10Q
What type of literature is this? (primary, secondary, or tertiary)
summarized from primary literature
source of answers to straight forward questions
tertiary literature
What type of literature is this? (primary, secondary, or tertiary)
original research
clinical evidence raw and most recent form
evaluation skills are necessary
synthesis addresses more complex questions
primary literature
What type of literature is this? (primary, secondary, or tertiary)
searchable databases that enables location and retrieval of primary and tertiary resources
catalogue w/ indexing and filtering
secondary literature
Examples of primary literature:
controlled trials
cohort studies
case reports
Examples of secondary literature:
PubMed
Medline
Embase
IPA
Google Scholar
Web of Science
Examples of tertiary literature:
Compendia (Micromedex, Lexicomp)
Textbooks
review article
clinical practice guideline
package insert
What is the BEST method to search your literature?
a. primary lit —> secondary databases —> tertiary
b. secondary databases —> primary lit —> tertiary
c. tertiary —> secondary databases —> primary lit
d. primary lit —> tertiary —> secondary databases
c.
tertiary —> secondary —> primary
Which of the following correctly describes tertiary resources?
a. provides info that is detail oriented, such as case studies
b. provides info that is summarized for a quick and easy overview
c. provides info that references the literature found in journals
d. provides info that includes details that are not yet published
b.
What are the pros and cons of tertiary literature?
pros: convenient, user friendly
cons: risk of out-of-date info
T/F When reading tertiary resources, you should look consult 2 or more resources as you may have different answers depending on what resource you utilize.
T
Non-systematic review articles:
What are they used for?
What are they not based on?
Advantages:
Used for: general background info (like disease state and tx)
NOT based on predefined lit search criteria
advantages: updates the research on new treatment strategies that may not be in guidelines yet
Describe Systematic Review, a type of tertiary literature:
clear and prespecified criteria for finding research and for rating quality of evidence
higher quality of review
may be considered primary considering it brings new understandings by combining earlier findings
Is Meta-analysis considered a primary or tertiary literature?
PRIMARY
What is a meta-analysis?
new research bc it mathematically combines findings of smaller studies, generating new knowledge from previously measured results
Prescribing information is generally considered as _________________ literature.
TERTIARY
What is the definition of Clinical Practice Guidelines?
systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances
T/F Best/high quality clinical guidelines will not continually review medical literature AND summarize old evidence to inform best practice standards
F
Guidelines WILL continually review medical literature AND summarize NEW CURRENT evidence to inform best practice standards.
How is a quality clinical practice guideline created?
transparent process is published/followed
specific methods used to find/synthesize evidence
ratings of evidence is determined beforehand and consistently applied
recommendations include an indicator of strength of supporting evidence
references provided
What is the name given to the compilation of information from FDA regarding safety and efficacy based on clinical trials?
Prescribing Information
aka the package insert,
prescription drug label,
PI,
product info
Do package inserts contain off-label or unapproved indications?
no
Where would you go to, to find package inserts?
DailyMed website maintained by NLM
Drugs@FDA website and mobile app
Manufacturer website
printed and attached to the product
What does the FDA Orange Book contain? How are things rated?
approved drug products w/ therapeutic evidence
reference listed drugs and ratings of therapeutic evidence of generic products
AB Rating
What does the FDA Purple Book contain?
licensed biological products w/ biosimilarity and interchangeability evaluations
What is the difference between biosimilar and interchangeable?
biosimilar- biological product that is highly similar and has no clinically meaningful differences in terms of safety or effective from an existing FDA approved reference produce
Interchangeable- is BIOSIMILAR ANDDDDD approved based on info sufficient to show that it can be expected to product the same clinical result in any given patient
Think: An interchangeable is biosimilar that meets additional requirements!
Which drug resources are available to use through LECOM?
FYI
lexicomp,
micromedex
natural medicine
UptoDate
+more
What resource is included in Micromedex and is unique for including pricing information - average wholesale price (AWP), wholesale acquisition cost (WAC), direct price (DP), suggested retail price (SRP), and federal upper limit (FUL)?????
Pharmacy Red book
What are secondary resources?
refers to literature that indexes the primary (and some tertiary) found in journals
Secondary resources help the used find relevant literature through indexing and/or abstracting. What do indexing and abstracting provide?
Indexing provides the bibliographic citation info
abstracting provides a brief description
What are the advantages of secondary databases?
enables you to retrieve compreshensive published literature specific to a topic
many different sources available
continually updated
easy to use
What are the disadvantages of secondary databases?
can be costly for subscriptions
may have to use multiple databases
If you use info found in a secondary resource… do you cite the secondary source?
FYI
no!
cite the info from where the secondary source found it
Describe primary literature:
ORIGINAL research
FOUNDATION on which all over literature sources are built
published or unpublished
using primary literature is the final step in the literature search
Unpublished or _________ literature is primary literature that contains drug info that has not been published in medical journals or resources. It also is generally not peer-reviewed.
Grey
The Journal Impact Factor or JIF is based on…
based on how often the articles are cited by other publications over a 2 year period
What are the components to journal quality?
author guidelines
very detailed instructions for authors to follow
peer review
ppl w/ relevent expertise review the article
authors must respond
conflict of interest
any financial interest must be disclosed
open access
journals are available to public at free/low cost
What are some examples of grey literature?
FDA review information that is located on the website, but hard to find or info that is not on the website bu available by a Freedom of Information Act request
internal data kept private by manufacturers
results of studies that authors didn’t publish
blogs, press reports, conferences, etc
When do we use primary literature?
if tertiary literature is conflicting/outdated
a clinical case is abnormal or falls outside normal parameters
development of standardized procedures, protocols, or guidelines
Advantages of primary literature:
ability to obtain complete, detailed, most relevant info regarding the topic in question
information is current
Disadvantages of primary literature:
requires comprehensive searches to find evidence
requires significant time and expertise