Principles of research methods: An integrated teaching approach
Lombardo, Fredric A
A two-credit (30 hour) course in principles of research has undergone five iterations and is herewith presented. This fully integrated course is comprised of the following components: (i) lectures from faculty in the School of Pharmacy, other units of the Health Sciences Center and other neighboring health professional units; (ii) group presentations of research publications by students; (iii) mock research proposals devised by each student; and (iv) an e-mail open book final examination. Student course evaluations for all five years have been universally positive. This course can serve as a model for further interdisciplinary course development.
INTRODUCTION
A review of the teaching methods involved in preparing Doctor of Pharmacy students for the techniques involved in conducting research, interpreting data and written reports are numerous(I-8). However, none provides a fully integrated approach to didactic, interpretive, interactive and internet-based skills involved in the three types of pharmacy research, i.e., clinical pharmacy, administrative pharmacy and basic pharmaceutical sciences. The course, “Principles of Research” provides these activities in an integrated framework. This two-credit (30 contact hour) course is offered to third-year Doctor of Pharmacy students in the spring semester prior to their fourth year, yearround professional practice rotations. The prerequisites are pharmaceutical biotechnology and biostatistics. Drug information and clinical toxicology is a co-requisite course. There are two required texts(9,10).
Although the course is listed in the Department of Pharmaceutical Sciences, the course was never considered to be the exclusive domain of that department, but was developed as a fully integrated offering. As previously noted by Draugalis et al. in their research methods course(6), the present course also addressed a number of specific educational outcomes and general ability-based outcomes (e.g., thinking abilities, communication abilities, responsible use of values and ethical principles and self-learning abilities and habits as suggested by the American Council on Pharmaceutical Education (ACPE)(1).
Further, ACPE accreditation guidelines 12.1, 12.2 and 12.3, which encourage integrating of subject matter, literature, theory and methods, as well as engaging in critical thinking to develop analytical, ethical, and professional skills needed to practice and advance the profession of pharmacy, are provided within this course (11). Approved by the curriculum and instructional resources committee for implementation in 1996, the course has undergone five iterations and is presented in its current form. Where appropriate, the indicated changes in curricular approach will be provided.
Course Description
The course is designed to introduce the students to the techniques and methods for identifying, solving and reporting of a specific problem relevant to pharmaceutical sciences and pharmaceutical care. Emphasis is placed on literature retrieval, design of studies, analysis and interpretation of data for a written research proposal. Students must also demonstrate their ability to critically evaluate published articles, with regard to the aims, objectives, study design, statistical accuracy and results; describe the role and function of the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Office of Radiation Safety; identify and discuss the legal, ethical and political issues related to the conduct of research when provided suitable examples; identify the critical areas involved in writing a research proposal; and describe the responsibilities of the principal investigator in the conduct of research.
A key component of this course is its interdisciplinary aspects. Throughout the course, numerous departments and disciplines have provided lecture/discussion and evaluation time to the course. Table I provides the interdisciplinary nature of the lectures supplied. To assure year-to-year continuity and class participation, both coordinators attend all lectures and group presentations. Further, all presentations are open to faculty in the School of Pharmacy, and, indeed, numerous faculty have attended and provided meaningful discussions.
This required course meets twice weekly for a fifty-minute period. The class size ranged from 25 (in the first year) to 102 in 1999 with an overall average of 82 students. Since 1999, classes have been held in a “Smart Room” which provides audiovisual, video- and audiotape as well as computer access from a central console. Students also have access to a computer room, with remote access to library holdings, and on-line full text journals and searchable databases, such as PubMed.
DIDACTIC SECTION
For a complete outline of the topics currently covered in the course and references for instructional materials related to these topics, see Appendix. For ease of comprehension, the topics will be arranged into five categories as follows.
Introduction
In addition to the general information provided (distribution of the course plan, obtaining the current e-mail addresses of the students, organizing into seminar presentation groups, and contacting a potential research proposal mentor), the students are provided an informal discussion of research from each coordinator, detailing their research and how it has evolved over the years from each perspective(12-16). This portion of the course has been constantly updated and provides a student with research from a basic science and clinical viewpoint.
Research Process and Methods
Research. This two-unit lecture on the scientific approach is based on fundamental principles. The development of an hypothesis, i.e., a preconceived idea, leads to the definitions of a dependent variable, the variable the research wishes to explain, and the independent variable, the variable that is expected to explain the change in the dependent variable. For example, in the following hypothesis -“Patients that use mailorder pharmacies have fewer drug expenditures” (“mail order pharmacies” is the independent variable and “drug expenditures” is the dependent variable).
Additionally, the research process and definitions follow the hypothesis: research design, the blueprint that enables the researcher to come up with solutions to the research problem; measurement, a description of how the research will be conducted; data collection, an explanation of how the data was collected; data analysis, an explanation of how the data was analyzed and the results of the research; and generalization, a discussion of how the results of the research apply to what is already known.
The two types of research (ie., proactive and reactive) are compared and contrasted. Proactive research, in general, is exploratory in nature, with original data collected, while reactive research involves analysis, and re-analysis of existing data. The types of research are further discussed in the second lecture and includes: (i) experimental research, analogous to proactive research previously described; (ii) non-experimental reactive research, such as meta-analysis; and (iii) case study research, which involves clinical evaluations and may be either proactive or reactive. The importance of sample size in a clinical study is stressed. Students are provided a history of the subject, given a definition and a discussion of various published studies involving meta-analysis. While reviewing and synthesizing the results of a meta-analytical case study, issues of conflict of interest are addressed. References are provided in the Appendix.
Human and Animal Subjects
The evolution of the Institutional Review Board (IRB) in clinical practice is described and the current role and function of the IRB is delineated. The role a pharmacist plays in drug studies is provided and real-life examples of “compassionate use” are given. After this lecture, an e-mail quiz is given to provide assurance that students can access the Howard University web site and print the informed consent statement that will be used in their research proposal.
Human Subject Rights. This unit covers the two predominant philosophies governing ethics in the Western world, (e.g., deontological view of I. Kant, and the utilitarianism view of J. Locke and J.S. Mill). Students are given the six principles of clinical bioethics, i.e., beneficence, nonmalficence, justice, autonomy, veracity and utility and the elements of informed consent. Also, egregious examples of unethical research are presented, e.g., the Tuskegee syphilis study (1932-1972), Nazi experiments on prisoners in World War II, the Willow Brook study, human radiation experiments, LSD experiments, Serratia marcescens experiments and the Bacillus subtilis experiments. Finally, the students are brought up to date with the Belmont report, the 45 Code of Federal Regulations (CFR) 46.111, and the Nuremberg Code. A discussion of informed consent completes this unit.
Use of Animals in Research. This two-period lecture provides the students with background for the current animal rights sentiment; the unique role of animals in research and current alternative methods in testing. As in the introductory lecture, both coordinators provide students with the impact animal research has assisted in their research.
Ethics in Research
A one-hour videotape “Susceptible to Kindness” on ethical problems in research highlights the Tuskegee Syphilis study. Also, a two-period lecture/discussion on responsible scientific conduct elaborates on the ethical conduct of research, and definitions of misconduct, fabrication, falsification, and plagiarism. The responsibility of the principal author and/or principal investigator in research is also covered.
Special Populations and Issues
This is a highly charged lecture on gender bias in research studies that explains the paucity of data on gender differences. In 1999, the discussion was enhanced by firsthand information from a student who participated in the summer industrial externship program in which the subject was raised. The industrial view that teratogencity was the limiting factor in the lack of the inclusion of females in drug evaluations was not considered valid by the majority of female students in each of the three years this point was raised.
Socio-Demographic Variables in the Treatment of AIDS Patients. Students are provided data on an assessment of the use of protease inhibitors in conjunction with older HIV medications that was conducted in a cohort of HIV positive patients at a large metropolitan AIDS clinic.
Overview and Introduction to Clinical Research in Pediatrics. Unique problems in the conduct of clinical research at the Children’s National Medical Center are presented. Examples include: informed consent; assent; waiver of assent; dissent; placebo trials; emancipated/mature minors; children with special challenges; and institutionalized and challenged children.
Radiation Safety. Students are given the rules and regulations for conducting experiments involving radioactive isotopes as well as delineating the role of the principal investigator in supervising students in their laboratory where isotopes are being used.
Gene Therapy. Students are introduced to the newer aspects of gene therapy as well as the problems currently associated with this technique. The pros and cons of gene therapy are also discussed.
Activities and Assessments
Research Proposal (45%). This part of the course was originally planned around the participation by a committee of faculty within the School of Pharmacy, chaired by the assistant dean, which would evaluate the proposals, in much the same manner as the research proposals in the previous BS/PharmD program. In the latter program, an actual research proposal was undertaken by students in fulfillment of the PharmD degree. This process was abandoned as the current mock proposals did not require committee concurrence. Thus, the assistant dean collected the proposals and assigned them to individual faculty members who would provide an assessment based on the previously approved criteria. Problems arose due to lack of distribution of the criteria to the students, the lack of uniformity in faculty grades and the tardiness of faculty assessments. Subsequently, the assistant dean provided the written criteria for the students and addressed the students on the research proposal.
The original proposals were give a single review, and as this portion of the course carried a considerable weight (45 percent), it was felt that the students could benefit from an initial assessment which would be followed by a final grade. Last year, this portion of the course underwent two significant changes: (i) assessment by the course coordinators exclusively; and (ii) a two-tiered evaluation involving a preliminary evaluation (due the Friday after Spring break ~ 3 weeks before the end of the semester), and the final evaluation due on the last day of class.
While the overall student assessment was improved, there still were problems. Faculty mentors were required to sign the preliminary proposals even though they had not thoroughly reviewed them; students turned in the proposals without faculty signatures; and students attempted to submit proposals after the deadline. As a result of a meeting with faculty mentors, the signature page was modified to include a check list indicating that the faculty mentor has neither reviewed nor approved the submitted initial proposal.
Additional problems with the research proposal concerned the inclusion of faculty mentors outside the School of Pharmacy. Since the institution of the course, we have had two research mentors outside the School of Pharmacy, both of whom were non-pharmacists. Faculty mentors outside the School of Pharmacy are interviewed as to their suitability and provided the research proposal guidelines. Students were also confused as to the difference between an abstract and a refereed article, both of which are acceptable in the proposal. This was cleared up by citing the letters to the editor (17, and the references cited therein) and the reply(18).
Seminar Presentation (15%). Four to six weeks before the course is to begin, depending upon the projected course enrollment, an equal number of research articles in each of the three disciplines (basic pharmaceutical science, administrative pharmacy and clinical pharmacy) is compiled by each course coordinator in collaboration with School of Pharmacy faculty.
Articles authored by School of Pharmacy faculty are not included, as students presenting the critique have been reticent in criticizing the article, and the grade provided on the presentation may be construed as not objective by the class. These articles are arbitrarily assigned a number. In the initial meeting with the class, students are instructed to arrange themselves in a group of not more than five students and assign a group captain. Each captain provides the coordinator with the names of the members of their group and meets with the coordinator for a drawing which would indicate: (i) the paper to review; and (ii) the date of the presentation. Each selection is done by a random drawing by group number. The presentations take place four weeks after the course begins to afford students adequate time for preparation.
This part of the course (15 percent) is also discussed by each coordinator in a lecture setting. In previous years, it was found that students were ill-equipped to attempt a rigorous critique, as most felt that a journal article was beyond criticism. Thus, a discussion is currently provided in which the format for the presentation is given by the coordinators and a scheduled meeting time for each presentation group is scheduled with the coordinators. Microsoft Power Point presentations are preferred. Each group is allotted a 15-minute presentation/critique, after which, the class and school of pharmacy faculty ask questions related to the article.
The overall grade for the students within the group is based on the evaluation of the presentation by the faculty (50 percent) and by each student within the group (50 percent). The former evaluation is based on a five-point Lickert scale based on organization, understanding the subject and related background/contemporary information, and the ability to answer questions from the audience. The latter evaluation is an individual assessment of the other group members’ participation in the development of the final presentation also on a five-point Lickert scale. While the individual overall grade is provided each student, the individual student evaluations are held confidential even after questioning by the students. In the past only faculty evaluations constituted the grade for the group, but at discussions on the course at the 1998 American Association of Colleges of Pharmacy (AACP) Institute, it was noted by others that students are excellent sources in evaluating group participation. It has provided a true insight into group dynamics.
Tests and Class Participation Final Examination (30%). The students were provided the final examination via the internet. It was sent two weeks before the last day of class and due on the last day of class along with the final draft of their research proposal. Students were encouraged to use additional sources as needed to answer the questions.
The final examination relied heavily on a PBS videotape “A question of genes: Inherited risks”(19). The prerequisite pharmaceutical biotechnology course and the gene therapy lecture provide a strong theoretical basis for this new approach to disease treatment, but lacked patient interaction. This videotape effectively bridged this gap. A comment from a student sums up the general sentiment of the class. … “Thank you for providing the tape for us. Before watching the video, I didn’t have a full appreciation for the impact of medical research. I need to spend more time watching PBS and the Discovery channel and less time on HBO”.
While the specter of cheating is always a problem with open book take home examinations, in the two years of instituting this examination, we have found no clear evidence of this activity. The nature of the examination precludes this behavior. The majority of the questions (> 60%) require an opinion and justification, which would be rather difficult to duplicate. We have not been faced with … “I don’t know” on one examination and… “I don’t know either” on another.
Unannounced quizzes (5%). Due to time constraints, the quizzes were submitted to the students via the internet. These quizzes are based on points raised during the discussion of the day and are open only to those students who attended the lecture in question. An example was previously provided in the lecture on the IRB.
Class Participation (5%). Questions raised during the oral presentation and/or lectures by students are encouraged and promote assertiveness.
COURSE EVALUATION
At the end of the course, instructor and course evaluations were conducted. Since its inception, the course has scored “excellent” to “good.” See Table 11 for a list of categories and scores.
During the exit interviews conducted by the associate dean the graduating class provided additional student concerns and comments related to the course. Their primary concern was the prerequisite course in biostatistics, which is offered in the College of Arts and Sciences. It was felt by a majority of the students that the biostatistics course was not tailored for pharmacy students. A portion of that course should address research methods. In addition, an applied course should be offered in the School of Pharmacy that would include items relevant to the specific needs of pharmacy students and the literature evaluation should be taught earlier in the curriculum. Due to the intensity of the course, it should be increased from two to three credits.
CONCLUSION
We have attempted to achieve interdisciplinary research that bridges the separate disciplines of clinical pharmacy, administrative pharmacy and basic pharmaceutical sciences. Student responses over the five years since its inception have been uniformly positive. Former students who have completed their residencies have remarked on how much the course provided a bridge to their postgraduate clinical activities, seminar presentations and ability to handle questions from the audience. Additional Note. Interested readers can contact the corresponding author for copies of the syllabus, related information, the final examination and the criteria for the research proposal.
References
(1) Draugalis, J.R. and Slack, M., “A course model for teaching research evaluation in colleges of pharmacy,” Am. J. Pharm. Educ., 56, 4852(1992).
(2) Lush, R.M. III, McAuley, J.W. and Kroboth, P.D., “Experimental design for clinical research: a student-centered problem-based approach,” ibid., 57, 39-43(1993).
(3) Dolinsky, D., “Teaching skills of research evaluation,” ibid., 58, 8286(1994).
(4) Ford, C., White, G., Jamison, G., Lazowick, A., Branch, E. and
McCorvey, E., “Teaching entry-level PharmD students research skills in a clinical seminar course,” ibid., 61, 79S(1997).
(5) Egbunike, LG., Osemene, N., Jackson, D.M., Plattenburg, P. and Lecca, P., “Systematic approach to clinical research projects for doctor of pharmacy students,” ibid., 61, 86S(1997).
(6) Draugalis, J.R., Carter, J.T. and Slack, M.K., “Survey course on research methods: Integrating statistical analysis and study design,” ibid., 62, 4752(1998).
(7) Ascione, F., Thompson, T., Knox, T. and Siden, R., “The use of webbased instruction to teach scientific evaluation skills,” ibid., 64, 1245 (2000).
(8) Sauer, K.A., and Draugalis, J.R., “Mock proposals and other group assignments: Bridging didactic research evaluation skills to research applications,” ibid., 64, 307-312(2000).
(9) On Being a Scientist-Responsible Conduct in Research, 2nd ed., National Academy Press, Washington DC (1999)..
(10) Leedy, P. D., Practical Research: Planning and Design, 6th ed., Macmillan, New York NY (1996).
(11) Accreditation Standards and guidelines for the Professional Program in Pharmacy leading to the Doctor of Pharmacy Degree, Adopted June 14, 1997.
(12) Edafiogho, LO., Hinko, C.N., Chang, H., Moore, J.A., Mulzac, D., Nicholson, J.M. and Scott, K.R., “Synthesis and anticonvulsant activity of enaminones,” J. Med. Chem., 35, 2798-2805(1992).
(13) Eddington, N.D., Cox, D.S., Roberts, R.R., Stables, J.P., Powell, C.B., and Scott, K.R., “Enaminones-versatile therapeutic pharmacophores. Further advances,” Curr. Med. Chem., 7, 417-436 (2000).
(14) Refs. 116 and 117 in Anger, T., Madge, D.J., Mulla, M., and Riddall, D., “Medicinal chemistry of sodium channel blockers,” J. Med. Chem., 44, 115-137(2001).
(15) Konzelman, J., Smith, K.J. Lombardo, F.A., Skelton, H.G. Ill, Holland, T.T., Yeager, J., Wagner, K.F., Oster, C.N, and Chung, R., “Iontophoresis of vinblastine into normal skin and for treatment of Kaposi’s sarcoma in human immunodeficiency virus-positive patients,” Arch. Dermatology, 128, 1365-1370(1992).
(16) Ward, F.T., Kelley, J.A., Roth, J.S., Lombardo, F.A., Weiss, R.B., Leyland-Jones, B. and Chun, H.G., “A phase I bioavailability and pharmacokinetic study of hexamethylene bisacetamide (NSC 95580) administered via nasogastric tube” Cancer Res., 51, 1803-1810(1991).
(17) Benbadis, S.R., Epilepsia, 41, 355(2000).
(18) French, J., Zahn, C., and Franklin, G. ibid., 41, 355(2000).
(19) Aired on PBS September 16, 1997. The tape with the educator’s guide is available through www.pbs.org/gene/
Fredric A. Lombardo, Emmanuel 0. Akala, Patricia B. Ayuk-Egbe, Monika N. Daftary, Bisrat Hailemeskel, Krishna Kumar, Beverly C. Mims, Rao S. Pippalla, Cynthia A. Warrick, Anthony K. Wutoh, and Kenneth R. Scott1 College of Pharmacy, Nursing and Allied Health, Howard University, 2300 4th Street,NW, Washington DC 20059
1Corresponding author.
Am. J. Pharm. Educ., 65, 340-346(2001); received 5/28/01, accepted 10/23/01.
Copyright American Association of Colleges of Pharmacy Winter 2001
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