Exam 1 Flashcards
What are the 4 methods of EBM
best evidence
patient factors
clinical expertise
patient preferences
What are the 5’A of EBM
ask
acquire
appraise
apply
assess
What are the different applications of EBM
therapeutic guideline development
managed care organizations
answering questions regarding complex patients
What is the importance of EBM
medical knowledge is constantly changing and increases
What is primary literature
Clinical research studies (randomized controlled trial, cohort, case-control)W
What is secondary literature
Searchable database allowing for identification of primaryor tertiary resources
What is tertiary literature
Provide information that has been summarized by anauthor or editor into a summary of the topic
What is the anatomy of an article
title
abstract
introduction
methods
results
discussion
conclusion
Defn of peer review
Process where reviewers provide comments andin sight on a submitted article for publication in the journal
Format for authors rules
-All authors listed
-Rule to follow for this class and moving forward: If more than 6 authors, list first 3, then et al.
-When listing authors, list last name, first and second initial
-The end of the authors section needs a period
Format for article title rules
-Only capitalize the first word or any proper nouns
-The end of the title needs a period
Format for journal title rules
Must be presented as an abbreviation, if applicable
Format for date of publication
-year, month (3 letter abbreviation)
-date is followed by a semicolon
Format for volume number rule
Volume number (issue number) is followed by a colon
Format for page numbers rule
Recommended to be concise. Will not be counted for or against you if written correctly
Page numbers is followed by a period
What are RCTs
Premier study design to measure and quantify differences in effect of an intervention versus control
what is the only type of literature that can establish causality
RCTs
What administration gives approval for a new medication or new indication for RCTs
FDA
then can conduct clinical trials
what phase is this:
First study in humans
Healthy volunteers
Small number of subjects (20-100)
Short duration (less than 1 year)
Often have a pharmacokinetic component
phase 1
what phase is this:
Can be split into 2 groups
IIa: Evaluates short-term safety
IIb: Evaluates efficacy and determines correct dosing range
Study done in patient population of interest
May not have a comparator
Higher number of subjects than Phase I (100-200)
Longer duration than Phase I (1-2 years)
phase 2
what phase is this:
Evaluates efficacy and safety of the medication compared typically to standard of care
Study done in patient population of interest
Usually multicenter
Higher number of subjects than previous phases (hundreds to thousands of patients)
Duration is typically at least 3 years
This phase is the basis for FDA approval
phase 3
what phase is this:
Occurs after drug approval
Study done in patient population of interest
These studies may be requested by the FDA
Do not have to be initiated by a FDA request
Drug company may want additional information on safety and efficacy
phase 4
What are the two designs of RCTs
intervention group compared to a control group
all RCTs randomized
There are 3 types of RTCS: Superiority, Noninferiority, Bioequivalence; what do they mean
Superiority: Prove new treatment is better than the standard or placebo
Noninferiority: Prove new treatment is not worse than the standard
Bioequivalence: Prove new treatment is about the same as the standard