OMT in Management of Recurrent Otitis Media inflammation0

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					                   OMT in Management of Recurrent Otitis Media
                  Suggestions for Completing Form 1a: Chart Review

This form will be the first one you fill out, though you don’t have to turn it in until the
end of the patient’s participation in the study, as it will be updated then if not on an
ongoing basis.

You will note the form has many pages. Don’t be discouraged. We have notation for
every two weeks of life from the time that the first ear infection took place. Most children
will enter into the study less than six months after their first ear infection and will only be
in the study six months, so you won’t necessarily be filling out every page. We have a
place for the date the child was seen, as well as the time from the first ear infection, for
your convenience. If the child was not seen at the office where they are presently
receiving care, for their first ear infection try to get information about those prior visits.
Remember, you must have permission to review any chart. This permission is included
with the informed consent form for the study.

In completing this form we are trying to accomplish two things:
1. to ascertain before the patient actually enters the study that they are qualified by the
    number of chronic ear infections they have, as well as age and other criteria; and
2. to record clinical and demographic data thereafter which will be analyzed to compare
    the clinical course of the children in each of the two study groups.

You may have to hunt a little, but try to be sure the child has not gotten any previous
OMT or surgery to the head or neck, or does not have a chromosomal anomaly (such as
Down syndrome) or an immune defect (such as AIDS). Being a premie does not exclude
the child from the study, nor does having had any other type of surgery before the study.
(Note below: the case is the opposite during the course of the study)

Because we are following rather stringent criteria about what constitutes an acute ear
infection, we are asking you to look at more than the doctor’s diagnosis to see if it fits the
criteria. The child must have both evidence of symptoms with two of three noted
(irritability, fever, or ear pain), and evidence of abnormal findings, particularly indicative
of inflammation of the tympanic membrane (a change in position, color, decreased
translucency or mobility).

We are going to be analyzing the data according to each ear, so if a finding has not
specified which ear, such as ear pain, record it in both right and left sides. By the same
token, if there is a history of trauma to the body, or notation of bruising, and it is not
noted to which side record it in both. This principle will apply to all other aspects of the
study for which you do not find a specific side of a finding when it is requested.

In respect to findings of acute symptomatology, a history of any fever associated with the
illness for which the child is seen as described by the initial history is sufficient. It does
not need to be measured by the office. Irritability can be indicated as such or as “fussy,”
or poor eating or sleeping. Ear pain can be indicated by that actual complaint or a
notation of pulling or batting at the ears.

Realizing that “fluid” may be associated with inflammation, we wish to separate out the
children with acute suppurative otitis (inflammation) from those with secretory or serous
otitis. The first children will have ears described as red, thick, bulging, or with a yellow
exudate noted behind the TM. The children with “just” fluid may have retracted, dull
TM’s with possibly a bluish coloration or a clear fluid level seen or bubbles noted in clear
fluid. There may be fluid noted on follow-up visit, but if there are not symptoms, and
there is no acute inflammation, this acute episode is considered resolved.

If a child is given a full course of antibiotics (which, in the case of some like Zithromax,
will only be for 5 days,) note that as such. If the antibiotic had to be changed after 2 or 3
days because it was not working, note that as a second antibiotic. Some physicians will
use a low dose of antibiotic for “suppression” when the child is not symptomatic if the
child is getting lots of ear infections, while fluid is present. If that is the case, note “1/2
dose.” Please note any other medications received, such as antihistamines and
decongestants, steroids, or bronchodilators. If you do not know what is in a particular
drug, just write it down and let us figure it out, or ask the central coordinator ( Teri
Bycroft) or OMT physician, not the pediatrician, but do not give specific data about the
patient’s identity.

Of course, we want to know if the child gets tubes in the ear (ventilatory tubes). This
may be heralded by a referral to the ENT. You may have to look at the correspondence
from the ENT to see if tubes were recommended. Note if adenoidectomy or
tonsillectomy was also done. The child may not come back to the pediatrician for follow-
up after placement of tubes, and it may not be in the chart. If you can’t figure out if the
surgery has been done, or when, just ask the mother. This does not exclude the child from
the study, although some surgery to another part of the body requiring general anesthesia
will require the child to be dropped from the study.

Anytime the space provided does not give you enough room to write what you like, do so
anyway. The more specific you can be, the better, and we will be looking at the forms
and not just having you enter the data in the computer. And of course, if you have any
questions, do not hesitate to call us.


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