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Phar 6132 Biostatistics and Drug


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									Phar 6132: Biostatistics and Drug Literature Evaluation
Fall 2009 Syllabus
University of Minnesota College of Pharmacy

Class Days and Time: Tuesdays and Fridays 10:10 am – 11:00 am
Place: 7-135 WDH (TC) and 163 LSci (Duluth)
Prerequisites: PD-II College of Pharmacy student or permission from course director
Credits: Two

Course Directors
TC campus                                              Duluth Campus
Shannon L. Reidt, Pharm.D., MPH, BCPS                  Marcia M. Worley, Ph.D., R.Ph. (Duluth)
Office: 7-103 WDH, Office Hours: By appt               Office: 225 Life Science, Office Hours: By appt
Phone: 612-998-5810, Fax: 612-625-9931                 Phone: 218-726-6006, Fax: 218-726-6500
Email: reid0113@umn.edu                                Email: worl0016@d.umn.edu

Course Instructors
Shannon L. Reidt, Pharm.D., MPH, BCPS (TC)             Marcia M. Worley, Ph.D., R.Ph. (Duluth)

Richard Brown, Ph.D. (TC)                              Tim Cernohous, Pharm.D. (Duluth)
Office: WDH 5-110H Office Hours: By appt.              Office: 130 Life Science, Office Hours: By appt.
Phone: 612-626-0811                                    Phone: 218-726-6005, Fax: 218-726-6500
Email: brown123@umn.edu                                Email: cern0037@d.umn.edu

Teaching Assistants (TAs)

Office Hours: We will announce TA office hours in class. You can also call or email to ask questions or
schedule a time to meet.

Name: Tao Jin (TC)                               Name: Randi K. Crenna (Duluth)
Office: 7-170 WDH                                Office: 162 LSci Cubicle C
Phone: 612-625-7677                              Phone: 218-726-6035 (phone available during office
Email: jinxx046@umn.edu                          hours only)
                                                 Email: cren0007@d.umn.edu
Name: Dewakar Sangaraju (TC)
Office: TBA
Phone: TBA
Email: sanga016@umn.edu

TAs have mailboxes in 232 Life Science (Duluth Campus) and 7-170 WDH (TC Campus)

Questions Are Welcomed.
You may email questions or call your faculty to schedule an appointment. The course faculty and TAs
will strive to answer emailed questions as promptly as possible.

September 2009                                                                                            1
Course Objectives
This course is designed to introduce pharmacy students to the concepts and methods of biostatistics and
study design. The overall goal of the course is for students to develop the ability to critically evaluate the
pharmacy and medical literature to identify findings that have implications for their practice. After
completing the course the student should be able to do the following:

       Explain key terms and concepts in statistics that are used in pharmacy and medical journals such
        as statistical significance, p-value, confidence interval, and power.
       Calculate commonly used statistics and discern if common statistical tests have been applied and
        interpreted appropriately in published research.
       Describe the parts of a research article and the elements that need to be included for the reader to
        confidently interpret the findings.
       Locate relevant articles using electronic databases, classify research studies according to type of
        study design, and identify the particular advantages and disadvantages of common designs.
       Understand the statistical portions of most research articles and be able to interpret data when
        presented in figures and graphs of publications.

Required—Beth Dawson and Robert Trapp. Basic & Clinical Biostatistics. 4th ed. Lange Medical
Books/McGraw Hill.

You will find the textbook helpful for the small group biostatistics projects and preparation for exams.

Other Class Materials
Lecture slides and homework assignments will be distributed in class and posted on VISTA/WebCT.
PDFs or links to required articles and small group materials will also be posted.

        VISTA site for Phar 6132
        Access to this site is available to all students registered for the course.
        To access the site, please do the following:
        1. Proceed to http://vista.umn.edu and log in using your X500 login and password
        2. Under Course List on the resulting myVISTA-WebCT page, find and click once on the
        course, Phar 6132--Section 001--Fall 2009.
        3. Follow the instructions contained within the course site. If you have trouble accessing the
        course site, please contact the Office of Educational Development (copoed@umn.edu). Please
        indicate exactly what problem you are having. In addition, please send the message using your
        University of Minnesota email account. Office of Educational Development (OED) staff will
        send responses only to University of Minnesota email accounts.

For your homework assignments, you will need to use either the calculator ―accessory,‖ commonly
included with the Windows Operating System on your computer or a small handheld calculator. PDAs or
personal computers cannot be used during exams.

“Clickers” (TurningPoint Student Response System)
You will be expected to bring your clicker to class every day. We intend to diagnose student issues with
course content and obtain feedback on course structure on an on-going basis.

September 2009                                                                                                 2
Class Format
The course will include lectures, group discussions, quizzes, exams, individual homework assignments
and small group projects. Assignments are listed in the schedule.

Exams and Quizzes
There will be three exams given during the semester. Each exam will be closed book and notes. Exams
will be multiple choice and short-answer with calculations. Individuals with a question for the test
proctor should identify themselves by raising a hand. The proctor will not provide any ad hoc hints, but
will announce any errors or misworded instructions where found so that both campuses are aware.

Make-Up Exams
Under no circumstances will make-up exams be given for unexcused absences. If a student has an
excused absence due to military service, an extended illness documented by a physician’s letter or a
family emergency, a make-up can be arranged. An excused absence is made through the College’s Office
of Student Services. These arrangements must be made in advance of the regularly scheduled exam.
Students are encouraged to contact the Course Director or any of the participating faculty with questions.

Individuals wishing to have a graded item regraded will have one week to request a regrade from the
respective course faculty after the graded materials are returned to you. All grade changes must be
approved by the respective course faculty. Please note that a regrade could potentially result in a lower
score due to closer scrutiny applied to the exam or other graded material.

An incomplete grade (I) will be given only in extraordinary circumstances such as the case of a
documented extended serious illness.

Small Group Projects
Detailed instructions about small group projects will be given in class.

To receive full credit for homework show your work and clearly label each question. Staple all pages,
your name on the front, and turn it in on time. One point will be subtracted for each day late. Sloppy and
incomplete work will not be graded. A key will be posted on the VISTA site and some problems may be
reviewed in class.

                      Tip: Make a copy of your homework before you turn it in.

You may work on or discuss homework problems together, BUT copying someone else’s work is
unacceptable. Each student must individually write up his or her own assignments. When part of the
assignment requires creativity or finding relevant articles, graphs or advertisements, this should be done
individually unless the instructions indicate that it is a group project. To get assistance with homework or
when homework grading questions arise, students are encouraged to contact the TAs.

Homework and small group assignments are due at the beginning of class on the date shown in the course
schedule unless otherwise noted.

September 2009                                                                                              3
Course Requirements
Students are expected to attend class, read the text, do homework and small group assignments; actively
participate in discussions; and take exams.

Disability Accommodations
Any student with a documented disability who needs to request reasonable accommodations must contact
Dr. Reidt on the Twin Cities campus or Dr. Worley on the Duluth campus. They must also contact their
campus’s respective Disability Service Center.
For TC students: Disability Services (612-626-1333)
For Duluth students: The Access Center/Disability Services (218-726-8217)

All discussions will remain confidential. Disability Services on both campuses will provide the student
and the instructor(s) with a letter describing the appropriate accommodations.

Course Evaluations
Your comments are used to revise the course. You will evaluate the overall course at the end of the
Honor Code
The College of Pharmacy Honor Code will be observed in all aspects of this course. Academic
misconduct is any unauthorized act which may give a student an unfair advantage over other students,
including but not limited to the following: falsification, plagiarism, misuse of test materials, altering an
examination in order to obtain more credit upon re-grading, or signing a small group project report when
one did not participate in the project.

The College of Pharmacy expects its students, faculty, and staff to behave professionally and show
respect and consideration to others at all times.

Course Waiver Policy
In order to be considered for a course waiver, a student must meet the minimum base criteria:
     Have graduate or professional program level coursework in at least one biostatistics course
     Have graduate or professional program level coursework OR experiential training/experience in
        health literature evaluation

Students who posses both criteria above should submit a written request for waivers to the appropriate
course director. This written request should include a list of relevant completed coursework in the form
of a highlighted transcript. (The transcript need not be official.) The written request should also include
descriptions of any experiential training/experience in health literature evaluation. The final decision
regarding course waivers is the responsibility of the course director(s) in consult with the other course
instructors. No course waivers will be granted after the first 2 weeks of the semester.

September 2009                                                                                                 4
Students are encouraged to access and verify their own grades during the semester on VISTA.

        Exams 1-3: 90 points (30 points each)
        Homework Sets A, B, and C: 30 points (10 points each)
        Small Group Projects 1 and 2: 50 points (25 points each)
        Maximum Total Points: 170
        Course grading is A-F only

        Final Grades will be set using the scale below (each student’s total accumulated points will be
        rounded to the nearest tenth of a percent before the scale is applied).

         A = 93.0-100.0%                  C    = 73.0-76.9%
         A- = 90.0-92.9%                  C-    = 70.0-72.9%
         B+ = 87.0-89.9%                  D     = 60.0-69.9%
         B = 83.0-86.9%                   F    less than 60.0%
         B- = 80.0-82.9%
         C+ = 77.0-79.9%
Students will be given the opportunity to review exams during a ten minute time period during class time.
This time will be determined by the course faculty and announced to the class for each exam. ALL
WILL BE DEDUCTED FROM THE STUDENT’S GRADE. If students need additional time to review
an exam, they will be encouraged to contact the course faculty to arrange an appointment to further
review their exam and ask questions.

Course Faculty and Instructors do not retain any graded materials for more than two (2) weeks beyond
the end of the semester.

September 2009                                                                                            5
                                                            Fall 2009 Schedule
Date    Topic                                   Readings*                                Assignment   Lecturer
09/08   Introduction to Course                  --                                                    All Course Faculty
09/11   The Scientific Method and Knowledge     Ch 1                                                  Dr. Brown
09/15   Elementary Statistics & Research        Ch 3                                                  Dr. Brown
        Design: Part 1
09/18   Elementary Statistics & Research        Ch 4                                                  Dr. Brown
        Design: Part 2
09/22   Elementary Statistics and Research      Ch 2,13,Glossary                                      Dr. Brown
        Design – Selecting Statistics by
09/25   Research Terminology: Blinding,         Ch 4,13,Glossary                                      Dr. Reidt / Dr. Cernohous
        Randomization, Bias
09/29   Article 1: Structure of a Research      Article 1: Graham DY, Malaty HM.         Hmwk A due   Dr. Reidt / Dr. Cernohous
        Article                                 Alendronate and Naproxen are
                                                Synergistic for Development of Gastric
                                                Ulcers. Arch Intern Med. 2001;161:107-
10/2    Type I and Type II Error and p-values   Ch 5                                                  Dr. Reidt / Dr. Cernohous
10/6    Sample size and Power                   Ch 5                                                  Dr. Reidt / Dr. Cernohous
10/9    Article 2: Sample size and Power        Article 2: Gallo M et al. Pregnancy                   Dr. Reidt / Dr. Cernohous
                                                Outcome Following Gestational Exposure
                                                to Echinacea: A Prospective Controlled
                                                Study. Arch Intern Med. 2000;160:3141-
10/13   Exam 1                                  --                                                    Dr. Reidt / Dr. Cernohous
        (through and including 10/9)
10/16   Fall Break – no class
10/20   Risk Ratios                             Ch 3
10/23   Literature Searches                     --                                                    Dr. Reidt / Dr. Cernohous
10/27   Determining Statistical Significance    Ch 5,6,8                                 Hmwk B due   Dr. Reidt / Dr. Cernohous
        and Clinical Significance from
        Confidence Intervals
10/30   Elementary Statistics and Research      Ch 5                                                  Dr. Brown

September 2009                                                                                                                    6
        Design – Examples
11/3    Elementary Statistics and Research      Ch 6                                                       Dr. Brown
        Design – Examples
11/6    Elementary Statistics and Research      Ch 7                                       Hmwk C due      Dr. Brown
        Design – Examples
11/10   Article 3: CI, Sample size, and power   Article 3: Audet M et al. Evaluation of                    Dr. Reidt / Dr. Cernohous
                                                Contraceptive Efficacy and Cycle Control
                                                of a Transdermal Contraceptive Patch vs.
                                                an Oral Contraceptive: a Randomized
                                                Controlled Trial. JAMA.
11/13   Intention to Treat and Per Protocol     Ch 9                                       Small Group     Dr. Reidt / Dr. Cernohous
        Analyses                                                                           1 Project due
11/17   Primary and Secondary Outcomes and      Article 4: TBD                                             Dr. Reidt / Dr. Cernohous
        Surrogate Markers Article 4:
        Outcomes and Surrogate Markers
11/20   Survival Analysis                       Ch 9 and Article 5: Sandler RS et al. A                    Dr. Reidt / Dr. Cernohous
                                                Randomized Trial of Aspirin to Prevent
                                                Colorectal Ademonas in Patients with
                                                Previous Colorectal Cancer. NEJM.
11/24   Exam 2                                  --
        (through and including 11/17)
11/27   Thanksgiving – no class
12/1    Small Group Project 2 Question and                                                 Small Group     Dr. Reidt / Dr. Cernohous
        Answer Session                                                                     2 Project due
                                                                                           12/7 at 1 pm
12/4    Meta-analysis                           Article 6: Miller ER et al. High-dosage                    Dr. Reidt / Dr. Cernohous
                                                Vitamin E Supplementation May Increase
                                                All-Cause Mortality. Ann Intern Med.
12/8    Survey Research Methods                 Article 7: TBD                                             Dr. Worley
12/11   TBD                                     Article 8: TBD                                             TBD
12/15   TBD                                     Article 9: TBD                                             TBD
12/18   Exam 3                                  --

September 2009                                                                                                                         7
*Chapters refer to Basic & Clinical Biostatistics, 4th edition by Dawson and Trapp. We expect that chapters are read *prior* to coming to class.
Articles are required reading and should be read *prior* to coming to class.

September 2009                                                                                                                                     8

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