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Patients’ directly reported outcomes in certain rare and chronic diseases are considered reliable for understanding the disease’s natural history, palliative treatments that focus primarily on symptom control, and quality of life. Electronic Patient-Reported Outcome Measures (ePROMs) are now allowing these patients to self-report health conditions and treatment effectiveness remotely. This is paving the way for improving patient care as ePROMs can be used to monitor patients with reported health conditions coming directly from the patient, so caregivers and clinicians can know about the patient’s health concerns outside the clinical setting.
Methods for collecting patient information involve questionnaire-based assessments with branching logic and scoring, computer-assisted telephone interviewing (CATI), interactive voice response systems (IVRS), and screen-based systems. ePROM may be administered at a clinic or remotely in an unsupervised setting, such as the home or workplace.
Remote assessments can relate to symptoms, functional outcomes, or side effects of medications, and enable more timely and accurate self-reporting while also preventing potential recall bias.1 The use of ePROMs has been shown to improve medication adherence, clinical effectiveness, quality of life, and long-term survival rates.2 For example, in a study by Scripps, ePROMs positively impacted patients’ quality of life in 61.5% of cases. Furthermore, in 46.15% of cases, ePROMs guided primary care teams in making ethical decisions.3
Monitoring Changes in the Clinical Status Remotely
A closer relationship between technology and healthcare has begun to develop with ePROMs, electronic health records (EHRs), and comparative effectiveness research, converging into more patient-centered, technology-driven patient healthcare outcomes. ePROMs can supplement traditional approaches to clinical trials with the potential to improve outcomes and reduce operational burdens.
For instance, patients complete ePROs (electronic patient-reported outcomes) remotely, so changes in their clinical status can be monitored. That data is then used to determine whether the participants require outpatient hospital treatment. In-person clinic appointments are offered only to those unable to complete remote assessments. As such, ePROs can effectively utilize limited healthcare resources for operational efficiency.
Concerns on Quantifiable Benefits of Implementing ePROM
Despite the advantages, there have been concerns about the quantifiable benefits of implementing ePROMs in the existing workflows. The evidence for the impact of patient-clinician communication on clinical parameters has been limited. This is in part due to a low number of eligible reports used to conduct a systematic review and a few registries used practically and clinically in the palliative and end-of-life care settings. As such, more registries are required to confirm and reiterate the results of ePROM outcomes.4
Modular ePROM for Better Patient Screening, Enrollment, and e-consent Communications
The use of ePROMs can also precipitate patients’ experiences of survey fatigue, associated with reduced propensity to complete surveys due to comorbidities, older age, and perceptions of response burden, which may lead to a steady decline in survey completion over time.5 However, participant fatigue can be minimized using a modular digital platform to achieve better patient screening, enrollment, e-consent, omnichannel communications, and enabling participants to complete questionnaires in installments. The tool provides valuable opportunities to transform the quality and delivery of care for medically complex patients. Still, best practices are needed for maintaining patient and clinical research team engagements.
Technological advances in ePROMs have raised questions about whether clinical researchers are keeping pace with the technology or missing out on essential tools to address patient needs. Proper user training and certifications can help ensure the effective implementation of ePROMs in clinical studies. The patients’ response rates can be maximized by tracking key metrics, continuous evaluation, and improvement in personalized messaging, alerts, notifications, and reminders.
Flexible and Compliant Patient Questionnaire
A well-designed drag-and-drop custom ePROM form creation enables cohort studies, patient registries, and clinical studies to proceed faster and in a scalable way while keeping the clinical research sites, sponsors, and Clinical Research Organizations (CROs) compliant at all times. Patient diaries can be configured for easy logging of medication adherence, concomitant medications, or unexpected health outcomes, while the logistical burden of paper-based processing is eliminated. A well-architected ePRO solution is hosted on a secure cloud, such as Amazon Web Services (AWS), with the ability to automatically scale the infrastructure without any programming or customization.
Anywhere, Any Device, and Any Browser Access
Researchers and clinical study teams can configure eDiaries specific to a trial as well as recurring or one-time assessments. An electronic solution captures patient-reported outcomes data in real-time on a centralized clinical database. With a Software-as-a-Service (SaaS) model for a web-based application, researchers can access ePRO data from any browser-enabled device, on a pay-per-use basis or based on the number of patients submitting assessments in the study, with no installation necessary. A platform that is device and browser agnostic enables users to access it from their own existing device without requiring any specialized hardware provisioning or the logistics of supporting them on a per-clinic trial protocol-fit basis that scales to enterprise licensing options.
Bolstering Flexibility with Add-on Modules
A flexible ePROM solution can be bolstered with the flexibility to add-on modules, such as e-consent, multimodal communications capabilities, and video calling. A Bring Your Own Device (BYOD) capability allows the ePROM to fit on any browser-enabled device screen size. A modular ePROM SaaS model can help clinical researchers manage study budgets on a simple, per-participant subscription basis with automated enrollment workflows, electronic or video patient-reported outcomes (ePRO/vPRO), video, audio, SMS, and email communication, report uploads, and adverse event reporting.
Ensuring the Study Sponsor’s Burden of Compliance
Modular ePROM offers a path forward for researchers and clinicians interested in generating reliable clinical evidence, accelerating patient recruitment and retention, minimizing regulatory risk, and maximizing compliance. A modular solution is designed to be compliant with data protection guidelines such as GDPR (General Data Protection Regulation), Institutional Review Boards (IRBs), Good Clinical Practice (GCP) guidelines by the International Code of Harmonization (ICH) E6 R2, Human Subjects Protection Guidelines, and local and regional guidelines. This way, the modular ePROM can ensure that the platform provider assumes the burden of compliance with no burden on the part of the clinical trial sponsor.