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RESEARCH

METHODOLOGY

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I. INTRODUCTION TO
RESEARCH

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INTRODUCTION…

RESEARCH:-
a way of examining your practice…
Research is undertaken within most professions.
More than a set of skills, it is a way of thinking:
examining critically the various aspects of your
professional work.
It is a habit of questioning what you do, and a
systematic examination of the observed
information to find answers with a view to
instituting appropriate changes for a more effective
professional service.

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INTRODUCTION cont’d
1.1. What is research?
Research is the systematic collection, analysis
and interpretation of data to answer a certain
question or solve a problem. OR

Research is serious and detailed study of a


subject that aimed at learning new facts, scientific
law, testing ideas, etc.

Health research is a research effort to address


health related problems and come up with better
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solutions to mitigate the prevailing problem
INTRODUCTION cont’d
When you say that you are undertaking a
research study to find answers to a question, you
are implying that the process;
1. is being undertaken within a framework of a set
of philosophies ( approaches);
2. uses procedures, methods and techniques that
have been tested for their validity and reliability;
3. is designed to be unbiased and objective .

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INTRODUCTION cont’d
Philosophies means approaches e.g. qualitative,

quantitative and the academic discipline in which


you have been trained.
Validity means that correct procedures have

been applied to find answers to a question.


Reliability refers to the quality of a measurement

procedure that provides repeatability and


accuracy.
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INTRODUCTION cont’d

Unbiased and objective means that you have

taken each step in an unbiased manner and


drawn each conclusion to the best of your
ability and without introducing your own
vested interest.
Bias is a deliberate attempt to either conceal

or highlight something
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1.2. Types (Categories) of research

Research can be functionally divided into two


1. Basic/pure research

-Is designed to extend the bases of


knowledge in a discipline, for the sake of
understanding itself

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2. Applied research
is problem oriented & directed towards

the solution of an existing problem


Concentrates on finding solutions to

immediate problems of practical nature

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The philosophical approach to research
is basically of two types:
1. Empirical research

2. Theoretical research

Health research mainly follows the empirical

approach, i.e. it is based upon observation


& experience more than upon theory &
abstraction.
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1.3 Approach In research
1. Qualitative
is a type of formative research that offers
specialized techniques for obtaining in-depth
responses about what people think and how they
feel.
It enables program management to gain insight
into attitudes, beliefs, motives and behaviors of
the target population.
It deals with the emotional and contextual
aspects of human response rather than with
objective measurable behaviors and attitudes.

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2. Quantitative
Involves studies that make use of statistical
analyses to obtain their findings.
Key features include formal and systematic
measurement and the use of statistics.
It deals with objective measurable
behaviors and attitudes.
In most cases, health science research
deals with information of a quantitative
nature.

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Characteristics of research

is directed toward the solution of a problem;

is based upon observable experience or

empirical evidence;
 involves gathering new data from

primary/using existing data for a new


purpose;
requires expertise;
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Characteristics cont’d…
is characterized by patient and unhurried activity;
is carefully recorded and reported;
emphasizes the dev’t of generalizations,
principles, or theories.
strives to be objective and logical, applying every
possible test to validate the procedures
employed, the data collected, and the conclusion
reached.

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Goals of Scientific Research
It is ultimately concerned with improving the
health of people and communities,
 by enhancing the efficiency and effectiveness
of the health system as an integral part the
overall process of socio-economic
development, with full involvement of all
partners.

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Research can be used for the purposes of:

a. Description:
 discovering the distribution of certain
attributes about some population i.e
magnitude of health problem.
The researcher is concerned not with
why the observed distribution exists, but
merely with what the distribution is.

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b. Explanation: why variables are relate,
simultaneous examination of two or more variables
i.e relationship b/n factors and disease outcome or
efficacy of an intervention(services)

c. Exploration: search device, when you are just


beginning your inquiry into a particular topic. Ex.:
piloting, FGD to develop tools for the main research

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Major differences among exploratory, descriptive, and explanatory research.
Exploratory Research Descriptive research Explanatory research

Purpose Gain familiarity, in-sight, Describe characteristics Test hypothesis,


ideas; conduct new area of of units under study answer cause-effect
research questions
Question to answer “What” “how” “Why,” “what will be”

Sequence Initial Follow-up Last

Knowledge about Little Somewhat A lot


subject
Research methods Qualitative (case study, Survey research Experiment or case-
field observation, focus control/longitudinal
group)
Sample size Small Large Medium or large

Statistical analysis Little Descriptive statistics Multivariate statistics

Expenses Inexpensive Reasonable Expensive


to expensive
Representativeness No Yes Yes

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summary
There is only one type of research: good research.
 Bad research does not deserve the name of research.
Badly done research is not only a waste of time,
money and effort.
It can be considered unethical if it exposes research
subjects to the inherent risks of experimentation with
no reward to them, to others or to their communities.
Good research ideas come from the knowledge,
work and attitudes of researchers.

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II. Study designs
Classification of Study design
- Observational studies
 the investigator simply observes the
natural course of an event
 the investigator measures but does not
intervene.
- Interventional studies
 the investigator assigns study subjects
to exposure and non-exposure, then
follows to measure for disease
occurrence.
 the investigator manipulates the
intervention or exposure.
Algorithm for classification of types study design
1. Observational study designs

1.1 Descriptive study


Describe patterns of disease occurrence within a

population in relation to person, place & time


 One of the first steps in outbreak investigation,

and always undertaken before initiating analytic


studies
Types of descriptive studies
a. Case reports and case series
Case report describes socio-demographic,
behavioral and/or medical Xics for a single patient
with a given disease.
The individual case report can be expanded to a
case series, which describes characteristics of a
number of patients with a given disease.
 Document unusual medical occurrences
 They provide the symptoms, signs, diagnosis, treatment,
and follow-up of an individual patient.
b) Ecological studies:
data from entire populations are used to
compare disease frequencies b/n different
groups during the same period of time or in
the same population at different points in
time.
Example:
Countries with low cigarette consumption
have lower lung cancer rates than those
countries with high cigarette consumption.
c) Cross-sectional studies/survey
Sometimes termed a frequency survey or a prevalence study,
cross-sectional studies are done to examine the presence or
absence of disease and the presence or absence of an exposure
at a particular time.
Thus, prevalence, not incidence, is the focus.
Since both outcome and exposure are ascertained at the same
time, the temporal relation between the two might be unclear.
For example, assume that a cross-sectional study finds obesity
to be more common among women with than without arthritis.
Did the extra weight load on joints lead to arthritis, or did women with
arthritis become involuntarily inactive and then obese? This type of
question is unanswerable in a cross-sectional study.
1. 2. Analytic study designs
Identify the cause of the problem

♣ Concerned with determinants of disease, the


reasons for low or high frequency of a
disease
♣ Used to test hypotheses concerning the r/s
b/n a risk factor and an outcome, and to
measure the magnitude of the association
effect, and its statistical significance
♣ Uses comparison groups
♣ Try to answer Why?/how?
Example

Why does HIV/AIDS more common in


certain group of population?

Why do some women fail to deliver at health


facilities?
Types of Analytic studies
 Case-Control Studies
 Cohort Studies
a. Case-Control Studies
People with a specific disease (the cases)
are compared with individuals who do not
have the disease (the controls).
The aim is to try to uncover what caused
the outcome in one group but not the other.
To reduce the number of factors that could
be related to the difference in cases and
controls, all participants should be recruited
from the same population.
can
Selection of cases
Subjects selected on the basis of disease
A case should be clearly defined with regard to
specific characteristic of disease
Needs standard diagnostic criteria
Sources of Cases:
hospital setting = hospital-based case-control
defined general population = population-based
disease registries with complete records
Selection of Controls
Be comparable to the cases: controls should
have the same characteristics as the cases
(except for the disease of interest)

Must have the same opportunity for


exposure as a case

Must be subject to the same inclusion and


exclusion criteria as cases
Sources of Controls
Hospital controls: patients attending or admitted to

the same institution for other diseases


Relatives, friends or neighborhood

Community (population) controls: selected from

the same source population as the cases


More expensive
b. Cohort Study
 Looking from exposure to outcome
 Identify group of
exposed subjects
unexposed subjects
 Both exposed and unexposed groups are followed
prospectively for a specified period of time for the
occurrence of the outcome
 Measure and compare the incidence of outcome
between the two groups
 Who will develop an outcome, when and why?
Prospective cohort study
Outcome
Exposure Study starts
occurrence

time

Selection based Prospective assessment


on exposure of outcome

• Exposure status is determined by genetics or biology (i.e., sex, presence or absence


of genetic disease, etc) or subjects choice (smoking, contraceptive use, sexual
behavior, food consumption, etc) or urban/rural differences, SES, etc
Prospective cohort design
Outcome present
Exposed to
risk factor Outcome absent
Population at Risk

Compare
Rates
Outcome present
Not exposed
to risk factor
Outcome absent

PRESENT FUTURE
Incidence
among
Exposed exposed
(8/15)

Incidence
among
Unexposed
un-exposed
(5/15)

Follow-up period
Retrospective cohort studies

Outcome
Exposure occurrence Study starts

time
Retrospective assessment of exposure and outcome

• The effect of birth weight on child mortality


• HIV mortality after diagnosis
Experimental/Intervention Studies
o Investigator assigns subjects to exposure and non-
exposure and makes follow up to measure for the
occurrence of a disease.
o It is usually prospective.
o Provides high quality data “Gold Standard” to
evaluate the effectiveness of health interventions
o Random allocation
o Assign E randomly, follow for D
o Experimental studies are generally termed as
Randomized Controlled Trials (RCT)
Randomised controlled trials (RCTs) allow
data on the safety and efficacy of health
interventions (e.g., drugs, diagnostics,
devices, therapy protocols) to be collected.
Trials can be conducted using healthy
volunteers or patients, depending on what
the trial is investigating and its stage of
development.
Examples:
Trials of the efficacy of a new drug
(e.g., Coartem) with the efficacy of other
drugs
Assessment of the efficacy of LLIN
compared with Indoor Residual
Spraying
The effect of health education on the
use of LLIN compared with its
utilization without health education
Structure of a RCT design
Identify population
of interest through suitable
sampling

Baseline measurement

Random allocation

Group A: Intervention Group B: Control


FOLLOW-UP

• Loss to follow-up
START

• Non-participation

Outcome measurement and analysis


Types of RCTs and Unit of Randomization
Type of RCT Unit of Randomization
Patients with a disease randomly
Clinical trial assigned to treatment or placebo
Individuals without a disease
Field trial randomly assigned to intervention
and non-intervention: vaccine trial
Community Groups or communities (cluster)
trial randomized to intervention or non-
intervention: e.g., Cluster randomized
trial, community intervention
Problems of Intervention Studies
More difficult to design and conduct
Ethical issues: Humans are not experimental
animals that could be manipulated
◦ Withholding: Beneficial exposure
◦ Exposing: Harmful exposure
Feasibility
◦ Very large sample size required, loss to follow-up
Cost : Very expensive than observational studies
Loss to follow-up: Some subjects will be lost to follow-
up, drop-out
The type of study design chosen
depends on
The type of problem

The knowledge already available


about the problem

The resources available for the study


III. SAMPLING
Sampling

The process of choosing a section of the


population for observation and study to
represent the entire population.
A sample is a collection of individuals
selected from a larger population.

The logic of sampling


 With a carefully selected sample, it is possible
to study a large population of interest efficiently.
Basic conditions:

The sample must be well chosen:


representativeness
 The sample must be sufficiently large:
minimizes sampling variation
There must be adequate coverage of the
sample: information should be obtained
from almost all.
Sampling....

A representative sample has all the important


characteristics of the study population from
which it is drawn.

Representativeness is essential to generalise.

Ensure representativeness before starting and


confirm once completed.
Advantages of sampling

REDUCED COST: ↓demands on resources

GREATER ACCURACY: lead to better


accuracy of collecting data.

GREATER SPEED: data collected &


summarized quickly.

FEASIBILITY: the only feasible method of


collecting data.
While selecting a SAMPLE, there are basic
questions:
What is the group of people (STUDY
POPULATION) from which we want to
draw a sample?
 How will these people be selected?
Defining study population and study unit
depends on the type of a problem.
Reference population (or target
population): the population of interest to
whom the researchers would like to make
generalizations.

Study population: the group that is studied,


either in total or by selecting a sample of
its members

Study unit: the units on which information


will be collected: persons, families,
housing units, health facilities, schools,
etc.
Drawback of sampling
•There is always a sampling error.

•Sampling may create a feeling of


discrimination with in the population.

•Sampling may be inadvisable where every


unit in the population is legally required to
have a record.
Sampling Methods

Two broad divisions

A. Non-probability sampling

Every item has an unknown chance of being selected.

There is an assumption that there is an even


distribution of a characteristic of interest within the
population.
Elements are chosen arbitrarily.
When to use Non probability Sampling
Group that represents the target population
already exists.
Difficult or impossible to obtain the list of names
for sampling (Homeless, IV Drug user).
All of the cases of interest may not be identified
ahead of time.
For rare population.
Most common types of
non-probability sampling

1. Convenience sampling
2. Quota sampling
3. Purposive sampling
4. Snowball sampling
1. Convenience Sampling:
For convenience, the study units that are available at
the time of data collection are selected
Many clinic-based studies
2. Quota sampling:
- is done until a specific number of units (quotas) for
different categories of populations have been selected.
3. Purposive sampling
The investigator assumes that they are typical of the
study population
People who are assumed to provide rich information
are selected
4. Snowball sampling

Chain referral sampling


People who are enrolled in the study are
asked to name others who fulfill the selection
criteria using their networks and contacts

Useful for identifying hard-to-find


individuals
Example: those with deviant or illegal
behavior, homeless people, MSM, IDU, etc.
B. Probability sampling

Involves random selection of a sample

A sample is obtained in a way that ensures

every member of the population to have a


known, non-zero probability of being
included in the sample.
Inferences can be made about the
population.
Probability sampling cont..
The methode selection is depend on
the available sampling frame,
how spread out the population is,
how costly it is to survey members of
the population and
Most common probability
sampling methods

1. Simple random sampling


2. Systematic sampling
3. Stratified random sampling
4. Cluster sampling
5. Multi-stage sampling
1. Simple random sampling

Involves random selection

Each member of a population has an


equal chance of being included in the
sample.
To use a SRS method:
Make a numbered list of all the units in the
population (sampling frame)
Each unit should be numbered from 1 to N
(where N is the size of the population)
Select the required number.
The randomness of the sample is
ensured by:

use of “lottery’ methods


a table of random numbers
Computer programs
Random number table
It is a table of random numbers
constructed by a process that
1. In any position in the table, each of
the numbers 0 through 9 has a
probability 1/10 of occurring.

2. The occurrence of any number in one


part of the table is independent of the
occurrence of any number in any other
part of the table.
Random numbers
…. 8094 2525 8247 1347 7433 3620 1897 ….
…. 3563 2198 8211 9045 2618 2751 2627 ….
…. 1330 6331 3753 9693 8738 6815 1538 ….
…. 3565 0016 2243 6432 4796 6095 5283 ….
…. 7850 5925 5588 7311 2192 4545 3530 ….
…. 4490 5417 9727 6153 5901 4878 9980 ….
…. 6545 9104 9318 8819 7537 2785 9373 ….
. . . . . . .
Example
Suppose your school has 500 students and
you need to conduct a short survey on the
quality of the food served in the cafeteria.
You decide that a sample of 100 students
should be sufficient for your purposes.
In order to get your sample, you assign a
number from 1 to 500 to each student in your
school.
Pick a starting point in the table (a row and
column number) and look at the random
numbers that appear there.

The first 100 different numbers between 001


and 500 make up your sample.
SRS has certain limitations:
Requires a sampling frame.
Difficult if the reference population is

dispersed
2. Systematic sampling

Sometimes called interval sampling,


systematic sampling means that there
is a gap, or interval, b/n each selected
unit in the sample
The selection is systematic rather
than randomly
Systematic random sampling…
3. Stratified random sampling

It is done when the population is known to have

heterogeneity with regard to some factors and those


factors are used for stratification
Using stratified sampling, the population is divided into

homogeneous, mutually exclusive groups called strata

(e.g., age, sex, province of residence, income, etc.).


A separate sample is taken
independently from each stratum.
Any of the sampling methods mentioned

in this section (and others that exist) can


be used to sample within each stratum.
1. Equal allocation:
Allocate equal sample size to each stratum
2. Proportionate allocation:
Example:
Village A B C D Total
HHs 100 150 120 130 500
S. size ? ? ? ? 60
4. Cluster sampling

The clusters should be homogeneous,

unlike stratified sampling whereby the


strata are heterogeneous
Cluster sampling…

Cluster samples are generally used if:


- No list of the population exists.
- Well-defined clusters, which will often be
geographic areas exist.
- A reasonable estimate of the number of
elements in each level of clustering can be made.

- Often the total sample size must be fairly large to


enable cluster sampling to be used effectively.
Steps in cluster sampling

Divide the population into groups or


clusters.
A number of clusters are selected randomly
to represent the total population, and then all
units within selected clusters are included in
the sample.
No units from non-selected clusters are
included in the sample.
Differs from stratified sampling, where some
units are selected from each group.
Example
In a school-based study, we assume

students of the same school are


homogeneous.
We can select randomly sections and

include all students of the selected


sections only
5. Multi-stage sampling

Similar to the cluster sampling, except

that it involves picking a sample from


within each chosen cluster, rather than
including all units in the cluster.
This type of sampling requires at least

two stages.
Zone PSU

Woreda SSU

Kebele TSU

Sub-Kebele

HH
Sample Size Calculations
Common questions:
“How many subjects should I study?”
Too small sample = Waste of time and resources

= Results have no practical use


Too large sample = Waste of resources

= Data quality compromised


= Any small difference can be
statistically significant
When deciding on sample size:

PRECISION COST

Sample size = Precision = Cost

Precision is related to confidence level


Sample size determination depends on:

Objective of the study


Design of the study
Descriptive/Analytic
Accuracy of the measurements to be made
Degree of precision required for
generalization
Plan for statistical analysis
Degree of confidence with which to
conclude
To find the desirable sample size:-

seeks to measure one single variable


(e.g. a mean, a rate or a proportion) in
one group with a certain precision, or

tries to demonstrate a significant


difference between two groups.
Sample size - single proportion
For making confidence limit statement (such as
prevalence study), the following formula can be used
to estimate minimum sample
2
size:
 Z  p 1  p 

n  2 

d2
For population <10,000, use finite population
correction
nf= ni
1+ni/N
Single proportion…cont.

Parameters in the formula


 n-is minimum sample size
 p-is estimate of the prevalence rate for the population
 From available data or Pilot study
 0.5 should be used to get the possible minimum large sample
size
 d-is the margin of sampling error tolerated (sample values do not
deviate from the true population values by more than 5%)
 Zα/2 is the standard normal variable at 1-α % confidence level
and α is mostly 5%
Usually 95% confidence level is used
 N=population size
 Q= 1-p
Sample size – other considerations
Non-response
Add contingency – 10%
 More – sensitive topic, self-administered questionnaire
( up to 30%)
Response rate for
 Cross-sectional survey >85%
 Cohort - >60-80%

Sampling technique
In complex samples (cluster, multistage) increase the sample
size to account for design effect
Suppose that you are interested to know the
proportion of infants who breastfed >18 months
of age in a rural area. Suppose that in a similar
area, the proportion (p) of breastfed infants was
found to be 0.20. What sample size is required to
estimate the true proportion within ±3% with 95%
confidence. Let p=0.20, d=0.03, α=5%
Suppose there is no prior information about the
proportion (p) who breastfeed
Assume p=q=0.5 (most conservative)
Then the required sample size increases
Significance Difference
Between Two Groups
Using power of a study to determine sample
size = significant difference = Hypothesis
testing

Aim: Have large enough samples to detect a


difference in population proportions
Studies that involve comparison
Types of error in hypothesis tests

Action Reality
(Conclusion)
Ho is true Ho is false

Reject Ho Type I error (α) Correct action


(Prob. = α = Sign. level) (Prob. = Power = 1-β)

Do not Correct action Type II error (β)


reject Ho (Prob. = 1-α) (Prob. = β= 1-Power)
Type I error (): the probability of
rejecting H0 when it is true.
Also called false positive
 It is the probability of being wrong when
Ho is true.
· Typical value for α (significance level) is
5%
92
Example:
A researcher conducts a study to determine whether
a new medication is effective in treating depression.
The new medication is given to Group 1, while a
placebo medication is given to Group 2.
If, at the conclusion of the study, the researcher
concludes that there is a significant difference in
levels of depression between Groups 1 and 2 when,
in fact, there is no difference, the researcher has
made a Type I error.

93
In simpler terms, the researcher has detected a
difference between the groups that in actuality
does not exist; the difference between the
groups occurred by chance (or error).

By contrast, if the researcher concludes that


there is no significant difference in levels of
depression between Groups 1 and 2 when, in
fact, there is a difference, the researcher has
made a Type II error.

94
In simpler terms, the researcher has failed to
detect a difference that actually exists between the
groups.
Which type of error is more serious—Type I or
Type II? The answer to this question often
depends on the context in which the errors are
made.

EX.: If a doctor diagnoses a patient with cancer


when, in fact, the patient does not have cancer
(i.e., a false positive), the doctor has committed a
Type I error.

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Type II error(false negative)
•Concluding there is no difference between
the groups being studied when, in fact,
there is a difference.
•There is an inverse relationship between
Type I and Type II errors, which means that
by decreasing the probability of making a
Type I error, the researcher is increasing
the probability of making a Type II error.

96
Power (1 - β) = 50%, Zβ = 0.00
Power (1 - β) = 75%, Zβ = 0.67
Power (1 - β) = 80%, Zβ = 0.84
Power (1 – β) = 90%, Zβ = 1.28
Power is one-sided and Zβ is always
one-sided
Most studies are recommend at power
of 80%.
General formula using power of a study to determine sample size
(Comparative CS, CC, Cohort) proportions

 Comparison between two proportions

∆ = p1-p2
Let p1=0.35, p2=0.25, and Δ=p1-p2
=0.35-0.25 =0.10
Sample size calculations shown above are
based on SRS
Stratification will increase precision
compared with others the same size,
smaller sample can be selected
Cluster sampling will reduce precision
compared to SRS of the same size, larger
sample will be needed (design effect)
Research Errors
Observations are made on a group of people, and
inferences are made about r/s or associations of
various ‘exposures’ to ‘outcomes’.
The inferences reached are always subject to
uncertainty due to the variation of characteristics
across the population.
The accuracy of the inference depends on:-
 the accuracy of the information collected and
 the representativeness of the subjects observed to the
larger group of subjects in the population,
 as well as on the accuracy of the statistical methods
used to draw the inference.

101
Common sources of error that need to be
controlled result from problems with ‘reliability’
and ‘validity’.
Our inference should have high reliability and
high validity.
The reliability and validity of inferences depend
on the
reliability and validity of the measurements (are we
measuring the right thing, and with accuracy?)
 reliability and validity of the samples chosen (have
we got a true representation of the population that
we are drawing inferences from?).
102
The reliability of a sample is achieved by
selecting a large sample, and the validity is
achieved by ensuring the sample selection is
unbiased.
The researcher evaluate whether study results
are valid by assessing the presence of three
alternative explanations:-
1. Bias
2. Confounding
3. Chance/random error

103
Bias

Bias may be defined as any systematic

error in study that results in an incorrect


estimate of the association between
exposure and risk of disease
Bias in research denotes deviation from the truth.

Types of bias may be grouped into two

categories:
104
A. Selection(inclusion/ exclusion) Bias
any error that arises in the process of identifying
the study populations.
can occur whenever the identification of
individual subjects for inclusion in the study on
the basis of either exposure (cohort) or disease
(case-control) status
 Non-response
 Loss to follow-up
 Volunteer / Compliance bias

105
B. Observation or information bias
 any systematic error in the
measurement of information on exposure
or outcome. Include:
 Interviewer bias:
Recall bias
Social desirability bias-

106
Recommendations to minimize bias at the time of data
collection & study design are:

Choose study design carefully.


Choose “hard” (i.e., objective) rather than
subjective outcomes.
“Blind” interviewers or examiners wherever
possible.
Use well-defined criteria for identifying a “case”
and use closed-ended questions whenever
possible.
Collect data on variables you do not expect to
differ between the two groups.
107
Improve the data collection by:
Training of data collectors
Pre-testing the questionnaire
Supervision
Use of different sources for comparison

108
Confounding

an extraneous (third) variable which is

associated with the exposure and,


independent of that exposure, be a risk
factor for the disease.

109
R/s b/n low level of mother’s education and
Ex.
malnutrition in under five children
Control for Confounding Variables
a) Randomization :-means that subjects are
assigned to the study groups through a
random process.
It generally ensures that compared groups
are balanced on both known and unknown
confounders, if the sample size is
sufficient.

111
b) Restriction:- means that admissibility
criteria for enrollment are limited.
EX.: Limiting the study population to one
gender or only one race.

c) Matching ( especially age and gender)


Means that study subjects with
identical or nearly identical
characteristics are selected.

112
EX.:- Consider a cohort study on the relationship
b/n exercise and the risk of colon cancer.
A literature review reveals that potential
confounders of this association include age,
gender, and obesity.
Thus, when an exposed subject (an exerciser) is
enrolled who is a 55-year-old male with a normal
body mass index; an unexposed subject (a non
exerciser) would be enrolled who is a 55-year-old
male with a normal body mass index.

113
Chance/Random Error
Unlike bias & confounding random errors
are considered unsystematic because they
arise from unpredictable process.
Evaluation of the role of chance is mainly
the domain of statistics and it involves:-
Hypothesis Testing
Confidence interval estimation

114
Chance… cont’d
1. Hypothesis Testing (test of statistical
significance)
 When we test a hypothesis, we typically want to
disprove a null hypothesis.
quantifies the degree to which sampling variability
may account for the observed results using P-
value
For medical research, the P value  0.05 is set
conventionally to indicate statistical significant.

115
Steps in testing for statistical significance

1. State null hypothesis to be tested


 The research question is typically
rephrased in the form of two opposing
hypotheses HO & HA

2. Select a sample and collect data

116
3. Calculate test statistics
 The test statistic is a measure of the
difference b/n population parameter
proposed by HO & its actual sample
estimate, expressed in terms of standard
deviation
In statistics, a result is called significant if
it is unlikely to have occurred by chance

117
•The P value is the probability that a difference
as large as we have observed could have
occurred simply by chance alone, assuming that
there is truly no association b/n exposure &
outcome under consideration (i.e., H0 is true).

• Indicates the probability that the association


between two variables might be due to chance .

118
4. Evaluate the evidence against HO
 The test statistic is compared with its
frequency distribution to determine the
probability of obtaining this value by random
chance when HO is true (i.e the p-value)
 The level of significance () is used to derive
a decision rule, a procedure defining the
conditions under which HO is accepted or
rejected

119
5. State the conclusion: HO is accepted
or rejected in accordance with the
decision rule
 If HO is rejected, the results are said to
be statistically significant ( i.e unlikely to
be due to chance) at chosen .
 If HO is not rejected, the results are
reported as not statistically significant
( i.e likely to be due to chance) at
chosen 
120
2. Estimation of Confidence Interval
The confidence interval represents the range
within which the true magnitude of effect lies
within a certain degree of assurance.
It is more informative than just P value
because it reflects on both the size of the
sample and the magnitude of the effect.
Components of Interval estimation:-
 Estimator
 Reliability coefficient
 Standard error
 Estimator + (reliability coefficient )x (standard error)

121
Confidence Intervals
Used for estimating the true value of the
population parameter

CI expresses upper and lower bounds for


anticipated true population parameter.

122
Lower limit = Point Estimate - (Critical Value)
x (Standard Error of Estimate)

Upper limit = Point Estimate + (Critical Value)


x (Standard Error of Estimate)

123
CI tells us how precise our estimate is likely
to be

A narrow CI implies high precision, while a


wide CI implies low precision.

A Narrow CI reflects large sample size or


low variability or both.

124
Example
A prevalence of 10% from a sample size of 20
would have a 95% CI of 3% to 23%,
which is not very precise or informative.
But, a prevalence of 10% from a sample of size
400
 would have a 95% CI of 7% to 13%,
 which may be considered sufficiently
accurate.

125
95% CI commonly used
Sometimes 90% and 99%
The 95% CI is calculated in such a way
that, under the conditions assumed for
underlying distribution, the interval will
contain true population parameter 95% of
the time.
Loosely speaking, you might interpret a
95% CI as one which you are 95%
confident contains the true parameter.

126
CIs can also answer the question of whether
or not an association exists or a treatment is
beneficial or harmful. (analogous to
p-values…)
e.g., if the CI of an odds ratio includes the
value 1.0 we cannot be confident that exposure
is associated with disease.

127
C.I. for a population proportion

128
Hence,

is an approximate 95% CI for the true proportion P.

129
Example:
A study on dental health practice. Of 300
adults interviewed, 123 said that they
regularly had a dental check-up twice a
year. What is the 95% C.I. for the true
proportion in the population?
 (0.36, 0.46).

130
IV. Data collection methods
Data collection techniques – allows us to
systematically collect information.

High quality data collection method is


required.
Quantitative Data collection techniques

1. Using available data


Morbidity reports
Mortality reports
Epidemic reports
Epidemic investigations
Laboratory data
Special surveys
Demographic data (census)
2. Observation
Involves systematically selecting, watching,

and recording behavior and characteristics.


Give additional, more accurate information on

behavior than interviews or questionnaires.


Checklists or a list of question are usually used.
3. Interviewing

Involves oral questioning of respondents,

either individually or as a group.


Answers are recorded by writing them or by

tape recording the responses.


4. Administering written questionnaires

Also known as self-administered

questionnaire
Written questions are presented to be

answered by the respondents in written


form.
QUALITATIVE DATA COLLECTION TECHNIQUES
A. Focus Group Discussion(FGD)

Individuals assembled by a researcher

Discussion from experience; Group

interaction between the participants


8-12 people; Homogeneous
B. Individual in-depth interviews

Detailed information obtained from individuals

One-to-one

Reliable for highly personal, sensitive or

confidential topics.
Interviewee can be either “key informants” or

“ordinary people”.
C. Key informant interviews

Key informant – actor in a social group

(community leaders, etc)


Links the researcher to the community

Provides detailed data on specific areas


Stage in data collection planning process

Three main stages can be distinguished


Stage 1: Permission to proceed (local authorities

….)
Stage 2: Data collection

Stage 3: Data handling


Points to consider while organizing the
data collection team

Selection of candidates

Payment to be given to the team members

Training

Planning, from the beginning, for possible

dropouts
RESEARCH INSTRUMENT/ QUESTIONNAIRE DESIGN
The quality of research depends to a large
extent on the quality of the data collection
tools.
Research instruments include
 Questionnaire, Checklist

A questionnaire is simply a list of


mimeographed or printed questions.
Factors to be considered in the design
include:
a. study objectives
b. study hypotheses
c. budget; and
d. the audience or target population:
Questionnaire format: Can be
1. Open-ended:
It permits free responses which should be recorded in the

respondents’ own words.


Such questions are useful for obtaining in-depth

information on:
 facts with which the researcher is not very familiar,

 opinions, attitudes and suggestions of informants, or

 sensitive issues.
For example:
‘What is your opinion on the services provided in the
ANC?’ (Explain why.)

2. Close-ended questions:
have a list of possible options or answers from which the
respondents must choose.
 the respondents express their opinions or attitudes by
choosing rating points on a scale.
EX: What is your opinion on the following
statement: ‘Women who have induced abortion
should be severely punished.’
1. strongly agree
2. agree
3. no opinion
4. disagree
5. strongly disagree
STEPS IN DESIGNING A QUESTIONNAIRE

Step 1:-Content
- decide which question need to measure variables & to

reach the objective

Step 2 :- Formulating questions


Formulate one or more questions that will provide

information needed for each variable.


Step 3 :- Sequencing of questions
Clear Instruction on how to fill in are placed on the
cover page
Start with interesting .
Pose more sensitive questions as late as possible.
( income, sexual behavior…)
Step 4:- Formatting the questionnaire
 Page setup
Sufficient space between Question items
Sufficient space for open-ended questions
Step 5:- Translation: E.g. English =Amharic
Questionnaire composition
Questionnaire composition includes
Background
Identification ( ID No, kebele, woreda, zone, region)

Socio demographic ( age, sex, religion, marital status, relation to


HH, etc)

Socio economic (education, income level, type of house, etc)


Other variables to be studied ex.:
Knowledge/awareness questions

Attitude/opinion/belief questions

Practice or experience questions


Pre testing

Conducted in a small number of similar


population (10 to 20 study units)
To orient and improve the skills of data
collectors
To determine average time per respondent
and number of data collectors required
To evaluate and revise the content of the
questionnaire content (clarity, flow,
difficulty, sensitivity, language, etc) based on
the report of data collectors
Data quality control

 Before and during data processing,


however, the information should be checked
again for completeness and internal
consistency.


V. DATA
PROCESSING
AND
ANALYSIS

151
1.Introduction
Data processing:-
Transforming or process the data
into a format suitable for analysis.

152
When it has to be started?
Should start in the field, with checking for
completeness of the data and performing quality
control checks.
Data of small samples may even be processed
and analyzed as soon as it is collected.

153
What should it include?
Data processing and analysis include:
 Sorting data
 Performing quality-control checks
 Data processing, and
 Data analysis.

154
I.SORTING DATA
An appropriate system of arranging, organizing/
the data to facilitating subsequent processing and
analysis.
If you have different study populations (for
example village health workers, village health
committees and the general population), you
obviously would number the questionnaires
separately.
Eg. Case - control studies.
/Users vs nonusers Fp service/

155
II. PERFORMING QUALITY CONTROL CHECKS
Most important data checks,
1.Accuracy of data
2.Checking outliers
3. Handling missed values
Accuracy
Verify the accuracy of sample of completed data.
Entered twice & compare

156
Performance quality…..
Checking outliers
Outliers:-values that are considerably
large/small, impossible/inconsistent with
information gathered.
Occur:-error on measuring , recording

157
Performance quality…..
Handling missed values
If an inconsistency is clearly due to a mistake
made by the interviewer on recording , it may
still be possible to check with the her/him and
to correct the answer.
If the inconsistency is less clearly a mistake in
recording, it may be possible (in a small scale
study) to return to the respondent and ask for
clarification.

158
Performance quality…..
Note:
A decision to exclude data of doubtful quality
is ethically correct and it testifies to the
scientific integrity of the researcher. You
should keep track of any questions you had to
exclude because of incompleteness or
inconsistency in the answers, and discuss it in
your final report.

159
III. DATA PROCESSING
Data processing in involves:
 categorising the data,
 coding, and
 summarising the data
manual:-data master sheets & without
master sheets,
by computer :-data entry and
verification.

160
DATA PROCESSING…..
1. Categorising
 categorical & numerical variables
 Decisions have to be made concerning
how to categorise responses.
 For categorical variables that are
investigated through closed questions or
observation (for example, observation of
the presence or absence of latrines in
household), the categories have been
decided upon beforehand.
161
Data processing…..
The numerical variables are often better
collected without any pre-categorization.
If your categories had been wrongly chosen
you cannot reclassify the data anymore.

162
Data processing…..
2. Coding
 is assigning a separate (non-overlapping)
numerical, letter code for separate answers
and missing values.

163
Data processing…..
Coding……
Grouped as:
1. Pre-coding ;-when questionnaire being written so
that coding categories & column location appear in
the questionnaire itself.
2. Post -coding:-…. After respondents have answered
questions.
 necessary mainly for open ended questions for
which response categories can't anticipate.
3. Recoding:-changes (including adding, combining &
removing) earlier coding to facilitate meaningful
analysis.
 done after data have been collected.
164
Missing values
Missing values occur when measurements were
not taken, or respondents did not answer questions
so forth.

 In general missing values should not be entered as


a ‘blank’, because some statistical packages
interpret blanks as zeroes.

 Ideally, a code should be chosen to denote a


missing value (e.g. a code ‘9’ or ’99’ or ’999’ is
often used missing values).

165
Code book preparation
Code book is essentially a list of each
variables, the column in which the
variable has been entered, and the codes
associated with the value of the variables

166
Examples of code book

Question/ Column Variable name codes


statement location

Respondent respid 1-100


ID.NO
1.Age (in years) age 1. 15-24
2. 25-34
3.>34
999. Missing
2. Sex sex 1.Male
2. female
3.Marital status mstatus 1.Married 2.Single
3.Divorced
4.Widowed
99. Missing
4.Religion: Rel 1.Orthodox
2.Muslim
3.Protestant
4.Catholic 5.others
167
9. Missing
Data processing…..
A. Coding conventions
Common responses should have the same code
in each question, as this minimizes mistakes by
coders.
For example:
 Yes (or positive response) code - Y or 1
 No (or negative response) code - N or 2
 Don’t know code -D or 8 No

168
3. Summarising the data using:

(1) Data master sheets


If data are processed by hand, it is often
most efficient to summarize the raw
research data in a so-called DATA
MASTER SHEET, to facilitate data
analysis.
 On a data master sheet all the answers of
individual respondents are entered by hand.

169
For example, the straightforward answers of the smoking
questionnaire for male smokers could be processed as follows
Table 13.1: Master sheet for smokers (males)

170
Data master sheets…..

171
172
(2) Compilation by hand (without using
master sheets)
 When the sample is small (say less than
30) and the collected data is limited, it
might be more efficient to do the
compilation manually.
 Certain procedures will help ensure
accuracy and speed.

173
3/Computer compilation
Before you decide to use a computer, you
have to be sure that:
 It will save time or that the quality of the
analysis will benefit from it.

174
Computer compilation……
 Computer compilation consists of the
following steps:-
I. Choosing an appropriate computer
program
II. Data entry
III. Verification or validation of the data
IV. Programming (if necessary)
V. Computer outputs/prints

175
Computer compilation……
Choosing an appropriate computer
program
The most widely used programs are:
 Epi Info
SPSS, which is a quite advanced Statistical
Package for Social Sciences (SPSS Inc.).

176
Statistical Methods for
Analysis of Categorical Data

177
Categorical Variables

Non-numerical
– Sex: Male, Female
– Marital Status: Married, single, widowed, divorced
– Yes/No
Can be nominal or ordered
Numeric (continuous) variables can be condensed to
categorical variables
Analysis is based on the frequencies associated with
each category of the variable

178
Categorical Variables analysis…

1. Chi-squared Test
Widely used in the analysis of contingency
tables.
Allows us to test for association between
categorical variables.
The Ho for this test is there is no
association between the variables.
Consequently a significant p-value implies
association.
179
180
TEST STATISTIC:

2-test for 2x2 Contingency table

nad  bc 
2
 2

(a  c)(b  d )( a  b)(c  d )

181
Test Statistic: 2-test with d.f. = (r-1)x(c-1)

O  E ij 
2

  2 ij

i, j E ij
i raw total  j column tot al Ri  C j
th th
Eij  
grand total n
Oij=observed frequency, Eij=expected frequency of the cell at the
juncture of I th raw & j th column

182
Assumptions of the 2 - test

Data must be categorical /must be categorized.

The data be a frequency data (counts for


frequency, proportions /difference of proportions
for prevalence & incidence).

The chi-squared test assumes adequate sample


size -that the numbers in each cell are ‘not too
small’
No expected frequency should be less than 1,
and no more than 20% of the expected
183 frequencies should be less than 5.
184
chi square table.docx

185
P‐Value
• When P is below the cut off level(α), say 0.05, the
result is called statistically significant( and below
0.01, it may be called highly significant); when
above 0.05 it is called not significant.
• It is important to distinguish between the significance
level and the p – value.
• The significance level α is the probability of making a
type I error. This is set before the test is carried out.
• The P – value is the result observed after the study is
completed and is based on the observed data

186
 Another way to state conclusion:
 Reject H0 if P-value < ,
 Accept H0 if P-value  .

the smaller the P-value the stronger the


evidence against the Ho.

187
2. Measures of Association
The chi-squared test tells us whether or
not an association exists.
It is useful, however, to know how strong
the association is.
The relative risk and the odds ratio are
appropriate measures of the strength of
the association.

188
Relative Risk
Consider the 2 X 2 contingency table in
which the outcome is the presence or
absence of disease and the other variable
is the presence or absence of a factor.

189
Relative Risk
2X2 Table

Disease
Factor
Present Absent

Present p1 1-p1

Absent p2 1-p2
190
Suppose the probability of getting the disease
when the factor is present p1 and the
probability of getting the disease when the
factor is absent is p2.

Thus the probability of not getting the


disease when the factor is present is (1-p1)
and the probability of not getting the disease
when the factor is absent is (1- p2)

191
Relative risk (RR) is simply the risk of
getting the disease when the factor is present
relative to the risk of getting the disease
when the factor is absent.

RR = Probability of getting the disease when the factor is


present
Probability of getting the disease when the factor is absent

192
Cohort/Experimental Design
ILL NOT ILL
Incidence
a
Exposed a b a+b
a+b

Not exposed c c
d c+d
c+d

Relative risk = Incidence exposed / Incidence not exposed

193
Cohort study
1st Give Breast Cancer
Birth Yes No Total

≥25 years 31 1597 1628

<25 years 65 4475 4540

Total= a/a+b
RR 96 6072 6168
c/c+d

194
a/a+b = 31/1628 = 0.019
b/b+d = 65/4540 = 0.014

Women who first give birth at an older age are 36%


more likely to develop breast cancer

195
In general: RR > 3 indicates strong

association
RR = 1.5 – 2.9 moderate
RR = 1.1 – 1.4 weak

196
Odds Ratio
Another commonly used measure of
association is the odds ratio (OR).
The odds in favor of an event happening
(such as getting a disease) is the probability of
the event happening relative to the probability
of the event not happening.
OR: Indicates odds of diseased relative to the
exposure status.
Odds of disease in exposed = a/b or a:b
Odds of disease in unexposed = c/d or c:d
197
 OR = odds in favor of disease when the factor is present
odds in favor of disease when the factor is absent
OR: is the chance of being exposed (or diseased) as opposed
to not being exposed (or diseased).
 It is possible to calculate either exposure or disease odds
ratio, which are exactly the same

198
Case-Control/Cross-sectional Designs

Cases Controls
Exposed
a
b

Not exposed c d
Total a+c b+d

Odds Exp = Odds Exp =


Cases a/c Controls b/d
a/c ax d
Odds ratio (OR) = OR
b/d bxc
a/(a+c)
199
Example: Case-Control
In a study of the risk factors for invasive
cervical cancer, the following data were
collected:
Example: Case-Control
• In a study of the risk factors for invasive
cervical cancer, the following data were
collected:

10/2/2011 262

200
The odds ratio is estimated by:

Women with cancer have an odds of smoking


that are 1.52 times the odds of those without
cancer

201
When the CI for the RR or OR
includes 1, we conclude that there is
no association

When the CI of RR or OR does not


include 1, we conclude that there is
an association

202
VI. HEALTH RESEARCH
FINDING
COMMUNICATION

203 Prepared by Taye Gari(Public health Lecturer) Saturday, July 13, 2024
Definition
Process of sharing information and
knowledge about research findings to
all relevant parties.
Why?
Research is not complete unless communicated

Promote utilization of results

Accessibility

Feedback mechanism
Communication, Dissemination & Utilization of Research
Findings

What Do You Think is the


Situation in our Setting
? ? ?
Big Gap!

Poor Dissemination,
Communication &
Utilisation of research findings
Big Gap!

“Significant amount of researches and results are


never been communicated beyond their immediate
circle of interest & are often Neglected.”

UNCED conference 1999


Need to take the knowledge to the grass root
Implications

Broad Implications of this for Development:


1. The need to address the failure of existing policies &
methods
2. The need to ensure community development
3. The need to address the loss of knowledge
4. The need to ensure value for money
The research conducted must be disseminated to

the widest possible audience


There are variety of ways to disseminate research

findings
Detailed report (as in thesis or consultancy work)
Scientific paper for publication in a journal
A conference abstract
Present research findings orally
Poster presentation
211 Prepared by Taye Gari(Public health Lecturer) Saturday, July 13, 2024
Sections of a Research Report
 Title
 Acknowledgment
 Abstract
 Introduction including problem statement
 Objective(general & specific)
 Method & Material
 Results
 Discussion
 Conclusion
 Recommendations
 Limitations
 References or bibliography
1. Titles
Title should accurately reflect the content of the

paper.
Purpose
to provide a brief, informative summary that will attract the
target audience
The attractiveness of a report or a scientific paper begins
from its title
It is the basis for the initial impression and is powerful in
encouraging or discouraging reading.
How should a title be constructed?
Guidelines for producing a good title
The simpler the title, the better
Consider the target readership
Be brief – short titles are clearer and more
arresting
Avoid excessive adjectives and noun strings
Titles should almost never contain
abbreviations
Content of the title page
1. The Title
2. Name of Investigator/s/
3. Type of the research report
4. Advisor name
5. Year and city and country name
2. Acknowledgements
It is important to acknowledge the source of research

funding.

Acknowledge those whose work enabled the study to

proceed.
3. The Abstract

Purpose
to highlight key points from the major sections of the article
It is a brief summary of the main points of the larger work
Second most read part of a paper
Could be the basis on which the work is judged.
Should be short, clear, informative and interesting
Should contain the whole essence of the paper
Should stand alone
Component of Abstract
Basic parts:-
Major purpose of the study (Why what was done was done) -
Introduction
Goal (objective)
Basic procedures (What was done) – Methods

Main findings (What was found) - Results

Principal Conclusions (What was concluded) - Discussion

Length may be defined by the journal (200-250 words)


4. The Introduction
Purpose of an introduction is to explain why the study was

undertaken.
Should be
Short

Impressive

Clearly tell the reader why you have undertaken the study
Important points to write an effective introduction
You must know your audience
Keep it short
Explain why you have done the study
Explain why it is important and how it is different from
previous work
Be convincing in describing that it adds value to what has
been done before
Try to make your first sentence impressive and catchy.
5. The Methods
Purpose

To describe, in logical sequence , how the


study was designed and carried out and how
the data was organized and analysed

Brief description of the study design


The Methods
How the study was carried out:
 Sampling
 Inclusion and exclusion criteria
 Data collection process and tools
 Ethical considerations
How the data were analysed
Statistical tests used, software used
Important tips in writing Methods
Clearly present and define analysis variables

Organize into logical subsections that illustrate

the steps you took to collect, organize and


analyse the data
Describe what you did

Respect chronology
6. The Results
Purpose
To describe the results of data analysis that
are relevant to the study purpose

It provides answers to the questions posed in


the introduction section

Use a mixture of text, tables, and illustrations


6. The Results
First, describe the participants of your study
Then, present the findings
Start with some text logically from the
beginning

Use tables to present the results and to establish


the statistical validity of your conclusions

illustration should be used for emphasis of


important points
Important tips for presenting your data in
Tables and Illustrations
Provide consistent row or column summation
Keep lines to a minimum
Use footnotes to clarify points of potential ambiguity
Make sure your title is adequately descriptive
Provide clear explanation where different sample sizes
have been used
Check: heading, labels of rows/columns, and footnotes
Provide appropriate legends
Define abbreviations and symbols
7. The Discussion
It basically answers the question: “What do the results
mean?”. The results you obtained are not isolated from
previous scientific knowledge.
Therefore, you not only provide the reader with
interpretation of the results, but you are also expected to put
your interpretation in context of the existing body of
scientific knowledge.
Purpose
To interpret the results and justify the interpretations
Begin by stating the main conclusions of the study, in a
sentence or two without repeating the data.
When comparing your findings with previous work, be
selective and use studies similar to that of yours.
Guidelines for constructing the discussion
Focus on the main results and conclusion
Restate the key result
Be clear about why results support this conclusion
Maintain connection with the purpose of the study
Interpret in context of literature
Present/compare with results of and methods used in other
studies on same or similar topics
Emphasize strengths of study and what is new or different
State limitations
Make recommendations
Changes in practice or policy
Future studies (with specific suggestions)
References
In general, references should include (Vancouver style):
All authors surnames and initials
Full title of the paper
Abbreviated or full title of the journal/book
The year of publication
The volume number
The first and last page numbers
Check the requirement of the journal you are
submitting your manuscript to
Research proposal

What is research proposal?


Research proposal
Is a document that presents a plan for a project to reviewers
for evaluation.

Can be a supervised project submitted as part of educational


degrees (masters thesis, PhD dissertation)

Can be a project proposed to funding agency


Research proposal
Purpose of a research proposal

to convince reviewers that the researcher is capable of


successfully conducting the proposed research project.

to provide clear indication of the topic in which the researcher


is interested

to give indication of researcher's ability to develop an


interesting research question
Research proposal
Reviewers have more confidence that planned projects will be
successfully completed
if proposal is well written and organized
If you demonstrate careful planning
Research proposal
is considered as preliminary indicators of the researcher’s area of
interest and potentials to undertake the research work without
problem.
will be considered in conjunction with researcher’s academic
qualifications and previous exposures in undertaking similar
research work
Research proposal

The proposal is similar to a research report, but


written before the research project begins
Research proposal
Describes research problems and its importance

Gives details of the methods that will be used and why they
are appropriate

Has plan for data collection and analysis

Includes schedules of the steps to be undertaken and


estimates of the time and budget required to carry out each
step of the research
Research proposal

The proposal for quantitative research has most


important parts of the research report:
A title
An abstract
Introduction: A problem statement, Rationale
A literature review
Research objective
A method or design section and
A bibliography

It lacks result, discussion, and conclusion sections


Research proposal
Research proposal is not only judged by its content,
but also by its form
Must look professional
Must be typed and written in good English
Should be well structured with section headings clearly
indicated
If photocopy, make sure that it is of high quality
Always include bibliography/references
Changes to research proposal

 It is natural for ideas to evolve and change


 You will not forced to adhere to specifics of your proposal

 However, you should avoid making any substantial


changes to the broad direction of your proposal after
acceptance by your donor, supervisors or organizations

 The proposal is your foundation of your working


relationship with your supervisors and potential donors
and thus it cannot be radically altered without discussion
and consultation with your supervisors.
Research Problem
Formulating problem statement and
justification of the problems
The first major section in a research proposal is
the “statement of the problem”

It should describe the problem that is to be


investigated and the question that will guide the
research process

Proper justification of the importance of research


Its likely contribution to knowledge
Its place in current debate or technological advance
What is a research problem?
All research is set in motion by the existence of a
problem
A problem is a perceived difficulty, a feeling of
discomfort about the way things are or a
discrepancy between what some one believes
should be the situation and what the situation is in
reality

While problems are initiating forces behind


research, not all problems require research
Why is it important to state & define the problem?
Because a clear statement of the problem :

is the foundation for further development of the research


proposal (objectives, methodology, work plan, budget,
etc)

makes it easier to find information & reports of similar


studies from which your own study design can benefit.

Enables you to systematically point out why the proposed


research on the problem should be undertaken & what
you hope to achieve with the study results. (during
presentation or defense)
What information should be included in
the problem statement?
Context in which the problem occurs
Nature of the problem
Major factors that may influence the problem
Justification for the study
Type of information expected
Definitions of crucial concepts and abbreviations
What information should be included in the
problem statement?

 Context in which the problem occurs

 A brief description of socio-economic &


cultural characteristics;
 Overview of health status & health-care
system;
 Relevant statistics.
What information should be included in
the problem statement?
Nature of the problem
description of the discrepancy between what is & what
should be)
description of the size, distribution & severity of the
problem (who is affected, where, since when, & what
are the consequences for those affected & for the
services).
For a descriptive or evaluation study the different
components of the problem should be elaborated.
What information should be included in
the problem statement?
Factors influencing the problem
An analysis of the major factors that
may influence the problem &

A discussion of why certain factors


need more investigation if the problem
is to be fully understood.
What information should be included in
the problem statement?
Justification for the study
A brief description of any solutions to
the problem that have been tried in the
past

How well they have worked, and

Why further research is needed.


What information should be included in
the problem statement?
Type of information expected

A description of the type of information expected to


result from the project and

How this information will be used to help solve the


problem.
What information should be included in the problem statement?

 Definitions and Abbreviations

 If necessary, a short list of definitions of crucial


concepts used in the statement of the problem.

 A list of abbreviations may be annexed to the


proposal, but each abbreviation also has to be
written out in full when introduced in the text for the
first time.
How to write a problem statement?

Problem statement should be


Precise & concise, while not forgetting to mention
essential points.

Summarized, & brief so the reader is not “drowned” in


detail.

Logical and well organized


( an outline listing the major points to be covered could be
prepared before any writing is done)
Literature Review
Why literature review?

 Comprehensive and focused literature review on your


particular topic is needed

 To define the set (or sub-set) of knowledge to which your research


relates to most directly

 To learn the major 'trends' or issues in that body of knowledge that


have been most significant in shaping your study

 To learn the theoretical agenda of that body of knowledge to which


your project relate to most directly

 To identify the major controversies that are important for your project
Why literature review?

It helps further your understanding of the problem


you plan to research, & may lead to refining of the
“Statement of the problem”.

It helps you find out what others have learned &
reported on your topic, & take account of this in the
design of your study.

It gives you a familiarity with the various types of


methodology that might be used in your study.
Why literature review?
It prevents you from “reinventing the wheel”.

If literature are properly reviewed they lays a


sound foundation for the study from which the
rationale for the study, the statement of the
problem, hypotheses or research questions, & the
design of the research emerge or concretize
Sources for Literature review

 Sources for LR include


 Card catalogues of books in libraries
 Indexes such as INDEX MEDICUS, INTERNATIONAL NURSING
INDEX etc. that identify journal
 Summaries of abstracts of books and articles
 Computer-based literature searches such as MEDLINE, PUBMED.
 Bibliographies such as those found at the end of the books, articles.
 Books, articles, newspapers, reports, etc.
 Statistics collected at the national, provincial, departmental levels.
 Studies conducted in the country or region.
 Responses to enquiries on ongoing research.
 Theoretical works related to the topic.
 Works on methodology & descriptions of methodologies of studies
 Opinions, beliefs, points-of-view.
 Anecdote, clinical observations, reports of incidents, etc.
Method of citation

 Information on an index card are easily available to find


all the data you will need for your report:
 For an article the following information should be noted:
 Author (s)’ Surname followed by initials. Title of article. Name of
Journal. Year, Volume, (number): page numbers of article.
 Example: Louria DB. Emerging- and re-emerging infections: The
societal variables. International Journal of Infectious Disease. 1996,
1(2):59-62.
 For a book the following information should be noted:
 Author (s)’ Surname followed by initials. Title of book. Place:
publisher, Year, Edition
 Example: Abramson JH. Survey methods in community medicine.
Edinburgh: Churchill Livingstone, 1990, 4th ed
 For a chapter in a book, the reference can include:
 Author (s) of chapter (Surname (s) followed by initials). Chapter
title. In: Editor (s) of book, (Surname (s) followed by initials). (eds).
Title of book. Place: Publisher, Year: Page numbers of chapter.
Significance of the study

 Brief importance of the study to

particular area/country and discuss the


rationale of conducting the research
with some detail
Research hypothesis
What is a Research Hypothesis?

is a guess about the nature of some


process or interaction which is tested.

 it is to collect data to prove or disprove


guesses
What is a Research Hypothesis?

Hypothesis statements are most applicable


for field intervention or evaluative studies.

Diagnostic or exploratory studies do not


normally require hypothesis statements
Research hypothesis

They indicate the major independent & dependant


variables of interest.

An independent variable causes, determine or


influence the dependant variables

Whenever the independent variable changes, the


dependant variable changes
Research hypothesis
Example:

Independent Cause, determine Dependant


variables or influence Variable

This model shows the direct relationship between the


independent and dependant variables.
Example:
Health education involving active
participation of mothers will produce more
positive changes in child feeding than
health education based on lectures.”
Independent variable: Type of health
education
Dependant variable: Changes in child
feeding
Format of research hypothesis

A hypothesis can be stated in the “null” format,


which simply states, for example as
‘there is no significant r/s b/n or among the
variables of interest’
A hypothesis can be stated in a “alternative” format.
Example: adolescents who perceive that their
parents enforce discipline inconsistently, are likely
to be more aggressive than those who perceive
their parents enforce discipline consistently.
Formulation of
Research Objectives
Research objectives

What is a research objective?

It is a statement that clearly depicts the goal to


be achieved by a research project.

In other words, the objectives of a research


project summarize what is to be achieved by the
study
Why should research objectives be developed?

 The formulation of the objectives will help you to


Focus the study (narrowing it down to essentials)

Avoid the collection of data which are not necessary for


understanding & solving the problem identified (to establish
the limits of the study)

Organize the study in clearly defined parts or phases

Facilitate the development of research methodology

Orient the collection, analysis, interpretation & utilization of


data
Research objectives

Characteristics of good objectives:

“SMART”
Specific
Measurable
Achievable
Realistic
Time bound
How should objectives be stated?

Objectives should be stated using “action


verbs” that are specific enough to be
measured
Example:
To determine……., To compare……..
To verify….., To calculate……
To describe….., to assess………etc
Do not use vague non-action verbs
To appreciate……
To understand……, to believe…….
Types of research objectives

1. General objectives
Is closely related to the statement of the
problem
Some times called purpose of the
research
Identifies in general terms what is to be
accomplished by the research and why
Types of research objectives

2. Specific objectives
smaller portions of the general objectives.
identify in greater detail the specific aims of the
research project, often breaking down what is to
be accomplished into smaller logical
components.
Identify questions that the researcher wants to
answer
specify what to do in a study, where & for what
purpose
Research Methods
Methods

The methodology of the research project is the core


of the study
Taking into consideration the work already done, i.e.
Selection of research problem, review of the literature
and identification of research objectives or formulation
of research hypothesis, the following questions need to
be answered when beginning to prepare a research
design for research proposal
Questions to be asked to prepare a research design
for a research proposal
What do I want to measure?
How can I measure it?
Where should I measure it?
What will I do with the answers collected?
How can I check whether my methods for measuring are
correct before beginning a large study?
What professional & non-professional staff do I need to
carry out this study?
What types of logistical support do I need?
Are there any ethical problems related to the study?
How can I avoid introducing biases into the study?
What constraints may affect this study?
Components of research design

 Components of a research design that should


be addressed in the methodology section of a
research proposal include
1. Variables
2. Study population
3. Sampling method
4. Plan for data collection
5. Plan for analysis of data
6. Plan for interpretation of the results
7. Staffing, supplies & equipment
8. Ethical considerations
Variables

What is variable?
Is a characteristic of a person, object or phenomenon,
which can be measured and take on different values
Example:
Age of a person
Weight (expressed in kilograms or in pounds);
Home - clinic distance (in kms or in minutes walking
distance);
Monthly income (expressed in Birr, or Dollars);
Number of children (1, 2, etc.)
Variables
Numerical Variables
Variables where it’s values expressed in numbers
The variable ‘age’ can take on different values since a
person can be 20 years old, 35 years old and so on
Categorical Variables
Variables whose values expressed in categories or
groups,
Example: The variable sex has 2 districts groups, male
or female.
Variables

How should variables for a particular study be


selected?
The variables selected for a study are those which are
directly relevant to the objectives of the investigation

The number of variables should be as many as


necessary, and as few as possible.

If too many variables are included for the study the
research may become difficult.
Research methods or techniques
The type of study design chosen
depends on
The type of problem

The knowledge already available about


the problem

The resources available for the study


Research studies
There are two broad groups of research studies
Experimental studies:
Set of observations, conducted under controlled
circumstances, in which the scientist 9researcher) manipulates
the condition to ascertain what effect such manipulations has
on the outcome
Non-Experimental
Surveys: a whole population or a sample is studied
Cohort studies: Subjects are selected with reference to their
exposure status and followed up
Case control studies: subjects are selected in reference to their
disease status
Sampling

 What is sampling?
 Sampling is the process involving the selection of a
finite number of elements from a given population of
interest, for purposes of inquiry
 What is a sample
 In research it is not always possible to study an entire
population.
 A decision is often made, therefore, to study only a
small fraction of the population, or a “sample” of it,
from which conclusions can be drawn about the whole
population.
 A sample should possess certain characteristics
 A sample is a representative part of a population
What are the characteristics a sample should
possess?

Should possess all the characteristics of the


population from which it is drawn, if possible, so
that it is fully representative of the population

The method of sample selection called sampling


procedure/process/ technique usually determines
its representative nature
Reason for sampling
 For an exploratory purpose, i.e. to get a general
impression of the total population of interest.
 In this case the selection of individuals to be included
in the sample can be quite subjective.

 For obtaining estimates on certain


characteristics of the population.
 Here, the sampling process is undertaken through a
set of rigorous & objective procedures to avoid
subjective bias.
Reasons for sampling
Three reasons that make sampling more useful than
complete enumeration
Time
Cost and avialbale resources
Practicability
There are several scientific methods of selection, some
are more practical than the others
Sample selection
There are two basic/general types of sampling techniques:
Probability (or random) sampling - PS
Non-probability sampling - NPS
The nature of the study will determine which type of
sampling technique one should use.
Large scale descriptive studies – PS
Intervention studies – NPS/PS
Qualitative studies - NPS
Probability sampling - PS
Sampling technique which employs random
procedure

Selection of sampling unit (individuals, groups of


people, objects, villages etc) is done on the basis of
chance.

This chance selection ensures that every member of


the population has equal chance of being included in
the sample.
Non probability sampling-NPS
NPS – refers to the selection of a sample that is not
based on known probability

Subjective judgment play a role in selecting the


sampling elements

NPS procedures are not valid for obtaining a sample


that is truly representative of a large population
Over select/under select some group of the population
Sample size determination
The size of the sample is one of the most
important determinants of the accuracy of survey
estimates.
 Samples size is estimated using formulae
 the selection of a formula depends on
sampling strategies (cluster Vs simple random sampling)
with population size
the type of variable being studied
study design (descriptive vs analytical)
study type (experimental vs non-experimental, )
type of statistical comparison planned.
Basic questions that should be asked when
choosing a sample
How large a sample can you collect?
The larger the sample the smaller the chance that the
sample will be different from the population it should
represent.
What is the prevalence of the condition you are
studying?
If one is studying a condition that appears quite often in
a population, better to take a smaller sample than if the
condition is rare.
What level of budget do you have for the study?
Research costs increase with sample size
Basic questions that should be asked when
choosing a sample
What staff are available to gather the sample?
Limited human resources may be a constraint on sample
size.

How much time do you have for the research?


You can only study a limited number of people in a
certain time.

Into how many cells or categories are you going to


divide your data for analytical purposes?
The more categories planned for analysis, the larger the
sample must be.
A sample size much
larger than the optimum

A sample size much


smaller than the optimum

Waste resource
Decreases precision
of the estimate
Narrows the range of
conclusions and
generalizations
Planning for data collection
A plan for data collection can be made in 2 steps:
Step 1
Listing the tasks that have to be carried out and who should be
involved
Make rough estimate of the time needed for the different part of
the study
identify the most appropriate period in which to carry out the
research
Step 2:
Scheduling the different activities that have to be carried out in
a work plan
Stage in data collection planning process

Three main stages can be distinguished


Stage 1: Permission to proceed (local
authorities)

Stage 2: Data collection

Stage 3: Data handling


Planning for data collection

Points to consider while organizing the data collection


team
Selection of candidates
Salary & fringe benefits to be given to the team members
Training
Planning, from the beginning, for possible dropouts
Additional training sessions for new members to fill for
dropouts,
What will happen to members hired, at the end? (Training or
certification, future employment possibilities)
Issues to consider concerning logistics support and arrangements during data collection

Mode of transport needed to go to the field


Mode of transport needed when working in the field,
repairs
Number of days in the field
Number of days of holiday (weekends, personal &
national) during data collection
 Food & lodging for data collection team
 Meeting place for the team
 Recreational facilities (if needed)
Planning: data analysis and
interpretation
Is important because it helps the researcher avoid
becoming aware at the end of the study, that:
Needed information has not been collected
Certain information collected has not been
analyzed
Certain information collected has not been
gathered in a form appropriate for statistical
analysis
Ethical Considerations
In designing research, especially research that
involves human subjects, it is important to
consider the underlying ethical principles
(described in the ‘Declaration of Helsinki’, 1975).

Proposals for such research must be reviewed by


the relevant Ethical Committee.

All Ethical issues must be dealt at inception


Ethical principles ‘Declaration of Helsinki’,
1975.
The main ethical principles include:
Scientific merit: any research should be merited, & the method
must be appropriate to the aims of the investigation.

Equitable selection of subjects

Informed consent: individuals must understand the nature of


the study & possible implications
Confidentiality
Ethical principles ‘Declaration of Helsinki’,
1975.
Coercion: the rights of individuals must be
protected. Coercion & deception must be avoided
at all costs.
Field trial (investigation) must observe & obtain
communal consent (community leaders, etc…)
Enhance the benefits & eliminate harms. The
overall problems of the community should always
be paramount
Provision of incentives; no hard rule should exist.
Care must be exercised in each situation
Ethical principles ‘Declaration of Helsinki’,
1975.
Feedback of the Results; the community must know
the findings, so as to relate to these findings. This will
reinforce future interest in community-based research.

Anonymity of communities; i.e. a community’s right


to confidentiality is important.
Ethical consideration
Stages of research at which a researcher should be
sensitive to ethical issues:
Selection of the project (identification with project)
Defining the statement of the problem
Review of literature
Research design
Personnel and administration
Analysis, reporting & dissemination of results
Work plan/implementation plan
Work plan/Implementation plan
What is work plan?
A work plan is a schedule, chart, or a graph
that summarizes, in a clear fashion, various
components of the research project and how
they fit together
The GANNT chart

The Gantt chart is a planning tool which depicts


graphically the order in which various tasks
must be completed and their duration of activity
A typical GANNT chart includes
The tasks to be performed
Who is responsible for each task; and
The time each task is expected to take
Budget preparation
Importance of budget preparation
Why do we need to prepare budget?

To identify which resources are already


available & which additional resources may
be required

The process of budget preparation will


encourage us to consider aspects of the work
plan we have not thought about before.
Importance of budget preparation
When should budget preparation begin?

A complete budget is not prepared until


the final stage of project planning

Remember there is a limit for research


project budgets
The Preparation of Budget
How should the budget be prepared?
Use the work plan as a starting point
Specify, for each activity in the work plan, what
resources are required
Determine for each resource needed the unit cost &
the total cost
The budget for the fieldwork component of the work
plan will include for personnel, transport, supplies,
incentive….
Use separate column for each funding source
(specially If more than one budget source is used,
indicate in the budget source for each cost
Appendix
Appendix
May include
The study questionnaire if you have it.
The consent form.
A copy of the approval from the Review Board
& if available from ethical clearing bodies.
Questions?

312
THE END
Thank You

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