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Presentation at Course Program held at King Fahad Medical City, Riyadh via Online Course at 10:00 AM - 12:00pm on 30 August 2020. by Professor Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics King Fahad Medical City, Chairman of the Institutional Review Board, King Fahad Medical City.
KEYWORDS:
• EBM = evidence based medicine.
• RCT = randomized clinical trial.
• Meta-analysis.
• Practice-based evidence.
• PBRN = Practice-based research network.
• Data mining.
• Knowledge discovery in data.
DEFINITION OF EBM:
• Use of the latest evidence in clinical decision-making.
• In 1996 David Sackett wrote that “evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.”
• Synonyms: Evidence-Informed Healthcare or Evidence-Based Health Care or Evidence-Based Practice.
• Bridge between research and practice.
FIVE STEPS OF EBM:
• Formulate the problem as an answerable question.
• Systematic retrieval of research articles.
• Critical appraisal of the evidence for internal and external validity.
• Application of results in practice after analysis and getting summary / combined measures by meta-analysis.
• Evaluation of performance.
APPLICATION OF EBM TO PATIENT CARE[1]
• Assess the patient.
• Ask a clearly focused clinical question.
• Acquire the best evidence available from the medical literature.
• Appraise the evidence.
• Apply the evidence to patient care.
LEVELS OF EBM EVIDENCE ACCORDING TO THE U.S. PREVENTIVE SERVICES TASK FORCE:
• Level I: Evidence obtained from at least one properly designed randomized controlled trial.
• Level II-1: Evidence obtained from well-designed controlled trials without randomization.
• Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
• Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
• Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
PROBLEMS WITH EBM[2]
• EBM is a new word but the concept is not new; medicine has always been evidence-based.
• The hierarchy of evidence is questionable: RCT is not always the gold standard.[2],[3]
• Complicated: GPs do not have the time, skills, or resources to use EBM.[4]
PROBLEMS WITH EBM, con’t.
• Complicated statistics of meta-analysis that the researcher cannot internalize[5],[2],[3] but the decision cannot be based on a single study we must combine evidence from various studies.
• Appraising the quality of the evidence is a difficult skill.[6]
• Basic science data is ignored.[2]
PROBLEMS OF EBM BASED ON RCTS:
• RCTs evidence, not representative: artificial population with severe inclusion/exclusion criteria, unrepresented populations, publication bias.
• RCTs may be biased in what diseases and treatments are studied because of sponsor interests.
• Lag time between the research and its publication.
• RCT evidence applies to groups; the individual patient may be different.
• Methodological and ethical violations in published RCTs.[3]
FROM EVIDENCE-BASED MEDICINE (EBM) TO PRACTICE-BASED EVIDENCE (PBE):
• Both EBM and PBE are evidence-based; the difference is the type of evidence involved.
• Problems of EBM have led to the consideration of PBE as an alternative.[7],[8]
• PBE involves collecting and analyzing real-time clinical data to reach various conclusions on diagnosis, screening, treatment, prognosis, etc.
FROM EVIDENCE-BASED MEDICINE (EBM) TO PRACTICE-BASED EVIDENCE (PBE), con’t.
• Mining clinical data.[9]
• PBE is a laboratory for studying actual practices in a natural environment.
• PBE is more realistic and more immediately usable.
EXAMPLES OF PBE:
• Psychotherapy data over 45 years.[10]
• Use of inpatient data to assess children's reactions to psychotherapy.[11]
• Associate patient and treatment characteristics with outcomes.[12]
EXAMPLES OF PBE, con’t.
• Nutrition evaluation.[13]
• Athletic related injuries in schools.[14]
• Periodontal care.[15]
PRACTICE-BASED RESEARCH NETWORKS (BPRN):
• PBE is a form of large data analysis.
• Collaboration between practices in collecting and analyzing health care data.
• Networks are very useful in primary health care research.[16]
PRACTICE BASED RESEARCH NETWORKS (BPRN), con’t.
• Examples of networks: radiation oncology registry[17], multi-morbidity.[18]
• Communication is the key to network success.[19]
• Models of electronic support for the networks.[20]
PBE AT KFMC:
• Saudi Arabia presents unique opportunities for research because of its genetic pool: paradoxically both open and closed.
• Some conditions like DM have unique presentations and natural history.
• We have a large database that represents the whole of KSA because we are a MOH referral hospital.
• We can make original contributions to medicine by publishing evidence from our practice.
• Problems: data quality and statistical software (Innovation Center).
REFERENCE:
1. South Med J. 2012 Mar; 105(3):136-43.
2. Can J Neurol Sci. 2013 Jul; 40(4):475-81.
3. Can J Neurol Sci. 2013 Jul; 40(4):465-74.
4. Br J Gen Pract. 2012 Jul; 62(600):e511-21
5. Curr Opin Psychiatry. 2010 Mar; 23(2):145-50.
6. South Med J. 2012 Mar; 105(3):114-9.
7. Int J Clin Pract. 2011 Jun; 65(6):639-44.
8. Arch Phys Med Rehabil. 2012 Aug; 93(8 Suppl):S127-37
9. PLoS One. 2013 May 23; 8(5):e63499.
10. Am J Psychother. 2013; 67(1):23-46.
11. Psychiatr Serv. 2013 Mar 1; 64(3):252-6.
12. Arch Phys Med Rehabil. 2013 Apr; 94(4 Suppl):S67-74.
13. Can J Diet Pract Res. 2012 Spring; 73(1):e233-40.
14. J Athl Train. 2012 Sep-Oct; 47(5):557-66.
15. J Periodontol. 2013 May; 84(5):567-71.
16. J Am Board Fam Med. 2012 Sep-Oct; 25(5):565-71.
17. J Oncol Pract. 2013 May; 9(3):e90-5.
18. BMC Fam Pract. 2013 Aug 7; 14:112.
19. J Am Board Fam Med. 2013 Sep-Oct; 26(5):571-8.
20. Ann Fam Med. 2012 Nov-Dec; 10(6):560-7.