Electronic toxicity monitoring and patient-reported outcomes Journal Article


Authors: Basch, E. M.; Reeve, B. B.; Mitchell, S. A.; Clauser, S. B.; Minasian, L.; Sit, L.; Chilukuri, R.; Baumgartner, P.; Rogak, L.; Blauel, E.; Abernethy, A. P.; Bruner, D.
Article Title: Electronic toxicity monitoring and patient-reported outcomes
Abstract: Understanding the potential profile of adverse events associated with cancer treatment is essential in balancing safety versus benefits. Multiple stakeholders make use of this information for decision making, including patients, clinicians, researchers, regulators, and payors. Currently, adverse events are reported by clinical research staff, yet evidence suggests that this may contribute to underreporting of symptom events. Direct patient reporting via electronic interfaces offers a promising mechanism to enhance the efficiency and precision of our current approach and may complement clinician reports of adverse events. The National Cancer Institute has contracted to develop and test an item bank and software system for directly eliciting adverse symptom event information from patients in cancer clinical research, called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. The validity, usability, and scalability of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events prototype are currently being examined in academic and community-based settings. Copyright © 2011 by Lippincott Williams & Wilkins.
Keywords: treatment outcome; review; drug safety; risk benefit analysis; unspecified side effect; antineoplastic agents; outcome assessment; antineoplastic agent; neoplasms; quality of life; breast cancer; computer interface; patient monitoring; practice guideline; information processing; cancer therapy; self report; electronic medical record; symptom; disease severity; health status; patient safety; drug monitoring; asthma; osteoarthritis; drug labeling; toxicity; gastroesophageal reflux; computer program; software; postmarketing surveillance; adverse drug reaction; hyperlipidemia; national health organization; adverse event; computer communication networks; research report; patient-reported outcome; pro; tolerability; ctcae; pro-ctcae; drug information; medical informatics
Journal Title: The Cancer Journal
Volume: 17
Issue: 4
ISSN: 1528-9117
Publisher: Lippincott Williams & Wilkins  
Date Published: 2011-07-01
Start Page: 231
End Page: 234
Language: English
DOI: 10.1097/PPO.0b013e31822c28b3
PROVIDER: scopus
PUBMED: 21799330
PMCID: PMC3855320
DOI/URL:
Notes: --- - "Export Date: 3 October 2011" - "CODEN: CAJOC" - "Source: Scopus"
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  1. Ethan Martin Basch
    180 Basch
  2. Laura S Sit
    22 Sit
  3. Lauren Jayne Rogak
    76 Rogak
  4. Emily Rose Blauel
    1 Blauel