8 / 86
This 2016 Home Study Course Section includes discussion of the following drugs and devices that have not
been approved by the United States Food and Drug Administration:
Name of drug or device
Nature of off-label Discussion
Neuromodulators
Reconstitution and storage
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.
June 10, 2016:
Section 4 suggested exam deadline to be received.
August 5, 2016,
midnight EST: deadline for
all exams
to be submitted.
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 at
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
7KLV GHVLJQ IROORZV D JURXS RI SDWLHQWV FDOOHG D ³FRKRUW´ RYHU WLPH WR GHWHUPLQH JHQHUDO RXWFRPHV DV ZHOO DV
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
RXWFRPH DUH LGHQWLILHG DQG ³PDWFKHG´ ZLWK SHRSOH ZKR GLG EHWWHU 7KHQ WKH HIIHFWV RI WKH WKHUDS\ RU KDUPIXO
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.