An excellent in introduction byt Dr Mona Aldabbagh, practical and systematic

1. @kaimrc_edu
1

2. HOW TO WRITE A RESEARCH
PROPOSAL FOR
OBSERVATIONAL STUDIES?
Mona Al-Dabbagh, MD, MHSc
RSS 2012

3. Objective
 To illustrate a guide to writing a research
proposal, outlining the important elements of a
research proposal for observational studies.

4. What is a research proposal?
 A detailed plan of action for scientific inquiry
 what the researcher intends to do, how, why,
where, and when
Dr. A. Attar

5. Why a research proposal?
 An important documentation of your approach to the
research question/objectives
 Demonstrate scholarly abilities
 A reference document during execution and also writing
up the results of the study
 Needed document for research committees and funding
agencies approval
Dr. A. Attar

6. „Title‟
Example:
Does shisha smoking cause lung
cancer? A prospective
Multicentre, observational study

7. Elements of research proposal
1. WHY?
Introduction and rationale
 Literature review of previous studies on the topic
 Burden of illness
 Biological rationale of intervention/exposure
 Statement of the problem and its importance to
public health
 What is the purpose of the study? (research
question)

8. What is the question?
 The primary question should be the one the
investigator is most interested in answering and
which is capable of being answered.
 It is the question upon which sample size is
calculated
 Needs special attention to the statistical power
(sensitivity) ability to show a difference when it
truly is present
 May be formed in the form of testing a hypothesis

9. Cont. What is the question?
 Secondary questions could be of two types:
1. The response variable is different from that of the
primary question:
Example:
Primary question: whether mortality from any cause
is altered by the intervention?
Secondary question:
 Cause-specific mortality rate?
 Age specific mortality rate?

10. Cont. What is the question?
2. Subgroup hypothesis
 Example:
A study of cancer therapy  looking specifically at
the stage of disease
 Subgroup hypotheses should be:
 Specified before the data are collected
 Based on reasonable expectations
 Limited in number

11. Elements of research proposal
1. WHY?
Study Objectives
 Primary objective
(sample size depends on this)
 Secondary objectives
Hypothesis

12. Example of Introduction
1. The Intro begins  Lung cancer is the leading cause of cancer death, and
broadly….. is associated with low 5 year survival rates if
diagnosis late. In 2005, the age-standardised
incidence rate of female lung cancer in France was
12.6, with a 5.1% annual increase [1]. While
incidence is still higher among men,……….……
burden of the diseases
2a. More specific….  Early epidemiologic studies demonstrated that
cigarette smoking is a major cause of lung cancer.
Tobacco smoking using the traditional forms of
tobacco (waterpipe , arguileh, hookah and shisha) is
an older form of tobacco consumption in the eastern
Mediterranean region [2]….……..rationale of
exposure

13. Example of Introduction
2b. Even more so....  Data from low quality studies showed that
waterpipe tobacco smoking is possibly associated
with a number of deleterious health outcomes
including lung cancer [3] …….. ….cite
landmark research/reviews here to
make key points
 However, there is paucity of high-quality studies to
identify the strength of association between shisha
smoking and risk for developing lung cancer
.........cite research gap/need for
study ….. problem
statement/importance of issue

14. Example of Introduction
3. Until you introduce  In this study, we examine the association between
your study….. shisha smoking and lung cancer in a large prospective
study……..include study’s unique
contribution
here/objectives/research question

15. Example of Objectives
 Primary objective: To examine the association
between Shisha (or equivalents) smoking and risk of
developing lung cancer
 Secondary objectives:
 To estimate the magnitude of association relative to
intensity, total duration of Shisha /equivalents
smoking, times-week; after adjusting for all potential
confounders.
 To estimate the magnitude of association relative to the
type of smoke used; after adjusting for all potential
confounders.

16. Example of Hypothesis
 We hypothesize that shisha smoking is associated
with increased risk of developing lung cancer.
OR
 We hypothesize that the risk of lung cancer
increases with increased intensity (or duration) of
shisha/equivalents smoking.

17. Methods
“The methods or procedures section is really the
heart of the research proposal. The activities
should be described with as much detail as
possible, and the continuity between them
should be apparent”
(Wiersma, 1995, p. 409).

18. Methods
 HOW?
1. Study Design
“Describe the research methods that could be used for the best
achievement of the study objectives and testing your
hypothesis”
 Study area
 Type of study
 Design architecture (flow-chart)
 Instruments for data collection (questionnaire, observation
recording form, etc.)  Include in appendix
 Endpoint (in prospective studies)
 Outline of study procedure (in observational studies)

19. Outline of study procedure Template
Example
Activity Time
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5
Consent
Blood test X
CT chest
Pulmonary function

20. Methods
 HOW?
2. Participant Selection (sampling)
“Mention the sampling technique that will be used in order to
obtain a representative sample for your target population”
 Recruitment and Enrolment (multicentre, single centre....etc)
 Study population (including sampling technique)
 Study participants
 Case definition
 Inclusion/Exclusion Criteria for cases
 Inclusion/Exclusion Criteria for controls

21. Sampling
 Study population: a subset of general
population defined by the eligibility criteria.
 Sample: the group of participants actually
studied in the study, and who are selected
from the general population

22. How Sampling Works…
 Imagine a well known
picture
 Since a picture is made
up of points of colour
(pixels), we will sample
the points of colour at
different rates.
1%
Dr. Mieke Koehoorn, UBC

23. How Sampling Works…
3%
Dr. Mieke Koehoorn, UBC

24. How Sampling Works…
3%
5%
Dr. Mieke Koehoorn, UBC

25. How Sampling Works…
3%
10%
5%
Dr. Mieke Koehoorn, UBC

26. The way we sample is reflected and corrected by
how we weight the data in the end.
Dr. Mieke Koehoorn, UBC

27. Inclusion criteria
 Participant should have the benefit form the intervention or
at high risk from exposure
 Choose people in whom there is high likelihood to detect
the hypothesized results of the intervention/ exposure
 Weigh the risks/ benefits of the exposure (ethical
considerations).
 People at high risk of developing conditions that may
preclude the ascertainment of the event of interest should
be excluded.
 Include people who are likely to be compliant.

28. Methods
 WHAT?
Conduct of Study
 What is the exposure
 What is/are the outcome(s)
 Detailed study procedure
 What variables are to be measured

29. Methods
 WHAT?
Evaluation of the outcomes
Tools (lab, radiology,.......etc)
Management of Patient Care (in prospective studies)
Protocol deviation and subject withdrawal (in
prospective studies)

30. Methods
 HOW MANY?
Biostatistical Considerations and Data analysis
 Sample Size Determination and pow
 Outcome Analysis (statistical tests used)
 Statistical package(s) used
Interim analysis (in prospective studies)

31. Work plan
 Timelines
 starting time
 duration of the study
 duration for each participant
Task Month
1 2 3 4 5 6 7 8
Progress report

32. Utilization and dissemination of
the results
 SO WHAT?
 What will this study add to the existing knowledge?
‘how this research will refine, revise, or extend existing
knowledge in the area to be investigated’
 Will the study results be generalized?

33. Adds on
STUDY MONITORING (in prospective studies)
ETICAL CONSIDERATIONS (consents, invitation letters)
BUDJECT AND RESOURCES
 Personnel
 Equipments
 Supplies
 Patients costs
 Training

34. Adds on
LIMITATIONS
‘Indicate any potential weakness in the study, analysis,
your instruments, the sample’
REFERENCES
‘Mention recent articles relevant to the study subject and
enumerated according to their order of appearance in
the text’
APPENDIXES

35. Thank you