In 2009, Chalmers and Glasziou estimated that 85% of all clinical research is wasted despite large financial investments, including public funding . They identified four stages within current research practises that lead to waste in research including: i) prioritising research questions that are irrelevant to health professionals and patients ii) conducting unnecessary or inappropriate studies or study designs, iii) failing to publish research findings and iv) selective reporting of research findings .
Ultimately, all this waste in clinical research has a detrimental impact on patients and members of the public: it prevents clinicians from using effective health interventions in practice and researchers cannot adequately prioritise future research questions.
Moreover, research waste is linked with ‘research integrity’, which is defined by the National Institutes of Health (NIH) as “the use of honest and verifiable methods in proposing, performing, and evaluating research; reporting research results with particular attention to adherence to rules, regulations, guidelines, and following commonly accepted professional codes or norms” . Thus, when inappropriate research priorities and practices are used, this calls into question the integrity of the research. Thus, when researchers, fail to ensure research integrity, this raises the question of whether the research is unethical. However, addressing ethics is beyond the scope of this commentary and we refer to discussion elsewhere [3, 4].
In 2014 The Lancet journal published a series of papers surrounding five sources of avoidable waste in research. In this series to authors advocated for greater consideration of research priorities , improved research design, conduct and analysis  obtaining appropriate regulatory and governance approvals , accessible research documentation  and appropriate research reporting .
In the wake of this increasing awareness about research waste and issues in ensuring research integrity, a new discipline of ‘research on research’ (also known as methodological-, secondary- and meta-research) emerged. By investigating research waste within the five sources mentioned above in more detail, we can develop and implement better research methods. Thus, this type ‘research on research’ aims to reduce research waste and ensure/improve research integrity.
In contrast to primary research in which studies are conducted with patients and often with outcome measures that are directly linked to patients e.g. changes in disease/health status, methodological research studies concern research methods used by other studies. Moreover, methodological research often investigates outcomes not directly linked to patient priorities or needs but on surrounding areas of the research process, such as the development of tools and guidelines for scientific reporting, peer-review process, and assessment tools for various phases of research studies.
A reduction of wasteful research is possible if the evidence that the research produces is valid and relevant to its users, including patients and members of the public . The importance of patient and public involvement (PPI) in the design and conduct of projects is gaining widespread recognition . PPI is important for several reasons. Firstly, patients’ lived experience and knowledge adds value in shaping research. Secondly, it is moral imperative that the voice of PPI has an impact on the research that will affect them, lastly, PPI is a way of recognising that patients are active, engaged individuals, as also expressed by INVOLVE’s definition of public involvement as: “research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them.” . Thus, the collaboration between patients and researchers has been described as reflecting, “a fundamental paradigm shift in health and social care research, away from paternalism towards partnership” . After all, doctors know about the illness and research but patients know about the daily impact of living with the health condition.
We believe this illustrates how PPI can improve the quality of research. If researchers are well informed about this importance and qualities of PPI, PPI will not only help to reduce waste, but equally improve the research integrity.
Furthermore, funding bodies are also becoming increasingly aware of the importance of PPI. In recent times, many funders stipulate that researchers must demonstrate how members of the public were involved in the design and development of the grant application, and if funded, how they will be actively involved in the planning and/or conduct of the study [11, 13].
PPI can occur at multiple stages of the research cycle, from identifying the research question, funding application, design, conduct and analysis, to dissemination and translation of findings into daily health services [14,15,16]. To date, PPI in research has mainly focussed on ensuring patients are equal stakeholders in an expert-dominated environment and integrating their lived experience and knowledge into clinically scientific studies [17,18,19]. Efforts to improve PPI, such as the experience and reporting of involvement and how different types of public contributors can add value, have been made [20,21,22], yet it is still a developing area and with much debate about its definitions, methods, operations, research integrity and ethical standards .
There are numerous ways of facilitating PPI including community involvement, PPI presence on committees or management groups, patient research partners; the most appropriate of which is likely influenced by the specific research question, health condition, population, and the available resources . However, despite no one-size-fits-all approach, we believe that involving public contributors, unless there is a good reason not to, should be the default position of all research teams. Thus, ensuring PPI in research is standard practice, yet not forcing a wrongful fit.
Thus, there are some common threads that all researchers should consider before and during the research process when including PPI contributors. This includes threads such as who to involve as research partners, when to involve PPI contributors, how to access and keep people involved in project, training and support mechanisms for PPI members, follow-up plans and dissemination approaches. It is important that research teams carefully consider, understand and acknowledge these issues. Failure to do so has the potential to cause unfavourable impact thus leading to more waste in research. One example of an unfavourable impact is tokenism, which is described as the “superficial and disingenuous” inclusion of small numbers of patients, with limited involvement and impact on the research [24,25,26,27]. Thus, it is becoming ever more apparent that researchers need to learn about and consider PPI as an aspect of health research throughout their career.
Early-stage researchers (ESRs) represent the next generation of scientific research. ESR’s are typically researchers in the first 4 years of their research activity, including the period of research training. Hence, it is important that they develop and foster PPI-related awareness, skills and expertise. This will enable them to champion meaningful PPI, and to produce more valid and relevant research evidence . Moreover, if the skills and values of PPI are introduced earlier in their training, it will help them adopt these practices better and thus, the involvement of public contributors will become a natural way of working, rather than a ‘tick box’ exercise.
The Methods in Research on Research (MiRoR) consortium is a training programme in the field of methods in clinical research. MiRoR is training 15 ESRs in numerous aspects of clinical research from planning of research, to conduct and reporting, including PPI, via educational training from numerous international experts in the field. All 15 MiRoR ESRs are undertaking PhD research in their chosen area.
The 15 MiRoR ESRs have a range of different backgrounds from public health, pharmaceutical science, statistics, biomedicine, mathematics, to computer science, and linguistics. Their individual PhD research projects cover many different topics in research on research. Some examples are the development of advanced statistical methods, improving peer-review processes and scientific reporting, evaluating the impact of collective intelligence, methods for identifying research gaps and improving current methods to evaluate research quality.
Interactive training in research methods is a key concept of MiRoR; it is achieved via webinars, online journal clubs, and writing exercises. The biannual training event in particular is a core component of the MiRoR training programme. These events allow the 15 MiRoR ESRs to receive specialised training from experts in the field in topics ranging from science communication to computer programming. Their purpose is to equip the ESRs with a variety of tools and skills they can draw upon within their current PhD projects, and throughout their research careers. Despite the differences in the ESRs’ backgrounds and individual PhD projects the MiRoR training programme, enables the 15 ESRs to gain a wide range of methodology knowledge and skills relevant to their individual research projects and across the various biomedical scientific disciplines.
In March 2017, the University of Liverpool hosted a MiRoR training event, with sessions dedicated to PPI in research and communication of research to the wider public. Multidisciplinary teams, which included patient and public representatives, delivered both sessions, educating the MiRoR ESRs, consortium members in attendance and students and researchers invited from the University of Liverpool. Applied training included the importance of PPI contributors to clinical trial research from design to conduct and dissemination of findings. Applied workshops dedicated to qualitative research skills including interviewing and focus groups, which can be used to enable patient participation in research were also provided.
At the latest MiRoR meeting held at the University of Split in Croatia (2nd -3rd October 2018) a patient and a funder were invited to introduce the ESRs and their wider networks to the merits and importance of including patients and the public in every aspect of their research. Over the course of 2 days, both speakers delivered presentations to a general audience comprising members of the MiRoR consortium and students and professors from the University of Split Medical School. They also engaged in round table discussion with the 15 MiRoR ESRs along with a number of professors from the MiRoR consortium. This provided a unique opportunity to further discuss and reflect on the advantages and challenges of PPI in methodological research, building on the presentations.
In the following, we first summarise the main messages from the talks and the round table interactions and then discuss the ESRs’ views on PPI in research.