Public involvement in health and social sciences research: A concept analysis

Abstract Background Research funding bodies have significantly increased emphasis on the need for public involvement in research with the requirement to evidence effective methods and approaches to achieving this. Specific definitions and approaches within published research remain tokenistic and vague. Objective The concept analysis explores and clarifies the nature and meaning of public involvement in health and social sciences research and identifies operational definitions which can be used to guide, develop and evaluate public involvement in research activity. Search strategy A literature search was conducted using online databases. Systematic literature reviews and broader studies on the impact of PPI were included as was grey literature such as guidance from INVOLVE and research funding bodies. Limits were set to papers published in the last 10 years and in the English language. A concept analysis framework adapted from Rodgers (Concept Development in Nursing: Foundations, Techniques and Applications. London, UK: Saunders; 2000) and Walker and Avant (Strategies for Theory construction in Nursing. Boston, MA: Pearson Prentice Hall; 2005) was applied. Main results Five operational definitions were developed from the concept analysis: undefined involvement; targeted consultation; embedded consultation; co‐production; and user‐led research. Typical examples of each approach were identified from the literature. Defining attributes included having clear and agreed meaning and purpose for any involvement; reciprocal relationships; and value and recognition of the expertise of all those involved. Conclusions The authors argue the need for researchers to more explicitly incorporate and evaluate details of approaches used. Impact of public involvement on a research study should be identified when reporting on findings to prevent tokenistic practices where involvement is viewed as secondary to the core research process.


| INTRODUC TI ON
There has been an increasing emphasis in recent years on the need for meaningful public involvement in all stages of the research cycle from shaping the health and social science research agenda to influencing what, why and how research is conducted and disseminated. [1][2][3] Funding bodies such as the Wellcome Trust, the Economic and Social Research Council (ESRC), Alzheimer's Research UK, Cancer Research UK and the National Institute for Health Research (NIHR) have significantly increased their emphasis on the need for public involvement in research. Funding bids must evidence effective methods and approaches to achieving this. There is a concern, however, that one of the main reasons for public involvement in research is political mandate 4 based on neo-liberal, consumerist models, 1,2 which can be satisfied with tokenistic participation.
As a University partnership for Public Involvement in Education and Research (PIER partnership), our role has been to promote and support best practice and to help embed a culture of meaningful involvement in research in ways which increase impact. Our experience has been that researchers are often aware of the need to involve the public in research but not always of how or why.
Research impact is defined by the ESRC as "the demonstrable contribution that excellent research makes to society and the economy." Impact of PPI in this analysis refers to how involvement enhances the capacity of a research study to achieve academic, economic and societal impact, that is, by making a study more relevant; as well as the perceived impact of the process on those involved. suggests, participatory research does not automatically guarantee better data or outcomes. The purpose of this study is to explore and clarify the concept of public involvement in research or the more commonly used term public and patient involvement (PPI). We identify operational definitions of different approaches as part of the process of identifying and developing involvement which has a clear purpose, maximizes impact and is meaningful for all involved.

| Concept analysis
A concept analysis is a process to guide the exploration of a concept that may be vague or ambiguous. According to Knafl and Deitrick,7 concept analysis "entails the systematic examination of the attributes or characteristics of a given concept for the purpose of clarifying the meaning of that concept." Whilst originating in mathematics, a number of concept analysis methods are now used across research disciplines and are commonly used in nursing science and education. 8,9 Whilst a concept analysis is often used to explore new and underdeveloped concepts and theories, it can also be used to clarify and define concepts which are open to individual interpretation, multiple truths and subjectivity. 10

| Aims of the analysis
The aim of the concept analysis was to explore and clarify the nature and meaning of public involvement in health and social sciences research and to develop operational definitions which can be used to guide, develop and evaluate public involvement in research activity.

| Clarify the meaning and nature of the concept
Integral to a concept analysis is the process of exploring how terminology is currently used within the literature and in practice and to clarify meanings that can be vague or ambiguous. To conduct the concept analysis, we adopted INVOLVE's definition of patient and public involvement. INVOLVE are a government-funded national advisory group that supports greater public involvement in NHS, public health and social care research in England. They define public involvement as "research being carried out with or by members of the public rather than to, about or for them". 13 They suggest public involvement can include consultation, collaboration and user-controlled research involving the public (including patients, potential patients, carers and people who use or represent people who use health and social care services), being co-applicants on research projects, identifying research priorities, being members of advisory groups, commenting on research materials, undertaking interviews and undertaking research. 13 Public involvement is our preferred term given its broad and inclusive definition although we acknowledge that public and patient involvement (PPI) is more commonly referred to within the papers being reviewed. looked at the impact of PPI in randomized clinical trials. Over half of researchers, they interviewed thought it had made a difference by influencing aspects of the trial or how they, as the principal investigator, thought about the trial. The level of impact was identified as dependent on the clarity of goals and plans for PPI and the quality of the relationships between those involved. Advisory groups and trial management groups had a greater impact than the more removed, steering and oversight groups. Evidence shows that involving the public in the development of research topics, design and dissemination, impacts on how research is conducted and ensures that research is relevant, participant friendly, ethically sound and improves outcomes for patients and service users. 16 How people are involved in research was also a defining attribute, in particular, the relationship between those involved. McKenna 17 explored the reciprocal relationships between impact and PPI in mental health nursing studies concluding that "the latter positively influences the former." Shippee et al 18 who conducted a systematic review of 41 sources identified that important factors within PPI included patient and service user initiation, reciprocal relationships, co-learning and re-assessment and feedback. Involvement can have direct benefits for the participants themselves and as such can enhance social capital. 19 Fudge et al 20 found that research involvement gave participants a sense of purpose and satisfaction in the knowledge that they are affecting change, as well as involvement increasing their own knowledge, skills and self-confidence. Staley 21 completed a review on the outcomes of using PPI and found that public involvement has the most impact when people have been included throughout the whole process rather than at certain stages.

| Undefined involvement
A research study which is planned, designed and conducted without consultation or involvement from the public or where the public involvement is claimed but not explained or evaluated. Typically, those with lived experience such as service users, patients, carers, end users or benefactors are only involved as research participants, respondents or research subjects. This model can be characterised as research done 'to' people rather than 'with' people.
Most papers identified in the literature, which claimed to use PPI or public involvement in the research process, fell within this operational definition; a finding which will be discussed later.   24 reports on a pilot where nine patient and public members were recruited to research advisory groups. Their roles were to attend and participate in the UKCRC board or board subgroups; contribute to discussions; and assist each group in understanding some of the perspectives of patients and the public that were relevant to the work of the group. Evaluation identified that by contributing to discussions, patient members made a difference by keeping discussions grounded; promoting issues or questions which members believe would be important to patients and the public and bringing in knowledge from other related experience. It was acknowledged, however, that it was difficult to judge the precise impact that one or two people will have had on the outcomes of group discussions. The academics acknowledge challenges regarding the skill set of the volunteers at the start of the process. One volunteer reported feeling negatively at the start, as the language was too academic and she did not understand until "they started talking about what I understood." to the findings as they had been identified and shared by people with that experience. Co-researchers suggested that participants felt more comfortable opening up about their lives due to shared experiences, informal style, shared language or proximity in age.

| User-led research
During analysis, co-researchers felt that their experiences ensured that they were aware of the significance of certain issues and ensured that these issues were noted during the dissemination of their findings. Academics did raise some concerns regarding possible bias in interviews (seeking out experiences which matched their own) or of missing issues which the academic felt to be of significance.
Whilst adequate training is essential, they suggest that this should not be to the extent where it prevents the unique perspectives and approaches that involving the public can bring.

| Identify antecedents and consequences for effective public involvement in research to take place
We identified positive outcomes from meaningfully involving members of the public with lived experience, in all stages of the research process. There were clear antecedents (events that must occur prior to the occurrence of the concept) and consequences (events that must occur as a result) 11 in all of the models. These included the need for: • Clear goals to be identified to clarify the purpose of the involvement • Sufficient preparation, training, support, supervision and financial remuneration to be provided to enable the public to fully contribute and undertake the roles required.  The proposed empirical referents identified in this study therefore seek to identify best practice as a way of measuring effective and meaningful public involvement, rather than being based on a hierarchical framework. Researchers are encouraged to view the operational definitions, typical cases and antecedents identified within this concept analysis when considering which approaches will achieve the most significant benefits, outcomes and impact. and impact is challenging. This is due to the nonstandard and nonempirical nature of much of the literature 14,18,[35][36][37] and the difficulty in isolating the direct action which causes a specific outcome. 37 We identified that this is also influenced by a lack of explicit reporting of how public involvement is undertaken when publishing research findings. It is clear from this concept analysis and the approaches and cases identified, that the greater and more meaningful the level of involvement the more likely there are to be positive outcomes for all involved. This is not to say that the public need to be involved at every stage for a study to be a relevant or of good quality. NIHR 38 advise that as each study is different, PPI should be used in areas believed to be the most beneficial to that particular study. Participation in studies can range from no public involvement at some stages to being user-led at others. Funk et al 39 conducted a participatory research study with street-involved young people and wished to find out factors that prevented this demographic from injection drug use. Initially, young people were consulted on the research. Over the course of the project, they engaged in team building exercises which increased how comfortable they were with the researchers and their participation increased. Whilst this unplanned development had implications for time and money, it led to the research analysis and findings being more relevant to the level of involvement being directed by the young people involved. Levels of involvement can evolve therefore as a study develops.

| CON CLUS ION
Significant growth in involvement activity has led to many claims of public involvement some of which remain at a tokenistic level. There is, however, a wealth of information and guidance which supports Recommendations for the future are for authors to more explicitly incorporate the details and impact of public involvement on the research study when reporting on findings.

CO N FLI C T O F I NTE R E S T
There are no conflicts of interest.