Lai-Kwon Julia, Jefford Michael, Best Stephanie, Zhang Iris, Cella David, Piccinin Claire, Reeve Bryce B, Rutherford Claudia
Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia.
Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Australia.
J Patient Rep Outcomes. 2025 Mar 6;9(1):27. doi: 10.1186/s41687-025-00855-8.
Monitoring for the side effects of novel therapies using patient-reported outcomes (PROs) is critical for ensuring patient safety. Existing static patient-reported outcome measures may not provide adequate coverage of novel side effects. Item libraries provide a flexible approach to monitoring for side effects using customized item lists, but the ideal process for matching side effects to items sourced from multiple item libraries is yet to be established. We sought to develop a pragmatic process for mapping side effects to items from three major item libraries using immune checkpoint inhibitor (ICI) side effects as an example.
Using a consumer- and clinician-driven list of 36 ICI side effects, two authors independently mapped side effects to Common Terminology Criteria for Adverse Event (CTCAE) terms, and then to three item libraries: the Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), the European Organisation for Research and Treatment of Cancer (EORTC) Item Library, and the Functional Assessment of Chronic Illness Therapy (FACIT) searchable library. The rates of inter-rater agreement were recorded. Following item collation from the item libraries, we devised criteria for selecting the optimal item for each side effect for inclusion in a future electronic PRO system based on guidance from the above groups.
All 36 side effects mapped to at least one CTCAE term, with eight mapping to more than one term. Twenty-three side effects mapped to at least one PRO-CTCAE term, 35 side effects mapped to at least one EORTC item, and 31 side effects mapped to at least one FACIT item. The inter-rater agreement rate was 100% (PRO-CTCAE), 83% (EORTC) and 75% (FACIT). Pre-determined criteria were applied to select the optimal item for each side effect from the three item libraries, producing a final 61-item list.
Using ICI side effects as an example, we developed a pragmatic approach to creating customized item lists from three major item libraries to monitor for side effects of novel therapies in routine care. This process highlighted the challenges of using item libraries and priorities for future work to improve their usability.
使用患者报告结局（PRO）监测新型疗法的副作用对于确保患者安全至关重要。现有的静态患者报告结局测量方法可能无法充分涵盖新型副作用。条目库提供了一种使用定制条目列表监测副作用的灵活方法，但将副作用与来自多个条目库的条目进行匹配的理想流程尚未确立。我们试图以免疫检查点抑制剂（ICI）的副作用为例，开发一种将副作用映射到来自三个主要条目库的条目的实用流程。
使用一份由消费者和临床医生驱动的包含36种ICI副作用的列表，两位作者独立地将副作用映射到不良事件通用术语标准（CTCAE）术语，然后再映射到三个条目库：不良事件通用术语标准的患者报告结局版本（PRO-CTCAE）、欧洲癌症研究与治疗组织（EORTC）条目库以及慢性病治疗功能评估（FACIT）可搜索库。记录评分者间的一致性率。在从条目库整理条目后，我们根据上述小组的指导意见，制定了为每种副作用选择最佳条目的标准，以便纳入未来的电子PRO系统。
所有36种副作用都至少映射到一个CTCAE术语，其中8种映射到多个术语。23种副作用映射到至少一个PRO-CTCAE术语，35种副作用映射到至少一个EORTC条目，31种副作用映射到至少一个FACIT条目。评分者间的一致性率分别为100%（PRO-CTCAE）、83%（EORTC）和75%（FACIT）。应用预先确定的标准从三个条目库中为每种副作用选择最佳条目，最终生成了一份61条目的列表。
以ICI副作用为例，我们开发了一种实用的方法，从三个主要条目库创建定制条目列表，以监测常规护理中新型疗法的副作用。这一过程突出了使用条目库的挑战以及未来改进其可用性工作的重点。
