What is the PRioRiTy Study?

The Prioritising Recruitment in Randomised Trials study (PRioRiTy) identified research questions which focus on how to improve the process of recruiting people to randomised trials. The study was a priority setting partnership (PSP) based on the methods of the James Lind Alliance (JLA). The JLA (UK) brings patients, carers and healthcare professionals together in Priority Setting Partnerships. These partnerships identify and prioritise unanswered questions about healthcare that the public, carers and professionals jointly agree are the most important.  The aim of this is to help ensure that those who fund health research are aware of what future research will really matter in everyday use. The PRioRiTy PSP was focussed on methodological uncertainties rather than on treatment uncertainties and therefore a modified JLA approach was developed and used.


Questions for Research

  • Q1
    How 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”
  • Q2
    What 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.”
  • Q3
    Does 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.”
  • Q4
    What 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.”
  • Q5
    What 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”
  • Q6
    What 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”
  • Q7
    What 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.”
  • Q8
    What 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.”
  • Q10
    What 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.”