4Research Methodology Research Materials& Methods Research Objectives Question(s)Research ObjectivesMaterials& Methods
5Question & Objective What is the incidence of perioperative stroke? What are the risk / protective factors ?What are the short and long term outcomes?Does preoperative statin decrease incidence of stroke?ResearchQuestionsResearchObjectives
6Research Question / Title P: PopulationI: InterventionC:ComparisonClinical sig.O: Outcomes
9# 12 : Medical research involving human subjects must conform to generally accepted“ scientific principles”be based on a thorough knowledge ofthe scientific literature,relevant sources of information ,adequate laboratory andwhere appropriate,animal experimentation
10Scientific Principles Research Methodology& Ethical considerationScientific PrinciplesRationaleLiterature reviewBackgroundResearch TitleResearch objectives
11& Ethical consideration Research Methodology& Ethical considerationQ1: What is the same consideration betweenresearch ethics and methodology?Both are concern of research budget.Both are concern of burden of the subjects.Both are based on scientific principles.Both are based on subject coercion & inducement.
12# 9: Medical research is subject to ethical standards that promoterespect for all human beingsprotect their health & rightsSpecial attention is also required for those whocannot give or refuse consent for themselves“ vulnerable subjects”
13# 18 : Every medical research study involving human subjects must be preceded bycareful assessment ofpredictable risks / burden…. in comparison withforeseeable benefits ….RiskBenefit
14the inherent risks & burdens to the subject….. # 21: Medical research involving human subjectsshould only be conducted if the importanceor the potential of benefit of the objective“ outweighs”the inherent risks & burdensto the subject…..RiskBenefit
15# 6: In medical research on human subjects, considerations related to“ the well-being”of the human individual subject shouldtake precedence over all other interests.
16# 32: The benefits, risks, burdens & effectiveness of a new method should be tested againstthose of the best current methods.“ This does not exclude the use of placebo,or no treatment, in studies where noproven method exists.”
17& Ethical consideration Research Methodology& Ethical considerationResearch subjectsWell beingRisks &BurdensHealth & RightBenefitsInclusion (potential benefit)Exclusion (possible risk)Withdrawal (Right, Well being)
18& Ethical consideration Research Methodology& Ethical considerationRisks & BenefitsSubjectsInterventionOutcomesDesign
19Observational study (No intervention) Descriptive study Research designObservational study(No intervention)Descriptive studyCase control studyCohort study
20Experimental study (Intervention) Randomized control study (RCT) Research designExperimental study(Intervention)Randomized control study (RCT)Non-randomized control studyCross - over studyBefore - after study
21Comparison effectiveness of a new method Research designComparison effectiveness of a new methodagainst those of the best current methods.Q:2 What is the best research design?A. Randomized control study (RCT)B. Non-randomized control studyC. Historical controlD. Observational study
22Smoking is a protective factor of PONV ??? Research designSmokers have low risk of PONV than nonsmokersSmoking is a protective factor of PONV ???Then, you choose RCT in your studyA: NoB: Yes
23& Ethical consideration Research Methodology& Ethical considerationQ 3: What make the RCT design insmoking study unethical?This design is inappropriate andwill result with invalid result.Risk and well being of the subjects arethe major factors.C. The RCT will result with too large sample size.D. It is not based on scientific principle.
24A: Observational study B: Experimental study What is research design? Smokers have low risk of PONV than nonsmokersA: Observational studyB: Experimental studyWhat is research design?
25The Tuskegee Syphilis Experiment (1932-1972) The Tuskegee Experiment : An Apology at Last“ The United States government didsomething that was wrong…….. deeply, profoundly, morally wrong.It was an outrage to our commitment tointegrity and equality for all our citizensclearly racist.”President Clinton's apology for the Tuskegee Syphilis Experimentto the eight remaining survivors, May 16,1997.africanpress.wordpress.com
27Sample size determination D. I. Y.Consult StatisticianorComputer programSAMEpi-infoPS-powerN -Query
28N O T How large of the sample? Too small Too large Sample size Unnecessarypotential risks& burdensbudget &resourcesUnable toprove hypothesisor make conclusion
29& Ethical consideration Research Methodology& Ethical considerationQ 4: Why too large/small samples is inappropriatein terms of research methodology and ethics?Possibly let the subjects expose to unnecessary risks/burdens.Inappropriate utilization of resources.Probably / always end up withinvalid / inconclusive result.D. All of the above.
30Sample size determination: Not just formula Not just number Rationale for that formula, numberAppropriateness with research designAppropriateness with outcomes
31Statistical analysis Statistical tests should be appropriated with measurement variablesdesign
32Random error Systematic error Chance Chance Direction Direction Adjusted byStatistical methodAdjusted byResearch methodDesignStatistical analysisRandomizationSample sizecalculationBlinding
34In Summary What make medical research ethical? Research methodology & Ethical considerationsIn SummaryWhat make medical research ethical?
357 considerations: What make clinical research ethical? 1. Social & Scientific value(prophylaxis, diagnostic, therapeutic)2. Scientific sounds / principles (Methodology valid)3. Expected research risks < Potential benefits4. Approved by IRBs or ECsEmmanuel EJ, Wender D, Grady C. What make Clinical Research Ethical?JAMA 2000;283:
36What make clinical research ethical? 7 considerations (cont.):5. Respect all research subject participants & Protecttheir health and rights (clear inclusion/exclusion criteria)6. Informed consent (Comprehensive, Understandable, Voluntary)7. The refusal of a patient to participate in a studymust never interfere with the patient-physician relationship.RiskBenefitEmmanuel EJ, Wender D, Grady C. JAMA 2000;283:
40“ ความสำเร็จที่แท้จริง มิได้อยู่ที่การเรียนรู้ “ True success is notin the learning,but in it’s application tothe benefit of the mankind ”“ ความสำเร็จที่แท้จริงมิได้อยู่ที่การเรียนรู้แต่อยู่ที่การนำมาใช้ เป็นประโยชน์แก่มนุษยชาติ ”