An Online Course For Clinicians
Martin Pusic, Ruth Elwood Martin, Ruth Milner,
Jonathan Berkowitz, Stefan Grzybowski
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Objective : To support postgraduate medical trainees in their learning of the principles of research design at a basic level; to have the learners read and manipulate real artifacts from the Canadian research community
Educational Methods : This is a 10-module online course that includes the following elements: required readings of texts and WWW material, problem-based educational activities, moderated e-mail discussions and statistical simulator exercises. The modules can be customized by individual programs.
Evaluation: Learners are evaluated by research preceptors identified within their own programs. Each module has actitivities that are to be completed to ensure a basic competence in the material. We have strived to leave the learner in control of the content of activities so that the activities can be maximally relevant to the learner's own project(s).
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Textbooks |
Required reading
Designing Clinical Research, Stephen B. Hulley, Lippincott, Williams & Wilkins, Second Edition 2001, 0-7817-2218-7
Required reading
User's Guides to the Medical Literature, Gordon Guyatt, Drummond Rennie, AMA-Press, First Edition 2002, 1-57947-191-9
Required reading
StatConcepts: A Visual Tour of Statistical Ideas, H. Joseph Newton, Jane L. Harvil, Duxbury Press, First Edition 1997, 0-534-26552-9. This program unfortunately does not run on computers with Windows more recent that Win98. A new updated version is meant to be released in the fall of 2004. The course links will be updated appropriately.
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Module 1: Refining a research question |
Objectives or Goals
Student will be able to develop a well-formed research question.
Topics
PICO Format; General and Specific Hypotheses
Readings
User's Guides Chapter 17; Hulley Chapter 2
Assignments
Discussion Point; Developing a sample question
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Module 2: Writing the Background Section |
Objectives or Goals
Skill: The learner will gain proficiency in performing and organizing literature searches.
Topics
PubMed Features; Bibliographic Software; Structure of the Background section
Readings
PubMed Tutorial; User's Guides
Assignments
- Literature Search
- PubMed Tutorial
- Creation of a Reference Manager Database
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Module 3: Study Designs I -- Cohort, Case Control, RCT |
Objectives or Goals
Student will be able to recognize the differences between observational and experimental designs and suggest the appropriate research design for a given research question.
Topics
- A survey of research designs emphasizing the indications of each
- Importance of control of assignment
Readings
- Hulley's Chapter 7&8: Obeservational Studies
- Hulley's Chapter 10&11: Designing an Experiment
Assignments
1. Write the Methods section for how you would answer your clinical question.
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Module 4: Study Designs II -- Surveys |
Objectives or Goals
Student will be able to recognize issues in the design of good survey and list cases where qualitative designs would be helpful
Topics
- Survey design and issues of validation
- Quality research theories and practice.
Readings
- Hulley's Chapter 15: Designing questionnaires
- Hulley's chapter on qualitative designs
Assignments
- Design a two-page survey that would aid you in gaining insight into your clinical problem
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Module 5: Study Designs III - Qualitative Designs |
Objectives or Goals:
The learner will gain a familarity for qualitative research designs -- both theoretical approaches and practical study designs.
Topics
Theories guiding Qualitative Research
Qualitative Study Designs
Assignment:
You elect to hold a focus group on a particular aspect of your problem. How would you prepare for this event?
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Module 6: Sample Size Considerations |
Objectives or Goals
Student will gain the ability to list issues related to sampling and make simple sample size determinations.
Topics
- Generalizing from a sample
- The sample distribution
- An approach to determining sample sizes.
Readings
- H's Chapter 3:Choosing the subjects
- H's Chapter 6:Estimating sample size
- WWW:Sample size calculators
- Statconcepts
- H's Chapter5: Sampling distribution lab
- H's Chapter 16: Power of a test
Assignments
- Write the subjects and sample size subsections of your Methods section
- Sample size exercise
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Module 7: Implementation Issues |
Objectives or Goals:
Student will gain the ability to list important issues when implementing a research study and will have strategy for dealing with implementation issues.
Topics
- Prestesting
- Quality control
- Protocol revisions
Readings
- H's Chapter 15: Designing data collection instruments
- H's Chapter 16: Data management
- Online Excel and Access tutorials
Assignments
- Create a data collection instrument for your study
- Create an Excel spreadsheet in which to collect your data
- Complete an ethics submission form
- Complete an informed consent document
- Write a budget and justify each item on the budget
- Draw up a timeline for the conduct of the project.
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Module 8: Analysis I - Statistical Hypothesis Testing |
Objectives or Goals
Student will be able to describe:
- the rational for Statistical Hypothesis testing
- an overall approach to the selection of statistical tests
Topics
- Population distributions
- Types of data: nominal, ordinal, continuous
- Parametric tests and nonparametric tests
- Statistical test selection
Readings
- An overview article that suggests when to choose what test
- Statconcepts' Chapter 8: Z,t, Chi, F-Critical Value
- Other Statconcepts Labs as chosen by committee
- www: web sites for Stata, SPSS, SAS and EpiInfo
Assignments
- Write the "Data Analysis" subsection of your Methods section. Here you will describe which statistical tests you will use to compare which variables
- Design the Table which will describe your final data
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Module 9: Analysis II - Modelling |
Objectives or Goals
Student will be able to describe:
- the basic assumptions underlying parametric and nonparametric tests
- the basics of statistical modeling.
Topics
- Dependent and independent variables
- Adjustment
- Models and their limits
- Subgroup analyses
- Intention to treat.
Readings
Norman
Assignments
- EpiInfo. Input a sample dataset or any dataset available in their environment.
- Run statistical tests on the main outcome variable in your data
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Module 10: Grant Writing |
Objectives or Goals
Student will be able to describe 1. the grant submission process of a national health research funding agency; and 2. the institutional review process at UBC.
Topics
- Funding opportunies
- Funding process
- Institutional review process
Readings
- How to write up a CV
- www.cihr.ca and www.creb.ubc.ca
- Grant writing CD-ROM
Assignments
- Apply for a CIHR operating grant for your project. Using only the information in your assignments to date, complete the Research Module(http://www.cihr-irs.gc.ca/services/funding/apply/acrobat/resmod_e.pdf)
- Complete the common CV module:(http://www.commoncv.net/index_e.html)
- Write a Letter of Intent to a local funding agency
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Data Management - to be developed |
Objectives or Goals
Learner will be able to:
- list important data management issues
- describe an approach to data management
- create a simple database and spreadsheet.
Topics
- Data collection; 2. Data Warehousing; 3. Data Cleaning
Readings
- H's Chapter 15: Designing data collection instruments; 2. H's Chapter 16: Data management; and 3. Online Excel and Access tutorials.
Assignments
- Create a data collection instrument for your study;
- Create an excel spreadsheet in which to collect your data;
- Create an Access database for the same purpose.
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Presentation and Publication - to be developed |
Objectives or Goals
Student will have the ability to create an effective presentation of research data.
Topics
Abstract presentation
Readings
Tufte: Visual display of quantitative information
Assignments
- Write up an abstract as you might submit to a national meeting
- Create a 10-minute ppt abstract presentation for a national meeting(use own subject and dummy data)
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