Sampling and Randomization

Objectives

• Understand the reasons for sampling

• Acquire an understanding about different
sampling methods
• Distinguish between probability & non
probability sampling
• Discuss the relative advantages &
disadvantages of each sampling methods
• Understand different randomization techniques
 Population
• In clinical research, we define the population
as a group of people who share a common
character or a condition, usually the disease.
• If we are conducting a study on patients with
ischemic stroke, it will be difficult to include
the whole population of ischemic stroke all
over the world. It is difficult to locate the
whole population everywhere and to have
access to all the population.
• The first step in planning a study is to identify
the overall group of people to which the
researcher intends to generalize findings.
• This universe of interest is the target
population, or reference population.
• The target population for a study of motor
skills could be defined as all children with
learning disabilities in the Egypt.
• Because it is not possible to gain access to
every child with a learning disability, some
portion of the target population that has a
chance to be selected must be identified.
• This is the accessible population.
• For example, an accessible population might
include all children identified as having a
learning disability in a given city's school
system. The units within this population are
the individual children.
• The study sample will be chosen from this
accessible population.
• In defining the target population, an
investigator must first specify selection criteria
that will govern who will and will not be
subjects
 Inclusion Criteria
• Inclusion criteria describe the primary
characteristics of the target and accessible
populations that will qualify someone as a
subject.
 Exclusion Criteria
• Exclusion criteria indicate those factors that
would prevent someone from being a subject.
• These factors will generally be considered
potentially confounding to the results; that is,
they are likely to interfere with interpretation
of the findings.
• It is vitally important to remember, however,
that as the researcher restricts the population,
and creates a more homogeneous sample, the
ability to generalize research findings will also
be restricted; that is, the findings will only be
applicable to a population with those specific
characteristics.
 Subject Selection
• Once an accessible population is identified,
the researcher must develop a plan for subject
selection, inviting members to participate.
This process may involve written invitations mailed to
potential subjects' homes, telephone calls or
personal contacts in the clinical setting.
 Sampling Frame
• The sampling frame is the list from which the
potential respondents are drawn.
 Sampling
• Taking a subset from chosen sampling frame
or entire population is called sampling.
• Sampling can be used to make inference
about a population or to make generalization.
 Sampling
• When doing a research study, we should
consider the sample to be representative to
the target population, as much as possible,
with the least possible error and without
substitution or incompleteness.
• The process of selecting a sample population
from the target population is called the
“sampling method”.
 Sampling Methods
• In general, sampling techniques can be
divided into two broad types:
 Sampling Methods

Probability Non- probability

or random sampling or non- random
sampling
 1. Probability Sampling
• Probability sampling means that every item in
the population has an equal chance of being
included in sample.
• Probability or random sampling has the
greatest freedom from bias but may represent
the most costly sample in terms of time and
energy for a given level of sampling error.
 1. Probability Sampling
• This technique is rarely used in practice
because of practical difficulties in accessing
total populations.
• Types of Probability sampling:
 1.1. Simple random sampling
• This method is used when the whole
population is accessible and the investigators
have a list of all subjects in this target
population.
The list of all subjects in this population is
called the “sampling frame”. From this list,
we draw a random sample using lottery
method, tossing a coin or using a computer
generated random list.
 lottery method
• A researcher randomly picks numbers, with
each number corresponding to a subject or
item, in order to create the sample.
• To create a sample this way, the researcher
must ensure that the numbers are well mixed
before selecting the sample population.
 Random Number Tables
• These are commonly found at the back of
textbooks on the topics of statistics or
research methods.
• Most random number tables will have as
many as 10,000 random numbers. These will
be composed of integers between zero and
nine and arranged in groups of five.
• SPSS Computer Programs
• Excel
 Computer Programs
• Random selections can be made by computer,
using statistical packages, given a numbered
list of subjects in a data set.
• The total data set usually will represent an
accessible population. The computer can then
generate a random list of any specified size to
select the sample.
 1.2. Stratified random sampling
• This method is a modification of the simple
random sampling therefore, it requires the
condition of sampling frame being available,
as well.
• However, in this method, the whole
population is divided into homogeneous strata
or subgroups according a demographic factor
(e.g. gender, age, religion, socio-economic
level, education, or diagnosis etc.).
 1.2. Stratified random sampling
• Then, the researchers draw a random sample
from the different strata.
 1.2. Stratified random sampling

The advantages of this method are:

• (1) it allows researchers to obtain an effect
size from each strata separately, as if it was a
different study. Therefore, the between group
differences become apparent, and
• (2) it allows obtaining samples from
minority/under-represented populations.
 1.2. Stratified random sampling
• Stratified sampling is often used where there
is a great deal of variation within a population.
Its purpose is to ensure that every stratum is
adequately represented (to obtain adequate
samples from all strata in the population).
 1.3. Systematic random sampling
(Interval sampling)
• In this method, the investigators select
subjects to be included in the sample based
on a systematic rule, using a fixed interval.
• For example: If the rule is to include the last
patient from every 5 patients. We will include
patients with these numbers (5, 10, 15, 20, 25,
...etc.).
 1.4. Cluster sampling
• It is used when creating a sampling frame is
nearly impossible due to the large size of the
population. In this method, the population is
divided by geographic location into clusters.
• Cluster :a group of similar things or people
positioned or occurring closely together.
• A cluster is a natural grouping of people—for
example, towns, villages, schools, streets, and
households.
Clusters
1.4. Cluster sampling (Multistage
sampling)
• A list of all clusters is made and
investigators draw a random number of
clusters to be included.
• Then, they list all individuals within these
clusters, and run another turn of random
selection to get a final random sample
exactly as simple random sampling.
 1.4. Cluster sampling (Multistage
sampling)
• This method is called multistage because the
selection passed with two stages:
• firstly, the selection of eligible clusters,
• then, the selection of sample from individuals
of these clusters.
 1.4. Cluster sampling (Multistage
sampling)
• An example for this, if we are conducting a research
project on primary school students from Egypt. It will
be very difficult to get a list of all primary school
students all over the country.
• In this case, a list of primary schools is made and the
researcher randomly picks up a number of schools,
then pick a random sample of students from the
eligible schools.
 Example
• The Prevalence of Scoliosis Screening Positive
and Its Influencing Factors: A School-Based
Cross-Sectional Study in Zhejiang Province,
China, 2022
• This paper aims to learn the prevalence of
scoliosis screening positive among students in
primary and secondary schools and to explore
the influencing factors.
• Study Design and Data Sources
• There are 6,000 primary and secondary
schools in Zhejiang Province. Cluster sampling
methods were used in this study.
• Samples were devided into urban areas and
rural areas
• seven schools in the urban area (two primary
schools, two junior high schools, two senior
high schools, and one vocational high school),
five schools in the rural area (two primary
schools, two junior high schools, and one
senior high school) were selected by the
method of random sampling.
• Then, based on the whole class, at least 80
students in each grade of primary school,
junior high school, and senior high school
were selected by the method of a random
sampling of the whole class, that is, at least
480 students were selected from each primary
school and 240 students were selected from
each junior high school, senior high school.
Non-probability sampling method
 2.1Convenience sampling
• Although it is a non-probability sampling
method, it is the most applicable and widely
used method in clinical research.
• In this method, the investigators enroll
subjects according to their availability and
accessibility.
2.1 Convenience sampling
 2.1 Convenience sampling
• Therefore, this method is quick, inexpensive,
and convenient. It is called convenient
sampling as the researcher selects the sample
elements according to their convenient
accessibility and proximity.
• Convenience sampling is selecting participants
because they are often readily and easily
available.
 2.1 Convenience sampling
• Convenience sampling often helps to
overcome many of the limitations associated
with research.
• For example, using friends or family as part of
sample is easier than targeting unknown
individuals.
 2.2 Purposive or judgmental sampling
• In this method, the subjects are selected by
the choice of the investigators.
• It is where the researcher includes cases or
participants in the sample because they
believe that they warrant inclusion.
 2.2 Purposive or judgmental
sampling
• For instance, in situations where a researcher
conducts convenience sampling to gather
feedback from employees about their
company but the fact that there are high
chances of the results to be skewed,
researchers prefer judgmental sampling to
select those employees who will provide 100%
feedback about the company.
Purposive or judgmental sampling
 2.3 Quota sampling
• Quota sampling is a non random sampling
technique in which participants are chosen on
the basis of predetermined characteristics so
that the total sample will have the same
distribution of characteristics as the wider
population.
 2.3 Quota sampling
• It is most commonly used in research studies
where there is no sampling frame available,
since it can help researchers obtain a sample
that is as representative as possible of the
population being studied.
 2.3 Quota sampling
• So, for example, with a sample of 200 people,
researcher may decide that 50% should be male
and 50% should be female; and 40% should be
aged over 40 years and 60% aged 39 years or
less.
• The difference with a stratified sample is that
the respondents in a quota sample are not
randomly selected within the strata. The
respondents may be selected just because they
are accessible to the interviewer.
 2.3 Quota sampling
• Suppose you are investigating the career goals
of students at your university.
• Depending on your research goal, you can
choose students from different class years,
subjects, or any other variable for the
stratification.
• You decide that you want to look at the
differences among majors, so your strata are the
different programs (e.g., orthopedics, neurology,
pediatrics).
 2.3 Quota sampling
• You decide to examine the difference between
orthopedics and neurology students in regard to
their career goals.
• The number of students from each major that
you include in your sample should be based on
the proportion of orthopedics and neurology
students to the total number of students in
these two programs.
 2.3 Quota sampling
• For example, if there are 2,000 university
students enrolled in the two programs, made up
of 800 (40%) orthopedics students and 1,200
(60%) neurology students, your sample should
comprise 40% orthopedics students and 60%
neurology students.
• If your desired sample size was 100 students,
your sample should include a quota of 40
orthopedics students and 60 neurology
students.
 2.3 Quota sampling
• Once you reach the quota of 40 orthopedics
majors, you stop and only recruit neurology
students until you meet the set quota of 60
economics majors.
 2.4 Snowball sampling
• Snowball sampling is a non random sampling
method that uses a few cases to help
encourage other cases to take part in the
study, thereby increasing sample size.
• This approach is most applicable in small
populations that are difficult to access due to
their closed nature, e.g. secret societies and
inaccessible professions.
 Snowball sampling
• In this method, the investigator asks each
subject to give him access to his colleagues
from the same population.
• This situation is common in social science
research, for example, if we running a survey
on street children, there will be no list with
the homeless children and it will be difficult to
locate this population in one place e.g. a
school/hospital.
 Snowball sampling
• Here, the investigators will deliver the survey
to one child then, ask him to take them to his
colleagues or deliver the surveys to them
Snowball sampling
Snowball sampling
Randomization
 Random Sampling vs. Random
Assignment
• Random sampling and random assignment are
fundamental concepts in the area of research
methods and statistics.
• Researchers should differentiate between
these two concepts.
 Random sampling
• Refers to the method you use to select
individuals from the population to participate
in your study.
• In other words, random sampling means that
you are randomly selecting individuals from
the population to participate in your study.
 Random sampling
• This type of sampling is typically done to help
ensure the representativeness of the sample
(i.e., external validity).
 Random sampling
• In practice, very few research studies use
“true” random sampling because it is usually
not feasible to ensure that all individuals in
the population have an equal chance of being
selected.
• For this reason, it is especially important to
avoid using the term “random sample” if your
study uses a nonprobability sampling method
(such as convenience sampling).
 Random assignment (Allocation)
• Refers to the method you use to place
participants into groups in an experimental
study.
• For example, say you are conducting a study
comparing the blood pressure of patients
after taking aspirin or a placebo. You have two
groups of patients to compare: patients who
will take aspirin (the experimental group) and
patients who will take the placebo (the control
group).
 Random assignment
• Ideally, you would want to randomly assign
the participants to be in the experimental
group or the control group, meaning that each
participant has an equal probability of being
placed in the experimental or control group.
• This helps ensure that there are no systematic
differences between the groups before the
treatment (e.g., the aspirin or placebo) is
given to the participants.
 Random assignment
• Random assignment is a fundamental part of
a “true” experiment because it helps ensure
that any differences found between the
groups are attributable to the treatment,
rather than a confounding variable.
• Random assignment=randomization
 Quasi-experimental study
• The prefix quasi means “resembling.”
• Thus quasi-experimental research is research
that resembles experimental research but is
not true experimental research.
• Although the independent variable is
manipulated, participants are not randomly
assigned to conditions.
 REASON FOR RANDOMIZATION
• First, subjects in various groups should not
differ in any systematic way. In a clinical
research, if treatment groups are
systematically different, research results will
be biased.
 REASON FOR RANDOMIZATION
• Suppose that subjects are assigned to control
and treatment groups in a study examining
the efficacy of a surgical intervention.
• If a greater proportion of older subjects are
assigned to the treatment group, then the
outcome of the surgical intervention may be
influenced by this imbalance.
 REASON FOR RANDOMIZATION
• The effects of the treatment would be
indistinguishable from the influence of the
imbalance of covariates, thereby requiring the
researcher to control for the covariates in the
analysis to obtain an unbiased result.
 REASON FOR RANDOMIZATION
• Second, proper randomization ensures no a
priori knowledge of group assignment (i.e.,
allocation concealment).
• That is, researchers, subject or patients or
participants, and others should not know to
which group the subject will be assigned.
 REASON FOR RANDOMIZATION
• The trials with inadequate or unclear
randomization tended to overestimate
treatment effects up to 40% compared with
those that used proper randomization.
• The outcome of the research can be
negatively influenced by this inadequate
randomization.
 REASON FOR RANDOMIZATION
• Random assignment is necessary and
guarantees validity for statistical tests of
significance that are used to compare
treatments.
 TYPES OF RANDOMIZATION
• Simple randomization:
• Randomization based on a single sequence of
random assignments
• This technique maintains complete
randomness of the assignment of a subject to
a particular group.
Simple Randomization
 Simple randomization
• The most common and basic method of
simple randomization is flipping a coin. For
example, with two treatment groups (control
versus treatment), the side of the coin (i.e.,
heads - control, tails - treatment) determines
the assignment of each subject.
Envelope Randomization
 Envelope Randomization
• Envelopes should be opaque, meaning that
they cannot be seen through. This is
important to help reduce bias.
• Have a method for sealing the envelopes.
Shuffle the envelopes so that the original order of
participant names is mixed up.
Store the envelopes in a drawer or container.
Using a Lottery System
Using a Lottery System
 Simple randomization
• A random number table found in a statistics
book or computer-generated random
numbers can also be used for simple
randomization of subjects.
 Simple randomization
• Simple and easy to implement in a clinical
research.
• Equal number of subjects In large clinical
research trials (group balance).
• Unpredictability
 Simple randomization
• an unequal number of participants among
groups in relatively small sample size clinical
research (group imbalance).
• May diminish credibility of results.
 Block randomization
• The block randomization method is designed
to randomize subjects into groups that result
in equal sample sizes.
• This method is used to ensure a balance in
sample size across groups over time.
• Achieves treatment allocation ratio (A:B =1:1).
 Block randomization
• Blocks are small and balanced units with
predetermined group assignments (list of
assignment), which keeps the numbers of
subjects in each group similar at all times.
• The block size is determined by the researcher
and should be a multiple of the number of
groups (i.e., with two treatment groups, block
size of either 4, 6, or 8).
Block randomization
 Block randomization
• Blocks are best used in smaller increments as
researchers can more easily control balance.
• After block size has been determined, all
possible balanced combinations of (permuted)
assignment within the block (i.e., equal
number for all groups within the block) must
be calculated.
• Blocks are then randomly chosen to determine
the patients’ assignment into the groups.
Block randomization
Block Randomization
Block randomization
• Balanced groups numbers and composition
• Powerful statistical Analysis
Block randomization
• Allows prediction in unmasked trials
• So, better to use difference block sizes
Permuted Block randomization
Permuted Block randomization
Permuted Block randomization
 Stratified randomization
• In stratified randomization (sometimes called
Stratified Permuted Block Randomization),
trial participants are subdivided into strata,
then permuted block randomization is used
for each stratum.
• The goal is to create a balance of clinical
factors (like gender, age, disease stage, or
obesity) , because the trial may not have valid
results if factors are not well balanced.
 Stratified randomization
• The stratified randomization method controls
for the possible influence of covariates that
would threaten the conclusions of the clinical
research.
• confounding variable has an influence on the
outcome of the clinical research.
• Stratified randomization can balance the
control and treatment groups for identified
covariates.
 Stratified randomization
• Stratified randomization guarantees treatment
balance within clinical factors.
• Process:
• 1. First define strata.
• 2. Randomization is performed within each
stratum, and is usually blocked.
Stratified randomization
 Stratified randomization

• Although stratified randomization is a

relatively simple and useful technique,
especially for smaller clinical trials, it becomes
complicated to implement if many covariates
must be controlled.
 Stratified randomization

• Increased number of stratification variables or

increased number of levels within strata fewer
patients per stratum. In small samples, sparse
data in many cells defeats the purpose of
stratification.
 Materials and methods
Randomization Participants were randomized to
one of the three study interventions after
stratification for disease severity.
• Disease severity was determined using the
Lower Extremity Functional Scale (LEFS), a 20-
item measure addressing lower extremity
physical function limitations associated with
musculoskeletal conditions affecting the lower
extremity.
 Materials and methods
Randomization
• After stratification, randomization was
performed using custom Matlab1 software,
with a block size of n = 6 and 1:1:1 allocation
ratio.
• The intervention arms included a yoga exercise
(YE) experimental group, a traditional exercise
(TE) active treatment comparison group, and a
no exercise (NE) control group.
 Materials and methods
Randomization Participants received group
allocation information in an opaque envelope.
• This process was completed by an investigator
who was not involved in data collection. All data
collection was led by an investigator who was
blind to group allocation and uninvolved in the
interventions.
 In Class Assignment 1
•
• You and your colleagues will examine the
effects of diaphragmatic breathing exercises
on pulmonary function in patients
undergoing abdominal surgery. A sample of
100 patients of both genders (18 to 80 years)
will be selected.
• Write about:
1- the appropriate sampling technique to recruit
participants
2- the randomization method to ensure balanced
groups (allocation ratio 1:1).
• Fundamental research is called…….
• a. Clinical research
• b. Applied research
• c. Basic research
• d. None of the above
• ………… design is used to examine events of
variable over prolonged period of time.
• a. Cross-sectional
• b. Longitudinal
• c. Blind design
• d. None of the above
• Applied or clinical research is carried out in
laboratory situation.
• First step of conducting research is analysis of
data.
• In stratified sampling, the population is
divided by geographic location into clusters.
 References
• Leslie G. Portney, Mary P. Watkins(2015): Foundations of Clinical Research
Applications to Practice 3rd Edition. F. A. Davis Company.
• Elfil M, Negida A (2017): Sampling methods in Clinical Research; an Educational
Review. Emergency; 5 (1): e52.
• Taherdoost H (2016): Sampling Methods in Research Methodology; How to Choose
a Sampling Technique for Research. (IJARM) 5(2) : 18-27.
• Suresh K. (2011). An overview of randomization techniques: An unbiased
assessment of outcome in clinical research. Journal of human reproductive
sciences, 4(1), 8-11.
• https://www.scribbr.com
• https://www.youtube.com/watch?v=WM52kDlb7xY
• https://tgmresearch.com/proportional-quota-sampling.html
• https://www.youtube.com/watch?app=desktop&v=EAGZ4dx5I00