ePROs: What are Electronic Patient Reported Outcomes?
The term patient-reported outcomes (PROs) refers to a health outcome directly based on patient self-reporting. PROs are a key aspect of clinical trials and treatments, and in modern health care settings, many organizations are transitioning away from pen-and-paper data collection methods and moving to electronic patient-reported outcomes (ePROs).
Analog vs. DigitalResearch has shown there are a number of issues with paper-based PROs, especially when individuals are unsupervised. Health journal Patient notes patients often provide untimely, unreadable, incomplete, or faulty data via paper-based approaches. For instance, an individual might back- or forward-fill diary entries in an effort to save time, skip over items on a questionnaire, or write answers illegibly. ePRO systems can help mitigate many of these issues, as they provide a more structured data-collection method. There are a number of benefits to using digital means to collect patient-reported data, including improved accuracy and compliance. With electronic data collection, the date and time of each entry is recorded, and patients cannot skip questions or provide out-of-range responses. Certain ePRO delivery systems can even provide alarms or reminders to patients if timely responses are imperative. These abilities often lead to more accurate, complete data.
Types of ePROsThere are three general collection categories for ePROs. Each type of ePRO has its merits, and a provider planning to incorporate ePROs should consider both the appropriateness of each collection method for their patient population and intended use, as well as whether more than one collection method should be used.
Interactive Voice Response SystemsA telephone-based Interactive Voice Response System (IVRS) is similar to customer care menus frequently used in industries like retail and banking, and feature automated calls and allow patients to record responses using a touch-tone keypad. An IVRS is extremely customizable on the back-end, and they are also easy for most patients to navigate. Further, according to Perspectives in Clinical Research, these systems are easy to deploy and scale, which is beneficial in trials with a large number of participants or when multiple trials are being conducted simultaneously.
Screen-Based Reporting DevicesAnother style of ePRO involves some type of electronic device, such as a smartphone, tablet, computer, or even a wearable medical device. Patients access software on the device that presents them with questions; they select their answers, which are digitally recorded. These types of ePROs can either be used in the patient’s home as an electronic diary for more timely data collection or in a supervised clinical setting. Originally, screen-based ePRO data capture was done on personal digital assistants that stored the data on the device until it could be uploaded to a central server. However, the major downsides of this strategy are the cost of supplying devices to all participants and training individuals on how to properly use the technology. Today, the more common option is web- and app-based ePRO solutions, many of which can be installed onto the patient’s own electronic devices—a practice referred to as Bring-Your-Own-Device (BYOD), according to research in Patients. Given the prominence of smartphones and tablets, this option is convenient and cost-efficient, and it typically requires less coaching, as individuals are already familiar with the device. However, BYOD programs still have a few disadvantages, including:
- Not all participants may own a compatible device.
- Not all participants may have consistent internet access.
- The physical and electronic security of devices may be compromised.
- Mobile operating systems are updated frequently, and app-based ePROs must be updated at the same pace.
- Having to convince patients to download an ePRO app would be a barrier to use.
SMS Text SolutionsIn recent years, the use of SMS text solutions in collecting ePROs has increased dramatically. It’s a trend that seems likely to continue, given the ubiquitous nature of cell phones and texting around the world, as evidenced by these statistics:
- 96% of adults in the U.S. own a cell phone.
- At least 97% of smartphone owners text regularly.
- Text messaging is the #1 preferred form of communication.
The Power ePROsePROs gather a whole range of measurements that cover a patient’s health status in terms of their physical and mental status as well as their social well-being. There is increasing recognition of the role that non-clinical factors, such as those that can be identified via ePROs, play in a patient’s overall health. A recent Kaiser Family Foundation report detailed how 60 percent of the factors that impact overall health were social and environmental in origin, while only 10 percent could be attributed to clinical care (the other 30 percent were genetic in nature). The ability to identify a wide range of issues that are ultimately clinically meaningful increases the ability of providers to address those issues and work proactively to preserve patient health. In addition, there is evidence that the real-time nature of ePROs also plays a role in the ability to improve outcomes. In a recent clinical trial, the survival interval of cancer patients who utilized ePROs increased by 5 months, possibly owing to the ability of clinical staff to respond quickly to potential issues and avoid adverse downstream consequences. A recent JAMIA report noted that electronic PROs have also been shown to improve recognition by clinical teams of chemotoxicity, help in comparing treatment decisions for osteoarthritis, and improve management of severe depression.
The Future of ePROsElectronic data collection is the new norm for data collection in clinical settings, and is increasingly being used as a way to better track and manage patients outside the clinical setting. ePROs have so far been used most extensively in the context of clinical trials, but there is an inexorable move towards ePROS in other arenas. The U.S. Food and Drug Administration recently deployed an app-based data collection system called MyStudies to inform regulatory decision-making. ePROs are also a feature in Oncology Care First, the proposed follow-up to the CMS Oncology Care Model. Like EHRs, ePROs are only valuable if the data they gather can be turned into action. Regardless, the potential benefits to patients in terms of outcomes and to providers in terms of efficiency and quality of care, along with the drive towards electronic data capture by various government entities, ensure that ePROs will see continued growth as an important component of high-quality care.
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