Developing alert thresholds and self-management advice for people receiving immune checkpoint inhibitors: a Multinational Association for Supportive Care in Cancer modified Delphi survey

Lai-Kwon, J; Rutherford, C; Best, S; Rugo, HS; Ruhlmann, CH; Jefford, M

Author(s): Lai-Kwon, J; Rutherford, C; Best, S; Rugo, HS; Ruhlmann, CH; Jefford, M;
Details: Publication Year 2025-01-07,Volume 33,Issue #2,Page 76
Journal Title: Supportive Care in Cancer
Publication Type: Research article
Abstract: BACKGROUND: Remote monitoring using electronic patient-reported outcomes (ePROs) may help identify immune-related adverse events (irAEs) and direct self-management. There is no consensus regarding thresholds to alert providers about potentially severe irAEs or when to instigate evidence-based self-management. We aimed to develop consensus around alert thresholds and self-management advice for side-effects suggestive of an irAE which can be deployed as part of remote monitoring systems. METHODS: A two-round international modified Delphi survey including co-authors of major international irAE guidelines and selected immuno-oncology experts was conducted. Round 1 (R1): participants reviewed alert thresholds graded as per the Common Terminology Criteria for Adverse Events (CTCAE) and self-management statements for 36 side-effects. Participants stated whether they agreed or disagreed with the proposed thresholds and self-management statements. If ≥ 75% of participants agreed, consensus was reached. Prior to Round 2 (R2), thresholds and self-management statements that did not reach consensus in R1 were modified. In R2, participants were asked whether they agreed or disagreed with the modifications. RESULTS: In R1, 34 participants responded (North America: 18, 52.9%; Europe: 12, 35.3%; Asia-Pacific: 4, 11.8%; median duration of experience in current role, 13.5 years (range, 3-46 years)), with 33 complete responses received. Twenty-nine alert thresholds and 33 self-management statements reached consensus. For R2, seven alert thresholds were increased from CTCAE Grade 1 to 2 based on participant comments, and three self-management statements were amended. Six self-management statements which achieved consensus were amended and re-presented in R2. In R2, 31 participants responded (North America: 18, 58.1%; Europe: 9, 29%; Asia-Pacific: 4, 12.9%; median duration of experience in current role, 13 years (range, 3-40 years)), with 30 complete responses received. All seven alert thresholds and nine self-management statements achieved consensus. CONCLUSION: This survey developed international consensus regarding alert thresholds and self-management advice for common, clinically relevant side-effects suggestive of an irAE for ePRO monitoring systems with international applicability. Self-management statements will inform written materials for patients.
Publisher: Springer Nature
Keywords: Humans; *Delphi Technique; *Self-Management/methods; *Neoplasms/drug therapy/therapy; *Immune Checkpoint Inhibitors/adverse effects/therapeutic use; Consensus; Patient Reported Outcome Measures; Surveys and Questionnaires; Delphi; Digital health; Electronic patient-reported outcomes; Immune checkpoint inhibitors; Immunotherapy; Patient-reported outcomes; Symptom monitoring
Department(s): Medical Oncology; Health Services Research; Australian Cancer Survivorship Centre
Publisher's Version: https://doi.org/10.1007/s00520-024-09110-0
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2025-01-21 06:44:56

Last Modified: 2025-01-21 06:46:48