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Research activity and patient outcomes in general practice - Call specification

 

Contents

Introduction

1. The NIHR, on behalf of the Department of Health and Social Care (DHSC), invites outline proposals for a single research project to find out whether research activity in general practice is associated with better outcomes for patients. This is an under-researched area, and findings will significantly influence the policy and practice for supporting research in general practice and the wider primary care setting.

Timetable and Budget

    • Deadline for stage 1 applications: 08 October 2019
    • Notification of outcome of stage 1 applications: January 2020
    • Deadline for stage 2 application: 18 February 2020
    • Notification of outcome of stage 2 applications: May 2020
    • Project start: June 2020
    • Budget: £750,000 for one project

Background

2. Research is increasingly core business for the NHS with 100% of NHS Trusts participating in research supported by the National Institute for Health Research (NIHR) Clinical Research Network (CRN) in 2018/19. Part of the rationale driving this increase, at a time of competing pressures, has been evidence that research participation leads to improved healthcare performance and better outcomes for patients[1-3]. Patients are supportive of clinical research, with survey evidence that 90% of patients had a good experience of participating in research[4]. Likewise, according to a recent report by RAND, NHS staff share a belief in the importance of research and evidence, and its value for health service improvement, patient care and outcomes[5].

3. The Industrial Strategy Life Sciences Sector Deal 2[6] sets ambitions to increase combined public and private expenditure on R&D to 2.4% of GDP by 2027. This is reinforced by commitments in the NHS Long Term Plan[7] to increase the number of people registering to participate in health research to one million by 2023/24. For primary care, a recent joint BMA/NHS England publication[8] states ‘we will use the opportunity created by Primary Care Networks to increase general practice research participation levels’.

4. Evidence of the benefits of participating in research comes exclusively from secondary/tertiary care. This is the case across disease-specific pathways including; colorectal cancer[9], coronary artery disease[10], ovarian cancer[11], acute lymphoblastic leukaemia[12], women’s health[13], and general acute admissions[3]. Additionally, the impact of research activity on healthcare performance has recently been thoroughly reviewed[1,2]. This provides strong support for the idea that when clinicians and hospitals engage in research, there is a strong association with improved performance (albeit with evidence strongest for improved processes of care).

5. In 2017, the NIHR led a partnership between Care Quality Commission (CQC) and the broader research community (Health Research Authority, Medicines and Healthcare products Regulatory Agency (MHRA), patient research ambassadors and R&D leadership) to develop markers of research activity in Trusts. This has led to the integration of questions on research into the Well-led framework, used by CQC in their inspections of Trusts, and to the inclusion in the annual inpatient survey, of a question about opportunities patients were offered to participate in research. This approach is further justified by recent evidence that research activity at Trusts is correlated to both reduced mortality rates and to those Trust’s CQC ratings[14]. Consequently, CQC has, since October 2018, included clinical research activity as a topic they could discuss in their assessments of Trusts.

6. The picture is different in primary care. Most patient contacts with the NHS are in primary care with over 300 million consultations each year compared to 24 million A&E visits. However, in 2018/19 only 38% of general practices were NIHR CRN research active (defined as consenting patients within their practice). This creates a major opportunity for research to add value which will only increase as the NHS shifts from acute to community or place-based care[7]. Research will need to follow this shift in activity, with more practices becoming research active in order to generate evidence and in doing so, we hope, improving outcomes for patients.

The Need for Research

7. We need research to inform on how best to achieve the ambitions and commitments for R&D laid out in the Life Sciences Sector Deal 2, the NHS Long Term Plan, and the GP Contract. This involves informing initiatives aimed at increasing research activity in general practice and the wider primary care setting, including:

  • increasing the uptake of the Clinical Practice Research Datalink (CPRD) in general practice
  • promoting and developing the Royal College of General Practitioners (RCGP) Research Ready initiative
  • using the Primary Care Network contract to increase the number of practices and patients participating in research
  • informing the development of metrics within the well-led framework for CQC inspections to help ensure that research is embedded as a core principle of general practice.

8. Better evidence is needed to assess whether clinical research in primary care affects patient outcomes and what measures can be used to increase research activity in the primary care setting.Initiallyfocussing on general practice, some research questions related to this include:

  • What evidence is there on the relationship between research activity in a primary care setting and patient outcomes – does increasing research activity correlate with better patient outcomes?
  • What are the characteristics of an effective research practice from the staff, practitioner and patient perspective?
  • What is the impact on patients (in terms of experience and outcomes) of attending and being treated in primary care settings which are research active, in the ways set out in the previous paragraph?
  • What are the possible mechanisms whereby more research active primary care settings might support better outcomes for patients?
  • What are the best ways to recruit general practices into research, both in terms of developing and possibly leading research in general practice and primary care, or supporting research led from elsewhere?
    • This also includes general practices acting as Patient Identification Centres (PICs) and referring to other sites and specialties other than primary care, whether led by industry or by university-based academic researchers.
  • What organisational or cultural factors facilitate or inhibit engagement with research at the practice level

Research Design

9. We would like research which is able to produce early interim output, within six months of commencement, to meet some of the needs outlined above, as part of a wider-ranging project. This implies a probable two stage approach.

10. Initially we envisage a quantitative evaluation of the association between research activity and patient outcomes in general practice. This is likely to involve an initial scoping and feasibility phase, reviewing available process (i.e. research and related activity) and outcome markers relevant to research in general practice/primary care, available from existing data sources or which require primary data collection. Quality markers for general practice that are available at a practice level, include;

  • the NIHR CRN activity dataset to define research activity;
  • the RCGP Research Ready dataset to define accreditation;
  • CPRD practice dataset to define engagement;
  • national datasets with practice-level data including Public Health England,
  • Open Prescribing, the Quality and Outcomes Framework dataset and the
    General Practice Patient Survey.

11. Analysis of these and other data, should enable an initial assessment of the association between different types of research activity and patient outcomes, leading to the stage 1 report. This would lead to a second stage, to validate and explore in more depth the markers for research processes and outcomes, informed by data collected from general practices, including from patients and clinicians. This should allow further elaboration of what works in terms of becoming research active, and the sorts of research activity which are associated with improved outcomes for patients in terms of quality and clinical outcomes.

12. The mechanisms whereby research activity improves patient outcomes in secondary care are not well-understood. It is possible that research activity may be a marker for other processes which improve outcomes. Alternatively, the process of a team of clinicians becoming involved in research may stimulate improvements which directly affect patient outcomes. Research into these causal mechanisms is likely to require in-depth and prospective methodologies beyond the scope of the current call. However output from the current call may suggest areas for future study.

Applicants’ Experience and expertise 

17. The successful applicants will need to demonstrate a relevant track record and expertise in:

  • systematic review and evidence synthesis
  • health systems research
  • big data analytics
  • coproduction of applied research findings
  • implementation of findings into practice

Budget and Duration and Specific Assessment Criteria

18. The research is expected to be delivered within a cost of £750,000 over a period of 24-30 months. Proposals which enable a timely start to the research will be favoured.

19. Outputs should include:   

  • published papers in peer-reviewed academic journals
  • interim report expected 6 months after commencement of the study
  • draft and interim reports, as agreed at project scoping
  • final publishable report with lay summary and executive summary
  • presentation(s) of findings to key stakeholders  
  • policy briefings for circulation through the Health Education England (HEE) and NHS systems

20. The duration of the research and individual projects within the contract will be no longer than is consistent with high quality studies. In assessing proposals, the Department will be seeking value for money as well as scientific excellence and, in particular, the potential for policy impact which is key.

21. Applicants are asked to address the timing and nature of deliverables, maximising staff resources and other options for interim reporting in their proposals.

22. Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against.

23. The successful application is expected to start within 2 months of funding being agreed, subject to pre-contract negotiations and specific requirements.

Governance

24. A research advisory group including relevant stakeholder groups such as, where appropriate, representatives of the DHSC, Arm's-length bodies, health research organisations, health professionals and patients, will provide guidance for the research, meeting regularly over the lifetime of the research. The successful applicants for this research should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. They will be expected to:  

  • provide regular feedback on progress
  • produce timely reports to the advisory group
  • produce a final report for sign off
  • Take advice from the advisory group about dissemination 

25. Research contractors will be expected to work with nominated officials in DHSC, its partners and the NIHR Central Commissioning Facility once the research project is due to start. Key documents including, for example, research protocols, research instruments and reports must be provided to DHSC in draft form allowing sufficient time for review.

26. A final report is required within 30 months after commencement of the project. The final report, with accessible executive summary, will be peer reviewed and circulated to policy makers in DHSC and its partners, and a summary placed in the public domain. Outputs resulting from expenditure of public funds are made available for public scrutiny and so should be fully understandable to the lay reader with plain language summaries.

27. Applicants must provide details of the pathway to impact. These should include plans for engaging relevant stakeholders to ensure beneficial research knowledge is translated into policy and practice. Monitoring and evaluation plans should be developed to determine the extent to how the activities proposed will deliver measurable benefits to patients and public. Applicants should consider the full range of audiences and ensure a plan for dissemination and, if appropriate, implementation into policy and practice. Key stakeholders include (not an exhaustive list):

    • Health Education England
    • NHS England and NHS Improvement
    • NIHR Clinical Research Network
    • MHRA CPRD
    • Royal College of General Practitioners
    • Public Health England
    • Care Quality Commission
    • NHS R&D Leaders e.g. Forum (primary care)

HEE expects that research data will be made available for analysis and re-use.

References and Key documents

[1] Boaz, A., Hanney, S., Jones, T. and Soper, B., 2015. Does the engagement of clinicians and organisations in research improve healthcare performance: a three-stage review. BMJ open, 5(12), p.e009415.

[2] Harding, K., Lynch, L., Porter, J. and Taylor, N.F., 2017. Organisational benefits of a strong research culture in a health service: a systematic review. Australian Health Review, 41(1), pp.45-53.

[3] Ozdemir, B.A., Karthikesalingam, A., Sinha, S., Poloniecki, J.D., Hinchliffe, R.J., Thompson, M.M., Gower, J.D., Boaz, A. and Holt, P.J., 2015. Research activity and the association with mortality. PLoS One, 10(2), p.e0118253.

[4] National Institute for Health Research Clinical Research Network Coordinating Centre, 2019. Report of the Patient Research Experience Survey 2018/19.

[5] RAND Europe, 2018. Enabling NHS staff to contribute to research: Reflecting on current practice and informing future opportunities.

[6] Department for Business, Energy & Industrial Strategy, 2018. Industrial Strategy Life Sciences Sector Deal 2.

[7] NHS England, 2019. The NHS Long Term Plan.

[8] NHS England and the British Medical Association, 2019. Investment and evolution: A five-year framework for GP contract reform to implement The NHS Long Term Plan.

[9] Downing, A., Morris, E.J., Corrigan, N., Sebag-Montefiore, D., Finan, P.J., Thomas, J.D., Chapman, M., Hamilton, R., Campbell, H., Cameron, D. and Kaplan, R., 2017. High hospital research participation and improved colorectal cancer survival outcomes: a population-based study. Gut, 66(1), pp.89-96.

[10] Majumdar, S.R., Roe, M.T., Peterson, E.D., Chen, A.Y., Gibler, W.B. and Armstrong, P.W., 2008. Better outcomes for patients treated at hospitals that participate in clinical trials. Archives of Internal Medicine, 168(6), pp.657-662.

[11] Rochon, J. and Du Bois, A., 2011. Clinical research in epithelial ovarian cancer and patients’ outcome. Annals of Oncology, 22(Suppl_7), pp.vii16-vii19.

[12] Hough, R., Sandhu, S., Khan, M., Moran, A., Feltbower, R., Stiller, C., Stevens, M.C., Rowntree, C., Vora, A. and McCabe, M.G., 2017. Are survival and mortality rates associated with recruitment to clinical trials in teenage and young adult patients with acute lymphoblastic leukaemia? A retrospective observational analysis in England. BMJ open, 7(10), p.e017052.

[13] Nijjar, S.K., D'Amico, M.I., Wimalaweera, N.A., Cooper, N.A.M., Zamora, J. and Khan, K.S., 2017. Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis. BJOG: An International Journal of Obstetrics & Gynaecology, 124(6), pp.863-871.

[14] Jonker, L. and Fisher, S.J., 2018. The correlation between National Health Service trusts' clinical trial activity and both mortality rates and care quality commission ratings: a retrospective cross-sectional study. Public Health, 157, pp.1-6

[15] Available from URL: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

[16] Medical Research Council. (2000). A framework for development and evaluation of RCTs for complex interventions to improve health [Online]. [cited 2008 March 26]; Available from URL: http://www.mrc.ac.uk/

[17] Medical Research Council. (1998). Guidelines for good clinical practice in clinical trials [Online]. [cited 2008 March 26]; Available from URL: http://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/

[18] https://www.gov.uk/government/publications/guide-to-the-general-data-protection-regulation

 

Standard Information for Applicants

29. The sections below provide standard information on different aspects of NIHR PRP funding and will contain details relevant to your application.

General Comments about Applications

30. The National Institute for Health Research Policy Research Programme (NIHR PRP) is a national programme of research dedicated to providing an evidence base for policy-making through the Department of Health and Social Care. It provides information to the Secretary of State for Health and his Ministers directly and through policy directorates in the Department of Health and Social Care and covers all aspects of the Department’s policy-making activity.

31. Applications will be considered from other UK countries (Scotland, Wales and Northern Ireland) provided they address the priority areas in a way that is relevant to the needs of the Department of Health and Social Care (England) and meet all other selection criteria.

32. Applicants are encouraged to submit multidisciplinary applications.

33. Applicants should consider the full range of potential audiences and describe how the research findings could be disseminated most effectively to ensure that the lessons from this research impact on policy and practice.

Research Management

34. Day-to-day management of this research will be provided by the principal investigator. They and their employers should ensure that they identify, and are able to discharge effectively, their respective responsibilities under the Health Research Authority (HRA) UK policy framework for health and social care research (Health Research Authority, 2017)[15], which sets out the broad principles of good research governance.

35. All successful research involving National Health Service (NHS) and social care users, carers, staff, data and/or premises must be approved by the appropriate research ethics committee (REC) or social care research ethics committee (SCREC). For further information on RECs, please visit the Health Research Authority website: http://www.hra.nhs.uk/

36. The successful research team must adhere to the Data Protection Act (1998) and the Freedom of Information Act (2000). Effective security management, and ensuring personal information and assessment data are kept secure, will be essential.

37. For any research involving clinical trials, the successful team will be expected to be familiar with the Medical Research Council (MRC) Framework for Evaluating Complex Interventions (MRC, 2000)[16], and to follow the principles of the MRC Guidelines for Good Clinical Practice in Clinical Trials (MRC, 1998)[17] in proposing structures for oversight of such trials and comply with the Medicines for Human Use (Clinical Trials) Regulations 2004.

38. The Institution leading the proposal should confirm that it has the capacity and is prepared to take on sponsorship responsibilities for clinical trials undertaken as part of the programme. Where the proposal includes a proposal for multi-site clinical trial activities the research unit should demonstrate that they have the experience of governance and management of clinical trials across multiple clinical trial sites.

Risk Management

39. Applicants should submit, as part of their proposal, a summary explaining what they believe will be the key risks to delivering their research, and what contingencies they will put in place to deal with them. Please ensure this is detailed in the Management and Governance section of the online application form.

40. A risk is defined as any factor which may delay, disrupt or prevent the full achievement of a project objective. All risks should be identified. The summary should include an assessment of each risk, together with a rating of the risks likelihood and its impact on a project objective (using a high, medium or low classification for both). The risk assessment should also identify appropriate actions that would reduce or eliminate each risk, or its impact.

41. Typical areas of risk for an evaluation study might include ethical approval, site variation in data gathering, staffing, resource constraints, technical constraints, data access and quality, timing, management and operational issues; however, please note this is not an exhaustive list.

Patient and Public Involvement (PPI)

42. The NIHR Policy Research Programme expects the active involvement of patients and the public (e.g. service users and carers) in the research that it supports, where appropriate. However, the nature and extent of patient and public involvement (PPI) is likely to vary depending on the context of the study. Applicants should describe how the issue of PPI will be addressed throughout the research process. For example, this could include patient and public involvement in refining research questions, designing research instruments, advising on approaches to recruitment, assisting in the collection and analysis of data, participation or chairing advisory and steering groups, and in the dissemination of research findings.

43. Applicants are required to detail what active involvement is planned, how it will benefit the research and the rationale for their approach. PPI needs to be undertaken in a manner that acknowledges that some people may need additional support, or to acquire new knowledge or skills to enable them to become involved effectively (see INVOLVE publications for guides for researchers). Applicants should therefore provide information on arrangements for training and support. In addition, applicants should note that a budget line for the costs of PPI is included in the finance form. Where no PPI is proposed, a rationale for this decision must be given.

44. For further information and guidance about PPI, please visit the INVOLVE website: http://www.invo.org.uk/.

Outputs and Reporting Arrangements

45. The research team will be expected to provide regular progress reports over the lifetime of the research and will be provided with a progress report template to complete at regular intervals. In addition to describing progress, these reports will allow researchers to indicate any significant changes to the agreed protocol, as well as setting down milestones for the next reporting period, giving an update on PPI and any publications or other outputs. Information on emergent findings that can feed more immediately into policy development will be encouraged and should be made available as appropriate.

46. A final report on the research, with an accessible executive summary, will be required within one month following completion of the research. The report will be peer reviewed and may be circulated among relevant stakeholders within the Department of Health and Social Care and its partners. Once the study is completed, a summary of the final report will be placed in the public domain, on the Policy Research Programme web pages found at: http://www.nihr.ac.uk/prp. This is where the outputs resulting from expenditure of public funds are made available for public scrutiny so it is important that the summary of your final report is easily accessible to the lay reader.

47. Research contractors are obliged to give at least 28 days notice before submission of any publication arising from research funded by the NIHR Policy Research Programme. In this instance, ‘publication’ concerns any presentation, paper, press release, report or other output for public dissemination arising from a research project funded by the PRP. Research contractors remain under an obligation to provide notice even after the contract has ended. Publication of PRP-commissioned research is subject to prior consent of the Secretary of State, which will not be withheld unreasonably and cannot be withheld for more than three months from the time the publication is submitted.

Dissemination

48. Applicants should describe how the research findings could be disseminated most effectively, ensuring that results of this research impact on policy and practice in the NHS, DHSC, and/or in social care.

49. Publication of scientifically robust research results is encouraged. This could include plans to submit papers to peer reviewed journals, national and regional conferences aimed at service providers, professional bodies and professional leaders. It might also include distribution of executive summaries and newsletters. Less traditional dissemination routes are also welcomed for consideration.

Transparency

50. In line with the government’s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information on the transparency agenda is at: https://www.gov.uk/government/publications/procurement-and-contracting-transparency-requirements-guidance.

51. If you wish to view the standard terms and conditions of the NIHR Policy Research Programme contract, please go to: https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/manage-my-study/contracts-and-intellectual-property.htm.

Application Process

52. To access the research specification and application form, please visit the NIHR Policy Research Programme Central Commissioning Facility (NIHR PRP CCF) website at or visit http://www.nihr.ac.uk/prp

53. The NIHR CCF runs an online application process and all applications must be submitted electronically. No applications will be accepted that are submitted by any means other than the online process. Deadlines for the submission of outline and full research applications occur at 1.00 pm on the day indicated and no applications can be accepted after this deadline.

54. We strongly recommend that you submit your application on the day before.Once the 1.00 pm deadline passes, the system shuts down automatically and CCF Programme Managers are unable to re-open it. If you are experiencing any technical difficulties submitting your application, please contact the CCF on 0208 843 8027 in good time, before 1.00 pm on the closing date.

55. Applicants are expected before submitting applications, to have discussed their applications with their own and any other body whose cooperation will be required in conducting the research.

56. In order for your full application to be validated and submitted you are required to gain electronic approval from the relevant authorities before the application deadline. The Declarations page must be approved:

  • by the Lead Applicant to confirm that the content of the application is complete and correct.
  • by an administrative or finance officer for the contracting (host) institution to confirm that the financial details of the application are correct and that the host institution agrees to administer the award if made.
  • by a Head of Department or Senior Manager to confirm that they have read the application and that, if funded, the work will be accommodated and administered in the named institution and that the applicants may undertake the work.

57. Until this is completed, the lead applicant is unable to validate and submit the application.

Commissioning Process

58. The standard NIHR PRP commissioning cycle includes the following steps:

59. In the standard 2 Stages’ Commissioning, outline applications or, in case of Expression of Interest (EOI), short EOI applications will be short-listed by a Commissioning Committee. Incomplete applications, applications too remote from the issues set out in the research specification, or applications that have clearly inadequate presentation or methods may be rejected at this stage.

60. Applications that are successfully short-listed by the Commissioning Committee will proceed to Stage 2 of the application process and will be invited to submit a Stage 2 full application for consideration.

61. All full applications submitted to NIHR PRP will be peer-reviewed by both stakeholder and independent academic referees. Wherever time permits, applicants will be given one week to respond to the peer reviewers’ comments.

62. Full applications, peer reviewers’ comments and any responses to those comments will then be considered by the Commissioning Panel, which is comprised of independent experts (possibly with observers from other government departments and executive agencies), who will advise the NIHR on which applications are most suited to receive funding. The Panel will be informed by the reviewers’ comments and any responses made to these comments by the researchers. However, it is ultimately the responsibility of the Panel to make any funding recommendations to the Department of Health and Social Care.

Selection Criteria

63. The Funding Committee members are directed to consider applications against the criteria stated in this research specification as well as selection criteria detailed below:

    • RELEVANCE of the proposed research to the research specification
    • QUALITY of the research design
    • QUALITY of the work plan and proposed management arrangements
    • STRENGTH of the research team
    • IMPACT of the proposed work
    • VALUE for money (justification of the proposed costs)
    • INVOLVEMENT of patients and the public

Contacts

64. General enquiries regarding the application and commissioning process can be directed to the PRP CCF Help Desk by telephone at 020 8843 8027 or by email to prp@nihr.ac.uk.