LEC 2 Developing Research Questions & Study Plan

Question 1

Key ingredients to developing a research question (4)

Answer 1

1. Experience
2. Imagination
3. Aware of new ideas/techniques
4. Mastering the literature

Question 2

Why is conducting thorough search & critical appraisal of published literature in the area of study important?

Answer 2

• identify what has been studied & what areas are lacking
• identify gaps & address them in your study
• retrieve suggestions on how to improve the study in the area from other researchers in their published article

Question 3

How to develop a good research question?

Answer 3

FINER criteria

Feasibility
Interest
Novel
Ethical
Relevance

Question 4

Feasibility considerations (5)

Answer 4

Adequacy in :

• sample size
• budget
• time
• technical expertise
• manageability

Question 5

How to determine the adequate sample size of study? (2)

Answer 5

• use sample size calculators to calculate the minimum required sample size
  eg OpenEpi
• +10-20% in case of loss to follow up etc

Question 6

Is the calculated minimum sample size achievable?

Answer 6

• do pilot testing or chart review

Question 7

If the calculated minimum sample size is not achievable,

5

Answer 7

1. Increase inclusion criteria
2. Eliminate unnecessary exclusion criteria
3. Lengthen time-frame for enrolling subjects
4. Use other sources of subjects
5. Change study design

Question 8

If the project cost > available funds, (2)

Answer 8

1. Use less expensive design

2. Source for additional funds

Question 9

Novel

Answer 9

• confirms, refutes or extends previous findings
• need not be totally original
  eg conduct same study but different population

Question 10

Ethicality

Answer 10

• require IRB approval

Question 11

IRB

Answer 11

Institutional Review Board

Question 12

Relevance

Answer 12

• to scientific knowledge
• to clinical & health policy
• to future research

Question 13

How to frame research question?

Answer 13

PICOT

Population
Intervention
Comparison
Outcome
Time-frame

Question 14

Time-frame

Answer 14

• duration of time for follow up to assess outcome, NOT the duration of treatment

Question 15

Hypothesis definition (2)

Answer 15

• a speculative statement that suggests an answer to the research question
• must be testable

Question 16

Study objective definition (2)

Answer 16

• the aim that the investigator sets out to achieve with the research
• primary or secondary

Question 17

Outline of study plan (6)

Answer 17

1. Research question
2. Background & significance
3. Design of study
4. Subjects
5. Variables
6. Statistical issues

Question 18

Structurer of research proposal (7)

Answer 18

1. Title
2. Introduction / background
3. Research hypothesis
4. Research objectives
5. Methods
6. Impact of the study
7. Relevant references