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WorksheetsCase Reports and Case Series Part 1
Total questions: 42
Worksheet time: 25mins
Describe or summarize information about the disease, events, or characteristics of study subjects without making any causal inferences
Descriptive studies
Observational Studies
While commonly viewed as less reliable information as far as providing evidence to establish causality, these studies help to identify problems or benefits that warrant a closer look
Descriptive studies
Observational Studies
Incorporate 5 critical elements pertaining to a new disease or occurrence
Descriptive studies
Observational studies
Demographics
who
what
why
when
where
Case definition of the disease-Inclusion/exclusion
who
what
why
when
where
Possible causal mechanism, requires more advanced analysis
who
what
why
when
where
Time frame- is this prospective or retrospective?
who
what
why
when
where
Place of occurrence
who
what
why
when
where
Which of the following are true about observational studies?
observe relationships between variables in a natural setting
occur in subjects that are not randomized
can be descriptive or analytics in purpose
can describe a phenomenon or to provide a causal interpretation of it
can only be descriptive
Which of the following is the sixth question?
who
where
so what
what
Case reports and case studies are basic descriptive studies but still contribute to our scientific understanding and improving public health
true
false
Most basic form of human evidence
case report
case series
Which of the following are true about case report?
1-2 cases
greater than 2 cases
brief report without comparison
provides an evaluation of the findings but not intended to answer a hypothesis
may progress to case series
Case series include everything from case report except
greater than 2 cases
group of patients with similar diagnosis followed over time
1-2 cases
Previously unknown or variant of known condition (reader must avoid generalizations)
disease identification
adverse drug reaction (ADR) reporting
new treatment approach
educational
quality assurance
Most common source of info for drug removal
disease identification
adverse drug reaction (ADR) reporting
new treatment approach
educational
quality assurance
Excellent tool for identifying rare/serious ADRs and identifying them in special populations
disease identification
adverse drug reaction (ADR) reporting
new treatment approach
educational
quality assurance
Useful to generate a hypothesis for further testing, may lead to off label usage
disease identification
adverse drug reaction (ADR) reporting
new treatment approach
educational
quality assurance
Present a scenario to help improve practice skills in clinical settings
disease identification
adverse drug reaction (ADR) reporting
new treatment approach
educational
quality assurance
Practice errors, when published, can illustrate flaws in processes
disease identification
adverse drug reaction (ADR) reporting
new treatment approach
educational
quality assurance
Which of the following are examples of Landmark Case Reports/Series
thalidomide-phocomelia
sulfonylureas from sulfa drugs causing hypoglycemia
oral contraceptives causing VTE
AIDS clinical symptoms
discovery of penicillin and insulin
_________ data is limited in duration and may miss delayed adverse effects or rare side effects (1 in 10,000) due to small sample size
pre-marketing
post-marketing
Special populations may not be investigated so ADRs in this group may not be known until _______
pre-marketing
post-marketing
ADRs are submitted through
MedWatch
VAERS
The naranjo scale
drug interaction probability scale
Tools for identifying an ADR from a patient scale
MedWatch
VAERS
The naranjo scale
drug interaction probability scale
Which of the following are true about retrospective study design?
more common
limitations involve the information and outcome measured recorded during the actual event
do we have all the information? is the information correct?
easier write up but more preliminary work
subsequent patient monitoring
Which of the following are true about prospective study design?
more common
pre-planning the proposed treatment approach and what information will be collected/outcome measured
do we have all the information? is the information correct?
easier write up but more preliminary work
subsequent patient monitoring
Which of the following are involved identification and preparation?
recognize unique situation
selection of journal
informed consent
what data will be collected
none of the above
Which of the following are done in order to recognize a unique situation?
literature research
consult colleagues
wikipedia research
consult nobody
What is the correct order for a manuscript structure?
1. Conclusion
2. Description of the patient case
3. Introduction containing background on the main point of the case
4. Abstract
5. Discussion of the case with respect to the available literature
4, 3, 2, 5, 1
1, 2, 3, 4, 5
4, 2, 5, 1, 3
A good case report...
has a clear tittle
emphasizes a relevant point (start with the intriduction)
is objective and complete
has figured and tables that are easy to read and enhance he material without repeating information from the text
does NOT draw conclusions that go beyond reporting what happened-that is, does not suggest a causal relationship
Which of the following contain objective information?
timeframe of condition onset and diagnosis
baseline characteristics
detailed clinical course of events
all medications and time frame
impact of removal and rechallenge
Which of the following evaluated in a case report to see its qualities?
documentation
educational
interpretation
objectivity
uniqueness
What does it mean if a case report has a score of 9-10?
valid and worthwhile contributions
should probably not be published
What does it mean if a case report has a score of 5 or less?
valid and worthwhile contributions
should probably not be published
Which of the following are the strengths of case reports?/
identifies rare occurrences
identifies delayed ADRs
requires minimal resources
generates hypothesis
requires many resources
Which of the following are the limitations of case reports?
cannot establish causal relationship
no statistical analysis
potential for reporting false results
potential reporting/recall bias
establishes causal relationship
How to we identify a journal to publish a case report?
reputation of journal
clear about type of peer review or if peer review has occurred
topics journal covers
target audience
length restriction
There are no comparison groups in case series
true
false
Case series involve a study of multiple similar cases (2-1000s) over a period of time
true
false
The purpose of case series is to evaluate which of the following?
disease course
ADRs
effectiveness of therapies
none of the above
Often, multiple case reports are needed to substantiate an issue and lead to development of a well-designed study as these take more time and resources
true
false
