Research Methodology 1

Dr. Tan Wei Leong

Medical Officer
Clinical Research Centre, Kedah
Sultanah Bahiyah Hospital
Alor Setar, Kedah
What is high quality
research ?
 High Quality Research

• Generalizable to other settings

• Based on some logical rationale and tied
to theory
• Can be replicated
• Doable
• Generates new questions or is cyclical in
nature
• Incremental
• Apolitical activity that should be
undertaken for betterment of society
 On the other hand …..

• Opposites of what we have

aforementioned
• Plagiarizing other people’s work
• Falsifying data to prove a point
• Misrepresenting information and
misleading participants
Outline for a Research Proposal

1. Title page
 Title;
 Author;
 Details of department and institution;
 Date
2. Introduction
 Literature review? – by Mr. Jaya and Mdm. Dela
 Why is this problem chosen? – by Mr. Jaya
 What is your research question/ hypothesis? – by Mr. Jaya
3. Objectives
 General – by Mr. Jaya
 Specific – by Mr. Jaya
Outline for a Research Proposal
4. Methodology
 Study design and type.
 Setting and study period.
 Population (inclusion/ exclusion criteria).
 Sampling method & sample size.
 Data collection technique & tools.
 Variables.
 Plan for data analysis and interpretation.
 Project management (Gantt chart & budget).
 Ethical considerations.
5. References
6. Appendices
 The tools.
 Relevant supplementary documents.
Research Design
 Research Design

Research Design

Observational Experimental
Study study

Cross Case Clinical Community

sectional Cohort
control trial trial

Diagram 1: Research design

Variables
 Variables

Discrete/ categorical
Example: smoking / non-smoking
Continuous/ numerical
Number of cigarettes smoked per day
Define the variables
Define the scale of measurement based on
the type of variables.
 Example of variables

Variable Definition Scale of measurement

Age Child’s age at admission to Months.

hospital, calculated from date
of birth.

Patient Response to a specific 1. Very satisfied.

dissatisfaction question. 2. Satisfied.
3. Don’t know.
4. Dissatisfied.
5. Very dissatisfied.
 Variables

Scale of measurement
Categorical
Nominal: Two or more mutually exclusive
categories, presented as counts but cannot be
graded one above another.
Ordinal: Number of categories that can be
ordered/ ranked one above another.
Numerical – continuum of measurement.
 Variables

Relationship between variables:

Independent (cause)
Dependent (effect/ outcome)
Confounding variables.
Potentially associated with both the problem
and cause.
May either strengthen or weaken the cause-
effect relationship.
Must be considered during the planning or data
analysis stage.
Sample size determination
Sample size determination

• Estimation (Confidence interval)

• Estimating a proportion
• Estimating a mean
• Hypothesis testing
• Comparing two proportions
• Comparing two means
 Sample size determination

Estimation a proportion
Examples:
• To estimate the prevalence of obesity among
secondary school student in Kedah
• To determine the prevalence of smoking among
male healthcare worker in Kedah
• To estimate the prevalence of fatty liver among
hyperlipidemia patients in Hospital Sultanah
Bahiyah
 Sample size determination

Estimation a mean
Example of calculation
• Objective: To estimate the mean knowledge score
on antibiotic prescribing among medical officers in
Kedah
• According to literature review, the mean knowledge
score on antibiotic prescribing was 5.2 + over 8 in
Kuala Lumpur.
• We will be using sample size calculator for
prevalence studies to determine the sample size.
• Sample Size Calculator for Prevalence Studies
Naing L, Winn T and Rusli BN. Sample Size Calculator for Estimations, Version 1.0.02. Available at:
http://www.kck.usm.my/ppsg/stats_resources.htm
Sampling Technique
 Sampling Technique

Sampling methods:
Probability sampling: random procedures to ensure that the
selection of samples are based on chances.
Simple random sampling
Systematic sampling
Stratified sampling – based on distribution of
characteristics.
Cluster sampling.
Multistage sampling.
Non-random sampling:
Convenience sampling.
Quota sampling.
 Sampling Technique

Random vs. non-random sampling:

Errors & bias.
Representative.
Undefined population; refusal; cost-
efficiency.
 Sample size determination

Simple Random Sampling

• Example
• Custom Random Number Generator
• Using SPSS
• Transform  Random number
Seed
 Sample size determination

Systematic Sampling
• Example:
• We estimate that we will have 400
patients in coming six months.
• Sample size calculated is 100
patients required.
• It means that we should take 1 from
every 4.
Sample size determination

Stratified Random Sampling

Male (60%)
Female (40%)

Total sample
size required:
200

To ensure that
the original
120 proportion is
80 maintained.
Techniques for Data Collection
Techniques for Data Collection

How to choose:
What the objectives to answer.
Ideas from literature review.
Expert opinion.
Feasibility to implement.
Need tool(s) for technique(s) that you choose.
Techniques for Data Collection

Data collection techniques:

Interview (face-to-face/ telephone).
Self-administered questionnaire.
Instruments.
Recorded resources.
Observation.
 Techniques for Data Collection

Validity & reliability

Measure what you are supposed to measure.
Repeatable.
Techniques for Data Collection

Interview/ self-administered questionnaire:

If possible, use or modify a pre-existing one.
Should contain:
Identifier – avoid repetition & keep track of total
distributed.
Introduction – purpose, confidentiality, use of
data & patient’s agreement.
Socio-demographic information.
Main study questions.
Closing statements.
Short & precise; non-sensitive; simple language.
Techniques for Data Collection

Recorded resources:
Data collection form.
Should contain:
Identifier – avoid repetition & keep track of total
used.
Socio-demographic information.
Main study items.
Definition (terms/ units to use).
Test-retest/ inter-rater reliability
Techniques for Data Collection

Observation:
Eye/ camera/ audio – may develop a data
collection form/ checklist to help you.
Instruments:
Validity & reliability.
Techniques for Data Collection

Pilot-tests: A small scale trial of a study technique.

Validity & reliability.
Limitations; time/ resource requirements.
Needs for revision.
 Techniques for Data Collection

Training for data collectors:

Supervisors: preferably who would have authority
over data collectors.
Limit the number of data collectors to reduce errors.
Clear understanding of the study and methods.
Periodical checks to determine the quality of data.
Thank you for your
attention !!!