Q1
What motivates a participant’s decision to complete a clinical trial?
- “For me mostly to improve healthcare for self and also that I would be getting additional attention from my consultant during treatment.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
- “Improved healthcare is very important, including access to new treatments (often seen as better) and additional follow up (often seen as missing from standard NHS care). From my Father’s experience better health care was crucial and likely saved his life.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director)
Q2
How can trials make better use of routine clinical care and/or existing data collection to improve retention?
- “What is a reasonable period to collect follow up data from participants?” (A trials methodologist)
- Sometimes the length of time between admission and follow up is quite lengthy and this tends to let the patient feel that they have been forgotten.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
Q3
How can trials be designed to minimise burden on staff and participants and how does this affect retention?
- “Follow up data should be as closely aligned to standard care as possible, or it runs the risk of being overly burdensome to collect, leading to missing or poor data. Streamlining studies not only makes it easier to administer and deliver, but also minimises the burden on patients and funders, and delivers results in a more timely manner.” (A trial methodologist)
- “Making the trial relevant to the individual participants is very important and avoiding too complicated or long information sheets or questionnaires which will not get generalisable responses” (Investigator (e.g. Chief Investigator, Principal Investigator, Co-investigator))
Q4
What are the best ways to encourage trial participants to complete the tasks (e.g. attend follow-up visits, complete questionnaires) required by the trial?
- “I suspect (but don’t have good evidence) that people are more likely to stay involved if they are getting “rewards” from continuing involvement. What constitutes a reward is likely to be context specific – but (I suspect) that cash or voucher incentives won’t always be seen as a reward.” (A trial methodologist)
- “Follow up is essential both for the doctors and particularly the participants. Too little feed back is given to patients at times. In some cases patients do their bit and then don’t get enough back. Follow is better done at home, I feel. Perhaps family members could contribute too.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
Q5
How does involvement of patients/the public in planning and running trials improve retention?
- “Include outcomes which are of importance to patients by discussing the issues with them when planning a trial. Their concerns may be different from those of the trial team.” (Investigator (e.g. Chief Investigator, Principal Investigator, Co-investigator))
- “As above, patients should be involved in this planning and decisions. But if the costs of doing this were not anticipated correctly and/or included in the trial budget, then it won’t happen. What clinicians think is important to measure probably differs from what patients regard as important – there needs to be a mechanism for discussion and agreement on combining these different views.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
Q6
How could technology be best used in trial follow-up processes?
- “I have a suspicion that trialists are all too eager to embrace digital means of keeping participants involved in trial – “let’s use an app!/online questionnaire…!” and often they’re not sufficient tested and/or adapted to people’s needs. … So the question is again how do we make technology work while not just using it as a panacea?” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “I think a hospital follow up initially then a later follow up at home via email or Skype. Some follow up could be done via telemeds rather than people having to travel. Email and a text instead of mail would be most effective.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
- “We also need to know whether & in what circumstances postal questionnaires, online questionnaires or telephone interviews are more acceptable, effective in optimising validity & response rates, and cost-effective.” (A trial methodologist)
- “Questionnaires could be sent out following a telephone call checking if they are still willing to receive but where patients may have returned to work it can be difficult to contact people. Perhaps a book with pre filled in dates and stamped envelopes for returning questionnaires may be helpful.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
Q8
How does a participant’s ongoing experience of the trial affect retention?
- “Environment is very important, if someone feels comfortable, respected and a valuable member of the team, they are more likely to continue to participate.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
- “People need to feel engaged in the research. Feeling part of the study will also ensure participants feel connected to the research and realise how important their contribution is.” (A trial methodologist)
- “Patients and carers are interested in the outcome from being involved, and at the moment feedback is very limited. These opportunities for re-enforcing the message are often missed at the moment. Far more work needs to be done around informing patients about the outcome of trials and the impact on improvement to clinical practice.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
- “Transparency is key, each stage should be clearly explained (the why and how) and results should be available to the participant if they want these.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
- “Participants can tell if follow-up is obviously worthwhile. It helps to explain to the participant what each thing will be used for in the trial so they are more likely to continue in follow-up. Text message reminders are good but including why the data is important. PPI can help wth this.” (A trial methodologist)
Q10
How should people who run trials plan for retention during their funding application and creation of the trial (protocol development)?
- “The protocol should specifically exclude patients who will not be easily available for follow up e.g. if face-to-face follow up is required, they should be excluded if their home is too far away or they are planning to move away from the area or they spend 6 months of the year in Spain; if only telephone follow up is required, then it might be advisable to only include patients who can be contacted by mobile phone.” (Investigator (e.g. Chief Investigator, Principal Investigator, Co-investigator))
- “Consult community and primary services when planning study follow up. Community services are often overlooked.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
Q11
What aspects of trial recruitment processes could be changed to improve retention?
- “The very few who were not really motivated to participate in the study but didn’t want to say no, or just ‘got it over with’, will be practically impossible to retain. I guess as trailists there is a need to think about whether we want to recruit to target regardless of their intention to remain in the trial or not. Or whether recruiters explore and assess intent to remain in the trial, almost as an inclusion/exclusion factor.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “I’m also happy to have the extra tests as I feel more comforted knowing that I am being more closely monitored than if I was just on standard treatment, so there is definitely a selfish motive too! I am also very interested to know if the outcome of the study and how it might shape future treatment.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial)
“I have found that the local CRN are far more interested in helping and supporting recruitment rather than follow up. Where support is normally available to recruit participants it often disappears when follow up appointments are due.” (A trial methodologist) - “Recruitment is not about gaining numbers for the trust! Nurses, especially are under pressure to meet targets and end up recruiting people who they feel probably are not really on board but sign them up anyway! From what I have seen, recruiting just for the numbers can have massive consequences for retention and whether the study is completed.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
Q12
What aspects of trial retention do participants perceive as burdensome and how can these be addressed?
- “Waiting in waiting rooms for appointments is demanding on people who are debilitated. Efforts should be made to keep to time with appointments and ensure access to parking close to the clinic or provide taxi transport to the appointment.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
- “This will be impacted by what being involved requires, e.g. multiple trips to a hospital for data collection, lots of waiting around, painful procedures etc. It is also affected by personal factors so their own health or that of other family members who they may rely on to accompany them to data collection visits or who they may have caring responsibilities for” (Investigator (e.g. Chief Investigator, Principal Investigator, Co-investigator))
Q13
What influence does the relationship between trial staff and participants have on retention?
- “From our experience, personal contact between the Research Nurses and participants helps maintain the relationship, and helps participants feel ‘part of something’. Personal relationships between research staff and research nurses, and between research nurses and participants is the glue that holds trials together.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “The relationship with the site and especially the nurses is key to the loyalty that helps with retention.” (A trial methodologist)
Q14
How does a sense of belonging or being part of something amongst trial participants affect retention?
- “For me, the team supporting me are key to keeping me involved. I’ve met another person on the same trial through a Facebook forum for our disease. That has been really helpful too, to compare notes. Some of my family and friends have also taken a great interest in the trial, supporting me to tease out the ethical dilemmas.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial)
- “Once recruited, patients tend to stay involved if they feel a sense of “belonging” as regards the trial – e.g. investing their time and efforts in attending visits/completing questionnaires helps them acquire some ownership in their participation.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “Information given out is poor quality. Patient information leaflets (PIL) are long, often technical (because they need to be from and ethical approval point of view) and visit schedule are rarely made explicit. Use of a brief leaflet to give basic outline about a study has worked well to ‘sell’ the study initially rather that put participants off using a multiple page PIL. Text message and email reminders are helpful but easy to ignore. Phone calls and study letters more formal and immediate communications and are harder to ignore a person on the phone.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- What should be considered for an effective Patient Information Sheet (P.I.S.)? The P.I.S. for the stroke trial my dad was on was appalling (and obviously scrappily photocopied). He didn’t even understand it was an RCT. It even took me a while to find that information on the sheet and I’m a researcher!? What elements make for good communication of key points? From personal experience, text message reminders work well for clinical appointments. (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial)
Q16
To what extent (if any) do studies that explore retention procedures before the main trial (i.e. feasibility study) lead to improvements in retention in the main trial?
- “What is appropriate for one RCT may not be for another. Study data collection should be discussed at the research design stage of the trial.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial)
- “I think online systems can make it easier for young people to access follow-up questionnaires, this is something that should be considered depending on the patient population at the planning phase. If parents are being asked to travel to a hospital for a follow-up (e.g. 6 week follow up) may be useful to consider if this could be carried out via phone by a research nurse to save them travel costs / make it more convenient. We recently offered this as an option in a feasibility trial and this was a positive for parents in terms of engagement because many lived a considerable distance from the hospital.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
Q17
How can trials make better use of routine clinical care and/or existing data collection to improve retention?
- “How can we encourage trialists to use routine data linkage more in measuring outcomes so as to reduce patient burden during follow up?” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “Integrate into routine care as much as possible. I am running a trial with close to 2000 patients and no data is collected additional to that in routine care.” (Investigator (e.g. Chief Investigator, Principal Investigator, Co-investigator))
Q18
What strategies (e.g. sending Christmas cards or saying ‘thank you’) make participants feel valued and how do they affect retention?
- “Any opportunity for patient contact, whether email, phone call, letter etc should start with a simple “thank you for your involvement” and a reminder of how important the patient’s data are. Patients need to be continually reminded of their value.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
- “Whoever it is, trial staff need to be able to develop rapport quickly with patients and make them feel the most valued person. Giving a little extra guarantees that patients will comply with things you need them to do. It’s all about quid pro quo. Christmas and birthday cards might also help, making participants feel valued, as they are generally giving themselves for free.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
Q19
What are the best strategies for using participant incentives (e.g. monetary or non-monetary) and how should they be implemented (e.g. when should they be provided) when collecting information from participants in clinical trials?
- “Financial incentives will be viewed suspiciously if high… and not very incentivising if low. On the other hand, participants welcome personal touches as the offer of a lift to the clinic, or a small gift token, or even just a profuse thank you for their help.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “Would a donation of a pre-specified amount of money to a charity of the participant’s choice on completion of the clinical trial improve retention?” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
Q20
How does continuity (e.g. seeing/speaking to the same staff) and consistency (e.g. of trial information) affect retention?
- “It’s always a danger during long-term follow-up in studies that staff turnover will mean that visits are lost/trials get forgotten about, especially in recruiting sites with busy portfolios. They would always be told to focus on active patients when covering for a colleague who may have left, which leaves the door open for missing follow-up data.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “I was always met by the study nurse and developed a relationship with her – a real incentive to stay… I had a very good experience with the study nurse. Keeping the same person as the
contact point makes a real difference.” (Patient or public member involved in a trial (as a participant or parent/carer of a participant, or as a contributor to design/delivery of trial))
Q21
What behaviours of trial staff (e.g. being friendly) result in improved retention?
- “But I think one of the main reasons people stay involved is because of the warm, personal style that myself and my colleagues try to use when meeting people.” (Frontline staff or other staff involved or invested in trial retention (e.g. Research Nurse, Trial Manager, regulatory or oversight role such as Sponsor or Research Director))
- “When conducting trial visits any staff involved in interacting with a patient should introduce themselves, explain the basics of what they will do before they do it and be friendly- important for retention. The human interaction aspect can be overlooked and rushed.” (A trial methodologist)
