Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
Lesson Title: Pharmacy Information Resources (Part 3) Materials:
✓ Study Designs • Pen
Lesson Objectives: By the end of this module, you should be • SAS
able to References:
1. Discuss what is study design • Pharmacy Informatics,
2. Differentiate the different types of study designs Anderson et. al (CRC
Press, 2010)
• PPHA Advocacy: Pharmacy
Information Services
Manual, 2018
Productivity Tip:
Before you start, give your brain and body a boost of energy by doing stretching and push ups (or
any light cardio exercise you can do in your home), breathe deeply, and shout your inspirational
message to start your learning journey (e.g “Laban!”, “Kaya ko to!”, “Fighting!” etc.) Don’t forget to
hydrate yourself occasionally. Also, don’t forget to write the important key concepts or words to
maximize your learning. After you finish the module, don’t forget to reward yourself for a job well
done. Rewarding yourself after a strenuous studying motivates you more to continue learning, so
forget that ok?
A. LESSON PREVIEW/REVIEW
1) Introduction (2 mins)
A beautiful and well-built house can be built if there is a blueprint as the
guide. An ideal class can be achieved when there is a good lesson plan as a
guide of our beloved teacher. What if in the aspect of research, what do we need
to do in order to create a good research paper worthy to be published and be
used in the professional world?
And this is where our study designs answer all questions mentioned here. Also,
in order to make the plans execute properly, methods must be placed and follow
faithfully. As an evaluator, you must know the general ideas of the methods used
because this is the most important part of the article.
2) Activity 1: What I Know Chart, part 1 (3 mins)
Instruction: On the table next page, write on the first column on what you know about on this topic
based on the question next to it. No worries if you aren’t sure with your answer for this is only your
guide on what you and what to focus for this topic. Keep the third column blank as you will encounter
them again on the part 2.
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
What I Know Questions: What I Learned (Activity 4)
1. What is study design?
2. Why is the randomized clinical
trial is the gold standard of
conducting studies in the field of
medicine (ex. Research for
vaccines)
[Link] LESSON
1) Activity 2: Content Notes (25 mins)
Instructions: Highlight and take note the important concepts you will encounter in the module.
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
Suggested Video Material to Watch
Search “Research Methods – Introduction by Greg Martin ” on YouTube to
learn more.
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
CLASSIFICATION OF STUDY DESIGNS
The figure above depicts a simple classification of research study designs. The Centre for Evidence-based
Medicine has put forward a useful three-point algorithm which can help determine the design of a research study
from its methods section.1
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
COMMONLY ENCOUNTERED BIOMEDICAL RESOURCES (STUDY DESIGNS)
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Course Code: PHA 006
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Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
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Course Code: PHA 006
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Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
2) Activity 3: Skill-building Activities (with answer key) (15 mins)
A. Identification: Identify the following if it characterizes to any of the following categories:
Analytical, Descriptive or Both. Write your answer before the number.
_________1. a descriptive record of a single individual in which the possibility of an association
between an observed effect and a specific intervention or exposure, such as an
adverse drug reaction, exists
_________2. a group of records (case studies) that documents a practitioner's experiences,
thoughts, or observations related to the care of multiple patients with similar medical
situations
_________3. a study design in which two groups are usually Compared which are made up of those
participants exposed and those non exposed to an agent
_________4. Also termed as case referent, case history, or retrospective study
_________5. Also known as prevalence survey
B. Describe in 2 sentences only the following terms
1. Cross sectional studies
_________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
2. Bioequivalence Trial
_________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
3. Stability studies
_________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
4. Cohort
_________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
5. Review article
_________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
3) Activity 4: What I Know Chart, part 2 (3 mins)
To review what was learned from this session, please go back to Activity 1 and answer the “What I
Learned” column. Notice and reflect on any changes in your answers.
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
4) Activity 5: Check for Understanding (10 mins)
Now it’s time for you to figure this one out on your own! Take time to read, analyze, and
understand the following scenarios. For this instance, you will not have the chance to check if you have
the correct answers since there are no more keys to correction. Answer key will be provided during our
discussion session
A. Multiple Choice: Choose the best and correct answer to every question. Write the CAPITAL
LETTER of your final answer before the number.
_____1. The following are statements that best describes study design, EXCEPT FOR
A. it is the specific plan of how you will make an abstract for the study
B. it constitutes the blueprint for the collection, measurement, and analysis of data
C. It ensures that the evidence obtained enables you to effectively address the research
problem logically
D. it refers to the overall strategy that you choose to integrate the different components
of the study in a coherent and logical way
_____2. It is defined as an observational research type that analyzes data of variables collected at
one given point of time across a sample population.
A. Cohort C. Case control
B. Longitudinal study D. Cross sectional study
_____3. This is a study where it follows the drug use after market approval.
A. Quality of life studies C. Systematic review
B. Post marketing surveillance studies D. Cross sectional study
_____4. A descriptive record of a single individual in which the possibility of an association
between an observed effect and a specific intervention or exposure, such as an
adverse drug reaction, exists
A. Cohort C. Case series
B. Case study D. Case report
_____5. A group of records (case studies) that documents a practitioner's experiences, thoughts, or
observations related to the care of multiple patients with similar medical situations
A. Case study C. Case series
B. Case control D. Cohort
_____6. Establishes the quality, safety, and efficacy of generic drugs to be the same as the
innovator product
A. Bioequivalence trials C. N of 1 trial
B. Stability studies D. Cohort
____7. This is a summary of research that lacks a description of systematic methods
A. Review articles C. N of 1 trial
B. Systematic review D. Meta analysis
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
____8. This is where two groups are usually compared which are made up of those participants
exposed and those non - exposed to an agent.
A. Cohort C. Case control
B. Longitudinal study D. Cross sectional study
____9. An analytical technique designed to statistically combine and weigh the data from multiple
studies to provide a quantitative and objective assessment.
A. Qualities of life study C. Meta analysis
B. Cross sectional study D. Case control
____10. Example of this study is the determination of generic drug products if it the same as
innovator drug.
A. Bioequivalence trials C. N of 1 trial
B. Stability studies D. Cohort
C. LESSON WRAP-UP
1) Activity 6: Thinking about Learning (5 mins)
A. Work Tracker
You are done with this session! Let’s track your progress. Shade the session number you just
completed.
P1 P2
1 2 3 4 5 6 7 8 9 10
B. Think about your Learning
It’s time to reflect! What interests you about the lesson today? Explain why.
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
________________________________________________________________________________________
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Course Code: PHA 006
(Pharmacy Informatics)
Student Activity Sheet Module #4
Name: _________________________________________________________________ Class number: _______
Section: ____________ Schedule: ________________________________________ Date: ________________
FAQ/s
[Link] Randomized controlled trial (RCT) is considered as the gold standard of study in the healthcare
section?
According to the hierarchy of evidence for the evaluation of health care outcomes — the best way for
seeking the truth are RCTs. They are considered as the gold standard because they deliver the highest level of
evidence, due to their potential to limit all sorts of bias.2
KEY TO CORRECTIONS
For Activity 3
A.
1. Analytical
2. Analytical
3. Descriptive
4. Descriptive
5. Both
B. (Answer may vary, as long as the idea of your answer matches with the answer key)
1. Cross sectional - Also known as prevalence surveys. It can be thought of as a snapshot (or slice) of time
because data are collected only once on members of the study population over a period and evaluated as a
single point in time
2. Bioequivalence Trial - Establishes the quality, safety, and efficacy of generic drugs to be the same as the
innovator product
3. Stability studies - defined by the United States Pharmacopeia (USP) as "extent to which a product retains,
within specific limits and throughout its period of storage and use (that is, its shelf-life), the same properties
and characteristics that it possessed at the time of its manufacture.".
4. Cohort - Two groups are usually Compared which are made up of those participants exposed and those
non exposed to an agent (e.g vaccine, medication, procedure, or environmental toxin).
5. Review articles - Summary of research that of lacks a description of systematic methods. Considered as
tertiary literature because it provides information in the same manner as found in textbooks but are sometimes
used like secondary references because they also contain extensive and up-to-date bibliographies.
CITATION
1
Ranganathan, P., & Aggarwal, R. (2018). Study designs: Part 1 - An overview and classification. Perspectives in clinical
research, 9(4), 184–186. [Link]
2
[Link]
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