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A descriptive record of a single individual based on an unusual observation where there may have been an association between cause and effect
Definition of case reports
Disease identification
ADR (Adverse drug reaction reporting
New treatment report
Educational
Quality assurance
General Types of case reports
Retrospective or prospective
Case reports can be ___ or ____
More common
Reports occurrence observed AFTER Event
Limited by information and outcome measures recorded during actual event
points about retrospective case reports
Preplanning the proposed treatment approach
Measurement of impact of the proposed treatment on patient outcomes
points about prospective case reports
Makes unique/novel or NEW point (adds to literature)
provides sufficient background
Clearly states timeframe
Describes key patient characteristics
Details full clinical course
Lists all medications
Characteristics of a good case report part 1
Reports effects of dechallenge and rechallenge
Includes patient outcomes, diagnostic workup, and lab results
Provides convincing evidence within report itself
Uses scientific evidence
Applies accepted evaluation tools to strengthen causality assessment
Ensures objectivity
Characteristics of a good case report part 2
A descriptive record of multiple individuals based on observations where there may have been an association between cause and effect in multiple patients
Case series definition
Research question
Study population
Interventions
Outcome measures
Statistical analyses
Discussion/conclusion
Features of a case series report (in order)
Describes new diseases/effects
MAY identify rare disease/presentation
MAY identify novel/new or rare side effect
MAY identify new potential use or benefit of a drug(s)
May generate hypithesis
Educational
Easy and cheap to do
Case reports/Series Advantages
Limited generalizability
Unable to establish causality
No comparator group
N = 1 or small sample size
Limitations of documentation (usually retrieved post-hoc)
Potential for recall bias/interviewer bias
Data collection may be incomplete
Case reports/Series diadvantages