Research Methodology

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A basic introductory presentation to medical research methodology.

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  • Problems with textbooks:Usually single authored chaptersLikely biased, author’s opinionNot peer-reviewedOutdated (at least 4 years)
  • Problems with textbooks:Usually single authored chaptersLikely biased, author’s opinionNot peer-reviewedOutdated (at least 4 years)
  • Research team:
  • Feasible: adequate participants & expertiseaffordable time & moneyInteresting: to youNovel:Extends, confirms or refutes previous findingsProvides new findingsEthicalRelevant:To scientific knowledgeTo clinical and health policyTo future research directions
  • An observational studyCompare 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 studyYou follow a group of people with certain risk factors and another group without these risk factorsYou follow them for a period of time and look for the outcome of interest
  • Research Methodology

    1. 1. Research Methodology<br />Sohail Bajammal, MBChB, MSc, FRCS(C), PhD(c)<br />ssbajammal@uqu.edu.sa<br />Assistant Professor, Umm Al Qura University<br />Consultant Orthopaedic Surgeon, Al-Noor Specialist Hospital<br />
    2. 2. What got me into EBM….<br />What is a double blind study?<br />Two orthopaedic surgeons<br />reading an ECG<br />
    3. 3. EBM is not new…….<br />“ثمنرقىفيالبحثوالمقاييسعلىالتدريجوالترتيبمعانتقادالمقدماتوالتحفظفيالنتائجونجعلغرضنافيجميعمانستقرئهونتصفحهاستعمالالعدللااتباعالهوىونتحرىفيسائرمانميزهوننتقدهطلبالحقلاالميلمعالآراء”<br />3<br />الحسنبنالهيثم<br />
    4. 4. Objectives<br />What is research?<br />Why do we need to do research?<br />What is the difference between research methodology and EBM?<br />What are the types of research?<br />How to do research?<br />4<br />
    5. 5. What is research?<br />Systematic investigation towards increasing the sum of knowledge<br />(Chambers 20th Century Dictionary)<br />5<br />
    6. 6. Perspectives of Research <br />Basic Science<br />Social<br />Health Problem<br />“Trauma”<br />Economic<br />Legal<br />Clinical<br />Diagnosis<br />Therapy<br />Prognosis<br />6<br />
    7. 7. Why do we need to do research?“locally”<br /><ul><li>Ethnic
    8. 8. Psychosocial
    9. 9. Cultural
    10. 10. Economic</li></ul>7<br />Different<br />
    11. 11. Research MethodologyvsEvidence-Based Medicine<br />8<br />
    12. 12. Doing<br />Research Methodology<br />Research<br />EBM<br />Using<br />9<br />
    13. 13. EBM<br />Research Evidence<br />Patients’ Preferences<br />Clinical Expertise<br />Clinical Circumstances<br />10<br />Haynes et al. BMJ 2002;324:1350<br />
    14. 14. 5As of EBM<br />11<br />
    15. 15. Is this a good question?<br />What is the best treatment of back pain?<br />12<br />
    16. 16. Asking a good question (PICO)!<br />Population<br />Intervention<br />Control<br />Outcome<br />13<br />
    17. 17. Is this a good question?<br />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?<br />P: Adult patients <50yr with acute LBP<br />I: Bedrest<br />C: Physiotherapy<br />O: Recurrence of pain within one year<br />14<br />
    18. 18. 5As of EBM<br />15<br />
    19. 19. 5S Hierarchy of Evidence<br />RCTs, Cohort, Case control, Case series<br />Expert Opinion: Classical Textbooks<br />16<br />
    20. 20. Primary Sources<br />Original articles<br />Using: PubMed, OVID<br />You have to retrieve and appraise the articles<br />Levels (strength) of evidence<br />17<br />
    21. 21. Levels of Evidence<br />18<br />http://library.downstate.edu/EBM2/2100.htm <br />
    22. 22. 19<br />
    23. 23. It’s time consuming<br />20<br />
    24. 24. 5S Hierarchy of Evidence<br />Computerized Decision Support<br />Evidence-Based <br />Guidelines & Textbooks<br />Critically-Appraised <br />Journal Articles & Abstracts<br />Systematic Reviews<br />RCTs, Cohort, Case control, Case series<br />Expert Opinion: Classical Textbooks<br />21<br />
    25. 25. To practice EBM, we need all four<br />Research Evidence<br />Patients’ Preferences<br />Clinical Expertise<br />Clinical Circumstances<br />22<br />
    26. 26. Research Methodology<br />23<br />
    27. 27. Research Methodology<br />Planning<br />Conducting<br />Publishing<br />24<br />
    28. 28. Research Question<br />Truth in the Universe<br />Study Plan<br />Truth in the Study<br />Actual Study<br />Findings in the Study<br />Design<br />Implement<br />Target Population<br />Phenomena of interest<br />Intended Sample<br />Intended variables<br />Actual subjects<br />Actual measurements<br />Errors<br />Errors<br />Infer<br />Infer<br />From Hulley et al. Designing Clinical Research. LWW<br />25<br />
    29. 29. Errors in Research Methodology<br />Random Errors: mistakes by chance<br />Systematic Errors: bias<br />26<br />
    30. 30. Assemble a research team<br />Ask a good research question<br />Do a literature search<br />Choose the proper study design<br />Determine the sampling design<br />Get ethical approval<br />Research Planning<br />27<br />
    31. 31. Research Team<br />Research is not a one man/woman show<br />You need a team at every step<br />Ask a research methodologist & a biostatistician EARLY<br />28<br />
    32. 32. Good Research Question (FINER)<br />Feasible<br />Interesting<br />Novel<br />Ethical<br />Relevant<br />PICO<br />29<br />
    33. 33. Sampling<br />The Universe<br />Study Population<br />Study Sample<br />30<br />
    34. 34. Bad Sampling<br />The Universe<br />Study Population<br />Study Sample<br />31<br />
    35. 35. Sample Size<br />You need to have enough research participants (patients) to show a difference<br />Depends on:<br />The incidence of the outcomes you are assessing in each group<br />The prevalence of the disease<br />32<br />
    36. 36. Sample Size<br />Compare applying pressure with no pressure to control active bleeding?<br />Compare antibiotics with no antibiotics for bad open fractures to reduce the risk of infection?<br />Compare antibiotics with no antibiotics for pneumonia to reduce septic shock?<br />Compare LMWH with Unfractionated heparin to reduce the risk of DVT after TKA?<br />33<br />
    37. 37. Types of Research<br />Quantitative<br />Qualitative<br />Mixed-Methods<br />34<br />
    38. 38. Quantitative Research<br />Descriptive:<br />Case report<br />Case series<br />Cross-sectional<br />Analytical:<br />Observational: cohort studies, case-control<br />Experimental: randomized trials<br />35<br />
    39. 39. Descriptive Studies<br />36<br />
    40. 40. Case Report<br />A descriptive study of one patient<br />Detailed profile of a “rare” presentation or treatment<br />Helpful in developing hypothesis to be tested later using analytic study<br />37<br />
    41. 41. Case Series<br />A descriptive study of multiple patients<br />“Rare” phenomenon occurring multiple times<br />Detailed profile of patients’ presentation and outcome<br />Helpful in developing hypothesis<br />38<br />
    42. 42. Cross-Sectional Studies<br />Descriptive “Survey”<br />One to one questionnaire, mail, telephone, online<br />Attention to details:<br />Sampling<br />Construction of the questions<br />Construction of the responses<br />39<br />
    43. 43. Analytical Studies<br />40<br />
    44. 44. Case-Control Studies<br />Cases<br />(e.g., Lung Cancer)<br />Shisha Smokers<br />GO BACK IN TIME<br />NOT Shisha Smokers<br />Ask patients<br />Read files<br />Control<br />(e.g., NO Lung Cancer)<br />Shisha Smokers<br />GO BACK IN TIME<br />NOT Shisha Smokers<br />41<br />
    45. 45. Case-Control Study<br />42<br />ODDS RATIO<br />
    46. 46. Problems with Case-Control Studies<br />Looking back in time (retrospective)<br />Recall bias<br />Measurement bias<br />You may miss important risk factors<br />43<br />
    47. 47. Prospective Cohort<br />Shisha Smokers<br />Lung Cancer<br />F/U<br />No Lung Cancer<br />NOT Shisha Smokers<br />Lung Cancer<br />F/U<br />No Lung Cancer<br />44<br />
    48. 48. Cohort Study<br />45<br />RELATIVE RISK<br />
    49. 49. Cohort Study<br />Prospective or Retrospective<br />Drawbacks:<br />Large number of patients<br />Follow them up for long time<br />46<br />
    50. 50. Randomized Controlled Trial (RCT)<br />Drug A<br />F/U<br />Outcomes<br />Patients with MI<br />RANDOM<br />Drug B<br />F/U<br />Outcomes<br />47<br />
    51. 51. Why RCT is the highest level of evidence?<br />Randomization: balance known and unknown prognostic factors<br />Blinding:<br />Patients<br />Researchers<br />Outcome assessors<br />Aim for complete follow-up<br />48<br />
    52. 52. Conducting Research<br />Ask for help  Research assistants<br />Monitor the conduct of the study<br />No deviation<br />Patients safety<br />Complete data<br />49<br />
    53. 53. Publishing Research<br />During the planning phase: who will do what?<br />Oral & written<br />Pick your audience (pick a Journal)<br />Write your paper with the Journal you picked in mind<br />Don’t give up, you will get rejected<br />50<br />
    54. 54. Take Home Messages<br />Research is not a one man/woman show<br />You need a team to do good research<br />Research is a science<br />You need to learn how to do it<br />Research is like riding a bicycle<br />You need to practice<br />51<br />
    55. 55. Take Home Messages<br />Research needs planning<br />If you fail to plan, you plan to fail<br />Not all of us need to do research<br />But all of us should practice EBM<br />Never ever give up<br />You will get rejected<br />52<br />
    56. 56. GCC EBHC<br />
    57. 57. http://eapps.ngha.med.sa/ebm/<br />
    58. 58. Objectives<br />What is research?<br />Why do we need to do research?<br />What is the difference between research and EBM?<br />What are the types of research?<br />How to do research?<br />55<br />ssbajammal@uqu.edu.sa<br />

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