slides

1. Day 1: Introduction to clinical research

2. Today’s activities
● Introduction of everyone
● Overview of the course
● Basic concepts of research question and research objective
● Group activity

3. What is Clinical Research?
● Research carried out on human (healthy or sick people) or health system
Improving knowledge of health conditions
Developing diagnostic methods
New treatments or medical devices to ensure better patient care.
● Must follow precise protocol
● Have the goal of increasing medical knowledge
● Be carried out by competent persons
● Take all necessary measures to protect those who lend themselves to research
● Obtain regulatory approvals and take all the necessary legal and ethical steps
● Collect the consent of those involved in research

4. Anatomy and physiology of research
Anatomy
What its made of?
Elements of research: research question, design, study population, variables, sample
size etc.
Physiology
How it work?
The goal is to minimize the errors that threaten the conclusions

5. Generic outline of a research
Research questions
What will the study address?
Background and significance
Why are these questions important?
Design: Time frame, epidemiologic approach
How is the study structured?
Subjects: Selection criteria, sampling design
Who are the subjects and how will they be selected?
Variables: predictor variables, confounding variables, outcome variables
What measurement will be made?
Statistical issues: hypotheses, sample size and analytic approach
How large is the study and how will it be analyzed?

6. Research questions
● Research question gives us the objective of the study
● The uncertainty researcher wants to resolve
● Research questions begin with a general concern that must be narrowed
down to a concrete, researchable issue
● There is no shortage of a good research question!
● There will always be new questions

7. Example
Should people go for morning walk?
• Good start
• Needs to break it down to more specific questions
How often do Nepalese go for morning walk?
Does going for morning walk lower cardiovascular risk?
Is there a risk of pollutants affecting health in elderly population going for morning walk?
Does morning walk increase the risk of COVID transmission among elderly population in Kathmandu ?

8. Be open
Be alert to new ideas and techniques
▪ Attend conferences
▪ Have a skeptical attitude
▪ Be updated about new technologies
Keep imagination roaming
▪ Observe things around you
▪ Teaching is also an excellent source of inspiration
▪ Creativity- imagining new methods to address old ideas
▪ Keep your mind open - ideas can come to you while walking, showering, cooking, operating, just sitting
and thinking

9. “So what?”
● A good research question should pass the “So what ?” test
● Can use the acronym FINER
F- Feasible
I – Interesting
N - Novel
E - Ethical
R - Relevant

10. Feasible
Number of participants
• Many studies do not achieve their purpose as they cannot enroll enough
participants
• Preliminary sample size is helpful
• But also keep in mind of real world circumstances
• How many will likely to be available within your time frame?
• How many would be excluded or refuse to participate?
• How many will be lost to follow-up
Technical expertise
• Investigators must have the skills, equipment, and experience in
designing, recruiting, analysing data
• Consultants can help, but the investigators must have a basic level
Cost in time and money
• Important to budget the cost and also timeline If its too
ambitious for the given timeline and budget, you may to
rethink your research questions
Scope
• Problems often arise when investigators try to
accomplish in too much in too little time
• Too many research questions complicates the
research and loses the focus
• Solution- narrow the scope of the study and focus
only one the most important goals

11. Interesting
● There are different motivations of pursuing research question
✔ Improve ERAS application (USMLE aspirants)
✔ Pass residency
✔ Provide financial support
✔ Need publication for promotion
✔ Getting at the truth of the matter is interesting
● Irrespective of the reason, it is wise to confirm that you are not the only one
who finds it interesting
● But first make sure, it interests you!

12. Novel
● Good research contributes to new information
● A study repeating what is already known is not worth effort and cost
● Although novelty is important, it need not to be entirely original
whether the research can be replicated to different settings
findings in one population also apply to others
improved measurement techniques can clarify relationships between risk factor
and a disease
a better designed study that overcomes the weaknesses of previous studies

13. Ethical
● Good research question must be ethical
● If study poses unacceptable physical risks or invasion of privacy, the
investigators must seek other ways to answer the question
● Institutional review boards play an important role and it is better to consult
when in doubt at an early stage

14. Relevant
● Nothing is more important than relevance
● A good way to decide- imagine various outcomes that are likely to occur
● Consider how each possibility might advance scientific knowledge, influence
practice guidelines and health policy, guide further research
● When uncertain, discuss with mentors, clinicians or any other experts in the
field

15. Developing the research question and study plan
● Write down the research question and a brief –one page outline at an early
stage
● Requires self discipline!
● Helps investigators to clarify ideas about the plan and to discover specific
problems that need attention
● Provides a basis for early comments from colleagues and mentors

16. OBJECTIVES

17. Must align with research question
Aim: what you hope to achieve.
Objective: the action(s) you will take in order to achieve the aim
Objectives should be SMART
Specific – be precise about what you are going to do
Measureable –you will know when you have reached your goal
Achievable – Don’t attempt too much – a less ambitious but completed objective is better than
an over-ambitious one that you cannot achieve.
Realistic – do you have the necessary resources to achieve the objective? – time, money, skills,
etc.
Time constrained – determine when each stage needs to be completed. Is there time in your
schedule to allow for unexpected delays?

18. General and specifics
General objective of your study states what you expect to achieve in general terms.
Specific objectives break down the general objective into smaller, logically connected
parts that systematically address the various aspects of the problem.
Your specific objectives should specify exactly what you will do in each phase of your
study, how, where, when and for what purpose.
● General Objective :
To examine the effect of the intervention on improving the knowledge of health workers on
family planning
• Specific Objectives :
1. Assess the change in knowledge after the intervention
2. Identify the factors associated with knowledge among health workers

19. Examples
● Assess the age of the patients undergoing
appendectomy
● Assess the gender of the patients undergoing
● Assess the occupation
● Assess……………..
Assess the general characteristics/ demographic
characteristics
MAKE IT
COMPREHENSIVE

20. Joining a Breakout Room

21. Joining a Breakout Room

22. Joining another Room

23. Leaving a Room

24. Group Activity
● Form a group of your choice
● Choose a research topic as a group
● Formulate a research question
● Present your research question and objectives