Bridging The Gap Between Research And Impact: Public And Patient Involvement In Health Research

Public and patient involvement (PPI) is key to closing the gap between research production and research use, and it is a way to achieve full transparency in health science. PPI is a cornerstone of responsible research and innovation. However, not all areas of health research are obvious or accessible to the public. Basic and preclinical biomedical research is not public-facing but is funded by the public and impacts the community. As such, PPI can be challenging to implement, even when a researcher may understand the value in doing so.

In a recent study in PLOS One, we explore the reasons that preclinical researchers are hesitant to implement PPI and develop open source tools to assist in overcoming these challenges.¹

Spending on medical and health research and development in 2016 rose to $171.8 billion in the USA alone, of which $56 billion was invested from non-industrial sources.² If you consider accessible publication, complete reporting, and good design to be the three essential criteria to avoid research waste, an estimated 85% of medical research is wasted.³ This is very similar to the reasons why new products fail. In response, product design has adopted iterative and user-based design approaches and a better understanding of the market and target audience to prevent this waste. In medical research, we are starting to adopt these principles in what is termed public and patient involvement in research (PPI).

PPI is not about unleashing the public on your pipettes; rather, it is about increasing research relevance and cooperating with the public and people living with a disease to enable careful and deliberate study design. This is not a new concept. In the words of the Royal Society’s 1985 report into the public understanding of science, “decisions made in the light of an adequate understanding of the issues are likely to be better than decisions made in the absence of such understanding.” Yet, public involvement in preclinical research is still the exception rather than the rule.

In this study, we explored the challenges faced by preclinical researchers in implementing PPI. A lack of clarity around PPI, institutional barriers (ethics, funding, and guidance), and time commitment were all identified as deterrents to PPI. Researchers worried about negative consequences on their research; they feared they may be forced to sacrifice long-term value for short term gains and that their scientific research objectives may be diluted by popular or politicized science. Researchers that use animal models for their research had major concerns around the public judgment of ethically approved research.

The current politicized climate and rush to judgment enabled by social media led them to worry about personal backlash and, as such, they were hesitant to fully open their research to the public.
Fundamentally, preclinical researchers did not feel equipped to meaningfully involve patients in their research. Effective communication, conflict resolution, and facilitation were major transferable skills identified as lacking in the preclinical researcher’s toolkit. The perceived lack of these skills combined with a lack of resources and institutional supports contributes to the delayed uptake in public involvement in preclinical research compared to other areas of health research.

In response, we developed a strategic planning tool for researchers to help them identify where they need to upskill and perform a strategic analysis as to whether it would be worth doing so. Adapted from the Business Model Canvas,⁴ the “PPI Ready: Researcher Planning Canvas” is an easy-to-use visual plan with elements describing a researcher’s challenges, proposed solutions, the solutions’ value proposition, research impact, financial burden, and time costs. It is designed to assist researchers in aligning their activities by illustrating potential benefits and trade-offs. It also allows researchers to reflect on their main theoretical challenges for implementing PPI in advance of starting a research project, thereby facilitating the downstream success of their PPI initiative.

There is much discussion in the health literature about whether PPI should be evaluated or assessed. We argue that, just like any area of the research cycle and design process, PPI should be assessed and improved iteratively in response to experience and lessons learned. Formalized PPI is only recently being adopted in preclinical research. All initiatives, especially paradigm shifts, have associated risks: the earlier in the project lifecycle you can identify risk, the better you can adapt your project design to overcome it. This may be difficult considering PPI, by its very nature, is not prescriptive. The form that PPI takes will be tailored to the needs of the research. However, the underlying concepts for valuable and meaningful PPI remain constant, and these can be measured and assessed.

We worked with patient insight partners to develop a PPI assessment survey. The simple 9 question survey is designed to be completed by patient/public insight partners iteratively throughout their role in the lifecycle of the research project. This approach has a number of benefits, including mitigated risks earlier because PPI elements can be integrated progressively; accommodation of changing requirements and procedures as experience is gained and lessons learned; refinement and improvement of PPI resulting in a more robust and meaningful initiative; knowledge exchange as institutions can learn from this approach and improve their process; and enhanced reusability of PPI initiatives.

The PPI assessment survey assesses (1) quality and clarity of the information and communication provided by the researcher(s) to the public insight partner(s), (2) consideration of the public partner(s) needs, and (3) how valued and valuable a public insight partner perceives the PPI initiative to be. The PPI assessment survey cannot tell you what the problem is but highlights that there is an issue in the first place. This allows easy follow up with the public insight partner to problem solve the underlying issue.

As time was a key issue hindering a researcher’s implementation of PPI; development of a PPI assessment survey (PAS) would be redundant unless it was quick and easy to use. Thus, we developed a simple automatic analysis tool for the PPI assessment survey. The analysis tool is simple by design, at the suggestion of preclinical researchers who did not want to require any further training in order to be able to use it. The analysis is multi-dimensional and uses a flagging system similar to that of standard quality control measures used by laboratory equipment and which preclinical researchers would be familiar with. These flags alert the researcher to issues with their PPI initiatives and allow them to put control measures in place. This can be used as an easy reporting measure for annual reports and for assessing a PPI initiative across the lifecycle of the project. The iterative use of the survey and assessment tool over time enables trend analysis to determine the success of the control measures.

Public involvement in research is increasingly recognized as the key to bridging the gap between research and impact. We, as researchers, have a professional responsibility to ensure our research is best practice, adequately informed, and good use of public funds. Science and research is a public good, and it is a researcher’s responsibility to make their research accessible. We have a duty to contribute to the public understanding of research. The goal of this study is to help researchers achieve this through meaningful public and patient involvement.

References:

1. Maccarthy, J., Guerin, S., Wilson, A. G. & Dorris, E. R. Facilitating public and patient involvement in basic and preclinical health research. PloS one 14, e0216600, doi:10.1371/journal.pone.0216600 (2019).
2. America, R. U.S. Investments in Medical and Health Research and Development. (Virginia, USA, 2017).
3. Glasziou, P. & Chalmers, I. Research waste is still a scandal—an essay by Paul Glasziou and Iain Chalmers. BMJ 363, k4645, doi:10.1136/bmj.k4645 (2018).
4. Clark, T. O., A; Pigneur, Y Business Model You. 257 (John Wiley & Sons, 2012).