What to Look for in an ePRO System

Electronic Participant/Patient Reported Outcomes (ePRO) are patient-entered submissions. Collecting this type of data is incredibly informative in human trials. While they can be subjective, they represent 'real world' data collected beyond the realms of laboratories and white coats. This valuable metadata can provide incredible insights into the wider functionalities of interventions tested in human participant research.

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ePRO began as physical forms (PRO) and has gradually evolved into digital data collection. Data submitted via an ePRO method is typically collected by web forms, or, by dedicated smartphone and web apps. While form-building software is not really a new concept, new innovations and integrations with other service providers (including wearables) can allow ePRO to be lightyears ahead of traditional PRO in terms of the value and actionable data that can be acquired.

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Top 9 features of a great ePRO system

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• Translation Options
• Data Validation and Field Limitations
• User-friendly Interface
• Auto-save/Drafts
• Offline Options
• Multiple Points of Contact
• Integrations
• Co-development Options
• Encryption and Security

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Translation Options

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As diversity in clinical research is becoming more important, we are finding that potential participants of many ethnic backgrounds can and should take part - excellent news. Depending on the research question, whether a participant is black, white, Asian, from the Americas or Chinese could be completely irrelevant - and we should welcome everyone. Let’s suppose we are exploring the potential of a nutritional supplement to reduce inflammation in young adults. A comprehensive study should address this in wider and more diverse cohorts. While English is a major language spoken across the world, Arabic, Spanish, Chinese and many other languages are dominant, too. By restricting your study to one language you are potentially losing out valuable data insights into real people from many different equally important backgrounds. Providing multiple language options can help reduce experimental bias by making research more inclusive than ever.

Data Validation and Field Limitations

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According to GCP guidelines, accurate and complete data (ALCOA-C) are essential in reporting robust and reliable outcomes in any study. Paper-based forms can allow for the introduction of many errors, and even digital systems without validation and field limitations can introduce many errors. If you are experienced in clinical research, you will likely have seen many errors in your time. Despite data being entered digitally, without field and data validation, a value for ‘height’ could still be logged as ‘N/A’, ‘70%’, ‘400 metres’ or other non-sensical values. Be sure that you look for these features in your ePRO vendor. Options which also come under this umbrella include required fields. Essential data critical to the study and its primary outcomes must not be missed. Not just for data completeness, but also for participant safety. When designing forms, you should be able to specify that some items can’t be skipped – whoever is entering it.

User-friendly Interface

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By the very nature of clinical trials, you can never truly envisage who your participants will be. Yes, you will be able to specify the inclusion/exclusion criteria, however, this rarely involves the participant conveying to you how comfortable and adept they are with technology, if they have used digital forms for data entry before and so on. An ePRO system must be simple and friendly and easy-to-use for users of all experience levels. If there is room for confusion and mistakes, it will likely happen at some point.

Auto-save/Drafts

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Some ePRO forms can be incredibly lengthy. Checkboxes, dropdowns and radio selectors are great for fast submissions, however, in the instance that users need to enter text to describe something in more detail (such as food diaries), this can take up significant amounts of time. By offering auto-save options and drafts, you not only allow the participant the flexibility to engage when it suits them, but also prevent a lack of interest when they might risk losing most of a form they have already filled in when they need to take a break. If you've ever been in a situation where a long form bugs out, or an accidental refresh starts you on a clean slate, you will know how frustrating this can be. Second time around? your data might be different. Your frustration might even change your responses - especially for mood and quality of life (QoL) items.

Offline Options

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Similar to the previous point, offline options are a must. Not everyone will have data availability or signal when submitting their forms. If participants are undertaking ePRO submissions on-the-go, they will more than likely encounter spaces with poor signal (perhaps in a tunnel whilst taking the train or bus). An ePRO system which can accommodate offline submissions which can be uploaded and synced to the data repository as soon as possible is a must.

Multiple Points of Contact

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Many study co-ordinators and sites are taking a step back when it comes to physical and verbal participant engagement. Emails and phone call communication is dropping significantly where technology can fill in this space with automations. However, there must always be a study contact in the case of an emergency – and this might be through multiple means. Tools including instant messaging integrations, email, phone call options, SMS and Fax (even a physical location to visit) should all be available through ePRO. Participants will likely have a smartphone with them most of the time. Allowing them a digital handbook with all the contacts they need can help protect them should a bad situation or adverse event arise. An ethical committee (IRB/REC) won't likely approve a study if your participants aren't offered the support they might need during the course of the study (even from a distance!).

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Integrations 

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Everyone will have systems of choice for given work activities, so why reinvent the wheel? If users want to continue to work with existing systems, then providing integrations surely makes both systems more powerful. Great software doesn't happen overnight and tried and tested web apps, data storage platforms or databases will have been improved over many years to provide excellent functionality and user interfaces. Software should be fun, and you should never feel locked-in. With the emergence of wearables, too, it's becoming more important for ePRO vendors to work with wearables companies to get value added data with ease.

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Co-development Options

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We've all heard it many times - a closed door policy on bespoke and customised features. A good ePRO vendor should work with you to provide solutions that work for you. Out-of-the-box, they might provide the 99% of what you need, but what about your ideas for a way to go that extra mile to achieve perfection? Every site, CRO or research team is different, and with more end users comes both more conversations and more opportunity for innovation. Speak to your ePRO vendor and ask what their policy is on joining with them on their roadmap journey. If they are willing, make sure the cost is reasonable, or free as part of their service.

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Encryption and Security

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Arguably the most important point of all – trials will often collect very personal information. This could be personally identifiable information (PII) and other metadata which are very private for the participant. Unless the data is both collected and stored in a secure way, there is a risk of a data breach. Data breaches are increasingly common, but they can be mitigated by taking essential steps. If data is sufficiently encrypted, even data taken by force through a breach can’t be decrypted (at least not easily) and still provides some protection over participant information. As we continually traverse the digital space in clinical trials, supporting participant health and wellbeing now, by association, includes their data, and frameworks such as HIPAA and GDPR help ensure that we are well-versed on the importance of data protection.

What do you look for in an ePRO system?

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