August 10, 2010
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.
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 choic
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, MD, 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, PhD, 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.”
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.
Download CTCAE v4.0
Some trials may use the previous version (v.3.0):
Download CTCAE v3.0