Research and evaluation briefing for Clinical Commission Groups (CCGs) and PCT clusters[1]: Existing functions and new opportunities
Executive summary
Context
This paper has been prepared by the Research Leadership in Clinical Commissioning Groups subgroup of the National Institute for Health Research, Clinical Research Network Advisory Group on research and the transition to GP commissioning in the New NHS. Its purpose is to provide background information and constructive proposals to help inform the future organisation, hosting, delivery and leadership of research in the CCGs and PCT Clusters. This background information can, and should, be supplemented by local data to inform local discussions and decision-making. This paper approaches the generic national issues by exploring:
- The current research and evaluation roles of PCTs and how these might best be transferred to Commissioning Groups (CCGs) and PCT clusters
- The relevance of research and evaluation and potential opportunities to Clinical Commissioning Groups (CCGs) and PCT clusters
- Examples of emerging approaches in supporting CCGs address their duty to promote research and innovation and use of evidence
Background and current position
The NHS Constitution requires that research is core NHS business and every patient should be offered the opportunity to engage with research activities. The government’s response to NHS Futures Forum report relating to the Health and Social Care Bill creates a duty for Clinical Commissioning Groups (CCGs) to “promote research and innovation and the use of research evidence.”
Current research and evaluation roles of PCT are being transferred to CCGs and PCT clusters. These include:
· Responsibility for research management and governance regulations and research audit
· Hosting of research contracts and in some cases NIHR Research Networks
· Responsibility for paying the excess treatment costs
· Deploying Flexibility and Sustainability Funding (FSF)
· Influencing local research policy and individual projects in particular as partners of a local Collaboration for Leadership in Applied Health Research and Care (CLAHRC) or Academic Health Science Centre (AHSC)
· Lead service evaluation and training through working with local academics. This approach provides a source of research questions.
The opportunities for Clinical Commissioning Groups
There are a number of well recognised arguments supporting the role of research in improving the health of patients, engendering a culture of quality improvement and in promoting the implementation of research findings within practice. The current transitional period presents an opportunity to radically improve how the contracting process contributes to these objectives. This is perhaps the key opportunity for enhancing the NHS as an evidence-driven organisation. If CCGs routinely specify in contracts that their providers should deliver research-responsive and appropriately evaluated services we can create a step change in the role of research within the NHS. CCGs will be in a position to both increase the chances that their patients will be able to participate in research and the likelihood that the services they commission deliver what is expected from them.
In addition the generation of primary care relevant research questions will be facilitated by an effective research, evaluation and knowledge management infrastructure within CCGs as members identify potential research questions that are relevant to their patients.
If CCGs can develop a strategy for managing and investing it in research there is an increasingly reliable income stream available from the NIHR Comprehensive Local Research Networks (CLRNs), via PCTs (particularly FSF) and through Industry trials. There is also, through collaboration with the CLRNs, an opportunity to consolidate the statutory compliance with the Research Governance Framework for Health and Social Care which is required for any research to take place on CCG premises or involving their staff.
Helping CCGs meet their duty of promoting research, innovation and the use of evidence
We conclude that prompt contact is required between leaders of the local NIHR research community and CCGs to ensure opportunities are not missed. Part-time CCG research leads funded by the NIHR, are our favoured mechanism for providing a point of contact between commissioning decision-making, NIHR clinical research networks, academics, patient groups, and service providers.
These roles would provide local leadership on resourcing and performance management of research activity. Furthermore, we envisage these roles as providing the clinical leadership necessary to embed research within the CCGs and, crucially, as part of the commissioned activity of providers whereby the research activity of NHS organisations are valued and recognised to the same extent that other activities are.
Research and evaluation briefing for Clinical Commission Groups and PCT clusters: Existing functions and new opportunities
1. Context
This paper has been prepared by the Research Leadership in Clinical Commissioning Groups subgroup of the National Institute for Health Research, Clinical Research Network Advisory Group on research and the transition to GP commissioning in the New NHS. Its purpose is to provide background information and constructive proposals to help inform the future organisation, hosting, delivery and leadership of research in the CCGs and PCT Clusters. This background information can, and should, be supplemented by local data to inform local discussions and decision-making. This paper approaches the generic national issues by exploring:
- The current research and evaluation roles of PCTs and how these might best be transferred to Commissioning Groups (CCGs) and PCT clusters
- The relevance of research and evaluation and potential opportunities to Clinical Commissioning Groups (CCGs) and PCT clusters
- Examples of emerging approaches in supporting CCGs address their duty to promote research and innovation and use of evidence
2. Background
The NHS Constitution states that research is core NHS business and every patient should be offered the opportunity to engage with research activities, within primary, secondary and social care. A key component of the Health Bill is that healthcare commissioning should be driven by clinical commissioners following the abolition of primary care trusts. The government’s response to NHS Futures Forum report relating to the Bill creates a duty for CCGs to “promote research and innovation and the use of research evidence.”
This drive to integrate research into the NHS started about 6 years ago with the formation of the National Institute for Health Research (NIHR). The NIHR has an annual budget of around £1 billion and this is being invested in research networks and centres, and in numerous research grant funding streams. The most visible aspects of this to primary care teams have been the Primary Care Research Network and the Comprehensive Local Research Network both of which support practices in recruiting to NIHR studies.
3. What roles do Primary Care Trusts have around research and the use of evidence?
This depends on individual PCTs as some have outsourced the majority of their R&D function whereas others have been the host trust for a collaborative of research active PCTs with their R&D function taking on a broad role around research, evaluation and knowledge management. The majority of PCT research activity can be described as being on the NIHR Portfolio. To be on the NIHR Portfolio, which is the only way that research attracts NIHR resources and includes academic and industry led studies, the research project has to meet a number of quality-related criteria. ‘Non-portfolio’ research tends to be smaller studies that may include PhD and Masters research projects and some commercial studies.
The capacity to generate evidence and use knowledge to inform decision making is strongest in high-performing organisations where research, innovation and evaluation are encouraged and supported. This paper discusses research and service evaluation together, as they are inter-related and often use the same methodologies. Both research and evaluation represent a culture of asking critical questions and seeking out best practice. Much high quality research is of an evaluative nature but it is important to note that the NIHR does not fund or support pure i.e. non-research service evaluation. This aspect is currently funded by healthcare commissioners and providers and will need to continue.
In broad terms, the research functions of the most research active PCTs can be broken down into seven headings. There will be local variation in whether PCTs perform some or all of these functions or have acquired additional roles.
3.1 Statutory compliance with research management and governance regulations and research audit
All NHS trusts have to comply with the Research Governance Framework for Health and Social Care. Trusts’ approval is needed to ensure that patients’ interests are protected and NHS resources are used appropriately.
3.2 Contracts with the Department of Health and Universities
PCTs often hold contracts with the Department of Health and sub-contracts with higher education institutions involved with research projects and as well as independent research companies. Some PCTs are also the conduit through which Clinical Excellence Awards are paid to senior academic primary care clinicians.
3.3 Excess treatment costs
During a research project where care is provided to patients that is an experimental treatment differing from the standard treatment for that condition, the difference between the total treatment costs and the costs of the standard treatment is called the Excess Treatment Cost (ETC). Responsibility for paying the excess treatment costs of research currently rests with PCT commissioners. The approach to ETCs is currently under review.
3.4 NIHR Flexibility and Sustainability Funding (FSF)
FSF is allocated to trusts by the Department of Health in proportion to NIHR grant income paid to the host NHS Trust in the previous calendar year. FSF is used to help research-active NHS organisations attract, develop and retain high-quality research, clinical and support staff by supporting the salaries of their researchers and associated workforce in a flexible manner. PCTs that receive FSF have a responsibility to spend it in way that builds the NIHR research portfolio, leading to a virtuous cycle of increasing research success which in turn leads to increased FSF that can be used to generate further NHS relevant research. This funding stream can be an effective tool to influence the development of research and foster alignment between researchers’ interests and NHS priorities.
3.5 Hosting NIHR clinical research networks
Some PCTs host regional branches of the NIHR Primary Care Research Network (PCRN) whose role it is to ensure high quality studies are able to recruit participants in sufficient numbers to permit valid results. PCRN benefits from a close relationship with practices and this is key to widening participation of the population in research. Some PCTs also host other research networks.
3.6 Influencing local research policy and individual projects to ensure they are NHS relevant
PCT representatives, through their links with secondary care trusts and higher education institutions, can have a voice in influencing the local research ambitions and how they relate to clinical services. This is especially true of PCTs that are part of a local Collaboration for Leadership in Applied Health Research and Care (CLAHRC) or Academic Health Science Centre (AHSC), both of which can become major platforms for conducting primary care relevant research.
There is also PCT representation at their Local Comprehensive Research Network Board and sometimes their executive group. The Comprehensive Clinical Research Network provides the required research infrastructure to embed research within the NHS to support patient participation in high quality clinical research studies across England. This representation ensures that primary care research issues are on the agenda.
The targeted spend of Flexibility and Sustainability Funding is an important additional way to influence the direction of research.
3.7 Leading service evaluation and evaluation training
Service evaluation provides the evidence needed to alter or decommission ineffective or costly services, and expand those that deliver high quality and cost effective patient outcomes. Until recently, appropriate evaluation has not been a consistent part of the commissioning process, but now some PCT R&D staff promote and support effective and relevant service evaluation through working with their commissioners and provider arms. Increasingly, academics are working with commissioners and providers to deliver high quality evaluations. The developing relationship between academics and NHS staff is a growing source of generalisable research questions.
4. Research and evaluation are important, but CCGs have lots of other pressing priorities. Why are research and evaluation relevant to consortia?
Promoting research and innovation and the use of evidence is one of many duties that CCGs will need to address. Notable among these is the requirement to maintain financial balance, so it is understandable that research is not at the top of the priority list. Nevertheless, with appropriate support, there are number of issues that CCGs need to consider:
4.1 Using research to improve the health of patients
The aim of expanding NHS-relevant research and evaluation is to improve the health of the population. Patients have a right to be part of research studies if they wish. Those who take part in a research trial, even in the control arm, tend to do better than equivalent individuals who are not involved in research. Larger numbers of participants increase the generalisibility of the results and the power to form strong conclusions.
With the considerable financial pressures being faced by CCGs, it is important that all commissioning decisions are well informed. Effective commissioning requires the use of best evidence followed by appropriate data collection and evaluation of the commissioned service. Evaluation can include clinical outcomes, cost effectiveness, patient acceptability or whatever criteria that the commissioner predefined as important at the outset of service design. The absence of such data makes it impossible to know whether the service is delivering what the commissioner expects. Accessing and appraising evidence and designing service evaluations are skills that commissioners could have access to by working with the academic community as the core skills around research and evaluation are the same. Research is needed to produce the evidence to inform clinical practice, and service evaluation provides the evidence for commissioning decisions.
4.2 Enhanced culture of quality improvement
Encouraging research and evaluation has wider benefits in terms of the culture of the organisation. Staff who take part in research and evaluation become exposed to new ideas and ways of thinking. They develop a critical approach to service delivery that asks the question “is this the best way of doing things, and if not, what can we do to make it better?” There is growing evidence that research activity is a marker of quality with NHS organisations that are research active have improved patient outcomes. Good staff generally want to be part of successful, quality-focussed organisations, and research activity can often provide some variety to staff’s usual work while providing personal development opportunities. All of this helps attract and retain high quality staff.
4.3 Implementation of research findings
Much published research evidence fails to impact upon practice. This is due, in part, to a disconnect between the evidence generators – usually university academics, and the evidence users who are usually healthcare professionals, commissioners and policy makers. By joining in with high quality research, service commissioners can not only inform research questions and study design, but are more likely to implement the findings of research that impact up patient care. This completes the circle of getting research into practice and represents a key aim of the NIHR CLAHRCs.
4.4 The use of contracting to make it easy for patients to take part in research and to ensure services are evaluated
Producing research evidence and giving patients the right to be involved in studies is vital for the NHS. The birth of new commissioning organisations is a very significant opportunity to properly integrate a comprehensive culture of evidence generation and use within the NHS. The patient voice is gaining strength around recognising patients’ rights to be involved in research. GP consortia will be closer to patients than their PCT predecessors and therefore be in a better position to respond to patient wishes in this area.
CCGs will be in a position to routinely specify in contracts that their providers deliver research-responsive services. With the current emphasis on contracting, things contained within a contract tend to get done at the expense of things outside a contract. A contractual requirement to give patients access to research studies will encourage providers to access NIHR resources, such as the research networks, to support research within their institution. The research networks routinely collect data on patient recruitment so they will be able to support contract monitoring. It is likely that providers will then find additional advantages from engaging with research opportunities.[2] This will ensure that recruiting people to research studies is core and becomes every day practice. Currently, whether or not a service provider gives patients access to research studies is too often down to individual doctors or managers, leading to widespread inequity in patients’ access to research and a marked failure to make the most of NHS infrastructure. Similarly, appropriate use of the contract can be used to ensure that providers independently evaluate their services on the basis of outcomes predetermined by commissioners and within the financial envelope of the service.
4.5 The generation of primary care relevant research questions
Much healthcare research has traditionally had a secondary or tertiary care focus. An effective research, evaluation and knowledge management infrastructure will help CCG members identify potential research questions that are relevant to their patients. Where appropriate, and through working with professional researchers, these ideas can be developed into fundable grant applications and inform the body of NHS evidence.
4.6 Income
Due to the benefits to the economy, health research is the only part of the public sector to receive increased funding at the Comprehensive Spending Review. Since the formation of the NIHR, research taking place in primary care has become extremely high quality and professionally delivered, together with appropriate reimbursement. Many trusts now recognise the value of the increasingly reliable and growing income from research. The same is now true of primary care with resources coming directly from the local NIHR comprehensive research network or via PCTs. For example, practices across Bristol, North Somerset and South Gloucestershire have earned nearly £300k in 2010/11 in return for recruiting patients into NIHR studies.
As explained above, some PCTs earn Flexibility and Sustainability Funding from the Department of Health in proportion to the value of the research that the trust hosts. While many PCTs did not earn any FSF in the last round, some, like NHS Oxfordshire and NHS Bristol have received substantial sums – £806k and £756k respectively. FSF can only be spent on research and CCGs will need to develop a strategy for responsibly investing it in future years within the strict criteria.
4.7 Statutory compliance
Compliance with the Research Governance Framework for Health and Social Care is required for any research to take place on CCG premises or involving their staff. This is achieved by trained staff performing the necessary governance checks. The NIHR local Comprehensive Research Network give PCTs the resources required to ensure research governance is completed appropriately for NIHR portfolio studies. Without this compliance, community based research of any kind would cease.
4.8 Non-portfolio work
The NIHR can only support work that related to NIHR Portfolio studies leaving PCTs and other trusts to perform governance checks and support other valuable non-portfolio work from their existing budgets. Examples of non-portfolio work might include PhD and Masters research projects, small scale industry studies, pure service evaluation, strategic R&D leadership and knowledge management activities.
5. How can research leads help CCGs meet their new duty of promoting research, innovation and the use of evidence?
For the reasons describe above, conversations between CCGs and their local NIHR research leaders need to start as soon as possible to ensure opportunities are not missed, and budget lines are not lost during the transition. These conversations should lead to the resourcing of CCG research leads as the key point of contact between commissioning decision making, NIHR clinical research networks, academics, patient groups, and service providers. Resources will need to found from the existing NIHR clinical research network envelope to support NIHR Portfolio activity, while CCGs will need to maintain a budget to support and develop relevant non-portfolio research and evaluation activity. This role would require about a half day per fortnight per CCG and could be considered as coming with an honorary academic contract subject to the agreement of the primary academic partner in the locality. The CCG research leads will need to work with the NIHR to benefit from training and peer support, perhaps through a tailored national development programme in collaboration with the Royal College of General Practitioners.
It is expected that the CCG research leads will find support and leadership through a variety of routes. Their roles will include integration of the RM&G, resourcing and embedding Network activities across Primary Care. The managerial and administrative support for these posts will need to be locally agreed between the individuals appointed, the Networks and the CCGs/Clusters.
6. Conclusion
Clinical commissioning groups will become a key part of the NHS and have been given a duty to promote research, innovation and the use of evidence. Their engagement in research and evaluation is needed in order to maintain the existing research and evaluation functions of PCTs and importantly, to realize the benefits in patient care that having research and evaluation considered alongside every commissioning decision will bring. Lead clinicians are required to be the point of contact between CCGs and the NIHR for all issues to do with research. Processes to identify these individuals need to begin now, together with consideration on how to resource the roles and provide them with ongoing support.
Dr Peter Brindle (Group lead)
Programme Director – Avon Primary Care Research Collaborative and Primary Care lead, Western CLRN
Director – South West Dementia and Neurodegenerative Diseases Research Network (SW-DeNDRoN)
GP clinical commissioning lead for dementia services, NHS Bristol
General practitioner peter.brindle@nhs.net
Dr Scott Wilkes
Clinical Lead PCRN Northern and Yorkshire
Primary Care Lead, Northumberland Tyne & Wear CLRN
Honorary Clinical Senior Lecturer in Primary Care, Newcastle University
GP Research Lead NHS North of Tyne
General Practitioner, Coquet Medical Group, Northumberland
Dr Stuart Eglin
Regional Director of Research & Development, NHS North West
Dr Seamus O’Neill
Senior Manager, Northumberland, Tyne and Wear CLRN
Professor Stephen Smye
Director of R&D, Leeds Teaching Hospitals
Director of the NIHR Comprehensive Clinical Research Network
Director of the NIHR CLAHRC for Leeds, York and Bradford Professor of Medical Physics & Health Research, University of Leeds
Ms Louise Young PCRN Manager (East Midlands and South Yorkshire)
Appendix 1
The role of the CCG research leads:
- To be responsible for all issues relating to research and evaluation within the CCG practices.
- To be the point of contact between the NIHR Clinical Research Networks, research practices and the CCG.
- To ensure that research and evaluation is considered in all commissioning decisions. For example, ensure that the service specification for the provision of home chemotherapy requires the provider to host research and recruit patients into studies. The appropriate use of contracting is key to patients having better access to research studies across secondary and tertiary care.
- To optimise the effective patient recruitment within primary care. This is through facilitating practices becoming primary care research sites to adopt NIHR portfolio studies. The research leads would be responsible for managing recruitment from their practices within the CCG in the same way as existing consortia manage the budgets and monitor prescribing and referral patterns of their member practices. Research would be a mainstream function of CCGs.
- To help connect researchers with population-relevant research ideas from patients, services providers and commissioners. This will increase the NIHR portfolio over the medium and long term.
- Enable local engagement with the primary and social care community to enable delivery of the study requirements.
- To attend local R&D strategy meetings
Appendix 2
Emerging models of engagement with commissioning groups
i) In Northumberland Tyne and Wear a number of primary care research functions (portfolio generation, RM&G & portfolio delivery) are being brought together in a virtual organisation during the transition phase of the NHS. Membership includes an executive of the Primary Care Research Collaboration, lead by a Clinical Director of R&D, Senior Manager, PCRN Clinical Trials Coordinator, RM&G manager, Portfolio delivery manager, TCRN and CLRN nominees and crucially GP Research Champions from each Clinical Commission Groups (CCGs) (n=8) and a patient representative. The latter two giving meaningful NHS engagement. These posts are currently funded positions except the latter which will be funded from within an existing primary care NTW CLRN budget envelope and will secure half a PA (one half day per fortnight) for each of the CCG leads. Additionally, some degree of matched funding will be expected from the CCGs to reflect the non-portfolio work that requires support.
ii) The Avon Primary Care Research Collaborative (APCRC) provides a comprehensive research and service evaluation to the Bristol, North Somerset and South Gloucestershire primary care trust cluster. It has been successful in developing a large portfolio of NIHR research and has the second highest allocation of FSF of any PCT in England. It is part funded from the three PCTs and from Western CLRN and plans to resource half a PA for three research leads – one from each of its three county based consortia. The collaborative, led by a clinical research and evaluation director and a band 8 manager, aims to provide its consortia with the necessary support to deliver their duty to promote research and innovation, while also maximizing the opportunities for the consortia and their patients. The guiding principle is to present the consortia with an attractive solution and not to offer additional problems. Western CLRN are also committing to resources for four additional consortia research leads in areas not covered by the APCRC.
iii) The East Midlands: A model has been developed over some months and is currently being finalised in collaboration between NHS Leicester City , PCRN East Midlands and South Yorkshire, local Clinical Commissioning Group for the establishment of a lead R&D Clinical Commissioning Group. Under this model there is the potential for a shared R&D service across a cluster arrangement comprising the following 3 functions: 1) research and development, incorporating RM&G and wider research and evaluation, 2) hosting and continued collaborative work with PCRN and 3) links across to CLARHC.
The value of such a comprehensive research service to consortia is through providing direct support to an evidence based approach to commissioning, links between research studies and evidence to strategic priorities and local health needs. In future, and longer term, research will assist with informing commissioning and possible de-commissioning decisions taken by the Clinical Commissioning Groups as they take over the commissioning of healthcare services for their local populations. Regular access to local and national research findings and systematic reviews of evidence should ensure a continued linkage of evidence to enable strategic informing and support at the decision making processes. Early developments are concerned with developing a research aware culture within the executive teams of consortia to promote and engage the future of research activity locally, enabling patients full access to studies, improving patient care and developing the evidence base.
iv) In Greater Manchester ReGrouP, representing the ten Greater Manchester PCTs, provides a one stop shop delivering streamlined Research Management and Governance. It is envisaged this service can be provided to clinical commissioning groups in that region.
v) In Cheshire and Merseyside one PCT takes responsibility for RM&G for six PCTs and it is anticipated this service could be offered to clinical commissioning groups in that region.
vi) The Cumbria and Lancashire CLRN deliver RMG services on behalf of NHS North Lancashire and NHS Blackburn.They feel it would be sensible for this service to continue to be offered to clinical commissioning groups.
vii) NHS Blackburn with Blackburn and Darwen Council are working with Blackburn College to enhance research and development across the public health sector for the Borough. Their aim is to develop and maintain a whole-system approach to ensure robust research activity is undertaken; responding more effectively to major funding initiatives and maximising grant income, aligning with corporate priorities and developing joint collaborative working with academia, GP Consortia, NHS Trusts and R&D networks.
[1] This paper provides generic information. Local NIHR research leaders are advised to modify and add to the text to include relevant local functions, statistics and contact details to support submissions to CCG shadow boards and PCT cluster boards.