ASSIGNMENT QUESTIONS
Write a proposal for an epidemiological study on a topic of your choice that you believe is relevant and important. The study may be in any setting (e.g. any country, region, workplace, primary care, population) allowing all students to take advantage of their local knowledge. You may use existing data or propose collection of new data. The proposal must be a standalone document meaning that the reader should be able to understand it without reading any of your references. However the references will be reviewed therefore ensure that they are appropriate.
If you are finding it difficult to think of a topic for your proposal a few example titles are listed below. However the choice is yours, the proposal is about applying epidemiological tools to any epidemiological research question.
The rules regarding the type of study you should design are below.
It must be quantitative.
It must use at least one of the study designs below but you may also suggest combinations of study designs (or a novel study design but if you do use a novel design you must explain why it is better than one of the standard designs below)
- Retrospective or prospective cohort
- A randomised controlled trial
- A natural experiment (quasi-experimental design)
- Case-control (case-referent)
Part 1. Title - the title should describe what you will do and include the setting and study design (see examples above).
Part 2. Introduction - maximum of 400 words and 10 references giving the rationale for performing the study.
Use this to explain why your topic is important and the current state of knowledge in this area.
- You will need to be familiar with the literature and give a balanced point of view but not a detailed literature search.
- Make sure that you describe any aspects that are unique to your setting; do not assume that the reader has knowledge of any particular country's healthcare system or health problems.
- Make sure the introduction is specific to your research topic and does not digress in to irrelevant literature.
- End the introduction with the general aim of your study -which makes it clear exactly what you are aiming to find out. Note that the introduction should make it clear why it is important and useful to achieve this aim
Part 3. State your specific research question and/or hypothesis and objectives - revise topic 1 to help you with this important step. You can have several related aims or objectives or just one. After reading this section the reader should understand exactly what you intend to do in your study. You must re-visit this aspect of your proposal regularly as you write and make sure that your proposal is consistent with your research question. If it is not, either amend your proposal or research question. If you have followed the discussion board for topic 1 you will understand the importance of this process.
Part 4. Type of study design - explain why you chose this study design over other study designs and why this approach is appropriate for your research question, the population and other factors. Also address potential weaknesses of the study design (e.g., reasons why you might not get the answers you are planning). Use the information in the literature to help you choose your study design e.g. consider what worked, or did not, previously. Revise topic 3 to help you with this.
Part 5. Study procedure - at an appropriate point in your protocol describe the planned study procedure. Use a flow diagram or a Gantt chart to show the specific steps in your study. Include the points below and any other relevant information specific to your study.
i. Selection of sample and sample size estimates
This may include (as appropriate for your study design) a description of the population and/or cohort, a list of exclusion and inclusion criteria, the method used for sampling explaining why this is the preferred method, the randomisation processes, case ascertainment, case and control selection, any other relevant aspects of sample selection that are relevant to your study population, an explanation of what parameters will be needed to calculate the sample size for your study given the choice of design but you are not required to undertake a sample size estimate (if you do make any sample size estimates make sure you reference the source of the information you use). Revise topic 4 to help with this.
ii. Measurement of exposures and outcomes
- Measurements - Describe precisely what measurements will you use?
e.g. disease outcomes, exposures, other relevant variables.
- Outcomes - how will you use your measurements described above to give you the answer to your question? You are not expected to give detailed statistical methods but do use the material covered by the AE course.
- Covariates and confounders - what other factors besides your outcome measurements will you need to consider in interpreting your study results?
- Case, control or comparator identification - describe how you will identify your cases and, where appropriate, comparator or control groups.
iii. Describe how error and bias will be minimized. Some considerations are listed below but consider all other potential sources of error and bias in your study
- Response rate and loss to follow up - what factors are likely to influence your response rate or loss to follow up? What can you do to mitigate this? How might these factors bias your study?
iv. Describe the methods you will use to interpret and/or analyse your results. This should include how your results will be organized to answer your research question and state the units of any measurements that you will make.
v. Outline any difficulties you foresee in undertaking this study and suggest how such difficulties could be addressed (or not, it is important to be aware of potential problems even they are unsolvable).
50/100 marks
Part 6. Ethical issues - describe any issues that you think may raise ethical concerns in your own opinion and also issues that might be raised by an ethics review board.
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