Hello, in this online course on Basic Course
in Biomedical Research
being offered by National Institute of Epidemiology
and Indian Council of Medical Research.
Today, I am going to give you Introduction
to Health Research.
Primarily, we have to understand that there
are many dimensions to health research.
Health research is conducted for theoretical
purposes and when we have some good evidence
created out of that we go for applied research.
There are also prevention and therapeutic
angles to doing health research as well, in
the sense some of the preventive technologies
as they emerge, they have to be tested out
through research methods as well as newer
therapeutic options become available they
need to be tested out through research methods.
Essentially, we have many a times heard of
and we have seen in the movies the bench best
research, where we have seen scientist in
white coats working in the laboratories trying
to do something with animals like mice and
monkeys and so on and so forth, but what they
do there has no significance until the findings
or the learning’s that they have got in
that particular research are carried further
and they become available to the bed side,
that is they are, they can be applied to the
human beings either for alleviating diseases
or for preventing diseases.
And this is a process which one has to understand
and one has to really follow correctly.
Sometimes the research is of exploratory in
nature, where in the sense we do not know
much about it right in the beginning, but
what we try to do is employ various methods
and try to figure out if we can get some clues
for further research.
Sometimes, it can be confirmatory, in the
sense some of the clues that have been obtained
by people can they be say sort of strengthened
or can we get additional information which
could be of practical significance?
That is called as Confirmatory Research.
There are other terminologies which are also
employed; one which has been recently employed
in a big way is Implementation Research and
Translational Research.
Many of the government programs get implemented
and what is important to understand at this
particular point of time is how these programs
are functioning well and it is also therefore
important to make mid course corrections,
if they are necessary or to decide in which
areas you need specific angles of the programs
to be strengthened and so on.
Transnational research basically talks about
the earlier concept of bench to bed site that
I talked about.
This is a process of development of technologies
for human benefit and human welfare.
There are some important principles that we
have to understand when we conduct health
research, but one thing which is really critical
is that the planning stage in research is
absolutely critical, why?
Because, if we do not spend enough time and
if we do not involve the right kind of people
in planning the research study, it is very
likely that some of the issues that we could
have earlier prevented or they get missed
which we could have prevented in the real
sense.
Hence, in my opinion team work is really critical
in research, very rarely solo research succeeds.
But for any kind of research to happen it
has to undergo several layers or levels of
reviews.
Scientific reviews are important because they
look at, what is the novelty in the concept
that is being looked at?
Is there rationality behind doing that?
And what is the justification for that?
And in that particular context the rational
for doing that particular study in a specified
country is also critically important.
Whereas, the ethics review primarily focuses
towards finding out, whether the human subjects
protection issues have been adequately taken
care of or not.
What is important is research definitely means
development, research definitely means advancements,
but it cannot be at the cost of human subjects.
People who are participating in the research
are described as human subjects or human participants
and we should do nothing that can really harm
them in the long run or in the short run.
So, ethics review ensures that this does not
happen.
There are certain ‘in country’ procedures
or ‘in country’ reviews called as Regulatory
Reviews and they are basically there to decide
about, what kind of foreign funding is being
received for that particular project?
Are there any sample shipments that are going
to happen?
Because there is a lot of intellectual property
also which is attached to this data sharing
which happens, we always should be protective
of our own intellectual properties and so
the regulatory authorities in our country
do take care of this and they ensure that
our intellectual property is properly protected.
Some projects do also involve exchange of
visitors and several countries have their
own rules and regulations regarding the visitors,
who are coming and going.
These are mandatory aspects and it is important
that the regulatory committees do review that
aspect as well.
One thing I would like to stress, the health
research or for that matter any research is
a process and it contains multiple components
and each and every component in this process
is of critical importance.
It all starts with collecting data.
We have to collect data with a specific purpose
and for that data to be of high quality, the
data collecting instruments also have to be
appropriately designed.
If the data quality is good, then we can draw
meaningful conclusions based on that and then
we can make appropriate decisions.
What is important is once these decisions
are made, the policy planners and the program
managers of the country , they decide, whether
this is the right time to take these particular
learning’s from research to appropriate
actions which can be employed at an individual
level or at a mass level.
This is what we call as ‘Evidence based
action’.
Primarily, all this is done so that we ensure
that there is a reduction in suffering and
ultimately improvement in health and well
being of the people or the community.
But when we talk about the kind of information
that we collect in research, it can have wide
range of breadth and depth as well.
There is some information which is required
to be collected with respect to the human
host for example, and they can be some times
healthy, they can be sometimes susceptible
to a particular condition or they can be suffering
from a particular disease, some of them may
have died because of the that particular disease
also.
We have to figure out, how we can get the
required information from these kinds of subjects
from these various kinds of host that I just
talked about.
The disease cannot occur in an individual
unless and until there are many factors which
come together and that is why we in the modern
times always say that there is a multi factorial
origin for occurrence of any particular disease
and we all know, the environment which is
surrounding us and the society in which we
live, plays a very significant role in occurrence
of diseases.
There could be factors like climatic factors,
there could be housing factors, housing related
factors, the vectors around us, the animals
around us, various socio-cultural practices
that we follow, the family structure with
which we live, all these factors can affect
not only the health of individuals which could
be physical or mental as well but they can
lead to an occurrence of a disease as well.
In addition to that one more dimension that
comes into the picture and which is really
important from the context of health is the
health care infrastructure.
Sometimes, people find it very difficult to
access health.
The access to health is a critical component
because many of these studies have shown that
if people are not able to access health in
time, the kind of complications that arise
and the death rates that result from that
are unusually high in nature.
So, there could be multiple angles which are
require to be collected, we call all those
like study variables.
We have to collect correct information on
those study variables when we carry out health
research.
Primarily, when we talk about the scope of
health research or the objectives of health
research they could be many.
For example, most of the times when we think
of research, we think of something like creating
new information but the objective could be
creating totally new information but we sometimes
also get additional information on something
which already exists.
Say for example, are more of diphtheria and
pertussis cases reported among adults in the
recent times?
We used to know that these were the diseases
of childhood earlier but now, it has been
seen that some rare instances the cases in
adults are also getting reported, so we need
to figure out why this is happening?
And where is it happening?
Similarly, in terms of getting new information
somebody might want to do research to find
out the full genome structure of hepatitis
B virus and hepatitis E virus.
It could have lot of implications in terms
of understanding what kind of pathogenic impact
it would have in human beings, also it could
have significant decision making with respect
to development of vaccine against those viruses.
Another objective that we also can pursue
through health research is to verify and confirm
available information.
Here is where, most of the research that happens
in our country is now-a-days happening.
For example, are etiologies of pediatric pneumonia,
you all know, pneumonia is a very serious
disease in childhood particularly in children
below 5 years of age.
So, are the etiologies different in the developed
countries and a resource limited countries
like India.
If one wants to figure this out, this could
fit under this particular objective.
Also, have the incidence and complications
of diabetes changed with increased consumption
of pre-cooked or packaged food.
We have seen this to change, the eating habits
of people have changed but has it got any
relation with the incidence and complications
we might want to study through health research.
Many a times health research is also focused
on finding out the cause and effect relationship
and this could be applied if you think about
it in multiple situations.
For example, there is a presence of a specific
receptor on a type of white blood cells which
are called CD4 cells in the human body and
they are believed to protect against HIV infection.
But whether they project against a particular
type of HIV infection, a particular sero-type
of HIV infection or they have a generalized
effect, this could be evaluated under a cause
and effect relationship related research.
You must also have heard that in the recent
times breast implant operations are undertaken,
but do these breast implant operations or
do these recipients, are they more likely
to develop breast cancers, this is something
like a cause and effect relationship, where
we can think of breast implant is a cause
and breast cancer is a effect.
One more important area in health research
is that testing of new interventions like
say, new drugs, new vaccines new tools or
newer prevention treatment technologies, etcetera.
For example, it has been said that tuberculosis
is one of the most common dreaded complications
or diseases to happen in HIV infected individuals
and mostly this is the disease which eventually
kills them.
So, can we introduce INH prophylaxis?
INH is a potent drug which is used against
tuberculosis, so can it be introduced among
HIV infected individuals, so that they can
be protected from getting tuberculosis.
This is an important intervention which could
be tried out and to reduce mortality associated
with HIV because of prevention of tuberculosis
in them.
Or for example, we are nowadays talking a
lot about indoor air pollution, particularly
in the rural areas.
So, if we decide to introduce smokeless stoves
in those areas, would that lead to reduction
in mortality and morbidity in the rural areas.
This could again be a part of an intervention
evaluation.
Sometimes, the government has various on going
programs, Public Health Programs which are
vertical in nature, which are operated by
the federal government or the central government
in our country.
All of you know that the general health services
are provided in our country by the state level
health services but the national level control
programs are operated and funded by the central
government.
So, for example, we have seen that there has
been large number of women noted with anemia
and this is one reason, why many complications
occur in pregnant women.
There has been this oral iron supplementation
has been the main stay for treatment of this
particular condition for many years, but nowadays
iron sucrose injectable iron has become avail
available and it is believed that it probably
can improve or tackle anemia during pregnancy
much better then oral iron.
So, evaluating that as been given in the program
could be an important thing that we can think
about under this part of research.
Also, the government has introduced a program
for several years now called as Integrated
Disease Surveillance Project or Integrated
Disease Surveillance Programs now.
So, can it predict the epidemics of newer
and emerging diseases likes H1N1 influenza
that has been affecting us recently.
So, these are some important objectives of
research that we have to keep in mind but
one important thing is, if we want to do sound
research, it is really critical that we make
the absolutely a right choice about the study
design over here because some kind of a miss
judgment here can lead to a futile kind of
a research or which does not help you to understand
it.
This can be broadly say described in terms
of some enquiries or some kind of health research
can be qualitative in nature, which requires
person to person interviews or discussion
in focus groups or just say free listing or
observations and things like that.
It mostly is observational in nature and it
is open ended and people do probe at times
to find out this information.
Whereas quantitative studies are mostly based
on structured questionnaires, that is where
people deal with questionnaires, which are
previously thought of and only the questions
with very specified options of answers that
can be made available are used or employed
in the study.
One more important differentiation that is
made is the observational study and experimental
studies.
In epidemiological terms, observational studies
are those wherein the investigators do not
change the environment in which the study
participants are living and the main thing
that distinguishes the experimental studies
is, this is where the participants are exposed
to some kind of an intervention at the will
of the investigators.
So, some kind of a change is made and that
is how this kind of studies becomes different
kinds of studies.
They also are described as retrospective studies
or prospective studies.
Retrospective studies are classically where
the information on the outcome that we are
trying to study in a particular health research
is already available.
But in a prospective study we only start the
study with people who are at risk or who are
susceptible to a particular disease , also
have a comparator arm or control group, comparison
group and then follow these two groups to
find out how many people in either of these
two groups develop a particular disease, which
they were free off at the beginning of the
study.
So outcome happens sometimes in the future
and it is called as a Prospective study design.
As I mentioned earlier, planning is a very
critical stage in research and some important
considerations in this particular phase, which
have to be kept in mind include, there should
be adequate justification for conducting that
particular research.
Always please remember research involves investment.
Investment in terms of money, investment in
terms of manpower and hence, it is absolutely
important that there should be adequate rational
or justification for conducting any research
study.
For this to happen, the original research
question should have total clarity and focus
only then the study becomes a good study.
Another important point to be considered is
that, the case definitions used for various
study variables and outcomes should be standard
and unambiguous.
For example, if you are looking at cancer
cervix then what we call as carcinoma in-situ
and what we call as invasive cancer has to
be known to everybody, who is involved in
that particular research.
For example, if you are collecting information
on oral contraceptive pills use, what is considered
to be as those women who are using oral contraceptives
pills versus those, who are not, should be
adequately clarified.
Another critical aspect that has to be kept
in mind is the sample and a sample size.
It has two dimensions to that, sample has
to be qualitatively representative of the
population in which the study is being conducted
because here this leads to what we call as
external validity or generalizability.
In simple terms, it means that if we are able
to just generalize the findings of our study
which are based on a particular sample adequately
and comfortably to the whole population from
which the sample was drawn then we have served
our purpose.
But this also has to be complimented with
adequate sample size as well because this
is, we should have enough power to draw meaningful
inferences and hence sample size should be
appropriately decided for any kind of a research
study.
We always have to remember research can never
be free from errors, but if we predict them
well then they can be minimised through appropriate
study design, this is an important aspect.
Sometimes errors happen because no two human
beings are equal, one person has a different
haemoglobin level than the other, one person
has a different height and a different weight
than the other and hence, we look at many
such people together there would be some kind
of a variation which would naturally be happening
in them and this is what we call as a random
error, which anyway is going to be there in
any kind of a research study.
How we minimize it is by taking a large sample
size.
If we take a large sample size this intra
individual variation within a particular sample
gets minimised to a large extent.
But sometimes, there could be another type
of error that could occur and the results
could be due to a something called as bias.
And this is a variation due to some kind of
distortion by some kind of a faulty procedure,
it might be a measurement error, it is may
be due to the kind of way the information
is collected, it might be due to the process
in which the participants are enrolled in
the research study.
So, one has to remember this kind of an error
can only be minimised by improving the study
design and taking care of that very adequately.
There will always be challenges in designing
and implementing any kind of a research study.
But the important thing that we have to understand
is how we predict those, and one way to tackle
this very appropriately is to do a thorough
literature research before we do any kind
of a study because it gives us an idea about
two important say entities which can affect
the result, they are called as Confounders
and Effect modifiers.
Well, confounders are the entities which affect
both the study variable as well as the study
outcome and invariably, if you just leave
out all those people having this confounding
characteristics, it is quite possible that
you may land up with a situation where you
do not have enough people to do research at
all and in this particular scenario therefore,
it is important that we understand which are
the confounders.
Collect the right kind of information on all
the confounding factors because statistical
analysis can take care of this confounding,
which happens in a research setting.
Effect modifiers are little difficult to deal
with because they can alter or distort the
true relationship between the study variable
that we are looking at and outcome by independently
effecting the outcome itself.
So theoretically, it is a good idea to be
aware of them and to also understand the kind
of effect they are likely to make on the outcome
variable, also one strategy that could be
tried is to not to include people with effect
modifiers in the study.
When we do any kind of a study, it can have
multiple stages.
It might be a good idea to do a pilot study.
Pilot study just helps us to carry out all,
what we want to do in the study in a say sort
a few individuals this kind of becomes a rehearsal.
It helps us to understand what kind of difficulties
we are likely to face in collecting the information,
carrying out certain procedures, doing the
interviews, doing the inform consents, peoples
understanding about informed consent forms
and so on which can be changed.
There have to be certain issues related to
study participants that need to be tackled
very well, which are the inclusion criteria?
And which are the exclusion criteria?
One has to be very specific about all of them.
Why?
Because, if we are very specific about inclusion
and exclusion criteria, enrolment of people
who are not eligible to participate in the
study can be substantially minimized.
Also, every research study has to move with
very specific research targets and it should
follow certain strategies, like in some studies
we might want to do the recruitments by going
out in the community, whereas in some we might
just want to do it based in the healthcare
facilities, this decision has to be taken
up front.
Data collection instruments are really critical
because if there are any mistakes the way
they have been designed we cannot make any
kind of a change at a later stage.
So, lot of work has to be done before hand
in drawing or in deciding the right kind of
data collection tools.
Measurements, here I am referring to all those
measurable items which are either using the
laboratory methods or assays.
They have to be properly standardized.
They should have proper internal and external
controls, here positive and negative controls
for quality control.
This lab also should probably be a part of
an external quality assurance program because
all this ensures quality control and assurance
at all levels.
It is also important that the plan for statistical
analysis for any kind of a study has to be
decided right up front, right in the beginning
because that gives you a very clear idea about
how we are going to collect this particular
information and how the results of this particular
study are going to look like eventually.
So when we are doing health research, we have
to have some kind of an orientation towards
either promoting behaviour or promoting health
then preventing disease and also preventing
mortality and then maybe.
So, how can we do that?
How can health of the population be improved?
This is something like a direction that we
have to think about.
How can we predict occurrence of a disease
in an individual?
How can various diseases be prevented?
How can we effectively cure the diseases and
reduce the cost and also the associated morbidity
and mortality?
What are the various societal community based
and programmatic interventions for disease
prevention and control?
These are the kinds of directions which health
research takes and follows.
But basically, what we try to do is to find
answers or practical solutions at individual
and community levels.
For example, at community levels we have to
see how healthy behaviour can be promoted?
What can be the personal prevention achievable
at an individual level?
How can early diagnosis be achieved at an
individual level and adequate and appropriate
treatment be instituted?
What kind of rehabilitation be done at an
individual level?
But when we think of the community level we
have to think of improving the community behaviour
and practices, prevention and control programs
as supporting the effected people or stigma
reduction.
All in all, healthy individuals only can build
healthy nations.
Thank you very much.
