Professional Documents
Culture Documents
The purpose of the three-credit (45 hours) required course is to ensure PharmD student competence in
selecting, interpreting, and evaluating clinical drug literature. The course is a prerequisite for a three-credit
Drug Information/Drug Literature Evaluation course in the professional curriculum. Topics covered include
principles of research design, acquisition and interpretation of data, statistical analysis, and validity of
conclusions. The essential connection between research design and statistical analysis is emphasized
throughout the course in lectures, examples, assignments, and exams. The purpose of this article is to share
the methods used to convey statistical analysis and research design concepts as well as methods for
assessing the students. The techniques and approaches described are also applicable to other courses in
the pharmacy curriculum. Examples also show how instructors used evaluation and revision to cultivate
integration of concepts, encourage more active learning and class participation, and enhance assessment
procedures.
INTRODUCTION in moving the course from the final didactic semester (prior
In 1992, an article was published that provided a description to the final year of clerkship rotations) to first semester of
of a three credit (45 hours) required research evaluation the second professional year. The Drug Information/Litera-
course in an entry-level PharmD program(1). The article ture Evaluation (DI) course is now in the semester immedi-
concluded with a list of course improvement efforts includ- ately following the Methods course, rather than in the
ing content changes, additions of assignments, and examina- semester preceding it. The DI course was also increased by
tion improvement. In that more institutions will be offering one unit to three units. Some topics previously covered in
a course of this nature by virtue of increased numbers of the Methods course (e.g., Meta-Analysis, Proposal Writing,
entry-level PharmD programs, this update details our on- Evaluation Methods, and article critique) have been moved
going improvement efforts as well as other refinements of to the DI course, in order to dedicate more time to statistical
the past six years. The materials and methods of this course techniques/data analysis as an introductory biostatistics
address a number of specific educational outcomes and course is no longer a prerequisite. This decision was made
general ability-based outcomes (including thinking abili- because prerequisite course content and student retention
ties, communication abilities, responsible use of values and levels were so varied. However, as the prepharmacy curricu-
ethical principles, and self-learning abilities and habits) lum is evaluated over the next year, an entry level biostatis-
deemed requirements of a competent pharmacy practitio- tics course requirement will be revisited. The pharmaco-
ner(2). As well, the course meets Standards 12 (teaching and economic evaluation component was deleted several years
learning processes) and 13 (student evaluation) in the new ago as this topic is now covered in much more detail in the
ACPE accreditation manual(3). Particularly relevant are Professional Practice Management course.
Guidelines 12.2 and 12.3 which encourage teaching ap- The overall course purpose is to provide the student
proaches that require problem solving capabilities and pro- with the skills and principles of clinical research design and
mote life-long learning to in turn, ensure professional com- biostatistics needed for interpretation and evaluation of the
petence. Guideline 13.1 specifically argues for an evaluation medical literature and assessment of research reports and
system that examines higher levels of learning, such as proposals. The overview of statistics module begins with a
integration, application, and synthesis rather than simply quotation from H.G. Wells, “Statistical thinking will one
testing for rote memorization of specific facts. Finally, a day be as necessary for efficient citizenship as the ability to
philosophy of teaching as scholarship as espoused by Boyer read and write.” Our quest for conceptual understanding
guides instructors in that the goal is to transform and extend over mathematical “plug-and-chug” begins in earnest on
knowledge, rather than simply transmit information(4). day one and continues throughout the course. Teaching
Although this paper provides examples for a specific con- students to be healthy skeptics, arming them with tools to be
tent area, the methods embraced and the techniques and proficient professional decision makers, and challenging
approaches used most certainly can be applied to many them to accept responsibility for their actions are necessary.
other courses in the pharmacy curriculum. Encouraging open-mindedness and discouraging the urge
to over-generalize based on an N of 1 are crucial. The
COURSE DESCRIPTION
overriding objective is to ensure competence in selecting,
interpreting, and evaluating clinical drug literature, includ-
In order for students to use the skills gained in this course ing principles of research design, acquisition and interpreta-
throughout their study plan, a curriculum revision resulted tion of data, statistical analysis, and validity of conclusions.
are shown how to use the demographic and disease informa- onyms for a term (e.g., research design) to completing in-
tion to describe the sample and relate it to patients they class exercises such as using a random numbers table to
might see in their practice. assign patients to treatment groups or to completing a
The research design concepts are presented based on a worksheet identifying research design issues related to an
core knowledge approach. That is, certain concepts are example research problem.
considered critical to learning additional concepts and facts. We use an integrated approach to discussing issues
We believe that by learning to recognize basic research associated with research design such as internal validity
designs and the characteristics of those designs that students issues and statistical issues. For example, threats to internal
can refine their skills as they gain more experience reading validity and research design are integrated by asking stu-
research reports. For example, until students learn to recog- dents to know the primary threat or threats to internal
nize an independent versus a dependent variable or to validity associated with each type of research design. Spe-
differentiate an experimental from a pretest-posttest de- cifically, that experimental mortality (attrition) is the pri-
sign, they cannot hope to recognize threats to internal mary threat to internal validity for an experimental research
validity or identify whether the statistical tests reported are design and that differential assignment to groups (selection)
appropriate. Continued self-learning is very difficult if the is the primary threat for a quasi-experimental design. We
student cannot recognize the critical features of a research discuss how other threats to internal validity, for example
study such as the independent and the dependent variable. history or experimental mortality, may be issues with a
On the exam at the end of the section, students averaged 93 quasi-experimental design but students are tested only on
percent on the items testing recognition of research designs the primary threat. An average of 82 percent of the students
last semester. correctly identify the primary threat to internal validity for
Active participation in learning is included during class the four research designs presented. Presentation of rel-
time to the extent possible. Students are provided with a evant statistical tests proceeds in a similar manner. Statisti-
complete set of notes so that time is not required during class cal tests appropriate for use with an experimental design
to transmit information. Important points or suggestions include a Student’s t-test, an ANOVA, or a chi square,
about learning the material are provided during the opening depending on the type of data collected.
segment of the class followed by a class discussion or small To facilitate student learning of the critical characteris-
group activities. The activities range from generating syn tics of each research design, a cognitive map is provided. An