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This 2016 Section 5 Home Study Course includes discussion of off-label uses of the following drugs and
devices which has not been approved by the United States Food and Drug Administration:
Name of Drug(s) or Device(s)
Nature of Off-label Discussion
Theophylline methylpropyl paraben
Used to try to improve taste and smell
Oral corticosteroids
Use in chronic rhinosinusitis
Macrolide antibiotics
Use in chronic rhinosinusitis
Topical antibiotic washes
Use in acute bacterial rhinosinusitis
Topical budesonide washes
Use in chronic rhinosinusitis
Oral antibiotics
Use in acute bacterial rhinosinusitis
Disclaimer
The information contained in this activity represents the views of those who created it and does not
necessarily represent the official view or recommendations of the American Academy of Otolaryngology –
Head and Neck Surgery Foundation.
October 10, 2016:
Suggested
Section 5 Exam submission deadline; course closed
August 4, 2017.
EVIDENCE BASED MEDICINE
The AAO-HNSF Education Advisory Committee approved the assignment of the appropriate level of
evidence to support each clinical and/or scientific journal reference used to authenticate a continuing
medical education activity. Noted at the end of each reference, the level of evidence is displayed in this
format:
[EBM Level 3]
.
Oxford Centre for Evidence-based Medicine Levels of Evidence (May 2001)
Level 1
Randomized
1
controlled trials
2
or a systematic review
3
(meta-analysis
4
) of randomized
controlled trials
5
.
Level 2
Prospective (cohort
6
or outcomes) study
7
with an internal control group or a systematic
review of prospective, controlled trials.
Level 3
Retrospective (case-control
8
) study
9
with an internal control group or a systematic review of
retrospective, controlled trials.
Level 4
Case series
10
without an internal control group (retrospective reviews; uncontrolled cohort or
outcome studies).
Level 5
Expert opinion without explicit critical appraisal, or recommendation based on
physiology/bench research.
Two
additional ratings
to be used for articles that do not fall into the above scale. Articles that are informational only
can be rated N/A , and articles that are a review of an article can be rated as Review. All definitions adapted from
Glossary of Terms, Evidence Based Emergency Medicine at New York Academy of Medicine a
t www.ebem.org .1
A technique which gives every patient an equal chance of being assigned to any particular arm of a controlled clinical trial.
2
Any study which compares two groups by virtue of different therapies or exposures fulfills this definition.
3
A formal review of a focused clinical question based on a comprehensive search strategy and structure critical appraisal.
4
A review of a focused clinical question following rigorous methodological criteria and employing statistical techniques to
combine data from independently performed studies on that question.
5
A controlled clinical trial in which the study groups are created through randomizations.
6
This design follows a group of patients, called a “cohort”, over time to determine general outcomes as well as outcomes of
different subgroups.
7
Any study done forward in time. This is particularly important in studies on therapy, prognosis or harm, where retrospective
studies make hidden biases very likely.
8
This might be considered a randomized controlled trial played backwards. People who get sick or have a bad outcome are
identified and “matched” with people who did better. Then, the effects of the therapy or harmful exposure which might have
been administered at the start of the trial are evaluated.
9
Any study in which the outcomes have already occurred before the study has begun.
10
This includes single case reports and published case series.