- Q1How can randomised trials become part of routine care and best utilise current clinical care pathways?
This question is about how might trials co-exist, routinely, alongside routine clinical care. Research is often viewed by clinicians as an extra burden or an added strain on already limited resources, rather than something that (should) co-exist alongside routine care.
- “How can we engage relevant clinicians in designing studies to cultivate a culture of clinical trials as part of the duty and routine workload of health professionals, many of whom see it as extra work or a burden?”
- “How can we better embed trials in routine healthcare so that trials are seen as routine rather than complex bolt-ons?”
- “It would be good if we could embed trials into routine healthcare so that it would be the norm to be in a trial (when indicated) rather than something out of the ordinary”
- Q2What information should trialists communicate to members of the public who are being invited to take part in a randomised trial in order to improve recruitment to the trial?
- “I often find the information given to simplistic. I appreciate that the information must be understandable to all, but I wonder if it is possible to have access to other more in depth information. I have managed to get more information, but usually it has to be requested and then given at a follow up.”
- “Too much information is given; it needs to be succinct, simple and easy to read/understand.”
- “General information should be given to each one explaining what the benefits are of participating in a study, explain ethics committees and the approval processes, that it is not mandatory to participate, that all data collected is treated in the strictest of confidence.”
- Q3Does patient/public involvement in planning a randomised trial improve recruitment?
- “Involve potential participants in planning and designing at every stage. The trial I’m in has several problems which probably wouldn’t have occurred if there had been PPI from the initial stages (their role was limited to patient info sheet)”
- “What is the impact of patient and public involvement (PPI) on the design of clinical trials? How can this impact (if positive) be maximised?”
- “PPI involvement is needed to ensure this and the information should be given at the earliest opportunity.”
- Q4What are the best approaches for designing and delivering information to members of the public who are invited to take part in a randomised trial?
Best approaches”’ might include, for example; website, leaflets,
- “Use of a website: read a web summary and people could click on a link to read more information if they wish or alternatively continue without it. – Posters – introduction to trials being undertaken in clinics etc. – Better pre-screening of electronic medical records (that are capable of being interrogated in this way)”
- “A small budget for designing trial posters, adverts, leaflets are also important, depending how large and public facing the trial will be. A more professional look will improve the validity of the trial to the public.”
- Q5What are the barriers and enablers for clinicians/healthcare professionals in helping conduct randomised trials?
“Barriers and enablers” might include, for example; time, experience, workload and training.
- “What are the technological barriers (e.g. access to web) which can impact of trial recruitment?”
- “the logistics of set up under the new HRA process makes it harder to carry out research”
- “clinical staff are overburdened with work and do a great job balancing research and clinical commitments in a constrained NHS”
- Q6What are the key motivators influencing members of the public’s decisions to take part in a randomised trial?
Key motivators might include, for example; altruism, aspects of care, benefit. Certain motivators for some people could be de-motivators for others; researchers might need to consider this if designing a study to addresses this question.
- “For people with a medical condition, motivators will depend on what is being offered- cure? Longer life? Reduction on symptoms? Or fewer side effects? There may also be a benefit in terms of feeling more looked after , perhaps with more appointments or maybe a special clinic.”
- “I think most people are motivated by the benefit they could receive by being on the trial and often recruits are happy that what they are doing may help others in the same situation as themselves”
- Q7What are the best approaches to ensure inclusion and participation of under-represented or vulnerable groups in randomised trials?
Under-represented or vulnerable groups might include, for example, children or people with rare diseases. This uncertainty is not about doing trials in these populations, exclusively, but about including participants from these groups where they are eligible as part of a ‘wider’ target population (e.g. the general public).
- “It is easy to try to keep trial costs down by only targeting those who are easiest to recruit. There should be a reviewer at the stage of NIHR applications who explicitly has to provide feedback on the extent to which a study contributes to understanding (or not) the wider application of the proposed study.”
- Q8What are the best ways to predict recruitment rates to a randomised trial and what impact do such predictions have on recruitment?
- “Questionnaires to consultants about anticipated recruitment rates, prior to the trial commencing, are extremely unreliable and we need a better way of estimating the patient populations”
- “Gaining better estimates of prevalence in order to estimate realistic recruitment rates (where such data do not obviously exist) as an initial phase of the study before the trial starts”
- “Can a realistic estimate be made of how possible it is to recruit into a trial?”
What level/ grade and what type of person (doctor, nurse, research assistant) is needed to gain informed consent?”
- “Consent forms, whilst required legally, can be off putting as there are so many boxes to initial. It can cause stress when it is perhaps not needed.”
- “Making the informed consent (or some version of it) understandable and useful. Videos, images, short… make it for the patient, not the institution. How did that even happen? : – )”
- “The person taking consent should prioritise the patients information needs over the urgency to recruit – e.g. allowing the patient to discuss with family members or to take leaflets home to read in private.”
- “… For low risk studies…can verbal consent be considered rather than written consent? – informed consent forms are too long, complicated and include too much legal terminology and should be simplified.”
- Q10What are the advantages and disadvantages to using technology during the recruitment process?
Technology might include, for example, mobile applications, websites and e-health.
- “Don’t assume everyone can use technology. There is a move towards electronic questionnaires, text messaging reminders etc. – this may alienate some populations and whilst other media may also be used, populations may feel that trials are not designed for people like them”.
- “We should also be looking at the use of technology to engage participation especially as more people are still working into their 60’s and 70’s as they often don’t have time to come to an appointment but could find 30mins to sit at their computer.”
- “I think using various methods of explanation of what is involved should be used. Each person has a different method of processing information, so need to use various methods to provide a comprehensive message. Using, technology, art, colours, social media, apps, group discussion, one to one discussion, family involvement, are ways that help people gain a full insight to the trial they are participating in.”
- Q11How best can clinicians and other health professionals be educated to optimise recruitment to randomised trials?
‘How best’ refers to where, when, what and by whom.
- “Training / information session prior to trial commencement are key for ensuring staff are adequately prepared for running the trial.”
- “All clinicians are potentially recruiters – they need more information, training and motivation”
- “Methods such as recruiter training workshops and QRIs (including audio-recording and analysis of recruitment consultations, recruiter feedback) can be powerful.”
- Q12Does feasibility testing of recruitment procedures lead to improvements in recruitment?
Eldridge et al (2016), in developing a framework to define feasibility and pilot studies in preparation for RCTs, describe feasibility as an overarching concept that can include the following three study types;
1. Randomised pilot studies in which the future RCT, or parts of it, including the randomisation of participants, is conducted on a smaller scale (piloted) to see if it can be done.
2. Non-randomised pilot studies are studies in which all or part of the intervention to be evaluated and other processes to be undertaken in a future trial is/are carried out (piloted) but without randomisation of participants.
3. Feasibility studies that are not pilot studies where investigators attempt to answer a question about whether some element of the future trial can be done but do not implement the intervention to be evaluated or other processes to be undertaken in a future trial, though they may be addressing intervention development in some way.
- “Feasibility is very important. Trials must be possible to do in the real world and without too many restrictive limitations.”
- “Having been involved in various feasibility and pilot studies, I’ve seen how important these can be in terms of informing the design of the main trial. They have highlighted issues to do with variation between clinical sites, (which had implications for how and when participants should be recruited), concerns from staff who would be involved in recruitment regarding time and how to describe the study to potential participants, and reasons for why staff and patients decline to take part.”
- Q13How can eligibility criteria for trial participants be optimised so that they aid recruitment to randomised trials?
Study eligibility plays an essential role in trial research as it defines the characteristics of the target populations, and is used for screening and recruitment to trials. Eligibility criteria also influences the generalisability of the trial’s results which are, subsequently, interpreted, implemented, and adapted by different stakeholders. In developing eligibility criteria for selecting study participants, researchers must consider scientific, ethical, regulatory, and safety requirements and translate these into unambiguous eligibility criteria (Kim et al. 2015). However, overly restrictive participant selection can compromise study generalizability and contribute to the difficulty in implementing and disseminating study results to real-world patients across many disease domains (Weng, 2015). An example of this might be an age cut-off exclusion criterion, such as <65years, even though individuals in this age profile might be helpful for answering the trial question. This priority question addresses uncertainty as to how eligibility criteria might be optimised to help recruitment to randomised trials.
- “Perhaps we need to be more pragmatic and so ensure our exclusion criteria are not leading to barriers to recruiting participants that can add value to findings.”
- “More accessible ways of assessing eligibility (an app?) might help”.
- “Are eligibility criteria evidence-based (contraindications to medication etc) or based on assumptions? Should eligibility criteria be harmonised between similar trials to improve meta-analysis (as with outcome measures) to ensure interventions are effective/not in similar populations?”
- Q14What is the value of making trials participants feel appreciated in being recruited to a trial and how can this be best achieved?
- “I think you can really made to feel like a pawn to the research when the researcher does not treat you like a valued client/human being!”
- “It is important that participant time is valued. It does not help if one feels taken for granted, or when there is a failure to recognise there is no such thing as a free lunch. If a participant’s time is not valued, it is a sacrifice on their part, but not the organisation benefiting from the offer of time.”
- Q15What are the best approaches to ensuring manageable workloads for clinical and research staff responsible for recruiting members of the public to randomised trials?
- “From my experience the biggest issue with recruiting to trials is having enough local support to manage all the detailed administrative requirements. Research Nurses generally have too many studies to be able to manage the volume of workload required to support trials properly and effectively. Because all staff are overloaded with their workload there is usually no cover for staff going on holiday meaning that there are lots of missing recruitment throughout the year.”
- “Trials are very labour intensive. Resources, including finances, staff, etc. need to be adequate to cope with this workload.”
- Q16Does involvement of (i) members of the public and/or (ii) members of the public participating in a randomised trial, in designing trial information improve recruitment?
- “Usually very standard format and they tend to be designed with getting through ethics rather than being most helpful to the potential participants even when PPI groups are involved in their development.”
- “Our PPI consultations on information sheets etc. consistently suggest most people find the info required by ethics committees to be overwhelming and off putting. The families we consult with want brief factual information.”
- Q17What are the incentives that motivate members of the public to agree to participate in randomised trials?
Incentives, in the context of this uncertainty, go beyond cash reimbursements for time lost or costs incurred by participating in a trial. Incentives might be wide and varied, including, for example, money/cash, vouchers and gifts.
- “I’m wary of cash incentives when a trial is based on a health intervention. There’s an element of pressurising people who might be very vulnerable”.
- “I suspect the best motivation is not from cash incentives or similar, but rather from a sense of belonging, duty etc; work in these areas seems most useful.”
- “People may be altruistic and feel they want to give back but they should not feel that they have to. Cash incentives are appropriate when people have to attend long visits or have to use equipment at home etc.”
- Q18Do trial recruiters who have received focused, specialised recruitment training achieve better levels of recruitment than non-trained recruiters?
- “How to train trial recruiters- essential components/advice to provide in that training- do and do nots of approaching participants to trials.”
- “Training in trial recruitment (explaining the trial, balancing treatment arms, conveying equipoise) is essential to optimising informed consent and recruitment.”
- Q19Do randomised trials which have a low participant burden/requirements achieve better recruitment than those that have a greater patient burden?
- “Patient burden should be a big consideration in trials with multiple visits and samples. Costs and ease of parking should also be considered if the participant is expected to attend a hospital for most of their visits.”
- “Should trials take place in places are that more convenient for participants, e.g., access to easy parking, city centre location.”
- Q20Does a central registry for members of the public (i.e. a list of people with contact details) who are interested in taking part in a randomised trial improve recruitment?
A central registry is a list of people, with their contact details, who have expressed an interest in taking part in a randomised trial
- “Would it be better to have a more general conversation with patient groups about adding their names to a registry if they are interested in participating in trials and therefore they would be able to contacted from that registry rather than when they are in hospital or at clinics.”