Assignment Task:

The Final Assignment is to prepare a research protocol. It should be typed, single-spaced in 12point font, and should not exceed 5 pages single-spaced or 10 pages double-spaced, (excluding Title page, Abstract, Appendices) – so, please write both effectively and efficiently! A majority of the marks will be for explaining why you have designed each element of your study. Again, you should design your research question around an area of clinical interest. You may use any of the types of study questions (for example, therapy, causation, diagnosis, etc.) that we have studied in the course. A guide for the organization of the final assignment is as follows:

(1) A title page that includes:
Project Title
Your name and U of T student number
Course number (i.e., CHL 5605)
Number of words
Four keywords (from index Medicus/Medline)

(2) A 150-word abstract of the proposal should immediately follow the title page.

(3) Research Questions:
Explicitly state the population, independent variable [the maneuver, including comparison group(s), if relevant] and dependent variable (the outcome of interest)
Ask in the form of a question that can be answered with “yes/no” or with a number.
Explain how your research question meets the “FINER” criteria as described by Hulley et al., Chapter 2

(4) Background:
An appropriately referenced “significance” section for your proposed research question (i.e., adequately justify why your research question should be pursued).
Make a logical argument – why must we do this study?
Each point should relate to the study you are doing – be explicit [i.e. tell us directly how each point impacts on why or how you are doing the study].
Apply your critical appraisal to the background literature.
Don’t get carried away. Keep your background brief and to the point.

(5) Study Design:
Specify, describe and justify a study design that you might use to address your proposed study (e.g. “retrospective cohort”, “case-control”, “randomized controlled trial”). Discuss the trade-offs between feasibility and potential for bias. Amplify on terms such as cross-sectional and randomized blinded trial by giving, as applicable, more information on the timing of visits, measurements, treatments, etc. You may find including a schematic diagram with a horizontal time sequence (Gantt Chart) as an appendix is useful.
Manoeuvre/intervention:
If your study will employ a “maneuver” or intervention,
Explicit/detailed description of what you will do
What potential bias(es) exists? How will you protect against bias?

(6) The population of Interest and Sampling Methods:
Describe the subjects needed for your proposed study—consider the following:
The target and accessible populations, specifying and justifying the selection criteria.
How the subjects will be sampled from the accessible population.
How you plan to recruit potential subjects identified by your sampling process.
Your strategies for retaining your study subjects.
Propose and commenting on some strategies for making your sample more representative of the population you wish to generalize to.
What potential sampling biases exist and how will you protect against them?

(7) Study Variables:
Specify what variables you will require for your proposed study. For the main outcome and predictor variables: describe the variable, the rationale for measuring the variable, and a detailed description of how the variable will be measured. Discuss or draw a diagram (can include as an appendix) to illustrate the nature of the association(s) you are investigating:
Draw in the outcome (aka: dependent, response) variable
Draw in the predictor (aka: independent, exposure, indicator) variable and indicate the causal association with an arrow.
List important variables that are potentially related to the outcome variable
List important variables that are potentially related to the predictor variable.
Which of the variables listed in c & d might be related to both the outcome and predictor variables (i.e., bias or confounding). Draw the potential causal relationships with these confounders using arrows in the appropriate direction.
How will you measure each of these proposed variables (what tools will you use)? What potential for bias exists? What have you done to protect against bias in measuring

(8) The variables included in your study? (8) Bias and Confounding:
Discuss how bias/confounding might affect your ability to study the causal association between the outcome and predictor variable (i.e. discuss how the confounding variables that you listed might affect the apparent relationship in terms of direction & magnitude, and explain why your list of confounders might indeed be confounders).

Depending on your proposed study design, carry out the applicable tasks designed to enhance causal inference (i.e., follow only A or B, below).

If you are working on an observational study,
(1) Develop at least two specific plans for coping with the potential confounding variables in your study;
(2) Discuss which strategy is best; and,
(3) Comment on the process of drawing causal inference from your study.

If you are working on an experimental study,
(1) Make a decision about whether or not to include each of the following strategies, specify how it will be done, and justify your decision:
Randomization
Blinded
Run-in design
Factorial design
Stratified blocked randomization
(2) If you are planning to do a randomized blinded trial, describe the details of how you will carry out tamper-proof randomization, and how you maximize the success of the efforts at blinding.
List important variables that are potentially related to the outcome variable
List important variables that are potentially related to the predictor variable.
Which of the variables listed in c & d might be related to both the outcome and predictor variables (i.e., bias or confounding). Draw the potential causal relationships with these confounders using arrows in the appropriate direction.

(9) Analysis, including Sample Size and Study Power:
Are you able to get the same answer using one of the formulas found in Hulley et al’s Appendix 6?

(10) Limitations:
Sum up the potential threats to validity (bias, chance) that you had described above, and why/why not they will be a problem for you

(11) Feasibility:
Convince us that you can pull off this study. Consider patient numbers, resources, expertise cost

(12) Significance:
Why is your study important?
Why should it be done?
“So what?” and “Who cares?”

Overall organization and clarity:
Your paper should be typed on a word processor. You may use point form lists where appropriate, as long as your paper is clear. Strive for clarity! Clarity is important when you are submitting a proposal for funding or ethics approval clarity is especially important when you are submitting a final paper for marking – if we cannot understand what you have written, we cannot mark it properly!!

 

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  • Uploaded By : Finn
  • Posted on : January 17th, 2019

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