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)

Arlene E. Chung, Kimberly Shoenbill, Sandra A. Mitchell, Amylou Dueck, Deborah Schrag, Deborah W. Bruner, Lori M. Minasian, Diane St Germain, Ann M. O'Mara, Paul Baumgartner, Lauren J. Rogak, Amy P. Abernethy, Ashley C. Griffin, Ethan M. Basch

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)276-285
Number of pages10
JournalJournal of the American Medical Informatics Association
Volume26
Issue number4
DOIs
StatePublished - Feb 20 2019

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National Cancer Institute (U.S.)
Terminology
Medical Dictionaries
Research
Neoplasms
Patient Reported Outcome Measures
Libraries
Multicenter Studies
Software
Surveys and Questionnaires

Keywords

  • free text
  • MedDRA
  • patient-reported outcomes
  • PRO-CTCAE
  • symptomatic adverse events

ASJC Scopus subject areas

  • Health Informatics

Cite this

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). / Chung, Arlene E.; Shoenbill, Kimberly; Mitchell, Sandra A.; Dueck, Amylou; Schrag, Deborah; Bruner, Deborah W.; Minasian, Lori M.; St Germain, Diane; O'Mara, Ann M.; Baumgartner, Paul; Rogak, Lauren J.; Abernethy, Amy P.; Griffin, Ashley C.; Basch, Ethan M.

In: Journal of the American Medical Informatics Association, Vol. 26, No. 4, 20.02.2019, p. 276-285.

Research output: Contribution to journalArticle

Chung, Arlene E. ; Shoenbill, Kimberly ; Mitchell, Sandra A. ; Dueck, Amylou ; Schrag, Deborah ; Bruner, Deborah W. ; Minasian, Lori M. ; St Germain, Diane ; O'Mara, Ann M. ; Baumgartner, Paul ; Rogak, Lauren J. ; Abernethy, Amy P. ; Griffin, Ashley C. ; Basch, Ethan M. / 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). In: Journal of the American Medical Informatics Association. 2019 ; Vol. 26, No. 4. pp. 276-285.
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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.",
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AU - Shoenbill, Kimberly

AU - Mitchell, Sandra A.

AU - Dueck, Amylou

AU - Schrag, Deborah

AU - Bruner, Deborah W.

AU - Minasian, Lori M.

AU - St Germain, Diane

AU - O'Mara, Ann M.

AU - Baumgartner, Paul

AU - Rogak, Lauren J.

AU - Abernethy, Amy P.

AU - Griffin, Ashley C.

AU - Basch, Ethan M.

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N2 - 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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