Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study

doi:10.21203/rs.2.12497/v1

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Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study

https://doi.org/10.21203/rs.2.12497/v1

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published 03 Apr, 2020

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Background

Recruitment and retention of participants in Randomised Controlled Trials (RCTs) is a key determinant of success, but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful.

Methods

A scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March-June 2018. Qualitative data were analysed using a content analysis and inductive approach.

Results

Responses from 24 CTUs (46%) identified that database-screening tools were the most widely used digital tool for recruitment, with the most frequent reported success criteria being saving General Practitioner time and reaching more patients. Fewer retention tools were used, with Short Message Service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: ‘security and transparency’, ‘inclusivity and engagement’, ‘human interaction’, ‘obstacles and risks’ and ‘potential benefits’. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants.

Conclusions

Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.

Internal Medicine

Integrative & Complementary Medicine

Translational Medicine

digital tool

participant recruitment

participant retention

qualitative

survey

clinical trials unit

Recruitment of participants to, and their retention in, randomised controlled trials (RCTs) is a key determinant of research efficiency, but it can be challenging.¹ In reviews of clinical trials funded by the UK Medical Research Council (MRC) and the National Institute for Heath Research (NIHR) Health Technology Assessment (HTA) programme² the proportion of trials achieving their original recruitment target ranged from only 31% (of 114 trials that recruited between 1994 and 2002) to 56% (85/151), with more than 80% of the final target sample size achieved in 79% (119/151) of RCTs reporting from 2004 to April 2016.^{3 4} Although there appears to have been some improvement over time, a recent study shows that, in the cohort of RCTs selected, 44% failed to reach their target,³ despite considerable interest in approaches that might improve study recruitment and reduce the need for study extension.^{5 6} Despite the vast amount of literature on strategies to improve recruitment and retention in clinical trials, the quality of the evidence is lacking.^5–10 The recently updated Cochrane Review on strategies to improve recruitment to randomised trials found only three studies with a high Grading of Recommendations Assessment, Development and Evaluation (GRADE) rated evidence.⁶ Given the lack of high quality evidence and certainty around resource intensive techniques to improve recruitment and retention, trialists and CTUs are increasingly exploring the value of digital tools as a potentially more viable option to identify, recruit and retain participants. Existing literature investigating this application of digital technology/tools has focused on the following:

Eligibility: searches and interactive medical record tools to support clinicians screening participants11
Recruitment: trial websites, social media and email campaigns to engage with the broader public12–15
Retention: Emails, interactive websites, text messages or apps to retain patients enrolled in trials and help them meet medication or behavioural adherence, or outcome assessment criteria9 10 16–18

In theory, these tools should reduce research costs and waste and speed up the delivery of results, improve recruitment reach and reduce recruitment of ineligible patients (around 6% in one study¹¹). However, selecting an appropriate digital tool for a trial is challenging because few have been evaluated rigorously. Also, different success metrics are used: for example, reduced screening time, improved coverage of recruitment or percentage of patients recruited. We need to understand which success metrics and tool features are most relevant to stakeholders to ensure wider uptake of effective tools.

One systematic review, on databases to improve trial recruitment, located only nine studies using reasonably robust methods out of the 101 eligible studies.¹⁹ It concluded that databases could reduce the time taken to screen participants, improve participant coverage and actual recruitment rates by between 14%, though four of the five studies making these measurements used an uncontrolled before-after design and the fifth was confounded. Therefore, there is a need to assemble, map and critically appraise the evidence base for these digital tools before synthesis, where appropriate. Only then can we confidently advise on the wider use of such digital tools by trialists, or on the need for further primary research.

The aim of this study was to answer the following two questions: i) What digital tools that could help identify, recruit or retain people in trials are used in UK CTUs? ii) What performance characteristics do trialists and CTUs require of digital tools for them to be judged useful?

The research reported here was part of a broader NIHR-funded project “User-focused research to identify the benefits of innovative digital recruitment and retention.” There were three phases in the main study:

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: i) A survey of CTUs on their experiences of digital tools; ii) 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; iii) 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

This paper reports on Phase 1 and the Phase 2 survey of CTUs and qualitative interviews. The other aspects of this project have been submitted elsewhere.²⁰

Phase 1: Scoping of searches and a survey of funder staff

A scoping exercise was conducted to inform the research team of examples of digital tools. The search was conducted in December 2017 and the results were shared with the project team to inform the content of the CTU survey questions and qualitative interview frameworks.

An online survey was sent to NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) research management staff in February 2018 to understand how many funded trials have used or are using digital tools across four NIHR research programmes (Efficacy and Mechanism Evaluation (EME), Health Services and Delivery Research (HSDR), Health Technology Assessment (HTA) and Public Health Research (PHR)). Some examples of relevant digital tools were provided to help inform the research manager’s review of their portfolio of funded research projects.

Phase 2: CTU survey

Preliminary findings from phase 1 were used to inform and develop the CTU survey. This survey was sent to all UK Clinical Research Collaboration (UKCRC) registered CTUs between March–May 2018. A webinar was conducted during March 2018 to help explain the nature of these digital tools and increase response and completion rate, and a follow up reminder email was sent to all participating CTUs. The survey asked CTUs to list up to five recruitment tools and five retention tools they have used, and then to expand on up to two tools that had impressed them within each category. The questions focused on what digital tools are currently being used to identify, recruit and retain participant; their benefits; the study context (type of study and population); ease of configuration; characteristics of digital tools that qualified them to be judged useful; and estimated effectiveness. (Additional file 1)

Phase 2: Qualitative interviews

The sampling of participants was purposive due to the availability of resources, participant availability and the appropriate number of participants required to reach data saturation. The project team were responsible for the eligibility criteria and individuals were chosen on a case-by-case basis (in agreement and consensus with project team members). This sampling approach identified research professionals with appropriate trial recruitment experience. Eligible participants for the stakeholder groups included staff in medical research funding organisations and charities; individuals working on trials in primary and secondary care; and research participant representatives (Table 1).. The initial plan was to engage with participant representatives through focus groups but we were unable to recruit the appropriate number of participants to take part (none of the participants agreed to participate in focus groups). We offered telephone interviews as an alternative and we were able to recruit the proposed number of participant representatives (n = 4).

Table 1 HERE

The decision to approach the agreed sampling groups was based upon consensus from discussions with the project team to provide sufficient data to answer the research question and provide wide coverage of the use of digital tools. Potential participants responded to an ‘invitation to volunteer’ from the study researcher through the CTU.

Participants engaged in a 45 minute, semi-structured telephone interview (refer to Additional file 2 for the interview framework for each stakeholder group). The professional group were not specifically asked about the acceptance of digital tools, and the participant representative stakeholder group were not specifically asked about the intended outcomes, participant perspective or their awareness of the evidence. The interview framework was developed from the CTU survey findings, and interviews were undertaken in May-June 2018. The participant’s identity remained anonymous in all reports and identifying data was password protected and only accessible by the research team (outlined in the General Data Protection Regulation (GDPR) May 2018).

An inductive approach was used to establish clear links between the interview framework for data collection and the summary of findings from the raw data (i.e. the interviews). Two researchers conducted dual coding and quality assurance measures. Data saturation was reached when no new constructs, categories or themes emerged from the data. A content analysis was conducted to provide a summary of the interview data. Both processes were conducted using Microsoft Excel 2016 (Microsoft Corporation). The theoretical framework for the interviews and schedules are available (Additional files 2 and 3 respectively). Ethics approval was granted by the Faculty of Medicine Ethics Committee, University of Southampton (Submission Number 32140) and the qualitative study was conducted to provide the 'Outcomes’ and 'Methodology’ of the PICO-M (Population, Intervention, Comparator and Outcomes-Methodology) that shaped the systematic mapping exercise and the study eligibility criteria.

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.

Tables 2 and 3 HERE

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.

Table 8 HERE

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)

The findings from both CTU survey and qualitative interviews demonstrate the potential role for digital tools in the recruitment and retention of participants in clinical trials. However, the potential benefits from using digital tools are still relatively unknown, despite the frequency of their use. This has important implications not only for research participants and trialists but also for funding organisations and medical research charities. The cost of setting up and maintaining some digital tools is expensive and this can have repercussions for not only trialists but also funders of research. Given the dearth of high quality evidence to validate or support the use of digital tools it is imperative that the evidence generated plays particular attention to the nuances particularly identified through the qualitative interviews that ‘not one size fits all’. There is also the need to appreciate that although the internet can be a potentially valuable tool, there are unchartered ethical considerations for trialists such as the security of personal data, given the new GDPR.²¹ Technology is also moving fast, which can make it difficult to identify what is best for a particular group of participants.

As the literature suggests, high quality evidence is needed to determine the value of digital tools and their potential. Despite this, some trials are already using these technologies to improve trial recruitment and retention with minimal understanding of their effectiveness or appropriateness (lack of evidence to support their use).^{6 9} By further investigating the use of digital tools for trial recruitment and retention we will be much better placed to understand their value and benefit for future clinical health research. Only then can we confidently advise on the wider use of digital tools by trialists / researchers, and the need for further primary research. This evidence-based approach is critical to counter the “apptimism” (excessive optimism about apps and other digital health tools) that has built up around the use of digital tools in health services research.²²

Strengths and weaknesses of the study

The main strength of the study was the inclusion of a broad spectrum of stakeholders, using mixed methods to understand their position on the use and experience of using digital tools for the recruitment to and retention in clinical trials.²³ The CTU survey was able to collect views from a range of CTU staff with different job roles. The qualitative interviews comprised of five stakeholder groups, including research participant representation, which provided an in-depth understanding of how digital tools are viewed from the patient perspective. This has important implications for the development of digital tools and their sustainability for use in trials; if participants are unwilling to, or do not see the authenticity / legitimacy of the invitation to participate in a study, problems with recruitment and retention will undoubtedly remain. By using an inductive approach, we were able to gain a valuable insight into what matters to these stakeholders, without influencing their perspective on the use of digital tools.

Although not all CTUs took part in the survey, the responses received provided adequate coverage to begin understanding the types of digital tools used and the variation of their use. The qualitative interviews were conducted with a small number of stakeholders (three for each category, with four research participant representatives) and yet the study achieved its recruitment target. By not recruiting to the intended focus group for the participant representative group, it was clear that telephone interviews were the preferred method for these individuals. This has important implications for future research, when considering the use of focus groups with participant representative groups. There is a potential risk of bias due to the sample being purposive and only being limited to randomised trials. However, given the restricted timeframe for completion, the findings from the qualitative interviews provided a rich dataset for analysis.

Implications

To help fill the gaps in the evidence base we encourage future research to consider conducting more defined and specific systematic reviews on particular digital tools commonly used by CTUs. Future primary research may benefit from greater guidance to improve the evidence base, including liaison with Trial Forge^{24 25}, so that assessment of promising digital tools can be evaluated within the NIHR Study within a Trial (SWAT) programme.²⁶ Possible topics might include: (i) a randomised trial comparing email with social media for recruitment in different age groups, studying the reach across differing socio economic groups, and (ii) further Delphi research into appropriate tools for people with different disease types and prevention vs treatment. One implication for researchers in this area is that we should study not only the various potential benefits of these tools, but also the potential challenges they raise, as documented in the qualitative study results.

Our study demonstrates the variety of digital tools being used and how they are seen to be successful by trialists, as well as noting the limited empirical evidence to support their use. Our examples of what constitutes a digital tool (see Box 1),, will help to inform the NIHR and wider research community about what is currently available, and help them identify potential tools to help with recruitment to and retention within their studies.

Ethical approval and consent to participate

Ethics approval was granted by the Faculty of Medicine Ethics Committee, University of Southampton (Submission Number 32140) for the qualitative interview study. Individual participants were approached or volunteered to participate in the qualitative study and survey. They received a short introductory email with information about the study, including explicit details about what would be involved. Participants were free to withdraw from the study at any time. Study conduct was consistent with standard practice in survey research. Consent was assumed by agreement to participate in meetings and complete online questionnaires.

Consent for publication

Not applicable. The Manuscript does not contain data from any individual person. Consent was obtained from all participating stakeholders in the qualitative study prior to submission.

Availability of data and material

The data generated or analysed during the current study are included in this published article (and its supplementary information files). Additional information is available from the corresponding author on reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This study was supported by an NIHR Clinical Trials Unit Support Funding grant for supporting efficient and innovative delivery of NIHR research (Southampton and Bristol CTU). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care. This study was not registered.

Authors’ contributions

GG and JW conceived the idea for the study and led the study team. GG, JCW and AJL designed the study and obtained the funding. JH provided project management to the team. For phase 1 ABJ completed the scoping exercise and funder staff survey. JN designed, conducted and analysed the CTU survey with support from the project team. LW, AB and ABJ designed the qualitative study and LW collected the data. ABJ and AB analysed the qualitative data with support from LW and other members of the project team. ABJ and GG wrote the first draft of the manuscript, with revisions for important intellectual content made by all authors. MM, RP, SF and NT provided oversight as members of the Project Board. All authors read and approved the final manuscript.

Acknowledgements

We would like to thank the responders of the CTU survey and those that participated in the qualitative interviews and NIHR NETSCC monitoring staff for responding to and providing information for the funder staff survey.

We would like to personally thank Alex Recio-Saucedo for her research support during the analysis and Jane Robertson from the Southampton CTU for identifying potential patient representatives and inviting them to approach us to participate. We would like to thank Project Board members, Helen George and Karen Underwood for their valuable input and contribution throughout the duration of the study.

Additional files

Additional file 1: List of questions used in the UKCRC CTU survey

Additional file 2: Qualitative interview theoretical framework for the interviews

Additional file 3: Preamble for the interview schedules for the five stakeholder groups

CTU: Clinical trials unit

CPRD: Clinical Practice Research Datalink

EME: Efficacy and Mechanisms Evaluation programme

EMIS: formerly known as Egton Medical Information Systems

EPR: Electronic Patient Records

GDPR: General Data Protection Regulation

GHR: Global Health Research

GRADE: Grading of Recommendations Assessment, Development and Evaluation

HSDR: Health Service and Delivery Research programme

HTA: Health Technology Assessment programme

MRC: Medical Research Council

NETSCC: NIHR Evaluation, Trials and Studies Coordinating Centre

NIHR: National Institute for Health Research

PHR: Public Health Research programme

PICO-M: Population, Intervention, Comparator and Outcomes-Methodology

RCT: Randomised Controlled Trial

SMS: Short Message Service

SWAT: Study Within A Trial

UKCRC: UK Clinical Research Collaboration

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Table 1: Stakeholders for qualitative interviews

Eligibility criteria	Roles held by participant	Stakeholder groups
Involvement in one or more of	One or other of the following	(number of participants)
Trial recruitment Management of trials (CTU staff)	Trialists and recruiters	Trialists in Clinical Trials Units (n=3) in secondary care
Leading funding applications	Principal Investigators	Research practitioners in Primary Care (n=3)
Contribute to decision-making of funding allocation	Funding committee members	Research funding bodies (n=3)
Contribute to decision-making on research ethics	Ethics committee members	Ethics committees and Health Research Authority (n=3)
Experience of participating in trials	Research participant representatives	Research participant/patient representatives (n=4)

Table 2: Breakdown of the type of NIHR funding schemes where a digital tool was identified in survey of NETSCC monitoring staff

N (%)

NETSCC programme: EME

HTA

HSDR

PHR

GHR

Work Stream:

Commissioned

Researcher Led

Themed call

4 (15.4)

16 (61.5)

5 (19.2)

1 (3.9)

0 (0)

14 (53.8)

11 (42.3)

1 (3.9)

Table 3: Types of digital approaches used in NIHR studies from funding staff (multi-responses)

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)

Table 4: Number of digital tools, by category, that CTUs mentioned they have experience of in relation to recruitment (including identification)

Recruitment tools	Number of times mentioned
Database tool (GPRD, in house built tool, disease registry)	19
Social media (e.g. facebook, twitter Youtube)	11
Trial Websites	7
ISRCTN, clinical trials.gov	3
Other - in house	1
Total	41

Table 5 Number of digital retention tools that CTUs mentioned they have experience of in relation to retention, broken down by category.

Retention tools	Number of times mentioned
SMS / email reminders	17
Study websites	3
Apps and web based data collection	3
Social media	2
Other - in house	4
Total	29

Table 6: Number of digital tools in relation to recruitment that CTUs mentioned they have experience of, broken down by category.

Recruitment tools	Number of times mentioned
Database tool (GPRD, in house built tool, disease registry)	10
Social media (e.g. facebook, twitter Youtube)	6
Trial Websites	4
ISRCTN, clinical trials.gov	1
Other - in house	1
Total	22

Table 7: Number of digital retention tools CTUs mentioned that had impressed them, broken down by category.

Retention tools	Number of times mentioned
SMS / email reminders	10
Study websites	0
Apps and web based data collection	0
Social media	1
Other - in house	4
Total	15

Table 8: Content analysis of responses from the five stakeholder groups

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

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published 03 Apr, 2020

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Editorial decision: Major revision
14 Oct, 2019
Review #1 received at journal
13 Oct, 2019
Review #3 received at journal
10 Oct, 2019
Review #2 received at journal
10 Oct, 2019
Reviewer #3 agreed at journal
23 Sep, 2019
Reviewer #2 agreed at journal
23 Sep, 2019
Reviewers invited by journal
19 Sep, 2019
Reviewer #1 agreed at journal
19 Sep, 2019
Editor assigned by journal
03 Sep, 2019
First submitted to journal
31 Jul, 2019
Submission checks completed at journal
31 Jul, 2019

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Using digital tools in the recruitment and retention in randomised controlled trials: Survey of UK Clinical Trial Units and a qualitative study

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Journal Publication

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Abstract

Figures

BACKGROUND

METHODS

Phase 1: Scoping of searches and a survey of funder staff

Phase 2: CTU survey

Phase 2: Qualitative interviews

RESULTS

Phase 1: Scoping of searches and a survey of funder staff

Phase 2: CTU survey

Phase 2: Qualitative interviews

DISCUSSION

Strengths and weaknesses of the study

Implications

Conclusion

Declarations

Ethical approval and consent to participate

Consent for publication

Availability of data and material

Competing interests

Funding

Authors’ contributions

Acknowledgements

Additional files

Abbreviations

REFERENCES

Tables

Supplementary Files

Status:

Journal Publication

Version 1