ARTICLE 6: Data collection: Exploring the pros and cons of a BYOD approach versus Provisioning Devices
In the sixth article of our series of articles on Managing Data and eClinical solutions for Medical Device Companies, the CRFWEB team look at the options available for patient reported outcomes. We review the pros and cons of deploying a “Bring Your Own Device” (BYOD) strategy for your study in comparison with directly providing devices to patients or subjects – the so-called provisioning devices (PD) approach.
We’ll explain the benefits and drawbacks of both BYOD and PD and suggest how and where each strategy is best deployed.
Going mobile
29th June 2007…anyone? Yes! the launch date of the very first iPhone- well done there, at the back. Since Microsoft’s Steve Ballmer famously mocked the “$500 phone…without a keyboard” that autumn, the world has witnessed an extraordinary uptake in these revolutionary pocket computers – not to mention tablets. The ubiquity of such devices is not confined to younger age groups. In 2020, some 87% of UK citizens between the ages of 55 to 64 had a smartphone, and even amongst the 65+ cohort, the number was 65%. All other age groups topped 95%. Whilst the UK has some of the highest figures for smart phone penetration in the world, much of Europe is pretty similar and, after a slower start, the US is catching up rapidly. Elsewhere in the world, mobile technology has allowed countries to leapfrog many more developed countries in the adoption of payment and trading technologies which has turbocharged previously sclerotic economies by creating ready access to liquidity and ease of transaction.
The technology required to ensure interactivity and privacy is well understood, and the use of apps is so commonplace that to offer a service WITHOUT an app places any commercial enterprise at a significant disadvantage.
Referencing apps was once the epitome of hipster cool, nowadays it would be more like dad dancing…however, it’s hard to underestimate just how important the WIFI and app revolutions have both been. These technologies, combined with rapid advances in privacy and interoperability, have allowed companies everywhere to develop sophisticated voice and data applications to deliver commercial services and transactions as well as fundamentally changing corporate data and technology infrastructures. Nowadays, employees can use their own devices to interact with their colleagues, their data, and the full range of internal services, securely and at no cost, offering very significant hardware and logistical savings.
The benefits of ePRO
Mobile technology, then, would seem to offer tremendous opportunities for clinical trials and investigations. However, the very natural conservatism and caution of the pharma/biotech and medical device sectors to adopt EDC in general has meant that, to date, electronic patient-reported outcomes (ePRO) technology has not, yet, been widely used in clinical trials and investigations. This is, however, now changing rapidly.
The key benefits of ePRO – either via a provisioned (supplied) device or via BYOD (Bring Your Own Device)- are clear:
- Efficient means of gathering and validating data.
- Provides a simple means of gathering more qualitative/subjective feedback from the patient or subject (the “patient voice”) and dramatically improving patient compliance over paper diaries and questionnaires.
- Reducing or entirely removing the burden of data entry from paper forms
- It opens up the potential of gathering subject consent electronically – eConsent. This in principle simplifies this essential element of the study or investigation process and specifically and enables the gathering of informed consent for decentralized trials much more easily than paper methods. A word of caution – eConsent can sometimes be seen as the holy grail of the future of clinical trials but it’s also one that is riddled with complexity, regulatory and compliance challenges.
- A move to eSource and away from the demands of Source Data Verification (SDV) – what can be a huge expense in the trial process is largely eradicated when the data source is the subject (although some of this is offset with subject compliance challenges).
Within the sector, there remain concerns about protocol compliance, data quality and data privacy when using the patients’ or subjects’ mobile devices, but the mobile technologies now widely available more than meet these challenges.
So, working on the assumption that ePRO is a GOOD THING, how then is it best delivered? Currently the most commonplace means is via a vendor supplied device, but BYOD is now garnering serious attention, too. In this article we’ll look at the benefits and drawbacks of both approaches. It’s important to recognise that BYOD will also bring into play other widely used and well understood devices – desktops, laptops, and tablets – not just smartphones.
Provisioned Devices (PD) – the benefits
Data collection platform standardization. Minimizing data variability in clinical data is, of course, always highly desirable but there will times when this is of central importance. Clearly, pre-market clinical trials for new drugs or devices of a higher risk class will often demand the highest level of data standardization and as such a provisioned device strategy will usually be far more preferable than BYOD, which, inevitably, will have a lower bound on data variability due to the vast array of devices on the market.
Minimizing patient/subject risk and protocol violation. With centralized control and change management, sponsors can more easily ensure that devices are used correctly and roll-out necessary changes as a study progresses; it’s easier to ensure that both risk to subjects/patients and protocol violations are both minimized. With BYOD, such ongoing control and change management is necessarily more complex.
Simplicity of recording eConsent. Not having to reply upon a standardized app means that the specific and appropriate eConsent for the trial or study can be more straightforwardly obtained.
Better network availability minimizing data loss. With PD, the patient or subject will be connecting to the best local 4G/5G network selected by the sponsor’s technology partner or will straightforwardly access the data centre via a pre-installed VPN using the study site’s own network. PD therefore will always provide the least levels of disruption due to the vagaries of local network availability.
Re-provisioning of devices. Sponsors can rapidly replace damaged or lost devices, minimizing or preventing loss of data and data integrity. With BYOD, device replacement is dependent on the actions of the patient or subject.
Support standardization. With PD, only 1 type of device needs to be supported – furthermore, there will no issues about where a support call should be placed – with the local network/device supplier or the study helpdesk.
Provisioned Devices (PD) – the drawbacks
The cost of provisioning, distributing, and supporting devices. Clearly, it’s possible that the cost of delivering PD could be huge. Some trials or studies involve 1000s of people over several countries and may last several years; this is the single most significant issue to consider when thinking about a PD approach to ePRO.
Compliance risk. Provisioned devices may not be accessed that often and, as they are accessed for one purpose only, it’s more likely that a patient or subject might either simply forget or are more likely to make errors – particularly if they belong to an older age group. Anecdotally, the capability of older age groups or patients/subjects that may have some level of visual impairment to access their ePRO account via desktop systems has also been cited as a benefit.
Upfront training costs. As subjects will be using an unfamiliar device, there will be an increased cost associated with training them on device use.
BYOD – the benefits
Ease of use and Compliance. The most widely cited benefit of BYOD is increased compliance. Patients or subjects understand their devices – they know how to use apps and where to find them, and of course, tend to have them at hand all day. They can also set their reminders and their preferences, and this familiarity and ready access should translate into increased compliance with protocols. Admittedly, this benefit is largely anecdotal as there is a shortage of independent, peer reviewed evidence. In contrast, vendor supplied devices may not be accessed that often and as they are accessed for one purpose only, it’s more likely that a patient or subject might either simply forget or are more likely to make errors – particularly if they belong to an older age group. Anecdotally, the capability of older age groups or patients/subjects that may have some level of visual impairment to access their ePRO account via desktop systems has also been cited as a benefit.
Reduced cost of delivering ePRO. Of course, NOT having to source, buy, distribute, and maintain a large number of mobile devices (often across several countries) is the obvious major benefit, but not the only one. The decision to use ePRO is not without other very significant cost considerations. Applications needed to be built and thoroughly tested; they will need to be hosted – and often that might mean being hosted in several countries in an international study to meet local data privacy laws – and they will need to be supported. Most of these costs are carried whether a vendor device or BYOD strategy is deployed, but BYOD scores here on support. The greater the patient/subject ease with their device, the less likely they are to need support, and this means the resources required to deliver this critical function will be reduced – often significantly.
Reduced cost of delivering patient/subject training. As above, greater device familiarity will also mean that the cost of training the patient/subject in ePRO usage should be quicker, easier, and therefore, less costly.
BYOD – the drawbacks
Application Equivalence. Patients and subjects’ devices will present a challenge in terms of cost to ensure that all users will be getting essentially the same experience, irrespective of the device and operating system in use. This is particularly challenging if users are expected to view and interact with highly graphical content. The good news is that, by and large, this problem is well understood by application developers and there are tried and tested ways of ensuring equivalence across the device/operating system matrix, but it comes at a cost, and is not fool proof. All developers will have stories of device/OS combos that defy resolution, but these are increasingly rare nowadays. However, upgrades can cause noise in the system and so the skills and capabilities to expertly troubleshoot these often-frustrating issues need to be in place in the support team.
The risk of Data Loss. With BYOD data loss could be an issue. Data might not get sent due to Wi-Fi issues or restrictions on data plans. The vagaries of how people use their devices might also present challenges – for example, turning off notifications and forgetting to turn them on again (a personal favourite) and missing a reporting window in consequence. Patients or subjects changing devices mid study and forgetting to migrate the ePRO software to the new device is not unheard of.
Patient/subject non-participation. Of course, some patients or subjects may not own a suitable device, or simply not wish to use it. Often then, a BYOD strategy will necessarily need to include a plan to provide and support devices for these participants. This is important where it is vital to ensure that outcomes are not skewed by sampling only those participants that own and wish to use appropriate technology.
App or Webapp?
We’ve discussed application equivalency above, but another consideration to make is whether to choose to use a native app or simply to make available a URL to a mobile-optimal webpage that has the look and feel of a native app – a so-called Webapp. Native apps have the upside that data can be collected without a network connection, but they DO have to be downloaded and this is where maintaining technical compatibility can be an issue with OS updates or if, as described above, participants change their device over the study time. Even so, a native app approach is still probably going to be a better bet where there is need to record data continuously over time (e.g., daily, or even more than once a day) or where connectivity is an issue. Webapp comes to the fore where data is recorded more episodically over a long period of time; connectivity can be better controlled in such studies and with webapp approach, there are no compatability issues. So, getting the choice between app and webapp wrong could impact badly on data collection.
Resistance is futile?
The growing world-wide ubiquity of devices and underpinning network technologies that support effective BYOD strategies for ePRO means that this approach may already be the default option for many protocols. However, there will always be study types – often dictated by patient/subject capabilities and/or the need for a more hands-on role for the study site staff, where a standardised device may continue to be the best option. For many other studies, too, there will remain a need to provide devices to make sure that device ownership does not skew outcomes.
How CRFWEB can help you
Bring Your Own Device (BYOD) Model
Our BYOD model is integrated into the CRFWEB system. A study, or visit, is designated for patient-led entry in the design page, logins and passwords created, and the subject is then able to download the CLINDOX app from the Apple APP store for IOS users, or from the google play store for Android users. Our latest release of the CLINDOX app, offers users a clear and simple user interface for ePRO or eDiary data entry.
Device Supplied Model
We partner with Stefanini, world leaders in the provisioned device field, for ePRO applications where provisioning is the desired fulfillment route. Our relationship ensures seamless integration. However, we are happy to work with the supplier of your choice.
The study is still designed and built using the CRFWEB eDiary or ePRO module and access is controlled via the supplied device.
