Facilitator's Guide Session III- How to Do Clinical Research At KEMU?

          
Second Session: How to do clinical research at KEMU?
Date: June 21st 2014
Format: Lecture via Google Plus
Faculty: Dr. Ahmad M Rashid MD,FCCP
Length: 90 Minutes
Objective:
The session was basically aimed at
 helping the students formulate their own clinical questions.
Give basic information of clinical research structure.
Pre-session work:
Students were directed to study  the document about clinical research provided by Dr. Mujtaba Rashid. Here is a link to that stuff:
http://kemumentoring.blogspot.com/2014/06/clinical-research-reading-before-session.html

The session was divided into following segments:

1. Introduction of clinical research with brief history
2. Basic structure of research
3. How to develop clinical question
4. Clinical hypothesis
5. Research methods
6. Research model
7. QA session

1.Introduction of clinical trials:
      Describing the history of clinical trials, Dr. Rashid told that James Lind, a Scottish physician is attributed to have conducted first ever known clinical trials. British trading ships and Navy were suffering from Scurvy. It was known that citrus fruit might help cure scurvy. James Lind conducted clinical trials to prove this hypothesis. The study design of his trials
He divided 12 scorbutic sailors into six groups of two. They all received the same diet but, in addition:
Group 1: was given a quart of cider daily
Group 2: twenty-five drops of elixir of vitriol (sulfuric acid),
Group 3: six spoonful of vinegar
Group 4: half a pint of seawater
Group 5: received two oranges and one lemon
Group 6: a spicy paste plus a drink of barley water
The treatment of group five stopped after six days when they ran out of fruit, but by that time one sailor was fit for duty while the other had almost recovered. Apart from that, only group one also showed some effect of its treatment.
The entire session was based on this first clinical trial. All the salient features of research were explained by dr. Rashid using Lind's trial .
2.Basic Structure of Clinical Research:
      Clinical research has following building blocks:
Clinical/Research Question
Hypothesis
Methods
Observations
Results-Statistics Conclusions
3.What is a clinical question and how to develop an answerable clinical question:
        A researchable question is an uncertainty about a problem that can be challenged, examined and analyzed to provide useful information. In case of first ever clinical trial mentioned above, the clinical question was

“Can Scurvy be treated by addition of citrus fruit to the diet of sailors?”
PICO model is used to develop a clinical question. PICO stands for:
P: Population of interest :Patient or the
problem to be addressed
I: Intervention: Exposure to be considered–
treatments/ tests
C: Control :Control or comparison intervention treatment/placebo/standard of
care
O: Outcome :Outcome of interest
To formulate  a research question on must perform:
Background research
Literature review
Dissect the questions into parts
Other relevant questions
4.Clinical Hypothesis:
             Clinical hypotheses are theories that could explain presenting behavior or facts. Their purpose is to guide current assessment and intervention. In case of Lind's trial the hypothesis would be
“Citrus fruit will stop “putrefaction” of sailors’ bodies hence preventing Scurvy.”
A good hypothesis should meet following criteria:
A hypothesis should concern information that still needs to be established.
A hypothesis should be a statement worded precisely and objectively in the present tense
A hypothesis can relate to a range of factors: nature of impairment, severity of impairment, impact of impairment etc.
A hypothesis should be based on clear evidence (reported or theoretical) which provides a rationale for formulating it.
A hypothesis should be specific enough to lead towards clear assessment and intervention objectives.

5.Research Methods:
Research studies can be Experimental or Observational
Experimental Studies:
    Experimental studies have following features:
allocation or assignment of individuals is under control of investigator and thus can be randomized.
investigator controls the assignment of the exposure or of the
treatment
symmetry of potential unknown confounders is maintained through randomization
Observational Studies:
       Observational studies have following features:
Allocation or assignment of factors is not under control of investigator
The combinations are self-selected or are "experiments of nature“
For those questions where it would be unethical to assign factors,
Investigators are limited to observational studies
6.Research model:
       Finally a research model was provided by Dr. Rashid to students to have a complete understanding of Research design. Model was based on the following topic:
"Dabigatran versus warfarin in the treatment of Acute venous Thromboembolism
The complete model is given in power point presentation to be uploaded on the blog:
kemumentoring.bogspot.com
7.QA session:
Students were encouraged to ask questions regarding the session. A few asked about their queries but due to shortage of time, the rest were asked to mail their questions. Everyone was provided with an online feedback form to be filled.

Overall this was a good session. Sound Quality was excellent. But the drawback was that a lot of things were tried to be covered in one session so many things remained unexplained. Most students were of the opinion that there should have been a separate session about clinical question as this is the foundation step for the new people in the field of research.