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Review
. 2011 Jul-Aug;17(4):231-4.
doi: 10.1097/PPO.0b013e31822c28b3.

Electronic toxicity monitoring and patient-reported outcomes

Ethan M Basch  1 , Bryce B Reeve, Sandra A Mitchell, Stephen B Clauser, Lori Minasian, Laura Sit, Ram Chilukuri, Paul Baumgartner, Lauren Rogak, Emily Blauel, Amy P Abernethy, Deborah Bruner
Affiliations
Review

Electronic toxicity monitoring and patient-reported outcomes

Ethan M Basch et al. Cancer J. 2011 Jul-Aug.

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.

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Figures

FIGURE 1
FIGURE 1
Screenshots of the PRO-CTCAE Web platform, version 1.0. A, Form builder for research staff to create a PRO-CTCAE form. B, Web interface for patients to complete questions in a form (also available via an automated telephone system).
FIGURE 1
FIGURE 1
Screenshots of the PRO-CTCAE Web platform, version 1.0. A, Form builder for research staff to create a PRO-CTCAE form. B, Web interface for patients to complete questions in a form (also available via an automated telephone system).
See this image and copyright information in PMC

References

    1. Institute of Medicine, National Academy of Sciences . The future of drug safety: promoting and protecting the health of the public. National Academies Press; Washington, DC: 2006.
    1. Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362(10):865–869. - PMC - PubMed
    1. Edgerly M, Fojo T. Is there room for improvement in adverse event reporting in the era of targeted therapies? J Natl Cancer Inst. 2008;100(4):240–242. - PubMed
    1. Duke J, et al. “A quantitative analysis of adverse events and ‘overwarning’ in drug labeling”. Arch Intern Med. 2011;171(10):944–946. - PubMed
    1. Trotti A, Colevas AD, Setser A, Basch E. Patient-Reported Outcomes and the Evolution of Adverse Event Reporting in Oncology. J Clin Oncol. 2007;25(32):5121–7. - PubMed

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