Understanding who is and isn’t involved and engaged in health research: Feasibility of capturing and analysing demographic data related to patient and public involvement and engagement within a clinical translational research environment

doi:10.21203/rs.3.rs-2279963/v1

Background: Patient and public involvement and engagement (PPIE) can improve the relevance, quality, ethics and impact of research thus contributing to high quality research. Currently in the UK, people who get involved in research tend to be aged 61 years or above, White and female. Calls for greater diversity and inclusion in PPIE have become more urgent especially since the COVID-19 pandemic, so that research can better address health inequalities and be relevant for all sectors of society. Yet, there are currently no routine systems or requirements to collect or analyse the demographics of people who get involved in health research in the UK.

Methods: We developed a questionnaire to assess the demographics of people taking part in PPIE activities run by Vocal. Vocal is a non-profit organisation which supports PPIE in health research across the region of Greater Manchester in England. We implemented the questionnaire across Vocal activities between December 2018 and March 2022. We analysed our findings and compared them against local population demographic data, and available national data related to public contributors to health research.

Results: Our results show that it is feasible to assess the demographics of people who take part in PPIE activities, through a questionnaire system. Further, our emerging data indicate that we are involving a greater diversity of people in health research, as compared to available national data. Specifically, we involve more people of Asian, African and Caribbean heritage, and include a wider range of ages in our PPIE activities.

Conclusion: Our ‘learn by doing’ approach to assessing who does and doesn’t take part in Vocal’s PPIE activities has informed our practice and continues influence our strategic priorities for PPIE. Our system and learning reported here may be applicable and transferable to other similar settings in which PPIE is carried out. We attribute the greater diversity of our public contributors to our strategic priority and activities to promote more inclusive research since 2018.

Patient and public involvement and engagement (PPIE) can improve the relevance, quality, ethics and impact of research thus contributing to high quality research. Currently in the UK, people who get involved in research tend to be aged 61 years or above, White and female. Calls for greater diversity and inclusion in PPIE have become more urgent especially since the COVID-19 pandemic, so that research can better address health inequalities and be relevant for all sectors of society. Yet, there are currently no routine systems or requirements to collect or analyse the demographics of people who get involved in health research in the UK.

Vocal is a non-profit organisation which supports PPIE in health research across the region of Greater Manchester in England. Here, we report on the development of ways to capture and analyse who does and doesn’t take part in Vocal’s PPIE activities. We find that it’s feasible to capture and analyse demographic data related to PPIE. Further, our emerging data indicate that we are involving a greater diversity of people in health research, as compared to available national data. Specifically, we involve more people of Asian, African and Caribbean heritage, and include a wider range of ages in our PPIE activities. We attribute this to our strategic priority and activities to promote more inclusive research since 2018.

In recent years, issues of health equity and clinical research have been brought into sharp focus and particularly highlighted during the COVID-19 pandemic. High quality research, including early phase, experimental medicine and clinical trials, are the basis for evidence-based healthcare and can change lives. High quality research requires inclusive and diverse patient and public involvement and engagement (PPIE) in order to be generalisable, benefit all in society, be relevant to patient needs, and address health inequalities [1, 2]. For clarity, we define PPIE as an active collaborative partnership between researchers and members of the public, patients, carers and/or communities, working alongside research teams and as part of research organisations.

PPIE is becoming an established feature of high quality health research in the UK and elsewhere and is expected by many funders. PPIE can ensure that research is prioritised and designed to meet the needs of those who might benefit the most from its results and is key to the relevance, applicability and uptake of research. PPIE can improve the relevance, quality, ethics and impact of research thus contributing to high quality research [2, 3]. Researchers that engage with PPIE gain new skills and changes in attitudes and priorities because of the knowledge and experience of working with people with different perspectives [4]. There is evidence to suggest that PPIE also increases the recruitment and retention of participants to clinical trials [5].

PPIE is not automatically inclusive but inclusive PPIE is an important mechanism for increasing diversity and addressing health inequalities in research. Evidence shows that people from deprived areas are more likely to experience poorer health outcomes and they are also less likely to be involved in health research [6]. In the UK, a 2018 survey of public contributors to NIHR research showed that the majority of people who get involved in research are over 50 years old, female and White [7]. The same survey in 2021 showed little change, with survey respondents predominantly female (57%), 61 years of age and over, White British (91%) and heterosexual [8]. People from lower socioeconomic groups and those experiencing racial inequalities feel less confident to be treated with dignity and respect in research [9]. Many reports have called for increased diversity and inclusion in PPIE [1]; initiatives and frameworks to address greater inclusion in PPIE are emerging eg. NIHR REPAG [10] & UK Public Involvement Standards (Inclusive Opportunities) [11].

An important aspect of demonstrating the effectiveness of any initiatives to increase inclusion of wider individuals and groups in PPIE is the need to collect and analyse data related to the demographics of those engaged and involved in health research. However, at least in the UK, there is no systematic way or requirement to do so. Therefore, no routine data or comparator baseline exists against which to assess the diversity of PPIE.

This paper reports on work carried out by Vocal [12], which aims to connect people and health research for everyone’s benefit. Vocal is a centre of excellence in PPIE in the UK, based in Greater Manchester (GM) in the North West of England, UK. GM has a population of 2,770,000 and is landlocked spanning 492.7 square miles (1,276 km2). It includes 10 Boroughs (metropolitan areas): a mix of high density urban areas, suburbs, semi-rural and rural locations, but overwhelmingly the land use in the county is urban. Since 2015, GM has adopted a devolved health and social care system enabling the region more power and control over budgets from central government, including in relation to health and social care.

Vocal is hosted by Manchester University NHS Foundation Trust (MFT) in partnership with the University of Manchester, and receives funding from the National Institute of Health Research (NIHR), the Wellcome Trust and others. We adopt a strategic and collaborative approach to PPIE across the Greater Manchester conurbation [13]. This is achieved by working as part of the NIHR Manchester Biomedical Research Centre (MBRC) [14] and NIHR Manchester Clinical Research Facilities (MCRF) [15], the North West Research Design Service, Wellcome funded research groups and other local research infrastructure. In this paper, we explore the feasibility of methods to capture demographic characteristics of people who are engaged and get involved in clinical research via Vocal PPIE activities, in a vibrant early phase translational clinical research ecosystem in the North West of England.

Designing a questionnaire for recording demographic data

The NIHR MBRC and MCRF Health Inequalities Steering Group (HISG [16]) works to collectively address health inequalities in the research that is designed, delivered and communicated by the respective organisations. The group exerts strategic influence and conducts activities across GM research infrastructure, in order to promote inclusive research. Co-chaired by the Vocal Director and a Professor of Public Health and Epidemiology, the group includes public contributors, research support staff, researchers from different disciplines, Equality Diversity and Inclusion (EDI) personnel and PPIE practitioners. In response to the issue of lack of routinely collected demographic data related to PPIE and participation in experimental medicine research, Vocal worked with the HISG to design a questionnaire to capture the demographic characteristics of those who participate, are engaged and actively involved in clinical research. Here we report on the process for PPIE. The process for collecting data on participation is reported elsewhere.

The form was designed and the decision on which fields to capture was informed by existing good practice and advice received from the EDI team within MFT, public health monitoring practices (including the use of multiple indices of deprivation indicators), the Data Protection Act and the Equality and Human Rights Commission. The form was reviewed for accessibility by the HISG (including public contributor members of the HISG).

The questionnaire used for capturing demographic data for PPIE is shown in Fig. 1. The questionnaire did not capture identifiable information (ie. the name of the person completing the questionnaire was not recorded) and used tick boxes for recording other information. Fields in the form relate to protected characteristics as defined by the Equalities Act 2010 and include additional fields as proxies for socioeconomic status, including employment status, level of education and postcode. Postcodes in the UK are alphanumeric codes designating an area with several addresses or a single major postal delivery point. The first part of the alphanumeric code (called the outcode) has between 2 and 4 characters and designates a postal code district. The second alphanumeric part of the code is the incode, which contains 3 characters. The incode designates the postal code sector and delivery point and often relates to groups of around 15 addresses. In the UK, postcode and geographical location can be linked to lower super output areas (LSOAs) – a Census area of appropriate 1,500 people and to the UK index of multiple deprivation [17].

The questionnaire preamble contains details of why demographic information is being requested and was drafted by members of the HISG.

In consultation with the Information Governance team of MFT (host organisation for Vocal and the MBRC and MCRF), and The Christie NHS Trust (partner site for the MCRF), the questionnaire was approved for use by the Information Governance Oversight Boards of each NHS Trust. Following feedback and instruction from Information Governance Oversight Boards during the initial development of the form, the incode was removed from capture from the questionnaire. The questionnaire further underwent a Data Protection Impact Assessment (DPIA) and its continued use is under regular and constant review by MFT’s Information Governance Team, with regular follow up DPIAs.

Having undergone thorough Information Governance review, it was not deemed necessary for the questionnaire to be submitted for ethical review. Further, the purpose of the questionnaire was to evaluate service provision (the ‘service’ being PPIE) rather than as a way of generating original research. As indicated by the HRA in the UK, PPIE activities are not considered research and therefore not subject to ethics review [18].

Capturing demographic data related to PPIE

The form developed above was introduced to Vocal’s routine PPIE practice, to:

Explore the feasibility of collecting demographic data from those taking part in PPIE activities
Describe the demographic characteristics of people involved in Vocal’s activities, during a period between 2018 and 2022 (a ‘snapshot’).

The demographic questionnaire was distributed at all Vocal-led PPIE events held between December 2018 and end of March 2022. Completion of the questionnaire was voluntary, and people were not obliged to answer any or every question. People were asked whether they wanted to complete the questionnaire. Completion of the questionnaire was taken as consent.

Data received were held in the Vocal Client Relationship Management (CRM) system. This is a contacts management database for PPIE set up within Vocal in line with Data Protection and Information Governance requirements, and using a bespoke GoodCRM platform. Data were stored in accordance with MFT’s GDPR and data protection regulations.

The form was initially distributed in paper form during Vocal PPIE activities, for example meetings of Vocal’s Research Advisory Groups [19], engagement activities in the time period (notably Vocal’s engagement campaign called Hearing Health Now [20]) and to public contributor members of research governance committees. The form was moved online in May 2021, using a secure survey platform (Qualtrics) hosted by the University of Manchester. Electronically, the form was filled out by public contributors independently in advance of or following PPIE online and in person activities, when follow up contact was made (for example when processing payments for PPIE and/or as part of evaluation activities). Where needed, Vocal staff provided support to public contributors if they had questions about the purpose of collecting data, needed further explanation and advice, or were unsure which categories to fill in.

Statistical analysis and comparator data

The results are of the questionnaire are summarised by numbers and percentages according to category (Table 1). To assess whether this sample of people are different from the GM population or national PPIE contributors two datasets were used as comparator datasets and also presented as number and percentages (Table 1)

GM population data were sourced from the 2011 Census [21]. At the time of writing, the 2021 Census results have yet to be published but would provide more up to date population data comparisons.

Comparator data about the demographics of PPIE contributors, nationally, were sourced from two surveys – one in 2018–2019 and one in 2020–2021 – carried out by NIHR in the UK [7, 8]. The first survey ran from December 2018 to January 2019, receiving 809 responses with a 72% completion rate. Headline data indicate that young people and minority ethnic communities were under-represented in NIHR’s public involvement at the time: younger age groups represented 2% of survey respondents (under 25) and 14% of respondents (aged 26–49). 3% of respondents were from Asian ethnic groups, and 3% from Black ethnic groups. Respondents were generally older, predominantly white and female (58% women, 35% men, 7%). 74% identified themselves either as patients, service users or members of the public with lived experience.

The second survey ran from July 2021 and consisted of 24 questions. These were a mix of questions which asked respondents to select answers from options given to them, and questions that enabled respondents to answer in their own words (free text). People were free to answer as many of the questions as they wanted. This meant not all respondents answered every question. There were 819 responses to the survey. Survey respondents were predominantly female (57%), 61 years of age and over, white and heterosexual. 47% of respondents (268 of 565) stated they had physical or mental health conditions, disabilities or impairments (most commonly mobility issues) that limited their ability to carry out certain tasks. Both NIHR surveys reported headline data via their websites. A more detailed report of the 2021 NIHR survey was made available by NIHR and provided on request to the authors of this paper. Data reported in Table 1 related to the 2021 NIHR survey are sourced from this more detailed report.

It should be noted that the NIHR surveys were not focused on demographics of public contributors and explored wider experiences of PPIE. This means that information related to the characteristics of public contributors were not always exactly comparable with our data. For example, NIHR surveys reported some ethnicity as related to being Black or Asian, without further granularity (eg. Black British African, Asian British Pakistani). Our survey categorised disability as according to the definition from the Equalities Act 2010, whereas in the NIHR 2021 survey respondents self-reported mental or physical health condition, disability or impairment that limited their ability to carry out tasks ‘a lot’, ‘a little’ or ‘not at all’. Where possible, data from our work have been compared against the most relevant comparator data set (Table 1). We reference comparator data from both NIHR surveys, as they both cover the time period covered by our questionnaire.

To the end of March 2022, a total of 329 forms were returned. Table 1 summarises the data received and compares against the demographics of local GM population (Census data 2011) [21] and data from the 2018 and 2021 NIHR national surveys of public involvement 7, 8]. Our findings indicate that assessing the demographic characteristics of people taking part in PPIE activities is possible, and that the people taking part in Vocal’s PPIE activities are more ethnically diverse, and represent a greater diversity in age range, than national indicators. Data also show good representation across other characteristics (including employment status and geographical spread). We attribute the diversity of contributors to Vocal’s PPIE activities as a result of Vocal’s strategic priority (2017-2022) [22] to increase inclusion in PPIE.

Return rate and completion of questionnaire

As of end of March 2022, 329 of Vocal’s public contributors had returned the demographic monitoring questionnaire, out of a total of 935 public contributors associated with Vocal at end of March 2022, so a return rate of 29.3%. We deem this to be a decent return rate and we are confident that it reflects the reality of our public contributor demographic.

Most people filling in the form completed all the fields, though there were a few forms that omitted some fields. The highest error rate was in the field capturing postcode, with 53 answers being illegible, not corresponding to a postcode, or left blank. We interpret this to mean that the questionnaire was generally considered accessible, especially the answers that required ticking a box, with errors introduced in the free text field capturing postcode. Vocal staff were able to support people to fill in the questionnaires, and this was occasionally needed. Where there might be sensitivity about answering some questions, ‘Prefer not to say’ options were sometimes ticked, suggesting that this field was appreciated by respondents.

Ethnicity

18.54% of people taking part in Vocal’s PPIE activities self-identified as Asian (including Asian or Asian British Indian, Asian or Asian British Pakistani, Asian or Asian British Bangladeshi, Asian Chinese and any other Asian or Asian British Background). This compares to 3% (in 2018) and 2.2% (in 2021) of public contributor respondents to NIHR surveys identifying as Asian (no sub-categorisation of Asian ethnicities). This indicates that public contributors taking part in Vocal PPIE activities include significantly more people of Asian heritage than national indicators. 10.14% of the GM population identify as Asian in 2011, indicating that Vocal is working with greater numbers of Asian contributors when compared to population demographics. However, most of Vocal’s public contributors are from the GM Borough of the City of Manchester, which includes 17.1% of the population of Asian heritage – which is in line with Vocal’s Asian public contributor demographics.

7.60% of people taking part in Vocal’s PPIE activities self-identified as Black (including Black or Black British Caribbean, Black or Black British African and any other Black or Black British background). This compares to 2% (in 2018) and 2.9% (in 2021) of public contributor respondents to NIHR surveys identifying as Black (no sub-categorisation of Black ethnicities). This indicates that public contributors taking part in Vocal PPIE activities include significantly more people of African or Caribbean heritage than national indicators. 2.26% of the GM population identify as Black in 2011, indicating that Vocal is working with greater numbers of Black contributors when compared to population demographics. However, most of Vocal’s public contributors are from the GM Borough of the City of Manchester, which includes 8.60% of the population of African or Caribbean heritage – which is in line with Vocal’s African and Caribbean public contributor demographics.

The percentage of people of mixed heritage taking part in Vocal’s PPIE activities (1.82%) is similar to national indicators of PPIE public contributors (2.6% in 2021 NIHR survey) and the GM population (1.02%).

Table 1: Demographic characteristics of people taking part in Vocal PPIE activities, cumulative data December 2018 to March 2022.

	Vocal public contributors (n=329)		NIHR public contributors 2018 (n=631) 2021 (n=819)	GM Census Data (2011)
Ethnicity	N°	%	%	%
White British	178	54.10%	No data	79.8%
White Irish	5	1.51%		1.29%
White Gypsy Roma Traveller	0	0		0.67%
Other White Background	4	1.21%		2.62%
White (total)	187	56.84%	77% (in 2018) 91.5% (in 2021)	84.38%
Asian or Asian British Indian	16	4.86%	No data	1.99
Asian or Asian British Pakistani	53	16.11%		4.85
Asian or Asian British Bangladeshi	5	1.52%		1.27
Asian Chinese	9	2.74%		0.97
Any other Asian or Asian British Background	3	0.91%		1.06
Asian or Asian British (total)	86	18.54%	3% (in 2018) 2.2% (in 2021)	10.14%
Black or Black British Caribbean	14	4.25%	No data	0.66%
Black or Black British African	10	3.04%		1.67%
Any other Black or Black English Background	1	0.30%		0.43%
Black or Black British (total)	25	7.60%	2% (in 2018) 2.9% (in 2021)	2.26%
Mixed White and Black Caribbean	0	0	No data	0.86%
Mixed White and Black African	2	0.61%		0.37%
Mixed White and Asian	1	0.30%		0.58%
Other Mixed background	3	0.91%		0.44%
Mixed (total)	6	1.82%	2.6% (in 2021)	1.02%
Arab	13	3.95%		0.56%
Any other ethnic group	5	1.51%		0.46%
Prefer not to say	7	2.13%
Sex
Male	120	36.47%	40.7% (in 2021)	49.44%
Female	207	62.92%	56.7% (in 2021)	50.56%
Religion
Christian	101	30.70%	No data	61.79%
Buddhist	7	2.13%		0.36%
Hindu	4	1.22%		0.88%
Jewish	8	2.43%		0.93%
Muslim	84	25.53%		8.68%
Sikh	0	0		0.20%
Other religion	23	6.99%		0.28%
No religion	61	18.54%		20.77%
Not stated	21	6.38%		6.12%
Sexuality
Heterosexual	287	87.23%	86.4% (in 2021)
Gay or Lesbian	6	1.82%	1.3% (in 2021)
Bisexual	11	3.34%	3.8% (in 2021)
Other	1	0.30%	2.3% (in 2021)
Undecided	2	0.61%
Not stated	21	6.38%	5.9% (in 2021)
Do you consider yourself to have a disability?
Yes	87	26.44%	‘A lot’: 15.6% ‘A little’: 31.9%
No	209	63.53%	‘Not at all’: 50.6%
Prefer not to say	31	9.42%	1.9%
Are you currently...
Retired	61	18.54%	66.48% aged 61 or over (in 2021)
Student	72	21.88%
Looking after home or family	23	6.99%
Working	111	33.74%
Unable to work	21	6.38%
Unemployed	14	4.25%		3.5%
Other	23	6.99%
What is your highest level of education?
No formal education	8	2.43%
Primary education	3	0.91%
Secondary education	91	27.66%
Higher education	75	22.80%
University education	141	42.86%

Data are compared against national surveys of public contributors carried out by the NIHR in England in 2018 [7] and 2021 [8], and against Census data relating to Greater Manchester from 2011.

Religion

Our data show that the majority of people taking part in Vocal PPIE activities are Christian (30.70%) or Muslim (25.53%). No comparator data were available from NIHR surveys of public contributors. However, when comparing with GM population data, we see greater numbers of public contributors are of Muslim, Jewish, Buddhist, Hindu and other faiths than are represented in the GM population. We include significantly fewer people of Christian faiths in PPIE activities, when compared to proportions of people in the GM population.

Sex and Gender

Most people taking part in Vocal’s PPIE activities are women (62.92%) compared to 36.47% men. This represents a less equal balance than national indicators of PPIE: the NIHR survey in 2021 includes 56.7% female respondents and 40.7% male respondents. In GM, there are slightly more women (50.56%) than men (49.44%). It should be noted that Vocal’s process for collecting information related to their sex and gender has been updated since the questionnaire reported here. Now, in addition to asking about sex (male/female) we ask if the gender the respondent identifies with is the same as their sex registered at birth, providing an option for respondents to enter their gender identity.

Sexuality

The proportions of people taking part in Vocal’s PPIE activities identifying themselves as heterosexual, gay or lesbian, and bisexual is similar to national NIHR indicators related to public contributors’ sexuality.

Working status and level of education

Our data indicate a good mix of public contributors from across different working status and levels of education. Working status and level of education were included in our monitoring, as proxy indicators of socioeconomic status, and were considered important especially in the absence of being able to capture full postcode (which would allow more granular analysis of indices of deprivation). Comparator data for working status and level of education are not available, but it is widely considered that public contributors tend to come from backgrounds with high levels of education. This is borne out by our findings, with the majority - 141 respondents (42.86%) - reporting a University education. However, we were encouraged to see that 91 respondents (27.66%) reported a secondary education as their highest level of education, suggesting that we are reaching considerable numbers of people without further or higher education. Likewise, the majority of people who take part in Vocal activities are working (111 or 33.74%), suggesting that we are not reliant on those who are retired and/or in a privileged working status to take part in PPIE activities.

Age

Table 2 details public contributors to Vocal PPIE activities, by year of birth. We find that public contributors to Vocal PPIE activities are from all ages, with a relatively even spread. The highest numbers of public contributors – 68 or 20.67% - have their year of birth between 1998 and 2003 (aged 19-24 in 2018) followed by those with a year of birth before 1958 (aged 65+ in 2018) at 65 or 19.67%. However, all other ages are well represented (Figure 2). When compared with national data from NIHR surveys, our results show a more diverse representation of age in PPIE activities: the majority of public contributors to NIHR research are over 61 years of age. NIHR respondents were most likely to be in the 71 to 80 year old age group (31.4%); 61 to 70 was the second most represented age group (30.1%); and the least represented age brackets were under 18 years old (0.4%), 19 to 30 year olds (1.9%), and 31 to 40 year olds (3.6%). Although the age categories do not match directly across Vocal age data and age data obtained from NIHR, we are confident in concluding that Vocal PPIE activities include people from a wider range of ages than national indicators. Most people living in Greater Manchester are adults aged 20-24 and 25-29 [23].

Table 2: Ages of people taking part in Vocal PPIE activities

Age of public contributor	Number	Percentage
Year of birth after 2003 (18 and under in 2018)	3	0.91%
Year of birth 1998-2003 (aged 19-24 in 2018)	68	20.67%
Year of birth 1988-1997 (aged 25-34 in 2018)	36	10.94%
Year of birth 1978-1987 (aged 35-44 in 2018)	40	12.16%
Year of birth 1968-1977 (aged 45-54 in 2018)	48	14.59%
Year of birth 1958-1967 (aged 55-64 in 2018)	57	17.32%
Year of birth before 1958 (aged 65+ in 2018)	65	19.76%
Did not say	12	3.65%

Geographical spread

Those taking part in Vocal’s PPIE activities come from Greater Manchester and beyond, from different areas of the UK. The majority of Vocal’s public contributors (58.05%) live in GM, with 25.83% living outside of GM. Figure 3 maps public contributors against Boroughs of GM, showing the greatest number (80 or 24.31% of total contributors) from the Borough of the City of Manchester. The Borough of Oldham shows the second highest numbers of people taking part in Vocal PPIE activities.

Our findings indicate that assessing the demographic characteristics of people taking part in PPIE activities is possible, and that the people taking part in Vocal’s PPIE activities are more ethnically diverse than national PPIE indicators, represent wider age ranges when compared to national PPIE indicators, and include good representation across other characteristics. This is probably due to Vocal’s strategic priority (2017–2022) [22] to increase inclusion in PPIE.

Feasibility of capturing demographic data related to PPIE

Our experience reported here shows that the introduction of a demographic monitoring process for PPIE is feasible and provides useful data to understand who we are (and aren’t) reaching in public involvement in research. In the absence of any standard or mandated practice of capturing information on the characteristics of people who get involved in research, the process described here provides an overview of our approach, and may be transferable to other similar PPIE contexts. Learning from and evolving our practice of capturing demographic data during this approach from December 2018 to March 2022 has informed our current practice of understanding who is (and isn’t) involved in our PPIE activities and this learning may also be useful to others. We are aware that we do not have our own baseline data against which to compare and benchmark the diversity of our PPIE activities and progress, and that external comparators might be limited. Nevertheless, the ‘snapshot’ of data reported here can serve as baseline data for our ongoing work and the data that we now collect routinely provides rich and meaningful insights into our programme of PPIE work..

A more diverse public contributor community?

Whilst this was not a comprehensive analysis, our results indicate that we are reaching a greater diversity of people, compared to national indicators from NIHR, in our PPIE activities supporting the GM research ecosystem. In particular, our data indicate that greater numbers of people with experience of racial inequalities contribute to Vocal PPIE, when compared to available national data (NIHR surveys of public contributors 2018 and 2021). The percentages of people with experience of racial inequalities included in Vocal PPIE activities mirrors the demographics of the GM population, as indicated with reference to the 2011 GM Census. We await the results of the 2021 Census. When conducting subset analyses, we note that the percentages of people of Asian, African and Caribbean heritage most closely approximate the populations in the Borough of the City of Manchester, where most of Vocal’s public contributors come from (Fig. 3). We attribute the relatively high levels of contribution from people of Asian, African and Caribbean heritage, to our strategic focus on increasing inclusion in PPIE within these populations over the last 5 years, including initiatives such as the community sandpit [24] and BRAG [25].

Our data also indicate that we are working with people across a wider range of ages, when compared to national indicators. This may be due, in part, to the success of our Voice Up group, a research advisory group of young adults aged 16–24, and to engagement initiatives that work with younger age groups [26, 27].

Our gender balance is skewed towards greater involvement of women. This is comparable to national data and will inform our approach in going forwards to involve more men.

We note than the percentage of those with a disability who get involved in our PPIE activities is lower than national indicators. This may be due to ambiguities in the definitions (our questionnaire uses the definition of the Equalities Act 2010) whereas the NIHR survey used self-reporting indicators of physical or mental health conditions, disabilities or impairments (most commonly mobility issues) that limit ability to carry out certain tasks. Whilst all of Vocal’s work is focused on PPIE, we work with large numbers of contributors from a variety of different communities (of geography, characteristics and/or identity) as well as patients, carers and people from all walks of life. This means that our activities are not limited to including people with lived experience of a particular health condition, though these groups are a pivotal part of our work as represented through our wide range of condition specific research advisory groups and networks [19]

We also note that the distributions of religion, level of education and working status show a good range and that Vocal’s public contributors come from across the UK and from across all Boroughs of GM. The largest number of public contributors - from the Borough of the City of Manchester – may be due to the fact that Vocal is physically located within the City of Manchester, and the Borough also contains the greatest concentration of research active institutions (for example, MFT and the University of Manchester). The Borough of Oldham – with the second largest number of public contributors – may be well represented as a major project engaging people with hearing health research (Hearing Health Now [20]).

Limitations and next steps

As a team, we have approached the work contained in this paper, through a ‘learn by doing’ approach. Throughout, we have reflected, as the Vocal team and in collaboration with the HISG and wider research and public contributor communities, on the limitations of the process described in this paper which include:

Duplication: we expect that there has been an element of duplication within responses though we have not systematically appraised this. Where public contributors were involved in several Vocal activities during the time period of monitoring, they may have completed the questionnaire more than once.
Length of the form: we are aware that the form requires responses to a large number of questions and that this could be off putting for some. We worked with public contributor, public health and EDI expertise in the development of the form and we concluded that it would not accurately reflect the needs of both researchers, public engagement practitioners and public contributors if we removed any of the fields. We were careful to include personal support (from Vocal staff) to complete the form.
Data collected: in our initial DPIAs, it was recommended that we remove the latter part of postcodes. This has presented limitations when analysing the data to understand the geographic and socioeconomic profile of public contributors, with a view to increasing their involvement. The first 3 digits of a postcode cover a large area which contain significant differences in indicators of deprivation – often from the highest decile of the Index of Multiple Deprivation (IMD) to its lowest decile. LSOAs provide better granularity.
Comparator data: We have attempted to benchmark our data against existing datasets, but this is limited. NIHR public contributor data provide the best comparison, together with GM population data. Our data to date, provide baseline data for us in going forwards.

To address the limitations above, we have worked closely with Information Governance teams across our host NHS organisations. From March 2022, following a further DPIA, it has been agreed that Vocal can:

Collect full postcode details of public contributors (in addition to the data already collected)
Link demographic data to the personal record of public contributors within Vocal’s secure CRM system. This has been enabled through the use of a different CRM platform (Zoho), which provides greater functionality and which is still subject to and compliant with all GDPR and Information Governance requirements.

To be clear, no data from public contributor’s health records is kept on Vocal’s CRM system, and providing demographic data is still voluntary. But, by having a much more systematic approach to the logistics of engaging with public contributors, we are better able to target opportunities for involvement to specific communities (of geography, characteristics or identities), avoid duplication of approaches, avoid public contributor ‘fatigue’ through being asked to contribute to too many things, systematically feedback the impact of their involvement and maintain up to date records and contacts. Staff engagement has been essential to the process of capturing demographic data, including within Vocal staff and wider host organisations and partners. We have shared our process informally with other local organisations, who are adopting this way of working.

Since 2017, Vocal has prioritised increasing the diversity of people who get engaged and involved in research, through developing more inclusive methods of PPIE. Our approach [13], strategy [22] and activities are reported elsewhere. Overall, we are confident that the data we present in this paper indicate that we are meeting our ambitions to diversify PPIE, to ultimately produce more inclusive research that is relevant to, and benefits all of us.

BRC

NIHR Manchester Biomedical Research Centre

CRF

NIHR Manchester Clinical Research Facility

CRM

Client Relationship Management

DPIA

Data Protection Impact Assessment

GDPR

General Data Protection Regulation

GM

Greater Manchester

HISG

Health Inequalities Steering Group

IMD

Index of Multiple Deprivation

LSOA

Lower Super Output Area

MFT

Manchester University NHS Foundation Trust

PPIE

Patient and Public Involvement and Engagement

Ethics approval and consent to participate

Not applicable. See also Methods section of this paper.

Consent for publication

Not applicable

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

All data generated or analysed during this study are included in this published article.

Competing interests

The authors declare that they have no competing interests.

Funding

This work was funded through the NIHR Manchester Biomedical Research Centre and NIHR Manchester Clinical Research Facility awards.

Authors' contributions

SI, SP and AK led the work contained in this paper. They devised the questionnaire, established the methods to implement the questionnaire, and collected data from Vocal activities between December 2018 and March 2022. They liaised with Information Governance and everyone involved in setting up and carrying out this work.

SI, BS, LH, TG, AV, TF and DF are members of the HISG. SI, LH and BS set up the HISG initially. TF and BS co-Chair the HISG.

AK, SW, KC, PA, EH, HTU implemented the questionnaire and collected data from Vocal activities between December 2018 and March 2022.

BS, AK and MS analysed the data contained in this paper.

MS established and maintained the CRM platforms used to collect data, and was responsible for follow up DPIAs and information governance compliance.

AV and TF advised on matters related to health inequalities, public health data and indicators of deprivation.

DF advised on community engagement.

AK and BS were the major contributors in writing the article.

Acknowledgements

We thank all the public contributors and people involved in Vocal activities who took the time to fill in the questionnaire described in this paper.

Authors' information

We dedicate this paper to Suzanne Parsons, one of the listed authors. Suzanne was fundamental to and a driving force behind this work and a source of inspiration, advice and support. Sadly Suzanne died in 2020.

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No competing interests reported.

Understanding who is and isn’t involved and engaged in health research: Feasibility of capturing and analysing demographic data related to patient and public involvement and engagement within a clinical translational research environment

Status:

Journal Publication

Version 1

Abstract

Figures

Plain English Summary

Introduction

Methods

Designing a questionnaire for recording demographic data

Capturing demographic data related to PPIE

Statistical analysis and comparator data

Results

Return rate and completion of questionnaire

Ethnicity

Religion

Sex and Gender

Sexuality

Working status and level of education

Age

Geographical spread

Discussion

Feasibility of capturing demographic data related to PPIE

A more diverse public contributor community?

Limitations and next steps

Conclusion

Abbreviations

Declarations

References

Additional Declarations

Status:

Journal Publication

Version 1