Assessment of Biostatistical Knowledge and Interpretation of Study

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“Assessment of Biostatistical Knowledge within the
Purdue University Doctor of Pharmacy Curriculum”
Learning Outcomes Assessment Grant Summary Report
May 2013
Purpose
Standard No. 13 of the Accreditation Council for Pharmacy Education (ACPE) outlines four
critical areas for effective patient care.1 These four areas are; 1) understanding of commonly
used statistical tests and their basis, 2) management of data sets, 3) evaluation of statistical
results, and 4) understanding of statistical versus clinical significance. The purpose of this
project was to assess the effectiveness of the Purdue University College of Pharmacy
professional degree curriculum with regards to biostatistics and literature evaluation instruction
and achievement of ACPE standard 13 throughout the four years of the professional degree
program.
Methods
A previously validated Biostatistical Knowledge Test Survey Instrument (BKTSI), developed by
researchers at Yale University School of Medicine, was administered to all students in the
graduating class of 2013 on an annual basis as they progressed throughout the professional
program. BKTSI Questions were developed based on the most common statistical methods
used in contemporary research published in six of the top general medical journals (e.g., New
England Journal of Medicine, Journal of the American Medical Association, Lancet, ect) in
2005.2 The instrument consisted of 20 questions and was previously administered to medical
residents to evaluate their understanding of biostatistics and interpretation of research results.
Qualtrics© Research Suite was used to provide the BKTSI in an electronic format. Students
received an electronic invitation to complete the BKTSI on four separate occasions; 1) following
completion of the first biostatistics course in the P1 year, 2) following completion of the drug
information and literature evaluation course in the P2 year, 3) following completion of the
Integrated Therapeutics Laboratory sequence in the P3 year, and 4) during the conclusion of
the Advanced Pharmacy Practice Experience (APPE) in the P4 year of the curriculum. As an
incentive for participation, students were awarded extra credit points by providing their Purdue
University Identification (PUID) number during the P1, P2, and P3 years. During the P4 year,
students provided their e-mail addresses to receive a $5 coffee gift card. All responses were
anonymous and PUID numbers and e-mail addresses were not used to identify the students or
their responses. The project was granted exempt status from regulations for the protection of
human subjects research by the Indiana University-Purdue University at Indianapolis (IUPUI)
Investigational Review Board. Data are presented using descriptive statistics.
Results
The student response rate for the BKTSI during the P1, P2, P3, and P4 years of the curriculum
were 80% (133/166), 85.5% (141/165), 73% (115/158), and 70% (109/156), respectively. The
percentage of students indicating the correct response to each question is shown in the table
below. Areas in which > 70% of respondents answered correctly in the fourth-year of the
program include: identifying continuous, ordinal, and nominal data; recognizing the purpose of a
double-blind study; identifying the t-test; and interpreting relative risk. Areas where there is a
need for continued improvement and emphasis throughout the curriculum include: recognizing a
case-control study; identifying ANOVA; identifying chi-square; interpreting the meaning of a Pvalue; identifying Cox regression; interpreting 95% confidence intervals; the relationship
between sample size, study power, and level of significance; and Kaplan Meier analysis.
BKTSI Question
1a. Identify continuous
variable
1b. Identify ordinal variable
1c. Identify nominal variable
2. Recognize a case-control
study
3. Recognize purpose of
double-blind studies
4a. Identify ANOVA
4b. Identify chi-square
analysis
4c. Identify t-test
5. Recognize definition of bias
6. Interpret the meaning of P
value > 0.05
7. Identify Cox proportional
hazard regression
8. Interpret standard deviation
9. Interpret 95% CI and
statistical significance
10. Recognize power, sample
size, and significance-level
relationship
11. Determine which test has
more specificity
12. Interpret odds ratio
13. Interpret odds ratio in
multivariate regression
analysis
14. Interpret relative risk
15. Determine strength of
evidence for risk factors
16. Interpret Kaplan-Meier
analysis results
Class of 2013
P1 Year
% correct
(95% CI)
N = 131
90.8%
(85.9-95.8)
87.0%
(81.3-92.8)
72.5%
(64.9-80.2)
34.4%
(26.2-42.5)
89.3%
(84.0-94.6)
64.1%
(55.9-72.3)
26.0%
(18.4-33.5)
61.1%
(52.7-69.4)
37.4%
(29.1-45.7)
43.5%
(35.0-52.0)
2.3%
(0.0-4.9)
44.3%
(35.8-52.8)
9.2%
(4.2-14.1)
38.9%
(30.6-47.3)
Class of 2013
P2 Year
% correct
(95% CI)
N = 141
95.2%
(91.8-98.7)
78.8%
(72.1-85.4)
74.7%
(67.6-81.7)
15.1%
(9.3-20.9)
89.0%
(84.0-94.1)
67.1%
(59.5-74.7)
37.7%
(29.8-45.5)
61.0%
(53.1-68.9)
19.9%
(13.4-26.3)
53.4%
(45.3-61.5)
52.1%
(44.0-60.2)
52.1%
(44.0-60.2)
16.4%
(10.4-22.5)
49.3%
(41.2-57.4)
Class of 2013
P3 Year
% correct
(95% CI)
N = 115
84.3%
(76.5-89.9)
82.6%
(74.5-88.5)
62.6%
(53.4-70.9)
20%
(13.7-28.3)
87.8%
(80.5-92.7)
48.7%
(39.7-57.7)
26%
(18.8-34.8)
58.2%
(49.1-66.8)
19.1%
(12.9-27.3)
63.5%
(54.3-71.7)
29.6%
(21.9-38.4)
47.8%
(38.9-56.8)
12.2%
(7.2-19.5)
31.3%
(23.5-40.2)
Class of 2013
P4 Year
% correct
(95% CI)
N = 109
83.4%
(75.3- 89.3)
79.8%
(71.2-86.3)
72.5%
(63.4-80)
19.3%
(12.8-27.7)
87.2%
(79.4-92.3)
59.6%
(50.2-68.3)
29.3%
(21.6-38.5)
69.7%
(60.5-77.5)
13.8%
(8.4-21.6)
51.4%
(42.1-60.6)
28.4%
(20.8-37.6)
56.9%
(47.5-65.8)
17.4%
(11.3-25.7)
43.1%
(34.2-52.5)
34.4%
(26.2-42.5)
27.5%
(19.8-35.1)
50.4%
(41.8-58.9)
35.6%
(28.9-43.4)
56.9%
(48.8-64.9)
32.2%
(24.6-39.8)
39.1%
(30.6-48.2)
53%
(43.9-61.9)
30.4%
(22.7-39.3)
45.9%
(36.8-55.2)
60.6%
(51.2-69.2)
30.3%
(22.4-39.5)
79.4%
(72.5-86.3)
9.9%
(4.8-15.0)
6.1%
(2.0-10.2)
80.8%
(74.4-87.2)
10.3%
(5.4-15.2)
8.9%
(4.3-13.5)
80%
(71.7-86.3)
14.8%
(9.3-22.5)
11.3%
(6.6-18.5)
79.8%
(71.3-86.3)
9.1%
(4.9-16.2)
4.6%
(1.7-10.6)
Impact of the project:
The results of this project have provided insight regarding the effectiveness of biostatistics and
literature evaluation instruction throughout the PharmD Curriculum. With the implementation of
the revised curriculum, several key concepts have been identified to target for quality
improvement. In addition, the results underscore the importance of integrative learning. In
general, the highest percentage of questions were answered correctly in the P1 year (following
completion of the biostatatistics course) and in the P2 year (following completion of the drug
information and drug literature evaluation course). The percentage of correct responses either
decreased or were maintained throughout the P3 and P4 years. Therefore, continued exposure
to these topics throughout the curriculum is necessary to continue to build on knowledge. It
should be noted that when comparing the results of this project to the previously published data
from medical residents, student pharmacists in the P4 year outperformed medical residents on
greater than 50% of the questions. Limitations to this project include the lack of incentive to
supply correct answers (versus any answer to gain extra credit points or a coffee gift card), the
timing of the survey during the week before, and week of, final exams, and the ability for
students to potentially work together on the test.
Future Plans
With the implementation of the revised professional degree curriculum, a three-credit course
(PHRM 84800—Principles of Drug Information and Literature Evaluation) will be implemented
during the P2 year of the curriculum (Fall 2013). This course will retain much of the same
foundational material from the previous curriculum, but with additional emphasis on the
interpretation of biostatistical methods and the practical implications of primary medical literature
through the use of small group case discussions. Four recently published clinical trials will be
reviewed and discussed throughout the semester to illustrate contemporary issues in the
interpretation of biomedical research. Additional focus will be place on the topics identified
through the results of this project. Continued emphasis of these concepts will be reinforced
throughout the curriculum through activities in the longitudinal professional practice skills
laboratories. Finally, we plan to continue to assess the effectiveness of our curriculum and to
share the share the results of this project with our colleagues on a national level.
References
1. Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading
to the Doctor of Pharmacy Degree. Accreditation of Council for Pharmacy Education
(ACPE). Available at https://www.acpe-accredit.org Accessed May 20, 2013.
2. Windish DM, Huot SJ, Green ML. Medicine residents’ understanding of the biostatistics and
results in the medical literature. JAMA 2007;298:1010-22.
Investigators:
Amy Heck Sheehan, PharmD
Associate Professor of Pharmacy Practice
Purdue University College of Pharmacy
Kevin Sowinski, PharmD, FCCP
Professor of Pharmacy Practice
Purdue University College of Pharmacy
Lindsay E. Davison, PharmD
Consumer Safety Officer
Division of Drug Information, US Food and Drug Administration (FDA)
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