The Scientific Method

Scientific method

It is a process that is used to find answers to questions

about the world around us.
Scientific method
There are several versions of the scientific method.
Some versions have more steps, while others may have only a few.
However, they all begin with the identification of a problem or a
question to be answered based on observations of the world around
us.
 VARIABLES

It is defined as an attribute of an object of study.

Data is a specific measurement of a variable and it is the value you record in
your data sheet.
In research, variables are any characteristics that can take on different values.

In scientific research, we often want to study the effect of one variable on

another one. For example, you might want to test whether students who
spend more time studying get better exam scores.
 VARIABLES
It may be weight, height, anxiety levels, income, body temperature and
so on.
Each of these properties varies from one person to another and also has
different values along a continuum.
It could be demographic, physical or social and include religion,
income, occupation, temperature, humidity, language, food, fashion, etc.
Some variables can be quite concrete and clear, such as gender, birth
order, types of blood group etc while others can be considerably more
abstract and vague
TYPES OF VARIABLES
There are different types of variables:

• Independent
• Dependent
• Active and attribute
• Continuous
• Discrete and categorical
• Extraneous variables and Demographic variables
Dependent and Independent Variables
Dependent Variable(s): The response or factors that are measured during
a study. The dependent variable responds to the independent variable.

Independent variables are what we expect will influence dependent

variables. A Dependent variable is what happens as a result of the
independent variable. For example, if we want to explore whether high
concentrations of vehicle exhaust impact incidence of asthma in
children, vehicle exhaust is the independent variable while asthma is the
dependent variable.
A discrete variable is a variable whose value is obtained by
counting. Examples: number of students present
number of children with malaria

• A continuous variable is a variable whose value is obtained by

measuring. Examples: height of students in class
weight of students in class
time it takes to get to school
 ACTIVE AND ATTRIBUTE VARIABLES
An active variable is a variable that can be manipulated. Active variables are also
called experimental variables.
Examples of this type of variable are teaching methods, training regimens, and
the like, which can be altered to gauge their effect on phenomena.

An attribute variable is a variable that cannot be manipulated.

An example of an attribute variable is gender, race, psychological condition, and
or any characteristic that is inherent or pre-programmed and cannot be altered.
EXTRANEOUS VARIABLES
Variables that may affect research outcomes but have not been
adequately considered in the study are termed as extraneous variables.

Extraneous variables exist in all studies and can affect the measurement
of study variables and the relationship among these variables.

Extraneous variables that are not recognized until the study is in

process, or are recognized before the study is initiated but cannot be
controlled, are referred to as confounding variables”
• Certain external variables may influence the relationship between the
research variables, even though researcher cannot see it.

• These variables are called intervening variables. For example, girl’s

knowledge and practices helps in maintaining menstrual hygiene.

• Here, motivation, mother and friends, mass media, are some

intervening variables which may also help in maintaining menstrual
hygiene.

• Thus, if these two factors are not controlled it would be impossible to

know what the underlying cause really is.
Discrete variable
Discrete variables are numeric variables that have a countable number of
values between any two values.

A discrete variable is always numeric.

Discrete data is information that can only take certain values. These values
don’t have to be whole numbers for example amount of sugar in the blood,
height of students in a class
Categorial variables
A categorical variable is a discrete variable that captures qualitative
outcomes by placing observations into fixed groups (or levels). The
groups are mutually exclusive, which means that each individual fits
into only one category.

The variable gender, for example, has only two values (male and
female). Variables that take on only a handful of discrete non
quantitative values are categorical variables.
 DEMOGRAPHIC VARIABLES
Demographic variables are characteristics or attributes of subjects that are collected
to describe the sample”.

They are also called sample characteristics.

It means these variables describe study sample and determine if samples are
representative of the population of interest.

Although demographic variables cannot be manipulated,

Researchers can explain relationships between demographic variables and dependent
variables.
Some common demographic variables are age, gender, occupation, marital status,
income etc.
MEASURING VARIABLES
In order to do an analysis, the variables have to be quantified; this
means measuring giving values and scale.

Sometimes identification of variables and determining how to measure

them looks quite simple, but due to vaguely defined variables measuring
can be difficult too.

There are four levels of measurements on a continuum of discrete and

continuous: nominal-scale, ordinal-scale, interval-scale and ratio-scale.

Nominal scale is used when the variables can be categorized but cannot
be ranked. E.g. gender, marital status, race, diagnosis, blood group etc.
Ordinal scale includes statistical data type where variables are in order
or rank but without a degree of difference between categories.
The ordinal scale contains qualitative data; ‘ordinal’ meaning ‘order’. It
places variables in order/rank, only permitting to measure the value as
higher or lower in scale. The scale cannot generate a precise comparison
between the two categories.

Interval scale can be defined as a quantitative measurement scale where

variables have an order, the difference between two variables is equal,
and the presence of zero is arbitrary. It can be used to measure variables
that exist along a common scale in equal intervals.

A ratio scale is a quantitative scale where there is a true zero and equal
intervals between neighboring points. Unlike on an interval scale, a zero
on a ratio scale means there is a total absence of the variable you are
 CLINICAL STUDY
A clinical study involves research using human volunteers (also called
participants) that is intended to add to medical knowledge.

There are two main types of clinical studies: clinical trials (also called
interventional studies) and observational studies (Non Intervention Studies).
Clinical Trials
In a clinical trial, participants receive specific interventions according to the
research plan or protocol created by the investigators.

These interventions may be medical products, such as drugs or devices;

procedures; or changes to participants' behavior, such as diet.

Clinical trials may compare a new medical approach to a standard one that is
already available, to a placebo that contains no active ingredients, or to no
intervention.
When a new product or approach is being studied, it is not usually known whether it
will be helpful, harmful, or no different than available alternatives (including no
intervention).

The investigators try to determine the safety and efficacy of the intervention by
measuring certain outcomes in the participants.

For example, investigators may give a drug or treatment to participants who have high
blood pressure to see whether their blood pressure decreases.
 Observation Study
In an observational study, investigators assess health outcomes in groups of
participants according to a research plan or protocol.

Participants may receive interventions (which can include medical products

such as drugs or devices) or procedures as part of their routine medical care,
but participants are not assigned to specific interventions by the investigator
(as in a clinical trial).

For example, investigators may observe a group of older adults to learn more
about the effects of different lifestyles on cardiac health.
Reasons for Conducting Clinical Studies

• Evaluating one or more interventions (for example, drugs, medical devices, approaches to
surgery or radiation therapy) for treating a disease, syndrome, or condition

• Finding ways to prevent the initial development or recurrence of a disease or condition.

These can include medicines, vaccines, or lifestyle changes, among other approaches.

• Evaluating one or more interventions aimed at identifying or diagnosing a particular disease

or condition

• Examining methods for identifying a condition or the risk factors for that condition

• Exploring and measuring ways to improve the comfort and quality of life through
supportive care for people with a chronic illness
Participating in Clinical Studies
A clinical study is conducted according to a research plan known as the
protocol. The protocol is designed to answer specific research questions and
safeguard the health of participants. It contains the following information:

• The reason for conducting the study

• Who may participate in the study (the eligibility criteria)
• The number of participants needed
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study
• What information will be gathered about the participants
Who Can Participate in a Clinical Study?
Clinical studies have standards outlining who can participate. These
standards are called eligibility criteria and are listed in the protocol. Some
research studies seek participants who have the illnesses or conditions that
will be studied, other studies are looking for healthy participants, and some
studies are limited to a predetermined group of people who are asked by
researchers to enroll.

• Eligibility. The factors that allow someone to participate in a clinical

study are called inclusion criteria, and the factors that disqualify someone
from participating are called exclusion criteria. They are based on
characteristics such as age, gender, the type and stage of a disease,
previous treatment history, and other medical conditions.
How Are Participants Protected?
Informed consent is a process used by researchers to provide potential and enrolled participants
with information about a clinical study. This information helps people decide whether they
want to enroll or continue to participate in the study.

The informed consent process is intended to protect participants and should provide enough
information for a person to understand the risks of, potential benefits of, and alternatives to the
study.

In addition to the informed consent document, the process may involve recruitment materials,
verbal instructions, question-and-answer sessions, and activities to measure participant
understanding.

In general, a person must sign an informed consent document before joining a study to show
that he or she was given information on the risks, potential benefits, and alternatives and that he
or she understands it. Signing the document and providing consent is not a contract.
Institutional review boards.
Each conducted clinical study and each study of a drug, biological product, or medical
device must be reviewed, approved, and monitored by an institutional review board (IRB).

An IRB is made up of health practitioner, researchers, and members of the community. Its
role is to make sure that the study is ethical and that the rights and welfare of participants
are protected.

This includes making sure that research risks are minimized and are reasonable in relation
to any potential benefits, among other responsibilities. The IRB also reviews the informed
consent document.

In addition to being monitored by an IRB, some clinical studies are also monitored by
data monitoring committees (also called data safety and monitoring boards).
NON-INTERVENTION STUDIES

• Exploratory studies
• Descriptive studies
• Comparative (analytical) studies
Exploratory studies

Is defined as a research used to investigate a problem which is not clearly defined.

It is conducted to have a better understanding of the existing problem, but will not
provide conclusive results.

For such a research, a researcher starts with a general idea and uses this research as a
medium to identify issues, that can be the focus for future research.

An important aspect here is that the researcher should be willing to change his/her
direction subject to the revelation of new data or insight.

Such a research is usually carried out when the problem is at a preliminary stage. It is
often referred to as grounded theory approach or interpretive research as it used to answer
questions like what, why and how.
Types and methodologies of Exploratory research
• While it may sound a little difficult to research something that has very little
information about it, there are several methods which can help a researcher figure
out the best research design, data collection methods and choice of subjects.

• There are two ways in which research can be conducted namely primary and
secondary. Under these two types, there are multiple methods which can used by a
researcher.

• The data gathered from these research can be qualitative or quantitative.

Some of the most widely used research designs include the following:

Primary research methods

Primary research is information gathered directly from the subject. It can be
through a group of people or even an individual.

Such a research can be carried out directly by the researcher himself or can
employ a third party to conduct it on their behalf.

Primary research is specifically carried out to explore a certain problem

which requires an in-depth study.
• Surveys/polls: Surveys/polls are used to gather information from a predefined group of
respondents. It is one of the most important quantitative method.
• Various types of surveys or polls can be used to explore opinions, trends, etc. With the
advancement in technology, surveys can now be sent online and can be very easy to
access.
• For instance, use of a survey app through tablets, laptops or even mobile phones. This
information is also available to the researcher in real time as well. Nowadays, most
organizations offer short length surveys and rewards to respondents, in order to achieve
higher response rates.

• For example: A survey is sent to a given set of students on assessment of the knowledge,
attitude and perception of COVID-19 vaccine. Based on such information
pharmaceutical organization can dig deeper into the topic and make business related
decision.
Interviews: While you may get a lot of information from public sources, but
sometimes an in person interview can give in-depth information on the subject being
studied. Such a research is a qualitative research method.

An interview with a subject matter expert can give you meaningful insights that a
generalized public source won’t be able to provide. Interviews are carried out in person
or on telephone which have open-ended questions to get meaningful information about
the topic.

For example: An interview with an employee can give you more insights to find out the
degree of job satisfaction, or an interview with a subject matter expert of quantum
theory can give you in-depth information on that topic.
Focus groups: Focus group is yet another widely used method in exploratory
research. In such a method a group of people is chosen and are allowed to express
their insights on the topic that is being studied.

Although, it is important to make sure that while choosing the individuals in a focus
group they should have a common background and have comparable experiences.
For example: A focus group helps a research identify the opinions of consumers if
they were to buy a phone.

Such a research can help the researcher understand what the consumer value while
buying a phone. It may be screen size, brand value or even the dimensions. Based
on which the organization can understand what are consumer buying attitudes,
consumer opinions, etc.
Observations: Observation research can be qualitative observation or quantitative
observation.
Qualitative observations are made when you use your senses to observe the results.
(Sight, smell, touch, taste and hear.)

Quantitative observations are made with instruments such as rulers, balances,

graduated cylinders, beakers, and thermometers. These results are measurable.

Such a research is done to observe a person and draw the finding from their reaction to
certain parameters. In such a research, there is no direct interaction with the subject.
• For example: Contribution of Different Risk Factors in the Occurrence of
Stroke
• The researcher observes the customers first reaction and collects the data, which is then
used to draw inferences from the collective information.
Secondary research methods
• Secondary research is gathering information from previously published primary
research. In such a research you gather information from sources likes case
studies, magazines, newspapers, books, etc.
• Online research: In today’s world, this is one of the fastest way to gather
information on any topic.
• A lot of data is readily available on the internet and the researcher can download it
whenever he needs it.
• An important aspect to be noted for such a research is the genuineness and
authenticity of the source websites that the researcher is gathering the information
from.
• For example: A researcher needs to find out what is the percentage of people that
prefer a specific brand phone. The researcher just enters the information he needs
in a search engine and gets multiple links with related information and statistics.
• Literature research:
Literature research is one of the most inexpensive method used for discovering a
hypothesis. There is tremendous amount of information available in libraries, online
sources, or even commercial databases. Sources can include newspapers, magazines,
books from library, documents from government agencies, specific topic related articles,
literature, Annual reports, published statistics from research organizations and so on.

• However, a few things have to be kept in mind while researching from these sources.
Government agencies have authentic information but sometimes may come with a
nominal cost. Also, research from educational institutions is generally overlooked, but in
fact educational institutions carry out more number of research than any other entities.

• Furthermore, commercial sources provide information on major topics like political

agendas, demographics, financial information, market trends and information, etc.
• For example: A company has low sales for a drug. It can be easily explored from
available statistics and market literature if the problem is market related or organization
related or if the topic being studied is regarding financial situation of the country, then
research data can be accessed through government documents or commercial sources.

• Case study research: Case study research can help a researcher with finding more
information through carefully analyzing existing cases which have gone through a
similar problem. Such analysis are very important and critical especially in today’s
health research.

• The researcher just needs to make sure he analyses the case carefully in regards to all the
variables present in the previous case against his own case. It is very commonly used by
business organizations or social sciences sector or even in the health sector.
• For example: A particular orthopedic surgeon has the highest success rate for
performing knee surgeries. A lot of other hospitals or doctors have taken up this case to
understand and benchmark the method in which this surgeon does the procedure to
increase their success rate.
• Exploratory research: Steps to conduct a research

• Identify the problem: A researcher identifies the subject of research and

the problem is addressed by carrying out multiple methods to answer the
questions.
• Create the hypothesis: When the researcher has found out that there are no
prior studies and the problem is not precisely resolved, the researcher will
create a hypothesis based on the questions obtained while identifying the
problem.
• Further research: Once the data has been obtained, the researcher will
continue his study through descriptive investigation. Qualitative methods
are used to further study the subject in detail and find out if the information
is true or not.
 Characteristics of Exploratory research
• They are not structured studies
• It is usually low cost, interactive and open ended.
• It will enable a researcher answer questions like what is the problem? What
is the purpose of the study? And what topics could be studied?
• To carry out exploratory research, generally there is no prior research done
or the existing ones do not answer the problem precisely enough.
• It is a time consuming research and it needs patience and has risks
associated with it.
• The researcher will have to go through all the information available for the
particular study he is doing.
Advantages of Exploratory research
• The researcher has a lot of flexibility and can adapt to changes as the
research progresses.
• It is usually low cost.
• It helps lay the foundation of a research, which can lead to further
research.
• It enables the researcher understand at an early stage, if the topic is
worth investing the time and resources and if it is worth pursuing.
• It can assist other researchers to find out possible causes for the
problem, which can be further studied in detail to find out, which of
them is the most likely cause for the problem.
Disadvantages of Exploratory research
Even though it can point you in the right direction towards what is the
answer, it is usually inconclusive.
The main disadvantage of exploratory research is that they provide
qualitative data. Interpretation of such information can be judgmental
and biased.
Most of the times, exploratory research involves a smaller sample,
hence the results cannot be accurately interpreted for a generalized
population.
Many a times, if the data is being collected through secondary research,
then there is a chance of that data being old and is not updated.
Importance of Exploratory research
Exploratory research is carried out when a topic needs to be understood in
depth, especially if it hasn’t been done before.

The goal of such a research is to explore the problem and around it and not
actually derive a conclusion from it.

Such kind of research will enable a researcher to set a strong foundation for
exploring his ideas, choosing the right research design and finding variables
that actually are important for the analysis.

Most importantly, such a research can help organizations or researchers save

up a lot of time and resources, as it will enable the researcher to know if it
worth pursuing.
 Descriptive Studies
Descriptive studies are observational studies which describe the patterns of disease
occurrence in relation to variables such as person, place and time.

They are often the first step or initial enquiry into a new topic, event, disease or
condition.

Descriptive studies can be divided into two roles - those studies that emphasize
features of a new condition and those which describe the health status of
communities or populations.

Case reports, case-series reports, before-and-after studies, cross-sectional studies

and surveillance studies deal with individuals. Ecological Studies examine
populations.
• Common misuses of descriptive studies involve a lack of a clear, specific and
reproducible case definition and establishing a casual relationship which the data
cannot support.
• Whilst descriptive studies can highlight associations between variables or between
exposure and outcome variables, they cannot establish causality.
• Descriptive studies do not have a comparison (control) group which means that they do
not allow for inferences to be drawn about associations, casual or otherwise.
• However, they can suggest hypotheses which can be tested in analytical observational
studies.
Uses of Descriptive Studies
1. Health care planning
Descriptive studies provide knowledge about which populations or
subgroups are most or least affected by disease. This enables public
health administrators to target particular segments of the population for
education or prevention programmes and can help allocate resources
more efficiently.

2. Hypothesis generation
Descriptive studies identify descriptive characteristics which frequently
constitutes an important first step in the search for determinants or risk
factors that can be altered or eliminated to reduce or prevent disease.
 Types of Descriptive Studies
Case reports
Case reports describe the experience of a single patient or a group of patients with a
similar diagnosis.

These types of studies typically depict an observant clinician identifying an unusual

feature of a disease or a patient's history. They can represent the first clues in the
identification of new diseases or adverse effects of an exposure.

A case report can prompt further investigations with more rigorous study design. Case
reports are quite common in medical journals.

A systematic review found that they accounted for over one third of all articles
published. They are useful to public health as they can provide an interface between
clinical medicine and epidemiology.
Case Series
A case series is a report that describes clinical findings seen in a
succession of patients who seem to display a similar condition or an
outcome of interest.

Another way of defining a case series is that case series are collections of
individual case reports which may occur within a fairly short period of
time and these are aggregated into one publication. No control group is
involved.

Something unexpected has been observed - e.g. more cases than usual of
a rare disorder or new signs and symptoms of an emerging disease -
hence the motivation to write it up and share it with the wider clinical
community.
• This study design has historical importance in epidemiology. It was
often used as an early means to identify the begining or presence of an
epidemic.
• Even now, the routine surveillance of accumulating case reports often
suggest the emergence of a new disease or epidemic. A convenient
feature of case-series is that they can provide a case group for a case-
control study.
• An advantage of case series over case report is that a case series can
help formulate a new and useful hypothesis rather than merely
documenting an interesting medical oddity. However, its disadvantage
is that it cannot be used to test for the presence of a valid statistical
association.
• Cross-sectional (Prevalence) Study
• This is the observation of a defined population at a single point in time or time
interval. Exposure and outcome are determined simultaneously.
• The cross-sectional study describes the presence and/or absence of various clinical
features, so it provides a cross-sectional comparison. This means that costs are
small and loss to follow up is not a problem.
• However, because exposure and outcome are measured at the same time point, the
temporal sequence is often impossible to determine. Sometimes the cross-
sectional study can be considered an analytic study, when it is used to test an
epidemiologic hypothesis.
• This can only occur when the current values of the exposure variables are
unaltered over time, thus representing the value present at the initiation of the
disease. For example, factors at birth.
• The cross-sectional survey is sometimes referred to as a prevalence study and it can
survey or assess the health status of a population - e.g. Health Survey of Ghana.
• A survey can be defined as a special inquiry which collects planned information from
individuals (usually a sample) about their history, habits, knowledge, attitudes or
behaviour.
• The principles involved include sampling, instrument design, non-response and accuracy.
• Reasons for non-response incorporate the effect of the topic, study design (postal,
telephone or face-to-face interviews), age, sex, social class, urban/rural location and
general attitudes to survey. See entry on Survey in Toolkit for more details.

• It is worth noting that the term 'cross-sectional' study is also used in social research.
Here, the cross-sectional study refers to a snapshot of a population at a particular point in
time.
• This contrasts with longitudinal studies which follow a population over a period of time,
where one population is compared with another within the same country and cross-
national, where one country population is compared with other countries.
• Ecological Study (or Ecological Correlational Study)
• Ecological correlational studies look for associations between exposures and
outcomes in populations rather than in individuals. They use data that has already
been collected.
• This could be argued to be a form of what social scientists call secondary
statistical analysis. The measure of association between exposure and outcome is
the correlation coefficent r.
• This is a measure of how linear the relationship is between the exposure and
outcome variables. (Note that correlational is a specific form of association and
requires two continuous variables).
• Advantages of an ecological study
1.An ecological study is quick and cheap to conduct.
2.It can generate new hypotheses.
3.It can identify new risk factors.

• Disadvantages of an ecological study

1.It is unable to control for confounding factors. This is often referred to as 'ecological
fallacy', where two variables seem to be correlated but their relationship is in fact
affected by cofounding factor(s).
2.It cannot link exposure with disease in individuals as those with disease may not be
expose.
3.Its use of average exposure levels masks more complicated relationships with disease.
4.Its units of study are populations not individuals. Therefore, the disease rates linked
with population characteristics and the association observed at group level does not
reflect association at individual level.
Case-control Study
• A case-control study is designed to help determine if an exposure is
associated with an outcome (i.e., disease or condition of interest). In
theory, the case-control study can be described simply.

• First, identify the cases (a group known to have the outcome) and the
controls (a group known to be free of the outcome).

• Then, look back in time to learn which subjects in each group had the
exposure(s), comparing the frequency of the exposure in the case
group to the control group.
• By definition, a case-control study is always retrospective because it starts with an
outcome then traces back to investigate exposures.
• When the subjects are enrolled in their respective groups, the outcome of each
subject is already known by the investigator.
• This, and not the fact that the investigator usually makes use of previously
collected data, is what makes case-control studies ‘retrospective’.
• Advantages of Case-Control Studies
• Case-control studies have specific advantages compared to other study
designs. They are comparatively quick, inexpensive, and easy.
• They are particularly appropriate for
• (1) investigating outbreaks, and
• (2) studying rare diseases or outcomes.
• An example of (1) would be a study of endophthalmitis following ocular
surgery. When an outbreak is in progress, answers must be obtained
quickly.
• An example of (2) would be a study of risk factors for uveal melanoma, or
corneal ulcers.
• Since case-control studies start with people known to have the outcome (rather
than starting with a population free of disease and waiting to see who develops it)
it is possible to enroll a sufficient number of patients with a rare disease.
• The practical value of producing rapid results or investigating rare outcomes may
outweigh the limitations of case-control studies.
• Because of their efficiency, they may also be ideal for preliminary investigation of
a suspected risk factor for a common condition; conclusions may be used to
justify a more costly and time-consuming longitudinal study later.

Cases
• Consider a situation in which a large number of cases of post-operative
endophthalmitis have occurred in a few weeks. The case group would consist of
all those patients at the hospital who developed post-operative endophthalmitis
during a pre-defined period.
• The definition of a case needs to be very specific:
• Within what period of time after operation will the development of endophthalmitis
qualify as a case – one day, one week, or one month?
• Will endophthalmitis have to be proven microbiologically, or will a clinical diagnosis
be acceptable?
• Clinical criteria must be identified in great detail. If microbiologic facilities are
available, how will patients who have negative cultures be classified?
• How will sterile inflammation be differentiated from endophthalmitis?
• There are not necessarily any ‘right’ answers to these questions but they must be
answered before the study begins. At the end of the study, the conclusions will be valid
only for patients who have the same sort of ‘endophthalmitis’ as in the case definition.
 Controls
• Controls should be chosen who are similar in many ways to the cases. The
factors (e.g., age, sex, time of hospitalization) chosen to define how controls
are to be similar to the cases are the ‘matching criteria’.
• The selected control group must be at similar risk of developing the
outcome; it would not be appropriate to compare a group of controls who
had traumatic corneal lacerations with cases who underwent elective
intraocular surgery.
• In our example, controls could be defined as patients who underwent
elective intraocular surgery during the same period of time.
 Matching Cases and Controls
• Although controls must be like the cases in many ways, it is possible to over-match.
Over-matching can make it difficult to find enough controls. Also, once a matching
variable has been selected, it is not possible to analyse it as a risk factor.

• Matching for type of intraocular surgery (e.g., secondary IOL implantation) would
mean including the same percentage of controls as cases who had surgery to implant a
secondary IOL; if this were done, it would not be possible to analyse secondary IOL
implantation as a potential risk factor for endophthalmitis.

• An important technique for adding power to a study is to enroll more than one control
for every case. For statistical reasons, however, there is little gained by including more
than two controls per case.
• Collecting Data
• After clearly defining cases and controls, decide on data to be collected; the
same data must be collected in the same way from both groups.

• Care must be taken to be objective in the search for past risk factors,
especially since the outcome is already known, or the study may suffer
from researcher bias.

• Although it may not always be possible, it is important to try to mask the

outcome from the person who is collecting risk factor information or
interviewing patients.
• An odds ratio without a confidence interval is not very meaningful. These calculations
are usually made with computer programmes (e.g., Epi-Info). Case-control studies
cannot provide any information about the incidence or prevalence of a disease because
no measurements are made in a population based sample.

Risk Factors and Sampling

• Another use for case-control studies is investigating risk factors for a rare disease, such
as uveal melanoma. In this example, cases might be recruited by using hospital records.
Patients who present to hospital, however, may not be representative of the population
who get melanoma.
• If, for example, women present less commonly at hospital, bias might occur in the
selection of cases.
• The selection of a proper control group may pose problems. A frequent source of controls
is patients from the same hospital who do not have the outcome.
• However, hospitalised patients often do not represent the general population; they are
likely to suffer health problems and they have access to the health care system.
• An alternative may be to enroll community controls, people from the same neighborhoods
as the cases. Care must be taken with sampling to ensure that the controls represent a
‘normal’ risk profile.
• Sometimes researchers enroll multiple control groups. These could include a set of
community controls and a set of hospital controls.

• Confounders
Matching controls to cases will mitigate the effects of confounders.
A confounding variable is one which is associated with the exposure and is a cause of the
outcome. If exposure to toxin ‘X’ is associated with melanoma, but exposure to toxin ‘X’ is
also associated with exposure to sunlight (assuming that sunlight is a risk factor for
melanoma), then sunlight is a potential confounder of the association between toxin ‘X’ and
melanoma.
Case-Control Studies: Advantages
and Disadvantages
• ADVANTAGES
 can obtain findings quickly

• can often be undertaken with minimal funding

 efficient for rare diseases

 can study multiple exposures

• generally requires few study subjects

Case-Control Studies: Advantages
and Disadvantages
• DISADVANTAGES
 cannot generate incidence data

 subject to bias

 difficult if record keeping is either inadequate or unreliable

• selection of controls can be difficult

 Cohort studies

• Cohort studies are a type of medical research used to investigate the

causes of disease and to establish links between risk factors and health
outcomes.
• The word cohort means a group of people. These types of studies look
at groups of people. They can be forward-looking (prospective) or
backward-looking (retrospective).

• Prospective” studies are planned in advance and carried out over a

future period of time.
• Retrospective cohort studies look at data that already exist and try to identify
risk factors for particular conditions. Interpretations are limited because the
researchers cannot go back and gather missing data.
• These long-term studies are sometimes called longitudinal studies.

Fast facts on cohort studies

• Cohort studies typically observe large groups of individuals, recording their
exposure to certain risk factors to find clues as to the possible causes of
disease.
• They can be prospective studies and gather data going forward, or retrospective
cohort studies, which look at data already collected.
• The Nurses’ Health Study is one example of a large cohort study, and it has
produced many important links between lifestyle choices and health by
following hundreds of thousands of women across Ghana.
• Such research can also help identify social factors that influence health.
Limitations
• They are less suited to finding clues about rare diseases.
A case-control study identifies cases of disease first and then analyzes
exposure to risk factors, whereas cohort studies follow exposure data and
watch for any emerging cases of disease.
• · They are typically unsuitable for identifying the causes of a sudden outbreak of
disease.

• A case-control study can give quicker results.

• · They are expensive to run and usually take many years, often decades, to produce
results.

• Participants may leave the cohort, perhaps move away, lose touch, or die from a
cause that is not being studied. This can bias the results.
 Observational study
designs
• Observational studies are ones where researchers observe the effect of a
risk factor, diagnostic test, treatment or other intervention without trying
to change who is or isn’t exposed to it
• It include ecological designs, cross sectional, case-control, case-
crossover, retrospective and prospective cohorts.

• An important subset of observational studies is diagnostic study designs,

which evaluate the accuracy of diagnostic procedures and tests as
compared to other diagnostic measures.

• These include diagnostic accuracy designs, diagnostic cohort designs,

and diagnostic randomized controlled trials.
INTERVENTIONAL STUDIES
• Interventional studies are often prospective and are specifically
tailored to evaluate direct impacts of treatment or preventive
measures on disease.
• Each study design has specific outcome measures that rely on the
type and quality of data utilized.

• There are two categories of intervention studies:

• experimental studies and
• quasi-experimental studies.
EXPERIMENTAL STUDIES
• Experimental studies are ones where researchers introduce an
intervention and study the effects. Experimental studies are usually
randomized, meaning the subjects are grouped by chance.

• Randomized controlled trial (RCT): Eligible people are randomly

assigned to one of two or more groups. One group receives the
intervention (such as a new drug) while the control group receives
nothing or an inactive placebo.
• The researchers then study what happens to people in each group.
Any difference in outcomes can then be linked to the intervention.
Quasi-experimental research
• quasi-experimental design aims to establish a cause-and-effect
relationship between an independent and dependent variable.

• However, unlike a true experiment, a quasi-experiment does not rely

on random assignment. Instead, subjects are assigned to groups
based on non-random criteria.

• Quasi-experimental design is a useful tool in situations where true

experiments cannot be used for ethical or practical reasons.
CONCLUSIONS
• Statistical conclusion validity is the degree to which conclusions about the
relationship among variables based on the data are correct or "reasonable".
This began as being solely about whether the statistical conclusion about the
relationship of the variables was correct, but now there is a movement
towards moving to "reasonable" conclusions that use: quantitative, statistical,
and qualitative data.
• two types of errors can occur:
• type I :finding a difference or correlation when none exists

• type II :finding no difference or correlation when one exists.

 Internal validity refers specifically to whether an experimental treatment/condition makes a
difference or not, and whether there is sufficient evidence to support the claim.
 External validity refers to the generalizibility of the treatment/condition outcomes.

History--the specific events which occur between the first and second measurement.
 Maturation--the processes within subjects which act as a function of the passage of time. i.e. if the
project lasts a few years, most participants may improve their performance regardless of treatment.
 Testing--the effects of taking a test on the outcomes of taking a second test.
 Instrumentation--the changes in the instrument, observers, or scorers which may produce changes
in outcomes.
 Statistical regression--It is also known as regression to the mean. This threat is caused by the
selection of subjects on the basis of extreme scores or characteristics. Give me forty worst students
and I guarantee that they will show immediate improvement right after my treatment.
• Selection of subjects--the biases which may result in selection of comparison groups.
Randomization (Random assignment) of group membership is a counter-attack against this
threat.
WAYS TO ENSURE VALIDITY OF A
RESEARCH
1. Triangulation facilitates validation of data through cross verification
from more than two sources.
• It tests the consistency of findings obtained through different
instruments and increases the chance to control, or at least assess,
some of the threats or multiple causes influencing our results.
• There are several types of bias encountered in research, and triangulation
can help with most of them.
• Measurement bias is caused by the way in which you collect data.
Triangulation allows you to combine individual and group research options
to help reduce bias such as peer pressure on focus group participants.
• Sampling bias is when you don’t cover all of the population you’re studying
or you cover only some parts because it’s more convenient Triangulation
combines the different strengths of these options to ensure you getting
sufficient coverage.
• Procedural bias occurs when participants are put under some kind of
pressure to provide information. For example, doing “vox pop” style
interrupt polls might catch the participants unaware and thus affect their
answers.
2. Control groups are essential to experimental design. When researchers are
interested in the impact of a new treatment, they randomly divide their study
participants into at least two groups:

• The treatment group (also called the experimental group) receives the
treatment whose effect the researcher is interested in.

• The control group receives either no treatment, a standard treatment whose effect
is already known, or a placebo (a fake treatment).

• The treatment is any independent variable manipulated by the experimenters, and

its exact form depends on the type of research being performed. In a medical trial,
it might be a new drug or therapy. In public policy studies, it could be a new social
policy that some receive and not others.
3. Pre-testing is the administration of the data collection instrument with a small set
of respondents from the population for the full scale survey. If problems occur in the
pre-test, it is likely that similar problems will arise in full-scale administration.
• The purpose of pre-testing is to identify problems with the data collection
instrument and find possible solutions.

• It is not possible to anticipate all of the problems that will be encountered during
data collection. Terminology used in questionnaires or interviews may not be
understood by respondents and information to be retrieved from documents may
not be readily available. Reducing error to acceptable levels requires the pre-
testing of data collection instruments.
Study Design
• The selection of a study design is the most critical step in the research
methodology.
• Crucial factors should be considered during the selection of the study design,
which is the formulated research question, as well as the method of participant
selection.
• Different study designs can be applied to the same research question(s).
• Research designs are classified as qualitative, quantitative, and mixed design.
• Observational design occupies the middle and lower parts of the hierarchy of
evidence-based pyramid. The observational design is subdivided into descriptive,
including cross-sectional, case report or case series, and correlational, and analytic
which includes cross-section, case-control, and cohort studies.
 Qualitative Study Design
• Qualitative research design varies depending upon the method used; participant observations,
in-depth interviews (face-to-face or on the telephone), and focus groups are all examples of
methodologies which may be considered during qualitative research design.

Although there is diversity in the various qualitative methodologies, there are also
commonalities between them.

The underlying reason for carrying out any qualitative research is to gain a richly detailed
understanding of a particular topic, issue, or meaning based on first-hand experience.

This is achieved by having a relatively small but focused sample base because collecting the
data can be rather time consuming; qualitative data is concerned with depth as opposed to
quantity of findings. A qualitative research design is concerned with establishing answers to
the whys and hows of the phenomenon in question (unlike quantitative).
QUANTITATIVE
Quantitative methods emphasize objective measurements and the
statistical, mathematical, or numerical analysis of data collected through
polls, questionnaires, and surveys, or by manipulating pre-existing
statistical data using computational techniques.

Quantitative research focuses on gathering numerical data and

generalizing it across groups of people or to explain a particular
phenomenon.
This research design is to determine the relationship between one thing
[an independent variable] and another [a dependent or outcome
variable] within a population.

It is either descriptive [subjects usually measured once] or experimental

[subjects measured before and after a treatment].

It also deals in numbers, logic, and an objective stance. Quantitative

research focuses on numeric and unchanging data and detailed,
convergent reasoning rather than divergent reasoning [i.e., the
generation of a variety of ideas about a research problem in a
spontaneous, free-flowing manner].
MIXED METHODS
• The term “mixed methods” refers to an emergent methodology of
research that advances the systematic integration, or “mixing,” of
quantitative and qualitative data within a single investigation or
sustained program of inquiry.

• Mixed methods can be use in the social sciences, health and medical
sciences including fields such as nursing, family medicine, social
work, mental health, pharmacy, allied health researches.
The core characteristics of a well-designed mixed methods study in
research include the following:

1.Collecting and analyzing both quantitative (closed-ended) and qualitative

(open-ended) data.
2.Using rigorous procedures in collecting and analyzing data appropriate to each
method’s tradition, such as ensuring the appropriate sample size for
quantitative and qualitative analysis.
3.Integrating the data during data collection, analysis, or discussion.
4.Using procedures that implement qualitative and quantitative components
either concurrently or sequentially, with the same sample or with different
samples.
5.Framing the procedures within philosophical/theoretical models of research,
such as within a social constructionist model that seeks to understand multiple
perspectives on a single issue for example, what patients, caregivers,
clinicians, and practice staff would characterize as “high quality treatment” in
medical field.