Week 9 (lecture 7) Flashcards
(23 cards)
Define EBM
Integration of best research evidence with clinical expertise and patient values
Differentiate internal and external validity
Internal validity
Factors that decrease internal validity
Variation from protocol (post hoc)
External validity
Factors that decrease external validity
Inclusion and exclusion criteria
Differentiate Clinical significance vs. statistical significance
Trials may be statistically significant but not have any clinical significance
Trials that are not statistically significant should not purport clinical significance due to random chance effecting outcomes
Give 2 examples of tertiary literature
1) Clinical practice guidelines
2) Review articles
Describe clinical practice guidelines
IDSA, AHA/ACC, CDC, ADA, AACE
Grading of Recommendation, Assessment, Development and Evaluation (GRADE)
Describe review articles
Assembly of already established knowledge qualifies it as a tertiary resource
Cochrane Collaboration is an international network of qualified experts that prepare evidence-based Cochrane reviews, searchable within the Cochrane Database of Systematic Reviews, which is part of the Cochrane Library of resources
Cochrane reviews are considered to be very reputable sources due to strict guidelines for ensuring only the highest quality of evidence
Give more examples of tertiary literature
1) Compendia: UptoDate, Epocrates, Micromedex, 5MinuteConsult
2) Textbooks
3) Package inserts
Secondary literature: Describe Indexing/abstracting services
PubMed
MEDLINE
Google Scholar
Other indexing services exist but are not available via South College Library
Secondary lit: Search strategies and keyword
Search strategies
Controlled vocabularies
Medical Subject Headings (MeSH)
Preferred
Keyword
Looks for selected word within abstract or title
Secondary lit: Describe Boolean operators and truncation
1) Boolean operators
AND / OR / NOT
2) Truncation
“Randomiz”
Randomize, randomized, randomization, randomizing
“Pharm”
Pharmacy, pharmaceutics, pharmacology, pharmacoeconomic
Secondary lit:
1) Describe wild cards
2) Describe specific terms
1) Wildcards
Help deal with variations in spelling
“randomi?ation” for both Z and S
2) Specific terms
Quotation marks restrict searches to exact phrasing and spelling
“Smoker’s cough”
Primary literature: List 4 different types
Clinical studies
Economic studies
Epidemiologic studies
Theses
Primary lit: Describe economic studies
Cost-effective analysis
Measures cost per unit health outcome in natural units (e.g., years of life saved, symptom-free days, etc.)
Cost-minimization analysis
Differences in costs among comparables
Cost-utility analysis
Attempt to assign “utility” weights to quality outcomes so that the impact can be measured in relation to cost (e.g., quality-adjusted life years)
Cost-benefit analysis
Monetary value is placed on both the costs of therapy and the beneficial health outcomes
What is the general article format?
Abstract – summary; determines if you should read the article
Introduction – what’s currently known; rationale of study; objective
Methods – inclusion / exclusion criteria; statistical methods; design
Results - primary analyses; secondary or sub-group analyses
Discussion – interpretation of results
References – AMA format
Describe AMA format
Author(s). Article title. Abbreviated Journal Name. Year;vol(issue No.):inclusive pages. DOI
List DOI if available and provided by the author
Use “et al” and the first three authors if you have more than six authors
What are some general considerations for appraising evidence?
(FYI information)
1) Peer-review?
2) Who funded the research?
Study: 370 randomized drug trials; concluded that trials funded by for-profit organizations had a more than five-fold increased odds of recommending the experimental drug as the drug of choice compared with trials funded by nonprofit organizations
Als-Nielsen B, Chen W, Gluud C, et al. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003;290:921–928.
3) ClinicalTrials.gov
Many major medical journals will not publish unless the trial is registered with ClinicalTrials.gov before the entry of the first study subject. The public is able to see the progress of such trials and expect results to be published regardless of the direction of the findings.
General considerations: Describe conflicts of interest
Sponsor inducements to the investigators
Immediate family have a relationship with the sponsor or potentially stand to gain from the results of the trial
Supervisor has an ulterior motive, financial or otherwise, for the employee’s research to produce biased results
Describe RCTS Consort and quality assessment
Consolidated Standards of Reporting Trials (CONSORT)
Minimum set of standards that are evidence-based for preparing reports of RCTs
Quality assessment
NHLBI
Jadad scale
Chalmers scale
Cochrane Risk of Bias tool
RCTS
Study sample
Recruitment
Inclusion / exclusion criteria
Baseline characteristics
Randomization / blinding
Allocation and stratification
Protocols for blinding
RCTS
Study sample
Recruitment
Inclusion / exclusion criteria
Baseline characteristics
Randomization / blinding
Allocation and stratification
Protocols for blinding
RCTS
Intervention and control groups
Adherence
Attrition
Clinical endpoints / Outcomes
Intention-to-treat analysis is the only method of evaluating data that preserves randomization
