Biomedical Literature Flashcards
BIOMEDICAL LITERATURE FOR DRUG INFORMATION:
Pharmacists must have skills of what
locating, critically analyzing, and effectively communicating drug information
TYPES OF BIOMEDICAL LITERATURE
Books and e-books
Conferences
3. Papers/posters
4. News/media
5. Journal articles
6. Government documents
7. Grey literature
consist of journals and other periodicals wherein medical and clinical studies are published.
They are usually disseminated in a wide variety of formats
Biomedical literature
BIOMEDICAL LITERATURE EVALUATIONS
1.Literature Evaluation
2. Importance of Literature
3.Evaluation to the Pharmacy Practice
4.Consort (Consolidated Standards of Reporting Trials)
5. Study designs
Importance of Literature Evaluation to the Pharmacy Practice
Continuing education.
2. Critically appraise or evaluate chemical studies.
3. Develop skills in literature evaluation.
4. Allows pharmacists to recognize which studies are important, reliable and deserve attention.
Used in other fields of pharmacy practice such as:
•
Solving therapeutic dilemmas.
• Patient counselling and information interpretation.
• Other health care professionals contact pharmacists for opinions.
• Decisions on drug policy management.
Provide standards, checklists, content suggestions
for authors to use when submitting manuscripts and medical journals
CONSORT
Consort (Consolidated Standards of Reporting Trials) journals
British Medical Journal
2. JAMA (Journal Of American Medical Association)
3. Lancet
4. Annals of Internal Medicine
5. STARDS (Standards for Reporting of Diagnostic Accuracy)
Clinical Studies
a. N-of-1 Study
b. Stability or In-Vitro Study
c. Bioequivalence Study
d. Programmatic Research
Determine cause and effect relationship
Clinical Studies
watches for outcomes, such as the development of a disease, during the study period
and relates this to other factors such as suspected risk or protection factor/s.
Prospective study
series of double blind, randomised “n of 1” controlled trials was performed.
N-of-1 study
Evaluate and determine the stability of drugs in various preparations under various conditions
Stability or In-Vitro Study
Assess the bioequivalence of two or more products
Bioequivalence Study
administered at the same dose by the same
route and under the same experimental conditions
Bioequivalence
Determine the impact of economic value of programs and services provided by pharmacists in
community and institutional settings
Programmatic speech
• Study the incidence, distribution and relationships of sociological and psychological variables through the
use of questionnaires applied to various populations
Survey Research
Evaluate use and adverse effects associated with newly-approved drug therapies
Post-Marketing Surveillance
Review articles, analyze, assess and evaluate previously conducted research studies
Overview
“General Overview”
Nonsystematic
Subjective summary of data
from multiple studies
Narrative review
Depend on feelings, experience and opinions of the patient
Subjective
Systematic
Qualitative and objective
summary of data from multiple
studies where the results are not
statistically combined
Qualitative
Depend on laboratory result other result and physician observation
Objective
Follows the plan
qualitative
Meta analyses
Systematic
Results of conducted clinical trials are
combined, statistically evaluated and
summarized
Quantitative
Type of medical studies
Explanatory and descriptive
Typea of explanatory
Observation and experimental
Types of descriptive
Case report And case series
Used to document and communicate experiences
o Investigator simply records data from observations made and draws conclusions as to possible
reasons for the events witnessed
o Describe unusual or new events
Descriptive
Based on the observations of individual patients
- Describe and adverse event following the use of a particular drug or group of drugs or to
report a possible DI
- Frequently generate hypotheses to serve as the basis for more rigorous studies
Case report
Document observations from a group or series of patients
- Used to examine the prior histories of patients with the same outcome in hopes of identify
a possible cause and effect relationship
- Useful for estimating the incidence of an adverse event of a newly marketed drug when
there is a limited information available about the particular event
- Used to help ensure that a certain adverse event is not associated with the use of a drug
Case series
More rigorous design to identify answers to questions that arise in clinical medicine
o Employed to determine the efficacy of medications or identify whether there is a true relationship
between the use of a drug and the occurrence of an outcome
Explanatory
Observational
- Investigators:
Bystanders
Does not conduct research
Observational
Examine the natural course of health events, gather data about the subjects included and
classify & sort the data
- Conducted when it is unethical or impossible to perform clinical studies
Observational
“Trohoc Study”
Case control
Cohort Study other name
“Follow- up study”
Determines association between disease states and exposure to various risk
factors
- Participants with a particular characteristic are compared to a similar group of
participants without the characteristic to determine the risk factors associated
with the development of that characteristic
Case control
Determine the association between various factors and disease state
development
Cohort
A group of subject already exposed to a certain factor are compared to an
unexposed group of subject and followed prospectively
- Development of a disease state of interest is observed during the study period
Cohort study
“Prevalence Study”
Cross sectional
Identifies prevalence of characteristics of diseases in populations, can be thought
of as a “snapshot” because data is collected and evaluated at a single point in
time even if the observations may cover a period of several months/years
- Surveys that evaluate opinions/situations at a fixed point in time and studies
focused on description, diagnosis and mechanisms of disease states
Cross sectional
Prospective trials in which an attempt to regulate the variables in a study occurs on the
part of the investigators
- Allows the investigator to help account for the possible influence that other outside factors
could have on a study’s outcomes independent of the drug being evaluated
Experimental
Using chance to divide people into groups means
that the groups will be similar and that the effects of the
treatments they receive can be compared more fairly.
- Reduces bias
Randomized Clinical Trial
process of assigning
patients by chance to groups that receive different
treatments. In the simplest trial design, the investigational
group receives the new treatment and the control group
receives standard therapy. At several points during and at the
end of the clinical trial, researchers compare the groups to
see which treatment is more effective or has fewer side
effects.
Clinical Trial Randomization
Inhibit psychological response
Reduce Bias
