Lai-Kwon Julia, Jefford Michael, Best Stephanie, Zhang Iris, Rutherford Claudia
Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
JCO Oncol Pract. 2024 Dec;20(12):1663-1675. doi: 10.1200/OP.24.00037. Epub 2024 Aug 16.
Electronic patient-reported outcome (ePRO) symptom monitoring may support the safe delivery of immune checkpoint inhibitors (ICI). There is no consensus on which side effects should be monitored in routine care. We aimed to develop a prioritized list of ICI side effects to include in ePRO systems and compare this to existing ICI-specific patient-reported outcome measures (PROMs).
We conducted a two-round modified Delphi survey. Participants were patients (or their carers) who had received/were receiving ICI or managing health care professionals (HCPs). Round 1 (R1) side effects were generated from a literature review and existing PROMs. In R1, participants rated the importance of 63 ICI side effects in an ePRO system on a five-point Likert scale. In round 2 (R2), participants ranked the 10 most important side effects from 36 side effects. Content mapping of the prioritized list against existing PROMs was conducted.
In R1, 47 patients, nine carers, and 58 HCPs responded. Twenty-eight side effects were rated important (I)/very important (VI) by >75% of participants and included in R2. Ten were rated I/VI by <50% of participants and excluded. Twenty-five were rated I/VI by 50%-75% of participants and discussed at an HCP roundtable to determine inclusion in R2. In R2, 39 patients, 11 carers, and 42 HCPs ranked seizures, shortness of breath, chest pain, diarrhea, and rash as the most important side effects for monitoring. Content mapping showed significant differences between the prioritized list and existing PROMs.
We developed a consumer- and clinician-driven prioritized list of 36 ICI side effects to include in future ePRO systems. This process highlights the importance of broad stakeholder engagement in side-effect selection and rigorously identifying clinically important side effects to ensure content validity and clinical utility.
电子患者报告结局（ePRO）症状监测可能有助于免疫检查点抑制剂（ICI）的安全应用。对于在常规护理中应监测哪些副作用尚无共识。我们旨在制定一份ICI副作用的优先清单，以纳入ePRO系统，并将其与现有的ICI特异性患者报告结局指标（PROMs）进行比较。
我们进行了两轮改良德尔菲调查。参与者为接受过/正在接受ICI治疗的患者（或其护理人员）或医疗保健专业人员（HCPs）。第一轮（R1）的副作用来自文献综述和现有的PROMs。在R1中，参与者以五点李克特量表对ePRO系统中63种ICI副作用的重要性进行评分。在第二轮（R2）中，参与者从36种副作用中对10种最重要的副作用进行排序。对优先清单与现有PROMs进行了内容映射。
在R1中，47名患者、9名护理人员和58名HCPs做出了回应。28种副作用被超过75%的参与者评为重要（I）/非常重要（VI），并纳入R2。10种副作用被不到50%的参与者评为I/VI，被排除。25种副作用被50%-75%的参与者评为I/VI，并在HCP圆桌会议上进行讨论以确定是否纳入R2。在R2中，39名患者、11名护理人员和42名HCPs将癫痫发作、呼吸急促、胸痛、腹泻和皮疹列为最重要的监测副作用。内容映射显示优先清单与现有PROMs之间存在显著差异。
我们制定了一份由消费者和临床医生驱动的36种ICI副作用优先清单，以纳入未来的ePRO系统。这一过程凸显了广泛的利益相关者参与副作用选择以及严格识别具有临床重要性的副作用以确保内容效度和临床实用性的重要性。
