Longo Raffaele, Goetz Christophe, Campitiello Marco, Plastino Francesca, Egea Julie, Legros Pierre-Olivier, Elnar Arpiné Ardzivian, Meraihi Salma, Luporsi Elisabeth, Noirez Véronique
Division of Medical Oncology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Clinical Research Support Unit, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
BMC Cancer. 2024 Dec 23;24(1):1568. doi: 10.1186/s12885-024-13312-4.
Cancer-treatment toxicity is common and symptoms must be identified quickly and accurately. Since symptom reporting during consultations is hampered by time constraints and patient/oncologist biases, patient-reported outcome-measure (PROM) questionnaires are useful. A strong shift to at-home cancer treatment has led to growing interest in remote symptom monitoring via electronic-PROMs (ePROMs). However, because PROMs are generally designed for medical-staff use, ePROMs must be adapted to patient comprehension/abilities. Here, to meet the oncological-healthcare needs of our region, we developed QuestOnco, a mobile-phone ePROM application. It is based on the symptom descriptions and severity grades of the PRO-CTCAE PROM and is designed for real-time on-demand reporting of 34 common or life-threatening cancer-treatment symptoms. This study describes the development of QuestOnco and its content validation relative to two comparators: PRO-CTCAE and the medical records.
The cohort study was conducted in a tertiary-care hospital in 2021 and consisted of two stages. Stage I assessed the comprehensibility of QuestOnco for patients: 24 cancer-therapy patients were asked to try the application for 30 min and then underwent semi-structured cognitive interviews. Stage II tested QuestOnco-content validity against the comparators: patients starting a ~ 6-week cancer-therapy cycle were asked to use QuestOnco in an on-demand fashion and to complete weekly paper PRO-CTCAEs. Total QuestOnco, PRO-CTCAE, and medical-record symptom reports were compared in terms of symptom and symptom-severity frequencies. Severity concordance of each reported symptom was assessed by Kendall's tau-b rank-correlation coefficients.
In the second round of 12 Stage-I patients (total Stage-I enrollment rate = 100%), 0% reported comprehension difficulties. 110 patients were recruited for Stage II (enrollment rate = 23%). QuestOnco, PRO-CTCAE, and the medical records detected 85%, 100%, and 62% of the target symptoms at least once, respectively, and reported grade-1, -2, -3, and -4 toxicities with similar frequencies (56-67%, 23-32%, 6-10%, and 2-3%, respectively). Overall symptom-severity concordance was moderate with PRO-CTCAE (tau-b = + 0.21, range = -0.03 to + 0.38) and strong with the medical records (tau-b = + 0.33, range = -0.01 to + 0.61). Few remarkable discrepancies were observed.
The QuestOnco application was well-understood by patients and demonstrated good content validity compared to its parent PROM and the medical records.
ClinicalTrials.gov No. NCT04915274.
癌症治疗毒性很常见，必须快速准确地识别症状。由于会诊期间的症状报告受到时间限制以及患者/肿瘤学家偏见的影响，患者报告结局测量（PROM）问卷很有用。向居家癌症治疗的重大转变引发了人们对通过电子PROM（ePROM）进行远程症状监测的兴趣日益浓厚。然而，由于PROM通常是为医务人员使用而设计的，ePROM必须适应患者的理解能力。在此，为满足我们地区的肿瘤医疗保健需求，我们开发了一款手机ePROM应用程序QuestOnco。它基于PRO-CTCAE PROM的症状描述和严重程度分级，旨在实时按需报告34种常见或危及生命的癌症治疗症状。本研究描述了QuestOnco的开发及其相对于两个对照物（PRO-CTCAE和病历）的内容效度。
队列研究于2021年在一家三级护理医院进行，包括两个阶段。第一阶段评估患者对QuestOnco的可理解性：24名癌症治疗患者被要求试用该应用程序30分钟，然后接受半结构化认知访谈。第二阶段针对对照物测试QuestOnco的内容效度：开始为期约6周癌症治疗周期的患者被要求按需使用QuestOnco，并每周完成纸质版PRO-CTCAE。比较了QuestOnco、PRO-CTCAE和病历中症状及症状严重程度的报告频率。通过肯德尔tau-b等级相关系数评估每个报告症状的严重程度一致性。
在第一阶段的第二轮12名患者中（第一阶段总入组率 = 100%），0%的患者表示存在理解困难。第二阶段招募了110名患者（入组率 = 23%）。QuestOnco、PRO-CTCAE和病历分别至少一次检测到85%、100%和62%的目标症状，并以相似的频率报告1级、2级、3级和4级毒性（分别为56 - 67%、23 - 32%、6 - 10%和2 - 3%）。与PRO-CTCAE的总体症状严重程度一致性为中等（tau-b = +0.21，范围 = -0.03至 +0.38），与病历的一致性较强（tau-b = +0.33，范围 = -0.01至 +0.61）。观察到的显著差异很少。
患者对QuestOnco应用程序理解良好，与它的母本PROM和病历相比，其内容效度良好。
ClinicalTrials.gov编号NCT04915274。
