Clinical Governance and evidence-based laboratory medicine
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Tommaso Trenti
, Claudia Canali and Annamaria Scognamiglio
Abstract
Background: Clinical Governance is described as “a framework through which the NHS organisations are accountable to continue to improve the quality of the service and safeguarding high standards of care by creating an environment in which excellence in clinical care would flourish”; it is aimed to ensure continuous improvement in the overall standard of clinical care, ensuring that clinical decisions are based on the most up-to-date evidence in terms of effectiveness.
Methods: If Clinical Governance is a framework through which NHS organisations are accountable to continuously improve the quality of their services and safeguarding high standards of care, Clinical Effectiveness is a vital part of Clinical Governance. Clinical Effectiveness is a term that refers to measuring and monitoring the quality of care, and comprises various activities, including: Evidence-Based Practice, Research and Development, Clinical Audit, Clinical Guidelines, Integrated Care Pathways, and Total Quality Management.
Results: The application of evidence-based medicine (EBM) in laboratory medicine or evidence-based laboratory medicine (EBLM) aims to advance clinical diagnosis by researching and spreading new knowledge, combining methods from clinical epidemiology, statistics and social science with the traditional pathophysiological molecular approach. EBLM, by evaluating the role of diagnostic investigations in the clinical decision-making process, can help in translating the results of good quality research into everyday practice.
Conclusions: If Clinical Governance is a framework through which organisations are accountable to improve the quality of care, health professionals should identify high quality standards, and systematically and rigorously monitor against them the process and outcomes that represent the diagnostic process. Within such a policy framework, practice guidelines are expected to play a major role, providing the basis to access the quality of care and guidance where clinical practice is found not in line with professional standards.
References
1. Department of Health. The new NHS: modern, dependable. London: Stationery Office, 1997.Search in Google Scholar
2. World Health Organization. The principles of quality assurance (report on a WHO meeting) WHO, 1983.Search in Google Scholar
3. Department of Health. A first class service: quality in the new NHS. London: Stationery Office, 1998.Search in Google Scholar
4. Donaldson EJ, Gray JA. Clinical Governance – a quality duty for health organizations. Qual Health Care 1998; 7(Suppl):S37–44.Search in Google Scholar
5. Grilli R, Donatini A, Taroni F. Healthcare reform and disease management in Italy. Promoting the effectiveness and appropriateness of health service use. Dis Manage Health Outcomes 2001; 9:441–9.10.2165/00115677-200109080-00004Search in Google Scholar
6. Swage T. Clinical governance in health care practice, 1st ed. Oxford: Butterworth Heinemann, 2000.Search in Google Scholar
7. Freedman BD. Clinical Governance: the experience in the UK. In: Plebani M, Trenti T, editors. Praticare il Governo Clinico: qualità, efficacia e professionalità in medicina. Torino: Centro Scientifico Editore, 2002:255–72.Search in Google Scholar
8. Guyatt G, Cook D, Haynes B. Evidence based medicine has come a long way. Br Med J 2004; 329:990–1.10.1136/bmj.329.7473.990Search in Google Scholar PubMed PubMed Central
9. Sackett DL, Straus SE, Richardson WS, Rosemberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. Edinburgh, Scotland: Churchill Livingstone, 2000.Search in Google Scholar
10. Haynes RB. Where's the meat in clinical journals? ACP J Club 1993; 119:A23–4.10.7326/ACPJC-1993-119-1-023Search in Google Scholar
11. Munro J, Booth A, Nicholl J. Routine preoperative testing; a systematic review of evidence. Health Technol Assess 1997; 1(12):i–iv,1–62.10.3310/hta1120Search in Google Scholar
12. Gabby J, Walley T. Introducing new health intervention. Br Med J 2006; 332:64–5.10.1136/bmj.332.7533.64Search in Google Scholar PubMed PubMed Central
13. Gluud C, Gluud LL. Evidence based diagnostics. Br Med J 2005; 330:724–6.10.1136/bmj.330.7493.724Search in Google Scholar PubMed PubMed Central
14. Barth JH, Seth J, Howlett TA, Freedman DB. A survey of endocrine function testing by clinical biochemistry laboratories in the UK. Ann Clin Biochem 1995; 32:442–9.10.1177/000456329503200502Search in Google Scholar PubMed
15. van Warlraven C, Naylor CD. Do we know what inappropriate laboratory utilization is? A systematic review of laboratory clinical audits. J Am Med Assoc 1998; 280:550–8.10.1001/jama.280.6.550Search in Google Scholar PubMed
16. Bareford D, Hayling A. Inappropriate use of laboratory service: long-term combined approach to modify request patterns. Br Med J 1990; 301:1305–7.10.1136/bmj.301.6764.1305Search in Google Scholar PubMed PubMed Central
17. Winkens R, Dinant GJ. Evidence base of clinical diagnosis. Rational, cost effective use of investigations in clinical practice. Br Med J 2002; 324:783–5.10.1136/bmj.324.7340.783Search in Google Scholar PubMed PubMed Central
18. Lundberg GD. How clinicians should use the diagnostic laboratory in changing medical world. Clin Chim Acta 1995; 41:775–80.Search in Google Scholar
19. Lundberg GD. The need for an outcomes research agenda for clinical laboratory testing. J Am Med Assoc 1998; 280:565–6.10.1001/jama.280.6.565Search in Google Scholar PubMed
20. Price CP. Evidence-based laboratory medicine: supporting decision making. Clin Chem 2000; 46:1041–50.10.1093/clinchem/46.8.1041Search in Google Scholar
21. McQueen MJ. Overview of evidence based medicine: challenges for evidence-based laboratory medicine. Clin Chem 2001; 47:1536–46.10.1093/clinchem/47.8.1536Search in Google Scholar
22. Sackett DL, Rosember WM, Gray JA, Hayes RB, Richardson WS. Evidence-based medicine: what it is and what it isn't. Br Med J 1996; 312:71–2.10.1136/bmj.312.7023.71Search in Google Scholar PubMed PubMed Central
23. http://www.ifcc.org/divisions/emd/c-eblm/definitions.asp (accessed January 2006).Search in Google Scholar
24. Berti E, Grilli R. Practice guidelines and clinical governance: do the means match with the ends? A quality appraisal of local practice guidelines. Clin Governance 2003; 8:312–7.10.1108/14777270310499405Search in Google Scholar
25. Hurwitz B. Legal and political considerations of clinical practice guidelines. Br Med J 1999; 318:661–4.10.1136/bmj.318.7184.661Search in Google Scholar PubMed PubMed Central
26. Watine J. Are laboratory investigations recommended in current medical practice guidelines supported by available evidence? Clin Chem Lab Med 2002; 40:252–5.10.1515/CCLM.2002.041Search in Google Scholar PubMed
27. Bruns DE, Oosterhuis WP. From evidence to guidelines. In: Price CP, Christenson RH, editors. Evidence-based laboratory medicine. Washington, DC: AACC Press, 2003:187–208.Search in Google Scholar
28. Grimshaw J, Russell I. Achieving health gain through clinical guidelines. I. Developing scientifically valid guidelines. Qual Health Care 1993; 2:243–8.10.1136/qshc.2.4.243Search in Google Scholar PubMed PubMed Central
29. Williams JG. Guidelines for clinical guidelines should distinguish between national and local production. Br Med J 1999; 318:942.10.1136/bmj.318.7188.942aSearch in Google Scholar PubMed PubMed Central
30. Read MC, Lachs MS, Feinstein AR. Use of methodological standards in diagnostic test research: getting better but still not good. J Am Med Assoc 1995; 274:645–51.10.1001/jama.1995.03530080061042Search in Google Scholar
31. Whiting P, Rujes AW, Reitsma JB, Bossuyt PM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003;3:25 (http://www.biomedcentral.com/1471-2288/3/25, accessed January 2006).10.1186/1471-2288-3-25Search in Google Scholar PubMed PubMed Central
32. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwing LM, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Chem 2003; 49:1–6.10.1373/49.1.1Search in Google Scholar PubMed
33. van Wijk MA, van der Lei J, Mosseveld M, Bohnen AM, van Bemmel JH. Compliance of general practitioners with a guideline-based decision support system for ordering blood tests. Clin Chem 2002; 48:55–60.10.1093/clinchem/48.1.55Search in Google Scholar
34. West S, King V, Carey TS, Lohr KN, McKoy N, Sutton SE, et al. System to rate the strength of scientific evidence. Evidence Report/Technology Assessment Number 47. AHRQ Publication No. 02E016. Rockville, MD: Agency for Healthcare Research and Quality, 2002 (http://ahrq.gov, accessed January 2006).Search in Google Scholar
35. AGREE Collaborative Group. Guideline development in Europe: an international comparison. Int J Technol Assess Health Care2000;16:1039–49.10.1017/S0266462300103101Search in Google Scholar
36. Oosterhuis WP, Bruns DE, Watine J, Sandberg S, Horvath AR. Evidence-based guidelines in laboratory medicine: principles and methods. Clin Chem 2004; 50:806–18.10.1373/clinchem.2003.025528Search in Google Scholar PubMed
37. www.pnlg.it (accessed January 2006).Search in Google Scholar
38. Jefferson T. Criteria for the assessment of evidence on the accuracy of diagnostic and prognostic test [abstract]. Clin Chem Lab Med 2005; 43:A132.Search in Google Scholar
39. Granata AV, Hillman AL. Competing practice guidelines: using cost-effectiveness analysis to make optimal decision. Ann Intern Med 1998; 128:56–53.10.7326/0003-4819-128-1-199801010-00009Search in Google Scholar PubMed
40. McQueen MJ. Evidence based medicine: its application to laboratory medicine. Ther Drug Monit 2000; 22:1–9.10.1097/00007691-200002000-00001Search in Google Scholar PubMed
41. Davies DA, Thomson MA, Oxman AD, Haynes RB. Evidence for the effectiveness of CME. A review of 50 randomized controlled trials. J Am Med Assoc 1992; 268:1111–7.10.1001/jama.1992.03490090053014Search in Google Scholar
42. Burgers JS. Guideline quality and guideline content: are they related? Clin Chem 2006; 52:3–4.10.1373/clinchem.2005.059345Search in Google Scholar PubMed
43. Watine J, Freidberg B, Nagy E, Onody R, Oosterhuis W, Bunting PS, et al. Conflict between guidelines methodologic quality and recommendation validity: a potential problem for practitioners. Clin Chem 2006; 52:65–72.10.1373/clinchem.2005.056952Search in Google Scholar PubMed
44. Barth JH. The role of clinical audit. In: Price CP, Christenson RH, editors. Evidence-based laboratory medicine. Washington, DC: AACC Press, 2003:209–24.Search in Google Scholar
45. Trenti T. Evidence based laboratory medicine as a tool for continuous professional improvement. Clin Chim Acta 2003; 333:155–67.10.1016/S0009-8981(03)00180-3Search in Google Scholar
46. Plebani M. Appropriateness in program for continuous quality improvement in clinical laboratories. Clin Chim Acta 2003; 333:131–9.10.1016/S0009-8981(03)00177-3Search in Google Scholar
47. Bero LA, Grilli R, Grimshow JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. Br Med J 1998; 317:465–8.10.1136/bmj.317.7156.465Search in Google Scholar PubMed PubMed Central
©2006 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Foreword
- Evidence-based policy-making
- Clinical Governance – from rhetoric to reality?
- Realising the developmental potential of Clinical Governance
- Re-energising Clinical Governance through Integrated Governance
- Clinical Governance: from clinical risk management to continuous quality improvement
- Involvement of patients in Clinical Governance
- Teaching and Continuing Professional Development: an Italian experience
- New National Healthcare Information System
- Clinical Governance and Laboratory Medicine: is the Electronic Medical Record our best friend or sworn enemy?
- Technology to improve quality and accountability
- Clinical Governance and evidence-based laboratory medicine
- ISO 15189:2003 – Quality management, evaluation and continual improvement
- External Quality Assessment: an effective tool for Clinical Governance in Laboratory Medicine
- Errors in clinical laboratories or errors in laboratory medicine?
- Laboratory request appropriateness in emergency: impact on hospital organization
- Point-of-care-testing and Clinical Governance
- Integration between the Tele-Cardiology Unit and the central laboratory: methodological and clinical evaluation of point-of-care testing cardiac marker in the ambulance
Articles in the same Issue
- Foreword
- Evidence-based policy-making
- Clinical Governance – from rhetoric to reality?
- Realising the developmental potential of Clinical Governance
- Re-energising Clinical Governance through Integrated Governance
- Clinical Governance: from clinical risk management to continuous quality improvement
- Involvement of patients in Clinical Governance
- Teaching and Continuing Professional Development: an Italian experience
- New National Healthcare Information System
- Clinical Governance and Laboratory Medicine: is the Electronic Medical Record our best friend or sworn enemy?
- Technology to improve quality and accountability
- Clinical Governance and evidence-based laboratory medicine
- ISO 15189:2003 – Quality management, evaluation and continual improvement
- External Quality Assessment: an effective tool for Clinical Governance in Laboratory Medicine
- Errors in clinical laboratories or errors in laboratory medicine?
- Laboratory request appropriateness in emergency: impact on hospital organization
- Point-of-care-testing and Clinical Governance
- Integration between the Tele-Cardiology Unit and the central laboratory: methodological and clinical evaluation of point-of-care testing cardiac marker in the ambulance