A QUALITATIVE STUDY EXAMINING PRO-CTCAE COVERAGE OF TREATMENT-EMERGENT ADVERSE EVENTS REPORTED BY PATIENTS WITH MULTIPLE MYELOMA
Author(s)
Karolina Schantz, MPH1, Kelly Kato, PhD2, Heather Gerould, MS3, Eva Katz, PhD4, Katharine Gries, PharmD, PhD5, Rikki Mangrum, MS3;
1Nashville, TN, USA, 2Janssen (Johnson & Johnson), New Brunswick, NJ, USA, 3Vector Psychometric Group, Chappell Hill, NC, USA, 4Johnson and Johnson, Raritan, NJ, USA, 5Johnson & Johnson, Raritan, NJ, USA
1Nashville, TN, USA, 2Janssen (Johnson & Johnson), New Brunswick, NJ, USA, 3Vector Psychometric Group, Chappell Hill, NC, USA, 4Johnson and Johnson, Raritan, NJ, USA, 5Johnson & Johnson, Raritan, NJ, USA
OBJECTIVES: The Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) was developed to support systematic reporting of treatment-emergent AEs (TEAEs) in clinical trials. Currently there is limited evidence on its use for assessing treatment-related symptoms for multiple myeloma (MM) therapies. This study aimed to evaluate whether the PRO-CTCAE system comprehensively measures TEAEs identified by MM patients, including TEAEs associated with steroids.
METHODS: Sixteen, sixty-minute, semi-structured, one-on-one concept elicitation interviews were conducted virtually with a US sample of English-speaking adults who self-reported MM diagnosis. Interviews were conducted between May and July 2023. Interviews elicited information about patient experiences with MM therapies, including therapies with steroids, which all participants reported having used. Interviews were transcribed verbatim and coded using NVivo qualitative analysis software. Researchers used content analysis to identify the TEAE concepts and terminology used by participants and mapped them to the TEAEs in the PRO-CTCAE.
RESULTS: The TEAEs most commonly referenced by participants were gastrointestinal issues; changes in energy level (fatigue and disruptive excessive energy); cognitive impacts; muscle, joint or head pain; neuropathy; changes in skin, nails or hair; mood changes (irritability and anxiety); and sleep problems. The most commonly reported steroid-related TEAEs were excessive energy and resulting sleep disruption, as well as irritability, taste changes, and undesired increased appetite/weight gain. While the PRO-CTCAE captured most patient-reported MM TEAEs, several gaps remained for certain common steroid-associated symptoms (excessive energy, irritability, undesired increased appetite/weight gain) as well as less commonly reported steroid-related symptoms (muscle weakness bitter/metallic taste, taste sensitivity, brittle nails).
CONCLUSIONS: The PRO-CTCAE covers most TEAEs reported by participants in this study, suggesting that it is a suitable option for MM clinical trials. However, additional PRO instruments may be needed to capture steroid-related TEAEs that are not currently addressed by the PRO-CTCAE item library.
METHODS: Sixteen, sixty-minute, semi-structured, one-on-one concept elicitation interviews were conducted virtually with a US sample of English-speaking adults who self-reported MM diagnosis. Interviews were conducted between May and July 2023. Interviews elicited information about patient experiences with MM therapies, including therapies with steroids, which all participants reported having used. Interviews were transcribed verbatim and coded using NVivo qualitative analysis software. Researchers used content analysis to identify the TEAE concepts and terminology used by participants and mapped them to the TEAEs in the PRO-CTCAE.
RESULTS: The TEAEs most commonly referenced by participants were gastrointestinal issues; changes in energy level (fatigue and disruptive excessive energy); cognitive impacts; muscle, joint or head pain; neuropathy; changes in skin, nails or hair; mood changes (irritability and anxiety); and sleep problems. The most commonly reported steroid-related TEAEs were excessive energy and resulting sleep disruption, as well as irritability, taste changes, and undesired increased appetite/weight gain. While the PRO-CTCAE captured most patient-reported MM TEAEs, several gaps remained for certain common steroid-associated symptoms (excessive energy, irritability, undesired increased appetite/weight gain) as well as less commonly reported steroid-related symptoms (muscle weakness bitter/metallic taste, taste sensitivity, brittle nails).
CONCLUSIONS: The PRO-CTCAE covers most TEAEs reported by participants in this study, suggesting that it is a suitable option for MM clinical trials. However, additional PRO instruments may be needed to capture steroid-related TEAEs that are not currently addressed by the PRO-CTCAE item library.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR137
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology