University of Medical Sciences and Technology

Research Methodology and Biostatics

Research Proposal

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Research Methodology Week Date Session/Semester Two Expected outcomes
Week Date Session/Semester One Expected outcomes 14 07-Mar-20 Study Design in Qualitative Research Students will be capacitae
1 07-Dec-19 Introduction to the research process Sampling Technique in Qualitative Research to use mixed study designs
Classification of Research Students will be oriented 15 14-Mar-20 Qualitative Data Analysis and Presentation (Qulatitative-Quantitative
Quantitative & Qualitative Research on the importance of Research Validity of Qualitative Data or Quantative-Qualitative
Basic & Applied Research in Medical field Trustworthiness to implement their research
2 14-Dec-19 Reasarch Protocol The steps of Research should Cronbach's alpha test
Steps of Research Proposal be known by medical students Biostatistics
Template of Research Proposal 16 21-Mar-20 Introduction to Biostatistics Introduce the importance
3 21-Dec-19 Identifying & prioritizing topics for research Students should be capable Population and sample of Biostatics to medical
Research area to formulate a research topic Sources of variation/Error students
Research topic and write a research title Study design principles
4 28-Dec-19 Literature Review 17 28-Mar-20 Handling Data (1) Students are capacitated
Concept and Importance of Literature review Students should be capable
Types of Data and Measurment scale to understand the types of
Structure for writing a literature review to write a introduction
Variation in Data data collected and perform
Writing a literature review and literature review for
Describing Grouped data appropriately descriptive
5 04-Jan-20 Literature Review proposal and thesis
Choosing appropriate descriptive statatistcis statistics to summarize
Sources of Biomedical literaterure
Tools for literature search
18 04-Apr-20 Handling Data (2) their data
Get Personnal ID code for use of PubMed Types of Data and Measurment scale
6 11-Jan-20 Statement of a Research Problem Students will be oriented to Variation in Data
Analysis of a selected Research Problem write the justification/rational Describing Grouped data
Writing a research Problem motivating their research Choosing appropriate descriptive statatistcis
7 18-Jan-19 Formulation of a Research Question Students will be capacitate 19 11-Apr-20 Probability Capacitate students to
Types of Research Question to identify the various research Probability theory understand the basis of
Structure of a Research Question questions and formulate the Diagnostic test statistical decisions
Writing a research Problem appropriate one to their studies 20 18-Apr-20 Hypothesis testing Introduce the concept of
8 25-Jan-20 Formulating Research Objectives Students will be capacita to Hypothesis testing inferential statistics to
Formulation of General objective formulate research objectives and Errors in hypothesis testing medical students
Formulation of Specific Objectives to design the appropriate research 30 25-Apr-20 Comparison of Means
9 01-Feb-20 Designing a Research tool to tool. They will be also provided Confidence intervals for a sample mean Capacitate students to
Types of study variables the capacity to choose the Confidence intervals for differences in means to implement inferential
Scale of measurment of Study variables 9 Paired comparison of two means-paired t test tests to determine
10 08-Feb-20 Appropriate Data entry tools management of their data. 31 02-May-20 Comparison of more than two Means association, difference or
Epi-Info 7 Oneway analysis of variance relationship
MsExcel
32 09-May-20 Chi-square tests
SPSS 23
Conteningency chi-square
11 15-Feb-20 Study design The students will master the
Assessing difference between two proportions
Types of study design study designs and write their
Paired comparison of two proportions
12 22-Feb-20 Study design research methodology
Types of study design 33 16-May-20 Correlation and Regression analysis
13 29-Feb-20 Sampling technique & Sample size estimation Correlation anlysis
Sampling technique Theory of regression analysis
Sample size estimation 32 23-May-20 Regresssion analysis
linear and logistic regression

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

 Why a protocol?
• To clarify the research question
• To compile existing knowledge
• To formulate a hypothesis and objectives
• To decide about a study design
• To clarify ethical considerations
• To apply for funding
• To have a guideline and tool for the
research team
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
How to judge a good protocol?
• Is it adequate to answer the research
question(s), and achieve the study objective?

• Is it feasible in the particular set-up for the

study?

• Does it provide enough detail (methodology)

that can allow another investigator to do the
study and arrive at comparable conclusions?
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
What is a Research Protocol?
A research protocol is a document
that describes the background,
rationale, objectives, design,
methodology, statistical evaluation
of the data, and organization of a
research project.

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

Need for Written Research Protocol
• forces the investigators to clarify their
thoughts and to think about all aspects
of the study –study conduct, analysis of
the data

• guide for a team working on research –

help ensure study is performed similarly
by different people over time

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

Need for Written Research Protocol
• essential if study involves research on human
subjects or on experimental animals, in order
to get institution institution’s ethical approvals

• essential component of a research proposal

submitted for funding

• use to start writing a manuscript when study

completed
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Research Protocol Format

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

 Project Title
• Should be descriptive of the
study, but concise

• May need to be revised after

completion of the writing of
the protocol to reflect more
closely the sense of the
study
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Introduction and relevant literature
• Sets the stage for why
the research project
should be done.

• Cite appropriate
references.

• Purpose of the study

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Statement and Research Problem
• Information about the research
topic that provoked the study
• The Scope of the problem General
characteristics of the population
of interest
• Why it is important to study the
problem
• The overall goal or aim of the
study or the question to be
answered.
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Research Hypothesis
• If any,
• Formulate research
hypothesis in case of:

• Comparative research
question

• Relation-based question
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Research Objectives
• The Research Question

• Research Objective

• Primary/General
objective

• Specific objectives
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Research Objectives
• The Research Question

• Always formulate one

research question

• Descriptive research question

• Comparative research question
• Relation-based research
question
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Research Objectives
• Research Objective
• Primary/General
objective
• Turn the research question in
affirmative to formulate your
research main objective

• Specific objectives
• Formulate SMART specific
objectives
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Methodology
• Study Design

• The choice of the design

should be explained - how it
will address study objectives

• The research design, methods

and procedures should help
answer your research
question(s s) as written in your
study objectives and aims
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Methodology

• Study area and Population

• Study area/setting
• Facility-based Study
• Community-based Study…

• Study population
• Population from which the
sample will be drawn
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Methodology
• Sampling technique and Sample
size
• Describe the sampling
technique to be used to
withdraw the sample from the
total population

• Estimate the sample size

needed
• Computational formula
• Sample size
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Methodology
• Data Management and Analysis
• Describe the statistical methods to be
used for each study objective

• The protocol should provide

information on what types of data will
be obtained and how the data will be
managed

• Describe plans for data and statistical

analyses, including the timing of
interim and subgroup analyses, as
appropriate
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Methodology
• Data Management and Analysis

• Describe which subjects will be

included in the data analysis for
each of your study objectives
(e.g., all participants, all
participants dosed, all evaluable
participants, etc.)

• What criteria will be used to stop

the study, if necessary?
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Methodology
• Ethical Consideartions
• Risks, Benefits of the study What
criteria will be used to stop the study,
if necessary?

• Recruitment plans
• Compensation for subjects in
study

• Informed Consent, Approval of

Institutional Board of Review

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

 Workplan / Gantt Chart

• List all the activities to be

implemented

• List personnel in charge of

each activities

• Remember Research is
time bounded- Provide the
timing
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Workplan / Gantt Chart

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

 Estimated budget and Justification

• Budget lines

• Budget justification by line

item

• Security and safe guard

• Value for money (VfM)

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

 Estimated budget and Justification

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]

 References
• List only literature cited
within the text. Use NIH
format: names of all
authors, title, book or
journal, vol, page, year.

• Suggested length: at least

12 references within the five
last years
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Appendices
• Approval of Ministry of Health

• Attached the Institutional Review

Boards approvals

• Ethical Clearance

• Informed consent

• Research tool
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Administrative endorsement of
the proposal
• Supervisor signatory

• Research Coordinator on
behalf of UMST

• Project Number

• Date of Submission
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
Research Work
? Time Load

Carrier Social
building Obligations
Training
University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]
 Research….

……do it and
Publish your
findings

University of Medical Sciences and Technology – Dr. Mounkaila NOMA , [email protected]