HOWARD UNIVERSITY

COLLEGE OF PHARMACY AND PHARMACEUTICAL SCIENCES

SCHOOL OF PHARMACY
DEPARTMENT OF CLINICAL AND ADMINISTRATIVE PHARMACY SCIENCES

BIOSTATISTICS & RESEARCH METHODS

FALL 2018
CRN # 83775-316

GENERAL COURSE INFORMATION

Meeting Time:
Monday (12.30pm-1.30pm), Wednesdays (1.00pm to 2.30pm), Thursday (Laboratory
Sessions) (1:30pm-3.00pm)

Main Instructor’s Office Hours: Wednesdays 11.00am to 1.00pm; Other times by

appointment (Office Room Number: Annex III Room 109)

Credit Hours: 4 credit hours

Course Coordinator:
Mary Maneno, Ph.D., Associate Professor, Howard University College of Pharmacy,
Research Fellow, Howard University, Center for Minority Health Services Research
(HU-CMHSR) mary.maneno@howard.edu

Additional Instructors:
La’Marcus Wingate PharmD Ph.D, Assistant Professor, Howard University College of
Pharmacy
Department of Clinical & Administrative Pharmacy Sciences
lamarcus.wingate@howard.edu

Teaching Assistants:
TBA

REQUIRED TEXT BOOK

• PRIMARY TEXT FOR READING ASSIGNMENTS: Basic & Clinical Biostatistics
by Beth K. Dawson, McGraw-Hill/Appleton & Lange; 4th Edition (2004). ISBN
0071410171.

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 - Online copy available online at http://accesspharmacy.com
(username=howardu; password (medicine)
- The school of pharmacy has paid the subscription per user so the
username and password information is proprietary information

BLACKBOARD QUIZZES
• You will have one or more quizzes on blackboard during designated weeks of the
course (See tentative schedule and due dates for more details). The courses
will cover questions from the lectures topics during the more recent weeks;
however older material is also eligible for questioning. These quizzes will be
available on blackboard. These quizzes may be timed in some cases.

POP QUIZZES
• You will also have pop quizzes that will be given anytime at the instructor’s
discretion

LABS & REQUIRED STATISTICAL SOFTWARE

You will have lab sessions where you will learn how to use the statistical software. You
must have the required statistical software by the first day of lab 1 on the schedule.
• Statistical Package for the Social Sciences version 23.0 or above SPSS. SPSS
Inc. Headquarters, 233 S. Wacker Drive, 11th floor, Chicago, Illinois 60606.
• SPSS can be purchased
- Follow instructions provided at the back of the syllabus
• You are required to obtain a legal and valid of SPSS software that is to be
installed on your provided laptops.

• SPSS versions that are illegal, trial only will not be deemed acceptable for use
in this course
• You are responsible for installing the software on your laptop for use in the
class. No excuses will be accepted for not having installed the software on the
first day of laboratory sessions.
• Lab assignments will have two components to be submitted
- 1) Output File (due 5.00pm on Blackboard submission link on the due
date)
- 2) Hardcopy of word version lab assignment due 5pm under Dr.
Maneno’s Office Door on the due date. (Email copy not accepted unless
in exigent circumstances with clear written approval from instructor)

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COURSE RATIONALE/DESCRIPTION
This course serves as an introduction to the principles of biostatistics, study design and
analysis. Students will learn basic statistical methods using contemporary computer-
based statistical packages, and the application of statistics to pharmacy-based
research. The course will introduce students to the elements of scientific research, the
scientific process, and the role of research in clinical practice and pharmaceutical care.
After this course, students should be able to understand the key elements of the
scientific process and study design, and the application of statistical analysis to this
process.

PRE-REQUISITES
None

HU COP CURRICULUM OUTCOMES:

This course will cover the following Howard University College of Pharmacy Curriculum
Outcomes which are adopted from CAPE 2013.

Outcome 1.1. Learner (Learner) - Develop, integrate, and apply knowledge from the
foundational sciences (i.e., pharmaceutical, social/behavioral/administrative, and clinical
sciences) to evaluate the scientific literature, explain drug action, solve therapeutic
problems, and advance population health and patientcentered care.

Outcome 2.4. Population-based care (Provider) - Describe how population-based

care influences patient centered care and influences the development of practice
guidelines and evidence-based best practices.

Outcome 3.1. Problem Solving (Problem Solver) – Identify problems; explore and
prioritize potential strategies; and design, implement, and evaluate a viable solution.

Specific learning objectives to be covered for each of the outcomes are shown below
Curriculum Outcomes Learning Objectives
1.1 Learner 1.1.4. Integrate knowledge of pharmaceutical,
social/behavioral/administrative, and clinical
sciences to solve therapeutic problems.
2.4 Provider 2.4.1. Access, analyze and apply population-
specific (sociologic, epidemiologic and
pharmacoeconomic) data to determine the needs of
a target population relative to health promotion and
disease prevention or detection.

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3.1 Problem Solver 3.1.2. Apply critical thinking skills, including
identification, investigation, application, analysis,
creativity, synthesis and evaluation, to clinical or
other professional problem-solving and decision
making.

ENTRUSTABLE PROFESSIONAL ACTIVITIES (EPAs)

EPAs are units of professional practice or descriptors of work, defined as specific tasks
or responsibilities that trainees are entrusted to perform without direct supervision once
they have attained sufficient competence.

EPA Assigned to this Course Example of EPA supporting Task

Use evidence-based information to - Retrieve and analyze scientific
advance patient care literature to make a patient-specific
recommendation.

WRITING MATTERS STATEMENT

Writing is an essential tool for thinking and communicating in virtually every profession.
Therefore, in this course I expect you to produce writing that is not only thoughtful and
accurate, but also organized, clear and consistent with the rules of Standard English. If
your writing does not meet these standards, I may deduct points or ask you to revise.
For assistance with your writing across the curriculum (WAC) website
http://cetla.howard.edu/wac/students.aspx

POLICIES ON CLASS ATTENDANCE, EXAMINATIONS, AND DRESS CODE

EVALUATION
• The exam schedule appears in the Schedule section as outlined. However, the
class, through its President, may request changing any or all of the scheduled
examinations due to conflicts with other courses only within the first ten (10)
working days of the semester. The Course Coordinator shall attempt to
accommodate this request while taking into account the need to include in each
examination a reasonable amount of course material. After distributing the final
revision, no change in the examination schedule shall be permitted except under

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 unforeseen circumstances determined by the Course Coordinator.

• The College/University policies concerning student Conduct and Cheating during

examinations described in the School of Pharmacy Orientation Manual and the
Howard University By-Laws on Student Code of Conduct and Judiciaries
described in the H-Book shall apply to this course.

• The School policy regarding Dress Code as described in the Student Manual
shall apply in this course.

• Students have the responsibility to take all scheduled examinations on the

announced date and time. Please adhere to EXAMSOFT rules and regulations
provided to you through the office of the dean

• An absence from an examination shall be considered “excused” in which the

student is allowed to take a makeup exam, if it occurs due to any one of the
following circumstances:

 Hospitalization of the student due to illness or accident.

 Death in the student’s immediate family (e.g., spouse, parents, guardians,
siblings and/or children).
 Summon of the student to appear for Jury Duty or before a court. In these
cases, the absentee student shall submit documents supporting the above
claims (Hospital admission form, Death Certificate/Newspaper
notice/Obituary, or Government/Court Subpoena) to the Course
Coordinator. Upon verification, the student shall be scheduled for a
makeup exam. The makeup may be an essay or multiple-choice format, a
term paper, or other assignment at the discretion of the Course
Coordinator.
• No Make-ups for family reunions, birthdays, alarm did not operate properly, etc.
If you must be out of town for University or College related meetings, etc.,
provide documentation to the course coordinator as soon as possible prior to
departure.

• All exams and written assignments must be completed in order to complete this
course, regardless of lateness.

• Unexcused late work will lose 10% of its point value for each weekday.
Arrangements to turn in late homework must be approved by the instructor.
 DO NOT EMAIL ANY ASSIGNMENTS! unless given permission by

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 course instructors
• Class Attendance policy is as follows
 All students are expected to attend classes regularly and promptly.
 Students who abstain from attending classes are held responsible for the
course materials.
 No food or drinks or entertainment media shall be allowed in class during
the lectures/conferences.

COURSE GRADES
• 20% Exam 1 (October 1st 2018)
• 20% Exam 2 (Nov 5th 2018)
• 25% Final Exam
• 15% Quizzes and in class assessments
• 15% Lab assignments
• 5% Attendance

* Course grades will be assigned as follows:

A: 90%-100% B+:86-89% B: 80-85% C+:76-79%
C: 70-75% F: Less than 70%
Academic dishonesty will result in a course grade of F.

REMEDIATION ELIGIBILITY & REMEDIATION PROCESS

Remediation proceedings for this course will follow the Howard University College of
Pharmacy (HUCOP) approved policy posted in the student handbook. Please refer to
the current HUCOP remediation policy for the semester.
Other criteria for remediation in this course as it pertains to additional requirements
by the course coordinator includes all of the following
1. >=90% class attendance (only official unexcused absences will be accepted)

2. Participation in face to face mandatory scheduled reviews with the coordinator if

you fail an exam
3. 100% completion of all quizzes
4. Participation in the class scheduled exam reviews (only official unexcused
absences will be accepted)

EXAM REVIEW PROCESS

The examination will be discussed during a class designated by the instructor. During
this session students will have individualized reports of questions they got wrong so as

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to follow in the exam review session. The exam review will be conducted during class
time for the entire class.

SPECIAL NOTES
A. A non-registered student is not authorized or permitted to continue in Integrated
Therapeutics IIB past the final day for registration. No exceptions are permitted. No one
will be allowed to remain in the class or participate in any class activity. If you have
registered for the course and paid your fees but your name is not on the class roll, you
may show the instructor an official University paid receipt for the course to remain
temporarily in class while you follow University procedure to be placed on the University
Official class roster as quickly as possible. Registration printout is not acceptable.

B. Students are encouraged to review and check their graded exam upon receipt.
The course coordinator or instructor may review exams in class upon return to students.
If however, you choose not to review your exams (bring any discrepancies, errors, etc.,
to the attention of the instructor) within 48 hours after the exams are distributed to the
class, not whenever you chose to pick them up, then you accept your exam score as is.
It is best to review your exams soon after it is taken and returned to the student, rather
than days later.

C. The Final Examination schedule is coordinated during the semester by the Office of
the Associate Dean. Do not schedule travel arrangements at the end of the semester
until after the end of the Final Examination Period. Final Exam times for this course will
not be adjusted to accommodate any changes except in the case of emergencies.

ADA STATEMENT

Howard University is committed to providing an educational environment

that is accessible to all students. In accordance with this policy, students in need of
accommodations due to a disability should contact the Office of the Dean for Special
Student Services (ODSSS) and provide documentation of disability and determination of
reasonable accommodations immediately after admission to the University, or as soon
thereafter as possible. The Office of Special Student Services is located in Suite 725 of
the Howard Center and may be reached at (202) 238-2420.

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 LECTURE SCHEDULE FALL 2018

Date Lecture # Topic Required items to Assignment Deadline

review prior to lecture
Mon Syllabus Review Syllabus Quiz Aug 22
August 20

INTRODUCTORY KEY TERMS IN BIOSTATISTICS AND

RESEARCH METHODS SECTION OF THE COURSE
Wed Lecture 1 Introduction of Key Terms and How Chapter 3 reading
Aug 22 to Collect and Summarize Data subheadings
-Scales of Measurement
-Summarizing Numerical
data with Numbers
-Summarizing Nominal
and Ordinal Data with
Numbers
(read only section on
proportions and
percentages)
PROBABILITY AND STATISTICAL THEORY SECTION OF
THE COURSE
Thur Lecture 2 Introduction to Probability Chapter 4 reading Quiz 1: Data Mon Aug
Aug 23 subheadings Collection 27
-Purpose of the Chapter
-The meaning of the term
probability Quiz 2:
-Basic Definition and rules Probability Quiz

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
Mon Lecture 3 Normal Probability Distribution of -Tegrity video on other
Aug 27 the Population and z scores on the distributions
Standard Normal Curve
Chapter 4 reading
sections
-Population parameters
and sample statistics
- Random variables and
probability distributions
-Binomnial
distribution,poisson
distribution and, gaussian
distribution
Wed Lecture 4 Normal Sampling Probability Chapter 4 reading
Aug 29 Distributions of means and sections
proportions and related z and t -Sampling distribution
scores on the Standard Normal -Sampling distribution of
Curve the mean
-The central limit theorem
- Points to remember
- Applications using the
sampling distribution of
the mean
Thur Lecture 5 Normal Sampling distribution and Chapter 4 reading Quiz 3: SNC Thur
Aug Confidence Intervals around sections and Normal Sep 6
30 means, proportions, and - Points to remember Probability
differences (other sampling Distribution of
distributions) the population
-Estimation and

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
Hypothesis testing Quiz 4:
The need for estimates SNC and
Properties of good Sampling
estimates Probability
Confidence intervals Distribution
and Confidence
Limits Quiz 5:
Confidence
Chapter 5 reading Interval Quiz
sections
-Introduction to t-
distribution
-The t distribution and
confidence intervals about
the mean in one group
-Confidence intervals for
a proportion of subjects
Mon NO CLASS LABOR DAY
Sept 3
APPLICATION OF BIOSTATISTICS IN CLINICAL RESEARCH SECTION OF
THE COURSE
Wed Lecture 6 Study Design in Clinical Research Chapter 1 reading
Sept 5 sections
- Classification of study
designs
- Observational Studies
- Experimental Designs or
Clinical Trials

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
Thurs Sept Lecture 7 Introduction to Journal Article Journal article will be Quiz 6 Study Mon
6 Reviews provided by instructor Design Quiz Sep 10th
(“Do-Over of
take home
exercise from
DI on exposure
and outcome
identification
from research
studies)

Mon Lecture 8 Types of Sampling Methods in Chapter 4 reading

Sept 10 Clinical Research sections
-Populations and samples
-Reasons for sampling
-Methods of sampling
Wed Lecture 9 Data Collection and Data Entry in Supplementary reading
Sept 12 Clinical Research Studies or video’s will be provided
- Introduction to a data entry by instructor
dictionary/code-book
- Data cleaning using
descriptive statistics
Thursday Lecture 10 Descriptive Statistics and its use in Chapter 3 reading Quiz 7: Mon
Sep 13 (Dr. Wingate) Clinical Studies subheadings Sampling Quiz Sep 17th
- Descriptive Statistical Displaying Numerical data
Analysis in tables and Graphs Quiz 8
and Data
Tables and Graphs for Collection and

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
Nominal and nominal data Descriptive
Statistics Quiz

Monday Lecture 11 Hypothesis testing in clinical Chapter 4 reading

Sep 17 research studies
- How do sampling
distributions relate to
hypothesis testing in clinical
research?
- What is the null Hypothesis
and alternative hypothesis in
hypothesis testing and p-
values and their use in
studies
- Inferential statistics
sections:
Hypothesis testing
Chapter 5 reading
sections:
-Mean in one group when
the observations are
normally distributed
-The t distribution and
testing hypotheses about
the mean in one group
-Assumptions in using the
t distribution
-Hypothesis testing
Equivalence of
confidence intervals and
hypothesis tests

-Errors in hypothesis tests

-Power
-P-values
-Analogies to hypothesis

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
testing

Wed Lecture 12 Types of hypothesis tests (types of Cheat Sheet will be

Sept 19 Statistical tests provided by instructor
- Review of types of statistical
tests cheat sheet)
Thursday LAB 1 Quiz 9: Types Thur
Sept 20 of Statistical Sept 27
Data Entry and Descriptive Analysis test (One
sample tests
and paired -t-
test)
Mon Lecture 13 One-sample t-test for means Chapter 5 reading
Sep One sample z test for means sections
24 One sample z test for proportions
Paired t-test -Means when the same
group is measured twice
- The paired t test for the
mean difference
Wed Lecture 14 Chi square test Chapter 6 reading
Sep 26 sections
- Using chi square to
compare two frequencies
- The chi square
distribution
- The chi square test
for independence
- Using chi square
tests
- Small expected

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
frequencies and Fishers
exact test

Thur Chi square test and Measures of Chapter 6 reading

Sep 27 Lecture 15 Effect (Odds Ratios, Relative Risk sections
Calculations) -Risk ratios vs. chi-square
-Overuse of chi-square
Mon SPSS output handouts to
October 1 Lecture 16 Interpretation of OR and Relative be provided by instructor
Risk

EXAM 1 SCHEDULED DURING

EXAM BLOCK
Wed EXAM 1 REVIEW DAY- MANDATORY ATTENDANCE
October 3 NEEDED TO BE ELIGIBLE FOR REMEDIATION

Thur LAB 2 Quiz 10: Types Mon

Oct 4 One sample t-test and paired t-test of Statistical Oct 8
Tests (Chi
square Test
and Measures
of Effect)
Mon Lecture 17 Independent T-Test Chapter 6 reading
Oct 8 sections
-Comparing means in two
groups with the t-test
-Comparing variation in
independent groups
- The f-test for equal

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
variances
- The levene test for equal
variances
Wed Lecture 18 One-way ANOVA test Chapter 7 reading
Oct 10 sections
-Purpose of the chapter
-the logic of the Anova
-Illustration of intuitive
calculations for ANOVA

Thur LAB 3 Quiz 10: Types Mon Oct

Oct 11 Chi Square t-test and ANOVA of Statistical 15th
Chi Square, risk estimates Test Quiz
(Independent
T-test and one-
way ANOVA)
Mon Lecture 19 Pearson Correlation test Chapter 8 reading
Oct 15 sections
- An overview of
correlation and regression
- Correlation
-Calculating the
correlation coefficient
-Interpreting the size of R
-The co-efficient of
determination
-Assumptions in
correlation

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
-Other measures of
correlation
-Spearman Rho (do not
read subsection section
on how to calculate)

Wed Lecture 20 Linear Regression Analysis Chapter 8 reading

Oct 17 Simple Linear Regression sections
(SLR)
-Linear regression
-Least squares method

-Calculating the
regression equation
- Assumptions &
inferences in regression
-Use of correlation and
regression
-Regression towards the
mean
-Common errors in
regression
Thur Lecture 20 Linear Regression Analysis Chapter 8 reading Quiz 11: Types Mon Oct
Oct 18 Multiple Linear Regression (MLR) sections of Statistical 22
- An overview of Tests Quiz
correlation and regression (Pearson
-Linear regression Correlation and
-Least squares method Linear
-Calculating the Regression)

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
regression equation
- Assumptions &
inferences in regression
-Use of correlation and
regression
-Regression towards the
mean
-Common errors in
regression
Chapter 10 reading
sections
-Multiple regression:
review of regression

Mon Linear Regression SPSS output to be

Oct 22 SPSS interpretation of MLS provided
Dummy Variables
Regression model fit
SPSS regression beta
interpretation

Wed Journal Article Review Chi square Journal Article to be

Oct 24 tests, t-tests, ANOVA, Pearson Provided
Correlation and Multiple Linear
Regression
LAB 4
Pearson Correlation and Linear Regression

Thur Lecture 21 Logistic Regression Analysis Chapter 10 reading Quiz 12: Types Thur Nov

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
Oct 25 Simple Logistic Regression sections of Statistical 1
SPSS interpretation of SLR - Predicting nominal or Test (Logistic
categorical outcomes Regression)
-Logistic regression
Mon Lecture 21 Logistic Regression Analysis Chapter 10 reading
Oct 29 Multiple Logistic Regression sections
SPSS interpretation of MLR - Predicting nominal or
categorical outcomes
-Logistic regression
Wed Multiple Logistic Analysis Chapter 10 reading
Oct 31 SPSS interpretation of MLR sections
- Predicting nominal or
categorical outcomes
-Logistic regression
Thur Journal Article Review Logistic
Nov 1 Regression
Mon Journal Article Review Logistic
Nov 5 Regression

EXAM 2 SCHEDULED DURING

EXAM BLOCK
Wed EXAM 2 REVIEW DAY
Nov 7 ATTENDANCE IS MANDATORY
TO BE ELIGIBLE FOR
REMEDIATION

Thur LAB 5
Nov 8 Simple and Multiple Logistic Regression

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
Mon NO CLASS VETERANS DAY HOLIDAY
Nov 12

Wed Lecture 22 Chapter 5 section

Nov 14 Non-parametric Statistical Tests readings
-What to do when
observations are not
normally distributed

-The sign test for

hypotheses about the
median in one group
-Mean differences when
observations are not
normally distributed
-Non-parametric analyses
& SPSS interpretation
Chapter 6 section
readings
Comparing means with
the wilcoxon
rank sum test
Thur Lecture 23 Statistical Tests used in Survival Reading Journal Article Quiz 13: Types Wed Nov
Nov 15 Analysis will be assigned of Statistical 28
Kaplan Meier Tests: Non-
Cox Proportional Hazards parametric
Regression Tests

Quiz 14: Types

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 Date Lecture # Topic Required items to Assignment Deadline
review prior to lecture
of Statistical
Tests: Survival
Analysis
Mon Journal Article Review Survival
Nov 19 Analysis
Wed LAB 7
Nov 21 Kaplan Meier
Cox Proportional Hazards
Regression
Thur NO CLASS THANKSGIVING HOLIDAY
Nov 22
Mon In Class Learning Activity
Nov 26
Wed In Class Learning Activity
Nov 28
Thur In Class Learning Activity
Nov 29
FINAL EXAM DATE TBA
Notice: The course co-coordinator reserves the right to alter the lecture schedule and syllabus content for the purposes of
streamlining course instruction and adapting to changes or new policies or ACPE requirements

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HOW TO PURCHASE SPSS ONLINE

1. GO TO
https://estore.onthehub.com/WebStore/OfferingsOfMajorVersionList.aspx?pmv=89cf975c-
47c3-e411-940a-b8ca3a5db7a1&cmi_mnuMain=2ff73789-74c7-e011-ae14-
f04da23e67f6&cmi_mnuMain_child=2a1143f0-74c7-e011-ae14-f04da23e67f6

2. YOU WILL GET A SCREEN WITH THE OPTIONS SHOWN BELOW SELECT & PURCHASE
THE 12 MONTH STANDARD GRADPACK OPTION THAT IS CIRCLED ( NOTE: MAC
USERS DOWLOAD THE MAC EQUIVALENT & PC USERS THE PC EQUIVALENT BY
SELECTION OF THE PLATFORM TYPE AT THE TOP OF THE SCREEN). THE 12 MONTH
RENTAL IS TO ACCOMMODATE THE USE OF THE SOFTWARE IN THE
PHARMACOEPIDEMIOLOGY CLASS NEXT SEMESTER AS WELL

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3. UPON CLICKING TO PURCHASE YOU WILL HAVE TO REGISTER AS A USER. PLEASE
MAKE SURE YOU REGISTER USING YOUR HOWARD.EDU EMAIL ACCOUNT IN ORDER
TO QUALIFY FOR THE STUDENT DISCOUNTS
4. PLEASE ENSURE THAT YOU RECEIVE THE CODE TO ACTIVATE YOUR SUBSCRIPTION
OTHERWISE YOU WILL DEFAULT TO A FREE VERSION THAT WILL EXPIRE WITHIN
30DAYS
5. PLEASE DO NOT WAIT UNTIL THE LAST MINUTE

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