Reston, VA, United States
Reston, VA, United States

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Basch E.,University of North Carolina at Chapel Hill | Basch E.,Sloan Kettering Cancer Center | Reeve B.B.,University of North Carolina at Chapel Hill | Mitchell S.A.,Outcomes Research Branch | And 22 more authors.
Journal of the National Cancer Institute | Year: 2014

The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). Because this approach underdetects symptomatic AEs, the NCI issued two contracts to create a patient-reported outcome (PRO) measurement system as a companion to the CTCAE, called the PRO-CTCAE. This Commentary describes development of the PRO-CTCAE by a group of multidisciplinary investigators and patient representatives and provides an overview of qualitative and quantitative studies of its measurement properties. A systematic evaluation of all 790 AEs listed in the CTCAE identified 78 appropriate for patient self-reporting. For each of these, a PRO-CTCAE plain language term in English and one to three items characterizing the frequency, severity, and/or activity interference of the AE were created, rendering a library of 124 PRO-CTCAE items. These items were refined in a cognitive interviewing study among patients on active cancer treatment with diverse educational, racial, and geographic backgrounds. Favorable measurement properties of the items, including construct validity, reliability, responsiveness, and between-mode equivalence, were determined prospectively in a demographically diverse population of patients receiving treatments for many different tumor types. A software platform was built to administer PRO-CTCAE items to clinical trial participants via the internet or telephone interactive voice response and was refined through usability testing. Work is ongoing to translate the PRO-CTCAE into multiple languages and to determine the optimal approach for integrating the PRO-CTCAE into clinical trial workflow and AE analyses. It is envisioned that the PRO-CTCAE will enhance the precision and patient-centeredness of adverse event reporting in cancer clinical research. © The Author 2014. Published by Oxford University Press. All rights reserved.

Basch E.M.,Sloan Kettering Cancer Center | Reeve B.B.,University of North Carolina at Chapel Hill | Mitchell S.A.,U.S. National Cancer Institute | Clauser S.B.,U.S. National Cancer Institute | And 8 more authors.
Cancer Journal | Year: 2011

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.

PubMed | SemanticBits LLC
Type: Journal Article | Journal: Journal of biomedical semantics | Year: 2011

The HL7 Clinical Document Architecture (CDA) constrains the HL7 Reference Information model (RIM) to specify the format of HL7-compliant clinical documents, dubbed CDA documents. The use of clinical terminologies such as SNOMED CT further improves interoperability as they provide a shared understanding of concepts used in clinical documents. However, despite the use of the RIM and of shared terminologies such as SNOMED CT, gaps remain as to how to use both the RIM and SNOMED CT in HL7 clinical documents. The HL7 implementation guide on Using SNOMED CT in HL7 Version 3 is an effort to close this gap. It is, however, a human-readable document that is not suited for automatic processing. As such, health care professionals designing clinical documents need to ensure validity of documents manually.We represent the CDA using the Ontology Web Language OWL and further use the OWL version of SNOMED CT to enable the translation of CDA documents to so-called OWL ontologies. We formalize a subset of the constraints in the implementation guide on Using SNOMED CT in HL7 Version 3 as OWL Integrity Constraints and show that we can automatically validate CDA documents using OWL reasoners such as Pellet. Finally, we evaluate our approach via a prototype implementation that plugs in the Open Health Workbench.We present a methodology to automatically check the validity of CDA documents which make reference to SNOMED CT terminology. The methodology relies on semantic technologies such as OWL. As such it removes the burden from IT health care professionals of having to manually implement such guidelines in systems that use HL7 Version 3 documents.

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