Transcript Shannon Potter, MLIS, CIM and Jan Zolkower, MSHL, CIP, CCRP

Writing an IRB
Protocol
Presented by:
Shannon Potter, MLIS, CIM and
Jan Zolkower, MSHL, CIP, CCRP
April 10, 2009
Financial Disclosure
Neither speaker has a financial interest
or relationship.
Agenda
Part I: Literature Search
 Literature Searches: the when, why and how of it
 Why is it important to conduct a literature search for a study protocol
 How to construct an effect literature search
 Consulting resources: Databases and Information Sources
 How to access them and use them effectively
Part II: Writing the Protocol
 Why is a protocol necessary
 What components need to be included in the protocol
 Examples of protocol sections
When is a literature search
useful?
 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
 Provide 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
Why do a literature search?
(i.e. why not just grab the papers lying around or do a
search?)
 Avoid missing important information
 Evidence-based medicine implies the need to base clinical decisions
on the results of prior scientific study
 Find out that work you are planning has already been done
 Stay abreast of new research and stimulate the discovery of novel
investigations
 Google: The secrets of a former librarian revealed
Sources of Information
 Digital Library vs. databases


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


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.
Effectively search the literature
 Abundance of information can make it difficult to find
useful information
 Searching can be time consuming and frustrating
 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
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 Primary
Data
 PubMed (Medline)


Key resource for biomedical literature
Multiple searching functions
 Search using subject headings (MeSH)
 Combine searches & use keyword searching

(vitamin C OR vitamin e) AND myocardial infarction
 Print articles

Check abstract link and Digital Library
Literature Search: Tracking
Investigators
 Web of Science

Searching of the references cited in paper

Search for citations to key papers to locate
similar research
PubMed
Strengths





Provides access to the biomedical journal literature, including over 18 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


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
Full Text Access via PubMed
Accessing Full Text Articles

What is the difference between PubMed and PubMed Central
(PMC)?
PubMed is a database that contains over 18 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 1 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.
Drug Information Portal
http://druginfo.nlm.nih.gov
Vanderbilt University PubMed
Policy Certification
The NIH Public Access Policy, effective April 7, 2008, mandates that peer
reviewed journal articles arising in whole or part from NIH funded research be
deposited within 12 months of publication in the freely accessible PubMed
Central (PMC) repository.
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

For additional assistance, contact the EBL’s Information Research
Advisory Group (IRAG) at [email protected]
Why is this
important
information?
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
QUESTIONS?
 Contact information for future questions:
[email protected]
(615) 322-2919
[email protected]
(615) 343-8395
THANK YOU!!