Methods and Materials

– It describes
• How you will conducted your study
• What materials and equipment's you will use
• What methods and procedures you will use
– The corner stone of your research/scientific
method
• ―The worth of all scientific findings depends heavily on the
manner in which the data were collected and analysed‖ 1
 Methods and Materials…
Possible sub-sections
• Study design
• Setting/study area
• Study population
• Sample size and sampling methods
• Variables
• Operational definitions
• Data collection
• Data processing/analysis
• Data quality control issues
• Ethical consideration
2
 Study Setting and area
• It is necessary to check the location where the study
would be conducted (where the data will be collected).

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• Describe the setting, locality of the source
population

Dr. Getabalew
• Describe the source population as related to the
disease of interest

• Describe the source population as related to

3
health service offered
 Study design
• A study design is a specific plan or protocol
for conducting the study, which allows the
investigator to translate the conceptual hypothesis
into an operational one

• Direct how the investigation is conducted

Classification of Study Design

5
 Choice of Design
Depends on:
– Research Questions
– Research Goals
– Researcher Skills and knowledge
– Nature and availability of information
– Available resources/funds
– Researcher Beliefs and Values

6
 What happened? Case-control study
Exposed

Cases

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Non-exposed

Exposed
Controls

Non-exposed
Time

Onset of study 7

Direction of enquiry
 What is happening? Cross-sectional study

With oucome

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Subjects
Selected for
Study

Without outcome

Time
Onset of study
No direction of enquiry 8
 What will happen? Cohort study
With outcome
Exposed
OR
Subjects

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Without outcome
Cohort
Selected
For Study
With outcome

Unexposed
OR
Controls
Without outcome

Onset of study Time 9

Direction of enquiry
Study Population: Who are your study subjects?

10
 Inclusion and exclusion
• Inclusion: Segment of population that will be
included into the study by sampling methods

• Exclusion criteria: special segment of population

which are excluded from the selection due to
different reasons.
• Eg. Severely sick, unable to communicate, Etc….
 Sampling
• sample is a group of people, objects, or items that
are taken from a larger population for measurement

• Sampling involves the selection of a number of study

units from a defined population.
Advantages of samples
• Cost - sampling saves time, labour and money

• Quality of data - more time and effort can be spent on

getting reliable data on each individual sampled. 12

• Sampling is a must in some situations:

 Sampling…
• If we have to draw a sample, we will
be confronted with the following
questions:
– What is the group of people (population)
from which we want to draw a sample?
– How many people do we need in our
sample?
– How will these people be selected?
Sample Size Determination
• Sample size determination depends on the:
• Objective of the study
• Design of the study
• Plan for statistical analysis
• Accuracy of the measurement to be made
• Degree of precision required for generalization
• Degree of confidence with which to conclude
 Sample Size Determination…
• There are several approaches to determine
the sample size.

• Depending on the type of response variable,

whether it is categorical or continuous, we will
have two sets of formulas.

15
Sample size formula for single
population mean
• Where
– α= The level of significance which
can be obtain as 1- confidence
level.
– σ=Standard deviation of the
population
– w= Maximum acceptable
difference
– z α/2 = The value under standard
normal table for the given value of
confidence level 16
Sample size formula of single
population proportion

17
COMPARISON OF TWO MEANS
(z1 + z2)2 2 (s2)
(μ2 – μ1)2

• WHERE
• n = Sample size per group
• z1= 1.96 for α error of 5% (95% confidence level)
•z2 = 1.64 for 95% power
• = 1.28 for 90% power
• = 0.84 for 80% power
• s = Standard deviation of the outcome in control
group
•μ2–μ1= Minimum meaningful difference between
means of intervention & control group
 COMPARISON OF TWO PROPORTIONS

(z1 + z2)2 2 p (1- p)

n= (p2 – p1)2

Where
n = Sample size in each group
Z1 = 1.96 for 95% confidence level

= 1.64 for 95% power

z2 = 1.28 for 90% power
= 0.84 for 80% power

p1 = proportion in intervention group

p2 = proportion in control group

p1 + p2
p = = average of p1 and p2
2
19
p2 – p1 = Minimum meaningful difference in proportions
between intervention and control groups
 Sampling Techniques/procedures

• Describe the methods of sample selection

• If needed, use diagrams to simplify the sample

selection process

• Sampling methods (Two broad divisions)

– Probability and non- probability 20
 Non-probability Sampling Methods
• We do not know the probability that each
1. Convenience
population element will be chosen
sampling
• Used when a sampling frame does 2. Quota sampling
3. Purposive
not exist sampling
4. Snowball
• No random selection (unrepresentative
sampling
of the given population)

• Inappropriate if the aim is to measure

variables and generalize findings obtained
21
from a sample to the population.
 Probability Sampling Methods
• A sampling frame exists or can 1. Simple random
sampling
be compiled.
2. Systematic
random
• Involve random selection
sampling
procedures. All units of the 3. Stratified sampling
4. Cluster sampling
population should have an equal
5. Multistage sampling
or at least a known chance of
being included in the sample.
• Generalization is possible (from 22

sample to population)
 Variables of the study

• Variable is measurable characteristic of a

person, object or phenomenon, which can
take on different values

• Identify the:

• Independent variable (exposure,

intervention…) or Covariate

• Dependent variable (outcome) 23

Commonly stated Study Variables
1. Dependent variable:
• The variable that is used to describe or measure
the problem under study.

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• That is affected by others.
• Also called outcome variable.
• Usually limited to one or two variables
2. Independent variable (risk factor):
• The program, intervention, or factor that you
believe leads to the outcome.
24
• Also called explanatory or exposure variable
Consideration for selecting variables
• Conceptual framework
• Programmatic needs/information for decision

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making
• Resources
• External requirements (government, donor,
headquarters)
• Data availability
25
• Standardized indicators
 Common mistakes in Selection
• Variables not linked to research objectives

• Poorly defined variables

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• Variables that do not currently exist and
cannot realistically be collected
• Eg. Low birth weight: cannot use in rural areas where
few births are in facilities

• Too many variables 26

 Operational definitions
• Many variables can easily be measured

• For some variables it is some times not

possible to find meaningful categories unless
the variables are made operational with one
or more indicators

• Operationalizing variables means that you

27
make them measureable
Operational definitions….
• ART Treatment adherence
• Good adherence: > 95% of total doses in the month
before the study was conducted.

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• Poor adherence: < 95% of in the month before the study
was conducted.

Dr. Getabalew
• Knowledge on HIV/AIDS and ART:
• Good knowledge= score > 9 out of 12
• Poor knowledge= < 9 out of 12.
• Attitude:
• Favourable = > mean 28
• Unfavourable = < mean
 Data collection and Management
Describe your:

• Data collection techniques and tools

• Where will the information come from (data

sources

• Who will collect the data?

• Who will supervise the data collection?

29
• How long will take the data collection?
Types of data
Essentially Two Types of data:

• Primary Data: are those which are collected

for the first time and are original in character.
• Secondary Data: are those which have already
been collected by someone else and made
readily available for researchers to use for their
own research. 30
Common Data Collection Techniques
1. Interviews
– Face-to-face
– Telephone interviews
2. Self-administered questionnaire
– In person
– Postal or mail method
– Web based
3. Using available information
– Medical record review
– Desk review 31
4. Observation
 Data collection methods…
• The selection of a method for collecting
information depends upon the :
– Resources available

– Credibility

– Analysis and reporting

– Resources

– The skill of the data collector 32

 1. Interviews
Interviews consist of oral questions by the
interviewer and oral responses by the
research participants.

33
Types of interviewing
Mode of interview
– Face to face interview

– Telephone interview

Flexibility
– Structured

– Semi structured
34
– Unstructured
 Structured Interviews
• A structured interview is a type of interview
in which the interviewer asks a particular set
of predetermined questions.

• In structured interviews, questions are planned

and created in advance, which means that all
respondents are asked the same questions in
the same order 35
 Unstructured interview

• An unstructured interview is a type of

interview in which the interviewer asks
questions that are not prepared in advance.

• In unstructured interviews, questions arise

spontaneously in a free-flowing conversation,
which means that different respondents are
36
asked different questions.
 Semi-structured interview
• A semi-structured interview is a type of
interview in which the interviewer asks only a
few predetermined questions while the rest of
the questions are not planned in advance

• In semi-structured interviews, some questions

are predetermined ,while others arise
37
spontaneously in a free-flowing conversation.
 Advantage and Disadvantage of Interviewing
Advantage
– The interview is more appropriate for complex situations
– It is useful for collecting in-depth information
– Information can be supplemented
– Questions can be explained
– High response rate
– More complete answer
– Appropriate for illiterates
Disadvantage
– Interviewing is time consuming and expensive
– The quality of the data depends upon the quality of the
interviewer
– The quality of data may vary when many interviewers are used
– The researcher may introduce his/her bias
– Small scale study
– Problem of anonymity 38
 Methods of conducting Interview
• A personal interview involves a lot of preparation.

• Generally a personal interview should go through the

following five/5 stages:
1. Rapport Building
2. Introduction
3. Probing
4. Recording
39
5. Closing
 Methods of conducting Interview
1. Rapport Building
– Interviewer should increase the receptiveness of the
respondent by making him believe that his opinions are
very useful to the research, and is going to be a pleasure
rather than an ordeal.
2. Introduction
– An introduction involves the interviewer identifying himself
by giving his name, purpose and sponsorship if any.
40
– An introductory letter goes a long way in conveying the
study’s legitimacy.
 Methods of conducting Interview…
3. Probing
– Probing is the technique of encouraging the respondents to
answer completely, freely and relevantly.
4. Recording
– The interviewer can either write the response at the time of
interview or after the interview.
– In certain cases, where the respondent allows for it, audio or
visual aids can be used to record answers.
5. Closing
– After the interview, interviewer should thank the respondent
41
and once again assure him about the worth of his answers and
its confidentiality.
 2. Self-administered questionnaire (SAQ)
• A SAQ refers to a questionnaire that has been
designed specifically to be completed by a respondent
without an interviewer

• Traditionally the SAQ has been distributed by mail or in

person to large groups, but now SAQs are being used
extensively for Web surveys.

• Because the SAQ is completed without on-going feedback

from a trained interviewer, special care must be taken in how
the questions are worded as well as how the questionnaire is
42

formatted in order to avoid measurement error.

 SAQ…
A written questionnaire can be administered in
different ways, for example:
– Sending questionnaires by mail with clear instructions
on how to answer the questions and requests for
mailed responses;

– Gathering all or part of the respondents in one place at

one time, giving oral or written instructions, and letting
the respondents fill out the questionnaires; or

– Hand-delivering questionnaires to respondents and 43

collecting them later.
 Advantages of Self-administered Questionnaire

• Considerably low cost

• Ease in locating respondents

• Saving of time

• Respondent’s convenience

• Greater anonymity

• Honest response

• Less chance of biasing error 44

 Disadvantages of Self-administered Questionnaire
• Low response rate
• Inflexibility
• Reasons for refusal not known
• No control over the sequence
• No control over the environment
• High incomplete response
• Cannot record spontaneous answers
• No way to supplement the answers

• No way to check the correct identity of the 45

respondents
Improving Response Rates in SAQ-Mail method

• Follow-up through repeated reminders

• Prior notification
• Return envelopes: send paid self-addressed
and stamped envelope

46
 3. Secondary Data
• Secondary data is the data that have been
already collected by and readily available from
other sources.

• Since the researcher did not collect the data, it's

important for them to become familiar with the
data set:
– who the population of study was
– how the data was collected
– what the response categories are for each question
and more.
47
 Secondary data
Advantages
– Ease of access
– Time saving
– Inexpensive—government data is often free
– Requires no access to subjects
– Longitudinal analysis-the study spans over a
long period of time
Disadvantages
– Data not consistent with needs
– Inappropriate units of measurement
– Data might be out of date
– You haven't control over data quality
48
– Incomplete data
– Disorganized storage
 Sources of secondary data
• Examples of sources of secondary data that
are commonly used in epidemiological studies
include:
– population census records
– surveys of individuals and households (eg. DHS)
– Information collected by Health facilities (HMIS)
– patient medical records
– disease registries
49
– Vital registries (birth and death certificates)
Questionnaire Development
• A questionnaire is a research instrument consisting of
a series of questions for the purpose of gathering
information from respondents.

• The design of questionnaires needs clear aims and

objectives, a selection of items that need to be
translated into questions, and a logical order.

• A well-designed questionnaire facilitates the

50
respondents to provide complete and accurate
information.
 Steps in Questionnaire Development
1.Decide the information required.
– what are the things one needs to know from the
respondent in order to meet the survey's objectives?
– What are the specific research questions?
– What are hypotheses?
– List variables that you should measure
2.Define the target respondents.
– in designing the questionnaire we must take into
account factors such as the age, education, etc. of the
target respondents
3.Choose the method(s) of reaching your target respondents.
– the method of contact will influence not only the
questions the researcher is able to ask but the
phrasing of those questions 51
 Steps in Questionnaire Development
4. Decide on content.
5. Develop the question wording.
– Formulate one or more questions that will
provide the information needed for each
variable
– Questions should be clearly worded and response
options clearly identified
– Consider requirements for effective questions
6. Put questions into a meaningful order
– Questions should flow in some kind of order, so that
one leads easily and naturally to the next
– Opening questions should be easy to answer and not in
any way threatening to the respondents
– Questions that are of special importance should, if
possible, be included in the earlier part of the
questionnaire 52
– Sensitive questions last
Steps in Questionnaire Development
7. Format the questionnaire
– The clarity of questionnaire presentation can also
help to improve the ease with which interviewers
or respondents are able to complete a
questionnaire
– Allocating sufficient space for answers
– Consider spacing., coding, skipping
8. Pre-test the questionnaire
9. Develop the final survey form.
53
 Types of survey questions
Closed ended questions (Single or
Multiple response )
– They allow your respondents to select one or
more options from a list of answers that you
define

54
 Open-ended
• Open-ended survey questions require respondents
to type their answer into a comment box and don’t
provide specific pre-set answer options.

• Responses are then viewed individually or by text

analysis tools.

• E.g. Do you have any other comments. Questions,

or concerns?
55
Requirements of questions
Be clear, specific, and direct
Vague: What is your income?
– For what time period? For just the respondent or
the entire household? Before or after taxes?
Specific: What was your household’s yearly income before
taxes in 2021?
Ask only one question at a time
– Each question should focus on a single item or concept.
This generally
means that questions should have one subject and verb.
– Double-barrel questions ask a respondent to evaluate
more than one thing in a question yet only allow for a
single response.
Ex. Do you take your child to a doctor when he/she has cold
or diarrheal? 56
Requirements of questions…
Avoid bias and leading words
A biased question will lead participants in the
direction of a particular answer.
Biased: We think this lesson on Survey
Question Writing is very helpful. How helpful do
you think this lesson is?
Unbiased: What do you think of this lesson on
Survey Question Writing?
Keep the survey short and don’t be greedy!
• Don’t waste people’s time–only ask for what you57
really need.
Requirements of questions …
Keep answers mutually exclusive

• If a participant can only select one response

, each answer should be distinct and not
cross- over.

• For example, options might be 0-5 or 6-10

rather than 0-5 or 5-10. Having the ―5‖ in both
58
answers makes them not mutually exclusive
Pre-testing questionnaire
Used to answer :
– Do the respondents understand the questions?
– Are there any difficulties?
– Are there any sensitive questions?
– Is the question order appropriate?
– Does the researcher understand the
respondent's response?

59
 Pre-testing
• Refers to the testing of the questionnaire on a small sample
of respondents(5-10%)

• A questionnaire should not be used in the field survey without

adequate pretesting.

• The respondents for the pre-test and for the actual survey
should be drawn from the same population.

• Pre-tests are best done by personal interviews, even if

the actual survey is to be conducted by mail, telephone,
or electronic means, because interviewers can observe
respondents'
. reactions and attitudes 15
8
 Structure of a questionnaire
1. Introduction- cover letter
– Identify the sponsoring organization
– Explain the purpose of the study
– State how long it take to complete
– The sample design - to indicate how the respondent was chosen
– How you assure confidentiality of information, making clear that there are no
wrong or right answers. Honest answers are also requested
– What will happen to the results
– A contact person /return address

2. Respondent Identification - (code, HH.No., ID.No., Card No, Registration No.)

3. Body- Instructions and Questions
4. Conclusion: ―Thank you for taking the time to complete this survey 61
 Data Processing and Analysis
• Should start in the field, with checking for
completeness of the data and performing quality
control checks
• Before you conduct analysis prepare the data
• Data preparation is the act of manipulating raw data
into a form that can readily and accurately be
analysed
62
• Is the process of cleaning and transforming raw data
prior to analysis
Plan for analysis….
Present :

• A detailed plan for entering, cleaning and analyzing

data

• Methods and Models of Data Analysis according to

types of Variables

• Indicate how you will test assumptions

63
 processing and analysis….
• Steps in data processing and analysis:

• Sorting data

• Performing quality-control checks,

• Data processing, and

• Data analysis
 Data processing and analysis…
A. Sorting Data
• If there are different study populations , number
the questionnaires separately

• In a comparative study, sort the data right after

collection into the two or the three groups that
compared during analysis.

B. Performing Quality-Control Checks

• Check the data in the field to ensure that all the
information has been properly collected and
recorded

• Recheck for completeness and internal consistency

Data Processing and Analysis………..
C. Data Processing
• During planning for data processing, decide
whether to process and analyze the data manually,

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using data master sheets (manual compilation of the
questionnaires) or by computer
• Data processing involves:
-Categorizing the data,
-Coding, and
-Summarizing the data 66
 Data Quality Control Issues
Describe/provide:
• Operational definitions of crucial concepts
• Selection and training of field workers/research staff
• Pre-test/pilot : Field testing the research methods and tools
• Daily Supervision
• Check for Completeness
– Missing values
– Outliers

67
 Ethical Considerations
• Professional obligation to safeguard the safety of
study subjects

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• Describe potential ethical concerns and

Dr. Getabalew
mechanisms to minimize harm and maximize
benefits
• Every research undertaking can potentially raise
ethical concerns – always address confidentiality
and privacy!! 68
 Ethical consideration
• common ethical principles:
• Respect for person

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• Beneficence

Dr. Getabalew
• justice

69
 Respect for Persons
1. Respect for autonomy: respect for their
capacity for self-determination

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2. Protection of persons with impaired or
diminished autonomy

Dr. Getabalew
70
 Respect for person…..
oAutonomy:
• Refers to the obligation of the investigator to
respect each participant as a person capable of
making an informed decision regarding

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participation in the study.
• Informed consent:

Dr. Getabalew
• The three basic elements are information,
comprehension and voluntarism
• Confidentiality
• The researcher(s) shall assure that information that
has been obtained in the course of investigation
remains confidential to protect participants from
possible harm at the revelation of such 71
information.
Beneficence:
• Refers to the obligation on the part of the
investigator to attempt to maximize benefits for the

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individual participant and/or community, while

Dr. Getabalew
minimizing risk or harm to the individual.
• Maximize possible benefits and minimize possible
harms
• Do not harm
72
Beneficence…
• Maximizing benefits: considerations

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• Communication of study results

Dr. Getabalew
• Provision of health care

• Training of local health staff

73
 Beneficence….
• Minimizing harm: considerations
• Careful use of local health resources and respect
for local priorities

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• Avoid stigmatization, prejudice, economic loss
• Prepare research staff for special situations

Dr. Getabalew
• Propose measures against eminent risks
observed during the study
• Avoid harmful publicity
• Respect local social and cultural norms
• Confidentiality
• Disclosure of conflict of interest 74
 Justice
• This is a question of justice, in the sense of
fairness/ equity in distribution of benefits

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and burdens of research.

Dr. Getabalew
• Another way of conceiving the principle of
justice is that equals must be treated
equally.
75
Work plan

• A visual outline or illustration of the

sequence of the project operations.

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(Gant chart)
• Includes:

Dr. Getabalew
Tasks to be performed
Who will perform the task including number
of staff needed to perform the task
When the task will be performed
76
 Sample Gant chart
S. ACTIVITY R. Star En TIME FRAME (year)
N BOD t d
sep oct nov dec jan feb mar Apr
O Y date dat
e
1 Topic selection

2 Protocol

3 Get funding

4 Prepare
questionnaire
5 Obtain
ethical
approval
6 Hire staff

7 Train staff

8 Data collection

9 Data validation

10 Data analysis

11 Report writing 77
 Budget
How should a budget be prepared?
• It is necessary to use the work plan as a starting
point.

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• Specify, for each activity in the work plan, what
resources are required.

Dr. Getabalew
• Determine for each resource needed the unit cost
and the total cost.
• The budget for the fieldwork component of the work
plan will include funds for personnel, transport and
supplies.
• Include a 5%-10% contingency fund 78
Budget cont…
The Budget Format and Justification

• It is not sufficient to present a budget without

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explanation

Dr. Getabalew
• The type of budget format to be used may vary

• Most donor organizations have their own special

project forms, which include a budget format.

79
Personnel costs
No Human NO Per No of Total in Remark
power diem/day days Birr
(Birr/day)
1

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3

Dr. Getabalew
4

Total
Cost of supplies
Item Unit Quant Unit Total price
ity price

80
 Budget summary
S.No Expense type Total
Personnel cost

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Supplies cost

Dr. Getabalew
Publication cost
Gross total
Contingency (10%)
Grand total
81