Name
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. |
Year | DOI | Venue |
|---|---|---|
2019 | 10.1093/jamia/ocy169 | JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION |
Keywords | Field | DocType |
PRO-CTCAE,patient-reported outcomes,free text,symptomatic adverse events,MedDRA | MedDRA,Knowledge management,Adverse effect,Intensive care medicine,Clinical research,Common Terminology Criteria for Adverse Events,Medicine,Cancer | Journal |
Volume | Issue | ISSN |
26 | 4 | 1067-5027 |
Citations | PageRank | References |
0 | 0.34 | 2 |
Authors | ||
14 | ||
Name | Order | Citations | PageRank |
|---|---|---|---|
| Arlene E. Chung | 1 | 1 | 3.39 |
| Kimberly Shoenbill | 2 | 0 | 0.34 |
| Sandra A. Mitchell | 3 | 0 | 0.68 |
| Amylou C Dueck | 4 | 0 | 0.34 |
| Deborah Schrag | 5 | 0 | 0.34 |
| Deborah W. Bruner | 6 | 2 | 0.88 |
| Lori M Minasian | 7 | 0 | 0.34 |
| Diane St Germain | 8 | 0 | 0.34 |
| Ann M O'Mara | 9 | 0 | 0.34 |
| Paul Baumgartner | 10 | 0 | 0.34 |
| Lauren J Rogak | 11 | 0 | 0.34 |
| Amy Abernethy | 12 | 0 | 1.01 |
| Ashley C Griffin | 13 | 0 | 1.35 |
| Ethan M Basch | 14 | 0 | 0.34 |