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Abstract：
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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).
BACKGROUND: ClinicalTrials.gov NCT03578731; https://www.clinicaltrials.gov/ct2/show/NCT03578731.
UNASSIGNED: RR2-10.2196/29271.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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).
BACKGROUND: ClinicalTrials.gov NCT03578731; https://www.clinicaltrials.gov/ct2/show/NCT03578731.
UNASSIGNED: RR2-10.2196/29271.
摘要：
背景：在癌症患者的临床研究中越来越多地使用电子患者报告结果（ePRO）的评估，并能够在患者的日常生活中进行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。
目的：当前的探索性分析旨在初步表明，与不使用真实世界护理应用程序的对照组相比，使用ConsiliumCare应用程序（最近更名为medidux；mobileHealthAG）对ePro的副作用进行结构化和定期自我评估对癌症患者的计划外咨询和住院的发生率具有可识别的影响。为了分析这一点，使用ConsiliumCare应用程序记录的癌症患者的计划外会诊和住院治疗的发生率,作为患者报告结局(PRO)研究的一部分,我们将其与在标准护理治疗期间在瑞士2个肿瘤中心收集的癌症患者的可比人群的相应数据进行回顾性比较.
方法：PRO研究中接受新辅助或非治疗性全身治疗的癌症患者（本分析中包括178例）通过ConsiliumCare应用程序在90天的观察期内对副作用进行了自我评估。在这个时期,参与医师记录了计划外(紧急)会诊和住院情况.将这些事件的发生率与从瑞士2个肿瘤中心获得的一组癌症患者的回顾性数据进行比较。
结果：两组患者在年龄和性别比例方面具有可比性，以及癌症实体和癌症分期联合委员会的分布。总的来说,每组139例患者接受化疗，39例接受其他治疗。看着所有的病人，Consilium组和对照组在每位患者的事件中没有发现显著差异(比值比0.742,90%CI0.455~1.206).然而,多元回归模型显示,Consilium组和"化疗"因子之间的相互作用项在5%水平上显著(P=.048).这激发了相应的亚组分析，表明在接受化疗的患者亚组中，干预组的风险相关降低。相应的比值比为0.53，90%CI0.288-0.957相当于Consilium组患者的风险减半，并表明临床相关效应在双侧10%水平上显著(P=.08，Fisher精确检验)。
结论：PRO研究的计划外会诊和住院情况与来自癌症患者的可比队列的回顾性数据的比较表明，定期使用基于应用程序的ePRO对接受化疗的患者具有积极作用。这些数据将在正在进行的随机PRO2研究(在ClinicalTrials.gov;NCT05425550注册)中得到验证。
背景：ClinicalTrials.govNCT03578731;https://www.clinicaltrials.gov/ct2/show/NCT03578731.
■RR2-10.2196/29271。
目的：当前的探索性分析旨在初步表明，与不使用真实世界护理应用程序的对照组相比，使用ConsiliumCare应用程序（最近更名为medidux；mobileHealthAG）对ePro的副作用进行结构化和定期自我评估对癌症患者的计划外咨询和住院的发生率具有可识别的影响。为了分析这一点，使用ConsiliumCare应用程序记录的癌症患者的计划外会诊和住院治疗的发生率,作为患者报告结局(PRO)研究的一部分,我们将其与在标准护理治疗期间在瑞士2个肿瘤中心收集的癌症患者的可比人群的相应数据进行回顾性比较.
方法：PRO研究中接受新辅助或非治疗性全身治疗的癌症患者（本分析中包括178例）通过ConsiliumCare应用程序在90天的观察期内对副作用进行了自我评估。在这个时期,参与医师记录了计划外(紧急)会诊和住院情况.将这些事件的发生率与从瑞士2个肿瘤中心获得的一组癌症患者的回顾性数据进行比较。
结果：两组患者在年龄和性别比例方面具有可比性，以及癌症实体和癌症分期联合委员会的分布。总的来说,每组139例患者接受化疗，39例接受其他治疗。看着所有的病人，Consilium组和对照组在每位患者的事件中没有发现显著差异(比值比0.742,90%CI0.455~1.206).然而,多元回归模型显示,Consilium组和"化疗"因子之间的相互作用项在5%水平上显著(P=.048).这激发了相应的亚组分析，表明在接受化疗的患者亚组中，干预组的风险相关降低。相应的比值比为0.53，90%CI0.288-0.957相当于Consilium组患者的风险减半，并表明临床相关效应在双侧10%水平上显著(P=.08，Fisher精确检验)。
结论：PRO研究的计划外会诊和住院情况与来自癌症患者的可比队列的回顾性数据的比较表明，定期使用基于应用程序的ePRO对接受化疗的患者具有积极作用。这些数据将在正在进行的随机PRO2研究(在ClinicalTrials.gov;NCT05425550注册)中得到验证。
背景：ClinicalTrials.govNCT03578731;https://www.clinicaltrials.gov/ct2/show/NCT03578731.
■RR2-10.2196/29271。
