Google Scholar PubMed

8. Cochrane AL. Effectiveness and efficiency: random reflections on health services. London: Nuffield Provincial Hospitals Trust, 1972.Suche in Google Scholar

9. Williams A. How should information on cost-effectiveness influence clinical practice? In: Outcomes in clinical practice. London: BMJ Publishing Group, 1994:99–107.Suche in Google Scholar

10. Trenti T, Canali C, Scognamiglio AM. Clinical Governance and evidence-based laboratory medicine. Clin Chem Lab Med 2006;44:724–32.10.1515/CCLM.2006.130Suche in Google Scholar PubMed

11. Plebani M. Evaluating laboratory diagnostic tests and translational research. Clin Chem Lab Med 2010;48:983–8.10.1515/CCLM.2010.188Suche in Google Scholar PubMed

12. Plebani M. The changing scenario in laboratory medicine and the role of laboratory professionals in translational medicine. Clin Chim Acta 2008;393:23–6.10.1016/j.cca.2008.03.013Suche in Google Scholar PubMed

13. Plebani M, Marincola FM. Research translation: a new frontier for clinical laboratories. Clin Chem Lab Med 2006;44:1303–12.10.1515/CCLM.2006.238Suche in Google Scholar PubMed

14. Plebani M, Lippi G. Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine. Clin Chem Lab Med 2016;54:1117–8.10.1515/cclm-2016-0217Suche in Google Scholar PubMed

15. Plebani M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013;51:741–51.10.1515/cclm-2013-0075Suche in Google Scholar PubMed

16. Plebani M, Lippi G. Personalized (laboratory) medicine: a bridge to the future. Clin Chem Lab Med 2013;51:703–6.10.1515/cclm-2013-0021Suche in Google Scholar PubMed

17. Zuccatelli G, Cerbo M, Arcangeli L, Cappelletti P, Fadda G, Fenoil R, et al. Address Lines for the reorganization of the Laboratory Medicine services in the National Healthcare Service. Rome: AgeNaS Agenzia Nazionale per i Servizi Sanitari Regionali (National Agency for Regional Healthcare Services), 2013.Suche in Google Scholar

18. Cappelletti P. Practicing the adequacy in laboratory medicine. An introduction. RIMeL/IJLaM 2013;9:1–7.10.3917/dunod.cappe.2013.01.0001Suche in Google Scholar

19. Lippi G, Mattiuzzi C. The biomarker paradigm: between diagnostic efficiency and clinical efficacy. Pol Arch Med Wewn 2015;125:208–8.10.20452/pamw.2788Suche in Google Scholar PubMed

20. Schünemann HJ, Mustafa R, Brozek J. Diagnostic accuracy and linked evidence – testing the chain. Z Evid Fortbild Qual Gesundhwes 2012;106:153–60.10.1016/j.zefq.2012.04.001Suche in Google Scholar PubMed

21. Beastall GH. The modernisation of pathology and laboratory medicine in the UK: networking into the future. Clin Biochem Rev 2008;29:3–9.Suche in Google Scholar

22. INAHTA-International Network of Agencies for Health Technology Assessment. Available at: http://www.inahta.org. Accessed 20 June 2011.Suche in Google Scholar

23. Trento Charter on Health Technology Assessment in Italy. Available at: http://www.sihta.it/carta-di-trento.Suche in Google Scholar

24. Plebani M. Clinical laboratories: production industry or medical services? Clin Chem Lab Med 2015;53:995–1004.10.1515/cclm-2014-1007Suche in Google Scholar PubMed

25. Moynihan R, Henry D. The fight against disease mongering: generating knowledge for action. PLoS Med 2006;3:e191.10.1371/journal.pmed.0030191Suche in Google Scholar PubMed PubMed Central

26. Institute for Quality and Efficiency in Health Care: what type of evidence being considered in the development of clinical practice guidelines for rare diseases? IQWiG Reports – Commission No. V10-01, Executive Summary, 2011.Suche in Google Scholar

27. Boudard A, Martelli N, Prognon P, Pineau J. Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment? J Eval Clin Pract 2013;19:697–702.10.1111/jep.12024Suche in Google Scholar PubMed

28. Ministry of Labor, Healthcare and Social Policies, editors. General direction healthcare planning, assistance levels and ethical principles of the system. Address Lines for the reorganization of the Laboratory Medicine services in the National Healthcare Service. Roma: AgeNaS – Agenzia Nazionale per i Servizi Sanitari Regionali (National Agency for Regional Healthcare Services), 2009.Suche in Google Scholar

29. Favaretti C, Cicchetti A, Guarrera G, Marchetti M, Ricciardi W. Health technology assessment in Italy. Int J Tech Assess Health Care 2009;25(Suppl 1):127–33.10.1017/S0266462309090539Suche in Google Scholar PubMed

30. Kristensen FB, Sigmund H, editors. Health technology assessment handbook copenhagen: Danish Centre for Health Technology Assessment, National Board of Health, Denmark, 2007.Suche in Google Scholar

31. Borowski HZ, Brehaut J, Hailey D. Luking evidence from health techology assessment to policy and decision making: the Alberta model. Int J Tech Assess Health Care 2007;23:155–61.10.1017/S0266462307070250Suche in Google Scholar PubMed

32. Migliore A, Perrini MR, Jefferson T, Cerbo M. Implementing a National Early Awareness and Alert System for new and emerging Health Technologies in Italy: The COTE Project. Int J Technol Assess Health Care 2012;28:321–6.10.1017/S0266462312000384Suche in Google Scholar PubMed

33. Battista RN. The evolving paradigm of Health Technology Assessment: reflections for the millennium. Can Med Assoc J 1999;160:1464–7.Suche in Google Scholar

34. Ehlers L, Vestergaard M, Kidholm K, Bommerie B, Pedersen PH, JØrgensen T, et al. Doing mini-health technology assessments in hospitals: a new concept of decision support in health care. Int J Technol Assess Health Care 2006;22:295–302.10.1017/S0266462306051178Suche in Google Scholar PubMed

35. Liguori G, Belfiore P. L’Health Technology Assessment (HTA) towards a process logic. In: Briganti C, Ferrara M, Salvatore D, editors. Emergent themes in healthcare organization studies. Torino: Giappichelli Ed, 2011:161–85.Suche in Google Scholar

36. Scaletti A, Lauro E, Belfiore P, Zamparelli B, Liguori G; Società Italiana di Health Horizon Scanning (SIHHS). The economic impact of the Stroke Unit in Campania. Ig San Pubb 2014;70:73–96.Suche in Google Scholar

37. Liguori G, Parlato A, Zamparelli AS, Belfiore P, Gallé F, Di Onofrio V, et al. Adult immunization with 13-valent pneumococcal vaccine in Campania region, South Italy: an economic evaluation. Hum Vaccin Immunother 2014;10:492–7.10.4161/hv.26888Suche in Google Scholar PubMed PubMed Central

38. Liguori G, Belfiore P, Cianciaruso B, Cirillo M, Creazzola S, D’Ausilio A, et al. An HTA Model to support the offer of a lypoproteic diet to CKD (Chronic Kidney Disease) patients in Campania region. Ig San Pub 2012;68:781–92.Suche in Google Scholar

39. Zamparelli B, editor. Innovating the innovation. Health Technology Assessment and Horizon Scanning tools for the assessment of emerging. Italy: Loffredo Editore, Napoli, 2009.Suche in Google Scholar

40. Cicchetti A, Marchetti M, editors. Manual health technology assessment. Roma: Il Pensiero Scientifico Ed, 2010.Suche in Google Scholar

41. Sanmartin C, Murphy K, Choptain N, Conner-Spady B, McLaren L, Bohm E, et al. Appropriateness of healthcare interventions: concepts and scoping of the published literature. Int J Technol Assess Health Care 2008;24:342–9.10.1017/S0266462308080458Suche in Google Scholar PubMed

42. Available at:http://www.molecular-summit.com/PDFs/2008presentations/Kovak. Updated 2014.Suche in Google Scholar

43. Trenti T. Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies. Clin Chem Lab Med 2016;54:535–43.10.1515/cclm-2015-0867Suche in Google Scholar PubMed

44. Rizzotti P. HTA and little ticket technology. RIMeL/IJLaM 2007;3(Suppl):44–7.Suche in Google Scholar

45. Treweek S, Oxman AD, Alderson P, Bossuyt PM, Brandt L, Brożek J, et al. The developing and evaluating communication strategies to support informed decisions and practice based on evidence (DECIDE): protocol and preliminary results. Implement Sci 2013;8:6.10.1186/1748-5908-8-6Suche in Google Scholar PubMed PubMed Central

Received: 2016-4-29
Accepted: 2016-5-26
Published Online: 2016-6-24
Published in Print: 2017-1-1

©2017 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Describing children’s changes using clinical chemistry analytes
  4. Review
  5. Assessment of vitamin D status – a changing landscape
  6. Opinion Papers
  7. Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)
  8. The principles of Health Technology Assessment in laboratory medicine
  9. Genetics and Molecular Diagnostics
  10. Functional polymorphism of lncRNA MALAT1 contributes to pulmonary arterial hypertension susceptibility in Chinese people
  11. General Clinical Chemistry and Laboratory Medicine
  12. Influence of pneumatic tube system transport on routinely assessed and spectrophotometric cerebrospinal fluid parameters
  13. Estimation of hematocrit in filter paper dried bloodspots by potassium measurement: advantage of use of perimeter ring samples over circular center sub-punch samples
  14. Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease
  15. Comparison of four immunoassays to measure serum ferritin concentrations and iron deficiency prevalence among non-pregnant Cambodian women and Congolese children
  16. Activity and expression of dipeptidyl peptidase IV on peripheral blood mononuclear cells in patients with early steroid and disease modifying antirheumatic drugs naïve rheumatoid arthritis
  17. Hematology and Coagulation
  18. Neutrophil CD64 Index as a superior biomarker for early diagnosis of infection in febrile patients in the hematology department
  19. Dilute Russell’s viper venom time reagents in lupus anticoagulant testing: a well-considered choice
  20. Reference Values and Biological Variations
  21. Pediatric reference intervals for alkaline phosphatase
  22. Cancer Diagnostics
  23. Transcript expression and genetic variability analysis of caspases in breast carcinomas suggests CASP9 as the most interesting target
  24. CDH1 (E-cadherin) expression independently affects clinical outcome in acute myeloid leukemia with normal cytogenetics
  25. Cardiovascular Diseases
  26. Association of monocyte to HDL cholesterol level with contrast induced nephropathy in STEMI patients treated with primary PCI
  27. Low concentrations of adropin are associated with endothelial dysfunction as assessed by flow-mediated dilatation in patients with metabolic syndrome
  28. Preoperative serum potassium predicts the clinical outcome after non-cardiac surgery
  29. Diabetes
  30. A simple colorimetric assay for measuring fructosamine 3 kinase activity
  31. Acknowledgment
  32. Acknowledgment
  33. Letters to the Editor
  34. Normalisation issues in glucose measurements using phlebotomy tubes with liquid additives
  35. Utility of dilution tests in investigating interference in the free thyroxine assay
  36. Plasminogen activator inhibitor-1 as a marker of cardiovascular response in professional mountain ultra-marathon runners
  37. Pitfalls of LSD screening assays: comparison of KIMS and CEDIA immunoassays with LC-MS
  38. A two site comparison of two point-of-care activated clotting time systems
  39. Detection of the common South-East Asian β0-thalassemia mutations in samples with borderline HbA2 levels
  40. Biclonal plasma cell myeloma with the simultaneous appearance of both secretory lambda and nonsecretory kappa monoclonal light chains
https://doi.org/10.1515/cclm-2016-0371
Schlagwörter für diesen Artikel
Health Technology Assessment; innovation; laboratory medicine

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Describing children’s changes using clinical chemistry analytes
  4. Review
  5. Assessment of vitamin D status – a changing landscape
  6. Opinion Papers
  7. Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)
  8. The principles of Health Technology Assessment in laboratory medicine
  9. Genetics and Molecular Diagnostics
  10. Functional polymorphism of lncRNA MALAT1 contributes to pulmonary arterial hypertension susceptibility in Chinese people
  11. General Clinical Chemistry and Laboratory Medicine
  12. Influence of pneumatic tube system transport on routinely assessed and spectrophotometric cerebrospinal fluid parameters
  13. Estimation of hematocrit in filter paper dried bloodspots by potassium measurement: advantage of use of perimeter ring samples over circular center sub-punch samples
  14. Evaluation of the first fully automated immunoassay method for the measurement of stimulating TSH receptor autoantibodies in Graves’ disease
  15. Comparison of four immunoassays to measure serum ferritin concentrations and iron deficiency prevalence among non-pregnant Cambodian women and Congolese children
  16. Activity and expression of dipeptidyl peptidase IV on peripheral blood mononuclear cells in patients with early steroid and disease modifying antirheumatic drugs naïve rheumatoid arthritis
  17. Hematology and Coagulation
  18. Neutrophil CD64 Index as a superior biomarker for early diagnosis of infection in febrile patients in the hematology department
  19. Dilute Russell’s viper venom time reagents in lupus anticoagulant testing: a well-considered choice
  20. Reference Values and Biological Variations
  21. Pediatric reference intervals for alkaline phosphatase
  22. Cancer Diagnostics
  23. Transcript expression and genetic variability analysis of caspases in breast carcinomas suggests CASP9 as the most interesting target
  24. CDH1 (E-cadherin) expression independently affects clinical outcome in acute myeloid leukemia with normal cytogenetics
  25. Cardiovascular Diseases
  26. Association of monocyte to HDL cholesterol level with contrast induced nephropathy in STEMI patients treated with primary PCI
  27. Low concentrations of adropin are associated with endothelial dysfunction as assessed by flow-mediated dilatation in patients with metabolic syndrome
  28. Preoperative serum potassium predicts the clinical outcome after non-cardiac surgery
  29. Diabetes
  30. A simple colorimetric assay for measuring fructosamine 3 kinase activity
  31. Acknowledgment
  32. Acknowledgment
  33. Letters to the Editor
  34. Normalisation issues in glucose measurements using phlebotomy tubes with liquid additives
  35. Utility of dilution tests in investigating interference in the free thyroxine assay
  36. Plasminogen activator inhibitor-1 as a marker of cardiovascular response in professional mountain ultra-marathon runners
  37. Pitfalls of LSD screening assays: comparison of KIMS and CEDIA immunoassays with LC-MS
  38. A two site comparison of two point-of-care activated clotting time systems
  39. Detection of the common South-East Asian β0-thalassemia mutations in samples with borderline HbA2 levels
  40. Biclonal plasma cell myeloma with the simultaneous appearance of both secretory lambda and nonsecretory kappa monoclonal light chains
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