What is the PRioRiTy Study?
The Prioritising Recruitment in Randomised Trials study (PRioRiTy) identified research priorities for how to improve the process of how people are recruited to clinical trials. The partner study, PRioRiTy 2 identified research priorities to improve the process for how to improve retention in clinical trials. Both studies employed 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 PSPs were focussed on methodological uncertainties rather than on treatment uncertainties and therefore a modified JLA approach was developed and used.
The PRioRiTy studies were the first time a modified JLA approach was used to address methodological uncertainties within randomised trials. This was an Ireland and UK initiative and was funded by several funders, including: the Health Research Board (Ireland), Chief Scientist Office of the Scottish Governments Health and Social Care Directorate, and the Medical Research Council).
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 recruiting people to 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.
Who took part in the survey?
- Members of the public who have been asked to take part in a randomised trial by a health professional or researcher
- Members of the public who has taken part in a randomised trial steering committee
- Health professionals or any member of a research team who has ever been involved in helping people to join randomised trials
- People who have designed, conducted, analysed or reported on randomised trials
- People who have experience of the methods of randomised trials.
Who is running this project?
A Steering Group that represents the public, researchers, health professionals and trial experts carried out each of these projects. The project is based on a process developed by the James Lind Alliance, which brings patients, carers and healthcare professionals together in Priority Setting Partnerships. This partnership identified and prioritised unanswered questions about methodological uncertainties in recruitment and retention to trials 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.
Who developed / conducted the PRioRiTy study?
The PRioRiTy studies was developed and conducted by the Health Research Board- Trials Methodology Research Network, the MRC-Hubs for Trials Methodology Research network, Trial Forge, The James Lind Alliance and the National Institute for Health Research. Each study was governed by a Steering Group with public, researcher, health professional and trial expert representation.
Steering Group Members
Priority I
| Name | Affiliation / Title | Bio |
|---|---|---|
| Dr Katie Gillies | Senior Research Fellow, Health Services Research Unit University of Aberdeen | Katie Gillies is Director of the Healthcare Assessment Programme, Senior Research Fellow and MRC Methodology Fellow working in Methodological Research related to participant centred trials. From May 2017 Katie took on the role of Director for the Health Care Assessment programme. |
| Prof Shaun Treweek | Professor, Health Services Research Unit University of Aberdeen | Shaun is a professor at the Health Services Research Unit, having previously worked at the University of Dundee as Assistant Director of the Tayside Clinical Trials Unit. He is leading an initiative called Trial Forge (http://www.trialforge.org) that aims to be more systematic about how we generate and use research evidence in making trial design, conduct, analysis and reporting decisions. |
| Heidi Gardner | Research Fellow, Health Services Research Unit University of Aberdeen | Heidi joined the Health Services Research Unit (HSRU) as a Research Assistant in June 2018; she works across ImproveHD, PRioRiTy II and various other trial methodology projects. Prior to this, Heidi undertook her PhD project based at HSRU under the supervision of Prof Shaun Treweek and Dr Katie Gillies. This project focussed on improving the efficiency of clinical trials, with particular focus on participant recruitment. She is now beginning a new role as Research Fellow in within HSRU in March 2019. |
| Dan Brunsdon | Research Assistant, Health Services Research Unit University of Aberdeen | Dan Brunsdon is a medical anthropologist and Research Assistant within the Health Services Research Unit, who joined in May 2018, specialising in qualitative support. His background is in anthropology, having studied BA Anthropology with Political Science at the University of Birmingham and an MSc in Medical Anthropology at Durham University. Currently he is working across a number of different clinical trials, including PUrE, RAACENO and UK-REBOA. |
| Ms Beccy Maeso | Senior Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) / NIHR/James Lind Alliance | 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. |
| Mrs Caroline Whiting | Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) / NIHR/James Lind Alliance | 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. |
| Dr Sandra Galvin | HRB-TMRN (Programme Manager) | Sandra Galvin is the Programme Manager for the HRB-TMRN and a Senior Research Fellow based in the School of Nursing and Midwifery, National University of Ireland Galway. Sandra is responsible for the development , strategic direction, implementation and running of the HRB-TMRN activities across all 5 Irish university partner sites, as well as responsible for establishing international collaborations for the network. |
| Dr Patricia Healy | School of Nursing & Midwifery, NUI Galway (Research Fellow) | 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. |
| Prof Declan Devane | Director of the Health Research Board-Trials Methodology Research Network / Project Principal Investigator and steering group Chairperson | 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. |
| Dr Linda Biesty | Lecturer Above The Bar, School of Nursing and Midwifery, NUI Galway | Linda Biesty is a Lecturer in Midwifery at the School of Nursing & Midwifery, NUI Galway. A registered midwife, nurse and tutor with the Nursing & Midwifery Board of Ireland, she holds an MSc Midwifery, Post Graduate Diploma in Clinical Sciences Education (with distinction) & PhD from Trinity College Dublin. A midwife since 1997, Linda has practised midwifery in London, Australia and Ireland, in hospital and home / community settings within obstetric-led and midwife-led models of maternity care. |
| Prof Carrol Gamble | Kings College London/Retention Cochrane Review Lead | Dr Valerie Brueton RN, RM, is a lecturer in adult nursing at King’s College, London. Her PhD focused on participant retention in clinical trials. Valerie led the Cochrane review of strategies to improve retention in randomised trials. She has managed recruitment and follow-up in research in the UK and Africa. Her clinical expertise lies in surgical nursing and reproductive health. |
| Prof David Torgerson | Prof David Torgerson Director, York Trials Unit, University of York | Professor David Torgerson, Director of the York Trials Unit, joined the Centre for Health Economics at the University of York in 1995 and became the Director of the York Trials Unit in 2002. Originally a health economist, he is a trial methodologist and has published widely on the design and conduct of randomised controlled trials including the book “Designing Randomised Controlled Trials in Health, Education and the Social Sciences (Palgrave Macmillan 2008)”. |
| Prof 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. |
| Prof Kerry Hood | Director, Centre for Trials Research, Cardiff | I am Professor of Trials and the Director of the UKCRC Registered Centre for Trials Research at Cardiff University. I am a Senior Research Leader and mentor for Health and Care Research Wales. I am a Fellow of the Royal Statistical Society and the Higher Education Academy and a member of the Society for Academic Primary Care and the Society for Clinical Trials. |
| Mr Derek Stewart OBE | 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. |
| Mrs Joan Jordan | EUPATI 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. |
| Dr Jim Elliott | HRA PPI lead | TBC |
| Mr Andrew Worrall | PPI Partner | Andrew Worrall is a PPI co-applicant on two surgical/anaesthetic trials and has been a lay member of NIHR funding panels and regional networks. He has worked in teaching and children’s services. He now chairs a regional music education partnership, a music charity and is a gardener and writer. He lives in the English midlands. |
| Amanda Roberts | PPI Partner | Amanda Roberts has helped run a support group for carers of children of eczema (www.nottinghameczema.org.uk) for over twenty five years. She is passionate about, and active in, patient involvement in health service design, delivery and research. Having been on the steering group for the JLA Priority Setting Partnership for Eczema, she welcomed the chance to be involved with Priority II. |
| Irene Soulsby | PPI Partner | Irene lives near Newcastle upon Tyne and worked as a secretary for 35 years. She had a cancer diagnosis in 2003 and was successfully treated, and decided to take early retirement in 2009. Irene discovered taking part in research projects "quite by accident" and has participated in several over the years and likes to say that she is "here because of research". She enjoys meeting people from different backgrounds and says that "It's been a great experience to take part in Priority II where I have felt very valued." |
| Doris Lanz | Queen Mary University London | Doris has been working as a trial manager for more than a decade, both in the UK and in Switzerland. She’s worked in cancer research, mental health as well as surgical trials and is currently overseeing trial development and management in women’s health at Queen Mary University of London. She has a special interest in trial efficiency and in patient and public involvement in research. |
| Sharon Wren | Data Co-ordinator, Health Services Research Unit University of Aberdeen | Sharon Wren, joined the Health Services Research Unit in March 2016 as a Data Co-ordinator/Secretary and is working on PUrE, ALLEGRO, and TISU. She is responsible for inputting, retrieving and maintaining data, along with other secretarial duties relating to the trials. |
| Imogen Skene | Senior Research Nurse, Barts Health NHS Trust | Imogen Skene is a senior clinical research nurse at Barts Health NHS Trust. Her clinical speciality is emergency nursing & she has worked clinically in emergency departments in England, Australia & New Zealand She has worked on a number of clinical trials in emergency care, recruiting patients in the emergency department. Her CLAHRC fellowship work focused on clinical research practitioners experiences of taking informed consent to research in the emergency department setting. |
Priority II
| Name | Affiliation / Title | Bio |
|---|---|---|
| Dr Linda Biesty | Lecturer Above The Bar, School of Nursing and Midwifery, NUI Galway | Linda Biesty is a Lecturer in Midwifery at the School of Nursing & Midwifery, NUI Galway. A registered midwife, nurse and tutor with the Nursing & Midwifery Board of Ireland, she holds an MSc Midwifery, Post Graduate Diploma in Clinical Sciences Education (with distinction) & PhD from Trinity College Dublin. A midwife since 1997, Linda has practised midwifery in London, Australia and Ireland, in hospital and home / community settings within obstetric-led and midwife-led models of maternity care. |
| Prof 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. |
| Dr Valerie Brueton | Kings College London/Retention Cochrane Review Lead | Dr Valerie Brueton RN, RM, is a lecturer in adult nursing at King’s College, London. Her PhD focused on participant retention in clinical trials. Valerie led the Cochrane review of strategies to improve retention in randomised trials. She has managed recruitment and follow-up in research in the UK and Africa. Her clinical expertise lies in surgical nursing and reproductive health. |
| Prof Declan Devane | Director of the Health Research Board-Trials Methodology Research Network / Project Principal Investigator and steering group Chairperson | 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. |
| Dr Jim Elliott | HRA PPI lead | TBC |
| Dr Sandra Galvin | HRB-TMRN (Programme Manager) | Sandra Galvin is the Programme Manager for the HRB-TMRN and a Senior Research Fellow based in the School of Nursing and Midwifery, National University of Ireland Galway. Sandra is responsible for the development , strategic direction, implementation and running of the HRB-TMRN activities across all 5 Irish university partner sites, as well as responsible for establishing international collaborations for the network. |
| Dr Katie Gillies | Senior Research Fellow, Health Services Research Unit University of Aberdeen | Katie Gillies is Director of the Healthcare Assessment Programme, Senior Research Fellow and MRC Methodology Fellow working in Methodological Research related to participant centred trials. From May 2017 Katie took on the role of Director for the Health Care Assessment programme. |
| Dr Patricia Healy | School of Nursing & Midwifery, NUI Galway (Research Fellow) | 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. |
| Prof Kerry Hood | Director, Centre for Trials Research, Cardiff | I am Professor of Trials and the Director of the UKCRC Registered Centre for Trials Research at Cardiff University. I am a Senior Research Leader and mentor for Health and Care Research Wales. I am a Fellow of the Royal Statistical Society and the Higher Education Academy and a member of the Society for Academic Primary Care and the Society for Clinical Trials. |
| Mrs Joan Jordan | EUPATI 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 | Queen Mary University London | Doris has been working as a trial manager for more than a decade, both in the UK and in Switzerland. She’s worked in cancer research, mental health as well as surgical trials and is currently overseeing trial development and management in women’s health at Queen Mary University of London. She has a special interest in trial efficiency and in patient and public involvement in research. |
| Ms Beccy Maeso | Senior Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) / NIHR/James Lind Alliance | 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. |
| Amanda Roberts | PPI Partner | Amanda Roberts has helped run a support group for carers of children of eczema (www.nottinghameczema.org.uk) for over twenty five years. She is passionate about, and active in, patient involvement in health service design, delivery and research. Having been on the steering group for the JLA Priority Setting Partnership for Eczema, she welcomed the chance to be involved with Priority II. |
| Imogen Skene | Senior Research Nurse, Barts Health NHS Trust | Imogen Skene is a senior clinical research nurse at Barts Health NHS Trust. Her clinical speciality is emergency nursing & she has worked clinically in emergency departments in England, Australia & New Zealand She has worked on a number of clinical trials in emergency care, recruiting patients in the emergency department. Her CLAHRC fellowship work focused on clinical research practitioners experiences of taking informed consent to research in the emergency department setting. |
| Irene Soulsby | PPI Partner | Irene lives near Newcastle upon Tyne and worked as a secretary for 35 years. She had a cancer diagnosis in 2003 and was successfully treated, and decided to take early retirement in 2009. Irene discovered taking part in research projects "quite by accident" and has participated in several over the years and likes to say that she is "here because of research". She enjoys meeting people from different backgrounds and says that "It's been a great experience to take part in Priority II where I have felt very valued." |
| Mr Derek Stewart OBE | 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. |
| Prof David Torgerson | Prof David Torgerson Director, York Trials Unit, University of York | Professor David Torgerson, Director of the York Trials Unit, joined the Centre for Health Economics at the University of York in 1995 and became the Director of the York Trials Unit in 2002. Originally a health economist, he is a trial methodologist and has published widely on the design and conduct of randomised controlled trials including the book “Designing Randomised Controlled Trials in Health, Education and the Social Sciences (Palgrave Macmillan 2008)”. |
| Prof Shaun Treweek | Professor, Health Services Research Unit University of Aberdeen | Shaun is a professor at the Health Services Research Unit, having previously worked at the University of Dundee as Assistant Director of the Tayside Clinical Trials Unit. He is leading an initiative called Trial Forge (http://www.trialforge.org) that aims to be more systematic about how we generate and use research evidence in making trial design, conduct, analysis and reporting decisions. |
| Mrs Caroline Whiting | Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) / NIHR/James Lind Alliance | 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. |
| Mr Andrew Worrall | PPI Partner | Andrew Worrall is a PPI co-applicant on two surgical/anaesthetic trials and has been a lay member of NIHR funding panels and regional networks. He has worked in teaching and children’s services. He now chairs a regional music education partnership, a music charity and is a gardener and writer. He lives in the English midlands. |
| Sharon Wren | Data Co-ordinator, Health Services Research Unit University of Aberdeen | Sharon Wren, joined the Health Services Research Unit in March 2016 as a Data Co-ordinator/Secretary and is working on PUrE, ALLEGRO, and TISU. She is responsible for inputting, retrieving and maintaining data, along with other secretarial duties relating to the trials. |
| 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. |
