What is PRIORITY II about?
If you want to go straight to the latest survey, to vote for the questions that you think are most important, click https://www.surveymonkey.co.uk/r/BQ6X556.
If you’d like to watch a 2 and a half minute video outlining PRIORITY II, click on the play button in the video below.
PRIORITY II is a research project that aims to identify the most important things that we currently don’t know about things that affect whether people stay involved in trials. This is important because trial teams work out the number of participants they need for a trial to produce meaningful results. If lots of people drop-out of the trial early, then the trial results may become unreliable or unstable.
The project started with a survey, which involved people across the UK and Ireland who are, or have been, involved directly, in designing, running, analysing, or taking part and/or staying involved in randomised trials (see below for an explanation of what trials are). Most trials collect data from participants as part of their continued involvement in the trial and will help to answer whether one treatment is better than another. This is known as “follow-up”. Some trials collect data long after the treatments being tested have been given.
Retention refers to the number of people staying involved or “followed up” in trials and whether they complete or provide all the measurements the trial team needs. For example, the trial may ask participants to return for a study visit or return a questionnaire. This is important because if people join a trial but cannot be followed up, the trial results may be inaccurate and misleading which wastes vital research time and money.
Our first survey collected people’s suggestions for important questions about trial retention that still need answering. Those questions have been reduced to a shortlist of 27 questions. Our second survey asks people to choose their top 10 questions from this shortlist. These top 10 lists will feed into the next stage of the process, which will produce the final list of the 10 most important unanswered questions in trial retention.
We want your help in improving the future of clinical trials by improving what we know about the best ways to encourage people to stay involved in clinical trials.
The survey is at https://www.surveymonkey.co.uk/r/BQ6X556
What do we mean by “trials”?
A randomised trial is a type of research study that compares groups of people receiving different interventions and looks at which of these improves health outcomes the most. An intervention is anything that aims to make a change to someone’s health. For example, providing a counselling service, giving a drug, or giving people information and training are all described as interventions. The decision about which group a person joins is at random (for example, by a computer deciding the group the person is put into), which means that a person is put into one of the groups by chance. Challenges in how randomised trials are planned and carried out are often experienced by researchers at different stages of the research project. For example, difficulty in keeping people involved in a trial often results in a delay in completing the trial or difficulty in using the trial results to make informed decisions about clinical care. For this reason, it is important that research into how trials might be ‘done better’ is considered so that the strength of trials’ findings are increased. Your questions and comments, based on your experience of randomised trials, will help us identify those important research questions.
Please find an explanation of research terms here.
Who should take part in the survey?
You can reach the survey at https://www.surveymonkey.co.uk/r/BQ6X556
We are looking for people from the following groups to help us find the 10 most important questions:
- People who have been invited to take part or have taken part in a randomised trial
- Parents or carers of people who have taken part or been invited to take part in a randomised trial
- People who have participated in aspects of trials as partners in the research (e.g. helped to secure the funding, members of trial committees, commented on patient information such as leaflets or letters etc).
- Health professionals and research staff whose work includes encouraging people to stay involved in randomised trials once they have agreed to take part.
- People who have designed, run, analysed, reported on or regulated (e.g. ethics committees) randomised trials
- Anyone with experience of the methods of randomised trials (i.e. how trials are done).
What would we like you to do?
We would like you to complete the survey at https://www.surveymonkey.co.uk/r/BQ6X556
We would like you to choose the 10 questions that you think are the most important for future research to answer from a shortlist of 27 questions. These questions all came from the first survey that we ran earlier in the year.
All answers will be treated confidentially. We will not share your personal details with anyone.
If you would prefer to give us your answers on paper, please contact firstname.lastname@example.org and we will send you a paper copy of the survey.
How else can you get involved?
It is important that the survey reaches as many people as possible. We would particularly like public or professional organisations to help get information about the survey out to their members. If you can do this, please contact us using the information below.
- Follow us on Twitter @Trial_Forge, @hrbtmrn and @LindAlliance and tweet using hashtag #trialretention. Download the PRioRiTy 2 Tweet Sheet for ideas
- Mention the work in your next newsletter or blog. We can supply written information about the project for emails, newsletters or websites – please mention us wherever you can.
What will happen to your feedback?
Once we have collected enough answers to this survey, we will bring approximately 30 people together for a face to face workshop. At the workshop we will discuss the questions about retention to trials that people believe are important, and come to an agreement on what the final Top 10 priority questions for future research are.
Attendees at the face to face workshop will come from a range of locations and have experience of different health areas.
We hope that this final Top 10 list of priorities will improve the process of how people can be helped to stay involved in trials. Results of this survey will be made publicly available in early 2019.
Who is running this project?
A Steering Group that represents the public, researchers, health professionals and trial experts runs this project (many of whom are in the photograph on the right). The project, supported by the University of Aberdeen, the Chief Scientist Office of Scotland, the Health Research Board (HRB, Ireland) and working with the James Lind Alliance (JLA, England) is based on a process developed by the James Lind Alliance, which 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.
Steering Group Members
The project is managed by a Steering Group, which includes representation of patient/carer groups, clinicians and researchers.
Linda Biesty, School of Nursing and Midwifery, National University of Ireland Galway
Peter Brocklehurst - Professor of Women's Health and Director of the Birmingham Clinical Trials Unit
Valerie Brueton, King's College London
Declan Devane - Director of the Health Research Board-Trials Methodology Research Network
Jim Elliott, Public and Patient Involvement Lead, Health Research Authority
Sandra Galvin - Coordinator for the HRB-TMRN
Carrol Gamble, Professor of Medical Statistics at the University of Liverpool
Katie Gillies - Research Fellow, Health Services Research Unit, University of Aberdeen
On completion of her PhD (Biochemistry) Katie moved to applied research and joined HSRU in 2007 taking up the post of Trial Manager for the CATHETER Trial. Whilst working as a Trial Manager she gained an MSc in Health Services and Public Health Research from the University of Aberdeen. During this degree Katie became interested in trials methodology more broadly and specifically how people make decisions about their healthcare and specifically how people make decisions about participation in clinical trials.
Katie was awarded a CSO Postdoctoral Fellowship (2009) to explore stakeholder's perspectives about the acceptability and usefulness of decision aids to support decisions about trial participation. This work is now being further developed through support from an MRC Methodology Research Fellowship (2014). This current fellowship aims to conduct a methodological investgation of core components and outcome measures for decision aids for clinical trial participation.
From May 2017 Katie took on the role of Programme Director for the Health Care Assessment programme.
Patricia Healy – Postdoctoral Researcher, School of Nursing and Midwifery, NUI Galway
Kerry Hood, Cardiff University
Joan Jordan - Public Representative
Doris Lanz, Trial Manager, Queen Mary University London
Beccy Maeso - Senior Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC)
Amanda Roberts, Public and Patient Involvement Partner
Imogen Skene, Senior Research Nurse, Barts Health NHS Trust
Irene Soulsby, Public and Patient Involvement Partner
Derek Stewart - Associate Director for patient and public involvement for the National Institute for Health Research Clinical Research Networks Coordinating Centre
David Torgerson, Head of the University of York Trials Unit, University of York
Shaun Treweek - Health Services Research Unit University of Aberdeen
Caroline Whiting - Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC)
Andrew Worrall, Public and Patient Involvement Partner
Sharon Wren, Health Services Research Unit, University of Aberdeen
Want to keep in touch?
If you would like to hear more from us throughout the project, and for us to tell you the results as soon as they are available, please get in touch.
Follow us on Twitter @Trial_Forge, @hrbtmrn and @LindAlliance