Background
- Eligibility: searches and interactive medical record tools to support clinicians screening participants [11];
Methods
- Phase 1: Scoping of searches and a survey of NIHR funder staff to determine what digital tools are currently being used by funded clinical trials.
- Phase 2: (1) A survey of CTUs on their experiences of digital tools; (2) the development of a logic model to help classify the digital tools into generic categories and identify potential outcome measures for Phase 3 and future primary studies; (3) qualitative interviews with key stakeholders to identify the characteristics of digital tools that they would judge useful and potential disadvantages of these tools.
- Phase 3: A systematic mapping exercise to identify and describe studies of the effectiveness and accuracy of digital tools for recruitment and/or retention in RCTs [20].
Phase 1: Scoping of searches and a survey of funder staff
- Digital / tools to improve study recruitment / retention in trials / clinical trials
- Digital platforms for trial recruitment
- Retention in research studies / digital platforms in use
Phase 2: CTU survey
Phase 2: Qualitative interviews
Stakeholder groups (number of participants) | Example of the type of roles held | Eligibility criteria (involvement in one or more of) |
---|---|---|
Trialists in CTUs (n = 3) in primary/secondary care | Trialists and recruiters | Trial recruitment |
Management of trials (CTU staff) | ||
Research practitioners in primary care (n = 3) | Principal Investigators | Leading funding applications |
Research funding bodies (n = 3) | Funding committee members / Charities | Contribute to decision-making of funding allocation from charities or NIHR |
Ethics committees and Health Research Authority (n = 3) | Ethics committee members | Contribute to decision-making on research ethics |
Research participant/patient representatives (n = 4) | Research participant representatives | Experience of participating in trials |
Results
Phase 1: Scoping of searches and a survey of funder staff
n (%) | |
---|---|
NETSCC programme | |
EME | 4 (15.4) |
HTA | 16 (61.5) |
HSDR | 5 (19.2) |
PHR | 1 (3.9) |
Work stream | |
Commissioned | 14 (53.8) |
Researcher-led | 11 (42.3) |
Themed call | 1 (3.9) |
Example of digital tools used | n (%) |
---|---|
Social media (e.g. Facebook, Twitter) | 6 (23.1) |
Text messaging | 6 (23.1) |
Online project websites | 6 (23.1) |
Named online services (e.g. Quintet) | 3 (11.5) |
Software / Apps (e.g. bespoke for intervention such as StopApp digital intervention or unnamed digital software platform reported) | 4 (15.4) |
Limited information reported | 5 (19.2) |
Phase 2: CTU survey
Recruitment tools | n (%) |
---|---|
Database tool (CPRD - Clinical Practice Research Datalink, in-house built tool, disease registry) | 19 (46) |
Social media (e.g. Facebook, Twitter, YouTube) | 11(27) |
Trial websites | 7 (17) |
ISRCTN, clinicaltrials.gov | 3 (7) |
Other – in-house | 1 (2) |
Retention tools | n (%) |
---|---|
SMS / email reminders | 17 (59) |
Study websites | 3 (10) |
Apps and web-based data collection | 3 (10) |
Social media | 2 (7) |
Other – in-house | 4 (14) |
Recruitment tools | n (%) |
---|---|
Database tool (Clinical Practice Research Datalink [CPRD], in-house built tool, disease registry) | 10 (45) |
Social media (e.g. Facebook, Twitter, YouTube) | 6 (27) |
Trial websites | 4 (18) |
ISRCTN, clinicaltrials.gov | 1 (5) |
Other – in-house | 1 (5) |
Retention tools | n (%) |
---|---|
SMS / email reminders | 10 (67) |
Study websites | 0 (0) |
Apps and web-based data collection | 0 (0) |
Social media | 1 (7) |
Other – in-house | 4 (18) |
Task | Target | Possible tools |
---|---|---|
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 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
Stakeholder group → | Trialist secondary care | Primary care | Ethics committee | Funding committee | Participant representation | Totals |
---|---|---|---|---|---|---|
Interview framework topics ↓ | ||||||
Generic statements | 3 | 3 | 3 | 3 | NA | 12 |
Benefit | 2 | 2 | 0 | 3 | 4 | 11 |
Intended outcomes of digital tools | 1 | 0 | 0 | 1 | NA | 2 |
Acceptance | NA | NA | NA | NA | 4 | 4 |
Challenges/barriers | 2 | 3 | 3 | 3 | 4 | 15 |
Participant perspective | 2 | 2 | 2 | 1 | NA | 9 |
Awareness of evidence | 2 | 1 | 3 | 2 | NA | 8 |
Funding issues | 2 | 1 | 0 | 2 | 1 | 6 |
Ethics | 2 | 2 | 3 | 0 | 2 | 9 |
GDPR / Security | 2 | 1 | 1 | 1 | 4 | 9 |
PPI | 3 | 1 | 2 | 1 | NA | 7 |
Evidence | 2 | 2 | 0 | 3 | NA | 7 |
Tools used | 3 | 3 | 0 | 1 | NA | 7 |
Knowledge of digital tools | NA | NA | NA | NA | 4 | 4 |
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
For participant representatives, there was greater concern about how and where data are stored and how to legitimise the point of initial contact.‘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)
‘… 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 atclinicaltrials.gov, you know it is part of the government framework.’ (ID4 – Participant representative)
Theme 2: Inclusivity and engagement
‘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)
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.‘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)
‘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
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.‘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)
‘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
‘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)
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.‘ … 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)
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 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)
‘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
‘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)