1. Research is a systematic investigation to increase knowledge. It is needed locally to account for ethnic, cultural, economic factors. 2. Research methodology involves designing and conducting research, while EBM uses existing research evidence along with clinical expertise and patient preferences. 3. The main types of research are quantitative (descriptive, analytical) and qualitative. Descriptive studies observe phenomena while analytical studies assess relationships.

1. Introduction to Research Methodology Sohail Bajammal, MBChB, MSc, FRCS(C), PhD(c) [email_address] Assistant Professor, Faculty of Medicine Vice Dean Academic Development, Faculty of Dentistry Umm Al-Qura University

2. EBM is not new……. “ ثم نرقى في البحث والمقاييس على التدريج والترتيب مع انتقاد المقدمات والتحفظ في النتائج ونجعل غرضنا في جميع ما نستقرئه ونتصفحه استعمال العدل لا اتباع الهوى ونتحرى في سائر ما نميزه وننتقده طلب الحق لا الميل مع الآراء” الحسن بن الهيثم

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

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

6. Why do we need to do research? “locally” Ethnic Psychosocial Cultural Economic Different

7. Research Methodology vs Evidence-Based Medicine

8. Research Methodology EBM Research Doing Using

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

10. 5As of EBM

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

12. Asking a good question (PICO)! P opulation I ntervention C ontrol O utcome

13. 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. 5As of EBM

15. 5S Hierarchy of Evidence RCTs, Cohort, Case control, Case series Expert Opinion: Classical Textbooks

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

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

19. It’s time consuming

20. 5S Hierarchy of Evidence RCTs, Cohort, Case control, Case series Systematic Reviews Critically-Appraised Journal Articles & Abstracts Evidence-Based Guidelines & Textbooks Computerized Decision Support Expert Opinion: Classical Textbooks

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

22. Research Methodology

23. Research Methodology Planning Conducting Publishing

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

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

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

29. Sampling The Universe Study Population Study Sample

30. Bad Sampling The Universe Study Population Study Sample

31. 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. 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. Types of Research Quantitative Qualitative Mixed-Methods

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

35. Descriptive Studies

36. 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. 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. 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. Analytical Studies

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

41. Case-Control Study ODDS RATIO Lung Cancer Yes No Shisha Smoking Yes No

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

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

44. Cohort Study RELATIVE RISK Lung Cancer Yes No Shisha Smoking Yes No

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

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

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

49. 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 Publishing Research

50. 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. 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. GCC EBHC

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

54. 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? [email_address]