? What is research.

1

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 :

  

It demands a clear statement of the problem. It requires a plan. It builds on existing data. It collects new data.

1.4 Research purposes :

Research serves two major purposes: 1- Generates new knowledge and technologies to deal with major unresolved health problems (basic research) . 2. Identifies priority problems and designs and evaluates policies and programs (applied research) .

1.5 Steps in development of research proposal Questions to ask
1. What is the problem and why should it be studied?

Steps
Selection, analysis and statement of the research problem

Elements of steps
Problem identification. - Problem priorization. - Problem analysis. - Problem definition.
-

2. What is information is already available

Literature review

Look for possible sources of information. - Review available information. - Present information needed. - Avoid bias. - Refer to author.
-

3. What do we want to carry out the research? What do we hope to achieve?

Formation of objective

- General objectives. - Specific objectives. - Hypothesis.

Cont.

Questions to ask
4. What data needed?  How much is needed?  How to collected?  How to process and analyze?

Steps

Elements of steps
Variables.  Type of the study.  Data collection techniques.  Sampling.  Plan for data collection.  Plan for data processing and analysis.  Ethical consideration.  Pre-test or pilot study.

Research methodology

5. Who will do what and when and where?

Work-plan

 

Personnel. Time table.

6. How to manage the project? 7. What resources are needed for carrying out the study?

Plan for project administration

 

Administration. Monitoring.

Budget

Material support and equipment.  logistics.  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: 1. Perceived discrepancy between what is and what should be. 2. A question about why the discrepancy exists. 3. More than one possible and plausible answers to the question.

2.1.2. Example of non research problem
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 - Relevant - Very relevant = 0 = 1 = 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 - Study feasible considering available resources - Study very feasible considering available resources = 1 = 2 = 3

4. Political acceptability :
- Topic not accepted to policy makers - Topic more or less accepted - Topic fully accepted = 0 = 1 = 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 - Information is needed but delay is acceptable - Information very urgently needed for decision making 7. Ethical acceptability : - Not ethically accepted - Minor ethical problem - No ethical problem = 0 = 1 = 2

= 1 = 2 = 3

2.3. Problem analysis
Once the problem has been identified and justified in depth analysis of the problem needed. Problem analysis focus on two issues : 1. Identify factors that may have contributed to the problem. 2. Clarify the relationship between the problem and contributing factors. Problem analysis diagram helps to visualize the interrelationship between the problem and the contributing factors. Contributing factors in general, could be grouped into three main categories : Service- related factors. Disease related factors. Socio- cultural factors.

Elements of the problem analysis diagram :
Factor Proble m Factor

Problem analysis diagram (PAD) is composed of a central cell ( the problem) surrounded by peripheral cells (factor) and arrows denoting the relation between the factors and problem and the factors among themselves. PAD is very important for selection and designing of data collection tools. All factors that appear in PAD should be addressed in the questionnaire e.g. age, occupation or in the observation checklist e.g. weight, height. If weight is a factor there is a need for weighing scale, if height is a factor there is a need for measuring tape and if presence of a parasite in blood is a factor there is a need for a microscope and special stain.

Problem analysis diagram
Factor Factor Facto r Proble m

Facto r

Factor

3. Literature Review
3.1 Why we review literature?
1. To prevent duplication. 2. To refine statement of the problem. 3. To formulate the suitable type of methodology. 4. To support the argument for need of the research.

3.2. Possible sources of the information
1. Individuals, groups and organizations. 2. Published information ( books, articles, indexes and abstracts journals ) . 3. Unpublished information (reports, records and computer data bases).

3.3. How to refer to source :
3.3.1. For an article :
Author (s) (Surname followed by initials), title of article, name of journal, year, volume number : page numbers e.g. Gwebu ET , Metero S, Dube N, Tagwirey J T, Mugwagwa N, Assessment of nutritional status in pregnancy : Use of reference table of weight for height, Central Africa Journal of Medicine, 1985, 31: 193- 196.

3.3.2 For a book :
Author (s) (surname followed by initials) title of book, edition, place: publisher, year: number of pages in the book. e.g. Abramson JH, Survey method in community medicine, 2nd edition
Edinburgh: Churchill Livingstone, 1979: 229.

3.5. Sources of information at different administrative level
Administrative level
Clinic and hospital based data from routine .statistics registers Opinions; beliefs of key figures (through -.(interview Clinical observations, reports of clinical ;incidents ect .Local surveys ,Annual reports Statistics issued at provincial and district .level

Community and District or provincial level

Cont.

National level

Articles from national journals -books identified during literature searches at university .and other national libraries Documentation reports and raw data from ministry of health, .central statistical offices NGOs

Cont.

: Information form
International levels

Bilateral

and multilateral --

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”

4.2. Criteria of research objective : . A well prepared objective satisfy the following criteria :
S M A R T Specific Measurable Achievable Realistic 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: . Objectives of research are of two categories
4.5.1. General objective: State what is expected to be achieved by the study in general terms. 4.5.2. Specific objective: Is the breakdown of the general objectives into smaller, logically connected parts.

Examples :
General Objective : “To test the validity of the syndromic approach as diagnostic procedure for sexually transmitted diseases and to assess its applicability by the medical assistants at the primary care level in order to help policy makers take decisions to adopt it as measure for control of STDs”

Specific Objectives:
1.” To compare the sensitivity, specificity and predictive value of the syndromic approach in diagnosis of gonococcal urethritis in cases of urethral discharge encountered during the study period in Mayo with that of the a etiological approach “ 2.” To assess the antibiotic sensitivity of the gonococcus gonorrhea organism or other organisms isolated from urethral swabs of the cases of urethral discharge studies to the antibiotics recommended by the syndromic approach for treatment of urethral discharge”

Cont. 3. To compare the cost per patient of gonococcal urethritis treated by syndromic approach during the study period with the cost per patient if treated with a etiological approach.

4. “ To assess the capability of the medical assistants trained in this study of correctly applying the syndromic approach for management of STDs”.

4.6 . Hypothesis
“Hypothesis is a prediction of a relationship between one or more factors and the problem under study which can be tested”.

4.7. Title of the study * When objectives are well defined and a hypothesis is
formulated the title for the study can easy be generated.

Cont. * Criteria for the title: 1. Aim specific: “telling exactly what your study aim at.” 2. Place specific: “telling where you undergo the study.” 3. Time specific: “telling when you undergo the study.”

Example
Wrong Correct : “a study of utilization of child welfare clinics” : “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

Questions asked
3.

Component of research design Selection of variables

What new information do we need?

8.

How will we collect this information?

Selection of type study

Cont.

3. What tool do we need to collect it?

Selection of data collection Techniques and tools

4. Where should we collect it? How many subjects do we include in the study? How do we select them?

Sampling

5. How do we collect the data?

Plan for data collection

Cont.

6. What will we do with collected data?

Plan for data processing and analysis

7. Are we going to cause harm as a result of the study?

Ethical consideration

8. Are the methods for data collection correct? Do they need adjustment?

Pre-testing methodology

5.2. Selection of variables

5.2.1. What is a variable?
“A variable is a characteristic of person, object or phenomenon that can take on different values .” A variable could be expressed in number ( numerical variable) or in categories (categorical variables.)

5.2.2. Examples of variables:
Numerical (Quantitative) : age, weight, monthly income, distance between home and clinic, waiting time in clinic…etc. Categorical ( Qualitative ) : color, outcome of disease, level of knowledge…etc.

5.2.3. Factors and variables :
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 - long waiting time - Absence of drugs - Lack of supervision visits.

Variable - waiting time. - availability of drugs. - frequency of supervisory

5.2.4. Types of variables
1.

Dependent variables: the variable used to describe or measure the problem under study it is affected by change in the independent variable e.g. serum level of iodine in simple goiter. 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. 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. Background variable: such as age, sex, level of education, socioeconomic status and religion if they are not dependent, independent or confounding variables in the study.

3.

5.

7.

5.2.5. Operationalization of variables:
Some variables are directly measurable e.g. (age) “level of knowledge” these need to be operationalized.

*Operationalizing a variable means making it measurable. That us possible by using certain indicators e.g.: The variable “level of knowledge: is not measurable . It needs Operationalization . A series of 15 questions can be designed to assess the level of knowledge . Answering correctly 0 – 5 question is poor knowledge, 6 – 10 questions is reasonable knowledge, 11 – 15 questions is good knowledge. The number of questions answered is the indicator for Operationalizing the variable.

5.2.6. Scales for measurement of variables:
1. 2. 3. 4. Nominal scale. Ordinal scale. Ratio scale. Interval scale.

5.2.7. Diagram for classification of variables

Qualitative (categorical) Variables

Nomina l Ordinal

Binary (sex)

Non-numerical (colour)

Discrete Quantitativ e (numerical)

Continuou 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.

5.3.2. Classification of study types
depends on research strategy. Two major types exist :  Observational studies (non-intervention studies).  Experimental studies (intervention studies).

5.3.3. Non intervention studies:
Non-intervention studies include : Exploratory studies. Descriptive studies. Comparative (analytical).

5.3.3.1.Exploratory studies :
An exploratory study is a small-scale study of relatively short duration, which is carried out when little is known about a situation or a problem. Small-scale studies that compare extreme groups are very useful for detecting management problems. Comparison is a fundamental research strategy to identify variables that help explain why one group of persons or objects differ from another. Small scale studies may be called exploratory case studies if they lead to plausible assumption about the causes of the problem and explanatory case studies if they provide sufficient explanations. If the problem and its contributing factors are not well-defined it is always advisable to do an exploratory study before doing a large scale descriptive or comparative study.

5.3.3.2. Descriptive studies :
give a clear picture of particular situation. - Descriptive study is concerned with observing and describing the distribution of disease or health related characteristics by time , place, and person. - Procedures involved in descriptive studies include: 1. Defining the population under study. 2. Defining the disease under study (operational definition rather than clinical definition) 3. Describing the diseases by: time, place, and person. 4. Measurement of disease. 5. Comparing with known indices. 6. Formulation of an aetiological hypothesis.

- A descriptive study involves the systematic collection and presentation of data to

Cont. 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 * Socio-economic characteristics : behavior, knowledge, attitudes, beliefs, opinions etc. Cross-sectional surveys cover a sample of the population. If the total population it is called a census.

5.3.3.3. Analytical studies:
Descriptive
- Look at entire population - Formulate hypothesis

Analytical
- individual within the - test hypothesis.

An analytical study attempts to establish causes or risk factors for certain problems. This is done by comparing two or more groups some of which have or develop the problem and some of which have not. Analytical studies comprise two types of observational studies: - Case control study. - Cohort study.

5.3.3.1. Case control study. “ retrospective studies ”:
The case control study is the first approach to 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. - Group matching - Establish appropriate controls. - Keep the frequency distribution of the matched variables similar in study and control groups.

- Matching by pairs : for each case a control is chosen.

3. Measurement of exposure:
By interview, questionnaire, study past records.

4. Analysis:
(1) find out exposure rates among cases and controls. (2) Estimate disease risk associated with exposure (odds ratio) - Relative risk = incidence among exposed incidence among non exposed - Odds ratio (cross product ratio)

5.3.3.1.(c) Advantages and Disadvantages of case control study: (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 Risk factor present Control Risk factor not present

Frame-work of case control study (The 2X2 contingency table)
Risk factor Present Absent Total Cases (disease present) a c a+c Control (disease not present b d b+d

d rates : es =a a+b /

for control = c c+d

b b+d

e risk =a a+b =axd bxc

atio

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

Exposure to risk

Developed disease No disease

Compare Developed disease Not exposed risk

No disease

(e) Frame work of cohort study
Cohort Disease developed Total

No Yes
Exposed

b

a

a+b

Not exposed

d

c

c+d

Incidence of disease in the exposed

=

a a+b

Incidence of disease in the non exposed =

c c +d

Relative risk

=

a / a+b

c c+d

Attributable risk = a a+b a a+b c c+d

(f) Types of cohort study :
1 - Prospective cohort study 2 - Retrospective cohort study , historical cohort study, prospective study in retrospective or non-concurrent prospective study 3 - Combination of retrospective and prospective cohort studies.

eps of a cohort study :
1 - Selection of study subjects. 2 - Obtaining data on exposure. 3- Selection of comparison groups.

w up. is.

Selection of study subjects:
a – General population ( if exposure is frequent). b – Special groups : - Select groups(e.g professional group, doctors etc). - Exposure groups.

ning data on exposure from :
a – Cohort members. b – Review records. c – Medical examination or special tests. d – Environmental surveys. Information about exposure should tell about : 1 – whether exposed or not. 2 – Level or degree of exposure.

Selection of comparison groups:
(1) Internal comparison (different levels and duration of exposure). (2) External comparisons. (3) Comparisons with general population rates.

ow up :

eriodic medical examination. Reviewing physician and hospital records. Routine surveillance of death records. Mailed questionnaires etc.

Analysis in terms of :
1- Incidence rate of outcome among exposed and non-exposed 2- Estimation of risk : Relative = incidence of disease among exposed Incidence of disease among non-exposed

Attributable risk

=Incidence of disease among exposed

– Incidence of disease among non-exposed

Incidence rate among exposed

Case control
1 2 Proceeds from ``effect to cause`` Starts with the disease

Cohort study
Proceeds from ``cause to effect`` Start with people exposed to risk factor or suspected cause. Tests whether the disease occurs more frequently in those exposed , than in those not similarly exposed

3

Test whether the suspected cause occurs more frequently in those with the disease than among those without the disease

4

Usually the first approach to the testing of a hypothesis, but also useful for exploratory studies

Reserved for testing of precisely formulated hypothesis

Cont.

Case control
5 6 7 Involves fewer number of subjects Yields relatively quick results Suitable for the study of rare diseases Generally yield only estimate of RR (odds ratio) Cannot yield information about disease other than that selected for study Relatively inexpensive 10

Cohort study
Involves large number of subjects Long fellow-up period often needed, involving delayed results Inappropriate when the disease or exposure under investigation is rare Yields incidence rate, RR as well as AR Cannot yield information about more than one disease outcome Expensive

8 9

5.3.4. intervention studies :
“It involves manipulation of a situation and measurement of the effect of this manipulation” Two categories exist : 1- Experimental studies. 2- Quasi-experimental studies.

5.3.4.1. Experimental studies : 5.3.4.1.1. Role :
- An experimental design is the only type of study design that can actually prove causation.

5.3.4.1.2. Methodology : - 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 Study group First data collection (before intervention) Intervention (manipulation)
Comparison group

First data collection (same as in study group)

Last data collection (after intervention)

Compare Randomization eliminates the effect of confounding variables.

Last data collection (same time as in study group)

5.3.4.2. Quasi experimental studies:

5.3.4.2.1. characteristics:
quasi experimental study there is an intervention and at least one characteristic of a true experimental study is missing (either randomization or control).
* In

5.3.4.2.2. Diagram of a quasi-experimental study Study group intervention study group (after intervention) compare Control group (same time) non-intervention control group (same time)

5.3.4.2.3. Before and after study :
* 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 ). Study group Intervention Study group (after intervention )

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

. .... .. . . ..

.. ...

Valid and reliable

Reliable but not valid
.

… . .

. .

. . . .

.

Valid but not reliable

Neither valid nor reliable

5.3.6. Threats to validity
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):

- sampling of registered cases - non-response - studying volunteers Sampling Bias - missing cases of short duration (fatal cases/mild cases) - taramic bias. - seasonal bias. - migration bias. - perkson ‘s bias.

Factors affecting the internal validity (instrument bias)
* Faulty instrument. - Poorly designed questionnaire. - Defective measurement tool ( sphygmomanometer, balance, scale….etc) * Faulty measurement -Inter-observer bias. Recall bias - Intra-observer bias. Hidden events (sad - Respondents bias. (events
Please

interviewer * Faulty adjustment - Confounding.

5.4. Selection of data collection techniques

5.4.1. What is data collection technique ?
“Data collection technique is a technique that allows researcher to systematically collect information about the study population ( people objects, phenomena….etc) and the setting in which they occur”

5.4.2. Types 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.

8- Life histories taking. 9- Scales and test batteries. 10-Essay analysis. 11-Case studies. 12-Mapping. 13-Rapid appraisal techniques. 14-Participatory research. A single study may involve more than one technique.

5.4.3. What is data collection tool ?
“ Data collection tools are the tools applied in data collection. A particular technique can involve different tools”

5.4.4. Example of tools
Questionnaire. Weighing scale. Measuring tabe. Sphygmomanometer. Observation checklists. Microscope.

Data collection techniques and data collection tools used:
Data collection techniques
Using available information Observing Interviewing Administering written questionnaire Focus group discussion Nominal group technique

Data collection tools
Checklist, data compilation forms Observation checklist, eyes and other senses, pen and paper, watch, scales, microscope Interview schedule, checklist, questionnaire, tape recorder Open ended questionnaire, closed questionnaire Focus questions, checklist of topics NGT statement or question, paper and pens, board, listing ideas, individual expression, discussion, voting and ranking, discussion, 2nd vote and ranking Circulating questionnaire Key questions Highly structured questionnaire with highly standardized sequence of questions School children hand-writing books Checklist Paper and pen, measuring ruler or tabe

Delphi technique Life history taking Scale and test batteries

Essay analysis
Case studies Mapping

5.5. Sampling
5.5.1. Definition
“Sampling is the selection of a number of study units from a defined study population.”

Target Population

Study Population

Ssmple

Sample

“A representative sample has all the important characteristics of the population from which it is drawn”

5.5.2. Sampling questions

For sampling we need to answer 3 questions : 1- What is the group of people from which we want to draw a sample? (study population). 2- How many people do we need in our sample? (sample size). 3- How will these people be selected? (sampling procedures).

5.5.3. Choice of sampling method :
* Choice of sampling method depends on availability of sampling frame. “ Sampling frame is a list of all the units that compose the study population”

Non-probability Sampling Methods

Not Present

Sampling Frame

Present

Probability Sampling Methods

5.5.4. Sampling Methods
There are two major categories :

Non-probability sampling method :
- Convenience sampling . - Quota sampling.

Probability sampling methods :
- Simple random sampling. - Systematic sampling. - Stratified sampling. - Cluster sampling. - Multistage sampling.

5.5.4.1. Non probability sampling method
5.5.4.1.1. Convenience sampling :
“ Is a method in which for convenience sake all the study units that happen to be available at the time of data collection are selected in the sample.”

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 :

All units have the same chance of being selected. o All units listed in number. o Sample size decided. o Required size taken randomly from the listed numbers. o Units having the numbers chosen are included. o Table of random number can be used.

5.4.2.2. Systematic sampling :
“ Individuals are chosen at regular intervals (sampling intervals) from the sampling frame. The first starting number is selected randomly .” It is requires a sampling frame and a sampling intervals .

Sampling intervals = Size of study population Required sample size

5.4.2.3. Stratified sampling :
Stratification can be used with simple random sampling or systematic sampling to ensure the desired representative of specific groups. Stratification can be made by age (age groups ) race ( ethnic groups ), or any other basis required e.g. type of family planning method used. The sample fraction can be decided on the size of different strata in the study population so as to have strata representative of the total population or equal fractions can be used.

Cont.

Stratum

Study population

Stratification

Stratum

Random sampling Or Systematic sampling Sample

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.

5.5.4.2.5. Multi Stage Sampling
Used to draw samples from very large and diverse population.

First stage :

Divided the population into naturally occurring cluster and then draw a sample of them.

Second stage : Sample individual elements from each of the sampled
clusters.

Cont.

The first stage can be of many stages e.g. • States are selected in the first stage. • Provinces are selected in the 2nd stage. • Localities are selected in the 3rd stage. • Popular committees in the 4th stage. • Individuals in the last stage.

5.5.4.2.6. Probability proportional to size (PPS) :

This procedure is a variation on multistage sampling in which the probability of selecting a cluster is proportional to its size and an equal number of elements is sampled within each cluster . The PPS methods of sampling is useful when the cluster vary greatly in size. In such situation the PPS often reduced the sampling variance and the data collection costs.

5.6. plan of data collection
Having selected your variables to be studied and decided on the type of study needed and the data collection techniques and sampling method a clear plan for data collection is needed. The plan should include : 1- Type and number of data collection tools needed. (questionnaires, measuring tabes, weighing scales, sphygmomanometers etc) 2- Categories and number of data collecting personnel (doctors, nurses, nutritionist, sociologist etc) 3- Duration and content of training needed. 4- Schedule for data collection (Selection of personnel, training, preparation of tools, preparation of logistics, starting date, closing date, time for each study phrase etc.) 5- logistical support (vehicles, fuel, lubricants, food, drinks etc.) 6- Estimated budget for data collection phrase (budget for tools, budget for training, budget for logistics, budget for perdiems)

5.7. Plan for data processing and analysis 5.7.1. Time for plan :
The plan for processing and analysis of data must be prepared before the data is collected in the field so that it is still possible to make change in the list of variables or the data collection tools.

5.7.2. Why is it necessary to prepare a plan for processing and analysis of data?
1- To assure that all needed information are going to be collected in a standardized way. 2- To avoid collecting unnecessary data.

5.7.3. Content of the plan:
The plan should include :
1- Sorting data (data collection). 2- Performing quality control checks (data cleaning). 3- Data processing. 4- data analysis.

5.7.3.1. Sorting data:
 

If studying more than one study population number the questionnaire separately. In comparative study sort the data right after collection into the groups that you will compare.

5.7.3.2. Performing quality control checks :
  

Checks for completeness : missing questions. Checks for consistency. Range checks.

5.7.3.3. data processing
Decide an either processing. • Manually • By computer Processing involves : • Categorizing • Coding 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.

Respondent (Number – name)

Age M

Sex F <4 >12

Schooling 4-12

Smoking Yes No Response No

Number of cigarette

Master sheet
Category Level No. of care providers Availability of lab Availability of drugs

Govern Non govern

Hosp

HC

Dis

Dr.

MA

G.S

DFM

Cul

K P Cot Tet Met Nyst

5.7.3.5. Data Analysis:
   

Prepare dummy tables. Frequency counts (numbers). Relative frequency. Cross tabulation.

5.7.4. Plan for the processing and analysis of data:
A plan for the processing and analysis of data includes: 1- Decision on means of processing : hand or computer. 2- preparation of dummy tables. 3- Decision on the sequence in which tables should be analyzed . 4- Decision on how qualitative data should be analyzed. 5- Estimate of total time for analysis. 6- Decision on staff needed for analysis. 7- Estimate of total cost for analysis.

5.8 Pre-test or pilot study
Definition :
 

Pretest means small-scale trail of a particular research component . Pilot study is the process of carrying out a preliminary study going through the entire research procedure with a small sample.

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. 2- Data collection tools to determine : - If they allow to collect information needed. - If they are reliable. - If collected data relevant information. - How much time needed to administer the questionnaire. - If there is need to revise the format in sequence, wording or space for answers.

Cont.

3- Sampling procedures to determine: - If instructions are easily followed by all staff. - the time needed to complete the sample size 4- Staffing and activities of the research team to determine: - Work output of each member. - Benefits gained from training. - Adequacy of logistical support. - Adequacy of staff supervision. 5- Procedures of data processing and analysis to determine: - Appropriateness of data master sheets and dummy tables. Effectiveness of the system for quality control.

Cont.

6- The proposed work-plan and budget for research activities to determine: - Appropriateness of time for different phases. - Accuracy of scheduling of various activities. - Appropriateness of budget allocated for different aspects.

Staff and time for pre-test:
- All the research team should be involved in the pre-test. - Time and duration for pretest is determined by: 1- Size and duration of the research. 2- Complexity of the methodology used.

6. Work-Plan 6.1. What is work-plan ?
A work plan is regarded as: 1- tool for planning the details of the project activities and budgeting funds. 2- An outline of the sequence of project operations. 3- A management tool for the researcher and his team showing required tasks and activities, their timing and who will do what. 4- A tool for monitoring and evaluation.

6.2. When to prepare the work- plan?
Work-plan should be prepared when the project proposal is developed. A more detailed work-plan should be prepared after the pretest of the methodology.

6.3. How could a work-plan be presented?

Gantt chart is the best tool for presentation of a work-plan. Gantt chart indicates: 1- The task to be performed. 2- Who is responsible for each task.

Here is an example of Gantt chart of the work- plan for the research on assessment of validity and applicability of syndromic approach for management of STDs at primary level in Mayo Hay El Nasr health area 1998-1999

7. Plan for project administration
Based on the activities and tasks in the work-plan a clear project administration should be prepared. This plan should focus on : 1- Selection of participants in the study and clarification of the role of each and necessary contacts to confirm their participation. 2- Necessary field contacts and preparations for field activities. 3- Preparation of logistical support for field activities (transport -food – drinks – refreshers). 4- Preparation of needed tools for data collection. 5- Regulate flow of data from field to office for analysis. 6- Clear financial regulations for payment of perdiems and logistical support.

8. Budget
Realistic estimation of budget is a fundamental part of the research proposal. Realistic detailed budget estimation convince authorities for release. Detailed budget should include all requirements for the study. missing to estimate budget for minor activities e.g. meeting with community leaders, letters for concerned local authority, fuel for such contacts may severe the research activities . An example of budget estimation for the research on assessment of validity and applicability of syndromic approach for management of STDs at primary level, Mayo Hay El Nasr 1998 – 1999 is presented below:

Budget :
a- Total budget for the study 9,978,000 Sudanese’s pounds 1- Manuals 2- Stationeries 3- Training 4- Salaries 5- Medicines 6- Lab testing fees 7- Transportation 8- Consultancy Total 216,000 150,000 252,000 1,660,000 4,200,000 2,000,000 1,000,000 1,000,000 9,978,000

b- Budget justification
1- Manuals:
Each manual consist of 60 pages printing 60 x 600 Photocopying of 1200 pages x 150 Total 3600 180000 216000

2- Stationeries:
- Photocopying papers - Box files - Transparencies - Writing pens Sub total 80000 30000 30000 10000 150000

3- Training:
- Perdiems for trainee 10 x 2000 x 7 140,000 - Perdiems for trainers 800 x 2 x 7 112,000 - Manuals (above) - stationeries (above) - Rent of the hall, video, tel, overhead projector, slide projector - Refreshers, breakfast (included in perdiems) - Prep of video tape for training Sub total 252,000

donated donated

4- Salaries:
Three month work / (M.A) 1000 x 10 x 90 Two month work / 2 (assistants for analysis) x 2 x 90 Three month work / 3 (lab assistants ) 2000 x 2 90 Eleven month work / 1 driver 11 x 20000 Total 900,000 180,000 360,000 220,000 1,660,000

5- Medicines:
Minimum sample of 600 patients 7000 each for the medicines 4200,000

6- Lab invest. :
Sample of 400 (u.s0 for C/S, 5,000 each 2,000,000

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
A final draft of research proposal should include the following headings:

1. Introduction
1.1. 1.2. 1.3. Background information. Statement of the problem. Literature review

2. Objectives:
2.1. General objectives. 2.2. Specific objectives.

3. Methodology:
3.1. Study type. 3.2. Study area. 3.3. Study population. 3.4. Variables under study. 3.5. Data collection techniques. 3.6. Sampling procedure and sample size. 3.7. Plan for data collection. 3.8. Plan for data processing and analysis 3.9. Ethical consideration. 3.10. Pre-test.

4. Project management:
4.1. 4.2. 4.3. Staffing and work-plan Administration and monitoring Plan for utilization and dissemination of results

5. Budget:
5.1. Total budget. 5.2. Budget justification (details)

Annexes:
1. References 2. List of abbreviations 3. Questionnaires (data collection tools)

Cont.

A one page summary containing essential information is usually prepared as a cover. This include: - Title - Duration - Total budget - Contributions - Research team - Name of principals researcher Brief summary a problem statement. Objectives and methodology.

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