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

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

9. 9
University 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 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

20. Research Methodology
21

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

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 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

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