Introduction to Research Methodology

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An introductory presentation on the principles of research methodology

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  • Problems with textbooks: Usually single authored chapters Likely biased, author’s opinion Not peer-reviewed Outdated (at least 4 years)
  • Problems with textbooks: Usually single authored chapters Likely biased, author’s opinion Not peer-reviewed Outdated (at least 4 years)
  • Research team:
  • Feasible: adequate participants & expertise affordable time & money Interesting: to you Novel: Extends, confirms or refutes previous findings Provides new findings Ethical Relevant: To scientific knowledge To clinical and health policy To future research directions
  • An observational study Compare two groups: CASES: a group with the outcome of interest (e.g., non-healed fractures) CONTROLS: a similar group without the outcome of interest (e.g., healed fractures) Determine how many patients within each group have the risk factor (e.g., smoking Shisha)
  • An observational study You follow a group of people with certain risk factors and another group without these risk factors You follow them for a period of time and look for the outcome of interest
  • Introduction to Research Methodology

    1. 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. 2. EBM is not new……. <ul><li>“ 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” </li></ul>الحسن بن الهيثم
    3. 3. Objectives <ul><li>What is research? </li></ul><ul><li>Why do we need to do research? </li></ul><ul><li>What is the difference between research methodology and EBM? </li></ul><ul><li>What are the types of research? </li></ul><ul><li>How to do research? </li></ul>
    4. 4. What is research? <ul><li>Systematic investigation towards increasing the sum of knowledge </li></ul><ul><li>(Chambers 20th Century Dictionary) </li></ul>
    5. 5. Perspectives of Research Economic Legal Therapy Basic Science Social Diagnosis Prognosis Clinical Health Problem “ Trauma”
    6. 6. Why do we need to do research? “locally” <ul><ul><li>Ethnic </li></ul></ul><ul><ul><li>Psychosocial </li></ul></ul><ul><ul><li>Cultural </li></ul></ul><ul><ul><li>Economic </li></ul></ul>Different
    7. 7. Research Methodology vs Evidence-Based Medicine
    8. 8. Research Methodology EBM Research Doing Using
    9. 9. EBM Haynes et al. BMJ 2002;324:1350 Clinical Circumstances Research Evidence Patients’ Preferences Clinical Expertise
    10. 10. 5As of EBM
    11. 11. Is this a good question? <ul><li>What is the best treatment of back pain? </li></ul>
    12. 12. Asking a good question (PICO)! <ul><li>P opulation </li></ul><ul><li>I ntervention </li></ul><ul><li>C ontrol </li></ul><ul><li>O utcome </li></ul>
    13. 13. Is this a good question? <ul><li>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? </li></ul><ul><li>P: Adult patients <50yr with acute LBP </li></ul><ul><li>I: Bedrest </li></ul><ul><li>C: Physiotherapy </li></ul><ul><li>O: Recurrence of pain within one year </li></ul>
    14. 14. 5As of EBM
    15. 15. 5S Hierarchy of Evidence RCTs, Cohort, Case control, Case series Expert Opinion: Classical Textbooks
    16. 16. Primary Sources <ul><li>Original articles </li></ul><ul><li>Using: PubMed, OVID </li></ul><ul><li>You have to retrieve and appraise the articles </li></ul><ul><li>Levels (strength) of evidence </li></ul>
    17. 17. Levels of Evidence http://library.downstate.edu/EBM2/2100.htm 
    18. 18.
    19. 19. It’s time consuming
    20. 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. 21. To practice EBM, we need all four Clinical Circumstances Research Evidence Patients’ Preferences Clinical Expertise
    22. 22. Research Methodology
    23. 23. Research Methodology Planning Conducting Publishing
    24. 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. 25. <ul><li>Random Errors: mistakes by chance </li></ul><ul><li>Systematic Errors: bias </li></ul>Errors in Research Methodology
    26. 26. <ul><li>Assemble a research team </li></ul><ul><li>Ask a good research question </li></ul><ul><li>Do a literature search </li></ul><ul><li>Choose the proper study design </li></ul><ul><li>Determine the sampling design </li></ul><ul><li>Get ethical approval </li></ul>Research Planning
    27. 27. Research Team <ul><li>Research is not a one man/woman show </li></ul><ul><li>You need a team at every step </li></ul><ul><li>Ask a research methodologist & a biostatistician EARLY </li></ul>
    28. 28. Good Research Question (FINER) <ul><li>Feasible </li></ul><ul><li>Interesting </li></ul><ul><li>Novel </li></ul><ul><li>Ethical </li></ul><ul><li>Relevant </li></ul>PICO
    29. 29. Sampling The Universe Study Population Study Sample
    30. 30. Bad Sampling The Universe Study Population Study Sample
    31. 31. Sample Size <ul><li>You need to have enough research participants (patients) to show a difference </li></ul><ul><li>Depends on: </li></ul><ul><ul><li>The incidence of the outcomes you are assessing in each group </li></ul></ul><ul><ul><li>The prevalence of the disease </li></ul></ul>
    32. 32. Sample Size <ul><li>Compare applying pressure with no pressure to control active bleeding? </li></ul><ul><li>Compare antibiotics with no antibiotics for bad open fractures to reduce the risk of infection? </li></ul><ul><li>Compare antibiotics with no antibiotics for pneumonia to reduce septic shock? </li></ul><ul><li>Compare LMWH with Unfractionated heparin to reduce the risk of DVT after TKA? </li></ul>
    33. 33. Types of Research Quantitative Qualitative Mixed-Methods
    34. 34. Quantitative Research <ul><li>Descriptive: </li></ul><ul><ul><li>Case report </li></ul></ul><ul><ul><li>Case series </li></ul></ul><ul><ul><li>Cross-sectional </li></ul></ul><ul><li>Analytical: </li></ul><ul><ul><li>Observational: cohort studies, case-control </li></ul></ul><ul><ul><li>Experimental: randomized trials </li></ul></ul>
    35. 35. Descriptive Studies
    36. 36. Case Report <ul><li>A descriptive study of one patient </li></ul><ul><li>Detailed profile of a “rare” presentation or treatment </li></ul><ul><li>Helpful in developing hypothesis to be tested later using analytic study </li></ul>
    37. 37. Case Series <ul><li>A descriptive study of multiple patients </li></ul><ul><li>“ Rare” phenomenon occurring multiple times </li></ul><ul><li>Detailed profile of patients’ presentation and outcome </li></ul><ul><li>Helpful in developing hypothesis </li></ul>
    38. 38. Cross-Sectional Studies <ul><li>Descriptive “Survey” </li></ul><ul><li>One to one questionnaire, mail, telephone, online </li></ul><ul><li>Attention to details: </li></ul><ul><ul><li>Sampling </li></ul></ul><ul><ul><li>Construction of the questions </li></ul></ul><ul><ul><li>Construction of the responses </li></ul></ul>
    39. 39. Analytical Studies
    40. 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. 41. Case-Control Study ODDS RATIO Lung Cancer Yes No Shisha Smoking Yes No
    42. 42. Problems with Case-Control Studies <ul><li>Looking back in time (retrospective) </li></ul><ul><li>Recall bias </li></ul><ul><li>Measurement bias </li></ul><ul><li>You may miss important risk factors </li></ul>
    43. 43. Prospective Cohort Lung Cancer No Lung Cancer Lung Cancer No Lung Cancer Shisha Smokers NOT Shisha Smokers F/U F/U
    44. 44. Cohort Study RELATIVE RISK Lung Cancer Yes No Shisha Smoking Yes No
    45. 45. Cohort Study <ul><li>Prospective or Retrospective </li></ul><ul><li>Drawbacks: </li></ul><ul><ul><li>Large number of patients </li></ul></ul><ul><ul><li>Follow them up for long time </li></ul></ul>
    46. 46. Randomized Controlled Trial (RCT) Outcomes Outcomes Patients with MI RANDOM Drug A Drug B F/U F/U
    47. 47. Why RCT is the highest level of evidence? <ul><li>Randomization: balance known and unknown prognostic factors </li></ul><ul><li>Blinding: </li></ul><ul><ul><li>Patients </li></ul></ul><ul><ul><li>Researchers </li></ul></ul><ul><ul><li>Outcome assessors </li></ul></ul><ul><li>Aim for complete follow-up </li></ul>
    48. 48. <ul><li>Ask for help  Research assistants </li></ul><ul><li>Monitor the conduct of the study </li></ul><ul><ul><li>No deviation </li></ul></ul><ul><ul><li>Patients safety </li></ul></ul><ul><ul><li>Complete data </li></ul></ul>Conducting Research
    49. 49. <ul><li>During the planning phase: who will do what? </li></ul><ul><li>Oral & written </li></ul><ul><li>Pick your audience (pick a Journal) </li></ul><ul><li>Write your paper with the Journal you picked in mind </li></ul><ul><li>Don’t give up, you will get rejected </li></ul>Publishing Research
    50. 50. Take Home Messages <ul><li>Research is not a one man/woman show </li></ul><ul><ul><li>You need a team to do good research </li></ul></ul><ul><li>Research is a science </li></ul><ul><ul><li>You need to learn how to do it </li></ul></ul><ul><li>Research is like riding a bicycle </li></ul><ul><ul><li>You need to practice </li></ul></ul>
    51. 51. Take Home Messages <ul><li>Research needs planning </li></ul><ul><ul><li>If you fail to plan, you plan to fail </li></ul></ul><ul><li>Not all of us need to do research </li></ul><ul><ul><li>But all of us should practice EBM </li></ul></ul><ul><li>Never ever give up </li></ul><ul><ul><li>You will get rejected </li></ul></ul>
    52. 52. GCC EBHC
    53. 53. http://eapps.ngha.med.sa/ebm/
    54. 54. Objectives <ul><li>What is research? </li></ul><ul><li>Why do we need to do research? </li></ul><ul><li>What is the difference between research and EBM? </li></ul><ul><li>What are the types of research? </li></ul><ul><li>How to do research? </li></ul>[email_address]

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