Outlines of a research proposal
Badr Mesbah
Research
Research is the systematic collection, analysis and interpretation of data to answer a certain question or solve a problem.
Characteristics of Research
• It demands a clear statement of the problem. • It requires a plan. • It needs data (existing or new)
Steps in the Development of a Health Systems Research Proposal Questions you must ask
What is the Problem and Why Should it be studied?
Steps you will take
Selection, analysis and statement of the research problem
Important elements of each step
•Problem identification
•Priorities problem •Analysis
•Justification
Steps in the Development of a Health Systems Research Proposal Questions you must ask
What information is Already available?
Steps you will take
Literature Review
Important elements of each step
•Literature and other available information
Steps in the Development of a Health Systems Research Proposal Questions you must ask
What do we want to carry out? What do we hope to achieve?
Steps you will take
Formulation of Objectives
Important elements of each step
• General and specific objectives hypotheses
Steps in the Development of a Health Systems Research Proposal Questions you must ask
What additional data do we need to meet our research objectives? How are we going to collect this information?
Steps you will take
Important elements of each step
• Variables
Research Methodology
•Types of study •Sampling •Plan for data collection
•Plan for data processing and analysis •Ethical considerations •Pre-test or pilot study
Steps in the Development of a Health Systems Research Proposal Questions you must ask
Who will do What, and When
Steps you will take
Work plan
Important elements of each step
• Manpower •Timetable
Steps in the Development of a Health Systems Research Proposal Questions you must ask
How will the project be administered? How will utilization of results be ensured?
Steps you will take
Plan for project administration and utilization of results
Important elements of each step
• Administration • Monitoring • Identification of
potential user
Steps in the Development of a Health Systems Research Proposal Questions you must ask
What resources do we need to carry out the study? What resources do we have?
Steps you will take
Important elements of each step
• Materials and equipment
Budget
• money
Steps in the Development of a Health Systems Research Proposal Questions you must ask
Steps you will take
How will we present our proposal to Proposal Summary relevant authorities and potential funding agencies?
Important elements of each step
N.B. Development of a research proposal is often a cyclical process.
The Research Protocol
It can be viewed as a written agreement between the investigator, the subjects and the scientific community.
The Research Protocol
• Its vital scientific function is helping the investigator to organize his research in a logical, focused and efficient way.
Anatomy • Is the set of elements that make up the study plan: Research question, design, subjects …. Etc.
• Challenge: • Designing a study plan with elements that are fast, inexpensive and easy to implement.
Physiology • How the study works? • 1) Internal validity: Inferences about what actually happened in the study sample.
• 2) External validity: Events in the world outside.
• Challenge: • Adequate control over the two major threats: • a) Random error (chance)
• b) Systemic error (bias)
A good way to develop study plan 1) One sentence summary.
2) Extend to 1 to 2 pages that sets out the study elements in a standardized sequences.
3) This preliminary plan can be expanded into the protocol and the operational manual.
Essential Elements of A Research Protocol 1) Title 2) Abstract 3) Introduction and review of literature 4) Aim of the work and objectives
5) Research Question 6) Hypothesis 7) Design Architecture 8) Ethics 9) Budget
10) References, Bibliography 11) Appendices
1) Title Informative • - The problem • - Study site • - Study design • Interlocking nail versus plating in treatment of femoral shaft fractures in adults : a randomised trial in makkah area.
2) Abstract • Should be able to stand alone - it may be all the reviewers read • Publishable quality • Clear, concise, one page, single space • Cover all key elements in order
3) Introduction and review of literature
• Problem identification.
• Why should it be studied?? - Rational and justification.
3) Introduction and review of literature Review of literature is very important to: • identify valid research question(s) • refine research question(s) • avoid un-needed research • avoid duplication • avoid pitfalls of previous studies • to provide a scientific background • give a rationale for the study
4) Aim of the work and Objectives • Both the aim and objectives should flow logically from the statement of need. • The aim convey the ultimate intent of the proposed project, the overarching philosophy. • The opening statement of this section should begin with “the aim of this project is to…”
Objecvtives • The objectives state the essence of the proposed work in terms of what will be accomplished. • Break the goal down to specific measurable pieces, the outcomes of which can be measured to determine actual accomplishments.
Primary objectives
• These are the objectives that the investigator is bound to achieve by the end of his study. They are taken into consideration during selection of study design, and in the estimation of sample size
Secondary objectives
• These objectives could be achieved "by the way" during the study without use of extra-resources. They are not included or considered during the estimation of the sample size.
5) Research Questions
• The formulation of a research question is a process of refinement of the research objective(s) into a simple question(s) that the study should answer
6) Research hypothesis • Hypothesis is a statement of the research question in a measurable form • A statistical significance test is actually a test of hypothesis
Research hypothesis To be sound, a hypothesis must: • • • • • •
be based on plausible scientific background be a translation of the research question reflect the study design use the study variables test only one relationship or phenomenon be stated in measurable term
Research hypothesis • A prospective cohort study was designed to answer the research question: " is hypercholesterolemia (HC) a risk factor for coronary artery disease (CAD)?". What would be the hypothesis?
1. All subjects having HC will develop CAD 2. Dietary habits affect the risk of CAD 3. Rats given high fat diet will develop CAD 4. Atherosclerosis is associated with a high risk of CAD 5. Increased serum cholesterol and triglycerides and decreased HDL lead to increased risk of CAD 6. CAD is high among hypercholesterolemic subjects 7. Subjects with HC have a higher risk of developing CAD compared to subjects without HC 8. The prevalence of CAD among HC subjects is higher than that in subjects without HC 9. The probability of HC in CAD patients is higher than in subjects without CAD.
Example: • • • •
Research area: Cardiology Research topic: Ischemic Heart Diseases (IHD) Aim of the work: To contribute to prevention of IHD Primary objective: To determine the effect of reducing s.cholesterol (LDL) on the occurrence of MI • Secondary objective: To describe the side-effects of lowering s.cholesterol
• Research question: Does hypocholesterolemic agent "A" decrease the risk of MI? • Research hypothesis: The risk of MI among patients treated with hypocholesterolemic agent "A" is lower than the risk among controls not treated with hypocholesterolemic agents.
7) Design architecture • Often the most detailed and lengthy section • What specific activities will allow you to meet your objectives • Task oriented, specific, detailed • Essential that you demonstrate all the steps necessary to complete project with each flowing logically from the previous to the next.
7) Design architecture • Walk the reader through your project • Describe the activities as they relate to the objectives • Develop a time line and /or organizational chart
7) Design architecture • If methodology is new or unique explain why it is better than that previously used • Specify research design and why it was chosen. • Include descriptions of variables and their relationships. • Define all important terms
7) Design architecture • Provide descriptions of data sources including subjects, how they will be selected, the size of subject pool, and the size of the sample. • Describe all procedures • Include pilot instruments and data when possible • Step-by-step work plan
Questions for Methodology • • • • • •
How will the activities be conducted? When? How long? Who? Where? What facilities?
8) Ethical Considerations • Benefit over weighing harm. • Free informed consent.
• Freedom from assault. • Confidentiality.
9) Budget • A restatement in money terms of the methods section - no surprises • Realistic, don’t inflate • Two parts to a budget
• the budget form which breaks the budget into specific categories • a budget narrative that explains how you arrived at these figures and why you need the money
10) References
Use standard format
11) Appendices • Letters of approval of concerned authorities. • Unpublished data on methods.
• Copies of questionnaires, informed consents.
Writing (holds people back)… • If you can think, you can write • Whatever you can imagine, you can create • If you can’t write it, it hasn’t been thought out well yet • Websites available on writing, on writing grants in particular
Good Luck