Research is the future: get involved

In an editorial entitled "Research is the future: get involved”1, Fiona Godlee supports and re-emphasises the positive points about NIHR clinical research networks that are made in Anne Gulland’s paper, “It’s the duty of every doctor to get involved with research”.2 Gulland notes that an increasing number of patients are taking part in studies hosted by the NIHR research networks and, more generally, that the NIHR has transformed the research landscape. We welcome this support for research networks and for the part they can play in the more fully integrated research/healthcare system that the NIHR is seeking to promote.

There is a widely held assumption that research engagement by clinicians and healthcare organisations improves health services performance. However, a review that we conducted for the NIHR HS&DR programme in 2012/3 found the situation to be complex: the available evidence was largely positive, but there was relatively little direct empirical evidence to support the view that, in addition to improved processes - such as providing evidence-based care - there was actual improvement in health outcomes as a consequence of the engagement in research.3 Thirty three papers were included in the analysis and 28 were positive, but only seven of these identified improved outcomes.

Of these 28 positive papers, 17 reported improvements (in processes and/or outcomes) in healthcare performance resulting from engagement in research and occurring as a by-product of research that was conducted with the primary aim of testing a specific therapy or approach. We also included 8 studies where improved healthcare performance resulted from engagement in a research network, and another 3 in which there had been an explicit intention to produce improvements in healthcare performance of the organisation as a direct consequence of research engagement by healthcare staff through interventions such as collaborations, participatory research, and/or organisational approaches. Our findings have since taken account of more recent evidence and will be soon become more widely accessible through a forthcoming article in BMJ Open.4

Gulland reports a transformation in the research landscape, and raises other issues about the importance of developing staff capacity and organisational cultures that support research and research use. As part of our brief from the NIHR we explored the contexts in which the positive changes we identified had occurred, and examined the mechanisms involved. Overall we found a key change in thinking about research engagement and its potential. Initiatives such as the NIHR Collaborations for Leadership in Applied Health Research and Care and the Academic Health Science Networks in England, the NIH Road Map for Medical Research in the USA, and the associated development of research networks, have resulted in an increasing formalisation of attempts to ensure that research engagement by clinicians, and by healthcare organisations, leads to improved healthcare performance.3 The culture and intentions of research funders, and of the research and health service community more generally, are changing: research engagement leading to improved performance is shifting from being a by-product to an intended outcome of research funding.

The eight included papers on engagement in research networks in our review came solely from the US, reflecting the more established nature of formal research networks in the USA, and an approach to evaluation that was consistent with the inclusion criteria used for the review. At that time we were only able to capture recent UK developments (such as the outcomes of research networks) through a conference abstract.5 However, there was also evidence of growing international interest in the benefits that might come from research networks,3 and additional evidence has emerged since our review that research-active UK NHS trusts have lower risk-adjusted mortality for acute admissions.6 The increasing number of research networks in the US, in the UK, and elsewhere, should provide new opportunities to explore these findings further.

Gulland also comments on the huge differences in support for research provided by, and within, NHS trusts. To date the effect of institutional research activity on patient outcomes and the organisational factors that can facilitate or hinder provider participation in research and that underpin implementation effectiveness has not been investigated extensively.3 But we did find papers that explored the need for a supportive context that enables clinicians and their organisations to participate in research and in research networks, and some evidence that initiatives such as those mentioned above are beginning to result in progress along the pathway from research engagement to improved healthcare.3 This work not only covers provider participation, but also, and more recently, engagement in NHS research by commissioners, patients and the public (an issue raised in the editorial but not by Gulland), and local industry.7 8

We noted in our review report that systematic analysis of the data related to the engagement by clinicians and healthcare organisations in research is in its infancy. What has changed since then (and is exemplified in the Gulland paper and the subsequent editorial) is a wider understanding that this issue matters. Attempts to increase the integration of research and healthcare systems, including strengthening research networks, developing research capacity, and ensuring that healthcare organisations (both providers and commissioners) see the research function as an integral component of their overall structure, need to be linked to further empirical research that considers not only the research engagement of all relevant actors but also the organisational determinants of the impact on practice of such engagement.

1. BMJ 2015;351:h6525
2. BMJ 2015;351:h6329
3. Hanney S, Boaz A, Jones T, Soper B. Engagement in research: an innovative three-stage review of the benefits for healthcare performance. Health Serv Deliv Res 2013;1(8).
4. Boaz A, Hanney S, Jones T, Soper B. Does the engagement of clinicians and organisations in research improve healthcare performance: a three-stage review. (In press) BMJ Open 2015;5:e009415 doi: 10.1136/bmjopen-2015-009415
5. Morris E, Downing A, Gregory W, et al. LB36 – Colorectal cancer research activity and its relationship to clinical outcomes. Eighth NCRI Cancer Conference. Liverpool; 2012. http://conference.ncri.org.uk/abstracts/2012/abstracts/LB36.html
6. Ozdemir BA, Karthikesalingam A, Sinha S, et al. Research activity and the association with mortality. PloS One 2015;10(2).
7. Soper B, Hinrichs S, Drabble S, et al. Delivering the aims of the Collaborations for Leadership in Applied Health Research and Care: understanding their strategies and contributions. Health Serv Deliv Res 2015;3(25).
8. The AHSN Network. Spreading innovation, improving health, promoting economic growth. AHSN Impact Report 2015. www.ahsnnetwork.com/wp-content/uploads/2014/12/AHSNs-impact-report-2015.pdf

“Now let’s make sure that patients are properly involved, not just as participants but in trial conception, design, and conduct and the analysis, reporting, and dissemination of results.” I completely agree, and children and young people should be no exception. Well-conducted clinical research with children and young people is essential if we are to improve our understanding of childhood disease, and provide healthcare based on the best possible evidence.

The Nuffield Council on Bioethics recently published a major report on children and clinical research (www.nuffieldbioethics.org/children), challenging the assumption that all children are necessarily vulnerable, an assumption that too often prevents research from going ahead. We concluded that a partnership with children, young people and parents throughout the whole endeavour of research - from deciding what research to prioritise, to the development and design of the research and to ethical review - was critical in ensuring that children were not placed in situations where they might be vulnerable.

Changes are needed if this approach is truly to be adopted. Amongst other things, Research Ethics Committees (RECs) should generally require researchers to involve children and parents in the development of their studies. The commercial sector should contribute to funding for groups like Young Persons’ Advisory Groups (YPAGs) that facilitate the involvement of children. We suggest that the UK Departments of Health, NHS and Universities UK should protect the time needed for experts in children’s healthcare to contribute to RECs. We also put forward additional guidance for researchers and those responsible for the scrutiny of research, to ensure that children’s voices are being heard at every step in the process.

The Council’s report and animation ‘Health Research – making the right decision for me’ can be found at www.nuffieldbioethics.org/children

Katharine Wright
Assistant Director, Nuffield Council on Bioethics

Dear Ms Goodlee,

Whilst I agree wholeheartedly with your desire to involve patients in both the design, conduct, analysis and dissemination of research, it remains the case that BMJ and the medical journal editors generally have focused on taking Medical research further and further away from front line care!

As editors sought to impose a fools gold standard on papers accepted for publication, the statistical significance of papers rises but the clinical relevance falls.

Moving away from the mechanistic paradigm of health (i.e. excluding patient's input into care and trial design) into a more complex co-productive paradigm of health, where there are no universal truths only constantly evolving heuristics, we will expect to see the BMJ under your editorship champion observational studies conducted with rigour on real patients over RCTs on carefully selected (biased) subsets.

If not then perhaps I regret the empress is as Danny Kaye would put it "in the all together"!
I believe if we put patients' needs as paramount we must dissociate our selves from the sort of studies preferred by the Research Councils and Journal Editors, and work towards developing a robust evidence base founded on rigorous evaluation of what works in our own practice populations, obviously using nationals norms as a starting point.

I await events with interest.