Efficace Fabio, Breccia Massimo, Fazi Paola, Cottone Francesco, Holzner Bernhard, Vignetti Marco
Data Center and Health Outcomes Research Unit, Italian Group for Adult Haematologic Diseases (GIMEMA), Rome, Italy.
Department of Precision and Translational Medicine, Sapienza University, Rome, Italy.
JMIR Res Protoc. 2021 Jun 1;10(6):e25271. doi: 10.2196/25271.
The COVID-19 pandemic has raised unprecedented challenges in the management of patients with cancer and has increased the demands for digital health tools that, for example, could facilitate remote monitoring of patients. Based on this, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) has recently developed a digital health tool dedicated to patients with hematologic malignancies: the GIMEMA-ALLIANCE platform.
The main objectives of this web-based platform are to generate relevant data to better understand quality of life, symptoms, and medication adherence during the COVID-19 pandemic and postpandemic era; to develop a prospective real-life registry on outcomes of patients with hematologic cancer, with or without a diagnosis of COVID-19; and to facilitate patient-centered care in routine practice.
The platform consists of physician- and patient-secure portals and enables electronic patient-reported outcome (ePRO) assessments with real-time graphical presentation to physicians of individual patient symptoms and quality-of-life outcomes. Automated alerts are sent to treating hematologists based on the following predetermined criteria: presence of clinically important problems and symptoms, problems with adherence to therapy, and risk of COVID-19 diagnosis. The platform also allows physicians to set up video consultations. Clinical information regarding disease and treatment as well as clinical and survival outcomes are also prospectively collected.
Recruitment of participants started in December 2020. As of April 2021, a total of 116 patients have been enrolled in this study. Use of this platform may help to improve patient-physician communication and help hematologists in the early recognition of clinically important problems and symptoms of their patients. More than 20 community and university-based hospitals have currently agreed to participate. In addition to patient-reported outcome data, the prospective collection of disease- and treatment-related information, as well as data on possible COVID-19 diagnosis and COVID-19 vaccination, will allow the development of a large database to also identify subgroups of patients at risk of poor outcomes.
Data generated via this platform will help to answer clinically relevant questions for patients with hematologic malignancies during the COVID-19 pandemic and postpandemic era. The use of the GIMEMA-ALLIANCE platform in routine practice may also contribute to enhancing patient-centered care.
ClinicalTrials.gov NCT04581187; https://clinicaltrials.gov/ct2/show/NCT04581187.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25271.
新型冠状病毒肺炎（COVID-19）大流行给癌症患者的管理带来了前所未有的挑战，并增加了对数字健康工具的需求，例如有助于对患者进行远程监测的工具。基于此，意大利成人血液疾病研究组（Gruppo Italiano Malattie Ematologiche dell'Adulto, GIMEMA）最近开发了一种专门针对血液系统恶性肿瘤患者的数字健康工具：GIMEMA-ALLIANCE平台。
这个基于网络的平台的主要目标是生成相关数据，以更好地了解COVID-19大流行期间及大流行后时代的生活质量、症状和药物依从性；建立一个关于血液系统癌症患者（无论是否诊断为COVID-19）结局的前瞻性真实世界登记系统；并在日常实践中促进以患者为中心的护理。
该平台由医生和患者安全门户组成，能够进行电子患者报告结局（ePRO）评估，并向医生实时以图形方式展示个体患者的症状和生活质量结局。根据以下预先确定的标准向血液科主治医生发送自动警报：存在具有临床重要性的问题和症状、治疗依从性问题以及COVID-19诊断风险。该平台还允许医生进行视频会诊。还前瞻性收集有关疾病和治疗的临床信息以及临床和生存结局。
参与者招募于2020年12月开始。截至2021年4月，共有116名患者纳入本研究。使用该平台可能有助于改善医患沟通，并帮助血液科医生早期识别患者具有临床重要性的问题和症状。目前已有20多家社区和大学附属医院同意参与。除了患者报告的结局数据外，前瞻性收集疾病和治疗相关信息以及可能的COVID-19诊断和COVID-19疫苗接种数据，将有助于建立一个大型数据库，也有助于识别预后不良风险的患者亚组。
通过该平台生成的数据将有助于回答COVID-19大流行期间及大流行后时代血液系统恶性肿瘤患者的临床相关问题。在日常实践中使用GIMEMA-ALLIANCE平台也可能有助于加强以患者为中心的护理。
ClinicalTrials.gov NCT04581187；https://clinicaltrials.gov/ct2/show/NCT04581187。
国际注册报告识别码（IRRID）：PRR1-10.2196/25271。
