Trojan Andreas, Kühne Christian, Kiessling Michael, Schumacher Johannes, Dröse Stefan, Singer Christian, Jackisch Christian, Thomssen Christoph, Kullak-Ublick Gerd A
Oncology, Breast Center Zürichsee, Horgen, Switzerland.
Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
JMIR Form Res. 2024 May 6;8:e55917. doi: 10.2196/55917.
The evaluation of electronic patient-reported outcomes (ePROs) is increasingly being used in clinical studies of patients with cancer and enables structured and standardized data collection in patients' everyday lives. So far, few studies or analyses have focused on the medical benefit of ePROs for patients.
The current exploratory analysis aimed to obtain an initial indication of whether the use of the Consilium Care app (recently renamed medidux; mobile Health AG) for structured and regular self-assessment of side effects by ePROs had a recognizable effect on incidences of unplanned consultations and hospitalizations of patients with cancer compared to a control group in a real-world care setting without app use. To analyze this, the incidences of unplanned consultations and hospitalizations of patients with cancer using the Consilium Care app that were recorded by the treating physicians as part of the patient reported outcome (PRO) study were compared retrospectively to corresponding data from a comparable population of patients with cancer collected at 2 Swiss oncology centers during standard-of-care treatment.
Patients with cancer in the PRO study (178 included in this analysis) receiving systemic therapy in a neoadjuvant or noncurative setting performed a self-assessment of side effects via the Consilium Care app over an observational period of 90 days. In this period, unplanned (emergency) consultations and hospitalizations were documented by the participating physicians. The incidence of these events was compared with retrospective data obtained from 2 Swiss tumor centers for a matched cohort of patients with cancer.
Both patient groups were comparable in terms of age and gender ratio, as well as the distribution of cancer entities and Joint Committee on Cancer stages. In total, 139 patients from each group were treated with chemotherapy and 39 with other therapies. Looking at all patients, no significant difference in events per patient was found between the Consilium group and the control group (odds ratio 0.742, 90% CI 0.455-1.206). However, a multivariate regression model revealed that the interaction term between the Consilium group and the factor "chemotherapy" was significant at the 5% level (P=.048). This motivated a corresponding subgroup analysis that indicated a relevant reduction of the risk for the intervention group in the subgroup of patients who underwent chemotherapy. The corresponding odds ratio of 0.53, 90% CI 0.288-0.957 is equivalent to a halving of the risk for patients in the Consilium group and suggests a clinically relevant effect that is significant at a 2-sided 10% level (P=.08, Fisher exact test).
A comparison of unplanned consultations and hospitalizations from the PRO study with retrospective data from a comparable cohort of patients with cancer suggests a positive effect of regular app-based ePROs for patients receiving chemotherapy. These data are to be verified in the ongoing randomized PRO2 study (registered on ClinicalTrials.gov; NCT05425550).
ClinicalTrials.gov NCT03578731; https://www.clinicaltrials.gov/ct2/show/NCT03578731.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/29271.
电子患者报告结局（ePROs）评估在癌症患者临床研究中的应用日益广泛，可在患者日常生活中实现结构化和标准化的数据收集。到目前为止，很少有研究或分析关注ePROs对患者的医疗益处。
当前的探索性分析旨在初步表明，在现实世界的护理环境中，与未使用应用程序的对照组相比，使用Consilium Care应用程序（最近更名为medidux；移动健康股份公司）通过ePROs对副作用进行结构化定期自我评估，是否对癌症患者计划外会诊和住院的发生率产生可识别的影响。为了分析这一点，将治疗医生作为患者报告结局（PRO）研究的一部分记录的使用Consilium Care应用程序的癌症患者计划外会诊和住院发生率，与在2个瑞士肿瘤中心进行标准治疗期间收集的可比癌症患者群体的相应数据进行回顾性比较。
PRO研究中的癌症患者（本分析纳入178例）在新辅助或非根治性治疗环境中接受全身治疗，在90天的观察期内通过Consilium Care应用程序对副作用进行自我评估。在此期间，参与的医生记录了计划外（紧急）会诊和住院情况。将这些事件的发生率与从2个瑞士肿瘤中心获得的匹配癌症患者队列的回顾性数据进行比较。
两组患者在年龄、性别比例以及癌症实体分布和癌症联合委员会分期方面具有可比性。每组共有139例患者接受化疗，39例接受其他治疗。从所有患者来看，Consilium组和对照组之间每位患者的事件发生率无显著差异（优势比0.742，90%置信区间0.455 - 1.206）。然而，多变量回归模型显示，Consilium组与“化疗”因素之间的交互项在5%水平上具有显著性（P = 0.048）。这促使进行相应的亚组分析，结果表明在接受化疗的患者亚组中，干预组的风险有相应降低。相应的优势比为0.53，90%置信区间0.288 - 0.957，相当于Consilium组患者风险减半，提示在双侧10%水平上具有显著的临床相关效应（P = 0.08，Fisher精确检验）。
将PRO研究中的计划外会诊和住院情况与可比癌症患者队列的回顾性数据进行比较，表明基于应用程序的定期ePROs对接受化疗的患者有积极影响。这些数据将在正在进行的随机PRO2研究（在ClinicalTrials.gov注册；NCT05425550）中得到验证。
ClinicalTrials.gov NCT03578731；https://www.clinicaltrials.gov/ct2/show/NCT03578731。
国际注册报告标识符（IRRID）：RR2 - 10.2196/29271。
