Transcript Shannon Potter, MLIS May 10, 2013 - Vanderbilt University Medical

Literature Searching
for the IRB Protocol
Shannon Potter, MLIS
May 10, 2013
Financial Disclosure
Neither speaker has a financial interest
or relationship.
Agenda
 Why is it important to conduct a literature search for a study protocol
 How to construct an effective literature search
 Consulting resources: Databases and Information Sources
Protocol Content
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Study Schema
1.0 Background
2.0 Rationale and Specific Aims
3.0 Animal Studies and Previous Human Studies
4.0 Inclusion/Exclusion Criteria
5.0 Enrollment/Randomization
6.0 Study Procedures
7.0 Risks of Investigational Agents/Devices (side effects)
8.0 Reporting of Adverse Events or Unanticipated Problems involving Risk
to Participants or Others
9.0 Study Withdrawal/Discontinuation
10.0 Statistical Considerations
11.0 Privacy/Confidentiality Issues
12.0 Follow-up and Record Retention
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Appendices
OHRP Determination Letter
 Ellen Roche, a healthy volunteer, died as a
result of her participation in a research study at
John Hopkins.
 OHRP noted “the investigators and the IRB
failed to obtain published literature about the
known association between hexamethonium
and lung toxicity.”
OHRP Determination Letter to John Hopkins is located at:
http://www.hhs.gov/ohrp/detrm_letrs/jul01a.pdf
Why do a literature search?
 A comprehensive and systematic literature search is the best
practice to:
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avoid missing important information
demonstrate need for proposed research
ensure that the research question has not already been answered
stay abreast of new research
 With respect to the IRB protocol:
 Missing information can lead to major problems in the approval the
protocol or even compromise the safety of participants
 Poorly constructed protocol lacking the scientific background information
may not yield useful or replicable results
How does the literature search
support the protocol?
 Provide background information on a study protocol
 Cite the incidence or prevalence of a condition or a
disease
 Summarize the information or lack of information to
support the purpose and relevance of the research
question
 Identify existing data to support the number of
participants needed to demonstrate a difference in a
comparative study
 Identify the distribution, frequency and types of possible
adverse events or effects
Effectively searching the
literature
 Challenges include:
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Abundance of information can make it difficult to find the
best, relevant information
Searching can be time consuming and frustrating
 Why not just use
Sources of Information
 Digital Library vs. databases
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Digital Library is a portal to electronic resources (books, journals,
databases)
Databases contain article citations (e.g. PubMed, Web of
Science)
 Getting started: background information
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UpToDate® is a database of synthesized clinical evidence and
practice expertise. Content is based on journal literature to offer
current practice recommendations supported by high-quality
evidence.
MDConsult is a virtual medical library that includes the full-text of
well-known journals and textbooks, clinical guidelines, drug
information, and patient education handouts in English and
Spanish.
Prepare to ask a useful question
and generate an effective query
 Identify the context and key concepts
 Establish limits such as date of
publication or specific journal titles
 Decide whether the search must be
exhaustive or specific
 Select appropriate databases and
resources
 List the all the terms and keywords
Types of Literature
MetaAnalysis
Systematic
Review
Randomized
Controlled Trial
Cohort studies
Case Control studies
Case Series & Case Reports
Animal research & Laboratory studies
Literature Search: Locating Journal
Articles
 PubMed (Medline)
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Key resource for biomedical literature
Multiple searching functions
 Search using subject headings (MeSH)
 Combine searches & use keyword searching
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(vitamin C OR vitamin e) AND myocardial infarction
 Print articles
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Check abstract link and Digital Library
Literature Search: Tracking
Investigators
 Web of Science
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Searching of the references cited in paper
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Search for citations to key papers to locate
similar research
National Center for Biotechnology Information (NCBI)
PubMed
Strengths
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Provides access to the biomedical journal literature, including over 22 million
citations from the mid-1960's to the present
Controlled vocabulary (MeSH) helps to focus your search
Provides links to full-text electronic articles
Updated daily
"Related Articles" feature uses a word-weighted algorithm to link from a particular
citation to additional relevant material
Weaknesses
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Can be time-consuming to search because of its size
Quick searches may omit relevant citations, with the danger that you may miss
important viewpoints in the literature
 Controlled vocabulary terms (MeSH) are updated annually, so may not
accommodate new concepts well
 Includes literature from over 70 countries, but has a North American bias and
may omit relevant European literature
How to Access PubMed
http://www.mc.vanderbilt.edu/diglib/
Full Text Access via PubMed
Accessing Full Text Articles
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What is the difference between PubMed and PubMed Central
(PMC)?
PubMed is a database that contains over 22 million
citations and abstracts of articles from life science,
medicine, veterinary medicine, and biotechnology journals.
It includes some links to full text articles in PubMed Central
and other locations.
PubMed Central (PMC) is the U.S. National Institutes of Health (NIH)
free digital archive of biomedical and life sciences journal literature.
It includes more than 2 million full-text articles archive that are
provided for free to the public. Most articles have a corresponding
citation in PubMed. PMC contains additional material, such as book
reviews, that are considered out of scope for PubMed.
PubMed Features
 My NCBI
save searches, save collections, receives email alerts
 Single Citation Matcher
conveniently find and access an article
 Limits
limit the set of results by language, date or journal subsets
 Extensive help and user documentation
includes tutorials and handouts
Example Search Strategies
 Complications:
("Mesh heading/complications"[MAJR] OR "Mesh heading/adverse
Effects"[MAJR]) OR (“Mesh heading”[MeSH] AND ("Postoperative
Complications"[MeSH] OR "Intraoperative Complications"[MeSH] OR “Treatment
Outcome”[MeSH]))
The subheading adverse effects includes the following subheadings: /toxicity and
poisoning
 Therapy:
(“Mesh term” [MeSH] AND “Therapeutics” [MeSH]) OR (“MeSH
term/therapy”[MeSH])
Consider including additional facets for specifics types of therapy (e.g. drug, diet,
surgery subheadings)
Example Literature Requests
 Relative rate of infection for subcutaneous access ports,
tunneled catheters, Hickman catheters and PICC lines for
long-term venous access
 Pharmacokinetics of intravenous lidocaine in normal and
pregnant subjects
 Databases:
PubMed, MICROMEDEX
Searching for Drug Information
 NLM/NIH Drug Resource
http://druginfo.nlm.nih.gov/
Access drug information from the National Library of Medicine
and other government agencies; search by trade or generic
name. Includes a link to resources for researchers.
 Micromedex
http://www.thomsonhc.com/hcs/librarian
provides searchable databases for drug information—
toxicology, drug interaction, contraindications, clinical effects,
dosing, and other details.
 FDA MedWatch
http://www.fda.gov/medwatch/
provides timely safety information on prescription and OTC medications,
as well as nutritional products and medical devices.
Literature Search: Additional Resources
 Other useful resources
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Pharmacology/drug studies: EMBASE (European literature)
Biosciences-related or animal studies: BIOSIS, Web of
Science
Behavioral/psychology: PsycInfo, Social Sciences Index
Nursing: CINAHL
Authoritative volume on citing print and electronic medical
information: NLM "Citing Medicine" at the NCBI Bookshelf
http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=citmed.TOC&depth=2
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For additional assistance, contact the EBL’s Research Informatics
Consult Service http://www.mc.vanderbilt.edu/km/ebm/rics.html
QUESTIONS