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.

Stakeholder perspectives on addressing adverse events from adjuvant cancer therapy: A qualitative study

“…We believe the results of the current study provide new insights into intrastakeholder and interstakeholder perspectives regarding the breadth of challenges to the development and use of AE information to improve adjuvant therapy, and offer a compelling call for further action. This call to action is timely in light of the growing cross‐sector focus on actively connecting patient experience with drug design, approval, and delivery using tools such as the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) and a May 2019 draft guidance from the US Food and Drug Administration (FDA) regarding the use of real‐world data and evidence in drug evaluation …”

“…This call to action is timely in light of the growing cross-sector focus on actively connecting patient experience with drug design, approval, and delivery using tools such as the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and a May 2019 draft guidance from the US Food and Drug Administration (FDA) regarding the use of real-world data and evidence in drug evaluation. [18][19][20] We also believe the specific needs identified in the current study provide starting points for those seeking to better understand, support, and/or engage with their peers in future actions to improve outcomes for patients receiving adjuvant therapy. The consistency in the themes reported across stakeholder groups, despite the very different modes of operation, funding, composition, and spheres of influence of these stakeholders, suggests that future efforts to collectivize or synergize change initiatives could be effective.…”

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer

“…This system makes possible reporting on a tablet, on a computer, or using an automated telephone interactive voice-response system. 28,29 PRO-CTCAE also provides text boxes where patients can add comments. The majority of this free text content can be mapped onto PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for adverse event reporting.…”

“…The majority of this free text content can be mapped onto PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for adverse event reporting. 28 Patients may also send their symptom information through other online software programs, such as REDCap 30,31 or ASyMS. 32 Given the widespread use of mobile phones, using apps to report symptoms might be more convenient than traditional paper-and-pencil format; however, evidence on mobile apps is very limited, 33 indicating the need for more research in this area.…”

From Patient Engagement to Precision Oncology: Leveraging Informatics to Advance Cancer Care

“…There is also concern that the use of structured questionnaires to assess PROs may limit the ability to capture the broad range of symptoms experienced by patients during treatment. Chung et al, examined whether patient-entered free-text narratives of symptomatic adverse events could be mapped to established terminologies from the National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [16]. Among 1,760 patients enrolled in three multicenter cancer trials, over half (58%) provided unstructured free-text entries, and most of these entries could be mapped post hoc to a PRO-CTCAE or Medical Dictionary for Regulatory Activities (MedDRA) term.…”