Research Protocol

Adapted by
Edgar Mandeng Ma Linwa, MD
17/11/2022

Originally Presented by
Prof. Dr. Soha Rashed Aref Mostafa
Professor of Community Medicine
Alexandria Faculty of Medicine
Introduction

Goals of research

-Identify a problem
-Collect new information
-Analyse the information
-Propose a solution
Maintain health and combat diseases
Provides evidence for policies and decisions on health and development
 Steps of conducting a health research

A. Prioritizing and selecting a research topic

B. Review of literature and other existing
information
C. Development of a research proposal
D. Implementation of study
E. Final research report
A. Prioritizing and selecting a research topic
F- Feasible: How possible within available resources?
I- Interesting: Does it captivate attention? Information needed?
N-Novel: Does it address a new/original problem?
E-Ethical: Is human dignity respected? Beneficence, non-maleficence,
justice and autonomy
R-Relevance: Is it pertinent/applicable in context?.

Research question
P- Population studied
I- Intervention or exposure studied
C- Control group
O- Outcome
T- Timeframe (period studied)
S- Study design * (very optional, usually left out)

Example: Are Children(P) raised by obese adoptive parents (I) also at

increased obesity risk (O) compared with those (P) who do not have
obese parents (C) between the ages 3 and 18 (T) using a randomised
controlled trial (S)?
B. Literature review

·Prevents duplication
·Up-to-date information (<5 years best)
·Previous research refines problem statement
·Familiarise with research methods
·Generates convincing arguments for study’s
importance

Tools: MEDLINE through pubmed, google scholar,

EMBASE, Cochrane database, conference papers,
theses, textbooks, opinions (consultants,
researchers, statisticians)
Warning: Avoid plagiarism!!!
Steps in literature review
C. Development of a research proposal

I. Title of the research

II. Introduction: Background information and
Statement of the research problem
(Scientific justification for the study)
III. Research objectives
IV. Research hypothesis
V. Methodology
VI.Work plan
VII. Plan for utilization and dissemination of
research results
VIII. References
IX.Annexes
I. Title of the research

·Short, accurate, and concise.

·Clear central objectives of the study clear

to the reader.

·Specify the population.

II. Introduction (Background information and
Statement of the research problem)

· Convince the reader (magnitude, severity

of the problem).

·Provide enough background data (factors

influencing the problem within what context)

·Geographical focus but involve beyond

III. Research objectives

Specific, Measurable, Attainable, Relevant, Time-

bound
1. Focus the study (essentials)
2. Avoid collecting unnecessary data
3. Organize the methodology

General: General terms (intangible, non-measurable)

Assess, Describe, Investigate, Explore, Characterise

Specific: Measurable.
Identify, Define, Estimate, Determine, Develop,
Demonstrate, Compare, Classify, Measure, Examine.
IV. Research hypothesis

Predicting the relationship between independent

variables (predisposing factor) and dependent
variable (outcome)

1-What’s the expected outcomes.

2-Not haphazard guesses

3-Describe how it came about.

Example: Children raised by obese adoptive parents are

at increased obesity risk compared with those who do
not have obese parents between the ages 3 and 18.
V. Methodology

Study design: Descriptive (e.g. cross-sectional surveys), Analytic (e.g.

cohort and case-control), Experimental strategies (e.g. clinical and
preventive trials).
Study population, Selection Criteria, Sample Selection and Size,
Sampling method.
Study Setting
Variables: Four types of variable are important in research:
-Independent (predisposing/risk factors),
-Dependent (outcome/condition/disease),
-Confounding.
-Background variables.

Numerical (continuous/discrete), or Categorical (ordinal/nominal).

Operational definition of different study variables should be clearly
phrased.
 Key study designs
All Studies
What was the aim of the
study?

Descriptive Analytic

When were the

Observational outcomes
Experimental
Survey (cross- analytic determined?
Qualitative
sectional)
Some time after the
exposure or Cohort study
Randomized intervention

(parallel group)
At the same time as
Cross-sectional
the exposure or
intervention (Analytic)
Randomized
(Cross-over)
Before the
Exposure assigned exposure was Case-control study
determined

Exposure not assigned

 Randomized controlled trials
Past Present Future
Evaluate for
outcome

Exposure
Outcome
Experimental
No outcome
Appropriate
patient
Randomize
spectrum
No exposure
Outcome
Patient population Control
No outcome

Measurement:
Multiple times
possible
 Prospective Cohort study
Past Present Future
Evaluate for
outcome

Outcome
Exposed
No outcome
Appropriate
patient
spectrum

Outcome
Patient population
Not exposed
No outcome

Measurement:
Multiple times
possible
 Case-control study

Past Present Future

Evaluate for
exposure
Outcome
Exposure
Case
No exposure
Appropriate
patient
spectrum

Exposure Patient population

Control
No exposure
 Cross-sectional study
Past Present Future
Evaluate for
outcome

Exposure 1

Outcome

No outcome
Appropriate
patient Exposure 1
spectrum Exposure 2
Exposure 2
Outcome
Patient population
No outcome

Measurement:
One point in time
V. Methodology

· Data collection procedure and tool

-Setting for data collection process (procedure)
-Concise and precise (useful variables)
-Pretested on 5% of expected sample
-Simple and comprehensible (1=Male, 2=Female

· Data entry
-Precise (Male, Mal, M, Ma NOT same)
-Avoid duplication
-Avoid text as much as possible (except qualitative
studies)
-Identify units
-Mock database after pretesting

Administrative and ethical considerations

Data collection form
Study title: Use of alternative and complementary
medicine survey Avoid duplication
Patient_ID Date
Study site Clinic 1
Clinic 2
Age Years
Gender (circle the appropriate Male
option) Female
Height Inches
Weight Kilos
Date of Birth (MM/DD/YEAR)
Date of visit (MM/DD/YEAR)
Visit number (circle the 1 2 3 4 5 6 7 8 9 10
appropriate option) Provide options to
Diagnosis choose from such
Date of diagnosis
(MM/DD/YEAR)
as:
TB, HIV, Hepatitis
etc.
Request minimal
free text
Data collection form
Study title: Use of alternative and complementary Unique
medicine survey identifier Provide units
Patient_ID
Study site Clinic 1
Clinic 2
Age Years
Gender (circle the appropriate Male
option) Female
Height Inches
Weight Pounds
Date of Birth (MM/DD/YEAR)
Date of visit (MM/DD/YEAR)
Visit number (circle the 1 2 3 4 5 6 7 8 9 10
appropriate option)
Diagnosis
Date of diagnosis Provide instructions
(MM/DD/YEAR)
VI. Work plan

1. The various tasks to be performed

2. When the tasks will be performed
3. Who will perform the tasks
VII. Plan for utilization and dissemination of
research results

-Progress reports
-Final report
-Publications
-Seminars, workshops, and conferences
-Discussion with policymakers and program
managers
VIII. References

-List of references (Vancouver, APA).

Reference management tools: Mendeley,

Zotero, EndNote, ProQuest.
IX. Annexes

- Interview schedule/ questionnaires

- Informed consent form
- Institutional/Ethical approval for the study
D. Implementation of the research

-Pretest questionnaires
-Mock database
-Timeline objectives
-Regular saving of work (emails, computers)
-Constant literature review for adjustments
-Regular meetings with supervisors
-Presentation of preliminary findings
D. Final Report Writing

According to the institution where report is to be

presented.

Use institutional templates

I. TITLE OR COVER PAGE

-Research title

-Names of the authors with their titles and

positions, and the institution that is
publishing the report.
II. ABSTRACT (SUMMARY)

Abstract/summary should be written only after

the final draft of the report.

- a very brief description of the problem (WHAT)

- the main objectives (WHY)
- the place of study (WHERE)
- the type of study and methods used (HOW)
- major findings and conclusions
- the major recommendations
III. INTRODUCTION

-Relevant background data

-Paragraph on what you hoped to achieve
with the results of the study.

Note:
-Be selective,
-Justify your study, not display your ability
to read literature.
IV. RESEARCH OBJECTIVES

The general and specific objectives as

stated in the proposal.

Not able to meet some of the objectives,

state in the methodology and discussion.
V. METHODOLOGY

-Study type
-Major study variables
-Study population, sampling method and the
size of the sample
-Data-collection techniques used
-How the data was collected and by whom
-Procedures used for data analysis, including
statistical tests (if applicable)
VI. RESEARCH RESULTS (FINDINGS)

- Present in relation to objectives

- Description of the findings by a limited

number of tables or graphs that summarize
the findings.
VII. DISCUSSION

- The findings can now be discussed by

objective or by cluster of related variables.

- The discussion may include findings from

other related studies that support or
contradict your own.

- Limitations of the study.

VIII. CONCLUSIONS

- Logical from discussion of the findings.

- As the discussion will follow the sequence

in which the findings have been presented.
IX. RECOMMENDATIONS

-Study population
-Policy-makers
-Health and health-related managers at different levels
-Health and health-related staff who could implement
the activities
-Potential clients
-The community at large
X. REFERENCES

1. Number references consecutively throughout

the body of the text in the order in which they are
first mentioned.

2. DO NOT include references in your abstract.

3. Use style recommended by the school, journal

article or conference board.
X. REFERENCES
Journals
Harrison KL, Forster TH. Instruction to authors. Aust J Med Sci 1996; 17: 45-
47.
Author(s) of a book
Murray-Smith S. Right Words: A guide to English usage in Australia. 2nd ed.
Melbourne: Penguin Books; 1990.
Author(s) of a chapter in a book
  Bogduk N. Spinal pain: backache and neck pain. In: Gandevia SC, Burke D,
Anthony M, editors. Science and practice in clinical neurology. Melbourne:
Cambridge University Press; 1993; 39-57.
Internet referencing:
1. Document/Individual Work
Tyner R. Sink or Swim: Internet search tools and techniques (version 3)
[WWW document]. Okanagan University College, 7 July 1998.
http://oksw01.okanagan.bc.ca/libr/connect96/search.htm [accessed 19 July
1998].
2. Journals
Zorn P, Emanoil M, Marshall L, Panek M. Advanced searching: Tricks of the
trade. Online [WWW]. 1996 May; 9 pages.
http://www.onlineinc.com/onlinemag/MayOL/zorn5.html [accessed 19 July
1998]. 
XI. ANNEXES OR APPENDICES

- Research procedures and data analysis.

- Examples of information:

Þ Tables referred to in the text but not

included in order to keep the report short.

Þ Interview schedule/ questionnaires

(and/or other data collection tools).