Introduction_to_Research_and Methods_Ebenezer Senu.pdf

Introduction To Research In Medical Sciences
And Research Methods
BY
Ebenezer Senu
President – (NAHSAG), Ashanti Zone
Research/Teaching Assistant – Molecular Medicine,
School of Medicine and Dentistry, KNUST, Ghana
8/10/2022 Research and Research Methods_ebensenu 1

Presentation Roadmap
Clinical research
Objectives
Qualities
How clinical research differ from standard care
Types of Clinical Research Methods
Research approaches
Research process and methods
Research Ethics
References

Research?
Is a systemic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalized knowledge
Research derived from middled French “rechereche” means “to go about
seeking” (1577)
Re Search
Again Find
Process
Step by step/
Phases

Objectives
Exploratory/formulative research: To gain familiarity with a
phenomenon or achieve a new insights into it
Descriptive research: To depicts accurately the characteristics of
particular individual, situation or a group
Diagnostics research: To determine frequency or association with
something
Hypothesis-testing: To test hypothesis of relationship between
variables

Qualities of Good Research
Systematic
Logical
Empirical
Replicable
Creative

Research Motivation
Desire to get a degree
Desire to face the challenge in solving unsolved problems
Intellectual joy of doing some creative work
Desire to be of service to society
Desire to get respectability
Desire for promotions and positions
Desire for employments

Types of Research
Descriptive
vs
Analytical
Applied vs
Fundamental
Quantitative
vs
Qualitative
Conceptual
vs Empirical Other types
One time
Cross-
sectional
Longitudinal
Cohort
Historical Diagnostics
Clinical/
cause
Experimental
RCT
Exploratory

Descriptive vs Analytical Research
Descriptive research includes surveys and fact-finding enquiries
of difference kinds, discovers causes
Researcher has no control over the variables; he can only report
what has happened or is happening
Analytical: Researcher has the facts or information already and
analyses these to make critical evaluation of the variables

Applied vs Fundamental
Research
Applied aims at finding solution for an immediate problem facing
society or industry: discover solution for pressing practical problems
Eg; Identify economic and political trends in Nigeria
Fundamental concerned with generations and formulation of
theory
Eg; Natural phenomenon concerning human behavior

Quantitative vs Qualitative
Research
Quantitative: Measurement of amount or generating numerical
data usable in statistics
Eg; Online polls or surveys
Qualitative: Primarily exploratory research. Involves understanding
reasons, opinions. Provide insight to a problem or ideas/hypothesis
Eg; Focus group discussion, participation or observations

Conceptual vs Empirical
Research
Conceptual: Related to abstract theories or ideas
Use by philosophers and thinkers to develop new concepts or to
interpret existing ones
Empirical research: Data based research, coming up with
conclusions which are capable of being verified by observation or
experiment
Research set hypothesis, set up experiment to prove or disprove the
hypothesis using generated data

Other types 1/2
One-time research: confined to single time period
Longitudinal: Carried over several time periods
Exploratory: It is the preliminary study of unfamiliar problem
about which the research has little or no knowledge. It aimed to
gained familiarity of the problem (Formulative research)

Other types 2/2
Experimental research: Designed to assessed the effect of one
particular variable on phenomenon by keeping the other variables
constant or controlled
Historical research: The study of past records and other
information sources, with the view to find the origin and development
of a phenomenon and to discover the trends in the past, in order to
understand the present and to anticipate the future

Problems In Research
Time and money
Lack of scientific training in the methodology of research
Insufficient interactions between university research
departments and business establishments or industries

Problems In Research
Lack of confidence on the part of industries to give information
Lack of code of conduct
Poor library management and functioning
Difficulty of timely availability of published data

How Does Clinical Research Differ From
Standard Care? 1/2
Involves human volunteers, these may be patients or can all be healthy
individuals who are not suffering from an illness or condition
Is carried out with the ultimate aim of improving standard care; testing
an intervention (e.g. a product or procedure) or collecting data about a
topic such as patient experience, disease management
Measures effects over a period of time using robust and reliable
methods to identify a lack of knowledge on issues such as costs,
improved care, better drugs, treatments or therapies, additional support

How Does Clinical Research Differ From
Standard Care? 2/2
May involve a comparison ‘control’ group, depending on the type of
research
Focuses on unknowns such as the effect of intervention, the
likelihood of a community to change their practices
Must stick to a protocol without deviation (within the investigator’s
clinical judgement). By comparison standard care is all about clinical
judgment, decisions and flexibility

During 20th century huge improvements seen in global health were
mainly a result of the knowledge gained through clinical research:
1920s: research
found that improving
Children' nutrition
helped combat rickets
and other childhood
diseases
1950s: epidemiological
research proved that
cigarette smoking
caused lung cancer
1980s: trials proved
that giving folic acid to
high-risk women
resulted in a reduction
of babies born with
spina bifida
1990s: clinical trials
showed that the
progress of AIDS could
be delayed by
combining antiretroviral
drugs

Research Approaches
Research
Approaches
Quantitative
approach
Qualitative
approach
Mixed
Method
Analysis of numerical data
and their relationship
Analysis of data using words
(interviews), pictures
(videos), objects (artifacts)
Combinations

Research Approaches
Research
Approaches
Quantitative
approach
Qualitative
approach
i. Deductive- From theory to fact
ii. Relate occurrence of a variable
with other variables
iii. Establish generalization for
predictions and control
i. Inductive- From fact to theory
ii. Explores factors that could
explain why given event occurs
iii. Establish patterns for why an
event occur

Research Process

i. Formulating Research Problem
Why are people having higher done normal body temperature?
Why are people growing very lean done normal?

ii. Extensive literature survey
Reference manager software
Medical data base

Develop Research Hypothesis
Null Hypothesis
High body temperature is not associated with COVID-19 infection
Alternate hypothesis
High body temperature is associated with COVID-19 infection

Study Designs
STUDY
DESIGNS
Observational Experimental
A. Descriptive
1. Case Report
2. Case Series
B. Analytical
1. Cohort
2. Case control
3.Cross sectional
RCT’s
Community trials
Field trials

Case Report
A detailed histories representation of a single case
Provide the symptoms, signs, diagnosis, treatment, and follow-up of
an individual patient
Unexpected associations between diseases or symptoms
Unexpected events in the course of observing or treating a patient

Case Report
Findings that shed new light on the possible pathogenesis of a
disease or an adverse effect
Unique or rare features of a disease or therapeutic approaches
A variation of the anatomical structures
Case reports allow us to uncover unexpected effects, new diseases
which can lead to increased knowledge

Case Report

Case Series
A number of patients with a particular disease

Cohort

Example of Cohort

Cross-Sectional

RCT’s

Did investigator
assign exposures?
Experimental/
Interventional study
Random Allocation
Randomized
controlled trial
Non-randomized
controlled trial
Observational study
Comparison group
Analytical study
Descriptive study
Direction?
Yes No
Cohort
Exposure → Outcome
Case-control
Exposure ← Outcome
Cross-sectional
Exposure & Outcome
No
No
Yes

Study Design: Key Points To Remember
There are different types of clinical research designs and the
question being investigated will determine the study design
Cohort studies follow specific groups of people over a period of
time to see how outcomes differ when they receive different
treatments and interventions
Case control studies compare people with a specific outcome to
individuals without that outcome to investigate the exposures that
may have caused the outcome

Study Design: Key Points To Remember
Cross sectional surveys aim to describe the relationship between a
health-related state and other factors of interest in a specified population
at a given time
Case reports are detailed histories of single cases and allow us to
uncover unexpected effects, new diseases, etc., which can lead to
increased knowledge
Clinical trials allow for collection of data on the safety and efficacy of
health interventions. They are thought by some to be the ‘gold standard’
of clinical research

Sampling
Deliberate sampling: Purposive or non-probability
That’s purposively selection of particular study participants
Convenience sampling

Sampling
Another Purposive or non-probability: Referral or Snowball
Sampling

Sampling
Simple random sampling: Chance or probability sampling
Where each and every item in a population has equal chance of
being included in a study

Sampling
Systemic sampling: Selection of every nth element until desire
number is secured. Eg; every 5th name on the list, every 10th house
on one side of the street

Sampling
Stratified random sampling: Prior to sampling, the population is
divided into mutually exclusive strata based on factors likely to
affect the outcome. Then, within each stratum, a simple or
systematic random sample is chosen
Proportional vs Disproportional

Sampling
Proportional Stratified random sampling: Sampling elements
are selected from each subgroup—stratum—according to their
proportion in the population of interest

Sampling
Disproportional Stratified random sampling: random elements
are selected according to the will of the investigator

Sampling
Cluster and area sampling: A cluster is a natural or convenient
collection of elements with one or more characteristics in common
Easier to get a list of clusters common objects than it would be to
get a list of individuals objects

Sampling
Multi-stage sampling

Sample Size Calculation
Different study designs have different formulae for sample size
determination
Case-Control Study
Cross-Sectional Study

Data Collection
Primary data
Experiment; Quantitative
measurements
Surveys: Interviews,
questions, observation

Statistical Analysis
Hypothesis testing
Research objectives
Cleaning coding data transformation re-coding
analysis

Generalization and Interpretation
Generalization and interpretation of results to the general
population

Validity Of Results

Research Ethics
These three basic principles are as follows:
Justice: no group should carry more than their fair share of the burdens
of research, those who participated should have access to the benefits of
the results and no group should be unfairly excluded from research
Minnies et al. (2008) emphasise that poverty, disease, lack of education,
hardship, submissiveness, the effects of war, famine, pandemics, and
social insecurity prevalent in developing countries all make participants
more vulnerable to research exploitation’
Beneficence: possible harms should be minimised and possible benefits
should be maximized
Respect for autonomy: individuals’ freedom to choose and act must be
respected and vulnerable individuals must be protected

Key Points To Remember
Uniformity of study and of quality assurance procedures are ensured by the
implementation and use of standard operating procedures (SOPs)
SOPs identify who is responsible for which task, provide the steps to be followed for
study procedures, help all staff to carry out a particular task in the same way, and
help to monitor site performance
All research study staff should be trained in and have access to a copy of the SOPs
SOPs also see to it that the quality of the data handling and processing is
maintained

References
Introduction to Clinical Research: https://globalhealthtrainingcentre.tghn.org/introduction-clinical-
research/
Introduction to Biomedical Research: https://alison.com/topic/learn/86302/overview-of-health-
research-learning-outcomes:
Research Methods For Health Sciences: https://courses.nextgenu.org/course/view.php?id=275
https://www.slideshare.net/RajasekarVr/introduction-to-research-methodology-86274378
Introduction to Qualitative Research: https://www.train.org/virginia/course/1046375
Research Process and Methods: https://www.train.org/virginia/course/1082906

ebensenurc@gmail.com
Twitter: @Eben_Senu
Instagram: @ebensenu
LinkedIn/Facebook: Ebenezer Senu

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