Phase 1: Scoping of searches and a survey of funder staff
The scoping exercise revealed 46 examples of digital tools, approaches or services: 23 online tools and applications, 16 clinical trial companies offering recruitment and retention services, and seven online forums or companies facilitating patient involvement. The preliminary survey was sent to all 28 NETSCC research managers in February 2018. Thirteen staff completed the survey (46%) yielding 26 examples of NIHR-funded trials using digital tools (either for recruitment or retention—Table 2) across four NIHR funding schemes (Table 3).. There was no evidence of digital tool efficacy and only a limited number of trials provided a detailed account of the digital technology used to help enhance the recruitment and/or retention of participants.
Phase 2: CTU survey
Twenty-four (46%) of 52 UKCRC CTUs responded to the survey; six (25%) stated no prior tool use and 18 (75%) reported five main areas of digital tool experience in recruitment (Figure 1 and Table 4) and retention (Figure 2 and Table 5).. In the 24 responses, 41 recruitment and 29 retention tools were mentioned, and CTUs provided detailed answers for 22 recruitment tools (Figure 3 and Table 6) and 15 retention tools (Figure 4 and Table 7).. The most frequently mentioned tools were general practice database screening tools (e.g. Clinical Practice Research Datalink (CPRD) and Egton Medical Information Systems (EMIS)) (19/41, 46%). Of those mentioned, 45% (10/22) were chosen to answer detailed questions. Database screening tools for recruitment were either commercial (4/10, 40%) or built in-house (5/10, 50%) and were mainly used across all disease areas (5/10, 50%) and for all study types (7/10, 70%). To configure these tools required an expert in most cases (7/10, 70%) and they were considered very effective (7/10, 70%). The most frequently mentioned success criteria for digital tools were saving GP/clinician time and reaching more patients (4/10, 40%). Although social media was mentioned second (6/22, 27%), the estimated effectiveness varied considerably, with only 17% stating “very effective” (1/6).
Figures 1, 2 3 and 4 HERE
Tables 4, 5, 6 and 7 HERE
Fewer retention tools were mentioned by the responders, with almost half reporting the use of SMS/email reminders, (17/29, 59%) and most CTUs choosing to expand on the use of SMS/email reminders than any other tool (10/15, 67%). The majority of the SMS/email reminder programmes were developed in-house and bespoke (7/10, 70%), used for more than one study (9/10, 90%) and required an expert to develop the tool (7/10, 70%). However, the certainty surrounding effectiveness varied and only one CTU stated their tool to be very effective (10%).
Box 1 provides a list of potential digital tools to support recruitment and retentions tasks that was developed from the survey results.
Due to technical limitations, Box 1 is only available as a download in the supplemental files section.and retention tasks
Phase 2: Qualitative interviews
Sixteen interviews were conducted across five stakeholder groups during a two-month period (May-June 2018). The content analysis based on the interview framework topics (see Table 8) revealed that the two most commonly discussed areas across all stakeholders were the barriers, challenges, and benefits of using digital tools. There were some necessary differences between the interview frameworks for the professional and participant representative stakeholders, and these are identified in Table 8 under NA.
In order to help shape the analysis and results, we captured key headlines for each stakeholder group by the topic areas covered in the interviews to demonstrate the variability and/or similarities between stakeholders. The initial analysis revealed nine themes but these were merged to five: security and transparency, inclusivity, engagement and diversity, convenience and potential benefits, obstacles and risks associated to their use, and consequences of reduced human interaction (shown in Box 2).
Due to technical limitations, Box 2 is only available as a download in the supplemental files section.and retention tasks
Although there was unified acceptance of the use of digital tools, all participants felt that they should not lose sight of the issues and barriers around security, legitimacy and transparency of data. The key findings from stakeholder professionals focused on people’s ability to use digital tools and the appropriateness for some participant groups.
“Some patients, they’re quite happy having everything emailed, others want telephone calls…its different for everyone so I think you just have to be flexible.” (ID10)
“Potential to exclude people based on their ability to use these tools…you might exclude people who don’t have a smart phone…” (ID3)
However, for participant representatives there was greater concern about how and where data are stored, and how to legitimise the point of initial contact.
“…I would Google the email address, which I do quite frequently now, with all the GDPR stuff…I would look to see if it was a bona fide email, and go in via the internet rather than something that has perhaps been linked essentially…I think as long as you know that it is a…it has got governance, I suppose when you are looking at clinicaltrials.gov, you know it is part of the government framework.” (IDPR04)
There was a clear distinction between stakeholders about the value, benefit and influence of existing evidence (or rather lack of this). Charities were more likely to take an evidence-user driven approach, rather than rely on existing academic evidence.
“…we tend to come at it from a ‘How does the market behave when you ask it to do something?’ rather than ‘We need evidence to do it’ because this isn’t trying to introduce a health intervention…recruitment methods for lots of companies like banks and other commercial organisations, there’s a lot to learn from those, so we tend to come at it from that angle…we work out what it is they want to do that doesn’t rely on research evidence…they get back from contributing to and that’s consumer behaviour.” (ID12)
The participant representatives were generally accepting of digital tools, although they felt that careful consideration is needed when applying these tools across different participant groups, the consensus was more focused on use of data, and accessibility to participate in clinical trials.
“ “I just think if it’s going to help someone else, then they’re welcome to it… No, that doesn’t bother me…I would be more worried about things like my bank account than, you know, someone might know what things that I’ve had or what I’m doing.” (IDPR02)
For some stakeholder groups, it was felt that a range of approaches and methods used to recruit and retain participants should be offered to potential participants, rather than relying on the use of digital tools alone. Therefore, providing flexibility and choice about the use of multi-methods in order to recruit. However, it was also noted how there needs to be some recognition of the speed at which digital technology is evolving and the risks associated to this for both participants and trialists.
I don’t think you could have total digital, and maybe a freedom to say to the person if you need contact…and maybe they just phone up, because that is one to one as well isn’t it? And so having that alongside?” (IDPR01)
“the rapidity with which things become obsolete, in terms of digital platforms, is frighteningly rapid. I think that does complicate this space; it makes it more difficult to identify what’s best practice and then replicate it at an industrial scale…it’s almost that what you sign up for at the beginning of the trial, in many respects, is not going to be fit for purpose by the end of the trial. " (ID11)
Overall acceptance of digital technology was clear across all stakeholder groups, despite the lack of or use of evidence to support their use for recruitment and retention of participants.
“People are not bothered about it. I think they’ve got over the botheredliness of it all…it’s accepted that digital tools are extremely useful and in some instance the only way you’re going to get your likely participants…I think we’re getting better at it.” (ID5)
“You’ve got to demonstrate that you’ve got the expertise to handle the electronic aspect of your research…and have people been offered a choice…the principles of fair consent are the same whether its electronic or face-to-face…the principles of good research are still the same whether you’ve doing it electronically or by traditional methods.” (ID4)