Guidelines to ensure assessment of patient symptoms and quality of life is ethical
Ethical guidelines for the collection of patient reported outcomes (PROs) in clinical research have the potential to reduce risk and burden for participants.
According to research at the University of Birmingham, ethical guidelines can also increase participation in research, and protect the welfare of participants.
In a new study published in JAMA, experts in the University’s Centre for Patient Reported Outcomes Research with international collaborators, set out the guidelines, designed to ensure clinical research which includes patient-reported outcomes is ethical, inclusive, equitable and optimal.
In developing the guidelines, the researchers, led by Dr Samantha Cruz Rivera, reviewed existing publications on ethical implications of PROs and consulted with international experts with an interest in PRO research, recruited with the support of the Health Research Authority.
The aim was to highlight the key issues that should be considered by research teams, ethics committees, patient partners and the public involved in the research, rather than to mandate how ethical research should look.
The use of PROs can provide invaluable insights into how research interventions are experienced from the participant’s perspective and it is vital that these are collected in a way that properly respects and protects both participants and researchers.
Senior author Professor Melanie Calvert said: “The increasing use of patient-reported outcomes in research and in clinical care may lead to uncertainties for patients about why data are being collected and used. At the same time, in situations where PROs reveal concerning information – for example psychological distress or physical symptoms – researchers need to know how to manage that data and ensure participants are well cared-for.”
In addition, PRO research may not reflect the perspectives of underserved groups such as older individuals, socioeconomically disadvantaged populations, and ethnic minorities, which could threaten the scientific validity of results. Use of the new PRO ethical guideline published in JAMA will help research teams, patients involved in the co-design of studies and research ethics committees help consider such issues resulting in higher quality data that can meaningfully inform care.”
Clive Collett, HRA Senior Policy Manager, said: “The use of PROs can provide invaluable insights into how research interventions are experienced from the participant’s perspective and it is vital that these are collected in a way that properly respects and protects both participants and researchers.
“The collection of high-quality PRO data in an ethical manner supports the HRA’s vision for high-quality health and social care research that protects and promotes the interests of participants and the public and improves people’s health and wellbeing. For research to be safe and ethical it is important that ethical thinking is embedded throughout the research journey and these guidelines will help researchers to do that.”
Phil Collis, patient partner, said “As patients, during our healthcare, we are asked to complete questionnaires about our experiences of care and treatments. Our responses provide valuable information that can help maintain or improve patient experiences and outcomes – informing clinical decision making on what is important to us in relation to patient care. These new ethical guidelines can ensure that the methods used in gathering, collating, and using this important patient information is carried out in an ethical, safe way.”
Professor Conrad Fernandez, IWK Health Centre and Dalhousie University, Canada, is a co-author on the paper. He said: "I believe these guidelines will strengthen the scientific and ethics review of Patient Reported Outcomes research leading to significantly enhanced participant protections, whilst ensuring that meaningful benefits we all strive for are kept central to the research at hand."
Lisa Campbell, Senior Medical Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) and co-author says: “Addressing ethical issues for PROs in clinical research is crucial to protect patients and improve shared-decision making across the healthcare system. These new guidelines provide useful recommendations that will help strengthen scientific and ethical review in order to support patient-centred care and access.”
The Birmingham led team will now work to promote the implementation of the new guidelines both in the UK and internationally.
This work was sponsored by the University of Birmingham and received funding from NIHR Birmingham Biomedical Research Centre, UK Research and Innovation, UK SPINE, European Regional Development Fund.
A podcast discussing the work has been published by JAMA.
Notes for editors
Notes for editors
- For media enquiries please contact Beck Lockwood, Press Office, University of Birmingham, tel: +44 (0)781 3343348.
- The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
- Cruz Rivera, S. et al (2022). ‘Ethical considerations for the inclusion of patient-reported outcomes in clinical research: The PRO ethics guidelines.’
- A Podcast (live after the embargo has lifted) will be available here: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2022.6421
- About NIHR
- The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
UK SPINE aims to improve healthspan (healthy life-years) for patients with multiple age-related conditions. Our mission is to accelerate the discovery, development and testing of new drugs, by better understanding the underlying biology which drives these conditions, and work with patients and the public to consider the regulatory needs for such treatment. This network, driven by six partner institutions throughout the UK, is committed to open sharing of knowledge, research and understanding of age-related illness.
The UK SPINE is funded by Research England’s Connecting Capabilities Fund (CCF), and places knowledge exchange at the centre of the network. It provides a platform for the geroscience community to share and exchange expertise, perspectives and experience.
The name ‘UK SPINE’ draws on the geographic spread of the founding partner hubs (Universities of Oxford, Dundee, and Birmingham, the Medicines Discovery Catapult at Alderley Park, and the Francis Crick Institute in London), which forms a spine, connecting the locations across the UK.