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V. METHODS AND MATERIALS
12/16/2023 1
MPH @JJU, by M. Omar
By: Mohamed Omar (Asst. Prof)
Learning Objectives
At the end of the session you should be able to:
1. Identify the pertinent questions to consider
when developing the methodology of a
research proposal
2. Describe and understand the various
components of the methods section
3. Explain the cyclical nature of the different steps
in designing research methodology
4. This describes the steps to be traced in
achieving the objective
12/16/2023 2
MPH @JJU, by M. Omar
Methods
 Now we have to decide exactly how we are going to
achieve our stated objectives
 Where should we collect it? Study area
 What new data we need to shed light on the problem?
 Data collection and process.
 What new information do we need? Selection of
variables
 How will we collect this information?
 Selection of type of study Design
 What tools do we need to collect it?
 Selection of data collection techniques
12/16/2023 3
MPH @JJU, by M. Omar
Cont….
 How many subjects do we include in the study
and how do we select them?
 Sampling
 Populations
 How do we collect the data?
 Plan for data collection
4
12/16/2023 MPH @JJU, by M. Omar
Cont.…
 What will we do with the collected data?
 Plan for data processing and analysis
 How can we determine whether our methods for data
collection are correct before implementing the study?
 Pretesting the methodology
 Are we likely to harm anyone as a result of the study?
 Ethical considerations
 How much time and money it cost me?
 Resource required
5
12/16/2023 MPH @JJU, by M. Omar
Main Components of the methods
• The major issues that must be examined when
developing research methods are:
 Study area and period
 Study design
 Population
 Sample size and sampling techniques,
 Measurement: main variables
 Data collection technique
 Pre-testing
 Data quality assurance
 Data processing and analysis
 Ethical considerations
 Limitations, and
 Operational definitions
 Plan for dissemination of data
12/16/2023 6
MPH @JJU, by M. Omar
Study Area and Period
• Study Area
Brief description of:
 The area (weather, distance, altitude)
 The population,
 The health service directly or indirectly related to
the problem under study,
 Study subjects distribution etc,
• Study period: the period for which the data is
generated or the reference period where the data is
available
12/16/2023 7
MPH @JJU, by M. Omar
Study Design
• It is a specific plan or protocol for conducting the
study which allows the investigator to translate the
conceptual hypothesis into an operational one.
Research question(s) dictates your study design
What do we want to know? (General Objective)
Your research question determines the “how” and
“what” of the research: design and data collection
method(s).
8
12/16/2023 MPH @JJU, by M. Omar
Criteria for selecting study design
The type of study design chosen depends on:
 The type of problem,
 The already available knowledge about the
problem, (personal experience)
 Audience
 The resources available for the study.
9
12/16/2023 MPH @JJU, by M. Omar
Study design Based on objectives:
 Descriptive,
 Explanatory and
 Exploratory
10
12/16/2023 MPH @JJU, by M. Omar
Problem
Problem exists but
little is known
Contributing factors
to the problem
Establish the extent
of contribution
factors
Sufficient
knowledge about
cause to prevent,
control, or solve the
Question
Nature/Magnitude
of the problem
Who is affected?
How do affected
people behave?
What are the
factors?
What is the cause?
Will the removal of
a factor prevent or
reduce the
problem?
What is the effect
of a particular
intervention
Design
Exploratory/Descriptive
Descriptive case study
Cross-sectional survey
Analytical (Comparative)
Cross-sectional-
comparative
Case-control
Cohort
Experimental/quasi
Experimental study
design
Experimental/quasi
Experimental study
design
11
12/16/2023 MPH @JJU, by M. Omar
Based on Design
1. Observational (Non-intervention studies)
Describes and analyzes researchable objects or
situations but does not intervene
Cross sectional, cohort and case control study
2. Intervention studies (Experimental)
Manipulates objects or situations and measures
the outcome of the manipulations
Randomized Clinical Trial (RCT), Community
Intervention Trial (CIT)
Quasi-experimental
12/16/2023 12
MPH @JJU, by M. Omar
Case-control
Cohort
Individuals
Intervention
Retrospective
Prospective
Descriptive
Populations
Analytical
Observational
Case-
series
Cross-sectional
Ecologic
al
Clinical trials
Epidemiological study designs
12/16/2023 13
MPH @JJU, by M. Omar
Case-report
Design Based on approach
1. Quantitative
2. Qualitative
3. Mixed
14
12/16/2023 MPH @JJU, by M. Omar
Population and Sampling
Population
 A group of individuals, objects, or items from
among which samples are taken for
measurement.
 Decisions must be made concerning the
population or individual units (persons,
households, etc.) to be investigated
 The population under consideration should be
clearly and explicitly defined in terms of place,
time, and other relevant criteria
16
12/16/2023 MPH @JJU, by M. Omar
Source population
 Those are the general population from which
the study subjects are selected
 Identify on whom to do the research.
 Think to whom the study result would be
inferred or concluded.
12/16/2023 17
MPH @JJU, by M. Omar
Reference Population
Source Population
Sampling Frame
Sample
Study Subjects
Jigjiga district School
Children
School children in Jigjiga
District Schools
Class (Student)
Registers of schools
Each 20 students
randomly selected from
each class in each
Schools in Jigjiga
Students who provide
information to the
research team
Schematic figure to illustrate sampling
12/16/2023 18
MPH @JJU, by M. Omar
Study population (Subjects):
These are subjects that would be selected for
the study.
i.e, these are people in which if they got the chance
of being selected would be enrolled in the study).
They are identified and selected from the
Source Population by using both inclusion
and/ or exclusion criteria of being a study
subject.
12/16/2023 19
MPH @JJU, by M. Omar
Inclusion and exclusion criteria
• 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….
• NB: Be careful about ethical issues
• Non- response: individual who refused to
participate in to the study from the beginning or
refused and drop from the study before
completing the survey
20
12/16/2023 MPH @JJU, by M. Omar
Practical questions in selecting population
• Is the proposed population the one that would give
the required information?
• Will the population cooperate to participate in the
study, or will it be a 'resistant' one?
• If it is proposed to study patients with a specific
disease, will it be possible to identify enough cases
to yield useful conclusions?
• If a long term 'follow up' study is planned, is the
population so mobile that it may be difficult to
maintain contact with the subjects?
21
12/16/2023 MPH @JJU, by M. Omar
Sample size and sampling
procedure
12/16/2023 22
MPH @JJU, by M. Omar
Sampling
• The population is too large to collect
information from all members
• Instead, select a sample of individuals hoping
that the sample is representative of the
population
• Sampling: The selection of a number of study
units from a defined study population
23
12/16/2023 MPH @JJU, by M. Omar
Sampling…
• Possible questions:
 What is the group of people (study population)
from which we want to draw a sample?
 How many people do we need in our sample?
 How will these people be selected?
– Sampling unit: is the unit of selection in the sampling
process ,e.g. in a sample of districts: a district
– Study unit: is the unit on which the observations will be
collected, e.g. in a study of family size: Households
24
12/16/2023 MPH @JJU, by M. Omar
Sampling…
 Sample design: The scheme for selecting the
sampling units from the study population
 Representativeness: to draw conclusions that
are valid for the whole study population draw a
sample in such a way that it is representative
of that population
 A representative sample has all the important
characteristics of the population from which it is
drawn
25
12/16/2023 MPH @JJU, by M. Omar
Exercise
• To Assess KAP towards modern contraceptive use
in kebribayah district
- Which study design is appropriate?
- Who is your study population?
- What is your sampling unit?
- What is your study unit?
- How do you select your sample?
• Individual assignment to be submitted on next
Friday via email: mahamadwehliye@gmail.com.
You should explain why you give the answer for
each question.
26
12/16/2023 MPH @JJU, by M. Omar
Sample size
• 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
12/16/2023 27
MPH @JJU, by M. Omar
Sample size
 For cross-sectional study
– Single proportion and mean sample size
determination is used
n = sample size
Zά/2 = Z value at (∞ = 0.05) = 1.96
P = Proportion of occurrence of the event to be
studied.
(Usually found from literature review).
D = Margin of error (Precision), (Usually < 0.05)
12/16/2023 28
MPH @JJU, by M. Omar
Sample size determination
• How many subjects are needed in the sample to enable
draw conclusion on the whole population?
– Depends on expected variation in the data and number of
units per cell for analysis
– The eventual sample size is a compromise between what
is desirable and what is feasible
– If the sample is to be taken from a relatively small
population (N<10,000): Sample size should be corrected nf
= n/(1+n/N)
– In multistage sampling, design effect is required
12/16/2023 29
MPH @JJU, by M. Omar
Design effect
• This provides a correction for the loss of
sampling efficiency resulting from the use of
cluster sampling instead of simple random
sampling
• The magnitude of DE depends upon two
factors:
– The degree of similarity or homogeneity of elements
within clusters, and
– The number of measurement units to be taken from
each cluster.
– WHO Design effect is 1.5,2, 3 etc 30
12/16/2023 MPH @JJU, by M. Omar
Allowance for non-response
• Non-response is a fact of life in surveys. Although
efforts to minimize the level of non-response are
strongly encouraged
• Allowances for non-response are customarily
made during the calculation of sample size
requirements.
• Allowance of 10 percent should prove adequate
in most situations
31
12/16/2023 MPH @JJU, by M. Omar
12/16/2023 MPH @JJU, by M. Omar 32

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The major issues that must be examined when developing research methods are: Study area and period Study design Population Sample size and sampling techniques,

  • 1. V. METHODS AND MATERIALS 12/16/2023 1 MPH @JJU, by M. Omar By: Mohamed Omar (Asst. Prof)
  • 2. Learning Objectives At the end of the session you should be able to: 1. Identify the pertinent questions to consider when developing the methodology of a research proposal 2. Describe and understand the various components of the methods section 3. Explain the cyclical nature of the different steps in designing research methodology 4. This describes the steps to be traced in achieving the objective 12/16/2023 2 MPH @JJU, by M. Omar
  • 3. Methods  Now we have to decide exactly how we are going to achieve our stated objectives  Where should we collect it? Study area  What new data we need to shed light on the problem?  Data collection and process.  What new information do we need? Selection of variables  How will we collect this information?  Selection of type of study Design  What tools do we need to collect it?  Selection of data collection techniques 12/16/2023 3 MPH @JJU, by M. Omar
  • 4. Cont….  How many subjects do we include in the study and how do we select them?  Sampling  Populations  How do we collect the data?  Plan for data collection 4 12/16/2023 MPH @JJU, by M. Omar
  • 5. Cont.…  What will we do with the collected data?  Plan for data processing and analysis  How can we determine whether our methods for data collection are correct before implementing the study?  Pretesting the methodology  Are we likely to harm anyone as a result of the study?  Ethical considerations  How much time and money it cost me?  Resource required 5 12/16/2023 MPH @JJU, by M. Omar
  • 6. Main Components of the methods • The major issues that must be examined when developing research methods are:  Study area and period  Study design  Population  Sample size and sampling techniques,  Measurement: main variables  Data collection technique  Pre-testing  Data quality assurance  Data processing and analysis  Ethical considerations  Limitations, and  Operational definitions  Plan for dissemination of data 12/16/2023 6 MPH @JJU, by M. Omar
  • 7. Study Area and Period • Study Area Brief description of:  The area (weather, distance, altitude)  The population,  The health service directly or indirectly related to the problem under study,  Study subjects distribution etc, • Study period: the period for which the data is generated or the reference period where the data is available 12/16/2023 7 MPH @JJU, by M. Omar
  • 8. Study Design • It is a specific plan or protocol for conducting the study which allows the investigator to translate the conceptual hypothesis into an operational one. Research question(s) dictates your study design What do we want to know? (General Objective) Your research question determines the “how” and “what” of the research: design and data collection method(s). 8 12/16/2023 MPH @JJU, by M. Omar
  • 9. Criteria for selecting study design The type of study design chosen depends on:  The type of problem,  The already available knowledge about the problem, (personal experience)  Audience  The resources available for the study. 9 12/16/2023 MPH @JJU, by M. Omar
  • 10. Study design Based on objectives:  Descriptive,  Explanatory and  Exploratory 10 12/16/2023 MPH @JJU, by M. Omar
  • 11. Problem Problem exists but little is known Contributing factors to the problem Establish the extent of contribution factors Sufficient knowledge about cause to prevent, control, or solve the Question Nature/Magnitude of the problem Who is affected? How do affected people behave? What are the factors? What is the cause? Will the removal of a factor prevent or reduce the problem? What is the effect of a particular intervention Design Exploratory/Descriptive Descriptive case study Cross-sectional survey Analytical (Comparative) Cross-sectional- comparative Case-control Cohort Experimental/quasi Experimental study design Experimental/quasi Experimental study design 11 12/16/2023 MPH @JJU, by M. Omar
  • 12. Based on Design 1. Observational (Non-intervention studies) Describes and analyzes researchable objects or situations but does not intervene Cross sectional, cohort and case control study 2. Intervention studies (Experimental) Manipulates objects or situations and measures the outcome of the manipulations Randomized Clinical Trial (RCT), Community Intervention Trial (CIT) Quasi-experimental 12/16/2023 12 MPH @JJU, by M. Omar
  • 14. Design Based on approach 1. Quantitative 2. Qualitative 3. Mixed 14 12/16/2023 MPH @JJU, by M. Omar
  • 16. Population  A group of individuals, objects, or items from among which samples are taken for measurement.  Decisions must be made concerning the population or individual units (persons, households, etc.) to be investigated  The population under consideration should be clearly and explicitly defined in terms of place, time, and other relevant criteria 16 12/16/2023 MPH @JJU, by M. Omar
  • 17. Source population  Those are the general population from which the study subjects are selected  Identify on whom to do the research.  Think to whom the study result would be inferred or concluded. 12/16/2023 17 MPH @JJU, by M. Omar
  • 18. Reference Population Source Population Sampling Frame Sample Study Subjects Jigjiga district School Children School children in Jigjiga District Schools Class (Student) Registers of schools Each 20 students randomly selected from each class in each Schools in Jigjiga Students who provide information to the research team Schematic figure to illustrate sampling 12/16/2023 18 MPH @JJU, by M. Omar
  • 19. Study population (Subjects): These are subjects that would be selected for the study. i.e, these are people in which if they got the chance of being selected would be enrolled in the study). They are identified and selected from the Source Population by using both inclusion and/ or exclusion criteria of being a study subject. 12/16/2023 19 MPH @JJU, by M. Omar
  • 20. Inclusion and exclusion criteria • 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…. • NB: Be careful about ethical issues • Non- response: individual who refused to participate in to the study from the beginning or refused and drop from the study before completing the survey 20 12/16/2023 MPH @JJU, by M. Omar
  • 21. Practical questions in selecting population • Is the proposed population the one that would give the required information? • Will the population cooperate to participate in the study, or will it be a 'resistant' one? • If it is proposed to study patients with a specific disease, will it be possible to identify enough cases to yield useful conclusions? • If a long term 'follow up' study is planned, is the population so mobile that it may be difficult to maintain contact with the subjects? 21 12/16/2023 MPH @JJU, by M. Omar
  • 22. Sample size and sampling procedure 12/16/2023 22 MPH @JJU, by M. Omar
  • 23. Sampling • The population is too large to collect information from all members • Instead, select a sample of individuals hoping that the sample is representative of the population • Sampling: The selection of a number of study units from a defined study population 23 12/16/2023 MPH @JJU, by M. Omar
  • 24. Sampling… • Possible questions:  What is the group of people (study population) from which we want to draw a sample?  How many people do we need in our sample?  How will these people be selected? – Sampling unit: is the unit of selection in the sampling process ,e.g. in a sample of districts: a district – Study unit: is the unit on which the observations will be collected, e.g. in a study of family size: Households 24 12/16/2023 MPH @JJU, by M. Omar
  • 25. Sampling…  Sample design: The scheme for selecting the sampling units from the study population  Representativeness: to draw conclusions that are valid for the whole study population draw a sample in such a way that it is representative of that population  A representative sample has all the important characteristics of the population from which it is drawn 25 12/16/2023 MPH @JJU, by M. Omar
  • 26. Exercise • To Assess KAP towards modern contraceptive use in kebribayah district - Which study design is appropriate? - Who is your study population? - What is your sampling unit? - What is your study unit? - How do you select your sample? • Individual assignment to be submitted on next Friday via email: mahamadwehliye@gmail.com. You should explain why you give the answer for each question. 26 12/16/2023 MPH @JJU, by M. Omar
  • 27. Sample size • 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 12/16/2023 27 MPH @JJU, by M. Omar
  • 28. Sample size  For cross-sectional study – Single proportion and mean sample size determination is used n = sample size Zά/2 = Z value at (∞ = 0.05) = 1.96 P = Proportion of occurrence of the event to be studied. (Usually found from literature review). D = Margin of error (Precision), (Usually < 0.05) 12/16/2023 28 MPH @JJU, by M. Omar
  • 29. Sample size determination • How many subjects are needed in the sample to enable draw conclusion on the whole population? – Depends on expected variation in the data and number of units per cell for analysis – The eventual sample size is a compromise between what is desirable and what is feasible – If the sample is to be taken from a relatively small population (N<10,000): Sample size should be corrected nf = n/(1+n/N) – In multistage sampling, design effect is required 12/16/2023 29 MPH @JJU, by M. Omar
  • 30. Design effect • This provides a correction for the loss of sampling efficiency resulting from the use of cluster sampling instead of simple random sampling • The magnitude of DE depends upon two factors: – The degree of similarity or homogeneity of elements within clusters, and – The number of measurement units to be taken from each cluster. – WHO Design effect is 1.5,2, 3 etc 30 12/16/2023 MPH @JJU, by M. Omar
  • 31. Allowance for non-response • Non-response is a fact of life in surveys. Although efforts to minimize the level of non-response are strongly encouraged • Allowances for non-response are customarily made during the calculation of sample size requirements. • Allowance of 10 percent should prove adequate in most situations 31 12/16/2023 MPH @JJU, by M. Omar
  • 32. 12/16/2023 MPH @JJU, by M. Omar 32