Electronic submission of diaries initially began almost exclusively via “re purposing” devices such as palm pilots and PDAs to perform one function only – deliver the patient diary with its associated notifications and collect patient data. We refer to these devices as “dedicated devices” to illustrate their dedication to only the patient diary provision and collection function, where other functionalities of the device are disabled. With the advancement of technology, we can now choose from a variety of smartphones and tablets from different manufacturers and operating systems to be utilized for patient data collection.
A dedicated device approach today means we have chosen a specific device and an operating system platform to work with such as Android or Apple, where the study app is introduced for data collection and all other functionalities of the device are controlled externally by the electronic Patient Reported Outcomes (ePRO) provider. Functionality of the device is limited and can be modified remotely as the devices are controlled by central servers. Needless to say, this approach provides a tremendous amount of control over the device as it leaves the study centre with the patient, where notifications, diary delivery times and availability windows can be modified any time and pushed instantly to the device. This is also true for any ePRO instrument changes where questions can be modified and go live in a matter of seconds. Dedicated device ePRO approach means that every patient will get the exact same type of device and complete their diaries in the same manner as all other patients will.
While the conventional provision of ePRO is to provide patients with a handheld device dedicated to study use, an emerging alternative is the Bring You Own Device method. The adoption of the BYOD approach is driven by the widespread use of personal smartphones and tablets and the ability to leverage the use of the subject’s own internet or data plan. However, the utilization of BYOD raises a number of operative and scientific concerns that will need to be sorted out before it becomes a routinely used method.
There are two ways for patients to submit data through their own devices. One is to utilize their web browsers, a process that can provide very different experiences for the patients based on the combination of device and browser used. Functionality can vary across different browsers, and an even more significant concern is the transmission of data via an open internet connection. An alternative approach is to utilize a study specific ePRO app. With the exception of potential screen size differences across devices, the app would display the ePRO instruments in a consistent manner on all devices (Yeomans, 2014).
Native apps will allow for data entry while the device may not be connected to the internet which may be an advantage in some areas with poor connectivity (Coons, Eremenco, Lundy, & O’Donohoe, 2014). However, they pose a set of concerns with the Research Ethics Boards as the data is stored on the device itself, a feature that raises concerns over potential data loss and compromise of patient privacy in the event of device loss. Security measures have to be evaluated to ensure that the patient data is stored with a satisfactory level of security and in line with the relevant laws and regulations.
A challenge in both instances with app utilization is ensuring the wide range of devices and operating systems and internet browsers that are available are accommodated. Typically, apps are developed for the most popular operating systems such as Android and iOS, which still creates a risk for excluding some countries and populations.
In contrast with dedicated devices, the BYOD approach provides less control over the devices as app notifications and updates cannot be pushed on the patient’s personal device. In other words, the patient has control over their device, and the app has to be accommodating to the environment. If the patient shuts off the sound on their phone, they will be able to ignore audio alarms that may be automatically setup on the app. The subject may also delete the app anytime, and the methods to alert research staff of such actions is limited. These factors can be a significant threat to patient compliance in the study.