An electronic patient-reported outcome (ePRO) platform was rapidly developed in China to monitor COVID-19 symptoms, adapting an existing framework initially designed for lung cancer surgery patients. This system, known as ePRO-CoV-SM, has undergone several iterations to address the evolving symptom profiles of emerging SARS-CoV-2 variants.
Development of ePRO-CoV-SM
The initial ePRO-CoV-SM was constructed based on an existing ePRO symptom data collection platform used for lung cancer surgery patients. The platform utilizes a WeChat mini program for patient self-reporting, connected to Redcap via an application program interface (API). The system allows project administrators to define symptom monitoring processes, including measurement scales, assessment schedules, and follow-up plans. Patients can easily complete symptom self-assessments via their smartphones, with data transmitted securely to the platform server.
Symptom measurement items were extracted from the Protocol for COVID-19 Diagnosis and Treatment issued by the National Health Commission of China. Two trained symptom researchers independently performed the extraction, consulting with a senior researcher to resolve disagreements. The final symptom list and measurement properties were determined through discussions with a study group, including experts on PRO symptoms and medical staff who treated COVID-19 patients.
Adaptation to Emerging Variants: ePRO-CoV-SM (2.0)
In response to the emergence of the SARS-CoV-2 BA.2.2 variant in Shanghai in February 2022, an updated version, ePRO-CoV-SM (2.0), was developed to enhance automation and address the modified symptom profile. This version integrates with a commercially developed data management system, ePRO Vision, and the Real-World Data Management Platform (RWDMP).
ePRO-CoV-SM (2.0) includes a browser-based project design backend, a patient management front, and the WeChat mini program. Medical professionals can preset symptom monitoring frequencies, reminder messages, and response time limits based on disease characteristics and clinical needs. Automatic registration and electronic reminders were added to address medical staff shortages. The platform sends reminder messages to patients and alerts supervising physicians upon completion of symptom reports, enabling timely review and intervention.
The symptom list was revised through a literature review and evaluation by clinicians with experience in diagnosing and treating COVID-19. An expert panel finalized the symptom list for ePRO-CoV-SM (2.0).
Real-World Application and Validation
The ePRO-CoV-SM platform has been validated in multiple real-world settings. A cohort study in Wanzhou monitored symptoms of asymptomatic SARS-CoV-2 infections using the initial ePRO-CoV-SM platform. The validation of ePRO-CoV-SM (2.0) was conducted in Shanghai between May and June 2022, monitoring symptoms of asymptomatic carriers during a surge of SARS-CoV-2 Omicron BA.2.2 infection.
In November 2022, during an outbreak of SARS-CoV-2 Omicron BA.5.2 in Chongqing, ePRO-CoV-SM (2.0) was rapidly implemented to monitor symptoms in centralized isolation sites. An expert panel selected a clinically meaningful and concise symptom list from the ePRO-CoV-SM (2.0) symptom item bank to enhance practical application.
Statistical analysis included assessing response rates, missing item rates, and symptom burden. Moderate-to-severe symptom severity was defined as a symptom score ≥ 4 points on a 0–10 scale. Statistical significance was set at p < 0.05.
