SPPS-208 Syllabus
Winter 2015
SPPS 208
Clinical Research Design and Applications
Course Syllabus
Winter 2015
Course Chair and Faculty: Grace M. Kuo, PharmD, MPH, PhD, FCCP
Administrative Assistant: Victoria Banks
SPPS-208 WINTER 2015 SYLLABUS
COPYRIGHT ©2015 – UCSD SKAGGS SCHOOL OF PHARMACY AND PHARMACEUTICAL SCIENCES
ALL RIGHTS RESERVED
1
SPPS-208 Syllabus
Winter 2015
Goals: The Clinical Research Design and Applications course is intended to provide the
pharmacy student with basic skills needed to
1. Formulate a research question and design a clinical pharmacy/medication study
2. Critically appraise studies presented in the medical, pharmacy and healthcare literature
The focus will be on examining and designing different types of study that influence medication
use and decision making in pharmacy practice settings. Types of study design range from
randomized, controlled clinical trials to observational and evaluation studies. Not all possible
study designs will be covered in class; however, highlights of common designs relevant to
translational research in pharmacy practice will be reviewed in class.
Objectives– At the end of the course students should be able to:
1. List the study design elements that provide evidence for therapeutic decision-making
2. Design a clinical study related to medication(s) or pharmacy practice, including study
elements discussed in class
3. Compare and contrast major types of study designs used in clinical studies
4. Understand ethical issues associated with conducting clinical studies
5. Complete human subjects research training
6. Critically assess medical, pharmacy and healthcare literature to make clinical or practice
decisions across clinical practice settings
Contact Information:
Course Chair: Grace M. Kuo, PharmD, MPH, PhD, FCCP
Telephone: 858-822-7751; E-mail: gmkuo@ucsd.edu
Administrative Assistant: Victoria Banks
Telephone: 858-822-7807; E-mail: vbanks@ucsd.edu
Office Hours and Location:
Dr. Kuo’s office hours may be arranged by appointment. Please email Dr. Kuo to set up meeting times
Office Location: Pharmaceutical Sciences Building Room 2272
Lecture Times and Location:
Time: 1:00 PM – 2:50 PM on Tuesdays
Location: Health Sciences Education Center Auditorium (basement level of the Pharmaceutical Sciences
building at the Skaggs School of Pharmacy and Pharmaceutical Sciences)
Course Format:
The Clinical Research Design and Applications course consists of lecture/seminar sessions,
reading assignments, human subjects research training, a mid-term exam, and a final exam.
Reading Assignments (Materials Included in the Exam):
You can check-out the course textbooks from the Biomedical Library Reservation desk. Journal
articles are accessible via the Biomedical Library’s online Course Reserves.
Required Text (2 Copies are on reserve at the Biomedical Library):
• Designing Clinical Research. by Hulley SB, et al. Philadelphia, PA: Lippincott
Williams & Wilkins, 2013. 4th edition.
Optional Text (A copy is on reserve at the Biomedical Library:
2
SPPS-208 Syllabus
•
Winter 2015
Health Services research Methods by Leiyu Shi, DrPH, MBA, MPA. Clifton Park, NY:
Delmar Learning, 2008. 2nd Edition.
To Access Journal Articles via Biomedical Library Course Reserves:
• Go to the Course Reserves section of the Biomedical Library.
o http://libraries.ucsd.edu/resources/course-reserves/index.html
• Click on STUDENTS
• Select department: School of Pharmacy and Pharmaceutical Sciences
• Select Course: SPPS208
• ‘Accept' terms and you should be able to view/print all the journal articles
Course Website:
The official web site for this course can be accessed at ted.ucsd.edu. You are strongly
encouraged to visit this site to access handouts, exam score, and grades.
Use of Audience Response Clickers:
Students should bring your own TurningPoint clickers to class. Audience response participation
may be used by lecturers in class.
Performance Requirements/Evaluation Criteria:
1. Midterm Exam (40% of Course Grade) – includes Multiple choices, matching, or short
answers. Exam questions cover materials discussed in class and included in reading
assignments.
2. Human Subjects Research Training CITI Certificate (10% of Course Grade)
a. Go to www.citiprogram.org and click on the "Register" button located in the blue log
in box to the right of the homepage.
b. Enter “University of California, San Diego” in the Organization Affiliation search.
Select “Continue to Step 2”.
c. Complete Steps 2-4 of the registration.
d. At Step 5, select “No” when asked about CE credits.
e. At Step 6, select “Basic Human Subjects – Biomedical”.
f. At Step 7, Question 1, select “Biomedical Research Investigators”. Skip the other
questions.
g. Click “Finalize Registration”.
h. You can now begin the course. The course does not have to be completed in one
sitting. After you complete each module the date completed and score column will be
filled in the Gradebook.
i. Once you have completed the course, save the file name as CITI_LastName +
initial of your first name (e.g., CITI_Kuog).
j. Print a PDF copy (selecting File, Print, and print to PDF) of your Course Completion
Report gradebook page (showing your scores for each module, with your name on
top of page)) and upload to TED before the due date/time. Late submission will
receive a 10 point deduction every day passed the due date/time.
k. Your grade for the CITI certificate will be based on the average score you have
received from all required modules.
3. Journal Article Reviews, Critiques, & Applications Write-Up (10% of Course Grade) –
Turn in your write up at the beginning of class on February 17; your write-up should be
3
SPPS-208 Syllabus
Winter 2015
based on the Journal Critique Questions provided in the syllabus. No points will be given to
late submissions.
4. Final Exam (40% of Course Grade) – include Multiple choices, matching, short answers,
and study-based designs and critiques. Exam questions cover cumulative materials
discussed in class and included in reading materials.
Grading:
The final grade will be based on the percentage of points earned.
Grade
H
P
Y
F
Designation
Honors
Pass
Provisionally unsatisfactory
Fail
% Range
> 90
> 75
74 - 65
< 65
Policies:
Examinations
There will be two scheduled exams. Scantrons, calculators (when needed), and #2 pencils will
be provided. Electronic devices (cell phones, ipads, etc.) are to be turned off and put away in
backpacks or purses prior to the start of the exam. Backpacks and purses have to be put away
before the exam is distributed. Food is not allowed during the exam.
No bathroom breaks are allowed during the exams. Students may leave the exam at any time
for any reason, but there will be no re-entry into the exam room. If you have a medical condition
that requires you to leave and re-enter the room during the exam, please provide the course
chair with the appropriate documentation, such as a letter from your doctor.
Exam Review
Students will be able to review their exams after the scores have been posted. Students who
would like to review their exams can make an appointment with the administrative assistant and
the course chair.
Re-examination Policy
According to SSPPS Policy, students will be allowed to reschedule exams only with the
permission of the course chair and for the following reasons:
• documented illness
• approved personal or family emergency
• approved professional commitment
A score of 0 will be recorded for any examination that is missed due to an unexcused absence.
If a student is unable to take an exam because of illness, s/he must notify the course chair,
before the exam and receive permission to reschedule. If the illness is the result of a medical
emergency, the student must notify the course chair as soon as medically possible. In each of
these cases, the student is required to provide documentation of illness.
If a student is unable to take an exam because of a personal or family emergency, s/he must
notify the course chair before the exam and receive permission to reschedule the exam.
4
SPPS-208 Syllabus
Winter 2015
If a student wishes to reschedule an exam in order to meet a professional commitment, s/he
must contact the course chair at least three weeks in advance of the regularly scheduled
exam and receive permission to reschedule. Documentation of attendance at the
professional commitment may be requested by the course chair.
In each of the above situations, in addition to notifying the course chair, the student must notify
the Office of Student Affairs and inform the office of the arrangements that have been made
with the course chair.
The date and time of the rescheduled examination shall be at the discretion of the course chair
after discussion with the student.
Requests to reschedule exams in order to accommodate personal vacations or activities, or
to allow a student to attend non-essential activities will not be approved.
Posting of Grades
Following the grading of each exam, grades will be posted on the course website. You will have
access only to your grades and are asked to refer to the course website as grades will not be
publically posted.
Students who have earned a grade of Y this course will be offered the opportunity to take a
repeat examination to demonstrate competency, prior to the start of the next academic year.
The rectifying of the Y grade will occur during the summer, where at least 6 weeks will have
passed between the end of Spring quarter courses and the rectifying of the Y grade. A student
who has failed a course, or failed a repeat examination, and has been assigned a grade of F
must repeat the course.
Integrity of Scholarship
Integrity of scholarship is essential for an academic community. The University expects both
faculty and students to honor this principle and in so doing protect the validity of University
intellectual work. For students, this means that all academic work will be done by the individual
to whom it is assigned, without unauthorized aid of any kind. Instructors, for their part, will
exercise care in planning and supervising academic work, so that honest effort will be upheld.
Students with Disabilities
Appropriate academic accommodations for qualified students with disabilities will be provided
upon request. Please contact Kim Ciero, Director of Student Affairs (kciero@ucsd.edu) and
Shelly Fromholtz, Curriculum Coordinator (sfromholtz@ucsd.edu) to arrange for special
accommodations prior to each exam. Failure to prearrange accommodations will require that
you take the exam with the rest of the class at the regularly scheduled time.
Course and Faculty Evaluations:
Course and faculty evaluations provide important feedback to instructors to improve course
content and teaching methods. Completion of course and instructor evaluations is a requirement
for successful completion of this course. Students who have academically passed this course
but not completed evaluations will receive a grade of “I” (Incomplete) for the course.
5
SPPS-208 Syllabus
Winter 2015
COURSE SCHEDULE
Tuesdays 1:00 PM to 2:50 PM in the Health Sciences Education Center Auditorium
EXCEPTION: Wednesday March 11, 2015; 1:00 PM to 3:00 PM (Final Exam)
DATE
Week 1
Jan. 6
LECTURE TOPIC
LECTURER
DUE
Course introduction and Syllabus Review
Dr. Grace Kuo
Question, Hypothesis, Rationale, Specific Aim
Week 2
Jan. 13
Randomized Controlled Study
Dr. Grace Kuo
Week 3
Jan. 20
Crossover Study
Dr. William Norcross
Cross-sectional Study
Dr. Grace Kuo
Cohort Study
Dr. Tina Chambers
Case Control Study
Dr. Grace Kuo
Survey Research & Practice-Based Research
Dr. Grace Kuo
Week 4
Jan. 27
Week 5
Feb. 3
CITI
Certificate
Due by 1
PM
Program Evaluation Study
Mid-Term Exam
Dr. Grace Kuo & Proctor
Quality Improvement – Lean Performance
Study
Mr. Anthony Biondo, MBA
Week 7
Feb. 17
Journal Article Reviews, Critiques, &
Applications
UC San Diego
pharmacy residents
Week 8
Feb. 24
Interpretation of study findings from statistical
tests
Dr. Jonathan Watanabe
Week 6
Feb. 10
Research Using Existing Data
Week 9
March 3
Week 10
March 11
Drug Utilization Review & Medication Use
Evaluation
Dr. Katie Derry
Designing Your Study; proposals; IRB reviews
Dr. Grace Kuo
Final Exam
Dr. Grace Kuo & Proctor
6
Jounral
Critique
Write-Up
Due by
1pm
SPPS-208 Syllabus
Winter 2015
Lecturers and Staff (in alphabetical order of last names):
1
Victoria Banks
Administrative Assistant
vbanks@ucsd.edu
2
Anthony Biondo, MBA
Sr. Administrative Analyst
Department of Pharmacy
UC San Diego Health System
abiondo@ucsd.edu
3
Christina Chambers, PhD, MPH
Professor of Pediatrics
Director, California Teratogen Information Service and Clinical
Research Program
chchambers@ucsd.edu
4
Katie Derry, Pharm.D., BCPS
Pharmacoeconomic Specialist
Department of Pharmacy
UC San Diego Health System
klderry@ucsd.edu
5
Grace M. Kuo, PharmD, MPH,
PhD, FCCP
Professor of Clinical Pharmacy
Adjunct Professor of Family Medicine and Public Health
Associate Dean for Academic Clinical Affairs, SSPPS
gmkuo@ucsd.edu
6
William Norcross, MD
Professor of Clinical Family Medicine
Director, UCSD Physician Assessment and Clinical Education
(PACE) Program
wnorcross@ucsd.edu
7
Jonathan Watanabe, PharmD,
PhD
Assistant Professor of Clinical Pharmacy
Skaggs School of Pharmacy & Pharmaceutical Sciences
jhwatanabe@ucsd.edu
UC San Diego Residents:
UC San Diego Pharmacy Residents
William Cang, PharmD
Carissa Chan, PharmD
Nina Haste, PharmD
Jade Kozuch, PharmD
Wan-Ting Huang, PharmD
Trina Huynh, PharmD
Kathryn Medders, PharmD
Jeffrey Yin, PharmD
wcang@ucsd.edu
cac001@ucsd.edu
nhaste@ucsd.edu
jkozuch@ucsd.edu
wah007@ucsd.edu
trhuynh@ucsd.edu
kmedders@ucsd.edu
jfyin@ucsd.edu
8
7
SPPS-208 Syllabus
DATE
Week 1
Jan. 6
Week 2
Jan. 13
Winter 2015
LECTURE TOPIC
READING ASSIGNMENTS
Course introduction
Syllabus; CITI online certificate reading
Question, Hypothesis,
Rationale, Aim
Hulley (Chapters 1 & 2; 5; 19)
Randomized
Controlled Study
Hulley (Chapter 10)
Young JM, Solomon MJ. How to critically appraise an article. Nature
Clinical Practice Gastroenterology & Hepatology 2009;6:82-91.
Kendall JM. Designing a research project: randomized controlled trials
and their principles. Emrg Med J 2003;20:164-8.
Week 3
Jan. 20
Week 4
Jan. 27
Crossover Study
Ganiats, et al. Does Beano prevent gas?: a double-blind crossover
study of oral alpha-galactosidase to treat dietary oligosaccharide
intolerance. J of Fam Practice 1994;39:5:1-4.
Cross-sectional Study
Hulley (Chapter 7)
Cohort Study
Hulley (Chapter 7)
Chambers CD, Johnson KA, Dick LM, et al. Birth outcomes in pregnant
women taking fluoxetine. N Engl J Med. 1996;335(14):1010-5.
Week 5
Feb. 3
Week 6
Feb. 10
Case Control Study
Hulley (Chapter 8)
Survey Research
Chambers CD, Hernandez-Diaz S, Van Marter LJ, et al. Selective
serotonin-reuptake inhibitors and risk of persistent pulmonary
hypertension of the newborn. N Engl J Med. 2006;354(6):579-87.
Hulley (Chapter 15); Shi (Chapter 8)
Practice-Based
Research
Carter BL, Clarke W, Ardery G, et al. A cluster-randomized
effectiveness trial of a physician-pharmacist collaborative model to
improve blood pressure control. Circ Cardiovasc Qual Outcomes
2010;3(4):418-23.
Program Evaluation
Shi (Chapter 9)
Program evaluation in health care. Health Services Research Group.
CMAJ 1992;146(8):1301-4.
Quality Improvement
IHI White Paper – Going Lean in Health Care
8
SPPS-208 Syllabus
DATE
Week 7
Feb. 17
Winter 2015
LECTURE TOPIC
Journal Critiques
READING ASSIGNMENTS
Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson
JE, Hennekens CH, Buring JE. A randomized trial of low-dose
aspirin in the primary prevention of cardiovascular disease in
women. N Engl J Med 2005 Mar 31;352(13):1293-304.
Greenhalgh T. How to Read a Paper: Assessing the methodological
quality of published papers. BMJ 1997;315:305-8.
Greenhalgh T. How to Read a Paper: Getting your bearings (deciding
what the paper is about). BMJ 1997;315:243-6.
Week 8
Feb. 24
Week 9
March 3
Interpretation of study
findings
Hulley (Chapter 13)
Research Using
Existing Data
DUR/MUE
TBD
Designing Your Study
Hulley (Chapter 19, 16, 14)
9
SPPS-208 Syllabus
Winter 2015
Journal Critique Questions for Clinical Studies (20 points = 10% of total grade)
Introduction (4 points):
1. Study question(s) and aim(s) of the Study: Was there a clear statement of question
and aim? If yes, please state the specific aim(s). If no, how should the aim be
stated?
2. What was the chosen study design?
3. Were the hypothesis clearly stated? Please state the hypothesis.
4. Did the authors provide sufficient background information to demonstrate that the
study filled a knowledge gap?
Methods (6 points):
1. Who was the study about?
a. How were subjects recruited?
b. Explain the inclusion and exclusion criteria.
c. Was the sample size large enough to get a significant result? Explain.
2. What was the main exposure/intervention under investigation? How was it
ascertained, defined, and measured in this study?
3. What outcome(s) were measured, and how?
4. What possible confounding factors or sources of bias might be present?
5. Was the study adequately controlled?
a. Was the study randomized?
b. Were demographics for the comparison groups similar post randomization?
6. Were data collected appropriately?
Results/Statistical Aspects (5 points):
1. Had the authors determined whether their groups were comparable and, if necessary
adjusted for baseline differences?
2. Did the authors use appropriate statistical tests? Explain.
3. Data presentation and analysis:
a. How clear and complete?
i. Descriptive Statistics
ii. Complete presentation of numbers
iii. Measures of association and risk
4. Statistical significance
i. Were “p-values calculated and interpreted appropriately?
ii. Had confidence intervals been calculated and did the authors’
conclusions reflect them?
5. Was study power calculated? Could a Type I or Type II error have occurred? Was
there control for confounders and bias?
Discussions/Conclusions (5 points):
1. Did the authors compare their study results to those of a systemic review of all
previously published data?
2. Were the study conclusions consistent with the results?
3. Can you apply the findings to your patients? If so, how? Which patients or subset of
patients would the study be applicable to?
4. Would you recommend this article to a colleague as one that provides quality
evidence to seriously consider when making a therapy decision? Why or Why not?
5. How would you do the same study better? Look at all aspects of the study.
10
SPPS-208 Syllabus
Winter 2015
Study Design Elements for Proposal Writing (Reference)
1.
Study Question, Specific Aim, Hypothesis, & Rationale
a. State the study question
b. List primary specific aim (or objective)
c. List hypothesis to the study objective
d. Describe rationale for your study and knowledge gap identified
2.
Research Design Selection & Methods
a. Name your study design
b. State the observation or intervention methods
c. List comparison groups
d. Name who subjects or participants are
e. List inclusion and exclusion criteria
f. Subject selection
g. Recruitment strategy
3.
Outcome, Sample Size, & Statistical methods
a. Name the primary outcome endpoint and describe why this was chosen
b. List and describe the data collection instrument (e.g., survey, BP device)
to be used for the primary outcome endpoint
c. State sample size number and describe how it’s derived
d. Name the statistical method proposed for the primary outcome endpoint
and explain the rationale for selection
4.
Justification for the Selected Study Design
a. Reasons (i.e., advantages and disadvantages) why the selected study
design is the best
b. Reasons (i.e., advantages and disadvantages) why the other study
designs are not the best
11