Summer - 2.5 hour session twice a week, 1/2 lecture/ 1/2 tutorial (offered to IHPME students in the Clinical Epidemiology concentration only).
Winter - 2.5 hour session once a week, 1/2 lecture/ 1/2 tutorial (open to non Clinical Epidemiology IHPME students, students from outside IHPME with clinical knowledge or training, and auditing students).

Those interested in auditing the course in the Winter term must submit a letter of intent and a letter of approval from their supervisor by December 1 to clinepi.courses@utoronto.ca.

It is not recommended that students who are considering applying to the Clinical Epidemiology program audit the course. Please contact the Program Assistant (clinepi.courses@utoronto.ca) for more information.

To introduce principles of epidemiology as applied to clinical research, emphasizing diagnosis, prognosis, treatment, the measurement of signs and symptoms of health and disease, and the evaluation of diagnostic, treatment and compliance-improving maneuvers.

1. To introduce the clinical epidemiology program and the courses offered
2. To develop an approach for addressing health research questions using appropriate research methods
3. To introduce the types of research designs used in clinical and epidemiologic research, including those using primary and secondary sources of data
4. To understand the threats to the validity of different study designs, and to become familiar with the methods used to enhance the validity of clinical research
5. To be able to critically appraise a biomedical research article
6. To be able to write a clinical research protocol

Minimum one half course in research methods
One half course in biostatistics (HAD 5307H) or (CHL 5201H) or (MSC 1090H)

The students will work through the principles of measurement, and at each stage reflect on this for their chosen measurement instrument and need.  The assignment is best done as the course progresses.  By the end of the course, students are to apply measurement principles and methods in the critical assessment and development of measures employed in clinical and epidemiological research.  Many of our students have published their final assignments.

Evaluation:

The final mark is composed of: 

    • 15% - First Assignment  (Introduction of measurement need) 
    • 25% - Second Assignment  (Critique of development and practical usefulness of
       the scale/index)
    • 50% - Final Assignment  (Critical appraisal of development, practical usefulness,
       validity, reliability and responsiveness of the chosen scale/index, final decision
       as to whether you can use it). 
    • 10% - Presentation (in class presentation related to the topic for that day)

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HAD5301H - Introduction to Clinical Epidemiology and Health Care Research
HAD5307H - Introduction to Applied Biostatistics

1. To learn the principles of decision analyis
2. To learn how to use decision analysis software
3. To perfom a decision analysis by developing a model, gathering the relevant data, and perfoming complete sensitivity analyses
4. To learn how to present a decision analysis orally and in writing

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HAD5301H - Introduction to Clinical Epidemiology  OR equivalent
HAD5303H - Controlled Clinical Trials

1. To understand the characteristics of high-quality guidelines
2. To be able to develop an analytic framework to guide evidence extraction and synthesis 
3. To discuss criteria for grading quality of evidence wrt diagnostic tests and interventions
4. To understand strength of recommendations
5. To develop skills in forming recommendations based on strength of evidence

Evaluation:

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1. To recognize the diversity of research questions, data sources and methodologies that are applied in health care research using secondary data.
2. To identify key methodological issues in the appropriateness and utilization of secondary data sources for health care research.
3. To understand the importance of a critical appraisal approach in reviewing and interpreting health care research.
4. To develop basic skills and knowledge for carrying out health care research with secondary data:
   1. develop a research question for a health care issue,
   2. assess data validity,
   3. select an appropriate study design, and
   4. plan statistical analyses.
5. To further develop written and oral communication skills for use in critiquing, planning, and disseminating health care research.

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HAD5307H

1. To understand epidemiologic concepts as they apply to clinical epidemiology
2. To write a proposal for a non experimental study
3. To learn pragmatic issues of design and conduct of observational studies

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HAD5303H - Controlled Clinical Trials
HAD5305H or HAD5308H are recommended
Must have completed or near completed an RCT proposal that has been or will be submitted for ethics approval and funding.

Description:
Each session will be devoted to common issues or concerns that arise during the conduct of an RCT.  You will be expected to consider each issue in the context of your own clinical trial and to develop a written strategy to address the issue. You should be prepared to discuss the strategies you developed at each session.  Individual strategies can be developed by review of the pertinent published literature (a list of suggested references accompanies the assignments for each session), as well as relying on your own RCT experiences.  Each session related strategy should be no more than one page in length.  Course coordinators will collect the assignments on two occasions: mid term and at the end of the course.  These assignments will be used, in combination with your class participation, for your evaluation.

Sessions will be moderated by one of the two course coordinators and a content expert.  In addition, one student will be responsible for moderating each session.  The responsibility of the moderator is to encourage discussion among your colleagues. 

Evaluation:
Attendance and participation at each session: 20%
Mid term assignment: 40% (10% of which is completion of REB submission)
Final assignment: 40% (10% of which is your review of REB submission)

1. Minimum of 2 distinct evaluation methods:
   1. active participation in discussion at Synthesis sessions
   2. preparation of written comprehensive
   3. oral presentation of comprehensives - acceptable responses to committee questions regarding the materials
      
      
2. Breakdown of overall evaluation distribution:
   Students must achieve a passing grade in each of the 3 components, outlined above in (a), of the course to receive an overall passing grade for the course
   
   
3. Criteria for assessing participation (normally maximum 20%) - justify if over 10% of total
   (Append discussion if innovative or unusual methods of evaluation)
   relevant only for Synthesis component of course - student must make an important contribution to the discussion during each session, and attendance in each session is mandatory.
   
   
4. Responsibility of each evaluator (include TA's)
   Supervisor / Committee members - responsible for supervision of comprehensive component as outlined above - approval will be required by the Program Director, Clinical Epidemiology, regarding topic for each comprehensive prior to embarking upon the work. In the Synthesis component, each instructor will serve as the "expert" in a specific field of Clinical Epidemiology, and then provide her/his own perspectives related to students' career choice.

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1. Understand the theoretical assumptions used in decision modeling.
2. Develop advanced practical modeling skills.

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Description:
This course will cover topics in measurement theory and application beyond the basic principles covered in HAD5302H, Measurement in Clinical Research. Specifically, it will cover the theory, application and interpretation of more advanced approaches and statistical techniques such as confirmatory factor analysis, structural equation modeling, item response theory approaches, measurement error, minimally clinically important differences, response shift, conjoint analysis, discrete choice experiments and the mapping of measures to utility functions as they apply to measurement theory.
The course mainly will be structured such that the first week will provide the theory and with the subsequent week(s) providing discussion of study design issues and interpretation of data output. Students will not be analyzing data.

Objectives:
The intent of the course is that students will understand the theory of the approach such that they can consider when the application is appropriate to use and critique work published work from a methodological and interpretive perspective.

Evaluation:
Students will be responsible for writing a structured synopsis/review of maximum two pages on four topics, each worth 25% of the final grade. The review topics include: 1) confirmatory factor analysis/SEM; 2) measurement error and minimally clinically important differences; 3) item response theory approaches or conjoint analysis; and, 4) response shift. The articles to be reviewed will be provided to the student two weeks prior to the review due date.

• Systematically explore and critically appraise the cognitive theories, study designs, and measurement strategies that are currently most commonly used to elicit patients' preferences and expectations;
• Identify a key research question in a decision problem of particular theoretical, methodological, or clinical interest to the individual student;
• Draft a proposed strategy for addressing the research questions of particular interest to the student; and
• Gain awareness of the broader scientific, philosophical, and sociopolitical issues inherent in studying patients' decision making.

Evaluation:
Three assignments will be used to grade your achievements in this course:

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