Pharmacy Informatics: Study Design

Study Design
Research methods need to ensure that valid and reliable answers are retrieved.
Different study designs are required to answer different research questions. Study
designs may also reflect historical preferences for ways of doing research within
different disciplines. The choice of study design is often affected by pragmatic
issues such as funding or patient considerations (e.g., pool of potential participants
available).

Qualitative research is a naturalistic interpretive approach that seeks to describe and

explain how and why people act and make decisions, and how they understand
their situation. It may involve transcribing and analyzing interviews, or participant
observation methodologies.
Quantitative research seeks to identify factors or relationships in a sample that can be
assumed to be true of the population from which the sample was drawn.
Frequently a study will use mixed methods - that is, a combination of qualitative and
quantitative research.
Within these two broad categories, there are many different types of studies. Each
has advantages and disadvantages and has its own unique potential sources of
bias. One study design is not in itself better than any other. It depends on the
question being asked: some studies explore the natural history of a phenomenon
or experience, or describe its impact from the perspective of patients or caregivers;
others look for protective and risk factors, or causes; some test a new treatment or
service to see if it improves the outcomes or experiences of patients; while others
try to answer questions about patterns of practice, or of service use, or of adverse
effects, and so on.

 Descriptive studies are used to describe the frequency or possible

determinants of a condition, or the experience of a condition and/or its
natural history.
 Cross-sectional studies are a snapshot at a particular time looking at the
presence or absence of a disease or symptom or disease and the presence
or absence of an exposure.
 Cohort studies look forward to see if there is a correlation between exposure
and an outcome.
 Case control studies look backward to see if an outcome was preceded by a
common event such as a disease, symptom or exposure to a material.
 Non-randomized and randomized trials look forward but also compare the effects
from a common starting point for two groups.
o In a non-randomized group, investigators assign participants to a
group whereas in a randomized study, participant allocation is by
chance. Randomized allocation reduces the likelihood of a systematic
variable affecting the outcome.
o Randomized studies need to be carefully designed so that neither the
researchers nor the participants know what treatment the patient is
getting - this is called blinding (double blinding when neither knows).
o Studies in which participants know which treatment they are receiving
are called open label studies. Sometimes this is the only method
possible, however the results can be very strongly affected by the
“placebo effect” - in which patients respond positively to a treatment
that they think will be of benefit to them.
o Placebo controlled trials compare an intervention with a placebo (inactive
comparator) so that it is possible to identify whether the intervention
is responsible for the outcomes, or whether it is the placebo effect or
the natural history of the condition being studied which produces the
change.
This is important when a condition fluctuates, for instance pain or
delirium. When it is ethically feasible, a placebo controlled study of
treatments or interventions produces the most reliable conclusions.
However, at times it is more ethical and informative to patient care to
compare a new treatment with current best practice rather than a
placebo.
 Other rigorous study designs that are particularly valuable for some
situations in palliative care include n of 1 trials and crossover studies, where a
patient tries one treatment and then another or a treatment and then a
placebo or vice-versa.
 Some questions relate not to individuals but to populations.
o Research projects related to these questions may need to access
routinely collected information such as cancer registries, census data,
and other health related databases.
o Some research programs might involve establishing a dataset to use
for researching particular questions, for example longitudinal studies
which follow a group of individuals over a long period of time, disease
registries which collect all the cases of a particular disease, or repeated
market research surveys which may be able to estimate the
prevalence of a particular problem, need, or experience at a
population level and over time.
Points of Consideration When Writing a Report

Here are some important elements to consider as you prepare a report:

• Apply the four basic standards of effective writing (unity, support, coherence, and
clear, error-free sentences) when writing the report.

• Make sure each major paragraph presents and then develops a single main point.
For example, in the sample report that follows, the first paragraph summarizes the
book, and the three paragraphs that follow detail three separate reactions of the
student writer to the book. The student then closes the report with a short
concluding paragraph.

• Support any general points you make or attitudes you express with specific
reasons and details. Statements such as "I agree with many ideas in this article" or
"I found the book very interesting" are meaningless without specific evidence that
shows why you feel as you do. Look at the sample report closely to see how the
main point or topic sentence of each paragraph is developed by specific supporting
evidence.

• Organize your material. Follow the basic plan of organization explained above: a
summary of one or more paragraphs, a reaction of two or more paragraphs, and a
conclusion. Also, use transitions to make the relationships among ideas in the
paper clear.

• Edit the paper carefully for errors in grammar, mechanics, punctuation, word use,
and spelling.

• Cite paraphrased or quoted material from the book or article you are writing
about, or from any other works, by using the appropriate documentation style. If
you are unsure what documentation style is required or recommended, ask you
instructor.

• You may use quotations in the summary and reaction parts of the paper, but do
not rely on them too much. Use them only to emphasize key ideas.

• Publishing information can be incorporated parenthetically or at the bottom of

the page in a footnote. Consult with your instructor to determine what publishing
information is necessary and where it should be placed.
How to Cite a Journal Article in Print or Online in APA Format

Examples of Journal Article:

Mitchell, J.A. (2017). Why is it so important. Mendeley Journal, 67(2), 81-95.

Mitchell, J.A. (2017). Why is it so important. Mendeley Journal, 67(2), 81-95. Retrieved
from https://www.mendeley.com/reference-management/reference-manager

Citing a general webpage/website article without an author

Structure:
• Title of webpage/article. (Year, Month Date of publication). Retrieved
from URL

Website
Structure:
• Last, F. M. (Year, Month Date Published). Webpage title. Retrieved from
URL
SPIEL:
So after discussing the different sources of information, in this topic your reading
comprehension will be tested. The attached paper discusses different study
designs. Study designs are utilized when conducting research since it is also
valuable to conduct for drug information collection and others. Included also are
some point to consider when writing a report. This also a valuable knowledge to
adopt for future uses. At the end of the paper, there are also ways on how to cite
an article journal in print or online in APA format. Make sure to read the entire
paper before answering the quiz afterwards.