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Diagrammatic Summary of
               1. Research Methodology
               2. Ethical Considerations
              3. Statistical Considerations
“The Journey Towards Your Research Project:
        Writing Research Proposal”


          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
Diagrammatic Summary of Research Methodology, Ethics & Statistics
Diagrammatic Summary of Research Methodology, Ethics & Statistics
Doing
                       Research
                       Methodology




            Research

                       EBM

              Using

@bajammal
EBM
            (evidence-based clinical practice)

                Research          Patients’
                Evidence         Preferences

                            Clinical
                           Expertise

                           Clinical
                       Circumstances

@bajammal                              Haynes et al. BMJ 2002;324:1350
Perspectives of Research
                      Think Broad!

             Basic
                                       Social
            Science       Health
                         Problem
             Legal                     Economic
                         “Trauma”

                          Clinical
             Diagnosis               Therapy
                         Prognosis

@bajammal
Research Methodology Phases

                     Planning


                    Conducting


                    Publishing

@bajammal
Research Problem




                                     Methodological, Ethical & Statistical
              Research Question




                                       Considerations at Each Stage
               Research Design

               Data Collection

                Data Analysis

            Research Dissemination
@bajammal
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
@bajammal                From Hulley et al. Designing Clinical Research. LWW
Research




                                                                                      Mixed-
                                       Quantitative        Qualitative
                                                                                      Methods




                 Descriptive                                             Analytical




                                Cross-
   Case report   Case series                              Observational           Experimental
                               sectional




                                                 Case-Control       Cohort Study




@bajammal
Sampling
                                           Quantitative
                                            Sampling


                                                                      Non-
                    Probability
                                                                   probability
                     Sampling
                                                                    Sampling


   Simple                                  Multistage
            Systematic        Stratified                  Convenience        Snowball
  Random                                    Cluster




@bajammal
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)

@bajammal
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

@bajammal
Randomized Controlled Trial (RCT)

                        Drug A   F/U   Outcomes

    Patients
               RANDOM
    with MI


                        Drug B   F/U   Outcomes




@bajammal
Diagrammatic Summary of Research Methodology, Ethics & Statistics
Diagrammatic Summary of Research Methodology, Ethics & Statistics
bioethics.kacst.edu.sa
Diagrammatic Summary of Research Methodology, Ethics & Statistics
Diagrammatic Summary of Research Methodology, Ethics & Statistics
Diagrammatic Summary of Research Methodology, Ethics & Statistics
Types of
                                 Variables

             Categorical                          Quantitative
                                                   (Continuous or
            “Qualitative”                             Discrete)




   Nominal            Ordinal            Interval                   Ratio

     Nationality     Stage I, II, III    Temperature               Pulse
      Gender         & IV cancer        (0 is not zero)         (0 is dead)
@bajammal
Diagrammatic Summary of Research Methodology, Ethics & Statistics
Measures of Central Tendency
                                Best measure of
            Type of Variable
                               central tendency

                Nominal              Mode

                 Ordinal            Median

              Interval/ratio
                                     Mean
              (not skewed)
              Interval/ratio
                                    Median
               (skewed)

@bajammal
Normal Distribution
                          MEAN




                         68 % of
                       observations             1 SD

                                                 2 SD
                 95 % of observations

            99.7 % of observations              3D
-3   -2     -1        0       1       2   3

           STANDARD DEVIATIONS
                         Courtesy of Prof. Hassan Baaqeel
Choice of Statistical Tests
                         Parametric        Non-Parametric
                            Tests              Tests
                         Interval/Ratio    1. Ordinal
            Goal         (normal           2. Interval/Ratio       Nominal
                         distribution)        (skewed)

   Comparison of 2
                         Unpairedt-test    Mann-Whitney U
   unrelated groups
                                                                Chi-square Test
   Comparison of >2
                            ANOVA          Kruskal-Wallis H
   unrelated

   Comparison of 2
                          Paired t-test        Wilcoxon
   related groups
                                                               Binomial Sign Test
   Comparison of >2    Repeated measures
                                              Friedman
   related groups           ANOVA

   Correlation             Pearson’s        Spearman’s rho      Chi-square Test
@bajammal
Hypothesis Testing (α&β errors)
Null Hypothesis: No association between predictor & outcome
                                   Truth in the Population
 Results in the
 Study Sample          Association Between    No Association Between
                       Predictor & Outcome     Predictor & Outcome

 Reject null
                             Correct               Type I error (α)
 hypothesis


 Fail to reject null
                         Type II error (β)             Correct
 hypothesis



@bajammal

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Diagrammatic Summary of Research Methodology, Ethics & Statistics

  • 1. Diagrammatic Summary of 1. Research Methodology 2. Ethical Considerations 3. Statistical Considerations “The Journey Towards Your Research Project: Writing Research Proposal” 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
  • 4. Doing Research Methodology Research EBM Using @bajammal
  • 5. EBM (evidence-based clinical practice) Research Patients’ Evidence Preferences Clinical Expertise Clinical Circumstances @bajammal Haynes et al. BMJ 2002;324:1350
  • 6. Perspectives of Research Think Broad! Basic Social Science Health Problem Legal Economic “Trauma” Clinical Diagnosis Therapy Prognosis @bajammal
  • 7. Research Methodology Phases Planning Conducting Publishing @bajammal
  • 8. Research Problem Methodological, Ethical & Statistical Research Question Considerations at Each Stage Research Design Data Collection Data Analysis Research Dissemination @bajammal
  • 9. 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 @bajammal From Hulley et al. Designing Clinical Research. LWW
  • 10. Research Mixed- Quantitative Qualitative Methods Descriptive Analytical Cross- Case report Case series Observational Experimental sectional Case-Control Cohort Study @bajammal
  • 11. Sampling Quantitative Sampling Non- Probability probability Sampling Sampling Simple Multistage Systematic Stratified Convenience Snowball Random Cluster @bajammal
  • 12. 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) @bajammal
  • 13. 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 @bajammal
  • 14. Randomized Controlled Trial (RCT) Drug A F/U Outcomes Patients RANDOM with MI Drug B F/U Outcomes @bajammal
  • 21. Types of Variables Categorical Quantitative (Continuous or “Qualitative” Discrete) Nominal Ordinal Interval Ratio Nationality Stage I, II, III Temperature Pulse Gender & IV cancer (0 is not zero) (0 is dead) @bajammal
  • 23. Measures of Central Tendency Best measure of Type of Variable central tendency Nominal Mode Ordinal Median Interval/ratio Mean (not skewed) Interval/ratio Median (skewed) @bajammal
  • 24. Normal Distribution MEAN 68 % of observations 1 SD 2 SD 95 % of observations 99.7 % of observations 3D -3 -2 -1 0 1 2 3 STANDARD DEVIATIONS Courtesy of Prof. Hassan Baaqeel
  • 25. Choice of Statistical Tests Parametric Non-Parametric Tests Tests Interval/Ratio 1. Ordinal Goal (normal 2. Interval/Ratio Nominal distribution) (skewed) Comparison of 2 Unpairedt-test Mann-Whitney U unrelated groups Chi-square Test Comparison of >2 ANOVA Kruskal-Wallis H unrelated Comparison of 2 Paired t-test Wilcoxon related groups Binomial Sign Test Comparison of >2 Repeated measures Friedman related groups ANOVA Correlation Pearson’s Spearman’s rho Chi-square Test @bajammal
  • 26. Hypothesis Testing (α&β errors) Null Hypothesis: No association between predictor & outcome Truth in the Population Results in the Study Sample Association Between No Association Between Predictor & Outcome Predictor & Outcome Reject null Correct Type I error (α) hypothesis Fail to reject null Type II error (β) Correct hypothesis @bajammal

Hinweis der Redaktion

  1. 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)
  2. 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