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To address objective 1, a national scoping of studies within the six exemplar areas was undertaken

(October–December 2011).

Sample

Our sample here included current studies or those completed in the previous 2 years in the six exemplar areas and being undertaken in England. To ensure relevance to the NHS and scientific robustness, studies were limited to those registered with the UKCRN portfolio, excluding commercially funded studies. To ensure inclusion of studies most likely to have been designed since the embedding of PPI in the research

governance framework,1_{we excluded studies older than 2 years (end date of recruitment before}

1 September 2009). We also excluded studies funded by commercial organisations because, despite

current criticisms of the lack of transparency in drug trials,140,141_{access to the study documents required}

was likely to be limited.

Data collection

Studies were identified using the using the search terms in Table 4.

Details of each study were electronically searched via funding body databases. Relevant documentation such as reports, abstracts and protocols was reviewed for the type of research (e.g. laboratory based or qualitative) and any evidence of the nature and extent of PPI. Where information was not available electronically, the funding body was contacted and requested to provide further relevant details of the

Scoping response

In total, 1464 studies in the six broad topic/exemplar areas were downloaded from the UKCRN database. One hundred and two were excluded as not in the specific topic areas, 263 as more than 2 years old and 261 as commercially funded. A total of 838 studies were included (Table 5). These were then divided into the 478 included in the scoping, and 360 for the online survey. All of the latter group were within the four selected regions of England (Figure 4).

In the UK, clinical research networks have been established in each of the four UK nations funded by their health departments. These national networks form UKCRN. The UKCRN portfolio of studies was used as one single database to identify relevant research studies, and information including study title,

sample size, end date of recruitment and contact details was downloaded into an Excel®_{(version 14,}

Microsoft Corporation, Redmond, WA, USA) spreadsheet.

For studies not covered by the online survey, that is running outside the four selected geographical regions, including studies in Scotland, Wales and Northern Ireland, direct requests were made. Documents or e-mail replies were then reviewed by two team members independently for background study information and any evidence of the nature, extent and activities of PPI. The scoping exercise obtained information about PPI from 182 studies out of a possible total of 478 (38%) (Table 6). Documents received in response to requests for PPI information included 93 protocols, 12 journal articles, 64 e-mail replies, 10 interim/final reports and 3 Integrated Research Application System (IRAS) forms. Other documents (such as grant applications, reports to funders and lay summaries) were also provided. Some studies provided more than one source of information. The studies in the scoping had sample sizes ranging from 12 to 250,000,

TABLE 4 Search terms for topic areas accessed on UKCRN portfolio

Topic area Focus and key words/terms

CF Key word‘cystic fibrosis’

Diabetes mellitus Type 1 and type 2 and other

Arthritis Musculoskeletal, inflammatory and immune, genetics, primary care

Dementia Dementia and neurodegenerative diseases, Huntington_{’s disease, motor neurone disease, Parkinson’s} disease, other

IDD Searched on key words:‘learning’, ‘attention’, ‘Downs’, intellectual’, ‘autism’, ‘Asperger’. Mental health: learning difficulties theme. Specific syndromes listed by Royal College of Psychiatry142

Public health Primary care, infection, key word_{‘public health’} All topics Generic relevance and cross-cutting themes

TABLE 5 Search of UKCRN portfolio in six topic areas

Topic area

Number of studies identified on UKCRN portfolio Number of studies for inclusion % of total on UKCRN CF 23 8 35 Diabetes mellitus 512 277 54 Arthritis 399 188 46 Dementia 282 192 68 IDD 90 51 57 Public health 158 122 77 Total 1464 838 57

Search UKCRN portfolio database to identify current studies or those completed

in last 2 years (since 1 September 2009) and non-commercial studies

Outside four geographical regions

(n = 478)

Studies located in four geographical regions of England (North East, London,

East of England and South West)

(n = 360)

UKCRN portfolio: link for protocol request

Protocol available on funder’s or study’s website

On authors’ behalf, funder requests PPI information from study team

Authors directly approach chief investigator for protocol and PPI information

Online survey ACCESS METHODS E-mail Download E-mail E-mail

FIGURE 4 Flow diagram of scoping and survey.

TABLE 6 Scoping response rate by topic area

Topic Scoping response rate (%)

CF 40 (n= 2 of 5) Diabetes mellitus 34 (n_{= 46 of 137)} Arthritis 42 (n= 55 of 132) Dementia 38 (n_{= 35 of 93)} IDD 38 (n= 11 of 29) Public health 40 (n_{= 33 of 82)} Total 38 (n= 182 of 478)

with a median of 250. The two main funders were NIHR (29%) and charities (29%). The remaining funders were a mix of government departments, the European Union, research councils and others. Forty-two per cent of the scoping studies were clinical trials, 33% were mixed methods (qualitative and quantitative non-clinical trials), 10% were basic science and 15% were tissue bank/database.

Analysis

Variations in PPI were mapped against the type of research, topic area and funding body. Drawing on the

conceptual framework of Oliver et al.132_{and the PIRICOM systematic review,}29_{a scoping framework was}

used to assess the stages of the research at which PPI took place, whether involvement was of lay groups or individuals and where it was located on the continuum of PPI from user-led to minimal PPI. We also

assessed evidence of the‘architecture of involvement’:29_{those processes needed to enable PPI in research,}

which included a budget for PPI, defined roles for lay people, training and support, and means of communication between researchers and lay people. This was used to evidence the range of resources supporting PPI. The results from this analysis are presented in Chapter 5.