Professor Dr Norsa’adah Bachok [MBBS, MComMed, PhD]Unit of Biostatistics & Research Methodology,

School of Medical Sciences,Universiti Sains Malaysia

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A detailed research plan that has objectives, design & methodology of the study

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To convince others of the value of your research

To serve as a contract

To assist you as a planning tool

To demonstrate expertise & competency

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Candidates are required to present a research protocol Master & PhD research mode: end of first year

MMed: during second year

Panel in department / School Research Committee will comment and recommend on the feasibility of the research and set the minimal standard / level/ scope of the research project or whether the research project is too heavy for the student within the time frame.

Accept or reject the research protocol. Accept with minor changes will be done at supervisory level.

Accept with major changes may need representation.

Rejection of the protocol. Students need to find new topic and represent.

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Requirement for a degree.

Usually medical & health issues/ problems.

A good scientific value that contributes to the theory and body of knowledge within the chosen discipline

The candidates may use primary or secondary data Primary data: you collect the data primarily from the participants

Secondary data: you collect the existing data from hospitals, clinics, medical records, State Health Departments, District Health Offices, Statistics Department, other government agencies or non-governmental organizations.

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Novelty and innovation

Market / benefit

Have potential impact eg problem solving, policy development or evaluation

Contribution to theory

Contribution to body of knowledge within discipline

Create networks and partnerships

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Ideas

Brief Search

Supervisor

Feasibility

Extensive literature search

Writing protocol

Department approval

Conducting the study

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PASS

Protocol presentation

Department approval

Conduct the study

Writing thesis

Supervisor correction

Submit thesis

2 internal + external examiners

Correction

Awarded degree

FAIL

Title

Introduction

RQ / Objectives / Hypothesis

Literature review

Methodology

Expected results

Gannt chart & Milestones

Budget

References

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Adequate description of the study

Minimum word

No question mark

No abbreviation

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Overview of the disease / problem

Disease / problem burden

Problems clearly identified

Justification of study

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Sets the proposed study in context and gives its rationale in your own words (do not copy paste).

State the gap of knowledge about the issue.

New knowledge added.

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Research questions

General objective

Specific objectives

Study hypotheses

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Define Set down the precise meaning of a word or phrase.

Describe Give a detailed or graphic account.

Outline Give the main features or general principles of a subject.

Illustrate Use a figure or diagram to explain or clarify, or make clear by the use of concrete examples.

Review To make a survey of, examining the subject critically.

State Present in brief, clear form.

Trace Follow the development or history of a topic from some point or origin

Compare Look for similarities and differences between.

Contrast Set in opposition in order to bring out the differences.

Criticize Give your judgment about the merit of theories or opinions or about the truth of facts, and back your judgment by discussion of the evidence.

Relate Show how things are connected to each other and to what extent they are alike or affect each other.

Discuss Investigate or examine by argument, sift and debate, giving reasons pro and con

Evaluate Make an appraisal of the worth of something.

Explain To make plain, to interpret, and to account for.

Interpret Expound the meaning of; make clear and explicit; usually giving your own judgment also.

Justify Show adequate grounds for decisions or conclusions.

Summarize Give a concise account of the chief points or substance of a matter, omitting details and examples.

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Initially general, later more focused

Example:

General objective: to study the association of intravenous drug users (IVDUs) and AIDS epidemic in Malaysia

Specific objectives:

To determine the proportion of IVDUs that have been infected with the AIDS virus

To identify the risk factors that increase the chance of transmitting the AIDS virus

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In depth of the topics [prepare the readers about the issue]

Summarise & criticise

All aspects of the research eg disease, definition, research design, tools, statistical test, findings etc anything relevant

Loops & holes

Theoretical framework

Conceptual framework

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Perceived susceptibility Perceived seriousness (severity)

SociodemographyKnowledge

Perceived threat

Cues to actioneducationmass media campaignillness of family member or friend

Perceived benefitsPerceived barriers

to preventive action

Likelihood of taking recommendedpreventive health action

Figure 2.1: The Health Belief Model by Rosenstock (1966)

INDIVIDUALPERCEPTIONS

MODIFYINGFACTORS

LIKELIHOOD OF ACTION

Describe what & how to do.

Those who read should be able to replicate. Detail!!

The proposed methods must be appropriate to the type of research.

Summarise as flowchart.

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Study setting Study design

Study time & duration Reference population Target population Source population Sampling frame

Inclusion & exclusion criteria Sample size determination

Sampling method Research tools & materials

Data collection Intended statistical tests Operation definition Ethical clearance

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Be specific Specify the characteristics

that define populations that are relevant to the research question and efficient for study

Target population Demographic

characteristics Clinical characteristics

Accessible population Geographic characteristics Temporal characteristics

Example A case-control study of

breast cancer risk factors Females, histological

diagnosed breast cancer ICD-10 (WHO)

A study on dengue fever Diagnostic criteria:

Clinical? Serological? Platelet counts?

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Be parsimonious Specifying subsets of the

population that will not be studied because of: A high likelihood of being

lost to follow-up

An inability to provide good data

Ethical barriers

The subject’s refusal to participate

Not opposite to inclusion criteria

A 5-year trial of vitamin D for preventing osteoporosis might exclude subjects who are: Plan to move out of state

Disoriented or have language barrier

Kidney stone formers (which would increase calcium level)

Unwilling to accept possibility of random allocation to placebo group

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Sample size determination: formula / software

For each objective

Reference values

Show several calculation, then take one that is logical

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Questionnaires

Weighing scale

Random blood sugar (detail process of blood taking & laboratory test)

ValidityReliability Pre-tests

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Software used

Descriptive statistics

Univariable analysis

Multivariable/multivariate test

Assumptions checked

Diagnostic statistics: delete outliers

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Different researcher may use different definition. Egobesity. Some may use WHO cut off point, some use Asian.

Compulsory for every research. If you join in other researcher, it might been already approved.

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2 districts in Kelantan

List of all secondary schools

10 schools

One class per form

Anthropometric measurements

Overweight/obeseNon overweight / obese

Questionnaire Questionnaire

Statistical analyses

Writing report

Inclusion & exclusion

Simple Random Sampling

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Dummy tables Descriptive background of the sample

Descriptive of other findings

Bivariate table

Multivariate table

Graph if appropriate

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Sociodemography Intervention Group Control Group

Mean (SD) Freq (%) Mean (SD) Freq (%)

Age

Gender

Race

Educational status

Family Monthly Salary

Table 5.1 Sociodemographic characteristics of the respondents

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Intellectual honesty & integrity

Acknowledge work of others

Havard USM style: authors name, arranged alphabetically

Quoting references Citing: a process of formal recognition, within text, of resources from

which you have gathered your information

Reference: a detailed description of the item from which you have obtained your information

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Time frame - be realisticActivities Oct Nov Dec Jan Feb Mac Apr May Developing questionnairePreparation for data collectionPretest Data collectionData entry Writing introductionWriting literature reviewWriting methodologyAnalysing dataWriting resultsWriting discussionWriting conclusion & recommendationSubmission of thesis X

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Time Activity

1 Dec 2018 70% Introduction & LR

1 Feb 2019 75% data collection50% data entry100% Introduction & LR50% methodology

1 April 2019 Competed data collectionCompleted data analysis50% results

1 June 2019 Presentation in conferenceSubmission of manuscriptSubmission of thesis

If applying for fund

Tabung Insentif Pembangunan Pengajian Siswazah

Vot 21 travelling

Vot 27 materials & supplies

Vot 29 professional services

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Clearly defined research question

Appropriate literature provides a background to the problem

Use of other sources to identify/support the problem

Objectives clearly specified

Conceptual framework and theoretical assumptions clearly stated

Appropriate design and methodology

Promotes further research

Preliminary data/pilot study

Necessary resources available

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Choice of project Recycling existing project proposals Weak skills in proposal writing Too long, poor structure, language use Inappropriate use of technical terms Research too ambitious Inadequate literature review No integration of theory in literature review Literature review copied No theoretical foundation Methods not clear or inappropriate No references or bibliography

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Abramson JH & Abramson ZH. 1999. Survey Methods in Community Medicine. 5th edition. Churchill Livingstone: China.

Elwood, M. 2004. Critical Appraisal of Epidemiological Studies and Clinical Trials. 2nd Ed. Oxford University Press: USA.

Levy, P. 1999. Sampling of Populations: Methods and Applications. John Wiley & Sons: London.

Munro, B.H. 2004. Statistical Methods for Health Care Research. 5th Ed. Lippincott Williams & Wilkins: USA.

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Good luck!

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