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) Journal Article
| Authors: | Chung, A. E.; Shoenbill, K.; Mitchell, S. A.; Dueck, A. C.; Schrag, D.; Bruner, D. W.; Minasian, L. M.; St. Germain, D.; O'Mara, A. M.; Baumgartner, P.; Rogak, L. J.; Abernethy, A. P.; Griffin, A. C.; Basch, E. M. |
| Article Title: | 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) |
| Abstract: | 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. © The Author(s) 2019. |
| Keywords: | patient-reported outcomes; pro-ctcae; symptomatic adverse events; free text; meddra |
| Journal Title: | Journal of the American Medical Informatics Association |
| Volume: | 26 |
| Issue: | 4 |
| ISSN: | 1067-5027 |
| Publisher: | Oxford University Press |
| Date Published: | 2019-02-20 |
| Start Page: | 276 |
| End Page: | 285 |
| Language: | English |
| DOI: | 10.1093/jamia/ocy169 |
| PUBMED: | 30840079 |
| PROVIDER: | scopus |
| PMCID: | PMC6402312 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 April 2019 -- Source: Scopus |
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