PRioRiTy 2 - Trial Forge

What is PRIORITY II about?

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.

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 took part in the survey?

Who should take part in the survey?

We were 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 are currently preparing for a face-to-face consensus meeting to produce the final list of Top 10 priorities.

If you would prefer to give us your answers on paper, please contact k.gillies@abdn.ac.uk and we will send you a paper copy of the survey.

How else can you get involved?

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?

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?

PRIORITY 2 team 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

Peter Brocklehurst is Professor of Women's Health and Director of the Birmingham Clinical Trials Unit at the University of Birmingham. Peter is an obstetrician and clinical epidemiologist, with expertise in randomised controlled trials and observational epidemiology. He is an NIHR Senior Investigator and Fellow of the Academy of Medical Sciences.

Valerie Brueton, King's College London

Declan Devane - Director of the Health Research Board-Trials Methodology Research Network

Declan Devane is Professor of Midwifery at the National University of Ireland Galway and Director of the Health Research Board-Trial Methodology Research Network. He has led a number of clinical trials recruiting from 100 to over 3000 participants and serves on a number of Trial Steering Committees and Data Monitoring Boards. He is also an Associate Editor with the Cochrane Pregnancy and Childbirth Group, an Associate Senior Lecturer with the UK Cochrane Centre.

Jim Elliott, Public and Patient Involvement Lead, Health Research Authority

Sandra Galvin - Coordinator for the HRB-TMRN

Sandra Galvin is the Coordinator for the HRB-TMRN and is based in the School of Nursing and Midwifery, National University of Ireland Galway. Sandra is responsible for the development and running of the HRB-TMRN across all 7 university partner sites, as well as contributing to the strategic oversight of the network. Sandra graduated with a PhD in Bacteriology in 2010 from NUI Galway, after which she worked as a postdoctoral researcher the Department of Clinical Microbiology in the Royal College of Surgeons in Ireland in Dublin. Sandra became a HRB ICE Research Fellow (2012 - 2015) where she worked with on a complex intervention to improve antimicrobial prescribing in primary care.

Carrol Gamble, Professor of Medical Statistics at the University of Liverpool

Carol’s main area of research is in the design, conduct and analysis of clinical trials. Carrol predominantly works in clinical trials involving children and young people and has particular interests in the recruitment and retention of participants. Carrol is a member of the North West Hub for Trials Methodology Research and Chairs the Statisticians Operational Group within the UKCRC registered clinical trials units.

Katie Gillies - Research Fellow, Health Services Research Unit, University of Aberdeen

Katie Gillies is a Senior Research Fellow and MRC Methodology Fellow working in methodological research across both the Health Care Assessment and Delivery of Care Programmes within HSRU.
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

I am a midwife and children’s nurse. I trained and worked as a midwife in the Coombe women’s and infants Hospital in Dublin and as a children's nurse in Our Lady’s Hospital, Crumlin. My clinical speciality is special and intensive neonatal care where I spent many very rewarding clinical practice years. I hold a Nursing Degree and a Midwifery Masters from Trinity College Dublin, a Diploma in Health Services Management from University Limerick and a PhD from NUI, Galway. My PhD focused on cerebral palsy through which I developed a particular interest in quality and safety, risk management and clinical negligence in healthcare especially in the maternity services. As part of my PhD experience I worked for a time as a Clinical Risk Advisor in the Clinical Indemnity Scheme, which is a branch of the State Claims Agency. I am currently employed as a post-doctoral researcher at the school of Nursing and Midwifery, NUI, Galway. Through this post-doctoral work I have developed an interest in research methodology, clinical trials, systematic reviews, meta-analyses and evidence synthesis. I continue to indulge my great love of neonatal care by teaching across the undergraduate and postgraduate midwifery programmes whenever the opportunity arises.

Kerry Hood, Cardiff University

Joan Jordan - Public Representative

Joan Jordan was diagnosed with Multiple Sclerosis in 2010 and has participated in a clinical trial for two and half years. A Computer Science graduate, she had previously worked across the globe for over a decade on mobile communications projects. She is currently retraining and is studying medicine research and design on the 2015-16 EUPATI programme.

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)

I am a Senior Research Manager at the National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton. I lead the team that manages the James Lind Alliance (JLA). We provide the secretariat function to the JLA. This includes recruiting and training JLA Advisers, coordinating PSPs, looking after JLA communications and liaising with other parts of the National Institute for Health Research. I also support the work of JLA Advisers and act as a facilitator for some JLA Priority Setting Partnership final workshops.

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

Born in Scotland, Derek Stewart was treated successfully for cancer of the larynx in 1995. A former teacher working with challenging pupils, Derek became involved in numerous aspects of patient involvement at a local, network and national levels. A blog of his views can be found at Making a Difference. As former Chair of the National Cancer Research Institute Consumer Liaison Group, Derek assisted with the increase in patient participation in the establishment and work of the National Cancer Research Institute. Derek is a Trustee for onCore UK, the national cancer tissue resource, Chair of the Confederation of Cancer Biobanks and a member of the Cancer Reform Strategy Advisory Board. From 2001 until 2006 Derek was Chair of Gedling Primary Care Trust in Nottinghamshire. In 2005 he took up the role as Chair of Nottingham City Crime and Drugs Partnership. Derek still works as a freelance consultant with his own company providing training on patient and public involvement across charity and public sector. This contribution to health services in particular cancer led to being awarded an OBE in the Queen’s Birthday Honours list 2006. Derek is Associate Director for patient and public involvement for the National Institute for Health Research Clinical Research Networks Coordinating Centre and is Chair of the Throat Cancer Foundation. Read about what people say about us.

David Torgerson, Head of the University of York Trials Unit, University of York

Shaun Treweek - Health Services Research Unit University of Aberdeen

Shaun is a health services researcher interested in efficient trial design, particularly around recruitment and retention and the effective presentation of research evidence. He leads an initiative called Trial Forge that aims to be more systematic about how we generate and use research evidence in making trial design, conduct, analysis and reporting decisions.

Caroline Whiting - Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC)

I am a Research Manager at the National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton. My work as part of the team that manages the James Lind Alliance (JLA) gives me experience of a wide range of Priority Setting Partnerships and the different approaches they take to completing the JLA PSP method.

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