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Locating Observational
Studies and Trials
Lynn Kysh, MLIS
kysh@usc.edu
Information Services Librarian
Norris Medical Library
Evidence Pyramid – Publication Types
Evidence-Based
Guidelines

Systematic
Review & Metaanalysis

Higher Quality of Information

Fewer Articles

Randomized Controlled
Trials

Cohort Studies
Case Control Studies

Lower Quality of Information

More Articles
Case Series, Case Reports
Agenda
1. Define and locate:
a.
b.
c.
d.

Case reports & case series
Case control studies
Cohort studies
Randomized controlled trials

2. Build PubMed search skills
3. Introduce ClinicalTrials.gov
Allie Brosh - Hyperbole and a Half
http://hyperboleandahalf.blogspot.com/
ALL STUDIES

Descriptive

Case Report

Case Series

Analytic

Qualitative
Studies

Adapted from Derrick Bennett and John Emberson
Centre for Evidence Based Medicine
www.cebm.net
Case Report

Case Series

A report on an individual
patient with an outcome of
interest

A report on a series of
patients with an outcome of
interest.

• Helpful for rare or new diseases/disorders
• No control group
• Little statistical validity
• U.S. National Library of Medicine & National Institutes
of Health
• MEDLINE, life science journals, online books
• Over 23 million citations
• USC will connect you to full text options
Finding case reports and case series:
Use “Article Type” filter
ALL STUDIES

Descriptive

Case Report

Case Series

Analytic

Qualitative
Studies

Observational

Case-Control
Study

Adapted from Derrick Bennett and John Emberson
Centre for Evidence Based Medicine
www.cebm.net

Cohort Study
Case Control
Study

Compare patients with a
specific condition to
people without the
condition

Cohort Study
Identify a group of patients under
treatment or an exposure, follow
them forward over time, and then
compare their outcomes with a
similar unaffected (control) group

• Ethically safer, easier and cheaper than RCTs
• No blinding or randomization
• Hidden confounders
Finding case control studies and cohort
studies:
Use MeSH Terms
ALL STUDIES

Descriptive

Case Report

Case Series

Analytic

Qualitative
Studies

Experimental

Trials

Adapted from Derrick Bennett and John Emberson
Centre for Evidence Based Medicine
www.cebm.net

Randomized
Control Trial

Observational

Case-Control
Study

Cohort Study
Randomized
Control Trials
Participants are randomly allocated into an
experimental or control group and followed over
time for the variables/outcomes of interest

• Randomization
• Blinding
• Processes counteract bias
• Statistical analysis possible
Finding randomized control trials:
Use “Article Type” filter
Are all trials published?

NO.
•2007 FDA Amendment Act
• Drug and Device trials MUST post to
clinicaltrials.gov
• Abbreviated summary tables
• Within 1 year of completion
•It is not perfect...
• Only starts with trials in 2008
• Label use only
• Study from 2012 shows only 1 in 5 trials are
compliant
Prayle, A P 01/03/2012). "Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov:
cross sectional study". BMJ. British medical journal (Clinical research ed.) (0959-8138), 344, p. d7373.
Cannot rely on information being accurate
solely because it was published in a peer
reviewed journal
vs.
EBM
1. Ask
2. Acquire
3. Appraise
4. Apply
5. Assess
+ Advocate

Publication Bias
• Unreported
results
• Incomplete data
• Poorly designed
trials
• Ghost writing
Agenda
1. Define and locate:
a.
b.
c.
d.

Case reports & case series
Case control studies
Cohort studies
Randomized controlled trials

2. Build PubMed search skills
3. Introduce ClinicalTrials.gov
Allie Brosh - Hyperbole and a Half
http://hyperboleandahalf.blogspot.com/
Thanks!
Lynn Kysh, MLIS
Information Services Librarian
kysh@usc.edu
(323) 442-1124

Laney Griner
http://www.flickr.com/photos/sammyjammy/

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Keck Year 2 Evidence Based Medicine - Observational Studies and Trials

  • 1. Locating Observational Studies and Trials Lynn Kysh, MLIS kysh@usc.edu Information Services Librarian Norris Medical Library
  • 2. Evidence Pyramid – Publication Types Evidence-Based Guidelines Systematic Review & Metaanalysis Higher Quality of Information Fewer Articles Randomized Controlled Trials Cohort Studies Case Control Studies Lower Quality of Information More Articles Case Series, Case Reports
  • 3. Agenda 1. Define and locate: a. b. c. d. Case reports & case series Case control studies Cohort studies Randomized controlled trials 2. Build PubMed search skills 3. Introduce ClinicalTrials.gov Allie Brosh - Hyperbole and a Half http://hyperboleandahalf.blogspot.com/
  • 4. ALL STUDIES Descriptive Case Report Case Series Analytic Qualitative Studies Adapted from Derrick Bennett and John Emberson Centre for Evidence Based Medicine www.cebm.net
  • 5. Case Report Case Series A report on an individual patient with an outcome of interest A report on a series of patients with an outcome of interest. • Helpful for rare or new diseases/disorders • No control group • Little statistical validity
  • 6. • U.S. National Library of Medicine & National Institutes of Health • MEDLINE, life science journals, online books • Over 23 million citations • USC will connect you to full text options
  • 7. Finding case reports and case series: Use “Article Type” filter
  • 8. ALL STUDIES Descriptive Case Report Case Series Analytic Qualitative Studies Observational Case-Control Study Adapted from Derrick Bennett and John Emberson Centre for Evidence Based Medicine www.cebm.net Cohort Study
  • 9. Case Control Study Compare patients with a specific condition to people without the condition Cohort Study Identify a group of patients under treatment or an exposure, follow them forward over time, and then compare their outcomes with a similar unaffected (control) group • Ethically safer, easier and cheaper than RCTs • No blinding or randomization • Hidden confounders
  • 10. Finding case control studies and cohort studies: Use MeSH Terms
  • 11. ALL STUDIES Descriptive Case Report Case Series Analytic Qualitative Studies Experimental Trials Adapted from Derrick Bennett and John Emberson Centre for Evidence Based Medicine www.cebm.net Randomized Control Trial Observational Case-Control Study Cohort Study
  • 12. Randomized Control Trials Participants are randomly allocated into an experimental or control group and followed over time for the variables/outcomes of interest • Randomization • Blinding • Processes counteract bias • Statistical analysis possible
  • 13. Finding randomized control trials: Use “Article Type” filter
  • 14. Are all trials published? NO.
  • 15. •2007 FDA Amendment Act • Drug and Device trials MUST post to clinicaltrials.gov • Abbreviated summary tables • Within 1 year of completion
  • 16. •It is not perfect... • Only starts with trials in 2008 • Label use only • Study from 2012 shows only 1 in 5 trials are compliant Prayle, A P 01/03/2012). "Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study". BMJ. British medical journal (Clinical research ed.) (0959-8138), 344, p. d7373.
  • 17. Cannot rely on information being accurate solely because it was published in a peer reviewed journal
  • 18. vs. EBM 1. Ask 2. Acquire 3. Appraise 4. Apply 5. Assess + Advocate Publication Bias • Unreported results • Incomplete data • Poorly designed trials • Ghost writing
  • 19. Agenda 1. Define and locate: a. b. c. d. Case reports & case series Case control studies Cohort studies Randomized controlled trials 2. Build PubMed search skills 3. Introduce ClinicalTrials.gov Allie Brosh - Hyperbole and a Half http://hyperboleandahalf.blogspot.com/
  • 20. Thanks! Lynn Kysh, MLIS Information Services Librarian kysh@usc.edu (323) 442-1124 Laney Griner http://www.flickr.com/photos/sammyjammy/