@hrbtmrn Intro and welcome

Used adapted JLA type approach

Background & Rational Randomised trials face many challenges including slow or suboptimal recruitment; Across trials, it is estimated that less than 50% meet their recruitment target or do so only with an extension to the original trial duration; An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) identified ‘Research into methods to boost recruitment in trials’ as the topic of greatest priority for research (Tudor-Smith et al 2014); Under recruiting or stopping a trial early due to poor recruitment has major implications for the study outcomes;

Aim To identify unanswered questions around trial recruitment, and then prioritise those that stakeholder groups including members of the public, recruiting clinicians and researchers, agree are the most important. Priority Setting Partnership

Stakeholders The PRioRiTy study - Priority Setting Partnership (PSP) included stakeholders involved in all aspects of clinical trial recruitment; members of the public approached to take part in a randomised trial or who have sat on randomised trial steering committees; health professionals and research staff with experience of recruiting to randomised trials people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trial methodology.

Methods Modified James Lind Alliance PSP approach Eight key stages (i) formulating the PSP idea and identifying a unique, relevant prioritisation area within clinical trial methodology (ii) establishing an oversight Steering Group (iii) identifying and engaging with partners and stakeholders (iv) formulating an initial list of uncertainties from a stakeholder survey which used The ORRCA project (Online Resource for Recruitment research in Clinical triAls) (Harman et al 2015) recruitment research domain framework Guided by JLA guidebook

Methods Eight key stages cont’d (v) collating the uncertainties into research question format (vi) checking existing research evidence to confirm that the questions are a current recruitment challenge (vii) shortlisting questions in an interim priority setting exercise through another survey of stakeholders and (viii) final prioritisation through a face to face workshop with stakeholders to agree a top 10 list of priorities of methodological uncertainties around trial recruitment.

Public members from trials or Trial Steering Committees x 10 Group 1 Public members from trials  or Trial Steering Committees x 10 Group 2 Frontline researchers or non-researchers involved in recruitment (e.g., research nurses, doctors, midwives, allied health professionals) x 10 Group 3 Trial methodologist.  Expertise in designing, analysing and reporting trials x 5  Group 4 Researcher or Principal Investigator involved in aspects of trials other than frontline recruitment x 5    What we learned and how we adapted, picking up on reviewers comments on this positive aspect, but also hinting how we will manage capacity in the future award.

Results Initial survey – 790 respondents – 1,880 research questions “Whittling down” - Stage 1 - 496 Questions, Stage 2 – 32 Questions Interim Survey – 815 respondents – 25 questions Face-to-face workshop – Birmingham Dec 2016 – Top 10 (& top 20) questions Results: A total of 1,880 questions were extracted from 790 survey respondents, which after merging duplicate questions, was reduced to 496 questions. Merging appropriate questions together and excluding questions asked by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups resulted in 31 unique research questions. All questions were retained after confirming a lack of relevant, up to date research evidence addressing the question. For the final prioritisation workshop, twenty-five questions were brought forward for discussion and final prioritising by the group. We calculated response counts for each research question. Summed scores from each stakeholder group were calculated separately. For each of the stakeholder groups, the highest ranked question was allocated a score of a top score,  the next one down a lower score etc. until the lowest ranked question received a score of 1. To get the overall ranking, the scores for each question from each of the stakeholder groups were added together . The question with the highest aggregated score was ranked number one overall and the lowest score was ranked lowest overall. This gave the final overall ranking to the research questions.  

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Top 10 #1 How can randomised trials become part of routine care and best utilise current clinical care pathways? #2 ]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? #3  Does patient/public involvement in planning a randomised trial improve recruitment? #4 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? #5  What are the barriers and enablers for clinicians/healthcare professionals in helping conduct randomised trials?  #6 What are the key motivators influencing members of the public’s decisions to take part in a randomised trial? #7 What are the best approaches to ensure inclusion and participation of under-represented or vulnerable groups in randomised trials?   #8  What are the best ways to predict recruitment rates to a randomised trial and what impact do such predictions have on recruitment? #9 What are the best approaches to optimise the informed consent process when recruiting participants to randomised trials #10 What are the advantages and disadvantages to using technology during the recruitment process? This Priority PSP identified that stakeholders believe that to improve the process of how people are recruited to clinical trials, research attention needs to focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.

@hrbtmrn Intro and welcome