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 programmes (Table 3). Only a limited number of trials provided a detailed account of the digital tools 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 (Table 4) and retention (Table 5). In the 24 responses, 41 recruitment and 29 retention tools were mentioned, and CTUs provided detailed answers for 22 recruitment tools (Table 6) and 15 retention tools (Table 7). The most frequently mentioned tools were related to database screening tools (e.g. Clinical Practice Research Datalink (CPRD) and in-house built screening tools (e.g. Medical Information Systems (EMIS)) (19/41, 46%). Of these 19 database screening tools, 10 responders (45%) provided additional information, of which seven (70%) respondents felt these database screening tools were the most effective. The reason (and to whom) these tools were considered effective was in identifying potential participants (for both Site staff and CTU staff) and reaching recruitment target (for CTU staff/CI). The reasons for using these tools and most frequently mentioned barriers were to identify patients quicker and thus save time, poor record keeping, reminders to recruit etc. (6/10, 60%). Other performance characteristics of these tools were; they were either commercial (4/10, 40%) or built in-house (5/10, 50%) and were mainly used across all disease areas (6/10, 60%), they were not specific to the needs of any care group (e.g. children, frail, adults with learning disabilities etc.) (9/10, 90%), and for all study types (7/10, 70%). To configure these tools an expert was required in most cases (7/10, 70%). Although social media was only mentioned by six responders (6/22, 27%), and was the most frequently mentioned tool for “increasing trial reach to participants” (5/6, 83%), the estimated effectiveness varied considerably, with only 17% stating “very effective” (1/6).
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%).
No CTU mentioned a tool that had caused problems for recruitment or retention.
Box 1 provides a list of potential digital tools to support recruitment and retention tasks that was developed from the survey results.
Box 1: List of potential digital tools to support recruitment and retention tasks
Task
|
Target
|
Possible tools
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Publicise a trial
|
Recruiters (site and CTU trial staff)
|
Social media, email campaign
|
Identify possible patients for a trial offline
|
Recruiters (site staff only)
|
Database screening (e.g. CPRD)
Trial eligibility checklist on trial website
|
Identify patients for trial during consultation
|
Recruiters (site staff only)
|
Automated flag based on Electronic Patient Records (EPR)
|
Ensure patient really was eligible for trial when recruited
|
Recruiter (site staff only)
|
EPR database check on entry
|
Incentivise recruiters
|
Recruiters (site and CTU trial staff)
|
Automated league table, lottery for recruiters
Simplified trial recruitment workflow
Online patient information/video etc.
|
Raise public awareness about trials in general
|
Public / patients
|
Social media, email campaigns
|
Help patients find a specific trial
|
Public / patients
|
clinicaltrials.gov, trial website; Google ads or pop up on disease website
|
Improve public understanding of a specific trial
|
Patients
|
Trial website
eConsent video, animated patient information leaflet
Web chat with trial nurse
App (software) providing tailored information for patient
|
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 Not Applicable.
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 then merged to five themes: security and transparency, inclusivity and engagement, Human interaction, obstacles and risks, and potential benefits of digital tools (shown in Box 2).
Box 2: Summary of themes identified
Theme 1: Security and transparency
- Security and legitimacy of information and data [sharing]
- Efficiency and transparency of information and data
-
Theme 2: Inclusivity and engagement
- Equity and inclusion of populations
- Recognition of the ability / inability to use digital tools
-
Theme 3: Human interaction
- Trade-off between human face to face and digital tools
- Lose sight of human interface and the importance of face to face connection
Theme 4: Obstacles and risks
- Obstacles preventing the use of digital tools (e.g. evidence, barriers, solutions)
- Risk of technology overload
Theme 5: Potential benefits
- Unknown potential for the use of digital tools (e.g. evidence)
- Reducing the burden on participants (e.g. convenience, time)
Theme 1: Security and transparency
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. Concerns around the risk of data breach, suitable digital platforms and anonymization of data were key considerations and concerns to all participants.
“there was a fear…there still is a fear…where is it going to, who is holding this information?...If you’re throwing out an invitation you have to know where you are throwing it.” (ID5-Ethics Committee member)
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.” (ID4-Participant representative)
Theme 2: Inclusivity and engagement
Adopting the use of digital tools across different types of populations was considered essential for all participant groups. This not only focused on the perspective of the individual but also the availability and acceptance of using a digital device, including using a digital interface (e.g., downloading an application to a mobile device). The key findings from stakeholder professionals mainly 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-Practitioner in Primary Care)
“Potential to exclude people based on their ability to use these tools…you might exclude people who don’t have a smart phone…” (ID3-Practitioners in Primary Care)
“Approaching people by a different route is potentially a way of providing information to people that they wouldn’t otherwise be given through the typical kind of health professionals route. It opens up an avenue for actually getting greater dissemination about research opportunities.” (ID1-Trialist)
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." (ID2- Participant representative)
Theme 3: Human interaction
The trade-off between the use of digital tools and having human interaction was an important consequence for consideration when using these methods to recruit and retain participants in trials.
“digital recruitment can kind of be seen as a somewhat arm’s length approach, as opposed to a face-to-face discussion. And I’m not saying that you have one without the other, but I have seen some research that suggests people recruited digitally if you like, whilst the recruitment was better the retention was poorer than recruitment via a face-to-face meeting.” (ID1-Trialist)
However, it was felt by the majority of the participants that as long as the appropriate ethical and legal frameworks are adhered to, there is less risk involved and provides reassurance to those taking part in a trial.
“I suppose the potential participants might be a bit frightened of the new…once you stop to think about it, they don’t worry, but I think the initial thing is…this bit of a fear of the new…the cyber divide is breaking down and even older people will be able to embrace it.” (ID4-Ethics Committee member)
Theme 4: Obstacles and risks
For some stakeholder groups, it was felt that a range of approaches and methods 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?" (ID01- participant representative)
“…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.” (ID11-Funder)
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-Funder)
A number of issues raised by the stakeholder groups focused on staffing issues and the level of expertise required with information technology, the potential cost of developing and setting up of digital tools, the barriers of understanding for funders and ethics committees, the speed at which technologies are advancing and the rapid uptake of usability (e.g. the risk of being obsolete) and how the risk of technical issues can hinder recruitment progression.
“we want to wait for the evidence to grow, because it’s quite early days I guess for whether multi-media does enhance information and understanding of potential participants.” (ID7-Ethics member)
“sometimes you drop functionality in your digital tool in order to satisfy everybody….they definitely don’t understand the different levels of security…You’ll get lots of things where they don’t really understand what’s more secure, what’s less secure.” (ID2-Trialist)
Theme 5: Potential benefits
The 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. The use of digital tools were seen as having the potential to widen the reach of participant engagement and provide the flexibility for participants to complete data entry.
“I can’t see any reason why you wouldn’t want to store the data digitally. The data is going to end up in an electronic format anyway.” (ID3- Participant representative)
“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-Ethics Committee member)
“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…” (ID4-Ethics Committee member)