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Research Methodology

  SohailBajammal, MBChB, MSc, FRCS(C), PhD(c)
         Assistant Professor of Orthopaedics, Umm Al-Qura University
Director of CME & Research Administration, King Abdullah Medical City Makkah




                                 bajammal
Why are you here on
a THURSDAY morning?




                       2
3
Change starts with simple ideas!




  HattanBadr   @AbdulelahNuqali   DoaaMelebari   4
Simple ideas turn into
  national initiative




                @NayefDajim
                proposed the concept of
                Research Summer School
                when he was a medical
                student
                                          5
The first orthopaedic RCT in the region
    started by a 2nd year resident
         (Dr. Husam Al-Rumaih)




            @alrumaih
                                          6
Today is only a flavor of research




                                     7
It’s your decision where to be!




     Royal Australian College of General Practitioners
                                                         8
9
University of Galsgow Website
Future of Research




                     10
Research on Wheels




                University of Birmingham



                                    11
12
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
What is research?

Systematic investigation towards increasing
the sum of knowledge

               (Chambers 20th Century Dictionary)




                                                14
Why do we need to do research?
          “locally”

•   Environmental
•   Ethnic
•   Psychosocial    Different
•   Cultural
•   Economic


                                 15
Perspectives of Research

 Basic
                           Social
Science       Health
             Problem
 Legal                     Economic
             “Trauma”

              Clinical
 Diagnosis               Therapy
             Prognosis

                                      16
Doing
           Research
           Methodology




Research

           EBM

  Using

                   17
EBM

                   Research                 Patients’
                   Evidence                Preferences

                                     Clinical
                                    Expertise

                                      Clinical
                                  Circumstances
Haynes et al. BMJ 2002;324:1350                          18
The Bigger Picture of Translational Research




                                                      19
Harvard Catalyst, 2010
Research Methodology


                       21
Research Methodology

      Planning


     Conducting


     Publishing
                       22
Research Problem

  Research Question

   Research Design

   Data Collection

    Data Analysis

Research Dissemination
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                         variables



Truth 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
Physiology of Research
 Research
 Question

   Target
 Population




 Phenomena
  of interest



Truth in the
 Universe

                                                                       25
                 From Hulley et al. Designing Clinical Research. LWW
Physiology of Research
 Research                      Study Plan
 Question        Design


   Target                         Intended
 Population                        Sample




 Phenomena                        Intended
  of interest                     variables



Truth in the                  Truth in the
 Universe                        Study

                                                                       26
                 From Hulley et al. Designing Clinical Research. LWW
Physiology of Research
 Research                      Study Plan                          Actual Study
 Question        Design                           Implement


   Target                         Intended
                                                                       Actual subjects
 Population                        Sample




                                                                          Actual
 Phenomena                        Intended
                                                                       measurements
  of interest                     variables



Truth in the                  Truth in the                             Findings in
 Universe                        Study                                 the Study

                                                                                  27
                 From Hulley et al. Designing Clinical Research. LWW
Physiology of Research
 Research                      Study Plan                           Actual Study
 Question        Design                           Implement


   Target                         Intended
                                                                       Actual subjects
 Population                        Sample




                                                                          Actual
 Phenomena                        Intended
                                                                       measurements
  of interest                     variables



Truth in the                  Truth in the                             Findings in
 Universe                        Study                  Infer          the Study
                                                Internal Validity                 28
                 From Hulley et al. Designing Clinical Research. LWW
Physiology of Research
 Research                           Study Plan                          Actual Study
 Question           Design                            Implement


   Target                             Intended
                                                                           Actual subjects
 Population                            Sample




                                                                              Actual
 Phenomena                            Intended
                                                                           measurements
  of interest                         variables



Truth 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
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                         variables



Truth 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
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                         variables



Truth 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
The goal of research methodology

              Validity



         Errors
                                   32
Errors in Research Methodology

• Types of Errors:
  – Random Errors: mistakes by chance
  – Systematic Errors: bias

• Stages:
  – During Sampling
  – During Measurement
  – During Analysis
                                        33
Random Errors (Chance)
• The sample is too small to make inferences

• The measurement tool is not accurate (bad
  sphygmomanometer)




                                               34
Systematic Errors (Bias)
• Selection Bias: you are selecting healthier
  patients

• Measurement Bias: surgeons tend to over-
  estimate their own results/X-rays




                                                35
Research Planning
1.   Assemble a research team
2.   Ask a good research question
3.   Do a literature search
4.   Choose the proper study design
5.   Determine the sampling design
6.   Decide on data collection & analysis
7.   Get ethical approval
                                            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
2. Good Research Question
                  (FINER & PICO)
          FINER                      PICO
• Feasible                 •   Population
                           •   Intervention
• Interesting
                           •   Comparison
• Novel                    •   Outcome
• Ethical
• Relevant
                                              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
4. Types of Research


Quantitative               Qualitative



               Mixed-Methods


                                         40
SlideShare.net




                 41
Research




                                                                                   Mixed-
                                    Quantitative        Qualitative
                                                                                   Methods




              Descriptive                                             Analytical




                             Cross-
Case report   Case series                              Observational           Experimental
                            sectional




                                              Case-Control       Cohort Study



                                                                                        42
Research




                                                                                   Mixed-
                                    Quantitative        Qualitative
                                                                                   Methods




              Descriptive                                             Analytical




                             Cross-
Case report   Case series                              Observational           Experimental
                            sectional




                                              Case-Control       Cohort Study



                                                                                        43
Research




                                                                                   Mixed-
                                    Quantitative        Qualitative
                                                                                   Methods




              Descriptive                                             Analytical




                             Cross-
Case report   Case series                              Observational           Experimental
                            sectional




                                              Case-Control       Cohort Study



                                                                                        44
Quantitative Research
• Descriptive:
  – Case report
  – Case series
  – Cross-sectional


• Analytical:
  – Observational: cohort studies, case-control
  – Experimental: randomized trials

                                                  45
Descriptive Studies



                      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
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
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
Analytical Studies



                     50
Case-Control Studies
  Shisha Smokers
                     GO BACK IN TIME       Cases
NOT Shisha Smokers                     (e.g., Lung Cancer)



                       Ask patients
                        Read files


  Shisha Smokers
                     GO BACK IN TIME
                                         Control
                                         (e.g., NO Lung
NOT Shisha Smokers                           Cancer)
                                                             51
Case-Control Study


ODDS RATIO          Lung Cancer
                   Yes      No

             Yes
 Shisha
Smoking
             No

                                  52
Problems with Case-Control Studies

• Looking back in time (retrospective)

• Recall bias

• Measurement bias

• You may miss important risk factors


                                         53
Prospective Cohort
       Methodologically sound, but
              Unethical


  Shisha                              Lung Cancer
                    Follow Up
 Smokers                             No Lung Cancer



NOT Shisha                            Lung Cancer
                    Follow Up
 Smokers                             No Lung Cancer
                                                 54
Cohort Study


RELATIVE RISK      Lung Cancer
                  Yes      No

           Yes
 Shisha
Smoking
           No

                                 55
Cohort Study
• Prospective or Retrospective

• Drawbacks:
  – Large number of patients
  – Follow them up for long time



                                   56
Randomized Controlled Trial (RCT)

                    Drug A   F/U   Outcomes

Patients
           RANDOM
with MI


                    Drug B   F/U   Outcomes



                                          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
5. Sampling


    Target
The Universe
  Population
   Sample
  “Sampling
“Population”
   Frame”

               59
Bad Sampling



       Target
The Universe
     Population
“Population”
     “Sampling
      Frame”  Sample

                       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
Sampling
                                         Quantitative
                                          Sampling


                                                                    Non-
                  Probability
                                                                 probability
                   Sampling
                                                                  Sampling


 Simple                                  Multistage
          Systematic        Stratified                  Convenience        Snowball
Random                                    Cluster




                                                                               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
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
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
66
67
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                         variables



Truth 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
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
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
Research Methodology

      Planning


     Conducting


     Publishing
                       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
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
Research Methodology

      Planning


     Conducting        IRB

     Publishing
                             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
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
GCC EBHC
Research Summer School




                         79
Excellent Book




                 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

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UQUMRC KAMC Research Methodology 2012 Update

  • 1. Research Methodology SohailBajammal, MBChB, MSc, FRCS(C), PhD(c) Assistant Professor of Orthopaedics, Umm Al-Qura University Director of CME & Research Administration, King Abdullah Medical City Makkah bajammal
  • 2. Why are you here on a 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
  • 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 increasing the 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 Social Science Health Problem Legal Economic “Trauma” Clinical Diagnosis Therapy Prognosis 16
  • 17. Doing Research Methodology Research EBM Using 17
  • 18. EBM Research Patients’ Evidence Preferences Clinical Expertise Clinical Circumstances Haynes et al. BMJ 2002;324:1350 18
  • 19. The Bigger Picture of Translational Research 19 Harvard Catalyst, 2010
  • 21. Research Methodology Planning Conducting Publishing 22
  • 22. Research Problem Research Question Research Design Data Collection Data Analysis Research 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 variables Truth 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 interest Truth 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 variables Truth 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 variables Truth 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 variables Truth 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 variables Truth 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 variables Truth 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 variables Truth 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 Planning 1. Assemble a research team 2. Ask a good research question 3. Do a literature search 4. Choose the proper study design 5. Determine the sampling design 6. Decide on data collection & analysis 7. 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 Research Quantitative Qualitative Mixed-Methods 40
  • 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
  • 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
  • 50. Case-Control Studies Shisha Smokers GO BACK IN TIME Cases NOT Shisha Smokers (e.g., Lung Cancer) Ask patients Read files Shisha Smokers GO BACK IN TIME Control (e.g., NO Lung NOT Shisha Smokers Cancer) 51
  • 51. Case-Control Study ODDS RATIO Lung Cancer Yes No Yes Shisha Smoking 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 Cancer NOT Shisha Lung Cancer Follow Up Smokers No Lung Cancer 54
  • 54. Cohort Study RELATIVE RISK Lung Cancer Yes No Yes Shisha Smoking 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 Outcomes Patients RANDOM with 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 Target The Universe Population Sample “Sampling “Population” Frame” 59
  • 59. Bad Sampling Target The 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 Snowball Random 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 variables Truth 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
  • 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

Editor's Notes

  1. Problems with textbooks:Usually single authored chaptersLikely biased, author’s opinionNot peer-reviewedOutdated (at least 4 years)
  2. Research team:
  3. Feasible: adequate participants &amp; expertiseaffordable time &amp; moneyInteresting: to youNovel:Extends, confirms or refutes previous findingsProvides new findingsEthicalRelevant:To scientific knowledgeTo clinical and health policyTo future research directions
  4. 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)
  5. 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