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Free App helps
Caregivers record, grade Side Effects in
Clinical Trials
Newswise, August 2010 — A physician or nurse
making rounds can locate and page through a
200-page reference book that lists the
possible adverse events that may occur to
patients in a clinical trial, or can instead
keep all the same information in their
pocket, in a 4-ounce iPhone. For many in
healthcare, that’s an easy choice.
The classifications of adverse events
originated in the National Cancer Institute
as a way to help standardize record-keeping
of side effects occurring in patients
enrolled in clinical trials. Printed out,
the Institute’s Common Terminology Criteria
for Adverse Events (CTCAE) is a 200-page
handbook in its most recent edition, version
4.0.
The Center for Biomedical Informatics (CBMi)
at The Children’s Hospital of Philadelphia
converted all the reference information into
a software application, or “app” that anyone
with an iPhone® or iPod touch® can download
for free from the App StoreSM on the
internet.
People with iPhones can already find apps
for locating restaurants, planning travel
routes or translating phrases into foreign
languages. Now health care providers are
using apps in the interests of patient care.
From an alphabetized list of symptoms, tap
in “ear pain” or “tremor,” and the touch
screen will display a definition, and then
list grades of the problem—mild, moderate or
severe. Using these categories, a care
provider or clinical trial researcher can
log data into the trial’s records, so it can
be shared with other hospitals and
physicians having patients participating in
the same trial. A user can bookmark adverse
events and categories that require more
frequent access.
Monitoring the safety of treatments used in
clinical trials is crucial to providing the
best results for current and future
patients. “Researchers can use this app to
quickly access information at the point of
care, and improve the efficiency of our
research,” said Peter C. Adamson, M.D.,
director of the Office of Clinical
Translational Research at Children’s
Hospital, and chair-elect of the Children’s
Oncology Group.
Although the classifications used in CTCAE
originated in oncology research, they have
broader application in clinical trials for
other conditions, said Peter White, Ph.D.,
director of CBMi at Children’s Hospital, and
a leader of the team that created the app.
“When researchers write the protocol for a
clinical trial, they know that one element
of patient protection is standardized
record-keeping, so they may incorporate the
CTCAE rubric in their protocol.”
White added that in addition to researchers,
other caregivers such as attending
physicians and medical students have been
using the CTCAE app as an information
resource, independent of clinical trials.
“This app is one example of mobile health
development, in which we are assisting
healthcare staff in accessing the next
generation of information technologies,” he
added.
“Besides the immediate benefits for
efficiency, we feel that using this type of
technology has significant potential for
standardizing care delivery, reducing error,
an improving both quality of care and
patient safety.”
To download the CTCAE free of charge, users
with an iTunes account can search the App
Store for “ctcae” or click on one of these
direct links:
CTCAE v4.0: http://itunes.apple.com/us/app/ctcae-v4-0/id378487242?mt=8
Some trials may use the previous version
(v.3.0), available at
CTCAE v3.0:http://itunes.apple.com/us/app/ctcae3/id351401972?mt=8
The CTCAE app team at Children’s Hospital
included lead developer Michael Italia,
Byron Ruth, Lauren Frazier and Jeff
Pennington in CBMi’s Translational
Informatics Unit.
About The Children’s Hospital of
Philadelphia: The Children's Hospital of
Philadelphia was founded in 1855 as the
nation's first pediatric hospital.
Through its long-standing commitment to
providing exceptional patient care, training
new generations of pediatric healthcare
professionals and pioneering major research
initiatives, Children’s Hospital has
fostered many discoveries that have
benefited children worldwide.
Its pediatric research program is among the
largest in the country, ranking third in
National Institutes of Health funding. In
addition, its unique family-centered care
and public service programs have brought the
460-bed hospital recognition as a leading
advocate for children and adolescents. For
more information, visit http://www.chop.edu.
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