Chapter one: Research Methodology

RESEARCH METHODOLOGY

Research is the process of systematic collection, description, analysis and interpretation of

primary or secondary quantitative or qualitative data that can be promote, improve, and
change policy or decision related to human life.

Rationale for conducting research:

 The wide gap between planning and the available data for planning and decision.
 Evidence based program management projects will function effectively if based on
scientific sound data.
 The available information management system is not functioning efficiently, this leads
to:
1. Serious deficiencies in official statistics.
2. Data are not satisfactory to policy makers or managers
3. Poor quality of available data.

Characteristic of research:
-It demands a clear statement of the problem - It builds on existing data
- It requires a plan - It collects new data

Classification of health research:

1. Clinical research :
- Efficacy of preventive diagnostic and therapeutic procedures e.g drugs efficacy and
side effects.
- Natural history of disease.
2. Health system research:
- Policy research - Operational research
3. Bio-medical research:
- Biological processes - body structure and functions - pathological mechanisms.
4. Epidemiological research:
- Frequency distribution and causes of disease.

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Examples: Research Methodology
1.Biomedical : the effect of anti TB therapy on plasma zinc status in childhood TB.

2. Clinical: the efficacy of long acting penicillin on TB pt.s

3. Epidemiological: (epidemiology of TB in Khartoum & pattern of health problems in under five

children in Omdurman area)

4. Health system research:(HSR) assessment of waiting time for TB pt.s attending Khartoum teaching
hospital.

TYPEs of HSR:
1. Operational research: 2. Health policy research:
*The Process of identifying and solving HSR:
health program problems. *Focus on how well is the health system
*It designed to improve effectiveness and functioning, such as cost and quality of
quality of health services delivered by health health services, etc…
providers, the availability, accessibility and * aims to provide information which improve
acceptability of health services delivered. the health system.

CRITERIA OF A RESEARCH TOPIC:

1. Perceived discrepancy between what is existing and what is expected.
2. A question why this discrepancy exist.
3. More than one answer to the question is expected.

CRITERIA FOR SELECTION A RESEARCH TOPIC:

1. Feasibility: Within available resources & adequate number of subjects to be involved.
2. Interest: should be of interest to the researcher, communities and health system
stakeholders.
3. Novelty: adequate knowledge about the subject and up to date literature.
4. Relevance: to aim of the funding agency & influence clinical management and heath policy
or guide further research.
5. Ethics: in choosing topic. Acceptance of research by the study subjects is important
(consent).
* Definition of the problem and the research question: should be in concise clear manner.

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(#) TITLE PAGE
Name of the organization
Title
By: author(s) name and affiliation
Supervisor: name and affiliation

(1) INTRODUCTION:
1. Background
2. Basic description of the problem
3. Justification” mentions previous studies”

(2) OBJECTIVE & LITERATURE REVIEW:

Definition: Objectives are the goals achieved by the research project.
Why should the objective be developed?
1. Focus the study
2. Avoid collection of unnecessary data.
3. The specific objectives direct data collection
4. Specific objectives organize the study in clearly defined parts which help to achieve the
research goals.

Types of research:
General: identify the general terms, what is to be accomplished by the research project.
Specific: identifies in details the specific aims of the research project.
Example:

Research question: what are the reasons for low utilization of MCH services in Khartoum state?

General objective: to study the reasons for low utilization of MCH services in Khartoum state-2009.

 Note: general objective is clearly related to the statement of the problem and research question.

Specific objectives:

 To determine the level of utilization of MHC services in Khartoum state.

 To identify if there are relation between the utilization and: seasons & type of clinic.
 To determine the level of utilization of MHC services and social factors: age, occupation and education.

Types Of Specific Objectives:

1. Estimation: e.g. incidence rate
2. Association: between the factor of interest and particular event.

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3. Evaluation: to evaluate the effect of an investigation e.g. to verify the effect of H.E on
utilization of MCH services.

Characteristics Of Specific Objectives: ( S.M.A.R.T)

1. Specific: clearly stated and cover all aspect of the problem.
2. Mesurable: by using action verbs (to determine, to compare, verify, identify, list, etc…)
Avoiding non-action verbs (to describe study, notice, appreciate, etc…)
3. Attainable: can be achieved.
4. Realistic: feasible concerning resources.
5. Timely: to be conduct within allowed frame of the study.

* Properly formulated SPISIFIC OBJECTIVES will help in:

1. Select the right type of design.
2. Orientation of data collection.
3. Evaluation of the study.

HYPOTHESIS
It’s “a prediction of a relationship between one or more factors and the problem under the study
which can be tested”
It’s a frequent goal in quantitative research. E.g. consumption of more than ten cigarettes
percentage day for ten years is associated with Ca. bronchus.

Review of the available literature:

Why do we review list?
1- Prevent duplication
2- Assist in refining the statement of the problem
3- Strengthening the argument of selection of a research topic (justification)
4- It helps to get familiar with various types of research design

Source of information:
1. Articles from journals
2. Books
3. Indexes
4. Data base
5. International organization documents . e.g.(WHO,UNICEF)
6. Reports from MOH facilities
7. Vital statistics

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8. Census
9. Surveillance system
10. Surveys
11. Computer search for international literature (internet)
12. Opinions, beliefs of key persons (through interview)

How to write literature review:

- Use index cards - write in your own language
Bias in literature review:
- The presentation of available information in such away that it reflects opinions or
conclusions that does not represent the real situation
- Restricting refrences to those that support the point view of the author
- Drawing far reach conclusions from shaky or preliminary results
Ethical considerations in literature review:
- Bias
- Careless presentation and interpretation of data put researcher in wrong way
.loss of resources
.wrong decisions

How to write references:

1- From journals: author(s). Article. Journal. Year. Volume: pages (author: surname
followed by initials ) e.g. Ahmed MA, Osman SA, smoking among university
students in sudan. SMI. 2008; 12(3): 700-712.
2- From a book: author. title of the book. Edition. Place: publisher year: pages.
3- From a chapter in a book : author(s). chapter title. In: editors of the book. Edition.
Title of the book. Place. Publisher, year: pages

Study design:
Study design

Non interventional study interventional study

Exploratory study

descriptive study randomized control

analytical study
Quazai experimental

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Chapter one: Research Methodology

1- Descriptive studies:
Descriptive study designs: the systematic collection and presentation of data to give a clear
picture of a disease or health related events
a- Case studies: a case study describes in depth the characteristics of one or limited
number of cases
. A case may be a patient, health center, a village
. Can provide useful insight to the problem
.common in clinical medicine, social science, management and administration ……
. Associated with qualitative data and presentation is in a narrative way
Features:
- Should be will planned and data will be collected through predetermined questions.
- Should be flexible to deal with unexpected situations

Advantages:
It permits holistic approach to problem under investigation.
Disadvantages:
Not representative
Descriptive studies (surveys):
Use:
1- To collect information on demographic characteristics,age sex, education…….
2- To study characteristics on health related variables
3- To study attitudes, opinions, and beliefs
When is the disease occurring: (time distribution)
Where is the disease occurring (place distribution)
Who is affected (person distribution)

Procedure:
1. Define the population under the study [ case definition, inclusion criteria, exclusion criteria]
2. Define the problem under study "operational definition".
3. Describe the disease by time person & place.
4. Measurement of the disease.
5. Comparing with known indices.
6. Formulation of an etiological hypothesis.

2- ANALYTIC STUDIES:-
[1] Cross-sectional:
* Prevalence study.

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* The relationship between the disease and other variables of interest as they exist at one
particular point of time.

Example: CROSS-SECTIONAL STUDY OF HTN:

1. Measure the blood pressure among the study population (prevalence).
2. Collect data on age, sex, social class, occupation, etc...
3. Determine how hypertension is related to these variables.
4. Compare with finding of others.
5. Draw hypothesis.

[2] Case control study:-

*common features:
1. Both exposure and outcome have occurred before the start of the study.
2. Study proceeds back from effect to cause.
3. Presence of control group.
*basic steps:
1. Selection of cases.
2. Selection of controls.
3. Matching
4. Obtaining data on exposure.
5. Analysis and interpretation of results.
*selection of cases involves two specifications:
1. Diagnostic criteria: of the disease is to be stated clearly.
2. Eligibility criteria: to determine who is allowed to be included in the study. e.g.: only
newly diagnosed cases rather than old ones.

*sources of cases and controls:

1. Cases: pt. - general population.
2. Controls: pt. & relatives, neighbor-hood & general population.

* MATCHING: the process by which controls are to be similar to the study group.

* Types of matching:-
1. Individual matching 1.group matching

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*data on exposure and analysis:
1. The exposure rate among both the cases and controls
2. Odds ratio: can be used to estimate the relative risk as the incidence risk cannot be
determined in case control study design.
*thus the case control study is always suggestive of the etiological association between two
variables.
*case control study of smoking and Ca lung.
Status/// smoking cases controls Total
Yes 33(a) 55(b) 88(a+b)
No 2(c) 27(d) 29(c+d)
Total 35(a+c) 82(b+d) 117(a+b+c+d)

* the exposure rate among cases = a/a+c =33/35 =0.94*100 =94%

*the exposure rate among control =b/b+d =55/82 =0.67%
* odd ratio =a/c*d/b =891/110 =8.1

INTERPRETATION:
* From the exposure rates among the cases and controls : chi square test has to be used to
confirm that there is statistical difference between the two values.
*the odds ratio is found to be greater than 1, it means that there is positive etiological
association.
STUDY DESIGNs-2:
............ Chart

[3] Cohort study:

* A longitudinal study in which a group of individual are followed up for some time.
* It's group of persons who shared common characteristics or experience within a defined time.
* Features:
a. Identified before the appearance of the investigated disease.
b. The study group is observed over a period of time.
c. The study proceeds from case to effect.
Note: the incidence rate can be measured.
* Indications of cohort:
a. When there is strong suspicion of association between exposure and disease.
b. When exposure is rare but the incidence is high among the exposed.

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c. When the attrition of study population can be minimized.
*types of cohort:
1. Historical: start from point in the past to now.
2. Prospective: from now goes to future.
3. Retrospective prospective: from the past through now to the future.
*elements of cohort:
1. Selection of study group:
a- from general population
b- from special group
2. Obtaining data on exposure: by review of records, medical ex., interview, etc...
3. Selection of a comparison group:
a- Internal comparison, according to exposure level.
b- External comparison from outside the study group.
4. Follow up, by:
a- periodic medical ex.
b- Review of records
c- Review of death certificate
d- Mailed questionnaire
e- Telephone calls
f- Medical ex., etc,....
5. Analysis:
a- incidence rate
b- Relative risk.

Smoking and CA lung cohort study:

Smoking status Developed ca Didn't developed total
lung ca lung
Yes 70 6930 7000
(a) (b) (a+b)
No 3 2997 3000
© (d) (c+d)

Incidence :
 Incidence rate of ca lung among smokers = a\a + b = 70\7000 = 10\1000
 Incidence rate of ca lung among non- smokers = c\c + d =3\3000 =1\1000

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Chapter one: Research Methodology
Relative risk :
 Incidence of disease among exposed : incidence among non-exposed
 10\1000\1\1000 = 10
Attributable risk :
 This is the difference in incidence of disease or death between exposed and non
exposed group
 It is expressed as a percentage
 It measures the impact that removal of a certain factor will have an impact on the
incidence of the disease .

Analysis : attributable risk = incidence rate among exposed- incidence rate among non
exposed \incidence rate among exposed = 10 -1*100= 90%.

Experimental study designs:

In experimental studies the researcher manipulated a situation and measures its effect after
that .
Types :
1. Randomized control trial 2. Non randomized trails

1. Randomized control trail : those trails are used for assessment of methods of treatment
and prevention.
They include :
1. Intervension 2. Control groups 3. Randomization

Features of randomized control trail:

1. Manipulation: the researcher does some intervention(example provision of new drug) to one
of the study groups.
2. Control: the researcher introduces one or more control groups to compare with the
experimental group.
3. Randomization: each subject have an equal chance of being allocated to either of the two
groups ( study and comparison groups ).
Steps:
1. Drowing a protocol.
2. Selecting comparison and experimental groups .
3. Randomization

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Chapter one: Research Methodology
4. Manipulation (intervention)
5. Follow up
6. 6. Assessment of the out come
The protocol: one of the essential features of the randomized trials .

The protocol specifies :

1. The objectives .
2. The questions to be answered
3. The selection criteria
4. The sample size
5. The procedures of allocation of the subjects into experimental and control groups.
6. The treatment applied: how, what dose etc….
7. The details of the scientific techniques and interventions.
Note: once the protocol has been evolved, it should be strictly adhered to throughout the study
.
Randomization:
 Randomization is the statistical procedure by which the participants are allocated into
groups usually called study and control groups to receive intervention or therapeutic
procedure .
 Randomization aims at making the groups comparable and eliminate bias .
 Randomization ensure that the investigator has no control over the allocation of the
participants to either the study or control group, thus eliminating the selection bias.
 Every individual has an equal chance of being allocated into either group.
 Randomization is best done by using statistical random table .

Manipulation :
 Manipulation or intervention is usually done by application or withdrawal of the
suspected factor e.g. drugs, vaccine ,or dietary factor.
 This manipulation create an independent variable (drug, vaccine, or new procedure )
which effect is then determined by the measurement of the final outcome which
constitutes the dependent variable e.g. incidence of disease, recovery .
Follow up :
 This includes examination of the study and control groups subjects at defined intervals
of time in standard manner under the ame conditions in the same time frame till the
final assessment .

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The main difficulties encountered in the follow up process include : attrition from : death,
migration, displacement, and loss of interest etc…
Assessment :the final assessment of the trial is carried in terms of :
 Positive result: these include the benefits of the experimental study such as reduced
incidence of the disease or severity of the disease , cost of health services or other
appropriate outcome .
 Negative result : these include the severity and frequency of side effects and
complications. The incidence of positive\negative results is compared in both groups
and the differences are tested statistically .

2- NON RANDOMIZED TRIALS :-

(A)QUASI_EXPERIMENTAL STUDY DESIGNS :
 At least one of the characteristics of the true experiment is missing (RANDOMIZATION
OR CONTROL GROUP )
 -QUASI_EXPERIMENTAL STUDY DESIGNS ALWAYS INCLUDE MANIPULATION
(INTERVENTION)
(B) Before and after study:-
-include intervention _no control group
_no randomization _observation before and after the intervention
_test analysis
BIAS IN EXPERIMENTAL STUDIES : bias is the systematic difference between observed
results and the actual results.

Sources of bias :-
1-participant's bias : the participant report subjectively that they feel better or improved
if they knew that they were receiving new treatment .
2-Observor bias : the influence of the investigator measuring the outcome of the trial if
he knew before hand the particular procedure to which the patient has been subjected .

HOW TO REDUCE THE SOURCES OF BIAS ?

1-Randomization
2-Blinding

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Binding is carried in three ways :
1)Single blind trial : the trial is so planned that the participant is not aware whether he belongs
to the study or control group .
2-Douple blinding trial : the trial is so planned that neither the investigator nor the participant is
aware of the group allocation and treatment received .
3-Triple blind trial : the trial is so planned that the participant ,the investigator and the person
analyzing the data are all blind . This is the ideal but double-blinding is the most commonly
used .

DISADVATAGES OF EXPERIMENTAL STUDIES :-

1_ They are costly 2_Ethical problems 3_Feasibility is difficult

STUDY VARIABLES
-A variable : is a characteristic of a person, object or phenomenon that can take different
values and can be measured .

CLASSIFICATION OF VARIABLES :-
* Numerical : expressed in numbers
a)Discrete :- E.g. episode of diarrhea ,schistosoma eggs. B)Continuous:-
E.g. Weight , Height ,Distance between homes and clinic etc…
* Categorical: expressed in categories
a)Ordinal ,E.g. doctors ,soldier ranks
b)Nominal :-E.g. colors ,sex

TYPES OF VARIABLES :-
1-Dependant variable : use to measure the problem
2-Independent variable : cause or influence the problem
3-Confounding variables : variables associated with the problem and it's possible causes.
Confounding variables

Effect cause
Independent variable Depending variable
Mother education child malnutrition

Confounding variable (income)

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Confounding variables:-
-May affect results (Bias) -Must be considered particular case control studies
How to write variables?
Factor variables
- Long waiting time -waiting time
_absence of drugs _ drug availability

Operationalization of variables:
Determine whether the variables are measurable or need appropriate indicators e.g level of
knowledge, nutritional status weight / age, weight / height etc... (Standard growth curve).

Data collection:
Definition: data are variables or observations as collected from the field after processing and
analysis data becomes information
data collection tools : depending on the nature of the data / information to be gathered forms
for gathering data from official sources or population or patients etc...... Must be designed

1/ Questionnaires: set of questions used to collect data. They are useful in describing the
characteristics of a large population. Make large samples feasible to deal with. Simplify
analysis.
Types of questionnaires:
1- Open ended 2- Closed ended 3- Administered
4- Self –administered 5- structured 6- semi structured
Advantages:
1- Low cost 2- low bias 3- Greater Anonymity
Disadvantages: requires simple questions
- Pre-coding - Pre-testing

2/ personal interviews: the interview is an alternative method of collecting survey data rather
than asking the respondents to fill lout questionnaire interviewers ask questions orally and
record respondents answers. Personal interviews are a good way to gather information from
community leaders, or policy makers.
Advantages:
-Flexibility - control of the interviewer situation - high response rate

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Disadvantage:
-Higher cost(time) interviewer bias

3/ focus groups discussion: focus groups are useful in obtaining a particular kind of information
that would be difficult to obtain using other methodologies (qualitative)
A focus group: A group of people (7_12) who possess certain characteristics and provide data
of a qualitative nature in focused discussion. The size of the group must be small enough for
everyone to participate and large enough to provide diversity.
Advantages:
-Flexibility - analysis is easy - low cost
Guidelines for conducting a focus group:
-reserve a time and place - provide an incentive for participation
-selection of focus group participants - moderating the discussion
-Analysis of the results

How to write research proposal:

Components:
Title page
a) Introduction b) objectives
C) Methodology: 1- study design 2-study area 3- study population
4- Sampling 5- data collection 6- data analysis 7- ethical concern
d) Budget e) schedule f) references g) annex

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