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UQUMRC KAMC Research Methodology 2012 Update

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A presentation on important research methodology concepts for research proposals. Given for the UQU Medical Research Club "Your Journey Towards Research" held at King Abdullah Medical City, Makkah. …

A presentation on important research methodology concepts for research proposals. Given for the UQU Medical Research Club "Your Journey Towards Research" held at King Abdullah Medical City, Makkah. May 17, 2012


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  • 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
  • Transcript

    • 1. Research Methodology SohailBajammal, MBChB, MSc, FRCS(C), PhD(c) Assistant Professor of Orthopaedics, Umm Al-Qura UniversityDirector of CME & Research Administration, King Abdullah Medical City Makkah bajammal
    • 2. Why are you here ona THURSDAY morning? 2
    • 3. 3
    • 4. Change starts with simple ideas! HattanBadr @AbdulelahNuqali DoaaMelebari 4
    • 5. Simple ideas turn into national initiative @NayefDajim proposed the concept of Research Summer School when he was a medical student 5
    • 6. The first orthopaedic RCT in the region started by a 2nd year resident (Dr. Husam Al-Rumaih) @alrumaih 6
    • 7. Today is only a flavor of research 7
    • 8. It’s your decision where to be! Royal Australian College of General Practitioners 8
    • 9. 9University of Galsgow Website
    • 10. Future of Research 10
    • 11. Research on Wheels University of Birmingham 11
    • 12. 12
    • 13. Objectives• 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? 13
    • 14. What is research?Systematic investigation towards increasingthe sum of knowledge (Chambers 20th Century Dictionary) 14
    • 15. Why do we need to do research? “locally”• Environmental• Ethnic• Psychosocial Different• Cultural• Economic 15
    • 16. Perspectives of Research Basic SocialScience Health Problem Legal Economic “Trauma” Clinical Diagnosis Therapy Prognosis 16
    • 17. Doing Research MethodologyResearch EBM Using 17
    • 18. EBM Research Patients’ Evidence Preferences Clinical Expertise Clinical CircumstancesHaynes et al. BMJ 2002;324:1350 18
    • 19. The Bigger Picture of Translational Research 19Harvard Catalyst, 2010
    • 20. Research Methodology 21
    • 21. Research Methodology Planning Conducting Publishing 22
    • 22. Research Problem Research Question Research Design Data Collection Data AnalysisResearch Dissemination
    • 23. Physiology of Research Research Study Plan Actual Study Question Design Implement Target Intended Actual subjects Population Sample Errors Errors Actual Phenomena Intended measurements of interest variablesTruth in the Truth in the Findings in Universe Infer Study Infer the Study External Validity Internal Validity 24 From Hulley et al. Designing Clinical Research. LWW
    • 24. Physiology of Research Research Question Target Population Phenomena of interestTruth in the Universe 25 From Hulley et al. Designing Clinical Research. LWW
    • 25. Physiology of Research Research Study Plan Question Design Target Intended Population Sample Phenomena Intended of interest variablesTruth in the Truth in the Universe Study 26 From Hulley et al. Designing Clinical Research. LWW
    • 26. Physiology of Research Research Study Plan Actual Study Question Design Implement Target Intended Actual subjects Population Sample Actual Phenomena Intended measurements of interest variablesTruth in the Truth in the Findings in Universe Study the Study 27 From Hulley et al. Designing Clinical Research. LWW
    • 27. Physiology of Research Research Study Plan Actual Study Question Design Implement Target Intended Actual subjects Population Sample Actual Phenomena Intended measurements of interest variablesTruth in the Truth in the Findings in Universe Study Infer the Study Internal Validity 28 From Hulley et al. Designing Clinical Research. LWW
    • 28. Physiology of Research Research Study Plan Actual Study Question Design Implement Target Intended Actual subjects Population Sample Actual Phenomena Intended measurements of interest variablesTruth in the Truth in the Findings in Universe Infer Study Infer the Study External Validity Internal Validity 29 From Hulley et al. Designing Clinical Research. LWW
    • 29. Physiology of Research Research Study Plan Actual Study Question Design Implement Target Intended Actual subjects Population Sample Errors Errors Actual Phenomena Intended measurements of interest variablesTruth in the Truth in the Findings in Universe Infer Study Infer the Study External Validity Internal Validity 30 From Hulley et al. Designing Clinical Research. LWW
    • 30. Patho Physiology of Research Research Study Plan Actual Study Question Design Implement Target Intended Actual subjects Population Sample Errors Errors Actual Phenomena Intended measurements of interest variablesTruth in the Truth in the Findings in Universe Infer Study Infer the Study External Validity Internal Validity 31 From Hulley et al. Designing Clinical Research. LWW
    • 31. The goal of research methodology Validity Errors 32
    • 32. Errors in Research Methodology• Types of Errors: – Random Errors: mistakes by chance – Systematic Errors: bias• Stages: – During Sampling – During Measurement – During Analysis 33
    • 33. Random Errors (Chance)• The sample is too small to make inferences• The measurement tool is not accurate (bad sphygmomanometer) 34
    • 34. Systematic Errors (Bias)• Selection Bias: you are selecting healthier patients• Measurement Bias: surgeons tend to over- estimate their own results/X-rays 35
    • 35. Research Planning1. Assemble a research team2. Ask a good research question3. Do a literature search4. Choose the proper study design5. Determine the sampling design6. Decide on data collection & analysis7. Get ethical approval 36
    • 36. 1. Research Team• Research is not a one man/woman show• You need a team at every step• Ask a research methodologist & a biostatistician EARLY 37
    • 37. 2. Good Research Question (FINER & PICO) FINER PICO• Feasible • Population • Intervention• Interesting • Comparison• Novel • Outcome• Ethical• Relevant 38
    • 38. 3. Literature Review• To show that you are competent in this field• What was done?• How will you increase to the sum of knowledge? How is this study different?• What is the rationale of choosing specific study design, outcome measures, analysis? 39
    • 39. 4. Types of ResearchQuantitative Qualitative Mixed-Methods 40
    • 40. SlideShare.net 41
    • 41. Research Mixed- Quantitative Qualitative Methods Descriptive Analytical Cross-Case report Case series Observational Experimental sectional Case-Control Cohort Study 42
    • 42. Research Mixed- Quantitative Qualitative Methods Descriptive Analytical Cross-Case report Case series Observational Experimental sectional Case-Control Cohort Study 43
    • 43. Research Mixed- Quantitative Qualitative Methods Descriptive Analytical Cross-Case report Case series Observational Experimental sectional Case-Control Cohort Study 44
    • 44. Quantitative Research• Descriptive: – Case report – Case series – Cross-sectional• Analytical: – Observational: cohort studies, case-control – Experimental: randomized trials 45
    • 45. Descriptive Studies 46
    • 46. 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 47
    • 47. Case Series• A descriptive study of multiple patients• “Rare” phenomenon occurring multiple times• Detailed profile of patients’ presentation and outcome• Helpful in developing hypothesis 48
    • 48. Cross-Sectional Studies• Descriptive “Survey”• One to one questionnaire, mail, telephone, online• Attention to details: – Sampling – Construction of the questions – Construction of the responses 49
    • 49. Analytical Studies 50
    • 50. Case-Control Studies Shisha Smokers GO BACK IN TIME CasesNOT Shisha Smokers (e.g., Lung Cancer) Ask patients Read files Shisha Smokers GO BACK IN TIME Control (e.g., NO LungNOT Shisha Smokers Cancer) 51
    • 51. Case-Control StudyODDS RATIO Lung Cancer Yes No Yes ShishaSmoking No 52
    • 52. Problems with Case-Control Studies• Looking back in time (retrospective)• Recall bias• Measurement bias• You may miss important risk factors 53
    • 53. Prospective Cohort Methodologically sound, but Unethical Shisha Lung Cancer Follow Up Smokers No Lung CancerNOT Shisha Lung Cancer Follow Up Smokers No Lung Cancer 54
    • 54. Cohort StudyRELATIVE RISK Lung Cancer Yes No Yes ShishaSmoking No 55
    • 55. Cohort Study• Prospective or Retrospective• Drawbacks: – Large number of patients – Follow them up for long time 56
    • 56. Randomized Controlled Trial (RCT) Drug A F/U OutcomesPatients RANDOMwith MI Drug B F/U Outcomes 57
    • 57. 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 58
    • 58. 5. Sampling TargetThe Universe Population Sample “Sampling“Population” Frame” 59
    • 59. Bad Sampling TargetThe Universe Population“Population” “Sampling Frame” Sample 60
    • 60. Bad Sample• Prevalence of scoliosis in school boys in Makkah• If you did a study in AbdulrahmanFageeh Schools, this is a bad sample (biased) 61
    • 61. Sampling Quantitative Sampling Non- Probability probability Sampling Sampling Simple Multistage Systematic Stratified Convenience SnowballRandom Cluster 62
    • 62. Sample Size• You need to have enough research participants (patients) to show a difference or to make valid inferences about the population• Depends on: – The incidence of the outcomes you are assessing in each group – The prevalence of the disease 63
    • 63. 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? 64
    • 64. Sample Size Calculation• Different statistical sample size calculation formula for different study type• Consult a biostatistician• Sample size calculators – Online/Free – Commercial: e.g., SPSS 65
    • 65. 66
    • 66. 67
    • 67. 68
    • 68. Patho Physiology of Research Research Study Plan Actual Study Question Design Implement Target Intended Actual subjects Population Sample Errors Errors Actual Phenomena Intended measurements of interest variablesTruth in the Truth in the Findings in Universe Infer Study Infer the Study External Validity Internal Validity 69 From Hulley et al. Designing Clinical Research. LWW
    • 69. 6. Data Collection• What data will you collect?• What are the independent and dependent variables?• What are the primary & secondary outcomes?• Are you choosing disease-oriented outcomes or patients-oriented outcomes? 70
    • 70. Data Collection• The choice of your outcome will have implications on: – Data Collection Forms – Statistical Analysis• Which way will you collect data about age? – Categorical: <18, 18-25, 26-30 – Continuous 71
    • 71. Research Methodology Planning Conducting Publishing 72
    • 72. Conducting Research• Ask for help  – Research assistants – Biostatistician• Monitor the conduct of the study – No deviation from protocol – Patients safety & confidentiality – Complete data 73
    • 73. 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 74
    • 74. Research Methodology Planning Conducting IRB Publishing 75
    • 75. 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 76
    • 76. 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 77
    • 77. GCC EBHC
    • 78. Research Summer School 79
    • 79. Excellent Book 80
    • 80. Objectives• 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? bajammal 81