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ได้พิมพ์โดยPhak-phimonphan Rattanapong ได้เปลี่ยน 10 ปีที่แล้ว
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Research Methodology in Biomedical Research
Ethics in Research & Biomedical Research Aug. 30,2012 Siriporn Pitimana-aree, MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital
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…….Biomedical research
…………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 Outline of my talk: Introduction Research Methodology Error & Scientific validity Conclusion
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…….Biomedical research
…………………………………………………………… Introduction Ethics in Research & Biomedical Research Aug. 30,2012 งานวิจัย : การเก็บรวบรวมข้อมูลอย่างเป็นระบบ โดยใช้ ขบวนการทางวิทยาศาสตร์ เพื่อให้ได้คำตอบที่ ถูกต้อง มากที่สุด หรือ มีความคลาดเคลื่อน น้อยที่สุด
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“ค้นพบองค์ความรู้ใหม่”
…….Biomedical research …………………………………………………………… ทำไมต้องทำวิจัย Ethics in Research & Biomedical Research Aug. 30,2012 “ค้นพบองค์ความรู้ใหม่” ผลพลอยได้ : การมีผลงานตีพิมพ์ การเลื่อนตำแหน่งทางวิชาการ การเพิ่มรายได้ ความภูมิใจ
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…….Biomedical research
…………………………………………………………… Biological specimens: Blood, cells, tissues etc. Clinical information & / or Subjects’ confidential data Any types of study involving human subjects Ethics in Research & Biomedical Research Aug. 30,2012
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…….Biomedical research
…………………………………………………………… Research Methodology Frame research question Ethics in Research & Biomedical Research Aug. 30,2012 Literature review Proposal preparation Ethical approval Funding support Conducting a research Data analysis & Publication Data analysis & Publication
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Good Question Good Start Research Question ???? Understandable
(answerable) Feasibility Creativity & Clinically useful Good Question Good Start
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…….Biomedical research
…………………………………………………………… PICO P Population Inclusion/Exclusion criteria I Intervention (drugs/blood samples/surgery..etc) C Comparison Clinical significance Outcomes (SSI, MR, Satisfaction, Pain-VAS, PO complication etc.) O
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…….Biomedical research
…………………………………………………………… Outcomes Appropriate with research question Appropriate measurement tool All possible outcomes measured
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Research design …….Biomedical research Observational study
…………………………………………………………… Research design Observational study Descriptive study Case control study Cohort study
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Research design …….Biomedical research Experimental study
…………………………………………………………… Research design Experimental study Randomized control study (RCT) Non-randomized control study Cross - over study Before - after study
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Sample Size
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…….Biomedical research
…………………………………………………………… How large of the sample? N O T Too large Too small Unnecessary potential risks & burdens budget & resources Unable to prove hypothesis or make conclusion
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D. I. Y. Sample size determination Consult Statistician or
Computer program SAM Epi-info PS-power N -Query
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Statistical analysis Statistical tests
(appropriate for any measurement variables)
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Research result = Truth + Error
…….Biomedical research …………………………………………………………… Error & Scientific validity Ethics in Research & Biomedical Research Aug. 30,2012 Research result = Truth + Error
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Research result = Truth + error …….Biomedical research
…………………………………………………………… Error & Scientific validity Ethics in Research & Biomedical Research Aug. 30,2012 Research result = Truth + error
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…….Biomedical research
…………………………………………………………… Error Random error (การคลาดเคลื่อนแบบสุ่ม ) Systematic error (Bias) (การคลาดเคลื่อนเชิงระบบ)
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Biological variation, Sampling error,
…….Biomedical research …………………………………………………………… Random error No direction Chance Biological variation, Sampling error, Measurement error
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…….Biomedical research
…………………………………………………………… Random error Biological variation eg, : Fasting blood sugar Mean Individual variation
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…….Biomedical research
…………………………………………………………… Random error Sampling error : Polls for election of President 10,000 persons Too small sample size
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…….Biomedical research
…………………………………………………………… Random error Measurement error No ideal or perfect measurement tool The most appropriate measurement tool
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…….Biomedical research
…………………………………………………………… Systematic error (Bias) Selection bias, Measurement bias
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…….Biomedical research
…………………………………………………………… Systematic error (Bias) Selection bias It is an error which causes a systemic difference in outcomes due to an intentional selection of subjects.
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…….Biomedical research
…………………………………………………………… Selection bias Effect of exercise on the incidence of CAD A: Volunteer & let they select to group as want B: Office staffs & PI selects to group as PI wants C: Random sampling & random allocation to group
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…….Biomedical research
…………………………………………………………… Selection bias Conventional & Laparoscopic appendectomy A: PI know what group subject would be allocated, then PI excludes subject from the study B: PI does not know (concealed envelope) what group subject would be allocated, then PI allocates subject as what it’s assigned in the envelope.
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…….Biomedical research
…………………………………………………………… Methods for controlling selection bias Random allocation/ Randomization Concealed allocation
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…….Biomedical research
…………………………………………………………… Measurement bias Evaluator/ Assessor knows which group subjects are. Methods of measurement are not similar among groups Quantitative data /objective data VS Qualitative data / subjective data
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Recall bias Information bias …….Biomedical research Measurement bias
…………………………………………………………… Measurement bias Recall bias ( Case Control study) Information bias ( Retrospective study)
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…….Biomedical research
…………………………………………………………… Methods for controlling Measurement bias Valid methods of measurement Explicit criteria, Operational definition Blinding
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Random error Systematic error Chance Chance Direction Direction
Adjusted by Statistical method Adjusted by Research method Design Statistical analysis Randomization Sample size calculation Blinding
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Good construction framework
…….Biomedical research …………………………………………………………… Bias : cannot be eliminated entirely simply because of human nature, But it should be recognized and controlled as much as possible Good research design and Good construction framework
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Conclusion: …….Biomedical research ……………………………………………………………
Ethics in Research & Biomedical Research Aug. 30,2012 To make our study/ research result valid & usefulness…… We should sacrifice our effort to every steps of research methodology & avoid bias as much as possible
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Ethics in Research & Biomedical Research Aug. 30,2012
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