{"id":45256,"date":"2019-08-09T11:07:04","date_gmt":"2019-08-09T10:07:04","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=45256"},"modified":"2019-08-16T12:56:20","modified_gmt":"2019-08-16T11:56:20","slug":"virginia-minogue-and-bill-wells-patients-and-the-public-are-essential-to-reducing-research-waste","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/08\/09\/virginia-minogue-and-bill-wells-patients-and-the-public-are-essential-to-reducing-research-waste\/","title":{"rendered":"Virginia Minogue and Bill Wells: Patients and the public are essential to reducing research waste"},"content":{"rendered":"

To maintain efficiency in medical research we have to facilitate and empower participants, patients, and the public to recognise waste and take action, say Virginia Minogue and Bill Wells<\/p>\n

Waste in research is an important area of inefficiency in healthcare expenditure. Studies suggest that 85% of health research is wasted. [1] As a high percentage of research receives funding from the public purse, patients and the public have an interest in ensuring that research provides value for money and benefits the end user, which in clinical research is primarily the patient.\u00a0<\/span><\/p>\n

There are many potentially avoidable causes for the waste we see in research. These include the failure to publish research findings (particularly negative findings), failure to provide protocols and full information about methods and results, needless duplication of effort due to a failure to systematically review previous research in the same topic area, as well as poorly designed and conducted studies.\u00a0<\/span><\/p>\n

The role of researchers, regulatory authorities, policy makers, research managers, academics, and funders in reducing inefficiencies in research has been well documented<\/span>. [2,3,4,5,6] Progress has been made to address this issue (e.g. the Trials Tracker). [7] Although the role of patients and the public in the research process has vastly increased, their role in reducing waste has not yet been explored sufficiently or considered to any great extent. However, advisory and regulatory agencies such as NICE, EMA, and the HRA are systematically involving patients.\u00a0<\/span><\/p>\n

The last decade has seen increased patient and public involvement (PPI) in research\u2014particularly in the UK\u2014within roles such as co-researchers, members of study and advisory groups, and as co-applicants for funding applications. [8,9,10] PPI contributors have an interest and arguably a responsibility to ensure that the research they engage in is relevant, well designed, and has the potential to provide knowledge, but also value and benefit to patients and healthcare services. This should, therefore, lead to a shared responsibility with research teams, regulators, funders and sponsors to reduce waste and ensure high quality research.\u00a0<\/span><\/p>\n

The opportunities for patients and the public to identify research waste exist at two levels: in how PPI is realised in practice and in the research process itself. Waste can occur in PPI activity if this is not conducted rigorously and if the roles of PPI contributors are poorly delineated and organised\u2014resulting in a negative experience for those involved.<\/span><\/p>\n

PPI contributors can also recognise when wasteful practices are taking place within research studies, for example identifying irrelevant or inappropriate research questions, poor design, and ineffective dissemination plans. In reality, it may be hard for PPI contributors to challenge wasteful practice and they need to be empowered to do so by policy makers, regulators, funders, and lead investigators in research studies. Methods of doing so could include regular consultation and feedback. A study of PPI contributors’ views of research waste [11] found that the barriers to challenging wasteful practice included not being taken seriously, minimal effort to include the patient perspective, PPI being seen as a less important element of the process in research studies, and power imbalances and dynamics within research teams and institutions. To overcome the barriers, PPI representatives needed support, awareness raising, or training to enable them to recognise and challenge wasteful practices.\u00a0<\/span><\/p>\n

In a survey of research managers and governance leads, prioritisation of research and implementation of research were identified as the most important and valuable areas of waste to address. [12] Patient and public engagement in prioritisation was also seen as an important element in increasing the relevance of research. Yet there was an identified lack of PPI in priority setting, with research not addressing the issues that were important to patients and few patients taking a leadership role within research studies. It was recognised that involving patients early on in the design of research studies would make them more relevant.\u00a0<\/span><\/p>\n

The James Lind Alliance priority setting partnerships are a good example of how patients and the public have an important role at a more strategic level in identifying research priorities. The James Lind Alliance demonstrates the value of engaging patients in setting priorities and defining unanswered research questions to avoid the waste that occurs if questions are not relevant, do not have value, lead to duplication, wasted resources, and ineffective adoption of findings. PPI contributor\u2019s membership of NIHR funding panels, where the panel member reviews the PPI elements of the study proposal, is another opportunity for patients to play a part in identifying poor research questions or PPI that is likely to be ineffective or will not add value to a study. <\/span><\/p>\n

Of international research funders, (including Australia, North America, and Europe) the National Institute for Health Research (NIHR) was found to have the most extensive involvement of patients and the public in grant committees. [13] Building awareness of these opportunities for engagement would be a useful starting point. This could be undertaken by the NIHR patient research ambassadors (PRAs are volunteers who promote health research from the perspective of the patient) or by building on the PRA model and recruiting national patient research champions or ambassadors.<\/span><\/p>\n

In terms of implementation of research findings, the lack of PPI was seen as a factor affecting dissemination and local dissemination of research outcomes. PPI can be effective in terms of making reporting more meaningful and understandable. [14,15] It can also be useful in increasing awareness and increasing knowledge of new evidence in the patient population to inform healthcare decision making. <\/span><\/p>\n

Ways of facilitating patients to assist in the reduction of waste included awareness raising through workshops, briefings and use of social media, ensuring active partnerships with patients, and engagement in design at an early stage. Funders and sponsors have a particular role in ensuring high quality PPI within studies by requiring engagement in defining research questions and study design, and by assuring support for those involved to enable them to fulfil their roles and responsibilities. A number of funders, including the NIHR and Medical Research Council, require the inclusion of lay summaries and consideration could be given to this being coproduced or written by a PPI contributor.\u00a0<\/span><\/p>\n

It is clear that stakeholders across the research pathway, from regulators to researchers, have to share responsibility for increasing the efficiency of research through improved design, regulation, and integration into practice. This can only be achieved by working together in partnership and including the patient voice. Funders, such as the NIHR, need to increase awareness among public contributors of their role <\/span>in adding value to the research framework<\/span><\/a>. Funders should also seek feedback, at various points, on PPI activity in a study and whether PPI was meaningful and added value or was wasteful. Research teams need to ensure that PPI roles meet contributors\u2019 aspirations and conform to the national standards for PPI (NIHR 2018). [16] This can be verified by seeking regular feedback from contributors and feedback on the overall experience of involvement\u2014including whether PPI has added value and whether there has been any wasteful practice.\u00a0<\/span><\/p>\n

Research teams also have a responsibility to ensure that the PPI skills and experience gained through a study are not lost and wasted at its conclusion, and can be utilised in other ways e.g. in dissemination or in identifying further research questions. To achieve sustainability, the creation of user groups, integration into research systems, and provision of regular opportunities for engagement in research have been successful. [17] The inclusion of the patient voice in many final research reports [18,19] is a positive development, which enables the PPI contributors to reflect and report on their experience and perception of the value they have brought. This could be made mandatory. <\/span><\/p>\n

Finally, research managers need to engage PPI contributors in ensuring added value. Peer review or patient advisory panels are a vehicle for this e.g. the Public and Patient Involvement in Research Group based in Norfolk and Suffolk community and Primary Care. Policy makers and regulators should harness the expertise of those PPI contributors who have experience at a more strategic level, including involvement in NIHR INVOLVE, the NIHR national review of PPI, [16] to support drives to streamline processes and ensure the inclusion of the patient voice.\u00a0<\/span><\/p>\n

\"\"<\/a>Virginia Minogue<\/strong> is an independent consultant in the senior leadership team of the NHS Research and Development Forum
\n<\/span><\/i><\/i><\/p>\n

Twitter:<\/strong> @vminogue2\u00a0<\/a>
\n<\/span><\/i><\/p>\n

Competing interests:\u00a0<\/strong>None declared.<\/span><\/p>\n

 <\/p>\n

Bill Wells<\/strong>, Oxford Health NHS Foundation Trust<\/span><\/i>\"\"
\n<\/i><\/i><\/p>\n

Twitter: <\/i><\/strong>@billwells100<\/span><\/i><\/a>
\n<\/i><\/p>\n

Competing interests:<\/strong> None declared.<\/span><\/p>\n

Acknowledgements<\/strong>: Bill Wells is supported by the National Institute for Health Research (NIHR) Oxford Health Biomedical Research Centre (BRC-1215-20005) and the NIHR Oxford Cognitive Health Clinical Research Facility.
\n<\/span><\/i><\/p>\n

References:<\/b><\/p>\n

[1] Chalmers I and Glasziou P. 2009. Avoidable waste in the production and reporting of research evidence. Lancet<\/em> 2009; 374 (9683): 86 \u2013 89.
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\n<\/span>[4] Salman R Al-Shahi, Beller E, Kagan J, Hemminki E, Phillips RS. 2014. Increasing value and reducing waste in biomedical research regulation and management. Lancet<\/em> 2014; 383.9912: 176 \u2013 85.
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\n<\/span>[7] <\/span>Powell-Smith A and Goldacre B. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions [version 1; referees: 2 approved].\u00a0F1000Research2016,\u00a05:2629.
\n<\/span>[8] <\/span>Wicks P, Richards T, Denegri S, Godlee F. 2018. Patients roles and rights in research. BMJ<\/em> 2018; 362: k3193.\u00a0<\/span>
\n<\/span>[9] <\/span>Boaz, A., Biri, D., & McKevitt, C. 2016. Rethinking the relationship between science and society: Has there been a shift in attitudes to Patient and Public Involvement and Public Engagement in Science in the United Kingdom? Health Expectations<\/em>, 19(3), 592\u2013601. doi:10.1111\/hex.12295
\n<\/span>[10] Rose, D. 2017. Service user\/survivor-led research in mental health: Epistemological possibilities. Disability and Society<\/em>, 32(6), 773\u2013789. doi:10.1080\/09687599.2017.1320270
\n<\/span>[11] Minogue V, Cooke M, Donskoy AL, Vicary P, Wells B. 2018. Patient and Public Involvement in Reducing Health and Care Waste. Research Involvement and Engagement<\/em>, 2018 4(5).
\n<\/span>[12] Minogue V, Wells B. 2018. Adding Value, Reducing Research Waste, the Role of the NHS Research and Development Management Community. International Journal of Health Governance<\/em>.
\n<\/span>[13]\u00a0<\/span>Nasser M, Clarke M, Chalmers I, Brurberg KG, Nykvist H, Lund H, Glasziou. 2017. What are funders doing to minimise waste in research? Lancet,<\/em> Vol 389, March 11, 2017.
\n<\/span>[14]Banner D, Bains M, Carroll S, Kandola DK, Rolfe DE, Wong C, Graham ID. 2019. Patient and Public Engagement in Integrated Knowledge Translation Research: Are we there yet? <\/span>Research Involvement and Engagement <\/span><\/i>2019;5:8
\n<\/span>[15] Domecq JP., Prutsky G., Elraiyah T., Wang Z., Nabhan M., Shippee N., Brito JP., Boehmer K., Hasan R., Firwana B., Erwin P., Eton D., Sloan J., Montori V., Noor A., Abu Dabrh AM, and Murad MH. (2014). Patient engagement in research: a systematic review, <\/span>BMC Health Services Research<\/span><\/i>, Vol. 14, p.89.
\n<\/span>[16] National Institute for Health Research. (2015). Going the Extra Mile: Improving the nation\u2019s health and wellbeing through public involvement in research. The final report and recommendations to the Director General Research and Development\/Chief Medical Officer Department of Health of the \u2018Breaking Boundaries\u2019 strategic review of public involvement in the National Institute for Health Research. National Institute for Health Research. 2018. National Standards for Public Involvement in Research. NIHR Central Commissioning Facility.
\n<\/span>[17] Jinks C, Carter P, Rhodes C, Taylor R, Beech R, Dziedzic K, Blackburn S, Hughes R, Ong BN. 2016. Patient and public involvement in primary care research – an example of ensuring its sustainability. <\/span>Research Involvement and Engagement <\/span><\/i>2016;2:1
\n<\/span>[18] Marks S, Mathie E, Smiddy J, Jones J, da Silva-Gane S. 2018. Reflections and experiences of a co-researcher involved in a renal research study. <\/span>Research Involvement and Engagement <\/span><\/i>2018;4:36
\n<\/span>[19] Gordon J, Franklin S, Eltringham SA. 2018. Service user reflections on the impact of involvement in research. <\/span>Research Involvement and Engagement <\/span><\/i>2018;4:11
\n<\/span>[20] Howe A, Mathie E, Munday D, Cowe M, Goodman C, Keenan J, Kendall S, Poland F, Staniszewska S, Wilson P. 2017. Learning to work together \u2013 lessons from a reflective analysis of a research project on public involvement. <\/span>Research Involvement and Engagement <\/span><\/i>2017;3:1
\n<\/span>[21] Moher D, Glasziou P, Chalmers I, Nasser M, Bossuyt PM, Korevaar A, Graham ID, Ravaud P, Boutron I. 2016. Increasing value and reducing waste in biomedical research: who\u2019s listening? Lancet<\/em> 2016; 387. \u00a0 <\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

To maintain efficiency in medical research we have to facilitate and empower participants, patients, and the public to recognise waste and take action, say Virginia Minogue and Bill Wells […]<\/p>\n

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