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Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Publication ,  Journal Article
Chung, AE; Shoenbill, K; Mitchell, SA; Dueck, AC; Schrag, D; Bruner, DW; Minasian, LM; St Germain, D; O'Mara, AM; Baumgartner, P; Rogak, LJ ...
Published in: J Am Med Inform Assoc
April 1, 2019

OBJECTIVE: The study sought to describe patient-entered supplemental information on symptomatic adverse events (AEs) in cancer clinical research reported via a National Cancer Institute software system and examine the feasibility of mapping these entries to established terminologies. MATERIALS AND METHODS: Patients in 3 multicenter trials electronically completed surveys during cancer treatment. Each survey included a prespecified subset of items from the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Upon completion of the survey items, patients could add supplemental symptomatic AE information in a free text box. As patients typed into the box, structured dropdown terms could be selected from the PRO-CTCAE item library or Medical Dictionary for Regulatory Activities (MedDRA), or patients could type unstructured free text for submission. RESULTS: Data were pooled from 1760 participants (48% women; 78% White) who completed 8892 surveys, of which 2387 (26.8%) included supplemental symptomatic AE information. Overall, 1024 (58%) patients entered supplemental information at least once, with an average of 2.3 per patient per study. This encompassed 1474 of 8892 (16.6%) dropdowns and 913 of 8892 (10.3%) unstructured free text entries. One-third of the unstructured free text entries (32%) could be mapped post hoc to a PRO-CTCAE term and 68% to a MedDRA term. DISCUSSION: Participants frequently added supplemental information beyond study-specific survey items. Almost half selected a structured dropdown term, although many opted to submit unstructured free text entries. Most free text entries could be mapped post hoc to PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for AE reporting. CONCLUSIONS: Patient reporting of symptomatic AEs using a text box functionality with mapping to existing terminologies is both feasible and informative.

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Published In

J Am Med Inform Assoc

DOI

EISSN

1527-974X

Publication Date

April 1, 2019

Volume

26

Issue

4

Start / End Page

276 / 285

Location

England

Related Subject Headings

  • User-Computer Interface
  • United States
  • Software
  • Self Report
  • Patient Reported Outcome Measures
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Middle Aged
  • Medical Informatics
  • Male
 

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Chung, A. E., Shoenbill, K., Mitchell, S. A., Dueck, A. C., Schrag, D., Bruner, D. W., … Basch, E. M. (2019). Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). J Am Med Inform Assoc, 26(4), 276–285. https://doi.org/10.1093/jamia/ocy169
Chung, Arlene E., Kimberly Shoenbill, Sandra A. Mitchell, Amylou C. Dueck, Deborah Schrag, Deborah W. Bruner, Lori M. Minasian, et al. “Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).J Am Med Inform Assoc 26, no. 4 (April 1, 2019): 276–85. https://doi.org/10.1093/jamia/ocy169.
Chung AE, Shoenbill K, Mitchell SA, Dueck AC, Schrag D, Bruner DW, Minasian LM, St Germain D, O’Mara AM, Baumgartner P, Rogak LJ, Abernethy AP, Griffin AC, Basch EM. Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). J Am Med Inform Assoc. 2019 Apr 1;26(4):276–285.
Journal cover image

Published In

J Am Med Inform Assoc

DOI

EISSN

1527-974X

Publication Date

April 1, 2019

Volume

26

Issue

4

Start / End Page

276 / 285

Location

England

Related Subject Headings

  • User-Computer Interface
  • United States
  • Software
  • Self Report
  • Patient Reported Outcome Measures
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Middle Aged
  • Medical Informatics
  • Male