งานนำเสนอกำลังจะดาวน์โหลด โปรดรอ

งานนำเสนอกำลังจะดาวน์โหลด โปรดรอ

Siriporn Pitimana-aree, MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital Research Methodology in Biomedical Research Ethics in Research.

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งานนำเสนอเรื่อง: "Siriporn Pitimana-aree, MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital Research Methodology in Biomedical Research Ethics in Research."— ใบสำเนางานนำเสนอ:

1 Siriporn Pitimana-aree, MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital Research Methodology in Biomedical Research Ethics in Research & Biomedical Research Aug. 30,2012

2 …………………………………………………………… …….Biomedical research Ethics in Research & Biomedical Research Aug. 30,2012

3 …………………………………………………………… Introduction …….Biomedical research งานวิจัย : การเก็บรวบรวม ข้อมูลอย่างเป็นระบบ โดย ใช้ ขบวนการทาง วิทยาศาสตร์ เพื่อให้ได้คำตอบที่ ถูกต้อง มากที่สุด หรือ มีความคลาด เคลื่อน น้อยที่สุด Ethics in Research & Biomedical Research Aug. 30,2012

4 …….Biomedical research …………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 ผลพลอยได้ : การมีผลงานตีพิมพ์ การเลื่อนตำแหน่งทางวิชาการ การเพิ่มรายได้ ความภูมิใจ ทำไมต้องทำวิจัย “ ค้นพบองค์ความรู้ใหม่ ”

5 …….Biomedical research …………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 Biological specimens: Blood, cells, tissues etc. Clinical information & / or Subjects’ confidential data Any types of study involving human subjects

6 …….Biomedical research …………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 Research Methodology  Frame research question  Literature review  Proposal preparation Proposal preparation  Funding support  Ethical approval Conducting a research Data analysis & Publication

7 Research Question ???? Creativity & Clinically useful Feasibility Good Question Understandable (answerable) Good Start

8 •Outcomes •(SSI, MR, Satisfaction, Pain-VAS, PO complication etc.) O …….Biomedical research ……………………………………………………………

9  Appropriate with research question  All possible outcomes measured  Appropriate measurement tool …….Biomedical research …………………………………………………………… Outcomes

10 …….Biomedical research …………………………………………………………… Observational study • Descriptive study • Case control study • Cohort study Research design

11 …….Biomedical research …………………………………………………………… Experimental study • Randomized control study (RCT) • Non-randomized control study • Cross - over study • Before - after study Research design

12 Sample Size

13 …….Biomedical research …………………………………………………………… How large of the sample? NOTNOT Too large Too small Unnecessary  potential risks & burdens  budget & resources Unable to  prove hypothesis or make conclusion

14 Sample size determination D. I. Y. Consult Statistician Computer program SAM Epi-info PS-power N -Query or

15 Statistical analysis Statistical tests (appropriate for any measurement variables)

16 …….Biomedical research …………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 Error & Scientific validity Research result = Truth + Error

17 …….Biomedical research …………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 Error & Scientific validity Research result = Truth + error

18 …….Biomedical research …………………………………………………………… Error Random error ( การคลาดเคลื่อนแบบสุ่ม ) Systematic error (Bias) ( การคลาดเคลื่อนเชิงระบบ )

19 …….Biomedical research …………………………………………………………… Random error No direction Chance Biological variation, Sampling error, Measurement error

20 …….Biomedical research …………………………………………………………… Random error •Biological variation eg, : Fasting blood sugar Mean Individual variation

21 …….Biomedical research …………………………………………………………… Random error Sampling error : Polls for election of President 10,000 persons Too small sample size

22 …….Biomedical research …………………………………………………………… Random error Measurement error The most appropriate measurement tool • No ideal or perfect measurement tool

23 …….Biomedical research …………………………………………………………… Systematic error (Bias) Selection bias, Measurement bias

24 …….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.

25 …….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

26 …….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.

27 …….Biomedical research …………………………………………………………… Methods for controlling selection bias Random allocation/ Randomization Concealed allocation

28 …….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

29 …….Biomedical research …………………………………………………………… Measurement bias Recall bias ( Case Control study) Information bias ( Retrospective study)

30 …….Biomedical research …………………………………………………………… Valid methods of measurement Blinding Explicit criteria, Operational definition Methods for controlling Measurement bias

31 Systematic error Adjusted by Statistical method Adjusted by Research method Statistical analysis Sample size calculation Design Randomization Blinding Chance Direction Random error

32 …….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

33 …….Biomedical research …………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 Conclusion: 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

34 Ethics in Research & Biomedical Research Aug. 30,2012

35 “ True success is not in the learning, But in it’s application to the benefit of the mankind ” “ ความสำเร็จที่ แท้จริง มิได้อยู่ที่การ เรียนรู้ แต่อยู่ที่การ นำมาใช้ เป็นประโยชน์ แก่มนุษยชาติ ” Thank you


ดาวน์โหลด ppt Siriporn Pitimana-aree, MD Dept. of Anesthesiology, Faculty of Medicine Siriraj Hospital Research Methodology in Biomedical Research Ethics in Research.

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