In the last three years Surrey and Sussex has seen at best stasis in the numbers recruited into research projects and relatively few new studies started within the local Primary Care Research Network (PCRN). Despite research being made a duty for NHS bodies in the Health and Social Act 2012 it is not currently a priority in the newly emerging Clinical Commissioning Groups (CCGs) who are trying to set themselves up and agree a constitution. The specific reasons for the current picture are at present unclear although anecdotal evidence suggests multiple factors:
- One very large study two years ago artificially inflated numbers, giving the impression of recent decline
- Few primary care based principal investigators based in Surrey and Sussex starting studies
- No clinical trials centre within Surrey and Sussex
- Lack of any data repository, as available in other areas which allows:
- Ready identification of numbers of people available for trials (identities only available in individual practices)
- Work with practices willing to participate in rapid recruitment schemes
- Assist study designers develop protocols
A key deliverable of this project is to build a data repository to improve recruitment.
There are other reasons why primary care research studies might commence less:
- Primary Care Researchers have existing links with organisations outside of the region and have a preference to partner with established links rather than develop new ones with areas like Surrey and Sussex.
- Primary Care Researcher “Readiness” (Data readiness, Record system readiness, Governance readiness and Business process readiness) can affect confidence in the ability to engage with or develop studies.
- Other areas, e.g. Birmingham, Salford, have a centrally based regional data repository for routinely collected data. This type of respository does not currently exist despite Surrey and Sussex having some of the most computerised practices with the best longitudinal health data in the world; in many of our practices these data are continuous since the 1990s. .
Recruitment into research studies is challenging:
- Recruiting enough people to research studies can be challenging and additionally the National Health Institute for Research (NIHR) has set a target of recruitment within 30 days of receipt of NHS permission.
- Practitioner have time constraints which accompanies perceptions that they see few eligible patients; and there is confusion about recruitment strategies [i]
- Barriers to recruitment of ethnic minorities at the individual level includes having the right linguistic resources, and at the institutional level the nature of the clinic structure including time pressure.[ii]
- In mental health research: concerns about vulnerable patients, practitioners feeling they lacked the skills to recruit during a sensitive consultation, and within limited time clinical and administrative agendas took priority over research recruitment.[iii]
- The introduction of a practice incentive a scheme has improved engagement, but not necessarily brought recruitment to the levels of other networks.
Despite efforts of the Comprehensive Local Research Network (CLRN) and Primary Care Research Network (PCRN), the development of new trials and the subsequent recruitment remains a challenge within Surrey and Sussex. A review of the barriers to recruitment needs to be undertaken if a step change within Surrey and Sussex is to be achieved.
In order to establish the causal reasons for the year on year reduction in primary care research within the Surrey and Sussex region. A number of key stakeholders in the primary care research arena will be consulted to ensure a timely, accurate and rounded understanding of the situation.
This primary research should enable us to establish a clear picture of:-
- The challenges around the development of new “home grown” studies
- The feasibility of adoption of existing trials in “set up” phase to the NIHR portfolio
- Awareness of incentive schemes to encourage involvement in primary care research
- The implications of the changing NHS environment on research
During this phase, two tools will be engaged as mechanisms to ascertain the “readiness” of primary care practitioners to undertake research and review the feasibility of potential studies through the use of a data repository.
2(A) Readiness of Primary Care to participate in research
In order to determine if researcher readiness is an issue in terms of the declining numbers of primary care research studies, we will modify an existing tool (TiRRE) designed to assess readiness for International research for the Surrey-Sussex context. The “Researcher Readiness” tool across an agreed sample of practices – who have participated in primary care research.
2(B) Data Repository Pilot
2(C) Full Data Repository:
[i] Page MJ, French SD, McKenzie JE, O’Connor DA, Green SE. Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners’ recruitment of patients. BMC Med Res Methodol. 2011;11:35.
[ii] Joseph G, Dohan D. Recruiting minorities where they receive care: Institutional barriers to cancer clinical trials recruitment in a safety-net hospital. Contemp Clin Trials. 2009;30(6):552-9.
[iii] Mason VL, Shaw A, Wiles NJ, Mulligan J, Peters TJ, Sharp D, Lewis G. GPs’ experiences of primary care mental health research: a qualitative study of the barriers to recruitment. Fam Pract. 2007;24(5):518-25.