Chapter 2 - Partnership with Scottish Patients and the Public
The Scottish public are at the heart of clinical research, both as healthy volunteers participating in early stage studies and as patients benefiting from improved diagnoses or treatments. Without patients enrolling to take part in clinical research, very little of the research conducted in the NHS would be possible. The insights and views of patients, carers and relatives are also immensely useful in ensuring the successful delivery of well-designed, scientifically valid research that has relevance to the people of Scotland.
CSO Public Engagement Group
Since 2001, CSO has involved the public in both grant funding and policy areas. We acknowledge that the CSO Public Engagement Group ( PEG) plays a key role in representing the publics interest in CSO's work, providing a vital lay view of policy and research proposals.
We have recently carried out a fundamental review of public involvement activities both within CSO and the NRS Research Network structures. While there is much excellent work being undertaken by the Public Engagement Group we recognise jointly that there are opportunities to enhance it's role in providing advice and support to CSO. As a consequence:
- There will be broader lay representation in the work of CSO, including participation at CSO policy and strategic committees;
- Lay involvement will be built into the planning and review of CSO investments such as CSO funded units, NRS bio-repositories and safe havens, and
- CSO will liaise with the other UK administrations to share and learn from best practice.
Our NRS Networks also heavily involve the public at steering group level as well as directly with research. However, there is more that can be done in developing best practice in these areas and we will explore bringing these groups together to build a greater sense of common enterprise. CSO will continue to encourage the component parts of NRS to engage directly with patients and patient groups, and further develop ways in which members of the public can be empowered to become actively involved in clinical research.
13. CSO will require the NRS Research Networks to show evidence of public involvement in their work.
"The CSO has fully embraced public involvement in its work streams and, since I joined the Public Engagement Group ( PEG) 4 years ago, our role has expanded and now the Office is actively encouraging researchers to include lay or patient participation in their work. This is not just a paper exercise, our opinions have helped to shape the new strategy. Fascinating and absorbing work."
Barbara Lamb - Chair of CSO's Public Engagement Group
Scottish Health Research Register
CSO is also funding an initiative for members of the public who wish to express an interest in being contacted about participating in health research. Following registration on the Scottish Health Research Register ( SHARE), details will be maintained on a database of those who are willing to be approached about taking part in research studies. Through electronic linkage of health information, SHARE will be able to identify potential recruits for studies far more efficiently than at present. Initially funded through a CSO small grant, SHARE has now been brought within the NRS Infrastructure budget to ensure sustainability and facilitate larger scale recruitment. In October 2015 there were over 80,000 people on SHARE but the long-term goal is to create a far larger register for use in relevant studies.
Such a register is only of use if it facilitates recruitment into clinical studies. Although SHARE provides an opportunity for many to indicate a general willingness to be approached to take part in research, routes for facilitating involvement for patients who want to take part in specific studies are relatively underdeveloped. While medical researchers often find it difficult to identify suitable patients for clinical trials, it is often equally hard for patients interested in taking part in studies to find clear, accessible information. Current lists of active studies do not generally provide lay summaries of what projects involve, and current mechanisms to enable patients to express an interest in taking part are not always sufficiently targeted.
"As a clinical researcher, I know that having a strong and flexible recruitment strategy is key to study success. I have used SHARE to recruit to 2 studies involving older people, and have found it to be a user-friendly and efficient means of recruiting interested participants with a high probability of participation. My Ageing and Health team has a strong track record in recruiting the right number of participants within the planned timescale and working with SHARE is helping us to deliver this."
Professor Marian McMurdo - University of Dundee
14. CSO will review the effectiveness of SHARE in the first half of 2016.
15. The SHARE website will be developed to allow NHS patients across Scotland to identify clinical studies which are actively seeking participants. Patients will be able to review a list of available studies, and express their interest online.
Aggregate data derived from NHS health records allows planning and feasibility assessments of the potential success of research projects to be made. However, individual patient data are not currently used to inform patients about research projects that would be of personal relevance to them.
Projects such as SHARE therefore require potential participants to register their general agreement for their electronic records to be checked. This, however, limits the identification of patients who may benefit from new treatments available through clinical trials to those who have previously registered an interest. As a consequence, patients undergoing treatment in the NHS are not routinely informed of research taking place that could be relevant to them.
We believe offering patients participation in clinical studies should be a key aim of the NHS as an integrated part of patient care. Assisting GPs and hospital consultants in identifying patients who might be invited to participate in a research study relevant to their condition is therefore a service we believe worthy of consideration. NHS staff using NHS patient records solely to advise GPs and hospital consultants of studies that may be of interest to their patients strikes an acceptable balance of security and service to patients. The appropriateness of such a service was supported by those who responded to our general consultation exercise however we intend to consult specifically with members of the public on this issue.
In doing so we are aware of proposed amendments to the EU Data Protection Regulations that, if accepted, would prevent such service being provided. Our aim therefore is to conclude the further consultation and await the outcome of the EU consideration of these amendments.
16. CSO will conduct a more focused consultation with members of the public, including its own Public Engagement Group, before progressing this initiative.
Supporting Quality Improvement
While it is essential for CSO to continue to be outward looking in delivering success, we must also ensure that we use our research expertise to support key initiatives of importance to the Scottish Government. Underpinned by the Quality Strategy, the NHS in Scotland has made significant strides in improving patient safety and the quality of care in recent years. Quality Improvement is now a unifying theme of NHSScotland and increasingly across public service. While to date NHSScotland has used its expertise to drive changes forward and there has been limited research to develop new knowledge, or publication of our work in respected peer reviewed journals. As a consequence there is considerable scope to expand the volume of research related to quality improvement science in the context of the Scottish healthcare system.
"The SHARE register has been invaluable in helping us recruit healthy volunteers into our study. In previous years it has been extremely difficult to find asymptomatic volunteers who are willing to undergo an invasive procedure like endoscopy. SHARE has made recruitment a much easier process and as a result we are close to achieving our target number well within our time frame."
Dr David R. Mitchell - Senior Clinical Research Fellow, Gartnavel General Hospital
For this reason CSO is a partner in the creation of the Scottish Improvement Science Collaborating Centre ( SISCC). Co-funded in collaboration with NHS Education Scotland, the Scottish Funding Council and the Health Foundation, it is a national resource and centre of expertise in improvement science research, development and knowledge translation.
With the integration of Health and Social Care, it is important to recognise the benefits that will flow from research in this area. CSO already funds health research project grants with a social care component, and initiatives such as the SISCC have a social care dimension.
17. CSO will continue to support research in pursuit of health and social care integration and will work with colleagues within the Scottish Government to ensure this important agenda has a properly constituted research dimension.