Medical Research Methodology - UMF - Iuliu Haţieganu

Medical Research Methodology
TABLE OF CONTENTS
TABLE OF CONTENTS...........................................................................................................................1
INTRODUCTION ..................................................................................................................................2
NECESSARY PREVIOUS KNOWLEDGE ...................................................................................................3
ACADEMIC REGULATIONS...................................................................................................................4
DEPARTMENT REGULATIONS AND WORKPLACE SAFETY RULES ...........................................................5
TEACHING STAFF AND CONSULTATIONS .............................................................................................6
BIBLIOGRAPHIC RESOURCES................................................................................................................6
STRUCTURE OF THE LECTURE AND OF THE PRACTICAL ACTIVITIES.......................................................7
OBJECTIVES OF THE LECTURE AND OF THE PRACTICAL ACTIVITIES.......................................................8
TEACHING METHODS ..........................................................................................................................8
EVALUATION METHODS......................................................................................................................8
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INTRODUCTION
Development of digital computers has brought important changes in medical
research as in many other areas. Calculations can be performed quickly, easily and
accurately, with a wide range of instruments: from pocket calculators with incorporated
statistical functions to powerful computers capable of analyzing considerable amounts of
data. But the important thing to know is WHY certain calculations are made and which the
SIGNIFICANCE of the obtained results is. Hence, the danger that appears does not derive
from computers performing inexact calculations but from applying statistical methods
without following a particular purpose, or without understanding the significance of the
findings. Often a medical practitioner or researcher wonders about the significance of a
folder of printed pages. Most of the times, the answer is that another tree has died in vane.
Computers are a real support for laborious statistical analysis involving calculations
that would have taken days some decades ago and today they can be solved in seconds. But
the wide availability of computers, proved by the vast number of publications that include
sophisticated processing, frequently gave way to the use of inappropriate statistical
methods. This happens when users look at data analysis as a purely technical problem of
calculation and not as a methodological problem, thus asking computer experts for advice
rather than a research methodologist. They regularly receive helpful tips on how to proceed
but erroneous indications about how to collect and analyze data and how to interpret the
results. It is therefore extremely important that physicians, producers and consumers of
medical research, understand the use and limits of statistical techniques.
Clinical research, involves both the producer of science (designer and executor of the
study) and the consumer scientist (practitioner willing to apply the results of a
study). Communication between groups, sending and receiving messages between people of
different culture and education can be achieved only by accepting and applying universal
agreements, a common language of research.
Clinical scientific research methodology, without restrictions or scholasticism, offers
the possibility of communication between all those who devote their activity to cutting edge
medical practice.
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Medical Informatics and Biostatistics courses provide the foundations for understanding
Medical Research Methodology.
NECESSARY PREVIOUS KNOWLEDGE
Using the computer, basic level (working with files, text editing, Internet: WWW, email).
For the study of research methodology it is necessary to understand the material taught in courses of
Medical Informatics and Biostatistics.
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ACADEMIC REGULATIONS
1. To complete the number of credits allotted to a subject matter, undergraduates must attend 70%
of the courses of the respective subject matter.
2. Attendance to practical activities is 100% compulsory. No changes of schedule will be accepted
for practical activities.
3. All absences MUST be compensated.
4. A student is only allowed to compensate for up to 20% of the teaching activities.
5. Justified absences may be compensated for only AFTER a medical justification has been issued
by the Dean’s Office. The original justification must be presented no later than 10-working days
following the student’s resuming coursework along with a copy that will be kept as a record by
the assisting professor. Justifying documents which were not registered with the Dean’s Office
and with the Department within the above-mentioned period will not be taken into account.
6. Unjustified absences may be compensated for only AFTER a proof of payment has been issued
by the pay office of the University, based on the order of payment stating the number of missed
activity hours.
7. Absences can be compensated only AFTER proper justification or payment and only with the
assisting professor of the respective group. Compensations of absences with other members of
the teaching staff are not acceptable.
8. Students will not be allowed to sit an exam until ALL missed practical classes have been
compensated for. Only students who have compensated for ALL absences before the beginning
of the examination session may participate in the examinations. Missed practical classes may
NOT be compensated during examination sessions.
9. Students who have not compensated for ALL absences before the beginning of the examination
session will arrange, together with the assisting professor of their group, another time-span in
order to compensate for their absences (during the following semester / module, if that is still
possible during the same academic year, or during the following years, if that is not the case).
10. Practical / theoretical examinations are recognized during the same academic year. Students
who passed only one of the two examinations are not required to repeat the exam they have
passed, during the same academic year.
11. Students who are enrolled by transfer and need to pass supplementary examinations to
compensate for differences in the syllabi will schedule these examinations together with the
professor in charge of that course, before the beginning of the examination session, based on the
proof of payment issued by the Dean’s Office.
12. Students who need to pass examinations to compensate for transferred credits will schedule
these examinations together with the professor in charge of that course, before the beginning of
the examination session, based on the proof of payment issued by the Dean’s Office. Prior to
that, unless ALL academic responsibilities have been met in previous years (attendance of
courses and practical classes), a compensation schedule for missed classes must be agreed upon
and completed together with the former assisting professor of the group, based on proof of
compensation payment issued by the Dean’s Office.
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DEPARTMENT REGULATIONS AND WORKPLACE SAFETY RULES
1. Students may only use software installed by the network administrator. Installing and working
with external software is strictly prohibited.
2. Students may use the computers only for learning purposes, involving materials published on
the Department web site.
3. Students are not allowed to plug-in or plug-out any electronic equipment. Students may not
power-on or power-off the computers; this operation may only be performed by teaching or
technical staff of the Department.
4. For their own protection, students must announce any equipment malfunction to the
Department technician, in order to institute proper maintenance measures.
5. Every student must scan his/her personal access card using the electronic presence-registration
system at the ground-floor entrance, each time they enter or exit an activity at our Department
(course or practical activity).
6. Transmitting the personal access card or communicating the personal password to other users is
strictly prohibited.
7. Please keep the Department building tidy. For hygiene and safety reasons, eating or drinking in
the classrooms is not allowed. Any food or beverage must be kept inside a piece of luggage, in
properly sealed containers, only to be used outside the classrooms.
8. Smoking is strictly prohibited, both inside the Department building and within 25 feet (8 meters)
of its doorways.
9. Facilities inside the Department (equipments, restrooms, furniture, etc.) should be used in a
careful and civilized manner. Repair costs for any damage resulting from abuse of Department
facilities or other University property will be covered at the sole expense of the individual(s) who
produced the damage. In severe cases, future access to Department facilities may be denied to
individuals inflicting facility damage.
10. Students may enter the Department no more than 10 minutes in advance of their scheduled
activity (course or practical activity). Students who are more than 10 minutes late for their
scheduled activity will be marked absent for the whole duration of that activity. Students who
leave their classroom before the scheduled end of an activity, without an express approval from
their professor, will receive an unjustified absence for the whole duration of that activity.
11. Assistant professors and teaching assistants are entitled to expel from practical activities those
students who are distracted from learning by other activities than those published on the
Department web site. In such cases, the student will receive an unjustifiable absence for that
entire practical activity.
12. Any violation of the above regulations and safety rules may be sanctioned by withdrawing the
student’s right to access the Department, for a progressive time-span between 2 weeks and 1
semester, according to the severity of the violation. For all activities taking place during the
respective time-span, the student will receive unjustifiable absences.
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TEACHING STAFF
Lect. Dr. Horațiu Colosi
Lect. Dr. Daniel Leucuța
Assist. Dr. Dan Istrate
Assist. Drd. Andrada Urda
BIBLIOGRAPHIC RESOURCES
Laboratories are open between 8.00-18.00 hours. Unless a laboratory is occupied, students are
granted access to computers for teaching purposes only. The use of computers for personal or
entertainment purposes is not allowed.
Due to the highly dynamic concepts taught and assessed, courses are not fully covered by
bibliographic resources; therefore we encourage students to actively assist in the lectures.
Recommended bibliography:
1. Lecture presentations: http://www.info.umfcluj.ro/
2. Themes for practical activities: http://www.info.umfcluj.ro/
3. Achimaş A. Metodologia Cercetării Ştiinţifice Medicale. Cluj-Napoca: Editura Universitară Iuliu
Haţieganu; 1999.
4. Bolboacă S, Colosi H, Drugan T, Achimaş A, Ţigan S. Elements of Medical Informatics and
Biostatistics. Cluj-Napoca: Ed. SRIMA, 2003.
5. Machin D, Campbell MJ. Design of studies for medical research. Chichester, West Sussex: John
Wiley & Sons Ltd; 2005.
Scientific Circle
The Department of Medical Informatics provides access to its laboratories and facilities to conduct
research activities by students. When possible, we methodologically assist students in developing
their license thesis.
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STRUCTURE OF THE LECTURE AND OF THE PRACTICAL ACTIVITIES
LECTURES
No. Topics
1 Introduction
2 Medical research strategy. Research phases
3 Variables. Collection of data. Bibliographic documentation
4 Bias and confounders. Description of a new health phenomenon
5 Evaluation of a risk or prognostic factor
6 Survival analysis
7 Evaluation of a diagnostic test
8 Clinical trials for the evaluation of a therapeutic approach
9 Choosing statistical methods. Metanalysis
10 Evidence based medicine (EBM)
11 Estimators. Hypotheses testing
12 Data presentation
13 Medical writing
14 Research ethics
PRACTICAL ACTIVITIES
No. Topics
1 Safety rules. The Vancouver referencing system
2 Bibliographic documentation
3 Data collection and presentation
4 Evaluation of a prognostic factor. Case-control
5 Evaluation of a prognostic factor. Exposed-nonexposed
6 Evaluation of a diagnostic test . Phases II and III
7 Evaluation of a therapeutic approach. Randomized clinical trial
8 Survival analysis
9 Medical writing (oral communication of results – PowerPoint)
10 Medical writing (written communication of results – critical appraisal of a scientific paper)
11 Interpreting results of medical studies
12 Validity evaluation of medical studies and EBM
13 Recapitulative problems
14 Practical examination
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OBJECTIVES OF THE LECTURE AND OF THE PRACTICAL ACTIVITIES
The lecture offers to 2 nd year students of the Faculty of Medicine the fundamental knowledge
regarding:
1. Searching, recording and analyzing medical literature
2. Domains of medical research and types of clinical studies
3. Methods of medical research
4. Analysis and interpretation of results from medical studies
5. Principles of correct written and oral presentation of research results
6. Principles of Evidence based Medicine (EBM)
7. Ethical principles in medical research
The practical labs have as an objective the acquisition and practice of knowledge regarding:
1. Accessing relevant medical information through literature search
2. Formulating correct research questions, choosing a research aim and objectives. Selecting
and formulating research hypotheses. Identifying target populations. Understanding
sampling methods. Defining appropriate research variables. Writing a research protocol.
3. Understanding and choosing correct data collection methods
4. Understanding and choosing correct data analysis methods
5. Using specific computer tools to assist medical research
6. Understanding and using correct principles for medical writing and oral presentations of
medical research
TEACHING METHODS
Master lectures, interactive lectures, PowerPoint presentations
Examples, exercises, case studies and research scenarios, assisted by computers
EVALUATION METHODS
Practical examination – Applicative problems based on research scenarios, followed by an
interview. The ability to understand, to reason and to interpret research protocols and results, as
well as practical abilities to use computers for medical research will be evaluated (30% of the
final mark).
Written examination – Multiple-choice questions aiming to evaluate the theoretical
understanding and reasoning regarding the design of medical research, medical writing and
interpreting results of scientific medical papers (70% of the final mark).
Correction algorithm of the written examination:
Question with 1 correct answer:
- 5 concordances = 1 point
- less than 5 concordances = 0 points
Question with 2 correct answers:
- 5 concordances = 1 point
- 4 concordances = 0.5 points
- less than 4 concordances = 0 points
Question with 3 or more correct answers:
- 5 concordances = 1 point
- 4 concordances = 0.5 points
- 3 concordances = 0.25 points
- less than 3 concordances = 0 points
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