Current Issues in Biomedical Informatics

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MBL / NLM Biomedical Informatics Course

• Current Issues in Bio-medical
  Informatics
• September 24, 2009 Donald A. B. Lindberg, MD

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Current Issues

• Electronic health records
• Prospective population studies
• Truth and transparency in clinical trials
• Interactive publications
• NLMs International activities
• Disaster management information

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Electronic Health Records
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Proposed Solution

• Electronic health records for all, and a full
  copy for the patient

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Reasons to Register Clinical Trials and Report
Results

• Ethical Considerations
• Provide information to potential participants
• Assists ethical review boards and others to
  assess risks and benefits of studies being
  reviewed
• Promote fulfillment of ethical responsibility to
  human volunteers research contributes to
  medical knowledge
• Scientific Considerations
• Mitigates publication and outcome reporting
  biases
• Search engine enables users to conduct a fielded
  search to identify relevant studies, whether or
  not results have been published in a journal
• Improves transparency in the design, conduct and
  analysis of clinical trials
• Promotes more efficient allocation of research
  resources

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New Registrations Continue to Increase
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ClinicalTrials.gov Statistics (as of 08/10/09)

• Number Percent
• Total 77,096 100
• Type of Trial
• Observational 12,634
  16
• Interventional 64,240
  83
• Drug Biologic 47,156
• Surgical Procedure 8,250
  
• Behavioral, Gene
• Transfer, Other
  12,446
• Device 4,520
• International Sites (169 countries)
• US only 36,349 47
• Non-US only 27,073 35
• US Non-US 5,513 7
• Missing 8,161 11

222 records missing Study Type information 222
device trials delayed posting
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ClinicalTrials.gov Statistics (cont.)(as of
08/10/09)
Trials by Data Provider
Number Percent US Federal (including NIH)
19,006 25 Industry
24,127 31 University, Other
33,963 44 Total
77,096
User Statistics Page Views per month
40 Million Unique visitors per month
500,000
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ClinicalTrials.gov Visitors by Role(N13,097)
Source American Customer Satisfaction Index
(ASCI) Online Consumer Survey Six-Month Period
in 2007
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Why the legislation?
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Trans-Australia Journal of Orthopedics
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Info Required to be Provided for NLM Records re
Clinical Trials

• Registration of existence and design of trial
• Results of trial within one year
• No individual patient data
• No recommendations

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Demographic Baseline

• A table of the demographic and baseline data
  collected overall and for each arm of the
  clinical trial
• Sec. 282(j)(3)(C)(i)

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Default Required Measures
User-Specified Measure
Categories
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Participant Flow

• A table ..., including the number of patients
  who dropped out of the clinical trial and the
  number of patients excluded from the analysis, if
  any.
• Sec. 282(j)(3)(C)(i)

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Arms
Milestone
Reasons Not Completed
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Outcome Measures

• a table of values for each of the primary and
  secondary outcome measures for each arm of the
  clinical trial
• Sec. 282(j)(3)(C)(ii)

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Categories
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Statistical Analysis

• a table of values for each of the primary and
  secondary outcome measures, including the
  results of scientifically appropriate tests of
  the statistical significance of such outcome
  measures.
• Sec. 282(j)(3)(C)(ii)

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Statistical Analysis
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Certain Agreements

• Whether there exists an agreement (other than an
  agreement solely to comply with applicable
  provisions of law protecting the privacy of
  participants) between the sponsor or its agent
  and the principal investigator (unless the
  sponsor is an employer of the principal
  investigator) that restricts in any manner the
  ability of the principal investigator, after the
  completion date of the trial, to discuss the
  results of the trial at a scientific meeting or
  any other public or private forum, or to publish
  in a scientific or academic journal information
  concerning the results of the trial.

Sec. 282(j)(3)(C)(iv)
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Serious Adverse Events

• A table of anticipated and unanticipated serious
  adverse events grouped by organ system, with
  number and frequency of such event in each arm of
  the clinical trial.
• Sec. 282(j)(3)(I)(iii)(I)

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Quality Assurance Challenges

• Data tables will be the public representation of
  the studymust be clear and informative
• NLM QA Focuses on
• Apparent Validity (when possible)
• Meaningful Entries
• Internal consistency/logic
• Format
• Detailed Review of Results Submissionhttp//prsin
  fo.clinicaltrials.gov/DetailedReview.pdf

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http//prsinfo.clinicaltrials.gov/fdaaa.html
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ClinicalTrials.gov Results Database

• Required by US law (FDAAA)
• Summary results must be posted for certain
  clinical trials of drugs or devices
• New frontier in disseminating results of clinical
  trials
• No editorial/selection process
• Tabular format requires that data speak for
  themselves
• Structured database will permit very specific
  searches

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Current Status Basic Results(as of 08/10/09)

• Functional Web-based Data Entry System
• Launched in September 2008
• 1,310 Results records submitted
• Industry 957 records from 150 data providers
• Other 353 records from 225 data providers
• Rate of submission continues to increase
• 40 records per week now
• Anticipate about 150 per week

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Quality Assurance Challenges

• Data tables will be the public representation of
  the studymust be clear and informative
• Data must be entered by somebody familiar with
  the study design and data analysis
• QA process designed to ensure that data could
  make sense to somebody not already familiar with
  the study

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Quality Assurance Challenges

• Data tables will be the public representation of
  the studymust be clear and informative
• Data must be entered by somebody familiar with
  the study design and data analysis
• QA process designed to ensure that data could
  make sense to somebody not already familiar with
  the study

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Informative Entry
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Problematic Entry
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http//prsinfo.clinicaltrials.gov/fdaaa.html
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Next Challenge Adverse Events
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Then Another Even Bigger Challenge

• Narrative summary of results
• Understandable by scientists and the public

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Narrative Summaries Concerns

• Information about a single clinical trial is
  generally not relevant for the lay public (i.e.,
  should not influence clinical decision making)
• Summary of an individual trial would include data
  without critical appraisal of methods, which
  violates basic principles of EBM, and could be
  misleading
• Preferred approaches include links to systematic
  reviews and other authoritative assessments, as
  well as links to published articles

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Interactive Publications
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Interactive publications

• Current publications with simulated interaction

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elation of Intimal Hyperplasia Thickness to Stent
Size in Paclitaxel-Coated Stents
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Influence of Coronary Artery Bypass Grafting on
Heart Rate Turbulence Parameters
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After - Prevalence of Drug-Induced
Electrocardiographic Pattern of the Brugada
Syndrome in a Healthy Population
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True Interactive publications
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Laparoscopic Infracolic Necrosectomy Slide 1 PMID
14973724
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Laproscopic Infracolic Necrosectomy Slide 2
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Laparoscopic Ladds slide 2
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NLM Study of Interactive Publications

• 368 journal issues with 15,003 MEDLINE citations
• 258 articles (2) included interactive content
  video, audio, animation, or table-building
• PubMed Central already has 13,374 articles with
  supplementary data
• No standardization of metadata yet

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GOALS

• To develop an interactive software and curated
  database infrastructure Interactive Science
  Publishing
• To give authors the ability to submit their own
  databases and ISP-enabled figures in actual
  peer-reviewed journal articles
• To give readers and editors the ability to view,
  analyze, and interact with source data published
  in conjunction with an article
• To evaluate the educational value of ISP used
  within actual scholarly journal articles
• To explore the problems of archiving this medium

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Project Description

• Publish special journal issues on biomedical
  research topics in OSA journals, especially
  Optics Express
• PDF articles incorporate source data, videos, and
  other media objects which can be
• Visualized using ISP interactive viewing software
• Downloaded quickly and conveniently
• Authors, reviewers and readers asked for feedback
  at every stage
• Project includes a formal usability analysis and
  a user evaluation survey
• Articles and datasets are open access and are
  fully citable and archived in OSAs InfoBase
  database
• Databases including source data and metadata are
  searchable and accessible through a variety of
  search engines, not just OSAs
• Reader software is free

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Early Results

• Software version 2.2 deployed
• First issue, October 2008, 7 papers, 45
  datasets, Virtual Focus
• Second issue, March 2009, 17 papers, 242
  datasets, Optical Coherence Tomography in
  Ophthalmology
• Preliminary feedback from authors, editors and
  usability experts is positive

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Next Steps

• Issues 3 and 4 in process
• Digital Holography, October 2009
• Lung Cancer Imaging, January 2010
• One year assessment now in progress
• Monthly reports are generated through end of
  assessment period
• Preliminary results are very encouraging

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NLM Info for the Public Interactive Too
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NLMs International Activities
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Who uses NLM on-line services?
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2008 NLM Worldwide Page Views56.4 Million Page
Views Total
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2008 MedlinePlus Worldwide Page Views754 Million
Page Views Total
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MEDLINE Journals
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Top 10 Countries with Titles in MEDLINE

• 2009 2006
• 1. United States 2177 2050
• 2. England 1111 737
• 3. Netherlands 287 229
• 4. Germany 279 204
• 5. Japan 161 141
• 6. Switzerland 143 138
• 7. France 105 96
• 8. Italy 100 87
• 9. China 91 60
• 10. Canada 84 78

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Countries with Journals in 2009 but None in 2002

• Georgia
• Indonesia
• Iran
• Lithuania
• Macedonia
• Malawi
• Mali
• Nepal
• Philippines
• Slovenia
• Tanzania
• Uganda
• United Arab Emirates

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MEDLINE Journal Titles By Continent
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Electronic Full Text Access (8/14/2009)
About 80,000 NIH-funded articles are published
annually, 12 of articles indexed by NLM
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MedlinePlus in Multiple Languages

• Consumer health information
• in over 40 languages
• covers over 250 diseases, conditions, and
  procedures
• Popular topics
• Diabetes
• High blood pressure
• Tuberculosis
• Breastfeeding
• Pregnancy

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MedlinePlus Multiple Languages Collection

• Amharic (amarunya)
• Arabic (??????? )
• Armenian (???????)
• ASL (American Sign Language)
• Bengali (Bangla)
• Bosnian (Bosanski)
• Burmese (myanmasa)
• Chamorro (chamoru)
• Chinese - Simplified (????)
• Chinese - Traditional (????)
• Chuukese (Trukese)
• Croatian (Hrvatski)
• Farsi ( ????? )
• French (français)
• German (Deutsch)
• Gujarathi (???????)
• Haitian Creole (Kreyol)
• Hindi (??????)
• Hmong (Hmoob)

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MedlinePlus Content
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MedlinePlus Content
799 English 751 Spanish
1,000 monographs
173 tutorials
1,035 links
3500 articles gt2,000 images
42 topics
224 English 9 Spanish
15-20 stories added daily
Over 100 directories of doctors, hospitals,
clinics libraries
Weekly podcast
gt40 languages gt250 topics gt3,000 links
32 sites 44 of U.S. population
2 RSS feeds 13 daily weekly listservs
11 English issues 1 bilingual issue
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NLM Outreach in Africa
African Malaria Researchers (Multilateral
Initiative on Malaria Communications Network)
NLM Medical Info
African Medical Journals (African Medical Journal
Partnership Project)
African Medical Students (Medline Plus Tutorial
on Malaria)
African Medical Librarians (NLM Associates
Program Network of African Medical Librarians
Deans)
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Internet Access

• 19 sites in 12 countries

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First research network of its kind in Africa
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Gabon
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African Medical Journal Editors Partnership
Project
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African Medical Journal Editors Partnership
Project

• 6 African journals
• 6 journals from US and UK
• Objective
• African journals get into Medline
• Research carried out here available to
  international audience

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Information Retrieval in Action in the Village
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Malaria Tutorial
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Tutorial History

• Image creation by local artists in Uganda
• Cultural considerations

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Tutorial History
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Tutorial Field Testing

• As part of their curriculum, medical students
  take tutorials to the field for comments.

Medical student Ronnie Kiweewa
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Disaster Management Information Research

• Trans-NLM Project
• Bethesda Group
• Connections to National Efforts
• Director, Dr Steve Phillips

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pic of Steve Phillip
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National Library of MedicineDisaster Information
Management Research Center
U.S. Government Portal to provide tools,
literature, research methods to assist with
disaster preparedness, response, and recovery

• Steven J. Phillips, MD, Associate Director
• Specialized Information Services, NLM
• sphillip_at_mail.nih.gov

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NLM Long History
KATRINA
1998
CYBER TERRORISM
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NLM-supported Research Programs
automated bio-surveillance self-healing
wireless networks smart tags to track patients
during emergencies built the Influenza Virus
Resource with the NIAID OSIRIS a software
package to assist in identifying 9/11 victims
remains via DNA worked via NN/LM to
re-establish and maintain access to health
information in the Katrina-affected region
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CENTER OBJECTIVES

• Organize the disaster literature
• Maintain library operations
• Information tools
• Scalable reproducible models
• R D

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Sources Users of Disaster Literature
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• Who will identify, organize, distribute this
• varied, diverse, non-commercial literature?

• Government reports
• Homeland Security Presidential Directives
• National Incidence Management Systems
• National Response Plan Framework
• Conference Proceedings
• State publications
• Red Cross
• Commentaries
• NGO publications
• Official Reports
• Non peer reviewed publications
• Community resources
• Training design technologies
• Preparedness options
• Response plans for different events
• Sister Agency Publications
• Catalogues

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ANSWER THE DISASTER INFORMATION SPECALIST
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Disaster Information Specialist

• ASPR
• NYU
• USUHS
• SMH

• 160 on Listserv growing daily

Research ways to understand the settings
situations in users work, acquire, use
information
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• NLM Develops innovative products and services to
• support emergency preparedness and response
  activities

TOXMAP
NLMREMM ASPR NCI CDC
PTSD/TBI screener
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2004 Congressional Earmark
R D
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.

• Network back-up -laser and dark fiber
• Army MARS radio communications back-up
• Rx Hub/prescription access in disaster
• RFID patient tracking
• Digital triage forms data capture technologies
• Virtual world disaster training
• Lost person finder
• Disaster Information Specialist

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Virtual Environments for Training
Modeling and Simulation

• Used in NLMs TOXTOWN
• Virtual platform for drills and simulations
• 3-D mapping of Bethesda area

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Disaster Literature
Indexed for Pubmed
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What is Go Local? What is the Difference with
MedlinePlus?
Example Breast Cancer

• Health info MedlinePlus
• Symptoms, treatment, coping
• News
• Tutorials
• PubMed
• ClinicalTrials.gov
• Genetics Home Reference

• Services Go Local
• Health screening
• Cancer care facilities
• Support groups
• Exercise, yoga classes
• Providers of wigs and prostheses
• Oncologists

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Finding Go Local
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Go Local In the Beginning

• NC Health Info
• 2000/01 feasibility study
• 2002 system development and outreach
• 2003 site released
• 2004
• NLM begins to develop a centralized system with
  controlled vocabulary
• Request for proposals, 11 received and accepted
• 2005
• Beginning of more Go Local sites

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MedlinePlus Go Local May 2005
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Go Local Today
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Go Local Tomorrow
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Go Local Emergency Feature
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