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

…….Biomedical research …………………………………………………………… Ethics in Research & Biomedical Research Aug. 30,2012 Outline of my talk: Introduction Research Methodology Error & Scientific validity Conclusion

…….Biomedical research …………………………………………………………… Introduction Ethics in Research & Biomedical Research Aug. 30,2012 งานวิจัย : การเก็บรวบรวมข้อมูลอย่างเป็นระบบ โดยใช้ ขบวนการทางวิทยาศาสตร์ เพื่อให้ได้คำตอบที่ ถูกต้อง มากที่สุด หรือ มีความคลาดเคลื่อน น้อยที่สุด

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

…….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

…….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

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

…….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

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

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

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

Sample Size

…….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

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

Statistical analysis Statistical tests (appropriate for any measurement variables)

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

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

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

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

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

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

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

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

…….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.

…….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

…….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.

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

…….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

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

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

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

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

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

Ethics in Research & Biomedical Research Aug. 30,2012

มิได้อยู่ที่การเรียนรู้ แต่อยู่ที่การนำมาใช้ “ True success is not in the learning, But in it’s application to the benefit of the mankind ” “ ความสำเร็จที่แท้จริง มิได้อยู่ที่การเรียนรู้ แต่อยู่ที่การนำมาใช้ เป็นประโยชน์แก่มนุษยชาติ ” Thank you