How to write a research proposal for observational studies? By Dr. Hatem Al Jifri, RSS5 (Research Summer School)

1. HOW TO WRITE A RESEARCH
PROPOSAL FOR
OBSERVATIONAL STUDIES?
WORKSHOP

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

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

5. 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)

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

7. Example of Introduction
1. The Intro begins
broadly…..
2a. More specific….
 Lung cancer is the leading cause of cancer death, and
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
 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

8. 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

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

10. 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.

11. 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.

12. 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).

13. 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)

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

15. 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

16. Methods
 WHAT?
Conduct of Study
 What is the exposure
 What is/are the outcome(s)
 Key variables
 Detailed study procedure
 What variables are to be measured
 Development of lung
cancer

17. 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)

18. 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)

19. 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

20. 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?

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

22. 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

23. Thank you