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1.1 Literally :
Investigation undertaken in order to
discover new facts or get additional
information.
To search again.
1.2 Scientifically :
The systematic collection, analysis and
interpretation of data to answer certain
question or to solve a problem.
1.3 Characteristics of research :
- Problem definition.
Literature review
2. What is information is - Look for possible sources of
already available information.
- Review available
information.
- Present information needed.
- Avoid bias.
- Refer to author.
Money.
2. Statement of the research problem
2.1 Problem identification :
“ Problem is a discrepancy between what should be and what is existing”
. A well defined problem leads to good statement of research problem,
. Finding a problem is not hard but identifying one for research is not always
easy.
hypothesis, definition of key variables and selection of appropriate
methodology.
2.1.1. Criteria
Research problem has three criteria:
Problem situation:
In village x 1000 children should be immunized but not a
single is immunized.
Discrepancy:
1000 children should be immunized but no child is
immunized.
Problem question:
what factors are responsible for failure of immunizing the
children.
Answer:
No vaccines are available.
2.1.3. Example of research problem
Problem situation:
In village Z 60% of the children who are candidates for immunization are
not immunized.
Discrepancy:
100% of candidates for immunization should be immunized but only
40% are immunized.
Problem question:
What factors are responsible for failure of immunizing 60% of candidates
for immunization?
Possible answers:
1- The health worker is not exerting necessary efforts to cover the children
with immunization.
2- There is shortage of supplies.
3- The mothers are not willing to immunize their children.
Prioritizing problems for research:
Seven criteria are used for selecting a research topic. Final score for each
topic can be calculated by multiplication of the scores for all criteria:
1. Relevance :
- Not relevant = 0
- Relevant = 1
- Very relevant = 2
2. Avoidance of duplication :
- Sufficient information already available = 1
- Some information available = 2
- No information available = 3
3. Feasibility :
- Study not feasible considering available resources = 1
- Study feasible considering available resources = 2
- Study very feasible considering available resources = 3
4. Political acceptability :
- Topic not accepted to policy makers = 0
- Topic more or less accepted = 1
- Topic fully accepted = 2
Cont.
5. Applicability :
- No chance of recommendations being implemented = 1
- Some chance of recommendations being implemented = 2
- good chance of recommendations being implemented = 3
6. Urgency :
- Information not urgently needed = 1
- Information is needed but delay is acceptable = 2
- Information very urgently needed for decision making = 3
7. Ethical acceptability :
Factor Proble
m
Factor
Factor
Factor
Facto
r
Proble
m
Facto
r
Factor
3. Literature Review
Administrative level
: Information form
Bilateral and multilateral --
International
levels
Organizations e.g. (USAIL -
.(UNICEF ,WHO, UNFPA
Computerized searches for -
.international literature
4. Research objectives
4.1. What is objective?
The objectives of a research project summarize what is to be
achieved by the study . The objective answers three main
questions “what, where, why”
S Specific
M Measurable
A Achievable
R Realistic
T Timely
4.3. Role of research objective :
It helps to :
1- Focus the study
2- Avoid collection of unnecessary data
3- Organize the study in defined parts or phases.
4.4. How to state objectives:
An objectives should :
1- Cover the problem and contributing factor in coherent way
and logical sequence .
2- Be clearly phrased in operational terms.
3- Be realistic considering local condition.
4- Use action verb which are specific enough to be evaluated.
e.g. to compare , to calculate, to describe . Avoid to
understand to study, to appreciate
4.5 Categories of research objectives:
General Objective :
Example
Wrong : “a study of utilization of child welfare clinics”
Correct : “a study of the reasons for low utilization of child
welfare clinics in Khartoum state during the
year 1999”
5. Research
Methodology
5.1. Diagram of Components
6. What will we do with collected data? Plan for data processing and
analysis
Factors contributing to the problem in the problem analysis diagram are actually
variables having negative or positive values factors can be transformed into
variables as follows :
Factor Variable
3. Independent variable: the variable used to describe or measure the factors that
are assumed to cause or influence the problem e.g. iodine intake in case of
simple goiter.
5. Confounding variable: a variable that is associated with the problem and with a
possible cause of the problem e.g. living at high altitude for cases of simple
goiter. A confounding variable may either strengthen or weaken the apparent
relationship between the problem and a possible cause.
Binary (sex)
Qualitative Nomina
l
(categorical)
Ordinal Non-numerical
Variables (colour)
Discrete
Quantitativ
e Continuou
(numerical) s
5.3. Selection of type of study
5.3.1. How to select study design?
The type of study design selected depends on :
4. The type of the problem.
5. The knowledge already available about the problem.
6. The resources available for the study.
2. Defining the disease under study (operational definition rather than clinical definition)
4. Measurement of disease.
Cross-sectional surveys are example of descriptive studies that aim at quantifying the
distribution of certain variables in the study population at one point of time e.g.
Prevalence surveys
* Physical characteristics as
Evaluation of coverage
Descriptive Analytical
- Look at entire population - individual within the
- Formulate hypothesis - test hypothesis.
5.3.3.3.1.(a). Criteria :
Case control study has three important criteria:
a- Both exposure and outcome occurred before the start of the study.
b- The study proceeds backwards from effect to cause.
c- It uses a control or comparison group to support or to refute an inference.
5.3.3.3.1(b). Steps :
There are four basic steps in conducting a case control study:
1. Selection of cases and controls.
2. Matching.
3. Measurement of exposure.
4. Analysis and interpretation.
1. Selection of cases and control
* Selection of cases :
(a) Definition of a case:
- Diagnostic criteria e.g. ( for malaria are signs and symptoms enough or is
blood film is mandatory ).
- Eligibility criteria e.g. are all cases could be included or only new cases.
(b) Sources of cases:
- hospital.
- general population.
Cont
* Selection of controls
Controls must be:
- free from the disease under the study.
- as similar as possible to cases.
Sources of control:
- Hospitals “ source of selection bias”
- Relatives “ spouses and siblings ”siblings are not suitable when
studying genetic conditions.
- Neighbors.
- general population.
How many controls are needed?
- If cases are many, one control for each case.
- If cases are less than 50, take 2,3or 4 controls for a cases.
2. Matching:
- “ Is defined as the process by which we select controls similar to cases in certain
confounding variables ( e.g. age ) which are known to influence the outcome of the
disease .”
- Is used to ensure comparability between cases and controls.
- A confounding variable is a variable associated with the exposure and the
outcome.
- Matching procedures include:
- Stratification of cases based on
e.g. age, occupation, social class.
4. Analysis:
(1) find out exposure rates among cases and controls.
(2) Estimate disease risk associated with exposure (odds ratio)
(a) Advantages:
1. Relatively easy to carry out.
2. Rapid and inexpensive (compared with cohort study).
3. Require comparatively few subjects.
4. Particularly suitable to investigate rare diseases or diseases
about which little is known.
5. No risk to subjects.
6. Allows the study of several different aetiological factors (e.g.
sinking , physical activity and personality characteristics in
myocardial infarction).
7. Risk factors can be identified. Rational prevention and control
programmes can be established.
8. No attrition problems, because case control studies do not
require follow-up of individuals into the future.
9. Ethical problems.
Cont
(b) Disadvantages :
1. Problems of bias, e.g. relies on memory or past records, the accuracy of which
may be uncertain, validation of information obtained is difficult or sometimes
impossible.
2. Selection of an appropriate control group may be difficult.
3. We can not measure incidence, and can only estimate the relative risk.
4. Do not distinguish between causes and associated factors.
5. Not suited to the evaluation of therapy or prophylaxis of disease.
6. Another major concern is the representative ness of cases and controls.
Diagram of case control study
Past
Present Risk factor present
Cases
Risk factor not
present
Compare
d rates :
es =a for control = b
a+b b+d
e risk =a / c
a+b c+d
atio =axd
bxc
5.3.3.3.2. Cohort study (prospective study –
longitudinal study):
(a) Definition :
- Cohort is defined as a group of people who share a common
characteristic or experience within a defined period of time .
(b) Criteria :
- It has three important criteria.
a- Cohort are identified before the appearance of the disease.
b- Study groups observed over a period of time.
c- study proceeds from cause to disease.
(c) Role :
- Obtain evidence to support or refuse an association between
suspected risk factor and disease.
- Cohort study are the only sure way to establish causal relationship.
(d) Diagram of Cohort study
Present Future
Developed disease
Exposure to
risk
No disease
Compare
Developed disease
Not exposed
risk
No disease
(e) Frame work of cohort study
No
Yes
Exposed a+b
b a
Relative risk = a / c
a+b c+d
Attributable risk =
a - c
a+b c+d
a
a+b
(f) Types of cohort study :
w up.
is.
Selection of study subjects:
- Exposure groups.
ow up :
2- Estimation of risk :
Attributable risk =Incidence of disease among exposed – Incidence of disease among non-exposed
Incidence rate among exposed
Case control Cohort study
1 Proceeds from ``effect to cause`` Proceeds from ``cause to effect``
3 Test whether the suspected cause Tests whether the disease occurs
occurs more frequently in those more frequently in those exposed ,
with the disease than among those than in those not similarly exposed
without the disease
Expensive
Relatively inexpensive
10
5.3.4. intervention studies :
- in experimental study individuals are randomly allocated to two groups. One group
is subject to intervention or experiment while the other is not. The outcome of the
intervention is measured by comparing the two groups later after.
5.3.4.1..3. Characteristics:
- Experimental design has three characteristics:
1- Randomization.
2- Control.
3- Manipulation.
5.3.4.1.3. Diagram of experimental study :
Study population
Sampling
Study population
Randomization
Intervention
(manipulation)
Last data collection Last data collection
(after intervention) (same time as in study
group)
Compare
Randomization eliminates the effect of confounding variables.
5.3.4.2. Quasi experimental studies:
5.3.4.2.1. characteristics:
* Inquasi experimental study there is an intervention and at least
one characteristic of a true experimental study is missing (either
randomization or control).
* If there is neither randomization nor the use of a control group, the study
design is called pre-experimental design or (before and after study ).
Compare
5.3.5. Deriving Valid and reliable conclusions
“Whatever the research design selected the main concern is to reach valid and
reliable conclusion “.
“Validity means that the conclusions are true”.
“Reliability means that if someone else is using the same methods in the same
circumstances he will obtain the same results”.
Representation of validity and reliability combinations for 5 trials
...
..
......
...
..
.
.
. .
…
. .
. .
.
.
Many factors can distort the study and affect either its internal
validity or external validity. Internal validity means reaching true
conclusions for the study . External validity means that the true
conclusions of the study are fairly generalizable.
Factors affecting the external validity (selection bias):
* Faulty adjustment
- Confounding.
5.4. Selection of data collection techniques
Many data collection techniques can be used. All of them are either
based on ASKING or OBSERVING e.g. :
1- Using available information.
2- Observing.
3- Interviewing. ( face to face ).
4- Administering written questionnaires.
5- Focus group discussions (FGD).
6- Nominal group techniques (NGT).
7- Delphi technique.
Cont.
- Questionnaire.
- Weighing scale.
- Measuring tabe.
- Sphygmomanometer.
- Observation checklists.
- Microscope.
Data collection techniques and data collection
tools used:
Data collection techniques Data collection tools
Using available information Checklist, data compilation forms
Observing Observation checklist, eyes and other senses, pen and paper,
watch, scales, microscope
Interviewing Interview schedule, checklist, questionnaire, tape recorder
Nominal group technique NGT statement or question, paper and pens, board, listing
ideas, individual expression, discussion, voting and
ranking, discussion, 2nd vote and ranking
Delphi technique Circulating questionnaire
Scale and test batteries Highly structured questionnaire with highly standardized
sequence of questions
Essay analysis School children hand-writing books
Target Study
Population Population Ssmple Sample
Non-probability Probability
Sampling Sampling Sampling
Not Present
Methods Frame Methods
Present
5.5.4. Sampling Methods
There are two major categories :
Problems :
- Un-representative of the study population
- Over selection of certain study units.
- Under selection of certain study units.
- Missing of some study units.
5.5.4.1.2. Quota sampling
“ Is a method that ensures that certain number of sample units from different
categories with specific characteristic appear in the sample so that all these
characteristic are represented “.
o Useful when a convenience sample would not provide desired
balance of study units.
o Not representative of the entire population.
5.5.4.2. Probability sampling :
“Involves random selection procedures to ensure that each unit of the sample
is chosen on basis of chance. All units of the study population has an equal
or at least known chance of being included in the sample.”
5.4.2.1. Simple random sample :
Stratum
Random sampling
Study Stratification Or
Stratum Sample
population Systematic sampling
Stratum
5.5.4.2.4. Cluster sampling
Cluster are often “geographical units” e.g. provinces, villages, localities
or organized units e.g. clinics, training groups.
Cluster are selected using simple random, systematic random or stratified
sampling techniques.
All elements in each selected cluster are then studied.
1. Categorizing
- Categorizing is needed for (open- ended) questions where on the list there is
need for a category called (others).
- Closed- question has only two categories. Numerical variables can be
categorized after their collection.
2. Coding
- Coding is the translation of data into symbols appropriate for analysis e.g.
yes = 1 no = 2 no response = 9
5.7.3.4 Summarizing the data on
master sheet
- Data master sheet is needed if data is processed manually. On the master sheet all
the answer of individual respondents are tallied by hand.
Govern Non govern Hosp HC Dis Dr. MA G.S DFM Cul K P Cot Tet Met Nyst
5.7.3.5. Data Analysis:
Role of Pre-test :
Identify potential problems in the proposed study.
Enable to revise the methods and logistics of data collection before starting
the actual field work.
Aspects evaluated during pre-test :
1- Reaction of the respondents to the research procedures to determine :
- Availability of study population.
- Acceptability of methods used.
- Acceptability of questions asked.
- Willingness of respondents to answer the questions.
1- Manuals 216,000
2- Stationeries 150,000
3- Training 252,000
4- Salaries 1,660,000
5- Medicines 4,200,000
6- Lab testing fees 2,000,000
7- Transportation 1,000,000
8- Consultancy 1,000,000
Total 9,978,000
b- Budget justification
1- Manuals:
Each manual consist of 60 pages printing 60 x 600 3600
Photocopying of 1200 pages x 150 180000
Total 216000
2- Stationeries:
- Photocopying papers 80000
- Box files 30000
- Transparencies 30000
- Writing pens 10000
Sub total 150000
3- Training:
7- Transportation:
Fuel, engine oil, break oil
8- Consultancy ;qualified
Consultant statistician will work on data analysis, designing and data
9. Finalizing the research proposal
1. Introduction
1.1. Background information.
1.2. Statement of the problem.
1.3. Literature review
2. Objectives:
2.1. General objectives.
2.2. Specific objectives.
3. Methodology:
5. Budget:
5.1. Total budget.
5.2. Budget justification (details)
Annexes:
1. References
2. List of abbreviations
3. Questionnaires (data collection tools)
Cont.
- Title
- Duration
- Total budget
- Contributions
- Research team
- Name of principals researcher
Brief summary a problem statement. Objectives and methodology.