A basic introductory presentation to medical research methodology.

1. Research Methodology Sohail Bajammal, MBChB, MSc, FRCS(C), PhD(c) ssbajammal@uqu.edu.sa Assistant Professor, Umm Al Qura University Consultant Orthopaedic Surgeon, Al-Noor Specialist Hospital

2. What got me into EBM…. What is a double blind study? Two orthopaedic surgeons reading an ECG

3. EBM is not new……. “ثمنرقىفيالبحثوالمقاييسعلىالتدريجوالترتيبمعانتقادالمقدماتوالتحفظفيالنتائجونجعلغرضنافيجميعمانستقرئهونتصفحهاستعمالالعدللااتباعالهوىونتحرىفيسائرمانميزهوننتقدهطلبالحقلاالميلمعالآراء” 3 الحسنبنالهيثم

4. Objectives What is research? Why do we need to do research? What is the difference between research methodology and EBM? What are the types of research? How to do research? 4

5. What is research? Systematic investigation towards increasing the sum of knowledge (Chambers 20th Century Dictionary) 5

6. Perspectives of Research Basic Science Social Health Problem “Trauma” Economic Legal Clinical Diagnosis Therapy Prognosis 6

8. Psychosocial

9. Cultural

10. Economic7 Different

11. Research MethodologyvsEvidence-Based Medicine 8

12. Doing Research Methodology Research EBM Using 9

13. EBM Research Evidence Patients’ Preferences Clinical Expertise Clinical Circumstances 10 Haynes et al. BMJ 2002;324:1350

14. 5As of EBM 11

15. Is this a good question? What is the best treatment of back pain? 12

16. Asking a good question (PICO)! Population Intervention Control Outcome 13

17. Is this a good question? In adult patients younger than 50 years old with acute low back pain (< 6 weeks), does bedrest reduce the risk of recurrence of pain within one year compared with physiotherapy? P: Adult patients <50yr with acute LBP I: Bedrest C: Physiotherapy O: Recurrence of pain within one year 14

18. 5As of EBM 15

19. 5S Hierarchy of Evidence RCTs, Cohort, Case control, Case series Expert Opinion: Classical Textbooks 16

20. Primary Sources Original articles Using: PubMed, OVID You have to retrieve and appraise the articles Levels (strength) of evidence 17

21. Levels of Evidence 18 http://library.downstate.edu/EBM2/2100.htm

22. 19

23. It’s time consuming 20

24. 5S Hierarchy of Evidence Computerized Decision Support Evidence-Based Guidelines & Textbooks Critically-Appraised Journal Articles & Abstracts Systematic Reviews RCTs, Cohort, Case control, Case series Expert Opinion: Classical Textbooks 21

25. To practice EBM, we need all four Research Evidence Patients’ Preferences Clinical Expertise Clinical Circumstances 22

26. Research Methodology 23

27. Research Methodology Planning Conducting Publishing 24

28. Research Question Truth in the Universe Study Plan Truth in the Study Actual Study Findings in the Study Design Implement Target Population Phenomena of interest Intended Sample Intended variables Actual subjects Actual measurements Errors Errors Infer Infer From Hulley et al. Designing Clinical Research. LWW 25

29. Errors in Research Methodology Random Errors: mistakes by chance Systematic Errors: bias 26

30. Assemble a research team Ask a good research question Do a literature search Choose the proper study design Determine the sampling design Get ethical approval Research Planning 27

31. Research Team Research is not a one man/woman show You need a team at every step Ask a research methodologist & a biostatistician EARLY 28

32. Good Research Question (FINER) Feasible Interesting Novel Ethical Relevant PICO 29

33. Sampling The Universe Study Population Study Sample 30

34. Bad Sampling The Universe Study Population Study Sample 31

35. Sample Size You need to have enough research participants (patients) to show a difference Depends on: The incidence of the outcomes you are assessing in each group The prevalence of the disease 32

36. Sample Size Compare applying pressure with no pressure to control active bleeding? Compare antibiotics with no antibiotics for bad open fractures to reduce the risk of infection? Compare antibiotics with no antibiotics for pneumonia to reduce septic shock? Compare LMWH with Unfractionated heparin to reduce the risk of DVT after TKA? 33

37. Types of Research Quantitative Qualitative Mixed-Methods 34

38. Quantitative Research Descriptive: Case report Case series Cross-sectional Analytical: Observational: cohort studies, case-control Experimental: randomized trials 35

39. Descriptive Studies 36

40. Case Report A descriptive study of one patient Detailed profile of a “rare” presentation or treatment Helpful in developing hypothesis to be tested later using analytic study 37

41. Case Series A descriptive study of multiple patients “Rare” phenomenon occurring multiple times Detailed profile of patients’ presentation and outcome Helpful in developing hypothesis 38

42. Cross-Sectional Studies Descriptive “Survey” One to one questionnaire, mail, telephone, online Attention to details: Sampling Construction of the questions Construction of the responses 39

43. Analytical Studies 40

44. Case-Control Studies Cases (e.g., Lung Cancer) Shisha Smokers GO BACK IN TIME NOT Shisha Smokers Ask patients Read files Control (e.g., NO Lung Cancer) Shisha Smokers GO BACK IN TIME NOT Shisha Smokers 41

45. Case-Control Study 42 ODDS RATIO

46. Problems with Case-Control Studies Looking back in time (retrospective) Recall bias Measurement bias You may miss important risk factors 43

47. Prospective Cohort Shisha Smokers Lung Cancer F/U No Lung Cancer NOT Shisha Smokers Lung Cancer F/U No Lung Cancer 44

48. Cohort Study 45 RELATIVE RISK

49. Cohort Study Prospective or Retrospective Drawbacks: Large number of patients Follow them up for long time 46

50. Randomized Controlled Trial (RCT) Drug A F/U Outcomes Patients with MI RANDOM Drug B F/U Outcomes 47

51. Why RCT is the highest level of evidence? Randomization: balance known and unknown prognostic factors Blinding: Patients Researchers Outcome assessors Aim for complete follow-up 48

52. Conducting Research Ask for help  Research assistants Monitor the conduct of the study No deviation Patients safety Complete data 49

53. Publishing Research During the planning phase: who will do what? Oral & written Pick your audience (pick a Journal) Write your paper with the Journal you picked in mind Don’t give up, you will get rejected 50

54. Take Home Messages Research is not a one man/woman show You need a team to do good research Research is a science You need to learn how to do it Research is like riding a bicycle You need to practice 51

55. Take Home Messages Research needs planning If you fail to plan, you plan to fail Not all of us need to do research But all of us should practice EBM Never ever give up You will get rejected 52

56. GCC EBHC

57. http://eapps.ngha.med.sa/ebm/

58. Objectives What is research? Why do we need to do research? What is the difference between research and EBM? What are the types of research? How to do research? 55 ssbajammal@uqu.edu.sa